Theresa Huck v. Wyeth, Inc. D/B/A Wyeth Schwarz Pharma, Inc. and Pliva, Inc.

the institution submits “[i]f individual HUCK, Appellant, Theresa demonstrating facts

undisputed officials within the institution relevant ... alternative means considered WYETH, Wyeth; INC. Schwarz d/b/a rule as a matter of law that court could Pharma, Inc.; Pliva, Inc., duty”). Palm the institution had met its Appellees. obligation inquiry fulfilled its before er No. 12-0596. requested accommoda denying Cannon’s sighted X-rays. assistant to read tion of Supreme Court of Iowa. reasonably concluded that the Palmer has July ability personally interpret see and X- rays successfully is essential order

diagnose patients, rely and treat without

ing on the observations of an untrained Considering safety

sighted assistant. nothing there is unrea patients,

of future requirement. about this The ma

sonable

jority has not “struck a balance” between statutory rights ensuring those with “meaningful

disabilities access” to the

benefits offered educational institu “the legitimate

tions and interests” of preserving integ

those institutions in

rity programs. of their See Alexander v.

Choate, 287, 300-01, 469 U.S. 105 S.Ct. (1985).

712, 720, 88 L.Ed.2d

Rather, majority and the commission roughshod

have run legiti over Palmer’s integrity

mate interests Palm chiropractic program. Accordingly,

er’s I

respectfully dissent.

MANSFIELD, J., joins this dissent.

Terrence J. McGlynn Donahue Jr. of Mouton, & Rouge, Glisson Baton Louisi- ana, Eich, and James R. Dyke Van Van Dyke, PC, Carroll, Werden & Steger for appellant.

Henninger S. Bullock and Andrew J. LLP, Mayer York, Calica Brown New York, Mayer New and Carl J. Summers of LLP, DC, Washington, Brown appellee Pharma, Schwarz Inc. 1986). (Iowa Peck, Maichl, court of Linda Jo- N.W.2d E.

Jeffrey F. LLP, granted plaintiffs & appeals of Ulmer Berne affirmed. We seph P. Thomas Ohio, Cincinnati, Gregory M. Lederer review. application for further PLC, Craig Cedar of Lederer Weston below, explained For the reasons PLIVA, Inc. Rapids, appellee common tort plaintiffs hold state Lindsey Boney Newsom C. Kevin C. generic manufacturer Cummings Bradley Arant Boult IV of warnings inadequate based on Alabama, LLP, appellee Birmingham, preempted to the extent Wyeth, Inc. strong- implement manufacturer failed to by the in warning approved er FDA 2004. Ryan Koopmans and G. Sapp

Richard J. however, decline, long-stand- to alter We Goode, West, Hansell & Nyemaster, liability law ing products Iowa to allow Moines, P.C., O’Brien, appellees Des inju- recovery a manufacturer for against Pharma, Inc. Wyeth, Inc. and Schwarz competitor’s prod- of its ries caused use WATERMAN, Justice. thereby join overwhelming uct. the We courts, including majority every federal against action products This Reglan circuit appeals, holding court of presents pharmaceutical companies several brand are not liable to manufacturers involving interplay the between issues only the plaintiffs compet- who consumed prescription state law and federal tort ing generic Accordingly, formulation. many case is drug regulation. This one of vacate the court appeals, the decision of litigated federal nation- in state and courts judg- affirm court’s summary the district alleging pro- wide severe side effects from manufacturers, ment the brand reverse longed metoclopramide, use of sold under part summary judgment and Reglan compet- name as a brand manufacturer, generic and remand for fur- plaintiff formulation. The generic generic product. proceedings against this used ther that defendant case disorder, neurological alone. developing After generic

she sued the manufacturer of the Background I. Facts and Proceed- drug as well as the manufacturers of the ings. branded formulation. court a discussion plain- begin

The district dismissed all of of federal tiffs summary judgment drug labeling regulation provide claims in several court, rulings. relying necessary fighting The district context for the issues. PLIVA, 1984, -, Mensing, passed Inc. v. 564 Congress U.S. Hatch-Wax- -, 2567, 2580-81, Food, man Drug, 131 S.Ct. 180 L.Ed.2d Amendments to the 580, (FDCA) (2011), plaintiffs 595 ruled in order expand Cosmetics Act generic generic drugs by manufacturer were access to affordable re law preempted by requires ducing generic entry. federal barriers to market conformity Drug with the brand Competition manufacturers’ Price Patent Term warning approved labels the Food and Restoration Act of Pub.L. No. 98- (FDA). (codified Drug part Administration The district 98 Stat. 1585 relevant (1988)); summary judgment granted § court for the Mens U.S.C. also at -, Mulcahy ing, brand manufacturers based on 131 S.Ct. U.S. at Co., requires Eli which Prior Lilly proof & 180 L.Ed.2d at 588. federal compelled virtually companies manufactured or all file a supplied defendant costly new plaintiffs injury. drug application requiring that caused — approval trials —to receive FDA to ing drug product clinical because the listed is the drug. Mensing, market a [generic U.S. drug] approval.”). basis for -, 131 S.Ct. 180 L.Ed.2d at requirement that generic labeling mirrors eliminated this re Hatch-Waxman that of the brand generic ensures for a quirement generic drug applicant, manufacturers do not mislead consumers requiring applicant instead to demon by “inaccurately implying] therapeutic product’s biological strate its chemical and difference between the brand generic equivalence previously approved to a at -, drugs.” Mensing, 564 U.S. drug i.e., drug. a brand manufacturer’s S.Ct. at — L.Ed.2d at 590. Manu -,

See id. at 131 S.Ct. at 180 facturers —both brand and —are 588; L.Ed.2d see also U.S.C. required to propose stronger warning la (2006). 355(j)(2)(A) § bels to the FDA if they believe such warn at -, ings are needed.

When brand manufacturer first files a S.Ct. at 2576, 180 new drug application, ap- the FDA must L.Ed.2d at 591. prove accuracy adequacy of a The United Supreme States Court deci drug’s 355(a), label. See U.S.C. sions of Mensing parame Levine and set (b)(1), (d); Levine, 555, v. Wyeth 555 U.S. ters for when state-law failure-to-warn 566-67, 1187, 1195, 129 S.Ct. 173 L.Ed.2d preempted claims are by federal prescrip (2009). 51, 61 After the initial approval of drug labeling First, tion regulations. Le drug application, new a brand manu- vine held that federal drug regulations do may update facturer by filing its label an preempt state-law failure-to-warn application with the FDA to “add or brand manufacturers be contraindication, strengthen a warning, cause federal law allows brand manufac precaution, or adverse reaction” or to “add unilaterally turers strengthen their or strengthen an instruction dosage about 573, warnings. 555 at U.S. 129 at S.Ct. and administration that is in- intended to 1199, 173 L.Ed.2d at 65 (concluding requir crease the safe use of the drug product,” ing drug brand comply manufacturers to

but it need not wait for FDA approval. 21 with a state-law to warn would not 314.70(c)(6)(iii)(A),(C) (2006); C.F.R. see purposes objectives obstruct Levine, 567-68, also 555 U.S. at 129 S.Ct. drug federal labeling regulation). “The 1196, at 173 L.Ed.2d at equiva- 62. The Court did not significant find it that the lence of brand-name generic drugs FDA has authority reject unilateral la generic foundation of the drug approv- beling changes ... finding it ‘difficult to process, al accordingly, federal regula- accept’ the FDA would not have per “require tions that the warning labels of a mitted a change stronger to a warning.” drug brand-name and its generic copy PLIVA, Inc., 578, Fulgenzi v. 711 F.3d 582 thus, must always be the generic same— (6th Cir.2013) Levine, (quoting 555 at U.S. drug manufacturers ongoing have an fed- 570, 1197, 63). 129 at S.Ct. 173 L.Ed.2d at eral duty of ‘sameness.’” Mensing, 564 Levine, -, 2574-75, After some at courts reasoned that U.S. 131 S.Ct. at 180 589; also, generic drug e.g., L.Ed.2d at 21 manufacturers would then U.S.C. (4)(G); § 355(j)(2)(A)(v), subject also be 21 state-law failure-to-warn C.F.R. 314.94(a)(8), .127(a)(7); See, Actavis, Inc., §§ e.g., Demahy claims. v. Abbreviated (5th Cir.2010) 428, ([“Le Drug New 593 F.3d Application Regulations, 57 17950-01, 1992) Fed.Reg. (Apr. vine ] shadows our conclusion that the fed (“[T]he [generic drug’s] labeling regulatory must be eral regime governing generics drug effect.”), the same as the listed product’s label- is also preemptive without rev’d -, Id. at at -, neric manufacturers. 564 U.S. Mensing, nom. sub 2580-81, at 595. 587; 180 L.Ed.2d at Mens S.Ct. L.Ed.2d S.Ct. (8th distinguished the situation Inc., “The Court 588 F.3d Wyeth, [Levine], holding which it characterized Cir.2009) (“After ], we must view [Levine (i.e., impossibility’ possibility that ‘the defen generic mind the questioning with a denial) was not subsequent FDA possible in silently Congress argument dants’ preemption enough impossibility manufacturers of most grant tended hand, which concerned ‘the case at immunity from blanket drugs prescription (i.e., possible possibility’ possibility they market inade liability when tort state Fulgenzi, F.3d prior approval).” FDA rev’d sub nom. products.”), labeled quately Mensing, 564 U.S. at - (quoting at -, 131 S.Ct. at Mensing, 564 U.S. L.Ed.2d at at 2581 n. n. 131 S.Ct. 2573, 180 at 587. L.Ed.2d 8). acknowl Mensing Court 596 n. But, held otherwise Supreme Court that federal “the unfortunate hand edged manu involving generic a case Mensing, has dealt” those whose drug regulation metoclopramide. U.S. facturers of prescriptions their filled pharmacies -, 180 L.Ed.2d at 131 S.Ct. at metoclopramide Reglan. instead of generic majority noted the five-justice 586. The at -, 131 S.Ct. at Mensing, 564 U.S. “to allow interprets regulations its FDA 2581, 180 L.Ed.2d at 596. only when generic drug labels changes to FDA Mensing, pro- response changes manufacturer its generic labeling amend a rule to posed la updated brand-name label to match Supplemental Applications regulations. the FDA’s instructions.” bel or to follow Proposing Labeling Changes Approved at -, 180 L.Ed.2d 131 S.Ct. Products, Biological 78 Fed. Drugs and added). Otherwise, a (emphasis 2013) (proposed Nov. Reg. 67985-02 obligated copy is generic manufacturer Proposed (setting dead- Rule] [hereinafter label. approved the brand manufacturer’s comments). 13, 2014, for January line of -, See id. at S.Ct. parity” create proposed The rule “would Accordingly, L.Ed.2d at 590. Court manufacturers, generic between brand and interpretation the FDA’s of its agreed with unilaterally granting ability both the regulations “changes unilaterally labeling approval and then seek improve generic drug’s a warn strengthen made to from the FDA. Id. at 67986. label would violate the statutes and ing drug’s backdrop, la this we now turn to regulations requiring generic Against In the FDA counter the facts of this case. bel to match its brand-name -, -, drug application the new for me- approved Id. at 131 S.Ct. at part’s.” (em tablets, 2575, 2580, designed toclopramide which 180 L.Ed.2d at “[bjefore added) including tract digestive problems, to treat phasis (highlighting (acid law, reflux disease re- satisfy gastroesophageal state the Manufacturers could flux). for the approval to un This FDA allowed agency the FDA—a federal —had patented of a manufacture and distribution permitting effort them to special dertake so”). conflict, drug, was brand- formulation of the which do Due to this Court Wyeth, Inc. came to own the categorically preempts Reglan. ed held federal 19891 and Reglan approximately brand in against ge failure-to-warn claims state-law in interest to A.H. Robinson. Company, the successor 1. A.H. Robinson Inc. obtained original Reglan. Wyeth approval FDA label, rights sold the and liabilities associat- Administration” sections of the later Pharma, Reglan indicated, to Schwarz Inc. in “Therapy ed with new language should In the Re- December 2001.2 addition to not exceed 12 weeks in duration.” While by Wyeth tablets marketed glan language appeared this on the label for referred to collective- Schwarz [hereinafter Reglan, published Physi- it was not in the defendants], ly the brand Although required cians’ Desk Reference. was manufactured formulation of regulations federal to mirror the brand PLIVA, Inc. and distributed label, update defendant’s PLIVA did not metoclopramide packaging its to include February phy- Theresa Huck’s warning new approved in 2004. The Reglan to treat her re- prescribed sician why record is silent toas PLIVA failed to physician upon flux. Her relied informa- warning. add that Neither the published by the brand de- tion brand defendants Reference, fendants nor PLIVA Physician’s Desk which communicated the FDA-approved labeling contained the for new label information to Huck or her phy- drug. pharmacy pre- Huck’s filled this sician. Huck testified she never would scription generic. with the PLIVA have taken metoclopramide had she been possible warned its side effects included at the time FDA-approved labeling neurological disorder. began taking metoclopramide Huck stated “Therapy than 12 longer weeks has not Taking average of 2.7 pills per day, been evaluated and cannot be recom- Huck continued to refill her gener- PLIVA mended.” The label also contained a ic prescription until March Though effects, warning about possible side includ- Huck had experiencing been symptoms of dyskinesia. dyskinesia tardive Tardive time, dyskinesia tardive for some she was severe, often neurological irreversible diagnosed with the disease until June resulting involuntary disorder and un- 6, 2006. body controllable repetitive movements of growing Based on pro- evidence that slow or Symptoms belated onset. include longed metoclopramide use of tar- causes “grotesque grimacing open- facial dyskinesia, 26, 2009, February dive on mouthed, uncontrollable tongue move- imposed FDA heightened warnings for the ments, tongue thrusting, tongue [and] drug’s packaging. required The FDA chewing.” Pelstring, Fisher following warning strong- black-box —its (D.S.C.2011). F.Supp.2d There is metoclopramide: est—for no known treatment or cure for tardive dyskinesia. FDA-approved warning metoclopram- The Chronic treatment with dyskinesia dyskinesia, stated that tardive ide can cause tardive expect- was a ser- every ed to occur in one in five ious movement hundred disorder that is often patients. developing irreversible. The risk of dyskinesia tardive increases with the July approximately In five months duration of treatment and total cu- after Huck began taking metoclopramide, * * * mulative dose. FDA approved additional label warn- ing language requested by Schwarz. There is no known treatment for tar- however, dyskinesia; Printed bold on the first line of pa- both the dive in some Usage” “Dosage “Indications and and symptoms may and tients lessen or resolve again 2. Schwarz then manufactured and was sold. distributed Reglan February until when the brand response, by PLIVA. In factured treatment is metoclopramide after * * * summary moved defendants brand stopped. On filed no resistance. Huck judgment. than (greater Prolonged treatment 2, 2009, granted the district court March be weeks) should metoclopramide motion unresisted the brand defendants’ ther- rare cases where in all but avoided all claims. summary judgment on outweigh thought benefit apeutic undisputed that it was court noted district developing patient to the the risks not manufac- defendants “did the brand dyskinesia. tardive metoclopramide ture or sell against filed suit Huck May On and, Mulcahy, citing by ingested [Huck]” PLIVA, defendants, several the brand the brand against Huck’s claims concluded in the involved longer no defendants other as a matter of therefore failed defendants distinguish did not petition Her case.3 for recon- not file a motion law. Huck did PLIVA, the brand defendants between the rul- immediately appeal sideration or collectively as referring to them instead ing. total, “manufacturing defendants.” years, and one-half For the next two against these thirteen claims pled Huck PLIVA, her claims pursued Huck (1) prod- manufacturing defendants: strict defendant. On Febru- only remaining (2) manu- liability for a liability, strict ucts 26, 2010, PLIVA filed two motions ary (3) defect, liability for a strict facturing arguing genu- one no summary judgment, (4) defect, express war- breach of design existed and the ine of material fact issues (5) implied warranties ranty, breach were arguing Huck’s other (6) (based negli- warnings), inadequate on April law. On preempted federal (7) (based warnings), inadequate gence mo- ruled on PLIVA’s the district court (8) breach of misrepresentation, negligent First, rejected the district court tions. (9) fraud special duty, undertaking The dis- preemption argument. PLIVA’s (10) fraud, constructive misrepresentation, dispute ruled that a factual trict court also (12) (11) concealment, violation fraud would to whether Huck relating existed Act, Practices the Iowa Trade Unfair had she ingested metoclopramide infliction of emotional dis- intentional (or, intermediary if the learned received tress. received4 applied, physician her doctrine ) Product Identifi- court warning. Huck filed a “Notice of The district adequate claims,5 in- then several of Huck’s admitting on October 6 she dismissed cation” law claims for breach metoclopramide but her common gested only generic manu- following 5.The district court dismissed petition also named as defendants 3. Huck's warn, Physicians physicians, liability Trimark two of her strict for failure claims: (PLIVA's par- defect, defect, Group, and Barr Laboratories design design liability for strict granted company). defect, The district court ent manufacturing strict summary judgment Barr Laborato- in favor of implied express warranty, of breach of breach company Huck failed to serve the ries after warranty (excluding implied of war- breach physicians original Huck’s notice. (to merchantability), extent ranty fraud Group granted Physicians were later Trimark nondisclosure), they on breach are not based summary judgment based on Huck's failure undertaking special duty, Unfair timely expert designations. Huck did not file Act, intentional infliction Trade Practice summary judgments par- appeal for those appeal the Huck does not emotional distress. ties. dismissal of those claims. intermediary is not at 4. learned doctrine The appeal. in this issue implied warranty merchantability, the rule in Iowa ‘that a Plaintiff in a (based warn), on failure to

negligence neg- products liability action bears the burden fraud and ligent misrepresentation, mis- proving the Defendant manufactured or fraud, representation, constructive and supplied that the inju- caused by concealment were allowed to pro- fraud Co., ry.’ Mulcahy v. Lilly Eli & February ceed. Trial was set for (Iowa 1986).” The court further argument concluded Huck’s based 14, 2010, On December moved to PLIVA on Mensing was meritless and denied the stay all deadlines and continue the trial motion for relief as to the brand defen- based on the States Supreme United granted dants. district court PLIVA grant in Mensing, Court’s of certiorari summary judgment grounds on of federal which involving consolidated two lawsuits preemption. conflict against generic state tort-law claims meto- clopramide manufacturers. 564 U.S. at Huck appealed both the district court’s -, 2572-73, 131 S.Ct. at 180 L.Ed.2d at grant summary judgment in favor of granted 586-87. The district court PLIVA and its denial of her motion for stay, acknowledging that two of the cases relief the brand defendants. We it had relied on its denial of PLIVA’s transferred the case to the court of ap- preemption motion were at issue peals, which affirmed the district court’s at -, Mensing appeal. See id. 131 S.Ct. rulings. The court appeals held Huck’s 2573, 180 L.Ed.2d at 587. claims against PLIVA “attack the adequa- After Mensing held federal preemption cy labeling” and therefore are precluded claims, plaintiffs’ failure-to-warn preempted because they within “fall[ ] at -, 2580-81, see id. 131 S.Ct. at 180 Mensing’s sphere.” The court of appeals again L.Ed.2d at PLIVA moved to specifically rejected argument Huck’s that dismiss Huck’s claims based on federal PLIVA can be failing held liable for preemption. Additionally, September update its label provide the additional 26, 2011, Huck filed a “Motion for Relief’ warning bolded approved in reason- summary from the 2009 judgment dismiss prohibits federal law private attempts ing the brand defendants. Huck invoked generic to enforce a manufacturer’s obli- the district power court’s “inherent to cor gation to match the brand manufacturer’s interlocutory rect argued errors” defendants, label. As to the brand Mensing’s holding manufac appeals court of noted Huck failed to resist turers do not have the ability to unilater their motion for summary judgment, file a ally strengthen drug necessarily labels motion, postjudgment immediately ap- responsibility shifted for generic manufac peal summary judgment. Consequent- labeling turers’ insufficient to brand man ly, the court of appeals the only concluded ufacturers, who are able to unilaterally preserved relating issue summary strengthen labels. Asserting Mensing judgment ruling explicitly is the issue de- prior precedent, decision overturned Huck by the district court: whether the cided asked the court to reinstate her claims brand defendants owed Huck under against the brand defendants. Iowa law when she ingest prod- did not a 9, 2012, January On the district court uct manufactured or sold them. The ruled on pending motions. Regarding appeals court of Mensing held did not relief, Huck’s motion for the district court alter state-law principles requiring the dis- highlighted that it granted the brand de- brought against missal of claim a defen- summary fendants’ judgment upon “based product plaintiff dant whose never used. the district summary] judgment, allowing fur- for application Huck’s granted We deficiency.”). to consider the claim of court review. ther Analysis. III. of Review. II. Standard Any Huck’s Claims A. Whether rulings grant that review We Mensing. Against We PLIVA Survive er correction of summary judgment for court cor- must decide whether the district Inc., Jumpking, rors at law. Parish v. claims ruled that all of Huck’s rectly 2006). (Iowa Summary N.W.2d preempted Mens- against PLIVA when there is no appropriate is judgment court Applying Mensing, the district ing. the mov fact and issue material genuine PLIVA are ruled Huck’s claims judgment as a ing party is entitled impossible because it was preempted 1.981(3). P. matter of law. Iowa R. Civ. The court of to alter its label. PLIVA if it will affect the “A fact is material agreed. argues Mensing appeals Huck suit, applicable given of the outcome only require ge- preempts Parish, 719 N.W.2d at 543. “An law.” labeling vary manufacturer its neric ‘genuine’ is if the evidence issue of fact drug. points of the She from that branded fact that a reasonable finder of could such its label update out that PLIVA failed to for the non- return a verdict or decision FDA-approved warning include the 2004 to view the evidence moving party.” Id. We “Therapy not exceed stating, should most to the nonmov- light in the favorable Mensing in duration.” did not weeks ing party. Summary judgment Id. preempted. whether that claim is decide moving properly granted party when the Appeals for the Sixth Circuit Court no nonmoving party “the has evi shows however, recently adjudicated Fulgenzi, support dence to a determinative element very Mensing issue and held squarely this party’s claim.” Id. ge- preempt does not claims based on update its neric manufacturer’s failure actually review the issues We FDA warning language label with the ruling granting decided unresisted in 2004. 711 F.3d at approved Fulgenzi, summary judgment when the motion observed, the Sixth “not 584. As Circuit nonmoving party mo postjudgment filed up- independently could PLIVA have gave oppor tion that court the district labeling warning dated its to match [the error. tunity alleged to correct the See 2004], it to do added had a federal Cooksey Cargill Corp., Solutions Meat (citation omitted). find Ful- so.” (Iowa 2013); 831 N.W.2d 98-99 id. at persuasive Huck’s claims genzi and hold (Mansfield, J., dissenting); Otterberg they are preemption survive to the extent Co., v. Farm Bureau Mut. Ins. adopt PLIVA’s based on failure (Iowa 2005) (noting warning approved by language additional moving summary judgment party FDA in 2004. “to court the burden show the district that. genuine preemption there was no issue of material fact The federal doctrine that it was from the judgment Supremacy entitled to a a derives Clause law”); matter of Constitution. See Ackerman v. Bill Grunder’s Sons Federal Constr., Ganzer, Co., Cyanamid Inc. v. Am. 586 N.W.2d (Iowa 1998). 2004) (“[T]he (Iowa of con nonmovant Under the doctrine preserve by filing preemption, must at least error flict state federal “[when] conflict, give following directly state law must entry motion unresisted [the -, way.” Mensing, 564 at labeling U.S. federal duties” or if state law (internal 5.Ct. at 180 L.Ed.2d at 592 “would the purposes objec obstruct omitted). But, quotation is “[t]here marks drug labeling regulation.” tives federal presumption against preemption which Levine, 568, 573, See U.S. 129 S.Ct. preemp counsels a narrow construction of 1196, 1199, 173 L.Ed.2d Ackerman, provisions.” tion 586 N.W.2d willWe first evaluate her claims to de- at 213. must evaluate each of Huck’s they termine if impossible make it surviving implied claims6 —breach comply PLIVA both state and fed- warranty merchantability, negligence Next, eral law. we will decide if her (based warn), on failure to negligent mis pose an obstacle to the purposes representation, fraud and misrepresenta objectives of Congress. Finally, tion, fraud, by constructive and fraud con will consider PLIVA’s argument if that impossible cealment —“to determine it is Huck’s claims violate a comply prohib- PLIVA to with both the state- federal law law duties underlying iting private those claims and its enforcement of the FDCA.7 argues preserved only 6. PLIVA likely prevented Huck error injury most have in this breach-of-implied- to her failure-to-warn and case. warranty . sufficiently plausible claims. When .. [I]t PLIVA moved for is that the summary judgment warning disavowing use of a neutral Mensing, ap- in the wake of proval instead of warning a bold-faced argued Huck resisted this motion and affir- her matively 5, 2012, discouraging long-term proxi- use January claims were still viable. On mately [plaintiff’s] injury. caused Whether the district court dismissed all of re- Huck’s allegations in fact these are true a matter maining preempted Mensing. claims as proceedings. for further reconsideration, her motion for Huck men- agree Fulgenzi Id. We with the court’s reason- only tioned her failure-to-warn claims and ing. breach-of-implied-warranty Never- claims. stated, appeals The court of also "Huck has theless, preserved we consider error as to the argued updated] warnings— these [2004 additional claims because Huck resisted sum- providing argued faulty what she informa- mary judgment argues those claims on prevented tion—would have the harm she suf- appeal. fered." We do not find Huck has conceded that contrary, successfully issue. To the Huck argues 7. PLIVA that Huck cannot base her summary judg- resisted PLIVA’s motion for failure-to-wam claim up- on the 2004 label ment, argued in which PLIVA Huck was un- date because she has asserted the label was prove able to physician that if she or her "had inadequate language. even with the additional adequate warning, received an she would not appeals agreed, concluding, The court of ingested drug." The district court provide "Iowa law does not a cause of action motion, finding denied PLIVA's that based on failing allegedly inadequate to disseminate provided precluded record fact issues warnings.” This mischaracterizes the issue. summary judgment. Clinkscales v. Nelson Cf. argument This thing "títere is no such —that Sec., Inc., (Iowa 2005) 697 N.W.2d inadequately as a 'failure to warn' "—was re- (”[W]e reiterate the well-settled maxim that jected by Fulgenzi, the Sixth Circuit. questions negligence proximate cause F.3d at 587-88. As that court observed: ordinarily jury only exception- for the in— It prove proxi- well be more difficult to they al cases should be decided as a matter of warning law.”); Wil-Rich, mate causation in a case where the Lovick v. (Iowa provide 1999) that the defendant failed to was (affirming denial of directed claim; legally inadequate. also But there is no verdict on noting failure-to-warn severely reason to believe inadequate "proximate that a cause can be established show- warning injury would never cause an warning that a plain- would have altered the moderately inadequate warning would have injury”); tiff's conduct so as to avoid see also prevented. plaintiff (Third) prove A need not Restatement of Torts: Prods. Liab. i, warning (1998) ("Whether alternative would have been 2 cmt. illus. reasonable, objectively warning actually given it would was reasonable 364 have ap that the FDA would not dence Impossibility preemption.

1. label, change to proved [defendant’s] negligence claim Huck’s consider firstWe impossible for not conclude that it was will warn. Huck failure to PLIVA’s based on both federal comply to with [defendant] claim is failure-to-warn her concedes Accordingly, requirements.”). it and state PLI- required it to the extent preempted update PLIVA to impossible not was than that of a label different adopt toVA label and send informational letters its label, argues but she brand approved updated language, with the consistent negligence claim common law her can base and con warning professionals healthcare language adopt to failure PLIVA’s on therapy that metoclopramide sumers warning against 2004 use approved To the not exceed twelve weeks. should than twelve longer metoclopramide contrary, PLIVA a federal to had agree. We weeks. to 21 Wyeth’s. match its label See U.S.C. present of this case narrow The facts 331(a) § introduction into (prohibiting the Once Mensing preemption. around path drug that is any interstate commerce mis- ap language was warning additional 314.94(a)(8)(iii)(re branded); § 21 C.F.R. 2004, July PLIVA by the FDA in proved match label quiring applicant go “changes through needed 314.150(b)(10) § 21 drug); brand C.F.R. revise its label being process effected” FDA (providing ap withdraw label. updated to match the brand-name generic’s if the label “is no proval longer at -, Mensing, 564 131 S.Ct. See U.S. consistent brand- [the 2575, (citing at 180 L.Ed.2d at 589-90 name]”); Fulgenzi, 711 F.3d at also interpretation 21 C.F.R. FDA’s (“[Compliance with federal and state 584 314.94(a)(8)(iv)). process This allows just not it was possible; duties was re their label -with update manufacturers conclude quired.”). We therefore Huck’s waiting approval. out for FDA at negligent claim state-law failure-to-warn -, 2575, L.Ed.2d 131 S.Ct. labeling regula preempted federal Though rejected the FDA 589. could to the tions extent it is based PLIVA’s fact, request such a PLIVA’s after adopt warning lan failure the additional unlikely. would have been rejection approved growing A num guage 2004. Cf. Levine, 571, 1198, 555 U.S. at 129 S.Ct. at of courts the same conc ber have reached (“[A]bsent 173 L.Ed.2d at 64 clear evi lusion.8 3929059, 29, (E.D.Mo. 2013); July the circumstances is decided the trier WL to be *9 fact.”); Prempro Inc., 1055, re Prods. Liab. Wyeth, F.Supp.2d Phelps v. cf. 547, (8th Cir.2009) Litig., 586 F.3d (D.Or.2013); Teva Johnson v. Pharm. (" majority jurisdictions vast hold ‘[[T]]he USA, Inc., 404, No. 2:10 CV 2012 WL warning inadequate, plain- that where (W.D.La. 2012); 1866839, 21,May at *3 Coo presumption tiff is entitled to rebuttable Inc., 09-929-JJB, Wyeth, per v. 2012 WL No. adequate warning would have been heeded 733846, (M.D.La. 6, 2012); Lyman at *4 Mar. " given.’ (quoting had been Thom if one v. Inc., 2:09-cv-262, Pfizer, v. No. WL 848, Co., Squibb Bristol-Myers 353 F.3d 3, 2012); (D.Vt. at *5-6 Feb. Couick (10th Cir.2003))). today only decide Inc., 3:09-cv-210-RJC-DSC, Wyeth, v. No. preemption issue to Huck’s claims (W.D.N.C. WL Jan. at *5 proceedings PLIVA and leave for further is- Inc., 2012); PLIVA, B:11-113, Del Valle No. concerning adequacy sues warnings PLIVA's (S.D.Tex. Dec. 2011 WL at *5 warning updated whether an Fisher, 805; 2011); F.Supp.2d at In re physi- 2004 would have reached Huck or her Reglan Litig., WL cians and altered her behavior. No. 4, 2012); (N.J.Super.Ct. May Law Div. Has Neeley These courts v. WoltersKlu include: Health, Inc., JAR, 2013 wer No. 4:11-CV-325

365 claims, remaining Huck’s Moving problems product, its that it gener note at the outset “there is no learned about through adequate testing, al, pre inherent conflict between federal by altering product’s label rather require emption warning state [sic] than changing product, any then vitality ments and the continued of state challenge concerning negligent testing is damages Cipollone common-law actions.” preempted. Inc., 504, 518, 112 Liggett Grp.,

v. 505 U.S. Co., Wright Cyanamid v. Am. 2608, 2618, 407, S.Ct. 120 L.Ed.2d 424 (Iowa 1999). 668, 673 (1992). any “Of course challenge direct drug regulation Federal adds a wrinkle adequacy warning of a label or application to the generic this rule: Ackerman, preempted.” 586 N.W.2d at are prohibited manufacturers But, alter- also examine “[w]e whether a ing the composition of a drug because merely claim is another way alleging they must mirror the formulation of the label or warning inadequate. was Such an See, brand-manufacturer drug. e.g., challenge preempted.” indirect is also § 355(j)(2)(A) U.S.C. (requiring bioequiva- against If Huck’s claims PLIVA do not lence); (iii) § 355(j)(2)(A)(ii), id. (requiring require company to change labeling its generic drug to have the same “active in- label, to differ from approved that of the gredients,” administration,” “route of (“[OJur they are not preempted. See id. form,” “dosage and “strength” as its identify task whether [plain remains brand-name counterpart); id. predicated upon labeling claims are tiffs] § 355(j)(8)(B) (requiring the same “rate packaging requirements addition to Moreover, and extent of absorption”). required by different from those [fed both law].”). generic and brand manufacturers are eral prohibited from making major changes to argues Huck her for negligent “qualitative quantitative or formulation testing postmarket surveillance thus drug product, including active in- But, preempted. “merely are not to call gredients, or in the specifications provided something design testing or claim does in the approved application” after their automatically avoid preemption [the] approved. C.F.R. clause.” Id. at 214. The line between a 314.70(b)(2)®. claim for mislabeling negli- and a claim for gent testing is “razor thin.” See id. In light of these regulations, negli- way

[T]he rule is that a claim based on negli PLIVA avoid gent inadequate or testing will not be gent testing would be to withdraw from disguised considered a label-based chal- the market. This issue is addressed lenge adequate if testing Bartlett, would have Mutual Pharmaceutical Co. v. U.S. -, - 133 caused manufacturer to alter the 2466, 2477, S.Ct. (2013). itself. Conversely, the rule is 186 L.Ed.2d 622-23 In Bart lett, if defendant remedy any could Supreme rejected “stop Court (Pa.Su Dafoe, sett v. 74 A.3d recently the Fourth Circuit affirmed a sum USA, per.Ct.2013); see also Teva Pharm. Inc. mary judgment dismissing all claims Ct., Super. v. Cal.App.4th 158 Cal. Mensing's impossibility PLIVA based on Rptr.3d (relying Fulgenzi preemption, expressly conflict noting while to hold preempted failure-to-warn claim not update theory timely the 2004 was not made when manufacturers of alendronate USA,Inc., Drager in that case. PLIVA sodium did not mirror the branded Fosamax (4th Cir.2014). F.3d label). contrast, Appeals the Court of used”); metoclopramide option “if the of which was because selling” argument Ltd., impossi Grp. defeated a claim v. Brooke ceasing Wright to act also 2002) (Iowa would pre-emption (citing [sic] bility, impossibility ” -, 133 (Third) Id. meaningless.’ be ‘all but of Torts: Prods. Restatement at 2477-78, (quot at 622 2(b)-(c), (1998), 186 L.Ed.2d at at authority § S.Ct. as Liab. at -, 131 S.Ct. at Mensing, 564 U.S. ing warranty of implied to allow breach the 594) “[j]ust 2579, 180 (noting as L.Ed.2d at merchantability inadequate on claim based actor regulated that could prospect the Ackerman, 586 N.W.2d warnings); at cf. both state and federal liability under avoid (dismissing claim of breach of im- 213-14 market did not simply leaving the by law warranty merchantability based plied on analysis in impossibility the undermine preemption). federal ], analy it is irrelevant to our [Mensing so Finally, Huck the dismissal of appeals here”). But, her failure-to- as with sis fraud, misrepresenta- alleging her claims claim, negligent- we conclude Huck’s warn tion, fraud, constructive and fraud con- postmarket-surveillance and claims testing recognizes Our cealment. common to the extent claims preemption avoid prod- against fraud claims consumer adopt on PLIVA’s failure to are based manufacturer “made misleading uct who change. Wright, 2004 label Cf. intended to statements fact influence (concluding negligent-test at 675 consumers” or true statements of “made was disguised claim “a label-based designed fact to influence consumers and law). by federal preempted claim” acquire[d] subsequently information ren- argues Huck next her claim of breach of prior untrue or dering statements mis- warranty merchantability implied Ltd., leading.” Grp. Brooke 652 N.W.2d at warning escapes on Mensing based defects & n. 4 (declining to decide whether (1) metoclopramide preemption because preempted). such claims were We con- the ordinary purposes was unfit “for her misrepresentation clude fraud and goods namely, which such are used”— escape preemption to the extent (2) therapy; not prolonged did in- PLIVA they are based on the additional 2004 limiting clude the revised 2004 label warning language adopt. failed to PLIVA weeks; duration of use to and twelve Pmposes objectives analysis. and to metoclopramide did not conform Next, we must state consider whether tort appear statements of fact that on its label. against generic suits manufacturers 554.2314(c), (e), would (f) See Iowa Code (2005). purposes objectives frustrate the more, agree Once this claim thus Congress, warranting preemption.9 if may proceed ground she it on is able Levine, against held Court suits failure the 2004 adopt PLIVA’s addi- Fisher, Reglan manufacturers would not approved tional obstruct warning. See purposes objectives federal F.Supp.2d (denying PLIVA’s motion labeling regulation. summary judgment implied warran- 555 U.S. “the at 65. ty merchantability because Court 129 S.Ct. 173 L.Ed.2d long- respect find as a reach the same does not matter of law that conclusion ordinary purpose against term use was not for Huck’s claims PLIVA. argued objectives prong preemption Mensing

9. Because of the conflict defendants impossible at -, that it was for a manufac analysis. 564 U.S. 131 S.Ct. at strengthen unilaterally turer to its label with J., (Sotomayor, 180 L.Ed.2d dis law, running Mensing out afoul of federal senting). opinion purposes did not consider the recognized Congress Levine has not ward generic-drug manufacturers remedy opposed manufacturers], a federal for consumers provided [as brand and, by prescription drugs argument goes, harmed would increase costs and additional, such, Yet, law offers an reduce usage.” Fulgenzi “state important, layer protection of consumer hypothetical court held this difference does regulation.” justify FDA Id. at complements preemption. Id. Citing the 574, 579, 1200, 1202, 129 S.Ct. at 173 Mensing dissenters’ observation that “the that, (noting additionally inability L.Ed.2d at inadequate sue for warnings thought demand,” Congress may actually state-law suits “[i]f reduce consumer posed objectives, to its Fulgenzi obstacle it sure- empirical reasoned is an “[t]his ly would have enacted an express pre- question, affirmatively should not emption provision at point some dur- answer on the speculation [sic] basis of mere 70-year history”); Congressional FDCA’s about purposes.” 711 F.3d LLC, Agrosciences also v. Bates Dow 544 at 585. The court concluded: 431, 451, 1788, 1802, 125 U.S. S.Ct. 161 It is hard to see permitting how state (2005)(“Private 687, L.Ed.2d 707 remedies go tort suits to against forward same- misbranding that enforce federal require- ness-violating generic defendants frus- aid, ments would seem to rather than hin- policies trates federal where permitting der, law].”). functioning of [federal against suits compliant branded FDA — reasoning Levine Court’s on this issue vague policy defendants does not. A applies against to state tort claims both encouraging use of generic drugs, un- generic and brand manufacturers: Act, tethered from the structure of the

State tort drug suits uncover unknown not enough support purposes-and- provide hazards and objectives incentives for preemption. safety manufacturers to disclose risks (citation omitted). at 586 agree We promptly. They also serve a distinct analysis with this and hold Huck’s claims compensatory function that moti- survive impossibility preemption. injured vate persons to come forward right Private action. PLI- with information. Failure-to-warn ac- argues VA Huck’s merely claims are at tions, particular, lend force to the FDCA, tempts to enforce the which 21 manufacturers, premise FDCA’s 337(a) § U.S.C. disallows. The court of FDA, not the bear primary responsibili- appeals agreed. and district court That ty drug labeling for their at all times. section states: such proceedings “[A]ll 579, 1202,

555 at U.S. 129 S.Ct. at 173 enforcement, violations, or to restrain L.Ed.2d at 68-69. chapter of this shall be and in the name 337(a). The Sixth Circuit’s decision in § of the United States.” 21 U.S.C. Fulgenzi reinforces our conclusion that provision private This ensures suits do not Huck’s claims PLIVA do not frus “deprive ability [FDA] to use its congressional trate goals. Fulgenzi, authority enforcement achieve delicate the court considered the differences be statutory objectives.” balance of Fulgen manufacturers, zi, 377(a) generic tween brand 711 F.3d at 586. PLIVA reads singling “promotion out “private litigants to mean are barred from drugs, and the in asserting attendant reduction claims involving violations of the costs” as easily “[t]he most identifiable implementing regula FDCA FDA’s policy” of the FDCA. F.3d at 585. tions.” disagree and instead conclude “Permitting go state tort actions to for- Huck’s claims—as limited our decision to, allel,’ require rather than add federal traditional state tort on today based —are Lohr, 495, ments.”); 116 S.Ct. re 518 U.S. at federal supplement principles 2255, (“Nothing at at L.Ed.2d

quirements. right denies Florida [the statute] with a presents case us This remedy for damages a traditional provide ‘federalism con implicating “situation[ ] when common-law duties violations of primacy of state and the historic cerns require parallel those federal duties health of matters of and safe regulation ments.”). solely “But if the claims ‘exist ” by a ty,’ governed presump a situation scheme, they regulatory by virtue of the Buckman against preemption. tion Co. Fulgenzi, 711 F.3d preempted.” Comm., Legal U.S. Plaintiffs’ Buckman, (quoting 531 U.S. 1012, 1017, 148 L.Ed.2d 121 S.Ct. 1020, L.Ed.2d S.Ct. Medtronic, Lohr, (2001) (quoting Inc. v. FDA” claim (finding “fraud 2240, 2250,135 485, 116 S.Ct. 518 U.S. ... “the existence of preempted because (1996)). L.Ed.2d [a] “Where is a element” of federal enactments critical claim is on traditional state-tort-law based case)). plaintiffs private of a cause of principles, the lack al- attempt does to petition Huck’s not regulatory action within a federal scheme private a cause of lege prohibited federal damages preempt will not the claim for Rather, alleg- action the FDCA. she under (even regulations might if be state warranty es state common tort and 586; preempted).” Fulgenzi, 711 F.3d at regardless whether theories that exist of 464 Corp., accord Silkwood v. Kerr-McGee duty a required FDCA of sameness. 238, 625, 615, 104 S.Ct. U.S. Indeed, try could claims without Huck her (1984) (“[T]raditional L.Ed.2d Fulgenzi, reference to FDCA. ... tort law with Cf. principles apply state (noting logic F.3d “the of Buckman they expressly sup full force unless [are] encourage would exclusion of evidence Likewise, independent planted.”). state possible”). federal-law violations where parallels law cause of action federal a Fundamentally, with variations on requirements Riegel v. permissible. See theme, asserts: she Medtronic, Inc., 312, 330, U.S. (1) duty a her that had to warn PLIVA 999, 1011, S.Ct. 169 L.Ed.2d metoclopramide she should not take (“[The (2008) preemption express provision longer than twelve weeks.10 in the Medical Device to the Amendments (2) duty. breached PLIVA this prevent not a FDCA] does State (3) remedy long- providing damages metoclopramide for claims Huck took premised regula on a violation of FDA er than twelve weeks she was because tions; the not ‘par state duties such a case instructed otherwise. case, duty per

10. This is from the references federal law will distinct label same- se to imposed by prem- law. If ness federal Huck inevitably Mensing preemp- To arise. avoid sameness, duty her upon ised claim it tion, [plaintiff] language use must preempted attempt would be as an enforce proximate- FDA-approved in her label Fulgenzi, federal law. See F.3d at 588- (or merely) argument, not the fact cause not Yet, expect try Huck her we do update. standards the failure Federal case without reference to fact that the determining likely to arise in also approved warning against prolonged FDA warning, FDA adequacy of PLIVA’s since agree Fulgenzi use in 2004. We industry practices may approval be rel- court: duty of evant to the state care. Although violations here are not federal-law they negligence as relevant as would be damages as a result application Huck suffered find district court’s Mulcahy is metoclopramide for more correct.” ingesting than twelve weeks. Mulcahy applied require- a well-settled plaintiff ment of Iowa law—the prove must duty the federal of sameness nor Neither injury by product caused supplied sold or FDA duty report safety risks to the by the defendant. 386 N.W.2d at 76. This are “critical of her state law element[s]” long-standing requirement bars Huck’s re- Buckman, claims.11 See 531 U.S. at covery from the manufacturers aof brand 121 S.Ct. at 148 L.Ed.2d at 864. law, she never used.12 Under Iowa manu- way Federal law has limited the in which facturers owe duties to those harmed she can frame her claim: she cannot raise products. use of their We decline to a claim based on re- labeling that would change Iowa law impose a new quire unilaterally strengthen PLIVA to its manufacturers to those who never used managed label. She has to avoid that products their and were instead harmed difficulty because PLIVA did not include competitor’s product. use of a 2004 approved language. the additional responded FDA has to Mensing through a sum, Huck’s claims fit into a “narrow gap”: proposed rule to generic allow manufactur- suing she is for conduct that violates the update own, ers to their labeling on their FDCA, suing but she is not because the regardless of the brand manufacturer la- conduct violates the FDCA. See In re beling. Rule, Proposed See 78 Fed.Reg. at Medtronic, Inc., (8th 623 F.3d 67985. The change rule would vitiate the Cir.2010) (internal quotation marks omit- preemption defense of manufactur- ted). appropriate way ers. This is the to ad- dress the unfairness resulting from Mens- B. The Brand Defendants. We next ing, rather turning than Iowa tort address whether the district court correct- upside down. ly summary judgment entered dismissing against

Huck’s claims the brand defen- argues Huck we should reinstate her undisputed dants based on the fact that against claims the brand defendants be- only Huck consumed generic formula- cause was required PLIVA to use the tion by sold PLIVA —their competitor— warnings same that accompanied Reglan. Reglan. and never used The district court overwhelming An majority of courts ad- granted the brand defendants’ unresisted judicating this issue have judg- affirmed motion for summary judgment, applying granted ments or dispositive motions our in Mulcahy. decision The court of dismissing claims against the brand de- affirmed, appeals stating, “To the minimal plaintiff fendants when the only used argues Mulcahy See, extent Huck is either dis- e.g., formulation. In re tinguishable Darvocet, or not applicable, disagree Darvon Propoxyphene contrast, "[fjailure update from one correctly summary the district court entered adequate warning to another would violate judgment Mulcahy. in their favor based on FDCA, Fulgenzi, but not law.” [state] gave Huck opportunity the district court the F.3d at 586-87. light Mensing to revisit the issue in when judgment. she filed her motion for relief from preservation-of-error permit 12. Our rules us Ganzer, (requiring See 686 N.W.2d at 197-98 actually to review issues the district court postjudgment preserve motion to error for granting decided when an unresisted motion appellate summary judg- review of unresisted summary judgment. Otterberg, for ment). Accordingly, N.W.2d at we conclude error is 27-28. The brand defendants agree preserved preserved. error is to review whether about 917, statements 937- brand manufacturer’s 756 F.3d Litig., Liab. Prods. (6th 2959271, 40, *17-18 Cir. own as a basis its 2014 WL 2014) 27, (affirming dismissal caused manufactur- injuries by other June defendants when brand production over whose products, ers’ generic painkill- consumed no con- plaintiffs manufacturer had name brand twenty-two er; states applying laws trol.”). As the Sixth Court Circuit action with litigation in a multidistrict summarized, every “almost Appeals lawsuits); Wyeth, v. Moretti sixty-eight ... that a brand court has reasoned] — -, -, Inc., Fed.Appx. duty to a does not owe a manufacturer (9th 17, 2726886, at Cir. June *1 WL actually consumer unless the consumer 2014) (affirming summary judgment product.” used the brand manufacturer’s law); Nevada based on brand defendants Darvocet, 2014 WL F.3d Inc., 750 F.3d Lashley Pfizer, v. *4 E. (citing Victor (5th Cir.2014) (affirming sum- 476-78 Schwartz, al., Warning: Shifting et. Li- defendants mary judgments for brand Brand- ability to Manufacturers only generic plaintiffs ingested because Medicines the Harm Was Name When Wyeth Strayhom v. metoclopramide); Has Allegedly by Drugs Caused Generic (6th Inc., Pharm., 737 F.3d L.Rev. Effects, Fordham Severe Side Cir.2013) (noting “every federal court of 1857-58 [hereinafter appeals to consider this issue held Schwartz], following catalogs which cases are not that brand-name manufacturers trend). majority plaintiffs injured liable who for the Tenth Appeals Court drug”); generic manufacturer’s Schrock recently three principal discussed Circuit Inc., F.3d Wyeth, v. courts, concluding used by rationales Cir.2013) (10th (stating “the courts of not liable “brand-name manufacturers are overwhelmingly reject- states have other generic drugs”: to consumers very theory ed the advanced First, they based view on tradition- their Schrocks”); LLC, Wyeth, Guarino principles al common law under tort (11th Cir.2013) (“[T]he 1245, 1252 F.3d inju- which a manufacturer is liable for overwhelming national consensus—includ- See, by product. ries caused its own ... majority of district vast (hold- 604, e.g., Mensing, 588 F.3d country courts around the to consider ing name brand manufacturers liable for man- question that a brand-name —is by harm caused manufacturers generic injuries ufacturer cannot be liable for foreseeability the concept “stretches by generic of the ingestion caused omit- (quotation too far” and alteration product.”); Pfizer, of a Bell v. form ted)). Second, reason that brand- they (8th Inc., 1087, F.3d 1092-94 Cir. warnings rep- name 2013) manufacturers’ (affirming summary judgment for do a basis for resentations not create brand defendants because Bell never “ liability competitors’ consumers Reglan noting used over- ‘[a]n products because manufac- brand-name whelming majority considering of courts issue,’ turers to communicate Circuit, “intend[ ] Eighth this including customers, customers with their not the liability” rejected theory have Bell’s 9;n. competitors.” their Id. at 613 613)); (quoting Mensing, F.3d at Inc., Wyeth, Corp., Stanley v. Am. see also Foster Home Prods. (“A (4th Cir.1994) (“There 31, 165, manu- (La.Ct.App.2008) So.2d F.3d reasonably expect cannot that legal precedent using no for a name facturer (9th Cir.2003) rely consumers will on the information it (citing Norfolk, 464 provides actually ingesting when 35-36, anoth- U.S. 104 S.Ct. at 78 L.Ed.2d company’s drug.”). Finally, they er con- discussing common law doctrine public policy clude that considerations of prior jurisdiction). exclusive weigh against holding name-brand com- product-identification never relaxed petitors injuries by liable for caused requirement causation impose liability See, their competitor’s drug. injuries by caused compet- use of a Foster, e.g., (citing 29 F.3d at 170 product, itor’s and we decline to do so research, expense in development, and here. Mulcahy, 386 N.W.2d at 76 Cf. promotion by undertaken name-brand (“The imposition liability upon a manu- by manufacturers not undertaken gener- facturer for harm it not have manufacturers). ic caused ... is an act more closely identi- Schrock, 727 agree F.3d at 1285. We with fied as a assigned function legisla- each rationale. laws.”). ture under power its to enact Mulcahy, we squarely held that “un- Huck contends product-identifica- der Iowa plaintiff common law a in a tion causation requirement apply does not products liability prove case must that the to her negligent misrepresentation and injury-causing product product was a fraud disagree. claims. We plain- or supplied by manufactured the defen- tiffs in Mulcahy pharmaceutical sued dant.” 386 N.W.2d at 76. The brand companies personal injuries resulting correctly argue defendants “product- this DES, ingestion from the a synthetic identification requirement is decisive here estrogen compound. Id. at 69. The undisputed because it is did not [Huck] plaintiffs “set forth recovery theories of use product, brand defendants’ but instead against the defendants upon based strict generic equivalent used a liability, negligence, misrepresentation, was manufactured and sold another warranties, breach of liability, alternate company” competitor. —PLIVA—their enterprise liability, market liability, share We see no Congress indication intended to and concert of action.” (emphasis alter common principles of causation added). product-identifica- We held the liability injuries create caused “ tion requirement causation applied ‘[re- use of a competitor’s product. See Nor- gardless theory which Redev. & Chesapeake Hous. Auth. v. folk ” predicated upon.’ Id. at (quoting Va., & Potomac Tel. Co. 464 U.S. Annotation, Liability: Products Necessity 304, 307, 104 S.Ct. 78 L.Ed.2d Sufficiency and (1983) (“It is a well-established principle of Identification of Defen- dant or Seller Product statutory of construction that com- ‘[t]he Manufacturer of Alleged to Have Caused 51 Injury, mon law ... ought not to be deemed to be 2[a], (1973)). § A.L.R.3d 1344 repealed, language unless the of a statute be explicit clear and purpose.’” this Moreover, the negligent tort of (quoting Devisee v. Hunter’s Fairfax’s misrepresentation

Lessee, (7 does not Cranch) apply to sellers 603, 623, 11 U.S. 3 of 453, (1812))). products but rather is limited to those in L.Ed. 459-60 “Absent clear- indications, profession business or supplying er of impute we cannot to Con- gress repeal, silentio, guidance an intent to information for the of sub this others. Co., deeply-rooted legal See Pitts v. Farm Bureau principle.” State Ins. Life (Iowa 2012). Eng’r 91, v. S. Fork Band 818 Te-Moak Tribe 111-12 “We of Nev., W. accountants, Shoshone Indians 339 F.3d have found appraisers, school of of 372 See, e.g., Baymiller Ranbaxy v. bro- uct. and investment counselors

guidance 1302, Pharm., Inc., 894 1309-10 F.Supp.2d of potential this class fall within all kers (D.Nev.2012) cases). (noting Nevada law 112 (collecting Id. at defendants.” 552 application” of section “limited the “However, a suit refused allow we have concluding transactions and business where negligent misrepresentation purchase did not plaintiff because in the of was a retailer business defendant was no product, brand-name there busi servicing merchandise....” selling and ness and 552 did not transaction section Iowa law likewise applying courts Federal Pharm., Inc., apply); Strayhorn Wyeth v. negligent misrepresenta- tort of hold the (W.D.Tenn.2012) 1020, F.Supp.2d 1030 of apply products: not to sellers does tion plaintiffs’ negligent (rejecting negligence actions Even if Plaintiffs representation against and fraudulent by the contract’s limita were not barred brand manufacturers when Tennessee remedies, be Defendant would tion Supreme apply had sec Court declined summary judgment Plain entitled to on misrepresentation tion fraudulent 552 to claim. negligent misrepresentation tiffs’ liability previously), or in actions products that Meier v. Plaintiffs concede Alfa- (6th Cir.2013); aff'd, F.3d (Iowa 1990) Laval, Inc., Inc., 719 Mosley Wyeth, F.Supp.2d v. in this case. Meier court applies (S.D.Ala.2010) (finding that liability held that based the tort in a apply products section 552 did not misrepresentation was limited negligent action brand manufactur sup in the persons to those business of restatement, stating, ers “Under persons versus who plying information classed, drug manufacturers be cannot selling incidental give information least in the same sense as accountants Clearly Id. at goods. Defendant’s appraisers, ‘persons estate real accurately business is more described as a part make it of their business ... [who] selling goods supplying it is infor than to supply guidance information for the addition, even if mation. Defendant transactions,’” in their others business providing were in the infor business concluding, the facts of “under this mation, claim fail in Plaintiffs’ would Wyeth engage case did not Schwarz supply in that Defendant did not “false in any with the business transaction Mos- formation for guidance others (citations (alternation leys” original) their business transactions.” Restate omitted)); Darvocet, see also 756 F.3d at (Second) 552(1) ment Torts - 40, 2959271, at 2014 WL *16-18 (1965) Thus, summary judgment [ ]. (“After conducting state-by-state Erie appropriate negligent as to Plaintiffs’ Tompkins, [R.R. Co. 304 U.S. misrepresentation claim. analysis, S.Ct. 82 L.Ed. ] Inc., Breeders, Nelson v. Swine DeKalb highest we conclude that courts (N.D.Iowa 1996), F.Supp. implicated each of the 22 states would not aff'd sub nom. Brunsman v. DeKalb Swine recognize misrepresentation Plaintiffs’ Breeders, Inc., (8th laws.”). 138 F.3d Cir. claims under their state respective 1998). We too the tort of negli decline extend gent misrepresentation to the brand de in the Reglan litigation ap Courts only gener when Huck fendants used plied limiting principles the same to dis by ic their competitor. sold negligent misrepresentation miss product- against brand name manufacturers when We did not retreat from the plaintiff prod requirement used identification causation for Ltd., actions, in Group liability fraud cases Brooke as ucts we turn to the Prod Rather, argues. gen- Huck we noted the Ltd., ucts Restatement. See Grp. Brooke rule that “a manufacturer’s failure to eral N.W.2d 167. Huck cannot evade warn or to disclose material information proof requirements products Iowa to a claim.” Id. give does not rise fraud liability merely by law her labeling claim exceptions: at 177. We noted two as a common law negligent failure-to-warn (1) the manufacturer has “where made theory. Her claims injuries arise from misleading statements of fact intended to product from her use of a ge —PLIVA’s (2) consumers, influence or has made true metoclopramide. neric liability Products designed statements of fact to influence broadly legal refers responsibili consumers and in- subsequently acquires ty injury resulting for from the use of a rendering prior formation statements product. Bingham v. Marshall & Husc misleading.” (citing untrue or Id. Re- Co., (Iowa hart Mach. 485 N.W.2d (Second) 551(2)(b)- statement of Torts 1992). encompasses It neg the theories of (1977)). (c), But, exceptions ligence, liability strict and breach of war expressly were based on the existence of ranty. Although Id. each separate is a relationship between the “custom- and distinct theory recovery, the same manufacturer,” er/buyer and a relation- facts give often rise to all three claims. that created ship duty. never We See id. “The underlying theories ordinari suggested held or a fraud claim could be ly improper concern design, inadequate brought by plaintiff against a manufac- warnings, or mistakes in manufacturing.” plaintiff duty, turer who owed the no Feeds, Inc., Smith v. Air we conclude is the case here. Our deci- (Iowa added). Ct.App.1994) (emphasis sion in Brooke Group Ltd. also forecloses Thus, the Products applies Restatement liability another theory urged by Huck on this case and its specific provisions control appeal: liability “Good Samaritan” for a general over tort principles found in the voluntary undertaking. See id. at 177-78 (Third) Restatement provisions Torts marketing (holding advertising on the adopted Thompson. health of smoking effects are not an “un- dertaking” scope within the of Restate- Moreover, section of the Restatement (Second) 328). ment of Torts section (Third) of Torts duty, addresses not causa- (Third) tion. See Restatement of Torts: argues

Huck we should Mulcahy revisit 7,§ Liab. Physical Harm at 77. We light of our adoption of section 713 of (Third) have never applied section 7 to the Restatement eliminate of Torts: Liabili- requirement ty Harm, plaintiff Physical prove and Emotional Kaczinski, her Thompson injuries were caused sold (Iowa 2009). supplied by or dis- defendant or to impose agree. Thompson injuries products was not a lia- competi- caused case, bility applied product. and we have not section tor’s Nor any appellate other (Third) 7 of the Restatement country. Torts court in the product-identifi- products Rather, liability actions. in prod- cation requirement applied in Mulcahy re- provides: 13. Section 7 denying limiting liability particular in a (a) ordinarily cases, An duty actor has a to exer- class of a court decide that the cise reasonable care when the conduct actor's duty ordinary defendant has no or that the physical creates a risk of harm. requires of reasonable care modification. (b) cases, exceptional when an articulat- countervailing principle policy ed or warrants 374 persons property caused harm to or Circuit Court defect law. The Sixth good

mains law, by Nebraska ex- rules applying prevailing is determined the Appeals, of that section argument the rejected pressly governing causation tort.” principles liability on brand imposing supported 15, 7 § at 231. rule prevailing Id. The re- injuries of consumers the for defendants causation. See Re- quires cause-in-fact Darvocet, product. competing generic (Third) Liab. of Torts: statement 947-48, *27- at 2014 WL F.3d at (“Conduct § Physical Harm is a cause of harm when the harm factual the to no Prod- the points provision Huck not have occurred absent con- would would duct”). that eliminate Restatement lacking ucts is when the Cause-in-fact causation Mulcahy’s product-identification only competitor’s product, used plaintiff impose liability that or would requirement Mulcahy, not the defendant’s. See product plaintiff whose a defendant above, the N.W.2d at 76. As noted over- 1 and 2 We sections adopted never used. whelming majority apply of courts this the Products Restatement Brooke require- product-identification causation Ltd,., at 169. Those Group Reglan reject ment in claims litigation require the defendant’s provisions proof injuries against brand defendants Section 1 product injured plaintiff. by competitor’s generic use of a caused ... or provides, “One who sells distributes drug. product subject a defective persuaded by are not the two outlier by caused persons property for harm to or by Wyeth, Huck: appellate decisions cited (Third) of the defect.” Restatement Torts: —Weeks, So.3d— ,— , Inc. v. 1,§ Prods. Liab. Section defines at 5. *19, granted reargument WL warnings include or inadequate defect to 2013) 2013) (June 13, (Ala.Jan.11, (applying 2,§ 14. Section Id. instructions.14 law); Inc., Wyeth, Alabama v. Conte drugs specifically prescription addresses Cal.App.4th Cal.Rptr.3d 304-05 persons harm to imposes “liability law).15 6(a), (applying Both § California by caused the defect.” Id. at 144. product-identification provides, product Section 15 “Whether a concluded causa- 2(c) covery by competitor's for harm inflicted 14. Section states: product. F.Supp.2d See 762 at 708-09. Kel- product] is defective because inade- [A logg Mulcahy. unpub- is at odds with quate warnings when instructions or by similarly lished decisions cited Huck are posed foreseeable risks harm Mulcahy precedential odds with lack val- product could or have been reduced avoid- Appeals ue. A more recent Court of for the provision ed of reasonable instruc- Seventh Circuit In re GlaxoSmithKline case. warnings by tions or the seller or other LLC, (7th Fed.Appx. Cir. distributor, a predecessor or in the com- 2014), provided by subsequent to Huck oral distribution, mercial chain and the omis- argument Though unpersuasive. also warnings sion of the instructions renders only generic plaintiff ingested in that case reasonably safe. medication, the district court denied the (Third) Restatement Torts: Prods. Liab. summary brand manufacturer's motion for 2(c), at 14. judgment. peti- Id. manufacturer The brand tioned the for a writ of Seventh Circuit man- unpublished trial 15. Huck cites several court ruling. to correct Id. The damus Seventh allowing proceed against decisions acknowledged majority Circuit “that a of fed- plaintiffs defendants used brand when eral courts has ruled in favor of manufacturer,” [brand] formulation, published and one denied the brand but manu- decision, mandamus, Wyeth, Kellogg petition writ of district court facturer’s for a (D.Vt.2010). applied reasoning F.Supp.2d Kellogg legal could issue be re- that, Iowa's, permits appeal judgment. Vermont law unlike re- solved on from a final requirement liability tion for strict nothing to undermine the essential ratio- apply did not to fraud and negligent mis- in plethora nale pre- post- representation theories under the applica- [.Mensing] decisions holding that brand- —Weeks, at-, ble state law. So.3d name manufacturers are not liable for *19; Conte, WL 85 Cal. injuries by caused deficient labeling of Rptr.3d at 317-18. Iowa law differs. As generic drugs they neither manufac- Mulcahy, plaintiff we held in seeking fact, nor tured sold. as discussed recovery for the side effects of a prescrip- below, the opinion in [Mensing] express- pharmaceutical tion who company sues much, ly says as and opinions post- any theory, under including misrepresen- [Mensing] cases are even explicit more tation, prove injured by must she was us- saying so. prescription drug manufactured or —Weeks, at-, So.3d 2013 WL by supplied that defendant. 386 N.W.2d (Murdock, J., at *21 dissenting). It re- 69, 72-73, Additionally, the Ala- mains to be seen how the Alabama Su- Supreme bama subsequently grant- Court preme Court will ultimately decide wheth- Wyeth’s application ed for rehearing and er brand defendants be held liable reset for a argument Weeks second oral under Alabama law to consumers who used Laird, heard in September 2013. Lorelei only formulation by sold drugs Generic leave a bad pa- taste for competitor. suits, (Feb. filing tients tort ABA Journal Not is Huck unable to satisfy Mul- 2014), http://www.abajournal.com/ cahy’s requirement, causation she cannot magazine/article/generic_drugsUeave_a_ establish that the brand defendants owed bad_taste_for_patientsJBling_tort_suits/. her a duty. Hoyt Gutterz Bowl & Murdock, Judge in his Cf well-reasoned dis- L.L.C., (Iowa Lounge 829 N.W.2d decision, sent from the initial observed: 2013) (“[T]he determination of whether a [Ajlmost every one of the 47 reported duty is owed under particular circum- cases decided before the United States stances is a matter of law for the court’s Supreme [Mensing], Court’s decision in determination.”). We have made clear including cases by decided two United adoption that our of section 7 of the Re- States Appeals, Circuit Courts of hold (Third) statement in Thompson Torts that a manufacturer of a brand-name supersede did not precedent our limiting duty has no to the consumer of a relationships based between generic drug manufactured and sold parties. McCormick v. Nikkei & As- company. (Only courts, another three socs., (Iowa 2012) including the court certifying ques- (noting general duty of care under section ease, otherwise.) tion in this have held 7(a) “subject to ‘an articulated counter- Supreme Since the Court’s 2011 decision ” vailing principle 7(b), policy’ in section PLIVA, every one of the 11 cases that “ which ‘may be longstanding reflected in issue, have addressed the including deci- ” precedent’ (quoting [sic] Restatement sions three United States Circuit (Third) of Physical Torts: Liab. for Harm Appeals, Courts of has reached this 7(b) a, 77-78)). & cmt. In McCor- same conclusion. mick, we discussed duty how the law of indicate, As these numbers the Su- important remains intact ways after preme holding Court’s in [Mensing]— Thompson: that state-law claims against generic-

drag manufacturers are preempted by Historically, determination federal regulatory scheme—did focused on three factors: the relation- consumers). generic we con- duty foresee- a As parties, the the

ship between harm, policy. ability public expand and Mulcahy, tort cluded at 834. In [Thompson, 774 N.W.2d] the supply not make or to those who did foreseeability said that Thompson, we by plain- used the injury-causing product duty into calculus enter should not en- choices “social policy tiff involves deter- but should be considered within gineering appropriately more negli- was mining the defendant whether at 76. legislative domain.” 386 N.W.2d But not erase we did gent. Id. at symbiotic relation- Congress created rather, duty; law of remaining drug and generic between brand ship short, Id. at 834-36. reaffirmed it. relationship, In this manufacturers. if either the duty may lack of be found pub- parties relationship between brand manufacturers undertake [n]ame such lic warrants [policy] considerations expense developing drugs, pioneer a conclusion. necessary to ob- performing the studies McCormick, re- 819 N.W.2d at 371. We premarketing approval, tain and formu- duty previous law of was iterated “our lating labeling Generic information. alive and well.” otherwise still by expenses manufacturers avoid these judgment for the de- summary affirmed pioneer drugs successful duplicating fendant subcontractor under the electrical advertising their labels. Name brand predated Thompson. control rule generic competitors ge- because benefits 375; McCormick, N.W.2d see also sold generally nerics as substitutes Borkowski, Feld v. drugs, name more a brand so the 2010) (Iowa (applying & n. contact- prescribed, name brand Thompson sports predated rule that potential generic more sales exist for its player arising injury tort claim equivalents. during high school intramural softball (Third) game because the Restatement of Foster, 29 F.3d at 170. The Foster court Torts the notion that a rea- “expresses that, recognized compet- as between these duty applies sonable-care in each case companies, ing pharmaceutical it would be duty, unless a like the contact- special “especially unfair” to find brand manufac- specifically recog- sports exception, to those take ge- turers who (Third) nized” (citing Restatement “when, drugs here, generic neric as § Physical Torts: Harm 7 cmt. Liab. manufacturer reaps benefits 77)). a, at name brand manufacturer’s statements unique Due to of the rela- nature its coat- copying riding labels on the tionship between and brand manu- Id.; advertising.” tails of its also Kel- “ facturers, a ‘countervailing principle or ly, 2005 at *4 (highlighting WL policy denying liability in warrants [this] process drug] approval can be “[the ” particular Thompson, class of cases.’ very consuming costly time endeavor (quoting N.W.2d at 835 Restatement manufacturers], brand the manufac- [for as (Third) Physical Liab. of Torts: Harm turer bears cost of research and devel- 7(b), 90) Draft No. (Proposed Final clinical opment, performing well as 2005); Kelly No. Civ. Wyeth, accord safety drug’s studies of the and effective- A.MICV200303314B,2005 WL drugs, while makers of generic ness” 2005) “[t]he 6,May *4 (Mass.Super. (concluding contrast, expend not have to do “strong policy weigh social reasons” resources”). brand amount finding manufacturers owe same carefully legislation, crafted Id. at Through Epstein 514. Professor further not- im- Congress policy has made choices that ed:

pact prescription drug the economics judicial failure to understand the to increase access to medication. sales historical arc of the law of torts leads to nothing Huck cites in the text of the a second set of judgments unsound on congres- Hatch-Waxman Amendments or matters of institutional competence.... suggesting Congress sional record intend- There is nothing that erratic expen- and to brand ed render defendants liable to juries sive can do to make accurate sci- generic products. consumers of impose To judgments entific that will people allow liability such would alter relationship plan their conduct in advance. Stabil- between generic and brand manufacturers. ity expectations indispensable in Specifically, extending liability to brand marketing dangerous and, compounds, by generic manufacturers for harm caused for all failings, its manifest the FDA is competitors discourage would investments better at this task than juries. new, necessary develop beneficial drugs Id. at 522. As Professor Epstein elaborat- by increasing the downside risks. See ed: Schwartz, 81 Fordham L.Rev. at 1870-72 FDA, flaws, The all its does have one (elaborating why “expanding reasons lia- advantage system over a of tort liability:

bility a competitor’s product is not judgments It makes its on the overall policy”). sound health use, drug effects of particu- not on the lars of individual cases where the ques- Economic public policy analyses tion of proper warning is compromised strongly disfavor imposing liability tort on ways. a number of brand for harm by manufacturers caused generic competitors. See generally Rich- (footnote omitted).16 Id. at 488 Epstein, ard A. Theory What Tort Tells Us Huck fails to any persuasive articulate About Federal Preemption: Tragic The public case that health and safety would be Levine, Saga Wyeth v. Ann. N.Y.U. through advanced imposing liability tort on Surv. Am. L. 485 Ep- [hereinafter injuries brand defendants for caused Epstein As Professor stein]. observed: generic products sold competitors. We powerful influence of common agree with Epstein Professor that courts gratuitous decisions creates expense and are not institutionally qualified to balance uncertainty way interrelated, that feed their back complex, into the and divergent cycle drug development, testing, policy considerations in determining label- understood, marketing. Properly liability obligations of brand and duty-to-warn entire apparatus generic pharmaceuticals. Courts deal ad which; become a tax drugs, in some hoc with the record by private made liti- instances, may contrast, drive FDA, both old and new gants. By with its four products and, off the market in most budget, billion dollar engages public instances, will increase cost rulemaking allowing transparent input reduce the patient levels beneficial groups, guided all interest by its own use. qualified staff of scientists. Epstein Yet, preemption favors of state law fail- S.Ct. at 173 L.Ed.2d at 70. his policy arguments ure-to-warn claims brand apply greater defendants force to brought by Reglan, Epstein, consumers of efforts to extend state tort to brand rejected N.Y.U. Ann.Surv. Am. L. view injuries defendants to consumers who Levine, competing generic drug. Levine. See 555 U.S. at used 1970)). (Iowa PLI- ap- risk principles tort

Fundamental defendants, VA, profited no-duty the brand support further not portionment Liability generally generic case. sale of the formulation in this from its bolding; in our tort law. McCor- harmed follows control Huck. Cf.

mick, (noting party reject argument based on Huck’s pre- take positioned best “is control Inc., PepsiCo, Bredberg v. N.W.2d 321 identify take meas- risks and cautions 1996). (Iowa Bredberg relies on Huck But, safety”). the brand improve ures to liability on permits party Iowa law argue place [the “d[id] defendants or designs, who but does manufacture commerce, ability no product] ha[d] sell, product injured plaintiff. the the or quality product the control the plaintiff injured Bredberg, by was design, product of the with its conformance glass of Diet exploding bottle Mountain to treat opportunity not have and d[id] retailer, Dew. Id. at 323. He sued as a producing product cost the risk of (which Inc. made and sold the PepsiCo, liability insur- against which production concentrate), Mountain well Diet Dew as Am. L. Prod. can be obtained.” See ance Bottlers, (which Inc. Pepsi as Cola General that, (noting 5:10 under these Liab.Bd and distributed the soft drink un- bottled circumstances, “the defendant has not un- agreement). a license Id. at & n. der responsi- special and assumed [a] dertaken “required 1. The bottler to mix the was Ac- consuming public”). toward the bility pursuant provid- concentrate to a formula the brand defendants cannot be cordingly, n. by PepsiCo.” Id. at 323 1. The ed me- generic as the of the classified sellers for a directed on defendants moved verdict Huck See Restate- toclopramide ingested. grounds the evidence was insufficient to (Third) 1,§ Liab. ment of Torts: Prods. bottle Id. prove the was defective. at 324. at 5. purposes, for Importantly present PepsiCo A manufacturer cannot ensure brand not move a directed on did for verdict complies that a manufacturer with it grounds did not manufacture sell the all, are, compet- federal law—the two after The returned a jury bottle. verdict The brand had no con- itors. defendants plaintiff fifty percent and allocated fault trol over whether PLIVA used their im- retailer, percent five plaintiff, twen- proved by warning language approved bottler, ty-five percent twenty to the Indeed, FDA in 2004. this case PLIVA PepsiCo. percent to Id. 325. The dis- its update failed to label to conform the judgment trict court for half the entered warnings by the brand defen- improved damages, and and the PepsiCo ap- bottler by FDA in approved dants 2004. pealed. Id. 325. We transferred the have her day Huck will in court appeals, to the court of which re- case adopted products PLIVA. We Bredberg’s Id. granted appli- versed. place responsibility for the harm caused by Id. at cation further review. 326. In a party on the profits who its footnote, “PepsiCo we stated contends Grp. manufacture and sale. See Brooke licensing agreement its with Ltd., [the bottler] (noting pur- our Pepsi impute is not sufficient to liabil- Cola pose adopting products lia- principles Id. ity on it as a manufacturer.” at 326 n. to ensure costs bility was “‘that a case 4. We declined to follow based on a injuries resulting products from defective “says it Georgia nothing statute because by put are borne the manufacturers that ”) be PepsiCo on the about whether could held liable products (quoting such market’ Co., alleged by plain- as Hawkeye-Sec. product ‘designer,’ Ins. Co. v. Ford Motor contrast, in the against PepsiCo present By tiff case.” the brand defendants con- went on to review the evidence Id. We label, trol the brand but do not otherwise support it was sufficient to conclude noted, control PLIVA. As we PLIVA bottle verdict that the was defective. adopt failed to the new warning language at 326-29. We held the district court cor- used the brand defendants rectly posttrial denied defendants’ motions And, defendants, the brand who incurred judgment and affirmed the plaintiff develop Reglan, the costs to profit do not that basis. Id. at 329. from PLIVA’s sale of the competing ge- fighting in Bredberg issue was neric formulation. whether there was substantial evidence Judge limiting Murdock observed that that exploded bottle was defective. See id. liability to the defendant that made the at 327-28. That was the basis plaintiff used is consistent rulings on the directed verdict motion and principles “bedrock of tort law and of JNOV, the motion for rulings holding our economic realities underlying princi- those PepsiCo affirmed. Id. at 324-25. supplied ples”: and, therefore, the concentrate was a com- ponent parts supplier completed beginning, From the what Alexander product full bottle of carbonated soft —the Hamilton referred to as spirit “[t]he PepsiCo drink. See id. at 323 n. 1. essen- enterprise, which characterizes the com- tially the outsourced manufacture of the America,” mercial part of has animated glass bottle and the distribution of finished Americans to work produce hard to in- licensee, product Pepsi- to its the bottler. goods novative and services that have part Co controlled of the manufacturing themselves, benefited not but also (mixing) process very for the product that children, communities, their their and injured plaintiff. PepsiCo See id. was America as a enterprising whole. An in the thus chain of distribution of the alone, however, spirit enough. is not

injury-causing product, significant with protect The law must the fruits of enter- control over the process profit- for which it prise and create a climate in which trade PepsiCo ed. was held liable injuries and business innovation can flourish. by Pepsi product, caused the consistent Concomitantly, the law justly must allo- Mulcahy injuries from an —not exploding cate that by Coca-Cola bottle sold a com- risks are a function of that free petitor.17 trade and innovation. attempt support facility 17. Huck does not to adequate protection, her in- without flood and liability theory against novator the brand de- jury ultimately the plaintiff- found for the by relying profession- fendants on our court’s contractor. Id. at 12-13. We affirmed the malpractice al decisions in which defective negligence theory. submission of the Id. at See, plans specifications caused harm. support imposing does not liabili- Schiltz Assocs., Inc., e.g., & Schiltz Cullen-Schiltz ty engi- on brand defendants. The defendant (Iowa 1975). Schiltz, a paid design facility neer was hired and the professional engineering paid firm was to de- by plaintiff. engineer built the provided sign plans sewage for the construction of a service, product. a not a is not a case Schiltz plant. general treatment Id. at 12. The con- engineer copied in which a different and sold facility tractor built the in accordance with design by made defendant for another engineer’s design, provide which failed to project. attempt There was no Schiltz protection. for a dike for flood Id. at 12-13. impose liability designer on a remote who nearby damaged A creek flooded and the fa- paid was not retained and for the construc- cility. Id. at 13. The contractor sued project tion at issue. engineering negligently designing firm for duty no (concluding “Wyeth has needs have resulted dual These products”). users of other manufacturers’ always legal system that economic from the sale of the rewards coupled brand manu- unwilling are to make We tor- the costs of or service with good a compet- the de insurers for facturers facto the same. injury resulting from tious Schwartz, ing generic manufacturers. Cf. Indeed, corollary notion this (“Deep-pocket 81 Fordham L.Rev. are for their parties responsible that jurisprudence principle.”) law without others, competi- well be not those of so It foreseeable products, own design or legal will mimic a label. western tors organic to economic But, to step decline invitation Huck’s they rarely find need of thought a slippery slope imposing form onto expression. innovator on manufacturers for Weeks,-So.3d at-, 2013 WL product. competitor’s harm caused (alteration J., (Murdock, dissenting) at *20 If liability stop? would such a car Where (footnote omitted). original) recognized manufacturer indus- seat seat, designed popular car try leader prin adhere these bedrock injuries it be sued for sustained could today join multitude ciples using seat that competitor’s consumer defen courts that have concluded brand not, Why copied design? under dants owe no consumers theory, foreseeable Huck’s if it is others See, Darvocet, e.g., 756 F.3d at drugs. copy design? will - (af *17-18 938 2014 WL sum, we will not contort Iowa’s tort firming against dismissals claims brand in law order create brand Lashley, on no-duty grounds); defendants resulting manufacturers. The unfairness (“[B]ecause Appellants 750 F.3d at 476 did by Mensing addressed best Con- ingest prod the brand manufacturers’ gress Mensing, or the FDA. See U.S. ucts, these have no common- defendants at-, 131 S.Ct. at 180 L.Ed.2d at them.”); duty Strayhom, law 737 F.3d (“As always, and the Congress FDA “ ‘[although (acknowledging at 405 a authority change retain the the law and has a product generally duty manufacturer desire.”); Schwartz, if regulations they so dangers products, to warn of of its own Fordham 1875 (“Congress L.Rev. at duty it not have a to warn of does FDA ... appropriate and the are the arms prod dangers of another manufacturer’s government making [drug liability] ” Corp., (quoting ucts’ v. Kerr Barnes in the fashioning decisions context of (6th Cir.2005))); Schrock, F.3d care policy country.”); best health 727 F.3d at 1282 (recognizing “[w]hether Kazhdan, Wyeth generally Daniel duty not a exists depends on rela Inadequate Drug PLIVA: Law La- tionship parties” between the and “brand- beling, 27 Tech. L.J. 893 Berkeley any name manufacturers do not have rela (discussing Mensing and “pro- Levine and tionship” plaintiff ingested with the who ways companies, posing] drug (alteration (inter generic drug original) in FDA, Congress, states could and the rem- Bell, omitted)); quotation nal marks harmful edy effects of the Court’s dis- in Arkansas (“[N]othing F.3d drugs tinction between brand-name supports duty ... such a of care extending Indeed, drugs”). the FDA’s generic pro- using competitor to the customer rule allows posed generic manufacturers Foster, unilaterally 29 F.3d their labels. competing product.”); strengthen See Rule, CADY, Proposed Fed.Reg. Justice generally (concurring spe- Chief cially). abrogate 67985-02. This rule would

Mensing holding, permitting consumers of I opinion concur in the majority drugs bring against a claim generic PLIVA, on the claims Huck against but manufacturers consistent with the generic only. otherwise concur in the result I analysis. Levine agree with much of the dissent on the defendant, against claims the brand but will continue to apply decline at time public this to conclude the same rule long-standing applied causation policy ultimately considerations that drive Mulcahy, which Huck to required prove case, balance, the decision in this sup- the defendant or supplied manufactured port the imposition duty of a of care as product injury, that caused her and we suggested by Justice opinion. Hecht’s decline to extend the man After the Supreme United States Court injured by ufacturers to those use of a PLIVA, held Inc. v. Mensing, 564 U.S. competitor’s product. impose We will not -, -, 2567, 2580-81, 131 S.Ct. liability on the brand inju defendants for (2011), L.Ed.2d that warning using only ries to those the competing generic drug manufactur- generic formulation. The district court preempted, er were consumers of correctly concluded the brand defendants drugs harmed its label had little avenue summary judgment were entitled to except of relief to turn to the drug brand their favor. manufacturer. A credible legal theory of recovery against the brand manufac- Disposition. IV. turer has now pieced together been -with cases, the aid of our prior but these efforts reasons, For the foregoing we vacate the existing do not confront the congressional decision of the court of appeals, reverse preemption into the broad area of brand part the district summary judg- court’s generic drugs. The law can stitch ment for PLIVA and remand for further together legal legal theories into claims of proceedings against on Huck’s claims PLI- action, but the underlying public policy adopt VA based on its failure to the ultimately duty drives the creation of a of warning language approved by the FDA care. Normally, courts are able to discern Reglan. for We affirm the district court’s the public policy apply and it to reach an summary judgments dismissing the other outcome; case, but in this policies the exist against claims dismissing PLIVA and fully within an area occupied by Congress against Huck’s claims the brand defen- and which is still developing. public The dants. policy considerations normally play OF DECISION COURT OF AP- impose duty of care on manufacturers to VACATED; PEALS DISTRICT COURT protect product consumers are simply too PART, IN JUDGMENTS AFFIRMED general support and attenuated to the im- PART, REVERSED IN AND REMAND- position of liability market-wide on the ED WITH manufacturer, INSTRUCTIONS. brand especially at a time steadily

when its market share being by consumed the drug manufactur- CADY, C.J., justices except All concur protected liability. er HECHT, who specially, concurs and WIGGINS, APPEL, JJ., and who concur normally Courts seek to find remedies part in and dissent in part. wrongs, complexity for but the and sheer or in manufac- adequate warnings, defects inquiry area of and particular of

size turing. Id. by been assumed Con- role that has navigating through and regulating in gress manufac- liability of imposition courts more than make area should history in Iowa long defects has turing legal liability to create step in cautious See, e.g., Hawkeye-Sec. Ins. Co. caselaw. poli- manufacturers. The brand-name Co., Ford Motor currently being developed play cies (Iowa 1970). adopted In Hawkeye, we poli- and shaped Congress include and special, principle liability narrow of strict against court intervention cies that militate 402A the found in section of Restatement time. at this (Second) explained Torts. of We reasons, commercial policy for various HECHT, (concurring in and part Justice defectively prod- seller of a manufactured part). in dissenting uct be liable for harm caused regardless plaintiff whether defect analysis re- join majority’s I might negligence establish or breach of against As to Huck’s claims PLIVA. spect Id.; also warranty by seller. Re- “product-identifi- the majority’s18 I believe (Third) however, of Torts: Prods. statement Liab. requirement,” causation cation (1998). a, § 1 at 7 the facts cmt. While application no a case where the rise of man- Hawkeye gave to a claim warning allegedly responsible defect, our identified, ufacturing explanation strict injury be- have been suggested the strict liability principles lia- regarding cause I believe our caselaw bility theory might applicable be support factual cases possibili- causation here, involving allegations design defect ty liability of the brand I defendants’ well. Hawkeye, (quot- majority’s from the respectfully dissent ing authority applying strict when analysis and disposition the claims “ ‘the design defect arose out of the or brand defendants. ” product). gave manufacture’ Liability I. Iowa Products Law theory might no whether indication Mulcahy. also apply giving a case rise to claim warn, failure to and it was until previously explained We have the law many later we years concluded failure-to- products liability in “may Iowa involve warn typically invoke a reasonable- in negligence, causes action stated strict ness incompatible standard with a strict liability, warranty,” among breach Prosoco, liability theory. See Olson v. Bingham others. v. Marshall & Huschart Inc., (Iowa 1994); 522 N.W.2d (Iowa Co., 1992). Mach. N.W.2d (Third) see also Restatement of Torts: We have these three noted theories a, § Liab. 1 cmt. Prods. at 6-7. separate recovery, theories of distinct single may give and a set of facts forth setting justifications rise After any liability combination of the three. v. our adoption theory Loviclc strict Wil-Rich, (Iowa given manufacturing 588 N.W.2d the claim of defect 1999). Typically, underlying Hawkeye, theories in we care to before us took note involve improper design, analysis any will claims of in- claim of was negligence of “a clear, analysis will analysis 18. I continue to refer to the in in Part III.B makes of opinion support opinion by Part III.B of Justice Waterman Justice Waterman’s has Cady “majority” only. justices, while as the for ease of reference of three Chief Justice Cady’s special only. in result As Chief Justice concurrence concurred matter.” Hawkeye, different N.W.2d sellers and distributors of products for had no in defects, at 685. We occasion decide manufacturing designs, defective Hawkeye negligence how theories of or inadequate warnings instructions and liability might apply strict cases not found sections of the Restate manufacturer, involving spe a because the (Third) ment of Liability. Torts: Products liability cial strict rule at issue there and 169; Wright, 652 N.W.2d at see also Re elucidated in section 402A no applica had (Third) statement of Torts: Prods. Liab. party engaged activity tion to a not in the 5, 14. §§ 1-2 at doing, so we reiterated making selling product part of as of the Restatement’s recognition that a tradi (Second) its business. See Restatement conception tional liability may strict well (1965). Torts 402A cmt. at 350-51 f appropriate be in manufacturing defect While it often be deceptively simple cases, but that negligence will principles regard liability injuries an actor’s relat often be more suitable in involving cases “strict,” product ed to a we cautioned types other Wright, of claims. 652 N.W.2d (Second) Hawkeye, the Restatement did at 168. preclude liability based on the alterna In the analysis course of our Wright, ground negligence negligence tive when we principles identified two further illumi- proved special could be rule of sec —the nating our examination of the brands’ ob- tion 402A often simply application had no First, ligations here. suggested Hawkeye, to those claims. 174 N.W.2d at instances, in certain manufacturers and 684-85; Wright see also Grp. Brooke parties may other be Ltd., (Iowa liable in tort for 2002). damages product suffered as a result of more recently We addressed the pros defect, regardless parties whether the ac- pect for injury caused tually produce the specific object causing in Wright, a presenting case the damages. See Wright, 652 claim of design Wright, defect. (examining civil conspiracy scenario N.W.2d at 169. acknowledged our where agree “manufacturers to suppress conclusion in involving Olson that cases information about their product for the claims of failure to warn should be ana purpose lawful of facilitating the sale of lyzed under rubric of negligence. their product, and in effectuating plan this Wright, 652 N.W.2d at 166. We noted subject themselves to liability for failure (Third) Restatement of Torts: Products to warn of the using prod- risks of their had, Liability in addressing de uct”). Second, and more importantly for defect, sign abandoned the consumer-ex here, purposes of our analysis in examin- pectations test traditionally employed in warn, a claim for failure to we ex- strict liability analyses in favor of a risk- plained “what really important is that utility typically test in negligence found the statements were purpose made for the analyses. Id. at 169. We concluded we influencing another,” the action of favored the preference Restatement’s these avoiding doctrinal claims need not designation design- busi- “involve[] ” defect ness transaction claims as between the involving negli parties.... claims gence then, or strict at In liability. Id. 175-76. Wright Id. Like the as Restatement, drafters of the Hawkeye, we we took care explained, to establish that we specific favored a functional risk-utility analysis products theories of liability, otherwise, for these application liability claims without of a whether strict or did doctrinal label. Id. adopted displace We therefore negligence, other claims of the framework for analyzing liability the of theory liability and each of must be liability manufacturing claims of strict for of the relevant facts terms

analyzed requirement involve a Wright, typically 652 N.W.2d defects principles. legal and defendant, we had the but 176; 174 N.W.2d 685. manufacture Hawkeye, at is- negligence the claims distinguished analytical these we made Long before to be those claims were sue and noted products liability refinements to our standard analyzed in accordance with our ques- certified Wright, we confronted Osborn, 290 negligence principles. See involving parents from a case tions federal 901; Wright, 652 N.W.2d at see also as damages a result who had suffered un- (explaining principles N.W.2d during ingestion mother’s DES the liability appropriate derlying [are] “strict Mulcahy Lilly v. & Eli pregnancy. See cases, negli- manufacturing defect but (Iowa 1986). Co., 67, 69 Un- 386 N.W.2d for oth- gence principles are more suitable manufacturer of the identify able to the cases”). cited our product er defective We mother, ingested by parents DES the the v. & earlier case of Schütz Cullen-Schiltz twenty-five drug com- brought suit Inc., Associates, N.W.2d or who marketed panies had manufactured (Iowa 1975), appropri- as illustrative of the during in which the moth- period DES the Osborn, analysis. negligence ate ingested parents it. Id. The er had N.W.2d at 901. negli- brought liability, claims of strict gence, breach misrepresentation, Schütz, In we had a claim encountered Id. no warranty, among others. We made design treat- alleging sewage defective of a specific reference whether Schütz, ment at 17. facility. defect, defect, design fail- manufacturing prevail that to a claim of explained warn, any ure others had ad- or been negligent design engineers, vanced, but no indication we had gave we fell short of prove claimant must work manu- any occasion to consider DES skill, learning care ordi- “degree of claims of de- liability design facturers’ narily en- possessed and exercised” in the or failure See fect to warn.19 id. at 69-70. gineering profession and the substandard Setting principles Notably, care in the Id. legal applicable damage. forth resulted claims, analysis analyzing parents’ negligence imposed tort our in Schütz had “plaintiff products requirement engineers noted a in a no ordinarily sewage action must built prove that a manu- or manufactured the defective provided Indeed, produced, facility. they facturer or supplier treatment See id. not, way responsible par- they plans was in some for the had had merely provided injury.” facility’s ticular that caused the for the con- specifications contractor, at 70. authority proposi- independent As for that struction to an (Second) tion, we cited who independent obligations inspect the Restatement had attending Torts section strict liability pro- 402A—the site and circumstances having application project vision no to negligence diligently pursue, supervise, and to 12- claims—and earlier case of Id. at complete our Osborn construction. Inc., Instead, Massey-Ferguson, purposes negli- 13. N.W.2d (Iowa 1980). impor- Mulcahy, gence analysis, we made clear the Osborn, similarly we had noted tant in Schütz were whether questions distinguished 19. Our failure to address the theories of not often those claims de- sign might defect to warn at- manufacturing and failure be point. claims for defect at that tributable the fact the DES manufacturers Mulcahy, See 386 N.W.2d at 69-70. manufacturers, were and to the we had fact engineers negligently designed given had the fa- the sheer possibly number of respon- cility negligence and whether had parties, sible we declined to adopt the 17; damages caused the suffered. Id. at special liability theories advanced & McCarthy see also J.P. Cullen Son plaintiffs and concluded we would not im- (Iowa 1972) Corp., 199 N.W.2d pose “liability upon a manufacturer (examining respect architects’ duties with harm it not have caused.” Id. at 76. plans specifications and noting duty and on our products liability Based princi protection adja- extended to of owners of ples, and based on specific problem properties cent from harms “which reason- Mulcahy, issue in I Mulcahy believe our ably expected could be to flow from” the analysis provides useful but guid limited plans). ance for our resolution of the case before acknowledged employed us. We are not faced here with a claim of principles Mulcahy of these cases in nei- liability strict for manufacturing defect on liability ther to elide theories of strict brands, behalf of the and thus the strict negligence, nor to suggest products all lia- requirement causation bility claims were to be treated as claims manufacturer be responsible for the manu defect, of manufacturing but to ensure defect, facturing set forth in cases like “causal connection between the defen- Hawkeye and Osborn imported dant’s product plaintiffs injury.” Mulcahy, inapplicable here. See Mul- Mulcahy, 386 N.W.2d at 70. Our general 70; Osborn, cahy, 386 N.W.2d at noted, negligence principles, require we 901; N.W.2d at Hawkeye, 174 N.W.2d at prove claimant to “the defendant caused 684; Wright, see also 164. complained of harm injury.” Id. at More importantly for purposes of our 72. involving many In a case apparent so analysis respect neg the claims of DES, manufacturers of some of which had here, ligence we are not faced with a case defendants, not been named as we ex- involving possibly numerous responsible plained, the claimants could not prove any involving defendants or possibility of the named defendants way “was some party unnamed might actually be responsi for,” responsible actually or had “caused ble for the harm suffered in lieu of any injury plaintiff. to” the Id. at named defendant. Mulcahy, See manufacturers, In a case involving fewer Instead, contrast, N.W.2d at 71-72. noted, the plaintiff might not have run parties here stipulated to the up against the same problem if, causation — relevant facts: the brands designed and instance, the “plaintiff established that manufactured Reglan; branded PLIVA only two products manufacturers’ DES manufactured the product actually pharmacy, were sold at a certain and [she] ingested; and regulations federal laws and bought her DES at that pharmacy establish obligations various for PLIVA identify but which e[ould not] brand she and the brand defendants. The purchased.” Id. causation at 73. Other theories of problem we liability, Mulcahy such as identified in enterprise liability, might there here, present also have fore does not legal causation itself and al “avoid[ed] problem though exposition that arises from an our inability general negli identify gence here, specific principles application manufacturer of the injury-causing product” Mulcahy gives specific us no involving guidance cases many possible responsible so parties, negligence but how to resolve the we found those inapplicable given theories scenarios like this one where all relevant Instead, the facts before Instead, us. Id. at 72. actors have been identified. 386 164; Hawkeye, at 174 we have set forth in 652 N.W.2d N.W.2d principles

negligence guide like must cases Schütz at 685. numerous here, cases have and those our resolution jurisdictions from numerous have Courts an who has breached actor required never and declined to recognized principles these care manufacturer of be a obligation an against brand defendants dismiss Schutz, liability. of tort See for purposes See, circumstances. given similar factual 17-18; Bredberg also v. 228 N.W.2d Corp., Dolin v. Beecham e.g., SmithKline (Iowa Inc., 821, 327 551 N.W.2d PepsiCo, (N.D.Ill. C6403, 804458, at 2014 *6 No. WL 1996) are also (noting product designers 2014) (“[Tjhese 28, parties Feb. stood in a claims). liability to strict subject that, relationship one another while Moreover, have not offered brands ‘direct,’ clearly not was sufficient for the must why as to we treat any explanation impose duty a of reasonable conduct law of our purposes manufacturers for them as Plaintiff.”); GSK for benefit of upon fact, analysis. parties all negligence Inc., Pfizer, v. F.Supp.2d Chatman stipulated the brands were involved have (S.D.Miss.2013) (“Chatman 641, may generic metoclo- not manufacturers of pursue her common-law claims under ‘old’ pramide ingestion. the time of Huck’s liability, though even state theories noted, prior prod we have numerous

As by have a injured she been liability need ucts cases held an actor another.”); by manufactured v. Kellogg analyz purposes be a manufacturer 694, (D.Vt.2010) Wyeth, F.Supp.2d liability, regardless the claim whether (“To date, however, Vermont not elimi liability. negligence is one of or strict See common for negligence nated law actions Co., Thermogas v. Weyerhaeuser merely they fraud prod or because involve (Iowa 2000) (noting sever N.W.2d ucts.”); Inc., Pasteur, Easter v. Aventis al justifications holding assembler (TJW), No. 5:03-CV-141 2004 WL negligence liability liable in both and strict (E.D.Tex. 11, 2004) at *9 Feb. component for the failure of a it did not duty (“Lilly, designer, as a has a to devel manufacture); Bredberg, 551 N.W.2d at Also, op a safe thimerosal. design for Schütz, 327; 18; cf. Lilly’s design intimate knowledge of and Wright, (adopting 652 N.W.2d at 169 sec gives about thimerosal also rise to a (Third) 2 of the tions 1 and Restatement inform users of hazards associated with Products Liability); Torts: Clark v. Therefore, the use of thimerosal. (Iowa McDaniel, 546 N.W.2d plaintiffs finds that Court ade 1996) (holding used-car dealer liable for stated quately design a defect claim misrepresentation quality). car Our —Weeks, Lilly.”); v. Wyeth, Inc. negligence always required cases have a So.3d-,-, 2013 WL at *19 negligent part act or on the of an omission (Ala. 11, 2013), reargument granted Jan. causation, actor, damages within the 2013) (June 13, (“Under law, Alabama See, scope liability. e.g., Thomp actor’s Kaczinski, drug company may brand-name held be son v. 774 N.W.2d (Iowa for fraud 2009); Eveleth, misrepresentation (by liable or Stotts 688 N.W.2d omission), (Iowa based on 2004); misstatement state Essen v. Van it made man Co., 716, ments in connection McCormick Enters. 1999). (Iowa prescription ufacture brand-name great As have taken by plaintiff claiming physical emphasize drug, injury products liability care to our cases, principle products no law caused manufactured displaces Wright, company.”); Wyeth, framework. See a different Conte v.

387 Inc., 89, Inc., (D.Minn. 1125, Cal.App.4th Cal.Rptr.3d F.Supp.2d 85 808 (2008) (“We 299, 2011) (“[U]nder Wyeth’s hold that the pre-2007 statutory common-law to use due care in for framework ... a brand-name manufactur- mulating product warnings its extends to er was the entity in the trifeeta of foreseeably rely whose on patients doctors (the FDA, actors the brand-name manu- product prescribing its information when facturer, generic) and the that could metoclopramide, prescription whether the label.”), strengthen inadequate in affd Reglan is written for filled with or and/or part, rev’d in on part grounds, other generic equivalent.”); Wyeth, its Lance v. (8th Cir.2012); F.3d 1161 Kellogg, 762 (Pa.2014) (“There 434, 85 A.3d (“A F.Supp.2d jury reasonable could supported presentation been no here which that inadequate, misleading conclude persuade companies would us to immunize inaccurate provided by information responsibility respond from the in dam was a ... [brand defendants] cause of her ages resulting for such a lack of due care —Weeks, injury.”); at-, So.3d death.”); personal injury in Clark (“In 135753, short, WL at *19 patient Inc., Pfizer, No. 2008 WL that, must show but for the false represen- 2008 Phila. Ct. PI. LEXIS Com. *29 tation warning, prescrib- made (Ct.Com.P1.2008) (“[T]he relationship be ing physician prescribed would not have purchasers tween the Gabapen- Rostron, the medication to patient.”); his tin and these defendant manufac [brand] 60 Duke L.J. at (“Throughout turers herein purchaser drugs long precedent line of that flowed out of which never would have been purchased Foster, repeatedly courts have made the [conduct].”). but for defendants’ See gen mistake, same dwelling on the irrelevant Rostron, erally Allen Prescription for concept being imposed on multi- A Approach Fairness: New to Tort Lia ple manufacturers uncertainty because of bility Drug Brand-Name and Generic about who made a product and conflating Manufacturers, 60 Duke L.J. concept separate and distinct (noting [hereinafter courts Rostron] issue of whether a manufacturer can be recognized have “[n]egligence and strict liable for wrongdoing other than making products liability separate and distinct and selling plaintiff re- liability” bases for and “do not automati ceived.”). Several courts have cally collapse reasoned merely into each other be law, “case cause there are some commonsense and fairness dic- situations which a plaintiff might be able to assert both tates” the types brands cannot both avoid claims (internal of claims” quotation marks omit of products liability strict ground ted)). they were not manufacturers of the gener- ic the drug, version of and avoid claims of

Several recognized courts have that giv- negligence ground on the they were manu- obligations en the created the Hatch- Chatman, of some drug. facturers other Act, problem Waxman the causation 960 F.Supp.2d (“[T]hey cannot have here, in Mulcahy identified is inapplicable Dolin, it ways.”); both see also 2014 WL because “whether a consumer ingests the (“GSK *4 why has not shown or generic given name-brand version of a precluded Plaintiff should be claiming drug is immaterial to the likelihood that GSK, at common law that independent of negligence design in the or warning label Dolin, capacity its as a injury.” of that will cause manufacturer ... was *5; also, e.g., negligent WL connection with [other its re- ”). Pharm., sponsibilities] Schedin v. .... Ortho-McNeil-Janssen ap- principles I believe of these proper each recognized Many courts us, I before and believe plicable turns not the case negligence claims resolution our liability and products a is both our law of of whether question aon involved, brand defen- analysis negligence of law of dictate the but on an somehow See, here. As e.g., may subject to principles. dants be negligence traditional noted, have the cau- Dolin, (rejecting *4-5 numerous authorities at 2014 WL immunity ap problem majority and has identified sation of manufacturer defense Mulcahy irrelevant the facts negligence given law to claims in is plying Illinois Easter, Instead, defendants); us. we must 2004 and before against brand given (rejecting analyze long-standing *9 defense of the claims our at WL to immunity negligence Tex task I turn applying principles and of manufacturer —a against to brand now. law claims negligence (re Lance, defendants); 85 A.3d at 458-60 Duty. II. immunity manufacturer

jecting defense of Pennsylvania negligence law and applying have noted while sum- often defendants); see to claims brand adjudication rarely mary appropriate Corey Corp., 721 also Kolarik v. Int'l cases, of negligence determination (not (Iowa 2006) 162-63, N.W.2d duty particular a is owed under whether “products” purposes olives were is a matter of law for circumstances allowing and nevertheless products liability See, e.g., Hoyt v. court’s determination. general negligence on plaintiff proceed L.L.C., Lounge Bowl & Gutterz warn). claim failure to (Iowa 2013); Thompson, N.W.2d In we Thompson, 774 N.W.2d at 834. Finally, persuasively courts have several adopted duty analysis of section a enor- argued decision to eviscerate an (Third) Liabili- the Restatement of Torts: segment our law negligence mous and Harm, Physical ty for and Emotional and “immunize companies responsibil- duty a generally we concluded an actor has a ity respond damages for such lack ac- to exercise reasonable care when the resulting personal injury” care of due physical tor’s conduct creates risk of “weighty consequence-laden policy- and 835; Thompson, harm. N.W.2d at making” judgment Congress best left to Borkowski, also Feld v. legislatures and the of which state —none (Iowa 2010) (“As rule, general our granted just yet. immunity have such recognizes every person duty owes a Lance, 461-62; 85 A.3d at see also Chat- caus- to exercise reasonable care to avoid man, (noting F.Supp.2d “the others.”). ing injuries to Mississippi legislature abolished cases, requirement privity explained ‘in all causes of We that most court injury for personal brought action ... on need not concern itself with the existence ” negligence’ (quoting duty, account of Miss. content instead should (West, remaining Ann. 11-7-20 ele- proceed analysis Code Westlaw (end) Thompson, First through Regular negligence liability. Ex- ments Feld, (end) 835; traordinary Sess.))); Kellogg, 762 774 see also (“Neither cases, exceptional F.Supp.2d the Vermont N.W.2d In noted, general duty nor to exercise legislature courts the Vermont actor’s might displaced or collapsed negligence actions into strict lia- reasonable care be bility products countervailing policy actions where in- modified based volved.”). no lia- justifying limited or considerations bility in certain classes of cases—but those The drafters also note section 315 of the (Second) policy depend reasons were not to on the Restatement of Torts has often pronouncements led to that “absent a specific any given Thomp- spe- facts of case. son, relationship cial an actor owes no detailing 774 N.W.2d at 835. this parties.” control third Id. Section analysis recently, more we have noted we however, addressed only affirmative duties principles look to the comments and parties to control third nothing had Restatement, of the current the comments —it say about ordinary duty “the of reasonable Restatements, principles prior regard care with might conduct that prior determining our caselaw in whether provide an party occasion for a third policy departure considerations dictate (Sec- harm.” cause Id. The Restatement from general recognition duty our of a ond) actually addressed latter scenar- in particular exercise reasonable care 302B, io in explain, section the drafters broadly drawn classes of cases. See providing duty for a of care when an ac- Assocs., Inc., v. Nikkei & McCormick “ tor’s exposed conduct ‘has created or (Iowa 368, 2012). recognizable other to a high degree of risk Duty Applicable Principles A. From through of harm such [third-party] miscon- ” and the Our Caselaw Restatements (Third) duct.’ Restatement of Torts: the Law. The drafters of the Restatement Physical Liab. for & Emotional Harm (Third) have set forth important several d, § cmt. at 5 (quoting Restatement duty principles guide analysis us in our (Second) 90). e, § of Torts 302B cmt. at here. The drafters explain an actor’s busi- Thus, note, the drafters both the Restate- operations may ness a provide fertile (Second) ment and the Restatement source for natural or third-party risks mis- (Third) provide for liability when actors conduct that creates risks that would not engage in conduct that increases mag- have occurred the absence of the busi- nitude of natural or third-party risks. Id. (Third) ness. Restatement of Torts: Liab. d, § cmt. at 4-5. Even when the actor Physical § & Emotional Harm 37 cmt. complete and victim are strangers and (2012). d, note, they Section spe- have relationship, no explain, drafters cifically forth sets the standard of care for ordinary the basis for the duty of reason- scenarios where an actor’s conduct increas- able care under section 7 is conduct creat- es the risk of third-party causing conduct b, 3; § risk to another. Id. 37 cmt. at adopted harm. Id. that reasoning in see also West v. Rope Broderick & Bascom Hoyt, where we concluded the duty of care Co., (Iowa (not- 1972) 197 N.W.2d applies all arising given risks from a ing Iowa courts have them- “extrieat[ed] conduct, course of if even also created in imposition selves the erroneous conduct, part by party’s a third regardless privity requirement”). A relationship, innocent, negligent, “whether or intention- words, in other typically does not define Hoyt, al.” 829 N.W.2d at 779. In cases duty the line between duty and no —in- where operations provide business stead, the line is by drawn conduct creat- risk, note, source of the drafters “the ac- (Third) ing risk to another. Restatement and, tor’s conduct creates risks of its own Physical of Torts: Liab. for & Emotional therefore, governed is ordinary b, 3; see, § Harm 37 cmt. at e.g., Keller v. duty of reasonable care in 7.” State, (Iowa 1991) [section] 475 N.W.2d (Third) Restatement of Torts: Liab. for (“[Linking the legal duty existence of to a Physical d, § & Emotional Harm 37 cmt. particular relationship between the parties at 5. unwavering requirement not an for all Chatman, torts.”); risk harm objectively an foreseeable also

negligence (“As rule, exist,” the drafters general question, and that must F.Supp.2d a relation- negligence note, question jury.” of fact for the context “is exist.”); duty to necessary d, for a is not ship § cmt. at 34-35. The section 39 Id. 141, 150 Kasey, 214 Ariz. P.3d Gipson justified duty, explain, the drafters both (“A rela- or direct special risk, of a even if by an actor’s creation however, essential in order is not tionship, absence of the nontortiously, “the care.”). duty there to be autonomy explanations” for pragmatic (Third) in section 37.20 no-duty rule set forth de- Further, the Restatement c, recognized 39 cmt. 32. We creating an entire section to conduct votes harm, pro- expressed risk of in section ongoing physical principles an conduct, prior See, Lovick, viding actor’s years. “[w]hen many e.g., tortious, creates a con- though (“Our even today confirms decision physical type harm of a tinuing risk of post-sale of a for manufac- existence conduct, the actor of the has characteristic ”); warn.... also Mercer v. turers to to pre- exercise reasonable care duty a to Pittway Corp., 623-24 minimize the harm.” Restatement vent or 2000) (“[T]he (Iowa inquiry is whether a (Third) Physical Torts: Liab. for & of or reasonable manufacturer knew should § Harm at 31. As the Emotional light of in of danger, have known the the clear, make the initial conduct drafters recognized prevailing best generally even tortious for need not be actionable or provide to knowledge, yet failed scientific §Id. duty a to arise under the section. customers.”). warning or adequate to users c, addition, they explain In cmt. at 31. (Second) Section 552 of the Restatement in the a court that even rare case declines provides insight. of Torts This additional general duty apply to the section section, setting requirements forth for the caselaw, in an actor recognized have our pro- negligent misrepresentation, tort of duty ongoing will nonetheless have an to that an false supplying vides actor infor- reasonable care to warn or otherwise use guidance may mation for the of others be § mitigate risk under 39. Id. section by justifiable losses liable for caused reli- d, cmt. at 33-34. Even if the actor does upon ance the See Restate- information. his or her has created not know conduct a (Second) § ment of Torts at out, 126-27. harm, the point risk of drafters long applying history We have duty provided in 39 exists. section Id. Iowa, d, case, however, principles in and we § 39 cmt. at 34. that section “[bjefore liable duty a breach of the occurs ... noted our caselaw ensures those (Third) pro- justification and 20. Section 37 of the Restatement between the section 37 our autonomy-based no-duty the standard common "values about humanitarian con- vides exceptions reflected rule: "An actor whose conduct has not creat- duct” is in the numerous physical ed a emotional harm to the rule in the Restatement. Id. risk elsewhere e, § 6. also duty another has no care to the other 37 cmt. at The section 37 rule justifications, pragmatic court one of less common unless a determines that other explain, provided ap- §§ the concern affirmative duties in 38-44 is the drafters such as that (Third) peril plicable.” duty an affirmative aid others in Restatement Torts: duty Physical might general § & Liab. for Emotional Harm be confused with self- e, § justification Id. at 5-6. As 2. The most common for this sacrifice. 37 cmt. rule, note, note, application drafters no in "relies on liberal drafters rule has entirety any where of the tradition of individual freedom and autono- case "the actor’s my” places "requiring ... [has] limits on affirma- conduct created risk harm.” c, e, § § Id. cmt. tive conduct.” 37 cmt. at 5. Tensions 3. weigh potential position applied reasoning uses We have presaging drafters’ section potential magni- analysis information for more See, century than a here in e.g., Iowa. probability of loss if the informa- tude Clark, 69, 72-73, v. 118 Iowa inadequate tion or incorrect. See Van Warfield (1902) (“If N.W. the defendant in Sickle Constr. Co. Wachovia Commer- falsely reported fact the financial condition Inc., Mortg., cial company his for the purpose of deceiv- (Iowa 2010). ing the public relation to its responsibili- (Sec- theAs drafters of the Restatement insurer, ty as an it seems clear to us ond) recognized long ago, there is “[w]hen say we should not aas matter of law that a public duty supply information he wrong intended to that particular ... question the maker of the negligent class, and that dealing those its stock misrepresentation subject becomes to lia- victims; were not his intended for he knew bility any persons of the class of companies stock in such was often benefit whose is created.” Re- sold, bought and and that reliance might (Second) 552 cmt. n § statement of Torts placed upon be his sworn statement rule, explained, the drafters therein.”). dealing those a general As applies public to both private officers and proposition, we have long recognized and corporations required by individuals or law continue to recognize an actor be to file information for the benefit of the liable to parties reasonably third who rely k, public. Id. 552 cmt. at 139. In cases upon information prepared by the actor where the group protected by to be the where the actor has reason to believe the one, filing requirement is a broad the information will upon by be relied the noted, drafters a corporation might See, Sickle, be lia- party. third e.g., Van “any ble to one may reasonably 691; Kanne, who be Ryan N.W.2d at (Iowa 1969). 395, expected rely on the N.W.2d information and The point of discussion, course, suffer a this loss as result.” Id. As an of illustra- a of brand defendant must owe a principle, duty tion the the drafters to a offered 552; consumer under section point, the following example: the instead, negligent is the tort of misrepre- A, a government United States food in- sentation is another illustration of the spector, performance in the of his official principle may that an actor create a of risk duties, negligently stamps quantity a of harm duty and thus owe a to another even B’s beef as A.” In “Grade fact the beef is in the having absence of sold or manufac- of quality. inferior In reliance the upon product. tured a Accordingly, majori- the D, stamps, buys C the beef from and ty misses the in concluding mark the pecuniary suffers loss as a A result. duty brand defendants owe no to Huck subject liability to C. because they product. never sold her a (Second) § Restatement of Torts 552 illus. Similarly, just applied as have the 139; i, § at see also id. 552 cmt. (Sec- duty principles of the Restatement (“When a misrepresentation a ond) creates risk for many years, we have also applied physical person, of harm to the land or duty principles the of the Restatement others, (Third) of chattels the of the mak- both before and after adoption our extends, er under the rules stated in general duty of the section 7 in Thompson. See, §§ 310 any person to whom he e.g., Hogan, Bohan v. 567 N.W.2d (Iowa 1997) (“An expect should harm physical to result may act or omission it.”). through action taken in upon negligent reliance be if the actor realizes or should duty. rise Id. at 237. We give to the involves an unreasonable it realize that negli- there through the thus to conclude that another were “unable of harm to risk proved the other or a that would conduct of be no of facts or reckless could set gent (Sec- Restatement (quoting negligence a actionable person.” support third claim of ond) 302A, 86)); § Fíala v. at of of’ Id. part printer. Torts the at (Iowa 1994) Rains, N.W.2d ap- have following Thompson Our cases Rapids (same); Mitchell v. also Cedar see Feld, we ex- In plied principles. same Dist., 832 N.W.2d Cmty. Sch. exercise duty all actors owe plained (Iowa 2013) (“[W]e duty adopted injury to causing care to avoid reasonable Restatement principles others, if the liable and the actor be (Third)....”); Hoyt, 829 at 775- re- conduct injury caused actor’s (examining duty principles 76, 776 n.4 actor’s rendering risks sulted (Third) 7, 19, sections Restatement Feld, 790 N.W.2d negligent. conduct 40). (Second) 75-76; Restatement also particularly in Bohan is analysis Our 284(a), (providing negligent Torts Bohan, 567 point. of this See illustrative acts “which the actor as conduct includes Bohan, group N.W.2d at 235-37. recognize involv- man should reasonable negligence claims for brought investors causing an ing an unreasonable risk of deception as a result of a losses suffered another”). We invasion an interest by a broker. Id. at 235. The securities ex- long-standing contact-sports noted our inves- from the broker had secured funds ception general duty to the to exercise certifi- by delivering tors them fictitious care, policy reasonable and noted various purporting cates of to have been deposit supported our reasons modification At Chicago issued bank. issue in realm general slow-pitch in the the case of the inves- were not claims Feld, high school softball. broker, against tors investors’ but general duty 76-78. retained a small printer Iowa who cases, it such that class of but modified printed certificates, knowl- had without games actors slow-pitch in softball edge of at the broker’s re- deception, have a avoid disre- duty now reckless lack quest. Despite printer’s Id. for the Similar- gard safety of others. Id. knowing involvement in the broker’s McCormick, in we we had af- ly, noted scheme, despite any special the lack of and recognizing general firmed our law relationship printer between and the explained duty Thompson in and an actor investors, we reasoned the investors had duty to reasonable generally has a exercise a printer’s stated claim of the “own active care when the actor’s conduct creates furnishing negligence instrumentality in McCormick, physical harm. risk harm to caused these claimants.” Id. 371, Concluding at the sub- N.W.2d principles at 236. the aid of the set With duty proper- contractor there owed no to a (Second) forth in section Restatement who had electro- 302B, (Third) ty employee owner’s been later in Restatement and by a we 37, switchgear, explained cuted 7, 19, duty sections we concluded a ‘risk of subcontractor had “createfd] when an exercise reasonable care exists ” harm,’ general neg- thus our harm, physical actor’s creates a risk of conduct principles and the ligence principles if negligent even the risk involves the or (Third) lia- support Restatement would not reckless id. at conduct another. See bility. (quoting Restatement special relationship, 236-37. No ex- at 374-75 (Third) Physical Liab. & plained, required parties between the Torts: was 77). 7(a), Finally, § in post-sale warning); Cooley Emotional Harm able care v. Co., Quick long-standing Supply rule Hoyt, we reiterated our N.W.2d (Iowa 1974) (explaining question of duty to exercise rea- whom that an actor has warning should receive is “to be decided care when his or her conduct cre- sonable [by jury] by standards of reasonable harm, explaining ates a risk of while no- care.”); Hawkeye, 685; 174 N.W.2d at duty rulings excep- should be limited Bengford Corp., v. Carlem 156 N.W.2d invoking specifically tional classes cases (Iowa 1968) (“Applying these rules to countervailing policy articulated consider- the evidence this case it seems clear a Hoyt, ations. 829 N.W.2d at 775. defendant, jury could find Ford Motor Notably, duty we never invoked the Company, failed to follow these recognized Bredberg at all in question Mulcahy. proximate standards of care and that as a 328-29; Bredberg, See 551 N.W.2d at Mul- plaintiff injured.”); cause thereof was cahy, majority 386 N.W.2d at 69-76. The Larson, 1202, 1222, Wagner v. 257 Iowa appears agree Mulcahy nothing had (“If a manufac- say duty about court there was con- —the turer does everything necessary to make majority’s cerned with the proposed “prod- the machine function ... properly then the requirement,” causation uct-identification manufacturer has satisfied the law’s de- duty because the existence of a was never mands.” (quoting Campo Scofield, question. duty principle most (1950))). N.Y. 95 N.E.2d As prominently applicable in both Mulcahy recently we have more explained, affirma- Bredberg was surely long-standing tive duties created as a result of a special products liability principle strict that “the relationship or undertaking, like the strict seller, by marketing his for use liability duty, may often overlap with the consumption, has undertaken and as- general duty, but the existence of an affir- special sumed a responsibility any toward displace mative does not general consuming public member of the who may See, duty. e.g., Hoyt, 829 N.W.2d at 775- (Second) injured by be it.” Restatement 76; 685; see also Hawkeye, N.W.2d at c, 349; § of Torts 402A cmt. see also (Third) Restatement of Torts: Liab. for Bredberg, 551 (citing N.W.2d at 326-27 Physical e, & Emotional Harm 6 cmt. 402A); section Mulcahy, 386 N.W.2d at 70 law, 68-69 (explaining special rules of (same); Vanderloo, also Moore v. 386 “such as various liability,” rules of strict (Iowa (“A 1986) drug may impose liability even the absence of manufacturer be liable held for a general duty, noting Restatement product defective in a liability strict ac- (Third) of Torts: Liability Products details tion.”). rules); liability c, § those strict id. 40 cmt. at 40 (explaining relationship gen- between liability however, That strict principle, duties); § eral and affirmative id. 40 cmt. was not the principle resolving the (same). h, at 42-43 duty question in any those cases or other products cases, because as we Application Duty B. of Our Princi- noted, long our longstanding general ples. Applying duty principles our as we duty of reasonable applicable care is also have, always the existence duty of a See, Osborn, in these cases. e.g., 290 should not be controversial here. (citing examining N.W.2d at 901 cases “de- brand defendants created in design- risks design fective of a product project or ing and manufacturing Reglan®, and cre- Lovick, negligence”); see also 588 N.W.2d ated in developing warning, risks its which, at (confirming duty law, 696 to exercise reason- virtue of federal generics 394 harm, and I physical a risk of gave Those risks creates to mimic. required

were propo- recognition are not novel duties set- These believe our those rise to duties. See, Cooley, e.g., in our caselaw. tles here. See Restatement question sitions (Third) (requiring “reasonable Physical 221 at 771 Torts: & N.W.2d Liab. information will reach 7, 77; that the § assurance also Harm at Emotional depends then- safety upon Feld, those whose 776-77; Hoyt, N.W.2d at (internal quotation marks omit- it” having 75-76; 774 N.W.2d Thompson, N.W.2d at West, ted)); (noting at 197 N.W.2d (Second) 835; Torts Restatement reasonable care “as to recognize duty (“One 327, § has at 146 who knows or reason- actor] which can any product [an ... that a is person reason to know third if dangerous negli- he is ably expect to be necessary ready to another to give aid sale”); Tice v. in its manufacture gent him, negli- prevent harm to physical 48, Wilmington Corp., Iowa Chem. per- gently or disables the third prevents (“When (1966) a man- aid, subject son such giving from ufacturer, distributor, producer or retailer physical harm caused to liability for representations as product markets a with he other absence of the aid which by the certainly to its condition there should most giv- third prevented person imposed accountability where be a strict con- ing.”). countervailing policy Whether relies those upon the ultimate consumer may modify is a siderations those duties injury....”); suffers representations and par- and a separate question, question PLTVA, Inc. v. Mensing, see also 564 U.S. directly, ties not address but I will do -, -, 2585-86, 180 131 S.Ct. analyze it in turn. J., (Sotomayor, L.Ed.2d however, tackling question, that I Before dissenting) requires drug FDA (noting “ application note of a relation-based even to revise label- companies ‘to seek their duty establish duties conception would provide FDA with in- supporting ” brands, on behalf of the because federal formation risks’ it explaining about responsibility establishes brands’ companies “undisputed” drug “have design and the both the under federal law monitor the Dolin, See, warning question e.g., here. safety of products”); their Restatement *4 (explaining brand WL (Third) 6(c), § of Torts: Prods. Liab. for” responsible generic’s “design “was (establishing duty of care to balance label”); and warning Mulcahy, see also prescription drugs risks and benefits liability may at 70 (explaining N.W.2d 6(d), respect design); with id. way attach actor “was in some re- when (establishing duty of care to balance risks sponsible particular prescription drugs and benefits of Lance, injury”); 85 A.3d at 453 caused respect and warning); instruction cf. imposes n.24 (explaining law also Co., Lamb v. Manitowoc “federal post-marketing duties (Iowa 1997) (“A pharmaceutical duty to warn exists companies, including obligation the to ‘en- party reasonably when a a dan- foresee[s] warnings that remain ade- sure] [their] injury to one ger damage less knowl- mar- quate long drug as the is on the edgeable adequate warning unless an ket’”). (Internal respect design, to federal With given.” quotation omit- marks ted.)). requires generic the version’s chemical majority par- Neither the nor the equivalence approved have to the brand-name suggested depart ties from our ingre- the longstanding drug: it must have same “active recognition general both ingredients,” “route of special and duties when an conduct dient” or “active actor’s administration,” form,” initially had the “dosage ability and the brands both counterpart. its “strength” as brand-name any upon investigation remedy and later to (2012). § 355(j)(2)(A)(ii)-(iii) 21 U.S.C. drug’s warning. defects in the design or “bioequivalent” must also generic be Dolin, *5-6; also WL see the same “rate and extent Co., Bottling Henkel v. R & S drug. as the Id. absorption” branded (Iowa 1982) (“A 185, 192 manufacturer (8)(B). respect § 355(j‘)(2)(A)(iv), With to anticipate must the nature of the environ- warning, majority explains, as the ment in which the used be [will] approve accuracy FDA must and ade- [design against] the foreseeable risk quacy labeling, generic brands’ attending product’s set- use that law, manufacturers are drug required, ting.”). A of authority mountain from oth- labeling “the the new proposed show jurisdictions supports er recognition of a same drug labeling approved is the as the duty on of a part brand manufacturer [approved drug.” for the brand-name] Dolin, given these considerations. See (b)(1), (2)(A)(v). And, 355(a), (d), § after (“[T]hese 2014 WL parties *6 applica- initial of the approval drug new that, relationship stood in a to one another tion, a brand manufacturer may update its ‘direct,’ while clearly was sufficient or strengthen label to “add a contraindica- impose duty law to a of reasonable tion, warning, precaution, or reac- adverse GSK upon conduct for the benefit of Plain- strengthen tion” or to “add or instruc- an Schedin, tiff.”); 808 F.Supp.2d at 1136 dosage tion about administration (“[T]he had jury sufficient evidence increase the safe of the intended use which to [the conclude breached its brand] by filing an with drug product” application duty to warn and that this breach caused FDA, but it need not wait for FDA generic injuries.”); see [the consumer’s] generic and the approval, manufacturers (“In Chatman, 960 F.Supp.2d also an subject ongoing obligation case, an misrepresentation affirmative 314.70(c)(6)(iii)(A), § sameness. C.F.R. a though even defendant does not have (C) (2008); 127(a)(7); 314.94(a)(8), §§ id. with the relationship plaintiff, it is still Regu- New Drug Application Abbreviated possible for the defendant to be liable for lations, 17950-01, Fed.Reg. (Apr. causing plaintiffs physical injury if the 1992) (“[T]he [generic labeling drug’s] plaintiff reasonably relies on false informa- drug prod- must be the same as the listed defendant.”); provided by Kellogg, tion labeling drug prod- uct’s because the listed (“To [generic approv- F.Supp.2d recognize uct is the basis for drug] al.”). Moreover, every drug state has a now brand name manufacturer owes law, requires substitution which duty to use reasonable care to avoid caus- pharmacists filling prescriptions under ing injury consumers generic most circumstances substitute bioequivalents ‘recog- of its drugs does not alternatives for branded avail- drugs when nize a enlarge new cause action or Dolin, n.5; able. WL at *5 ”); Easter, existing WL one’.... (2013). also, e.g., Iowa Code 155A.32 (“Lilly’s inti- design at *9 of and knowledge mate about also thimerosal doubt, then, be There can no brands gives rise to to inform users other pro- understood manufacturers were hazards associated the use of thimer- ducing generic drug, versions of the those —Weeks, osal.”); -, So.3d at required by were use the versions law to (“[I]t design label, and at *19 not warning brands’ consum- WL is fundamen- versions, purchasing tally unfair hold the manu- ers were those and to brand-name (Third) Physical of Liab. for on a it ment Torts: warnings product liable facturer i, § 82. Harm 7 cmt. Of manufacturing & Emotional produce because did not course, recognize, even that as the drafters misrepresentation irrelevant to is process subject important minor modification based, de- manufacturing theories generally recog- courts exception, as have itself, but on informa- product fects in the even duty nized the to warn extends deficiencies, those when warning tion drug “knows or patients company when misrepresentations were drafted alleged pro- to know that health-care reason manufacturer the brand-name be in to reduce position viders will not generic manufac- merely repeated by the harm.” Restatement risks of See Conte, turer.”); Cal.Rptr.3d at 315 (Third) 6(d)(2), § Liab. of Torts: Prods. (“We duty of care Wyeth’s hold that parties major- nor the at 145. Neither disseminating product information extends ity we discard suggestion has advanced injured by ge- who are patients to those pharmaceu- in the generally duties to warn metoclopramide pre- as a result of neric any and I believe industry, tical do not Wyeth’s written in reliance on scriptions jurisdiction any policy any court from or Lance, Reglan.”); information for principle support approach. would that (“Wyeth proponent 85 A.3d —as impact litigation I of do not discount the tort existing law—has of a contraction of industry. I pharmaceutical on the would regulato- federal persuade failed to us that note, however, presented we been have departure ry involvement warrants very purposes with little of information redress, of civil Pennsylvania’s system undertaking any comparison reasoned there is lack of due where a demonstrated impact with social im- substantial duty.”); existing in the face of an care pact filleting longstanding our Clark, 7668730, 2008 Phila. 2008 WL Ct. fault-based in Iowa. We do know (concluding PI. at *28-32 Com. LEXIS significant have been granted brands duty generic manufacturer owed brand advantages exchange for the burdens of purchaser). responsibility they design bear Accordingly, I both believe relation- They an labeling. are entitled to ini- duty conceptions based and risk-based tial period government-protected mo- compel duty our of a here. recognition patent nopoly privileges the form Policy Countervailing C. Consider- protection. § They See 35 U.S.C. noted, recognized ations. As cat- we have those entitled to extension of mo- principles egorical policy or considerations nopoly when versions of privileges modify- sometimes a basis for provide their drugs approval. receive FDA See id. longstanding gener- our eliminating extension); § Drug (patent-term Price duty broadly al of care for certain drawn Competition and Patent Term Restoration See, Feld, e.g., classes of actors. 98-417, Act Pub.L. No. Stat. at 76. In the context of prescrip- (codified part relevant U.S.C. drugs, (1988)) tion drafters of Restate- approval (pairing generic (Third) extension). ment explained general have patent-term We know long- trend has not been to disembowel the they enjoy “the fiscal rewards of name- instead, standing duty to courts recognition brand and the commensurate warn— ..., typically recognized duty, charge a ability higher price even slightly modified it after marketing period such exclusive ex- [their] Conte, pires.” at 317. generally provide Cal.Rptr.3d warn and instructions Moreover, know prescribing physician. recognition to the See Restate- our of a Furthermore, noted, duty subject any does not the brands to as I have the Su preme rejected Court has the notion obligation parties here —as all in- new negligence brand concede, defen already the brands are volved dants for failure to warn based on state obligations respect these with subject to tort preempted by are federal law. versions, the design the branded Levine, See 555 U.S. at 129 S.Ct. at the same for warning must remain 1204, 173 Yet, L.Ed.2d at 70. the majority generic versions. quotes length from an article authored Perhaps importantly, most we know by Epstein Professor asserting the Su Congress weighed each of these consider- preme got it wrong preemption. Court on ations in enacting the Hatch-Waxman Repurposing Epstein’s rejected policy ar FDCA, guments favoring preemption, notably, majority amendments to the advances them in favor of no-duty rule in made no reference to elimination of the they this case. As failed in furtherance of legal obligations. brands’ fault-based See preemption, they up must come short here Drug Competition Price and Patent Term as well. Restoration Act of Pub.L. No. 98- (1984). Indeed, 98 Stat. Epstein place great I be- would reliance on expertise of the FDA in assessing the legislatures

lieve both courts and posed by consumers, risks medications to typically regarded system pro- tort warn, allocating duty regulating viding powerful engage incentives to in re- warnings. content of But there is sponsible, reasonable behavior to promote story. another side of Supreme As the industries, safety in including numerous Levine, Court noted in the resources of the pharmaceutical industry. general- See FDA are limited while the volume regu- Levine, 555, 578, ly Wyeth 555 U.S. Levine, lated medications is vast. 1187, 1202, S.Ct. 173 L.Ed.2d 578-79, U.S. at 129 S.Ct. at (2009). general assembly Our codified (noting L.Ed.2d at 68 the FDA has limited recognition shortly after the Hatch- 11,000 resources with regulate which to amendments, noting Waxman gen- our medications). reality This has prompted a eral tort applicable duties are even in commissioner, former FDA along with a actions, products liability to actors well noted administrative law authority, to ex- outside the direct stream of distri- press agency’s reservations about the abili- bution in both negligence and strict liabili- ty effectively monitor safety of the See, ty. e.g., Iowa Code 668.12 consuming public, and to affirm the ameli- (“Nothing provid- [contained in subsection purposes orative served state tort law: ing state-of-the-art shall defense] diminish Our second concern is that the FDA’s assembler, of an designer, suppli- pro-preemption arguments are based distributor, er of specifications, manufac- what we see as an unrealistic assess- turer, concerning or seller to warn subse- agency’s ment of the practical ability— quently acquired knowledge of a defect or once it approved the marketing of a dangerous condition that would render the detect unforeseen adverse ef- —to product unreasonably dangerous for its fects of the drug and to take prompt and foreseeable use or diminish the liability for all, effective remedial action. After warn.”); Lovick, failure to so see also 11,000 there FDA-regulated drugs N.W.2d at (explaining “section 668.12 on the (including market both prescrip- clearly established our legislature’s under- tion drugs), and over-the-counter standing duty”). nearly one hundred more approved each the label is safe the FDA that finding by FDA does that the reality is The

year. approval to gaining federal for purposes the perform the resources have not represent not drug. It does market the monitoring compre- task Herculean labeled, never can drug, that the as finding drug every performance the hensively action, federal by unsafe later deemed be fail- regulatory Recent market. on the case, of state application in the or as this ineffectual agency’s ures, as the such law.”). Vioxx, demonstrated have response view, instructive, my that Con regard. shortcomings in this It is FDA’s the failure- preempt chosen to has not inability police gress FDA’s the Given brands. brought against own, cases question we to-warn its effectively on safety against preemption choice policy The to re- FDA’s efforts wisdom the more during the by Congress maintained complimentary or eliminate strict the FDA’s existence than seven decades by market fail- on the placed discipline val legislative branch that the evidences litigation. ure-to-warn in this effects of tort law salutary ues pre knows how to Congress clearly area. tools law- information-gathering The medi it did so in the as preemption, scribe are, by any meas- litigation have in yers in 1976. See U.S.C. cal device field the FDA’s. ure, than more extensive 574, S60k(a) Levine, (2012); at 555 U.S. 1200, The L.Ed.2d at 66. at 129 S.Ct. authority FDA’s Statutory in the gaps eschewing preemp by Congress choice information, especially post-ap- gather reveals pharmaceuticals tion for brand hamstring ability its to ensure proval, civil impact of the in the beneficial faith market. The safety drugs on the protec system augmenting justice may help Act close FDA Amendments Levine, FDA. See by afforded tions somewhat, they remain but gaps those at at 129 S.Ct. 555 U.S. liti- The benefits of this substantial.... (“If Congress thought state- at 66 L.Ed.2d lightly, not be discarded gation should objec to its posed suits obstacle said, and, see no benefit we have an ex tives, have enacted surely it would finding public FDA to the point at some provision press preemption pre-empted. litigation failure-to-warn history.”); see 70-year during FDCA’s Vladeck, A A. Kessler & David C. David at 1199- 129 S.Ct. also id. 555 U.S. FDA’s Examination Critical (“Congress did L.Ed.2d at 65-66 Efforts Claims, 96 Preempt Failure-to-Wam remedy for consum a federal provide (2008). 461, 465, 492, If the Geo. L.J. drugs by unsafe or ineffective ers harmed and Vla- advanced Kessler any subsequent reasons inor in the 1938 statute in Le- Supreme Court Evidently, deck—and it determined amendment. rejecting preemption of failure- vine—for of action widely rights available state any given prac- injured are to be to-warn claims relief provided appropriate apply recognized recognition, they must It also tical consumers. majori- force to the further consumer equal, greater, if not remedies that state-law doors manufacturers to by motivating courthouse ty’s protection contention and to drugs like Huck and effective to consumers safe produce should be closed (Footnote Levine, omit warnings.” no-duty give adequate rule. See by a court-made Rostron, ted.)); Duke L.J. 129 S.Ct. U.S. (“The oversight re J., regulatory FDA’s (Thomas, concurring) L.Ed.2d at 77 prevent insufficient to proven (“Initial peatedly of a label amounts to approval unreasonably dangerous drugs majority’s pharma- claim that reaching Tort law provides industry consumers. ceutical will substantially be for drug vital incentives makers to act harmed a rule imposing duty on the brands, appropriate ap care. Courts should who controlled the content of the ply encourages tort law in a manner that warning PLIVA legally required was use, is, drug companies view, to continue in producing my speculative and ov- Garber, novative but to products reasonably act erblown. See Steven Economic products that their ensure safe and ac Liability Product and Other Effects of companied by adequate warnings ac Litigation Involving and Safety and Ef- Striking right Pharmaceuticals, curate information. bal Rand In- fectiveness of challenge, Justice, ance is a but it is that (2013), one stitute for Civil at xv striving courts must continue to meet. available www.rand.org/pubs/ quite literally These issues can monographsAngl259.html be matters (suggesting pol- (Footnote omitted.)); of life and death.” icymakers be “wary should of broad Stoddart, Missing Allison Mens claims about economic pharma- effects of cf. after ing: Remedy A Drug liability, Generic Con ceutical including generalizations sumers, (2012) L.Rev.1967, 53 B.C. based on anecdotes or examples”).21 The (“The system tort incentivizes manufactur safety-based regulations promulgated by strengthen warnings by ers to allowing the FDA can comfortably coexist with the tort claims manufacturers when brands’ to exercise reasonable care the probability of harm from an in warning inade grave consumers of health quate warning greater than the attending burden risks pharmaceuti- use of enhancing is, See, Levine, the warning when cals.22 e.g., 555 U.S. at —that the manufacturer negligent.”). 129 S.Ct. at 173 L.Ed.2d at 78 Although advocating 21. constraining autonomy). interests restriction of Similarly, state nu- products tort contend certain have merous commentators have noted tort claims been either withdrawn or withheld from the operate important as an check even in feder- market because of costs associated with See, ally regulated e.g., fields. Catherine M. justice system, the civil there is scarce direct Sharkey, Preemption by Preamble: Federal empirical supporting evidence these conten- Law, Agencies and the Tort Federalization of tions. Even if we were to credit the conten- (2007) (criti- 56 DePaul L.Rev. 230-33 tions, however, analysis require our would cizing Safety the Consumer Product Commis- examination of questions: additional crucial express preemption sion’s inclusion of an products dangerous? Were the bad or Was flammability clause its mattress standards their withdrawal pub- from the market in the "[rjemoving significant incentive in- See, Schwartz, e.g., Gary lic interest? T. Real- improve meeting dustries to outside of ity Analysis in the Economic Tort Law: (internal quotation federal standard” marks Deter?, Really Does Tort Law 42 UCLA L.Rev. omitted)); McGarity, see also Thomas O. (1994) Schwartz], 410-13 [hereinafter Preemption War: When Federal Bureaucracies Trump (explaining Local Juries 236-38 Principles practicality of federalism and compli- common law reinforces incentives for understanding. bolster this Numerous com- regulations, gaps ance with federal fills recognized mentators and authorities have unanticipated consequences regulations, independent sovereigns states are in the fed- provides protection agencies while take system, play eral impor- a historic and responses time to problems); formulate regulation tant role the local of health and Schwartz, ("Likewise, See, 42 UCLAL.Rev. at safety. e.g., Young, Ernest A. Federal (first) (then) tort suits can uncover and Preemption Autonomy, dra- and State in Federal Powers, Preemption: way matize information in a States’ can set in National Interests (Richard regulatory Epstein response.”). general- motion a A. & Michael See eds., 2007) Sosnowski, ly (noting preemption Narrowing S. Greve H. Thomas problematically regulatory diversity by Against limits Implied Preemp- Field: The Case Field (“The inquiry as (Thomas, J., concurring) federal evidence-based risk/benefit entail, join I prohibited process tort would regulations neither statute forge seek to those commentators who warning required label stronger path recognizes the distinct benefits Wyeth nor insulated judgment, the state tort regulation that both liability.”). As the risk of state-law offer. explained, Rabin has Robert “require” anything duties Rabin,

Tort do in the Robert L. Territorial Claims damages. of If payment than the other Conflicting Harm: Domain Accidental of to a liability lead defendant tort does 74 Brook. Preemption, Tort Conceptions of greater in favor of 991, 993, 1002, assessment private L.Rev. measures, added). then precautionary future (emphasis course, tort, had a regulatory of has considerations, taking and Given these dictates partic- effect. But tort itself no range the vast of information account of change losing defendant’s con- ular in a balancing weighed that must be when duct. pharmaceutical industry interests of consumers, I do not believe

and those of [Tjhere that principle is inexorable no craft adequately we to equipped uniform national gains from productivity I bright-line no-duty rule here. would safety health and standards —a fre- general leave that to our as- policymaking quently preemp- invoked rationale recognize has continued to sembly, which by injury victims tion—should be borne realm. I would therefore duties this Moreover, of harm. cases residual long-standing hew to continue to and again, once it is critical underscore recognition gen- widespread of the brands’ dynamics Liability of tort. does eral and affirmative duties here. regulato- entail departure enforced III. Factual Causation. standards; only compels

ry payment it damage awards. In establishing addition existence duties, of a have often duty or we ex- plained products liability If the tort rests on an and tradi- claim assertion both evi- post-approval negligence plaintiff substantial new tional cases the “must light, relationship dence risk has come causal between establish a Lovick, neither been into a incorporated alleged negligence injury.” revised nor warning, rejected agency liability); (products ac- N.W.2d insubstantial, the cord Thompson, N.W.2d 836-39 risk/ben- foundational analysis agency which In the context of failure (negligence). efit certifica- Hence, inapposite. tion was claims, based have warn noted factual causa- not an the tort claim is to revisit by demonstrating tion is established “a effort supersede regulatory approval plaintiffs have warning would altered process. Lovick, injury.” conduct so as avoid generally, at 700. as the N.W.2d More (Third) ad- drafters of the Restatement have proposing a framework for “[cjonduct tensions, provided, a factual cause dressing based on fo- these harm agen- cused of whether the harm when the would not oc- examination Restatement cy grounded directive is the same curred absent conduct.” Law, (2013). Liability tion State Product 88 N.Y.U. L.Rev.

(Third) Physical Torts: Liab. for & her harm would not have occurred had the 346; § Harm Emotional accord brands not allegedly satisfy failed to their (adopt- care, 774 N.W.2d at 837-39 Thompson, obligation of reasonable and similar- (Third) Restatement factual causation ly, she has advanced evidence sufficient to scope principles); see also a jury warning allow to find a would have P.C., v. OB-Gyn Specialists, Asher 846 altered her conduct such that she would (Iowa 2014). This is tort Lovick, injury. have avoided See test, law’s familiar “but-for” and both the (“[C]aus[ation] N.W.2d at 700 can be es- First and Second Restatements of Torts by showing tablished a warning would providing endorsed this standard in “the plaintiffs have altered the conduct so as to harm would not have occurred had the injury.”). avoid See, negligent.” e.g., actor not been Re- Although analysis resolves the fac- (Second) a, statement of Torts 431 cmt. tual question simply causation and com- (Third) 429; also Restatement pletely, I think it prudent point out Physical Torts: Liab. for & Emotional general several principles relevant to the b, § Harm 26 cmt. at 347. analysis factual causation in products both Here, majority explains, Gya- as the Dr. liability general cases in and in the case we published by no relies information upon Dolin, actually confront here. 2014 WL purposes covering the brands —for both 804458, at *7 (noting courts have often versions of drugs gener- branded and their similar, facially two but “conflate[d] funda- counterparts Physician’s ic the Desk —in distinct, mentally liability problems”); tort in making prescription Reference decisions Rostron, (“[Cjourts 60 Duke L.J. at 1164 generally, and she relied on this informa- repeatedly mistake, have made the same prescribe tion in 2004 to branded Reglan dwelling on the irrelevant concept of liabil- Gyano for Huck. Dr. explained the ity being imposed multiple on manufactur- analysis risk-benefit she in making uses ers uncertainty because of about who prescription changed decisions has as a made a product and conflating that con- result of her access to the updated brands’ cept with the separate and distinct issue of information and labeling. supple- She now whether a manufacturer can be hable for ments the conversation she typically has wrongdoing making other than selling and patients with this risk-benefit infor- received.”). product plaintiff the making prescription mation before deci- noted, already As I have the factual Further, sions. she has noted she would scenario we confront here is not the one have modified her treatment conversations we examined in Mulcahy, where we could and decisions in way the same had she identify allegedly the actor responsible received this information back in and Instead, for harm. we face here a scenar- the information would have had the same injury io where an in occurred connection impact. Finally, Gyano Dr. and Huck given product with a and plaintiff can explained had this information been sooner, demonstrate available tortious conduct someone they and had discussed then, other than the product’s manufacturer had implications back Huck would a causal role in producing injury. never have taken metoclopramide, and This latter would never have scenario is not a novel in developed dys- tardive one products field of law. Applying principles general- kinesia. our of factual See fashion, ly causation in Madden & straightforward Liability we Owen Products (3d ed.2000) may safely 19:4, conclude Huck has advanced (collecting cases); Bush, jury evidence sufficient to allow a to find Melissa Evans Li- Products seed, issuing tag Li- defective blue Property and Intellectual ability censors, 311— stating representing quality Mitchell L.Rev. such and 22 Wm. cases). (2000)(collecting directory in of the seed the 1977 created jury an issue for the whether de ways, in numerous The scenario arises negligence was liable for fendant each, not hesitated in courts have misrepresentation.”). Similarly, negligent or Where an finding factual causation. organization a trade association or other ganization testing in the business setting safety insufficient standards for a affixing certifying the products and labels harms factually cause flow testing negligent its its results of plaintiffs prod from the use of the example, have con courts labeling, Smith, Inc., Meneely uct. See v. S.R. negligence may tester’s be a cluded Wash.App. P.3d injuries prod when these factual cause (“We hold the evidence and the reason perform in accordance with ucts fail See, support inferences therefrom labeling. e.g., Hempstead v. able Extinguisher findings Corp., jury’s negligently Fire that NSPI Gen. (D.Del.1967) (“If plain F.Supp. Meneefys injuries....”). caused Mr. charge in proving tiff his succeeds Perhaps point, recog more to the was negligent approving Underwriters McCarthy nized both Schiltz and de design extinguisher fire which signers suppliers specifications may imminently dangerous, was damages have a causal in resulting role thereof, injury plaintiffs was a result the failure of structures built accord must in respond dam Underwriters designs specifications. to those See ages.”). publisher When a is in the busi Schiltz, 17; McCarthy, 228 N.W.2d at 199 an placing ness of endorsement or seal of Schiltz, at 367-68. ex N.W.2d we products, fails to exer approval and plained plaintiff had advanced substan in ordinary care approving particu cise an firm engineering neg tial evidence had courts product, lar have concluded the designed ligently protective dikes for a publisher’s conduct may be a factual sewage facility treatment and substantial damages cause when the fails was a negligence evidence factual and in with the perform pub accordance legal old tort using our terminolo cause— See, representation. e.g., Han lisher’s Schiltz, gy plaintiffs damage. 228 —of v. berry Corp., Cal.App.2d Hearst 276 Similarly, at 18. in McCarthy, (1969) (“[I]ts 680, 519, Cal.Rptr. negligence in recognized architect’s and certification seal tend to induce and supplying plans specifications and for the encourage prod purchase consumers to might construction a school constitute magazine ucts advertised and “improper the factual cause collection certification.”). bear that seal which and discharge upon” and of surface waters Likewise, courts have concluded nonman- plaintiffs adjacent property. McCarthy, ufacturing seed certifiers constitute a 199 N.W.2d at 367. “in nontrivial link the chain of distribu propositions, In addition to I those note [places] which [product] tion commerce,” products liability cases never dis- stream and thus those age-old principle our placed torts that “an play any certifiers a causal role act intervening negligent will not relieve damage suffered parties relying third if that act or Rottinghaus on those defendant force certifications. v. Howell, 99, P.2d a normal of the Wash.App. consequence was defen- (1983) (“MPIA’s reasonably conduct or was foresee- certifying conduct dant’s by that Iowa Light requirement able defendant.” Elec. tion of the improvidently here Co., v. & Power Co. Gen. Elec. easily forsakes our clear and applied prin- (Iowa 1984); also, e.g., Rossell ciples of factual causation. I in- would Am., Volkswagen 147 Ariz. apply stead our traditional principles of (1985) P.2d “an inter- (explaining factual causation in this case and conclude vening superseding force becomes a cause Huck has advanced evidence sufficient to only when operation its was both unfore- jury allow a to find alleged the brands’ seeable when with the benefit of ‘hind- negligence awas but-for of the harm cause sight’ may it be described as abnormal or she has suffered here. I would therefore extraordinary” applying rule in case of entry reverse the district court’s of sum- negligent placement battery); of car Lar- mary judgment on Huck’s claims with re- Mach., Wallace, son Inc. v. 268 Ark. spect to the brands and remand for trial. 600 S.W.2d (explaining “[t]he mere fact that other causes intervene be- APPEL, JJ., WIGGINS and join this tween original negligence act of in part concurrence in part. dissent the injury recovery sought for which original sufficient relieve the actor if liability, injury is the natural and probable consequence original negli-

gent act or might omission and is such as

reasonably apply- have been foreseen” and

ing rule in spreader); ease of fertilizer (“[T]he

Weyerhaeuser, 620 N.W.2d at 831 resulting explosion fire and ... FEDERATION, were fore- IOWA FARM BUREAU intervening product’s seeable causes Association, [of Iowa Renewable Fuels supersede that did not defect] [defen- and Iowa Water Environment Associ responsibility.”); Zacher v. Budd ation, Appellants, dant’s Co., (S.D.1986) (ex- plaining “even if plaintiff is assumed contributorily negligent, whether that in- Agribusiness Iowa, Association of Asso

tervening supersedes force the defendant’s Industry, ciation of Business negligence is for the jury to decide” and Association, Iowa Cattlemen’s Iowa applying rule in case of wheel explosion). Cooperatives, Institute for Iowa Lime short,

In imaginable Association, universe of sce- stone Producers Iowa narios in which an actor who man- has not Association, Pork Producers Iowa ufactured a product may Poultry or sold neverthe- Association, Turkey Iowa less both cause and be damages liable for Federation, and Iowa Corn Growers caused is enormous. The majority’s pro- Association, Appellants, posed “product-identification re- causation quirement” does no work to address the ENVIRONMENTAL PROTECTION majority

vast of these scenarios. See Bo- Department COMMISSION and Iowa lin, (“Taken 2014 WL at *8 out of Resources, Appellees, Natural context, language identification ... may cases well appear support argument. truth, GSK’s the principles

for which Policy line of cases stands are Environmental Law & Center here.”). inapposite Midwest, majority’s invoca- Iowa Environmental

Case Details

Case Name: Theresa Huck v. Wyeth, Inc. D/B/A Wyeth Schwarz Pharma, Inc. and Pliva, Inc.

Court Name: Supreme Court of Iowa

Date Published: Jul 11, 2014

Citation: 850 N.W.2d 353

Docket Number: 12–0596

Court Abbreviation: Iowa