*1 76 II, 556, Klein 572
See 153 Vt. A.2d at 903. The exercise of this discretion must be based on the circumstances of the parties during period for which retroactivity could be Id. imposed. Here, magistrate made no finding these circumstances. addition, 1, 2002, mother sought retroactivity only January approximately family the date the court would have issued a child-support order absent its erroneous decision that it had no jurisdiction to do so. While she cannot control the child’s right support, child her lack of preservation is a factor magistrate to consider.
¶ 24. family We reverse the court decision retroactivity can extend no further back than the date of the motion to establish support child and remand for the child-support magistrate exercise its discretion to choose the date of retroactivity within the limits described this decision. Affirmed, part and remanded proceedings consistent for farther
with the views expressed herein.
Opinion 27, Filed October Reargument Motion for Denied December Stayed January Mandate January Petition for Certiorari Granted *5 Richard I. Rubin, Rubin and Kerry B. Kidney, DeWolfe Myer Barre, & DeWolfe, for Plaintiff-Appellee.
Allan R. Keyes and R. Joseph O’Rourke of Ryan, Smith & Carbine, Ltd., Rutland, Rein, and Bert Karyn W. K. Ablin and E. Sarah Botha of Wiley LLP, Rein & Fielding and Daniel S. Pariser of LLP, D.C., Arnold & Porter Washington, for Defend- ant-Appellant. Johnson, J. Defendant Wyeth, drug manufacturer, appeals jury
from a plaintiff Levine, verdict favor of Diana who suffered severe injury and the amputation of her arm as a result of being injected with drug defendant’s Phenergan. Plaintiff claimed at trial that defendant was negligent and failed to provide adequate warnings of the dangers known of injecting Phenergan directly patient’s into a vein. Defendant argues that the trial court should not have allowed the jury to consider plaintiff’s claims because the claims conflict with defendant’s obligations under federal law regulating prescription drug labels. We hold that there is no conflict between state and federal requires law that preemption of claim. Defendant raises two claims of error plaintiff’s relating also hold that jury damages. instructions We court’s correct, rulings jury on these instructions were and we affirm. 2000, plaintiff injected 2. In was with defendant’s April drug Health, Phenergan Washington County Community Northeast (“the Center”). drug Inc. Health The was administered to treat plaintiff’s resulting migraine nausea from a headache. Plaintiff injections. received two was first administered injection. day, plaintiffs intramuscular Later the same when continued, nausea she received a second aby dose direct intra- arm, injection venous into her known using procedure as “IV push.” injection injection The second resulted an inadvertent *6 result, artery. into an As a Phenergan artery severely was deterioration, damaged, causing gangrene. After several weeks of plaintiffs hand and forearm were amputated. brought 3. Plaintiff a court action superior negligence product liability, alleging
failure-to-warn that defendant’s inad- equate warning dangers of the known of direct intravenous injection Phenergan injuries. of caused her a During five-day jury trial, parties presented both expert testimony regarding the adequacy warnings placed of the defendant on Phenergan’s label. experts Plaintiffs testified that the label should not have allowed administration, push IV as a means of itas was safer to use other options, injection available such as intramuscular or administration through tubing of a hanging bag. IV Defendant’s expert allowing testified that IV push cautioning against with instructions injection inadvertent arterial was sufficient. The court instructed jurors that they could consider the approval FDA’s of the in label use at the time of plaintiffs injury, but that the label’s compliance requirements did not adequacy establish the of the or warning prevent adding defendant from to or strength- ening trial, the warning on the label. At the conclusion of the jury found in favor of plaintiff negligence on both the product-liability claims and awarded her million in economic $2.4 damages and million in damages. noneconomic Pursuant to $5 parties’ stipulation, $6,774,000 this award was reduced to a total of to account for prejudgment plaintiffs interest and in recovery settlement of a separate action she had filed the Health against Center. trial, 4. In a summary judgment prior motion in as well as timely trial,
its motion for judgment following as matter of law denied, superior both which the court defendant that argued preempted plaintiffs federal law claim. These in arguments rested part on defendant’s contention that it had adequate submitted an FDA, warning to the but the FDA rejected change because it did not favor strengthening Plaintiff warning.1 contended that neither warning would have been The adequate. stated, trial court in its decision on defendant’s motion for warning part: on the label was use 2000 read in relevant INTRA-ARTERIAL INADVERTENT Due to the INJECTION: close proximity commonly of arteries and veins in the areas most used for injection, intravenous extreme care should be exercised to avoid perivascular injection. extravasation or inadvertent intra-arterial Re- ports compatible injection [Phenergan], with inadvertent intra-arterial usually conjunction use, drugs with other intended for intravenous suggest irritation, pain, spasm severe chemical severe of distal vessels, gangrene requiring amputation likely and resultant are under injection such circumstances. Intravenous was intended in all the cases reported perivascular placement but extravasation or arterial suspect. proven needle is management now There is no successful this condition after it occurs .... intravenously [Phenergan] given When used should be in a concen- greater mg per tration no than 25 ml and at a rate not to exceed 25 mg per administering any minute. intravenously When irritant it usually preferable inject through tubing it an intravenous functioning satisfactorily. set that is known to be infusion added.) (Emphasis warning adopt The revised the FDA failed to read relevant part: INADVERTENT reports INTRA-ARTERIAL INJECTION: There are *7 leading gangrene, requiring of necrosis to amputation, following injec- [Phenergan], usually conjunction tion of drugs; with other the cases, intravenous route was intended in partial these but arterial or placement arterial suspect. of the needle is now . . . prevention:
There is no established treatment other than proximity 1. Beware of commonly the close of arteries and veins at injection possibility used sites and consider the of aberrant arteries. intravenously, [Phenergan] When used given should be a greater mg/ml concentration no than 25 and a rate not to exceed mg/minute. Injection through properly running 25 intravenous may possibility detecting place- enhance the arterial infusion of addition, delivery ment. In this results in a lower concentra- of any tion arteriolar irritant. added.) (Emphasis 84 law, rejected the FDA had although as a matter
judgment explain failed to its the “brief comment” warning, agency’s a new more than atten- “gave passing that it reasoning or demonstrate an infusion to administer of whether to use IV tion to the issue the use change did not address proposed labeling drug. that there was “no bag.” The court concluded free-flowing of a IV verdict. upheld jury’s preemption” basis for federal (1) ¶ to superior by: failing claims the court erred 5. Defendant Drug on the basis that the Food and plaintiffs dismiss claim Phenergan preempted of the label state approval Administration’s (2) inadequate; failing claims that the label was common law damages by reduce the amount of jury plaintiffs instruct (3) Center; and to instruct failing fault to the Health attributable for plaintiffs damages to calculate the value of jury present error, reject these claims of and we future noneconomic losses. We affirm. Preemption
I. Federal appeal 6. Defendant’s is that the court principal argument preempted have dismissed claim because it was plaintiffs should any duty federal law. Defendant asserts that state common law administering about the provide stronger warning dangers Phenergan by push approval IV conflicts with FDA’s law, is a we review the drug’s preemption question label. As Sholan, Support trial court’s decision de novo. Child v. Office of (2001) (mem.). 619, 620, 172 A.2d 1202 hold that Vt. 782 We did not conflict jury’s against verdict defendant for defendant labeling requirements Phenergan FDA’s because against IV-push prior could have warned administration without create a approval, labeling requirements and because federal floor, regulation. not a for state ceiling, provides 7. The that federal United States Constitution VI, art. cl. 2. The supreme law is the law of the land. U.S. Const. is the for the doctrine of Supremacy preemption, Clause basis to which “state law that conflicts with federal law is according ” Inc., Cipollone Liggett Group, ‘without effect.’ v. U.S. Louisiana, (quoting Maryland v. U.S. (1981)). analysis the relevant Cipollone, Court described intended a federal statute to determining Congress whether preempt state law:
85 may intent be stated Congress’ explicitly language implicitly statute’s or contained its structure an purpose. express congressional the absence of command, actually state law is if that law pre-empted law, if thoroughly conflicts with federal or federal law so legislative field as to make reasonable the occupies Congress inference that left no room for the States to it. supplement omitted). clear (quotations congressional
Id.
and citations
Absent
law,
duties,
law
supersede
including
intent to
state
state common
Medtronic,
there is a
Inc. v.
presumption against preemption.
(1996) (“[B]ecause
Lohr,
470,
518 U.S.
485
the States are inde-
in our federal
we have
pendent sovereigns
system,
long presumed
Congress
cavalierly pre-empt
does not
state-law causes of
(“Consideration
action.”); Cipollone,
¶ 9. Defendant presents two alternative bases for its assertion of (1) conflict preemption: specific context of the Phenergan label, the FDA was aware of dangers IV-push administra- used, tion and specifically warning ordered defendant to use the it making it for impossible comply defendant to with both its state law; of federal duty requirements and the common-law wording drug companies using FDA-approved penalizing labels, like an obstacle to plaintiffs present state tort claims labeling regulations. reaching of the FDA’s Before purpose *9 issues, the FDA’s role in briefly regulating these we examine the courts have drug general approach labels and prescription effect of federal preemptive labeling requirements. taken to the Regulatory Background A. distributing prescription drug 10. Prior a such as
Phenergan, Drug Applica- the manufacturer must submit a New 355(a). (NDA) § tion for FDA 21 U.S.C. The FDA must approval. criteria, it to meet approve application the unless fails certain including whether test results and other information establish that drug prescribed, the is “safe for use under the conditions recom- mended, thereof,” suggested proposed labeling or the whether drug there is “substantial evidence that the will have the effect it or is to have under the conditions of use purports represented recommended, or in the prescribed, suggested proposed labeling thereof,” whether, and “based on a fair evaluation of all material Id. facts, labeling any such is false or misleading particular.” 355(d). §
¶ 11. “FDA mandate the regulations general format and content prescription of all sections of labels for all well the drugs as as contain,” each approval risk information section must and “[f]inal upon applicant NDA is ‘conditioned incorporating directed, specified labeling changes exactly as upon appli- submitting cant to FDA a of the final copy printed prior label ” Inc., Pfizer, v. marketing.’ McNellis *4 2005 WL (D.N.J.) 201.56, 201.57, §§ 21 (citing quoting C.F.R. C.F.R. 314.105(b)). § approved, any Once a and its label have been to the changes ordinarily require ap- label submission and FDA Id.; 314.70(b)(2)(v)(A). “Supplemental § of a NDA.” proval C.F.R. ¶ 12. If process the NDA and the submission of changes FDA were the exclusive means of approval creating altering labels, prescription drug might very key this be a different case. A however, FDA a regulation, drug’s allows manufacturer to alter drug’s prior necessary. label without when The approval in relevant regulation provides part: agency may designate category changes that, in providing change for the the case of a purpose category, approved application such the holder of an may drug product commence distribution of the involved upon receipt by agency supplement of a for the include, change. changes These but are not limited to: (iii) Changes labeling accomplish any ... the following:
(A) contraindication, strengthen To add or warning, reaction; precaution, or adverse (C) strengthen To add or an instruction dosage about and administration that is intended to increase the safe use of drug produet[.] 314.70(c). C.F.R.
¶ 314.70(c) 13. Section creates a specific procedure allow ing drug change manufacturers to labels that are insufficient to consumers, protect despite their approval by the FDA. “The approved FDA’s label . . . can therefore be said to set minimum labeling requirement, necessarily and not the ultimate label where a improves manufacturer promote label to greater McNellis, safety.” 3752269, 2005 WL at *5. specific While federal labeling requirements and state common-law duties other might wise leave drug manufacturers with conflicting obligations, 314.70(c) § allows manufacturers to avoid state failure-to-warn (“[I]t claims without violating federal law. Id. is apparent prior FDA approval obtained, need not be nor will a product be mislabeled, deemed if the manufacturer voluntarily or even uni laterally strengthens approved warnings, precautions po or tential upon adverse reactions pursuant label to 21 C.F.R. 314.70(c)(6)(iii)(A).”). § There is thus no conflict between federal labeling requirements and state failure-to-warn claims. Section 314.70(c) allows, and arguably encourages, manufacturers to add that, strengthen warnings despite FDA approval, are insuffi protect cient to consumers. State tort claims simply give these manufacturers a concrete incentive to take this action as quickly possible. as
88 in Preemption
B. Other Jurisdictions Conflict 314.70(c) leeway by drug 14. In created light nearly courts have unani warnings, manufacturers to add been claims do not that state failure-to-warn tort holding mous McNellis, 3752269, See, 2005 e.g., conflict with federal law. WL (“[T]he do not conflict with regulations *7 FDCA and FDA’s regulations failure to warn those federal Jersey’s New law because minimum which manufacturers must merely set standards with McNellis is the latest a series of recent cases comply.”). Zoloft, addressing anti-depressant this issue as it relates to the allegedly patients. which increases the risk of suicide some See conflict (denying summary judgment rejecting id. at **7-8 case); Inc., Pfizer, v. preemption Zoloft accord Zikis 2005 WL (N.D. 1126909, Ill.); Inc., Pfizer, Supp. at **2-3 Witczak v. 377 F. (D. 726, 2005); Inc., Pfizer, 2d 729-30 v. 127 F. Supp. Minn. Motus (C.D. 1085, 2000); Pfizer, 2d also v. Cartwright 1096-1100 Cal. see 2005) (‘With (E.D. Inc., 876, F. Supp. 369 2d 882 Tex. little that have this exact issue exception, courts considered have concluded that state failure to warn claims are not preempted regulations.”). the FDCA and its attendant Contra Needleman v. (N.D. Tex.) Inc., 1773697, Pfizer, 2004 at *1 (granting WL summary judgment to the defendant on basis of conflict preemp tion).
¶ 15. representative general The Zoloft cases are of a rule that FDA of a approval drug’s preempt label does state See, e.g., failure-to-warn claims. Eve v. Sandoz Pharm. Corp., (S.D. Ind.) 181972, 2002 at **1-3 (rejecting preemp WL conflict Parlodel); regarding tion of failure-to-warn claim Caraker (S.D. 1018, v. Corp., Supp. Sandoz Pharm. 172 F. 2d Ill. 2001) (same); Roche, Inc., 723, v. Bryant 585 S.E.2d Hoffman-La (Ga. 2003) (heart medication); Lollar, Ct. Bell v. App. (Ind. 2003) N.E.2d 854-55 Ct. App. (prescription pain medi cation); Parke, Co., App Kurer v. Davis & 2004 WI (oral Richwood, contraceptive). N.W.2d 867 But see Ehlis v. Shire *11 2002) Inc., 1189, (D.N.D. 233 F. Supp. (granting summary 2d judgment preemption to defendant on basis of conflict of claim Adderall). regarding drug cases, Ehlis, 16. Defendant cites two Needleman and
support preemptive effect of the FDCA in failure-to-warn Needleman, regarding prescription drug cases labels. 2004 WL 1773697, *1; Ehlis, at 233 F. 2d at Supp. 1198. Needleman is not particularly helpful under the circumstances here. Its holding relied on the litigation, facts the Zoloft an FDA particularly statement that the warning by advocated the plaintiff would have been misleading. 2004 WL at *1. The courts the other Zoloft cases took approach statement, a different to the FDA’s part because the FDA’s statement was not “an agency official position,” and in part because the FDA later position retracted its the link regarding See, Witczak, between Zoloft and e.g., suicide. Here, 377 F. 2d Supp. at 730. the FDA has not indicated that a stronger warning would be so the misleading, reasoning of Needleman appears inapplicable to this case. Ehlis interpreted 314.70(c) § as allowing unapproved changes to a label tem- only porarily, only under “limited circumstances.” 233 F. 2d Supp. at 1197-98. We can support find no for this interpretation in the language of the regulation, which appears to allow unilateral changes labels whenever the manufacturer believes it will safer, make the product and places no limit on the duration of pre-approval warnings unless the FDA disapproves the change. 314.70(c). 21 C.F.R.
¶ 17. Defendant next attempts to draw a comparison to the
regulation of
FDCA,
medical devices under the
citing medical
device cases in which state tort
law has been preempted. See
Buckman
v.
Comm.,
Co.
Legal
531 U.S.
Plaintiffs’
(holding
“fraud-on-the-FDA” claim relating to device regu-
lated Medical Device Amendments to FDCA was preempted);
(3d
Horn v.
2004)
Thoratec Corp., 376 F.3d
Cir.
(holding
failure-to-warn claim was preempted by Medical Device
Amendments). We find this analogy unpersuasive. Neither
Buckman nor Horn weakens the force of the drug-labeling cases
cited above. The claim that
preempted
was
in Buckman was for
FDA,”
“fraud on the
warn;
not failure to
the Court held that the
presumption against preemption applies only when a claim impli-
cates ‘“the
primacy
historic
of state regulation of health and
”
safety,’ which is not the ease when the claim arises from a
federal statute. 531
Medtronic,
U.S.
347-48 (quoting
¶
relating
of cases
group
cites a third
defendant
Finally,
18.
recent use of
Court’s
Supreme
the United States
to
generally
relies
argument
primarily
fields. This
other
preemption
conflict
(2000).
Co.,
C. ¶ 21. Defendant contends that this case it was impossible *13 to comply with both state and federal law because the FDA prohibited the use of a stronger warning respect to IV-push Phenergan. administration of This claim is not supported by the evidence presented defendant to the trial court. The record lacks any evidence that the FDA was concerned that a stronger facts, warning supported by was not the that such a stronger warning would distract doctors provisions from other in the drug’s label, or that warning the might lead to less effective administra Instead, tion of the drug. defendant essentially relies on two (1) factual assertions: the FDA approved the label that was in use 2000; FDA, reviewing label for use in a different version of Phenergan, expressed opinion its adequacy of the warning the original by label stating, “Retain verbiage in current label.”
¶22. With respect assertion, to defendant’s first our analysis above demonstrates that FDA approval particular of a label does not a preempt jury finding that the label provided insufficient warning, 314.70(c) as § defendant was free under to strengthen the warning without prior FDA approval. Defendant’s second depends “[rjetain assertion instruction, meaning verbiage current label.” Tort liability for defendant’s failure to strengthen its warning could have created a direct conflict requir- ing federal if preemption only the FDA intended the instruction to
prohibit any language strengthening the original warning. other words, unless we interpret the FDA’s statement as evidence that it would rejected have any attempt strengthen defendant to its 314.70(c), label through we cannot conclude that it was impos- sible for defendant to comply with its state duty common-law without violating federal law.
¶ 23. Defendant argues that the instruction reflected the opinion FDA’s not only that a stronger warning unnecessary, was IV patients by eliminating have harmed it would but also does Phenergan. The record administering an for push option as provided Defendant has a number interpretation. this support regarding FDA and defendant by the exchanged of letters the FDA’s label, letters do not indicate but these Phenergan’s the letters administration. Neither IV-push of the value of opinion indicated that the presented jury to the any nor other evidence as a method of push the use IV preserve wished can infer such concern from the administering Phenergan. Nor we “[rjetain current instead of verbiage” instruction to agency’s warning. specific warning agency adopting proposed more original any in favor of the label did not indicate rejected administration was clearly original IV-push than the label unsafe, label plaintiff argued original which is what made the for rejected warning The FDA could have the new inadequate. reasons, including clarity accuracy, or technical any number warning. Defendant’s implicitly prohibiting stronger without warning the FDA saw the new as hypothesis that unsupported rejected as the among likely explanations, harmful seems the least an push option would not have eliminated IV as proposal administration, administering Phenergan.2 respect With IV read, intra- original administering any label “When irritant inject through tubing it is it venously usually preferable functioning an intravenous infusion set is known to be stated, satisfactorily,” proposed “[i]njeetion through while the label may possi- enhance the properly running intravenous infusion *14 addition, arterial In this results bility detecting placement. any a concentration of arteriolar irritant.” See delivery of lower ¶ 4 supra, (comparing proposed original warnings). Simply n.l and stated, different, stronger. was but not It proposed warning longer original warning, was also no or more than the prominent any IV-push appears interpret warning eliminate The dissent to that would inherently approval Phenergan FDA’s for administration as inconsistent with the inconsistency, general. approval a TV administration in We see no such as an that all methods of IV for IV administration is not the same as conclusion case, any jury simply in a failure-to-warn case administration are safe. verdict insufficient; warning it not mandate a establishes the relevant was does warning. may any ways particular replacement have been number of for There eliminating strengthen Phenergan warning completely defendant to without pointing proposed warning IV-push purpose in that the administration. Our out rejecting warning rejected push simply could did not eliminate IV this preserve push option. affirmative effort the FDA to IV as an not be seen as an it so could not have raised a concern that it might overshadow other warnings away on the label or drive doctors from prescrib- ing drug. There is no evidence that the FDA intended to prohibit defendant from strengthening Phenergan pur- label 314.70(c).3 Thus, suant we cannot it conclude that was impossible for comply obligations defendant to with its under both state and federal law.
D. Obstacle to Congressional Purposes Objectives and ¶24. Defendant next contends that state liability common-law for its use of an FDA-approved presents label an obstacle to objectives. federal We hold that plaintiffs claim does not interfere any objective legitimately that can Congress. be ascribed to ¶¶ agree We with the reasoning above, the cases supra, cited 14-15, that federal labeling requirements pursuant to the FDCA floor, create a not a ceiling, for state regulation. Defendant presents a new FDA rule containing language disputing this reasoning, but this statement does not alter our conclusion that there is no conflict objectives between federal and Vermont common law.
1. The Purposes Objectives and of Congress ¶25. In the absence of a conflict that makes it impossible regulated for a entity comply with both state and law, federal federal law will preempt state if only law it “stands as an obstacle to the accomplishment and execution of the full purposes objectives Congress.” Freightliner, 514 U.S. at omitted). 287 (quotations We must therefore examine what “the full purposes objectives of Congress” were with respect federal labeling requirements for prescription drugs. We agree with the McNellis court system that a under which “federal regulations merely set minimum standards with which manufac turers must comply” is
fully consistent with Congress’ primary goal enacting FDCA, which protect is “to consumers from danger- reject argument We also prosecuted defendant’s it would have been Witczak, “misbranding” strengthened prior approval. if it had the label without See (“The Supp. validity authority 377 F. 2d at 731 of state law . . . does not depend speculative hypotheticals” regarding “assumptions of what the FDA *15 response would stronger warning.). have done” in 94 Sullivan, 689, v. United States 332 U.S. products,”
ous the (1948), stated intent Congress’ as well as 696 laws,’ the but on the existing “‘must not weaken FDCA pro and extend that law’s contrary strengthen ‘it must ” Dotterweich, v. the consumer.’ United States tection of 152, 277[, Rep. S. No. 75th [quoting 320 U.S. 282] Sess., Cong., p. 1]. 1st Witczak, 3752269, *7; 2d at 731 Supp. see also 377 F.
2005 WL from certainly companies did not intend bar (“Congress FDCA; its was to enacting goal when protecting public Congress’s Any contrary interpretation . . . protect public. perverse.”). intent is
¶26. fact, clearly, its Congress expressed purposes has “protect that the statute was intended to only general sense specifically, respect but also more FDCA’s public,” FDCA, to the Con- effect. In the 1962 amendments preemptive effect of gress expressly limiting preemptive included a clause in the amendments made this Act to the “Nothing the statute: Food, and Cosmetic Act shall be construed as Drug, Federal . . . there is a direct invalidating any provision of State law unless provision conflict such amendments and such positive between (Harris Act), of 1962 Kefauver Drug of State law.” Amendments (1962). 87-781, §202, L. No. 76 Stat. Pub.
¶27. essentially This amendment removes from our con present of whether common-law tort claims question sideration purposes objectives Congress. Congress an obstacle to the in place except intended that the FDCA would leave state law positive where it created a “direct and conflict” between state and law. Amendments 202 This Drug language “simply federal superseded restates the that state law is cases of an principle ‘compliance actual conflict with federal law such that with both ” See S. regulations physical impossibility.’ federal and state is a Servs., (4th Blasting County, Inc. v. Wilkes 288 F.3d Cir. 2002) conflict” in the (interpreting positive language “direct and mate preemption governing explosive clause of a federal statute stringent requirements to allow states to more than “impose rials (quoting Hillsborough contained in the federal regulations”) those Labs., (1985)).4 County Inc., v. Med. Automated 471 U.S. *16 words, any In other it possible under circumstances where is to FDCA, comply with law both state and the the state law in question is with the purposes objectives consistent and of Con- Thus, gress. our discussion above defendant’s regarding impossi- ¶¶ 21-23, supra, bility argument, provides complete answer to question preemption. the of
¶ 28. We that our recognize dissenting colleague has reached the opposite conclusion. There is little say, beyond to what we have said, already that we except respectfully disagree with his analysis FDCA, of the FDA’s regulations, specific the and the context of concluded, this lawsuit. Numerous courts have over the course of decades, floor, that FDCA provides the not a ceiling, for state ¶¶ supra, regulation. See 14-15. While the dissent favorably cites view, minority agree the we with the majority view. There is much be said policy arguments to for the employed by courts adopting view, minority including this the argument that permitting too much state in activity this area will drugs make beneficial less available to Similarly, consumers. merit there is to the majority surrounding helps The debate the amendment that it confirm was intended to preserve right regulate beyond requirements the of states to the federal of the During House, subject FDCA. the in preemption floor debate the of the arose First, Congressman expressed times. several Smith of California concern that the bill, reported, language anything as “no says contained . . . which to the effect that particular laws,” thus, preempt this measure will all State and food might interfering own, risk the efforts of to some states make their stricter regulations. (“[I]t Cong. going Ree. me that if seems to we are to law, pass ought this to someone offer an to make amendment certain that the bill, passage gives Health, power Department of this which all of this the to of Education, Administration, Drug and Welfare and the Food and preempt any will not laws.”). thereafter, Shortly Congressman Arkansas, State primary Harris the bill, sponsor opinion House nothing the offered his that is “there in this bill that any way preempts authority prerogatives States.” Id. at 21047. Congressman agreed, very stating, “[mjany helpful Schenck of Ohio State laws are effect; many stronger such in some laws instances are even than Federal laws for protection public of human health Id. at interest.” Harris, Congressmen despite insisting Schenck and that the bill as written laws, preempt stronger eventually supported would not state the “direct and amendment, positive preemption conflict” and Schenck that reiterated should not apply “many in the drugs instances where State area laws of food and stronger health are even than some of the Id. at Federal laws.” 21083. Neither the desirability allowing regulate beyond states the FDCA nor the intent of the protect regulation preemption amendment to question such from was called into during the debate. issue here like the one at eliminating that lawsuits perspective in the event the recourse leave consumers without would strengthened warnings require quickly enough move cannot policy is that neither Our view they appropriate. are when of the statute language here. The plain is relevant argument with state intend to interfere Congress did not indicates absolutely necessary, see doing where so is except prerogatives ¶¶ makes 25-27, regulation of the supra, plain language and the ¶¶ supra, here, 12-13. This unnecessary see interference such rooted constitutionally presumption with the analysis is consistent broadly arguments relying look more To against preemption. efficiency apply is to safety and economic assumptions about — Congress could not presumption opposite presumption seems, intrude on what intended to allow states to possibly have It neither our expertise. an area of federal intuitively, to be FDA, question policy nor responsibility, *17 pose at issue here does not litigation judgments Congress. law, thus, and there is conflict with federal positive a direct and for preemption. no basis federal Preemption
2. The FDA’s New Statement on case, cited a Defendant, argument after oral this new to the relating preemp- FDA that contains a statement regulation changes the regulation effect of the FDCA. The substance of tive prescription drugs, for aspects labeling requirements certain to this because the new changes appeal these are irrelevant but Drug Food and Admin- rule did not take effect until June 2006. istration, Labeling Format of for on Content and Requirements Products, Supplementary Prescription Drug Biological Human (Jan. 2006). 24, Information, The rule’s Reg. 71 Fed. section, however, Information” contains broad “Supplementary failure- preemption of state common-law regarding statement statement, to-warn claims. Id. at 3933-36. In this asserts claims, including of these rejecting preemption that recent cases above, agency’s an to the enforcement of pose those cited obstacle Id. Among interpretations labeling requirements. (1) rejecting preemption claims are incorrect are: those agency (2) 314.70(c); stating labeling those that federal the basis of minimum standards and that law serves “[s]tate are requirements safety regulation appropriate supplementary as an source to disseminate requiring or manufacturers drugs by encouraging beyond risk information FDA under the act.” Id. required by at 3934.
¶ 30. ordinarily required agency’s We are to defer to an Chevron, U.S.A., interpretation of a statute it Inc. administers. v. (1984) (‘We Council, Natural Res. 467 U.S. have Def. long recognized weight that considerable should be accorded to an executive department’s statutory construction of a scheme it is .”). Plaintiff, however, entrusted to urges administer . . . us not to defer to the FDA’s statement because it “was without the adopted requisite comment period” force of law.” Presum “lack[s] ably, if plaintiffs we were to credit argument, we would owe the statement only the limited deference agency due to statements made outside the agency’s rulemaking authority. See United States v. Mead Corp., 533 U.S. 226-27 (stating Chevron deference it applies only appears “when that Congress delegated authority to the agency generally to make rules carry law, ing force of and that the agency interpretation claiming deference was in the promulgated exercise of that authority”). We need not decide this difficult question law, of administrative however, because we conclude irrespective level deference might we apply, statement would not affect the outcome of appeal. this Chevron, 31. Under agency’s deference to an inter
pretation is appropriate only when a statute is “silent or ambigu
respect
ous with
to the specific
considered;
issue” the agency has
otherwise,
court,
“the
as well as the agency,
give
must
effect to
the unambiguously expressed intent of Congress.” 467 U.S. at
Moreover,
842-43.
judiciary
“[t]he
is the final authority on issues
of statutory construction
reject
and must
administrative construc
tions which
contrary
are
congressional
clear
intent.” Id. at 843
court,
n.9. “If a
employing traditional
statutory
tools of
construc
*18
tion, ascertains that Congress had an intention on
precise
the
question
issue,
at
that
intention is the law and must be given
effect.” Id. When an agency’s interpretation
type
is not the
interpretation
deference,
entitled to Chevron
we must
grant
still
it
some respect,
only
but
“a respect proportional
‘power
to its
to
” Mead,
persuade.’
conflict The language preemption amendment. statement cites amendment, if Congress spoken but then as had not proceeds agency the issue of The relies on to its preemption. support Geier Congress’s positive language, “direct and conflict” disregard asserting legislative provision addressing that existence of a “[t]he pre-emption operation ordinary principles does not bar Geier, 71 Fed. at 3935 implied preemption.” Reg. (citing U.S. 869). state that even implied preemption applies at Geier does preemption expressly, a statute addresses at when U.S. agencies preempt but it does not allow courts or state laws that Instead, by Congress. simply been it expressly preserved have for the intent not to proposition Congress’s preempt stands (1) an provision a of state law cannot be inferred from either not include the state law in express preemption clause does question scope, prevents regulated its or clause that from federal as a using compliance entities law defense Geier, According state common-law suits. Id. at 869-70. inference that support negative Congress former clause does intended to it did not preserve expressly preempt; must have laws only preserve intended to some Congress the latter indicates only appears changes rule to make to 314.70 is that alteration new “Highlights” may prior the new section of a label not be made without Reg. approval. 71 Fed. *19 claims,
common-law
not that it intended to allow even claims that
conflict with federal
But
requirements.
(stating
Id.
see id. at 870
that even the latter
“preserve[]
clause would
those actions that
seek to
greater safety
establish
than the minimum
achieved
safety
floor”).
aby
regulation
federal
intended to
provide
Here,
we are not
to infer the effect of
attempting
statutory
language
only indirectly addresses the specific state
Instead,
law at issue.
we are
an
interpreting
unambiguous express
preemption clause that specifically preserves the
type
state law
circumstances,
at issue. Under these
ordinary preemption prin
ciples
give
must
toway
Congress’s intent to preserve state laws
that do not create a “direct
positive
conflict” with federal law.
Drug
§
Amendments
202. There is no such conflict here. Accord
ingly,
FDA’s statement
is neither an authoritative interpreta
tion of an ambiguous statutory provision
deference,
entitled to
Chevron,
842-43,
467 U.S. at
persuasive
nor a
policy statement
Mead,
entitled
respect.
II. Apportionment of Damages
¶ 35. Defendant next contends the court
erred
failing to
instruct
the jury to reduce plaintiff’s damages by the amount of
fault attributable to the Health Center.
“Reversing
jury verdict
based on allegedly faulty jury instructions is warranted where the
party claiming error establishes that the instructions were erro-
prejudicial.”
Rood,
neous and
Simpson
21, 5,
v.
2005 VT
178 Vt.
474,
(mem.).
¶ 36. Defendant argues that pursuant to Vermont’s com parative negligence statute a defendant is only liable for portion of the plaintiff’s damages directly attributable to negligence. defendant’s 12 V.S.A. 1036 Our traditional rule is that multiple tortfeasors are jointly severally liable. See Zaleskie v. Joyce, 133 Vt. 333 A.2d (“[T]he law of this state . . permits all, . a plaintiff pursue or any part, tortfeasor.”). recovery joint his from either According defendant, § applies only not under circumstances where plaintiff, alleged part negligence comparative action, sued in the same defendants are only multiple when from besides the recovers someone any plaintiff time but also reached Thus, the Health Center plaintiff and defendant. because injury, related to the same separate in a lawsuit a settlement to calculate jury required should have been claims the defendant and subtract negligence of causal proportion the Health Center’s from the verdict. percentage *20 states, “Compara of heading under the 37. Section 1036 negligence”: tive in an recovery shall not bar
Contributory negligence to legal representative, or his by any plaintiff, action death, per- in negligence resulting for damages recover if the was damage, negligence injury property sonal or negligence total than the causal greater defendants, dimin- damage shall be defendant or but in to the amount of proportion verdict general ished recovery is plaintiff. to the Where negligence attributed defendant, than one each defendant against allowed more the total dollar proportion for that shall be liable in the ratio of the amount damages amount awarded as negli- the amount of causal negligence of his causal recovery whom against attributed to all defendants gence is allowed. slightly under interpreted § We this statute V.S.A. Johnson, 270, Plante v. 152 Vt. 565 A.2d
different circumstances
Plante,
(1989).
joinder
resisted
the defendant
joint
in a
party, resulting
her and a third
plaintiffs
against
claims
a verdict
jury
verdicts. The
first returned
separate
trial with two
plaintiffs
for the entire amount of the
party
the third
against
amount,
the defendant for the same
damages,
against
then found
ap-
The defendant
judgments.
and the court consolidated the
party’s
made the third
share
that the first verdict
pealed, arguing
that under
1036 she was
the fault 100%. She concluded
liability
100% of the
for the
ruling apportioning
entitled to a
The defendant failed to
damages
party.
to the third
plaintiffs
trial,
§ 1036
making
holding regarding
argue
point
this
in depth
the statute
unnecessary.
nevertheless examined
We
was not
that our determination that
the defendant
demonstrate
than a technical omission.”
was “more
apportionment
entitled to
272,
Id. at
¶ 38. In reaching
conclusion,
this
we relied in
part
fact that “the New Hampshire Supreme Court has held that its
nearly identical statute
apply
does not
to create
liability
several
the absence of an allegation
negligence
on the part of the
plaintiff.”
Id. at
¶ 39. Defendant argues that
§
whether or not
applies,
1036
we
depart
can
from our common law and
joint
determine that
and
several liability should
longer
no
prevent apportionment among
joint
tortfeasors when one tortfeasor has
settled
a previous
action. We decline to do
In
so.
Spafford,
434,
Howard v.
132 Vt.
(1974),
III. Present Value of by failing contends the court erred Finally, defendant present plaintiff’s to calculate the value jury to instruct losses, and suffer pain for future noneconomic such as damages verdict, granted which jury’s Defendant claims that ing. damages, present in noneconomic exceeded plaintiff million $5 $856,073. rejecting requested amount plaintiff’s value instruction, that de pointed the court out proposed defendant’s as to how jury expert guidance with provide fendant failed calculated, “[j]udges lawyers and that value should be present calculations universally performing the discount incapable are the tables of historic interest or without a calculator and that it would have been inflationary agree factors.” We rates to make such a calculation jury to instruct inappropriate under these circumstances. testimony presented if defendant had 41. Even *22 calculation, an informed we would have
allowing jury to make First, defendant’s for several reasons. upheld jury’s verdict value present did not take account jury assertion that the
103
plaintiffs
of
noneconomic
is
damages
pure speculation,
plain-
as
tiffs calculation of her economic
was
damages
presented
terms
value,
present
jury
required
its
and “the
was not
to demon-
strate its calculations”
respect
plaintiffs
with
noneconomic
Vt.,
damages.
537, 543,
Debus v. Grand Union Stores
159 Vt.
(1993).
1288,
Second,
621 A.2d
1292
we limit prejudgment
interest
to economic
because
damages
damages
noneconomic
are “inchoate
rarely
injury.”
ascertainable at the time of
Turcotte v. Estate
LaRose,
196,
(1989).
n.2,
1086,
153 Vt.
569 A.2d
1088 n.2
These damages become no less inchoate
following judgment, and
juries
we will not require
apply
precise
economic calculation
figure
to a
we have
inherently imprecise.
identified as
Finally,
jurisdictions
most
and the Restatement
(Second)
reject
of Torts
the concept
juries
of requiring
to make
present-value calculations
respect
to noneconomic damages.
See, e.g., Taylor
R.R.,
v. Denver
& Rio Grande W.
438 F.2d
(10th
1971)
Cir.
(holding
instruction requiring present-
value reduction for pain
suffering
was error and stating that
most courts that have considered the issue have decided “that the
better reasoned authority supports the rule that
pain
future
suffering
worth”);
should not be reduced to current
Restatement
(Second)
of Torts
913A cmt. a
(stating that while future
pecuniary
value,
losses should be reduced
present
“an award
pain
future
and suffering or for emotional distress is not
fashion”).
discounted
this
But
Lines,
see Oliveri v. Delta S.S.
Inc.,
(2d
1988)
849 F.2d
Cir.
(stating
we were
“[i]f
slate,
on a
writing
clean
we might be inclined to accept the view
of the other
reject
circuits and
any
discounting
future non-
losses,”
pecuniary
previous
but
Second Circuit holdings required
form).
such
discounting
some
Defendant’s reliance on our
Roberts,
decision in
Parker v.
(1925),
99 Vt.
Affirmed.
¶43. Reiber, C.J., dissenting. overarching issue this appeal plaintiff’s is whether common-law claim for failure to warn conflicts with the regulation FDA’s of Phenergan, *23 injuries. jury’s I would conclude that the plaintiffs for responsible reasons. in conflicts with federal law for two verdict this case ¶ First, Wyeth for defendant impossible 44. it would be and federal law. of both state comply requirements with the Phenergan FDA administration of approved the IV Specifically, Phenergan listed on the and that IV administration be required contrast, Wyeth the case plaintiffs theory required By label. label, add Phenergan remove this use from the approved either to the indication that directly that would contradict label’s warning use, or, minimum, at a was a safe and effective IV administration types certain of IV administration should warning only add a that Thus, in with state law this case would compliance be used. the Wyeth Phenergan approved by to eliminate uses of require in required Phenergan labeling. FDA and to be included the Second, plaintiffs state-law claim conflicts with federal law In purposes objectives. it an obstacle to federal and poses that distribution, short, by approving Phenergan marketing for — FDA with its methods of drug approved concluded — was safe and effective. See administration and as labeled both 355(d) finding 21 criteria for (listing drug approval). U.S.C. warn, concluded that jury defendant liable for failure to a Vermont — its methods of administration and approved same — Town “unreasonably dangerous.” as labeled was See v. Lurton 304, 308, Bridport Sterling Corp., Clark 166 693 Vt. (1997) (to claim, plaintiff A.2d succeed on failure-to-warn product unreasonably must show that “failure to warn made the defective”). therefore These two conclusions are in dangerous and direct conflict.
¶46. For of these reasons I would conclude that both I preempted. respectfully state-law cause of action is dissent. Impossibility I. of Compliance explained by majority, 47. As because there is no clause law, must demon- expressly preempting Wyeth the FDCA state either that federal preemption implied by showing strate that is (a Wyeth law field claim that thoroughly occupies regulatory advance) does not or that there is an actual conflict between state conflict, turn, and federal law. Actual can be demonstrated by showing one of two it for the ways: impossible regulated party comply with both state and federal law or to the accomplishment state law “stands as an obstacle purposes objectives execution of the full of Congress.” Myrick, v. Freightliner Corp. (quotations U.S. omitted).
¶ 48. The in essence concludes that it is majority impossible Wyeth comply with both federal and state standards Wyeth sought because never FDA of a warn- approval “stronger ing” type by plaintiff. advocated to the According majority, with, FDA presented because the was not and therefore did not explicitly reject, such strengthened language, there is no reason to Therefore, presume disapprove. that the would majority reasons, there is no actual conflict federal between state and law. ¶¶ ante, inaccurate, however, See 21-22. It is to characterize the requirements imposed by jury verdict in this case as merely requiring Rather, a “stronger warning.” what plaintiff sought was an elimination of a use of Phenergan that had approved by been *24 Furthermore, the FDA. rejection the FDA’s Wyeth’s of efforts to alter the language warning of the in 2000 supports Wyeth’s claim that the FDA had an affirmative preference for the language of the original warning.
A. ¶ 49. The crux of plaintiff’s claim was not based on the label se, warnings per but on the approved See, uses listed e.g., there. ¶ (“Plaintiffs ante, experts testified that the label should not .”). have allowed push IV as a means of administration . . A . of plaintiffs complaint review and the evidence presented at trial makes clear that the standard plaintiff sought (i.e., to establish the change to the label that would required be of light — jury’s finding liability) was to remove IV administration or — least certain types as an approved use. example, For plaintiffs complaint asserted that the warnings on the label were inadequate and that: Phenergan by
[t]he sold defendant is . . . not reasonably intravenous administration because the foresee- safe for able risks of posed by harm intravenous administration of are sufficiently great in relation to its foresee- able theraputic benefits that reasonable health care pro- viders, knowing benefits, of such foreseeable risks and prescribe would not the drug intravenously any class patients. added.) brief, appellate plaintiff In her characterizes (Emphasis revealing Wyeth as “that was aware of research the evidence was un- indicating Phenergan that direct IV administration added.) Plaintiff further refers to testi- (Emphasis expert safe!’ Phenergan “that the label have restricted to intra- mony should injection presents as this method of administration no muscular or, if injection; alternatively, risk of inadvertent arterial IV used, by injecting Phenergan is it must be into administration added.) a direct IV.” hanging bag, through (Emphasis IV Here, the FDA addressed the risks clearly attending IV approved The label IV administration drug. administration dangers and warned of the of direct IV generally, specifically administration, injection inadvertent arterial including possibly this, In light argued it cannot be resulting amputation. (1) administration, did not assess the risk of IV direct administration and the associated risk of including IV (2) amputation injection; due to inadvertent arterial conclude that the benefits of IV administration with warn- allowing appropriate risk; ings outweighed regarding and reach a decision precisely warning language what should be used. These assess- are, fact, very ments essence of the FDA’s and approval objective are in furtherance of the federal of advancing public health by balancing drugs the risks and benefits of new 355(d) § their facilitating optimal (listing use. See U.S.C. factors in approving refusing drug application); to be considered or new (b)(2)(B) (FDA 393(b)(1), charged promoting U.S.C. public by acting promptly health on new drug applications health protecting public by ensuring drugs that new are both safe effective). majority 51. The reconciles this manifest conflict relying *25 314.70(c), § 21 drug C.F.R. which allows a manufacturer to alter a contraindication, strengthen warning, precau- label add or a “[t]o tion, or adverse or strengthen reaction” “add or an instruction dosage prior about and administration” to FDA On this approval.7 basis, majority Wyeth concludes that “was free under 7 approach employed by also the This is the numerous federal district court Ante, ¶ by analysis majority. disagree decisions cited 14. Because I with this 314.70(c), Instead, import persuasive. § I do not find these decisions to be Needleman, minority expressed I side with the view which concludes that 314.70(c) gives very unilaterally revising drug § manufacturers little latitude in Inc., (N.D. Tex.). Pfizer, 1773697, labels. Needleman v. 2004 WL at *3 314.70(c) prior ap- without strengthen warning
§
to
¶
Ante,
But,
it
to claim that
22.
is an overstatement
proval.”
314.70(c).
§
under
change drug
manufacturers are “free” to
labels
only
to add
contrary,
may change
To the
a manufacturer
label
use,
an
as
strengthen
warning,
approved
or
to eliminate
words,
In other
what
advo-
require
plaintiff
would
here.
plaintiff
directly
but
that would
stronger warning
language
cates is not a
the FDA.
language approved
by
contradict
and mandated
¶
314.70(c)
Further,
§
52.
is to allow
apparent purpose
risks. See
Fed.
newly-discovered
manufacturers
to address
(June
1979)
26,
37434,
Reg.
(allowing supplement
label
“whenever
harmful adverse effects associated with the
possibly
discovered”).
drug
use of the
are
Even courts that conclude that
314.70(c)
§
provides
warnings
manufacturers broad latitude to add
acknowledge
previ
to labels
that such
are aimed at
supplements
Inc.,
Pfizer,
risks. See McNellis v.
ously
unanalyzed
unknown and
(D.N.J.)
314.70(c)
3752269,
§
*6
(concluding
2005 WL
“was
quickly
to allow
manufacturers
promulgated precisely
drug
warnings
label
when evidence of new side effects
strengthen
[is]
discovered”)
(Jan.
1965));
Kurer v.
(citing
Reg.
30 Fed.
Parke,
Co.,
Davis &
2004 WI
¶ core, 54. At its in plaintiffs argument this case was not that the warnings on the label were that inadequate, approved but an (direct administration) use IV was in fact unreasonably unsafe. Plaintiff did not seek to “add or strengthen” warning a or a instruction, dosage/administration but rather to eliminate an ap- proved use of the drug. disagreement This is a that cannot be 314.70(c). § overcome operation of Plaintiffs claim in this case — that a method of administration of the drug should be partially — if entirely eliminated labeling from the represents substantive disagreement policy goes beyond labeling/warning disagreement issues alone. This creates opposing requirements, and a manufacturer could not satisfy both at once.
B. ¶ 314.70(c) 55. Wyeth argues if even theoretically allows a manufacturer to label, make unilateral changes to a in this case, the FDA actually rejected Wyeth’s in attempts 2000 to change the warning regarding intra-arterial injection and ampu- tation. The trial court concluded that the FDA gave only “passing Ante, attention” to the risks of IV administration 4. The majority similarly concludes that the record does not indicate “that the FDA preserve wished to the use of push IV as method Ante, of administering Phenergan.” I23. cannot agree with this assessment of the record.
¶ 56. Both the original label and Wyeth’s proposed alternative were titled “INADVERTENT INTRA-ARTERIAL INJECTION.” label, On the original the first two sentences of the warning read: Due to the proximity close of arteries and veins areas most commonly used for injection, intravenous extreme care should be exercised to perivascular avoid extravasation or inadvertent intra-arterial injection. Re- ports compatible with inadvertent injection intra-arterial [Phenergan], usually conjunction with other drugs use, intended for suggest intravenous pain, severe irritation, chemical vessels, severe spasm distal resultant gangrene requiring amputation likely are under such circumstances. read: warning label, sentence of the first proposed
On the requiring leading gangrene, are of necrosis reports “There conjunc- usually injection [Phenergan], following amputation, in these was intended the intravenous route drugs; tion with other needle is cases, placement or arterial partial but arterial *27 warning language to the change the suspect.” proposed now While it warning, in a plaintiff require not reflect what would may (1) warning alternative Wyeth’s proposed that disputed cannot be by amputation necrosis and on the risk of greater emphasis placed FDA the sentence, the gave it in the first and referencing advanced, warning specific, consider the alternative opportunity to in warning general. the adequacy as well as the of by Wyeth, retain Wyeth FDA mandated that this the Despite opportunity, The extent of the existing warning. alleged language the relevant, in my view. FDA’s consideration of the issue is not ¶ that health the FDA confirmed its assessment 57. to choose IV administra- permitted care should be professionals drug, where delivering in various forms as a means of tion its all forms of IV adminis- Wyeth could not both list appropriate. FDA, use, exclude required by an as and approved tration as unsafe, by required of administration as as all or some forms IV impossible comply in this case. It would be jury’s verdict requirements. with both Objectives and Purposes
II. Obstacle to Federal ¶ Wyeth I would further conclude that has demonstrated 58. by showing plaintiffs conflict that state-law preemption actual an federal and poses purposes failure-to-warn claim obstacle to issue, concluding this objectives. majority The does not address actual Wyeth option proving does not have the of this form of majority by conflict reaches this conclusion preemption. on the clause in the 1962 amendments to the relying following FDCA: in the Amendments made this Act to the
Nothing Food, Act Drug, Federal and Cosmetic shall be construed any as of State law . . . unless invalidating provision positive there is a direct and conflict between such and such of State law. provision amendments ¶ (Harris-Kefauver Ante, (quoting Drug 26 Amendments of 1962 (1962)). Act), 87-781, §202, Citing L. No. 76 Stat. Pub. Services, Southern Inc. v. Blasting County, Wilkes 288 F.3d (4th 2002), majority Cir. concludes that the provision “essentially question removes from our consideration the of whether common-law tort an present claims obstacle to the purposes objectives Congress,” of because the 1962 provision “simply restates the that state law is principle superseded cases of actual conflict with federal law such that compliance with both Ante, regulations federal and state is a physical impossibility.” (internal omitted). quotations words,” “In other majority explains, any “under where it possible comply circumstances is FDCA, with both state law and the the state in question law consistent with the purposes Id. objectives Congress.” Thus, the majority eliminates the possibility proving actual conflict preemption independently through prong “obstacle” that standard. But Blasting Southern passage neither the on which the
majority relies nor the United States Supreme Court decision8
cited as
authority
passage provide
an explanation or even
an affirmative
phrase
statement
“direct
positive
conflict”
the 1962 amendment eliminates the
prong
“obstacle”
Thus,
the actual
preemption
conflict
standard.
majority
elimi-
*28
nates one of the
by
two means
which Wyeth may show actual
conflict
single,
based on a
unclearly-reasoned Fourth Circuit
decision that
is
in
lacking
itself
case
support.
law
There is no
eliminating
standard,
basis for
this
prong
actual conflict
and
I disagree
majority’s
with the
conclusion
contrary.9
to the
then,
60. Assuming,
that Wyeth may demonstrate actual
preemption by
conflict
showing that state law is an obstacle to
Hillsborough County
Labs., Inc.,
(1985).
v. Automated Med.
See
471 U.S.
Hillsborough
passage
The cited
in
interpret
phrase
does not
the
“direct and
positive
merely
preemption,
conflict.” It
cites the
including
different forms of
the
prong.
“obstacle”
noting
It is worth
that
Geier v. American Honda
the federal statute at
in
issue
Co.,
(2000) (discussed below),
Motor
plaintiff and dissenting opinion majority like the in the — instant case viewed the federal regulation as a mini- setting mum safety standard that states were free to supplement or strengthen. However, Id. at examining comments accompanying regulation, the Court concluded that safety standard allowing passive choice of restraint systems while not mandating any particular system was a deliberate decision that reflected a balance of diverse policy concerns. See id. at 875 (noting that mix of allowing safety available devices available over costs, time would “lower safety overcome technical problems, encourage technological development, and win widespread con- sum, sumer “In acceptance”). . . . the 1984 safety version of [the embodies the Secretary’s standard] policy judgment safety promoted would best be if manufacturers installed alternative *29 in protection systems their fleets rather than particular one omitted). in system every car.” Id. at (quotations Accordingly, the Court concluded that the tort action sought impose duty to a ally objectives Constitution, through operation ordinary mandated the of pre-emption principles, Id. at 872. protect.” seeks to impose bags, types on manufacturers to air rather than other that this state-law was passive systems, requirement restraint mix objective allowing safety an to the federal a obstacle devices. in of the Court Geier Application Supreme precedent Geier, in in
dictates the same result this case. As with the DOT FDA primarily public safety. is concerned with The conclusion by arrived at public safety considering of what is best for is various factors that are sometimes in tension with one policy in example, developing safety regulation another. For issue Geier, only in which passive-restraint DOT considered scale, on an were most systems were safest absolute but which consumer gain acceptance. cost-effective and which would Simi- FDA larly, drug’s safety here the balances its assessment a into account that against drug’s efficacy, taking concerns for a drug necessarily public safer but less effective is not best for the (FDA 355(d) § safety health overall. See 21 U.S.C. must consider (b)(2)(B) (FDA’s 393(b)(1), efficacy); U.S.C. mission is to unsafe protect public drugs promote public from health manner). timely in In the approving regulated products specific labels, context of on the FDA warnings drug only considers not include, what information to but also what to exclude. As the “[tjhere context, in Eighth Circuit has noted the medical device are FDA why may prefer ... a number of sound reasons Howmedica, Inc., limit warnings product labels.” See Brooks v. (8th 2001). example, “[wjarnings 273 F.3d Cir. For about dangers with less basis science or fewer hazards could take confirmed, away attention from those that present higher risks.” Id. 63. No is without risks. The balances the risks of drug against availability
a its benefits to maximize the of beneficial treatments. The FDA’s in approving drug, decision a its uses and labeling reflect consideration of these and other policy factors. jury While a state-court shares the FDA’s concern presumably safe, drugs reasonably jury on the market be does not public assess the context of health and the reasonableness A analysis. jury engage associated risk-benefit does not Rather, measured and multi-faceted policy analysis. jury views safety the lens of a drug through single patient who already catastrophically injured. approach has been Such an virtually guaranteed provide different conclusions different *30 balancing ap- than the “reasonably safe” courts about what act, different conclusions were taken the FDA. proach in this case. reached prescription that “[a] 64. The in this case was instructed jury warnings or unreasonably dangerous inadequate due
drug is foreseeable risks regarding if reasonable instructions instructions and other medical physician of harm are not to the provided harm.” are in a to reduce the risks of professionals position who injuries, jury concluded plaintiff’s tragic Faced with administration was allowing Phenergan through to be delivered IV verdict conflicts “unreasonably dangerous.” jury’s squarely whether precisely with the FDA’s assessment of the same issue: through is safe and effective when delivered IV Phenergan preempted. administration. The claim is reasons, 65. For the above I dissent.
2008VT Stanley Mayo v. State Vermont A.2d [945 846] No. 06-335 Reiber, C.J., Dooley, Burgess, JJ., Zimmerman, Present: Johnson D.J., Specially Assigned January
Opinion Filed