Stengel v. Medtronic, Inc.

Mary Stengel, STENGEL; Lou Richard

Plaintiffs-Appellants, INCORPORATED, a

MEDTRONIC corporation, Defendant-

foreign

Appellee. 10-17755.

No. Appeals,

United States

Ninth Circuit. 13, 2012. Jan.

Argued and Submitted 16, 2012. April

Filed

Pitt, P.L.C., & McAnally, Tucson, Feldman AZ, for the plaintiffs-appellants. Brown, Ginger Pigott, Michael K. F.H. Baird, LLP, and Lisa M. Reed Smith Los CA, Angeles, for defendant-appellee. WALLACE, Before: J. CLIFFORD NOONAN, JOHN T. and MILAN D. SMITH, JR., Judges. Circuit Opinion by Judge WALLACE; Dissent by Judge NOONAN.

OPINION WALLACE, Senior Judge: Circuit Mary Richard Stengel brought Lou several state causes of action in Arizona against Incorporat- state court Medtronic (Medtronic) injuries ed sustained Richard Stengel (Stengel) from his use of a pain pump manufactured Medtronic. timely Medtronic removed the case to the United District States Court for the Dis- trict of Arizona. The district court dis- Stengels’ preempted missed the claims as federal law and the appealed. jurisdiction have We under 28 U.S.C. § 1291. We affirm.

I. pain pump Medtronic’s is a medical de- prescription vice infuses medication through a catheter into the intrathecal space within spine help control se- pain. In vere the Food Drug (FDA) gave premarket ap- Administration proval as a Class III medical device Cotter, Feldman, Stanley SynchroMed Thomas G. Medtronic’s Pump G. & Infusion Ported; Stephen Miller, T. System. Haralson FDA gave supple- We de for Medtron- review novo district approval premarket mental holding that all of the SynchroMed Pump EL intrathecal court’s ic’s catheter, expressly of Med- asserted claims were either the versions impliedly preempted. Martinez at issue in this action. Wells tronic’s device Inc., 549, Mortg., 598 F.3d Fargo Home 2000, Stengel pump had a Medtronic In (9th Cir.2010). 553 We review denial in his and surgically implanted abdomen to amend for abuse of discretion. leave through the began receiving medication 925, Corp., Alvarez v. 656 F.3d Chevron implanted in his In tip spine. catheter (9th Cir.2011). 931 2005, began ascend- Stengel experiencing lower extremities ing paralysis his II. (a type inflam- granuloma caused a 1976, Food, Congress amended the mation) spine that had formed at the in his (FDCA) by Act Drug and Cosmetic enact- Stengel’s doctors sur- tip of the catheter. Device ing the Medical Amendments of the hardware and most gically removed 94-295, (MDA), Pub.L. No. Stat. but in time to granuloma, prevent (codified amended U.S.C. Stengel granuloma rendering from § et The MDA a seq.). pre- 360c added paraplegic. permanently emption pro- clause to the FDCA which ge- vides, Stengels’ complaint subject The four exceptions, to limited negli- under Arizona law: neric claims ... no State ... with establish express implied and gence, breaches respect to a device for human intended warranties, liability. and strict The dis- any which requirement—(1) use is dif- to granted trict Medtronic’s motion court to, from, any ferent or addition re- ground that complaint on the dismiss the FDCA], quirement applicable [the under these expressly preempted (2) safety which relates to the or and claims. any or to effectiveness of device requirement included in a other matter pend- the motion to dismiss was While under applicable [the device to amend ing, the moved leave FDCA]. four re-allege their same 360k(a). 21 U.S.C. theory newly-proffered Supreme Court has examined the injury was Med- Stengel’s caused clause extent which procedures to implement tronic’s failure challenging common-law claims “bars and complaints pump about evaluate safety and a medical de- effectiveness of FDA, report failure to the information given premarket approval vice regulations. FDA required as was Inc., Medtronic, Riegel v. [FDA].” had Stengels alleged that if Medtronic 312, 315, 999, 169 L.Ed.2d U.S. 128 S.Ct. Medtronic complied regulations, (2008). the “rigor- reviewed The Court physicians about would have warned premarket approval process ous” Class newly-discovered danger pump medical devices: III inflammation, would might cause A submit what quicker diagnosis a of Sten- manufacturer must have allowed application. a multivolume It paraly- typically his gel’s symptoms prevented and includes, things, full re- among other Stengels’ motion for leave sis. The investigations of of all and ground ports that this studies amend was denied on safety was and effectiveness impliedly claim device’s “failure-to-warn” published have been or should reason- preempted. ably applicant; known to the a full S.Ct. 999. The sec recognized components, a prevent the device’s tion “360k does not State from statement ingredients, properties damages remedy providing for claims principles operation; principle premised regula or on a violation of in, used description full of the methods tions” because “the state duties such for, the facilities controls used to, ‘parallel,’ case rather than add manufacture, and, when processing, 999, requirements.” Id. at 128 S.Ct. relevant, of, packing and installation Lohr, quoting Inc. v. 518 U.S. device; samples compo- device 135 L.Ed.2d FDA; a required spe- (1996). nents the and plaintiff Because the that asserted proposed labeling. cimen of the Before the defendant’s device “violated tort approve applica- the deciding whether to notwithstanding compliance with the tion, may a agency panel the refer it to requirements,” relevant federal the Court experts outside request and addi- expressly preempt held their claims tional data from the manufacturer. ed. Id. spends 1,200 average The FDA an claims, Stengels’ they The appear as reviewing hours application each and complaint, initial expressly grants premarket approval only if it preempted Riegel. under section 360k and is a finds there reasonable assurance generally challenged The claims safety safety the device’s and effectiveness. pump effectiveness Medtronic’s (internal 317-18, at

Id. 128 S.Ct. 999 cita- any allegation without hint of an that Med- omitted). quotation tions and marks regulations. tronic’s conduct violated FDA successful, To be the claims would have premarket approval process The fact, required the trier of as a proposed includes review of matter the device’s law, safety state tort labeling to evaluate conclude the device and effective should have designed ness under the either been differ- conditions use set forth ently in the from what required label. Id. at the FDA 128 S.Ct. 999. through premarket approved, approval, After device is or “the MDA for labeled warnings make, bids the different from what manufacturer without Therefore, required. FDA permission, the district changes design specifi cations, correctly court processes, Stengels’ dismissed the ini- manufacturing labeling, any tial attribute, complaint. or other that would affect safety or effectiveness.” Id. at Stengels’ The claims proposed Any changes must be made complaint amended expressly are also approval after FDA of an application for preempted they rely to the extent on premarket supplemental approval, “to be theory that Medtronic should have sent a evaluated largely the same criteria medical device correction physi- notice to an initial application.” Id. cians, it, whether the FDA ordered

The Court then premarket held FDA regulations permitted because Med- approval process for III Class devices im- tronic to send the notice without prior 814.39(d). posed “requirements” applicable to FDA approval. See C.F.R. approved device, that common law tort The Seventh Circuit has addressed this question. duties constituted state “requirements,” precise It fed- held: “Where a “safety requirement permits effectiveness” of eral con- a course of subject the device was the plaintiffs duct obligatory, state makes it 322-23, common law claims. Id. at requirement 128 state’s is in addition to of its regarding intended use bone preempt- and thus is requirement Inc., improp- and that the devices were screws ed.” McMullen (7th Cir.2005). agree erly We clearance as a given market result. F.3d expressly 346-47, requirement Id. 121 S.Ct. 1012. Su- preempted. preme Court held were because, although the defen- preempted

III. allegedly require- dant had violated federal However, portions ments, allowing of the claims plaintiffs bring amended proposed injuries remedy state cause of action to express interpreted to survive could be by the would interfere caused violations proposed complaint al- preemption. congressional scheme. Id. with the As leged: explained, statutory “the federal and regulation, [Med- federal law

Under amply empowers pun- scheme the FDA to duty continuing was under a tronic] against the ish and deter fraud Adminis- product premarket ap- the after monitor tration, ... authority and this is used report and to the proval discover and the Administration to achieve somewhat any complaints product’s FDA about the statutory objectives” delicate balance of any health performance and adverse by allowing “can be skewed fraud- it consequences of which became aware on-the-FDA claims under state tort law.” may be and that are or attributable to 348,121 Id. at 1012. S.Ct. product. the The Court observed that FDCA “[t]he ¶ 13, Complaint, Substitute Amended ECF it leaves no doubt that is the Federal § (citing (require- No. 22-1 21 U.S.C. 360i private litigants Government rather than maintain submit information ment to who are authorized to file suit for noncom- 21 regulation); C.F.R. required pliance provi- with the medical device (requirement reports); § to submit 803.50 4, at n. 121 sions.” Id. S.Ct. 820.198(a) (requirement § 21 C.F.R. es- 337(a) (no private right § citing U.S.C. reviewing procedures tablish com- FDCA). The of action to enforce Court negli- of Medtronic’s plaints)). Because FDA “[s]tate-law held that fraud-on-the duties, gent perform failure to these the the FDA’s inevitably claims conflict with Stengels alleged, pump became defec- responsibility consistently fraud police purpose. tive and unfit its intended Id. Administration’s judgment with the ¶20. alleged To the extent Medtronic’s objectives.” at 121 S.Ct. 1012. Id. are action- regulations violations of v. distinguished Inc. law, Court obligations able under state Lohr, 470, 116 518 U.S. S.Ct. parallel requirements, the federal thus (1996), in which the expressly preempted. are not L.Ed.2d previously negligence held claims certain Nonetheless, theory Stengels’ in the expressly under preempted not to be express which survives amended 352-53, 121 531 U.S. at S.Ct. 1012. FDCA. ultimately fails because It claims [Lohr] reasoned that “the arose impliedly preempted claims are from the manufacturer’s failure Legal Commit- Buckman Co. Plaintiffs’ production in the use reasonable care tee, 341, 121 U.S. S.Ct. solely the violation (2001). Buckman, from product, L.Ed.2d 854 requirements,” of FDCA whereas plaintiffs alleged that defendant made solely by claims “exist vir- to the FDA Buckman fraud misrepresentations fraudulent of, source, requirements.” any tue of FDCA disclosure comes aware from that 352-53,121 531 U.S. reasonably suggests its device or have caused contributed to a serious meaningful no There is distinction injury. report § 21 C.F.R. 803.50. This Stengels’ between the failure-to-wam days than must be made no later after claims and the “fraud-on-the-FDA” claims day the manufacturer or receives be- preempted held Buckman. comes aware of the information. Section Therefore, Buckman, following hold we 803.50(a). information The FDA considers impliedly reasonably is known to the manufac- preempted.1 Stengels’ theory any turer to include information that the if Medtronic had acted with reasonable can contacting manufacturer obtain in complying regulations care reporter by testing initial device. required provide it to information to the 803.50(b). Section A manufacturer must FDA, required the FDA would have Med investigate each event and evalu- adverse tronic to warn physicians danger about the ate cause the event. Section of inflammation pump connected to its 803.50(b)(3). If the manufacturer cannot Stengel injury could have avoided complete report, submit information in a pump. caused See U.S.C. provide explaining must why statement 360h(a). is precisely This the same the incomplete the information was and the ory rejected that was in Buckman. The steps taken to obtain the information. Id. that, Buckman, only difference is Regulations require also manufacturer to allegedly defendant misinformed the FDA maintain information, complaint pro- flies and establish overtly providing false receiving, cedures for reviewing, whereas here and eval- allegedly the defendant mis uating tacitly by complaints formally designated informed the FDA a failing to report duty § information that it had a unit. 21 proce- to C.F.R. 820.198. These report. policing The of such conduct dures complaints must ensure that all are both instances exclusively is committed to manner, processed timely in a uniform and government, federal recognizing a complaints and that oral are documented state cause of action based on such conduct 820.198(a). upon A receipt. Section man- statutory would conflict with the scheme ufacturer must review evaluate all by Congress. established Cupek v. complaints to determine whether an inves- Cf. Medtronic, Inc., (6th 405 F.3d 423-24 tigation necessary, is and if it chooses not Cir.2005) (negligence per se claim due to to investigate, must record its reasons and “failure to comply with [FDA] conditions the name of the responsible individual of approval” preempted because it awas a not investigate. decision to Section claim”). “disguised fraud on the FDA 820.198(b). complaint aWhen describes reported an event that must to

The federal be regulations that Medtronic FDA, is to the records of impose investigation have must violated detailed reporting requirements categories contain respect with to a enumerated of informa- category broad separate of information. For tion and be exam- must maintained a ple, a manufacturer report portion must to the of flies or otherwise (e). clearly 820.198(d), information the manufacturer be- identified. Section argues The dissent scope that because the implied pre- Sten- does not determine the gels' claims are expressly preempted un- emption it because never considered the is- Lohr, they der impliedly preempted cannot be sue. under This Buckman. is not the law. Lohr manufacturing that state claims based on notification If FDA determines preempted were not under Buck- necessary to eliminate an defects is physicians to because, there not be a “[w]hile harm to man risk substantial unreasonable tort law1 health, can ‘traditional state claim an the FDA order public words, many so product after ‘adulterated’ issue the notification manufacturer to adulterated federal definition of medi consulting with the manufacturer. 360h(a). directly duty to cal devices is tied U.S.C. manufacturers to avoid foreseeable dan impos- contrast, Arizona common gers products complying their with fails manufacturer that to liability es on a (7th federal law.” 630 F.3d Cir. to inform a con- exercise reasonable care 2010). no opinion We offer to whether dangerous its condition product’s sumer is particular directly state claim that tied product likely or of the facts that make compliance to with federal law would be if dangerous, to the manufacturer case, preempted under Buckman. In this reason to know knows has duty federal manufacturers under likely dangerous is to be has product report law to FDA information re the consumer will no to believe that reason directly their garding devices is tied Anguiano condition. dangerous realize duty of manufacturers state law under Co., Inc., De v. E.I. Du Pont Nemours & dangerous warn consumers a device’s Cir.1995). (9th 811-12 F.3d contrary, On the condition. the enforce is al- regulations that Medtronic duty is an report ment of element of violated, have leged require inves- scheme is committed sole to the FDA tigation disclosure ly government. the federal so that FDA can particular manner notification of contend that Buckman is make a decision whether necessary, distinguishable only requires not tied to consumers because duty fraud-on-the-FDA-type to warn general consumers Thus, Stengels’ where the FDA has previously law. the failure- claims not Arizona claims, they the determined that the .manufacturer violated to-warn to extent survive reporting requirements. federal A warn- express preemption, solely exist virtue ing from the FDA to was requirements of the FDCA disclosure letter Medtronic are, therefore, proposed to the amended com- impliedly preempted. attached plaint, the FDA had al- shows that Nothing holding requires preemp- in our determined ready Medtronic violated challenging tion all claims the Thus, obligations. its federal disclosure safety of a medical device that has re- contend, they prove the could approval. premarket ceived But as anoth- second-guessing their claims without the it, “a aptly put gap er court it is narrow making. FDA’s decision through plaintiffs which a claim state-law escape express implied fit if it to We are not convinced the must is Inc., distinguish Buckman it preemption.” attempt In re because Buckman, on concurrence in Sprint Litig., Fidelis Leads Prods. Liab. based the (8th 1200, Cir.2010), disagreed specifi- quoting majority which with the 623 F.3d 769, cally majority did take Riley Corp., F.Supp.2d because the not Cordis (D.Minn.2009). Stengels. now position At least some claims advocated (Ste- 354, at 121 S.Ct. 1012 proven capable passing through have See 531 U.S. instance, vens, J., in concurring judgment). gap. For Bausch v. rationale, majority’s unlike the Stryker Corp., the held Buckman Seventh Circuit 337(a) concurrence’s, solely was not based on a man that [21 ] U.S.C. also limits jurors ability second-guessing pursue desire avoid of a private plaintiff to making; FDA’s decision was also based claims under state law theories where on the idea that state fraud-on-the-FDA claims collide with the exclusive enforce- pull “exert an on government”). claims would extraneous ment of the power by Congress,” in established the scheme Second, Hughes distinguished Buckman supposed the FDA was enforce because claims on depend “[did] requirements. disclosure the FDCA’s Id. speculation FDA would have tak- (majority opinion). at any particular en regulatory action in re- majority’s rationale remains relevant sponse to regulations violation of the at case, in this even where the has issue, Hughes, as in Buckman.” F.3d warning describing issued a letter Med- at But reasoning 775. follows the regulatory tronic’s violations. adopted by rationale Justice Stevens his acknowledge We that there is a division concurrence. See 531 at U.S. among the circuits whether state failure- (Stevens, J., S.Ct. 1012 concurring preempted by to-warn Buck- judgment). majority The Buckman never hand, Eighth man. On one Circuit adopted this limitation its holding. on impliedly has held that Third, Hughes argued allowing pre- preempts claim a state failure-to-warn emption would be with Rie- inconsistent claim extent the is based on the defen gel’s recognition that “parallel” claims are dant’s to provide failure the FDA with preempted. But F.3d sufficient information and failure file Riegel only established that such claims reports timely. adverse event See re expressly would not be preempted sec- Medtronic, 623 F.3d at On 1205-06. tion 360k. 552 U.S. at 128 S.Ct. 999. hand, other Fifth Circuit has held that Since the Riegel claims before the Court in a state failure-to-warn claim is not express failed under preemption, preempted. Hughes See v. Boston Scienti Court had no reason implied to discuss (5th Corp., 631 F.3d 775-76 Cir. fic join at all. See id. We 2011). Eighth Circuit holding that a failure-to- First, Hughes persuasive. is not it erro- warn claim on provide based failure to neously distinguished on Buckman disclosures impliedly FDA is ground plaintiffs in Buckman preempted. attempting “were to freestanding assert a action,” Hughes, federal cause of 631 F.3d IV. 775, at notwithstanding that Buckman de- scribed the at seeking claims issue as dam- Finally, turn we to the additional law,” Buckman, ages “under tort grounds state 531 for reversal offered the Sten 343, at U.S. 121 gels. They S.Ct. 1012. argue Buckman’s that the district court preemptive clearly to reach extends have should allowed them to their amend law causes of action. See complaint Nathan Kim- after removal conform to to mel, DowElanco, 1199, Inc. v. 275 F.3d pleading set standard forth in Bell (9th Cir.2002) (interference pro- 544, with Corp. Atlantic v. Twombly, 550 U.S. spective (2007). economic advantage 1955, claim 127 S.Ct. 167 L.Ed.2d 929 PhotoMedex, preempted); However, see also Inc. v. the district court did not dismiss Irwin, (9th Cir.2010) 919, 601 F.3d Stengels’ complaint ground on that (“The Supreme Court made clear Buck- it did not Twombly conform the stan- included ground proposed that the was as an exhibit dard, on the but instead and, therefore, was complaint amended preempted. claims were Stengels’ Moreover, pleadings. regard of the part Next, Stengels contend have judicial less of whether notice would by failing to con district court erred necessary it not because proper, been was a motion to dismiss into Medtronic’s vert sent the facts that Medtronic a correction then summary judgment for motion and that FDA a recall on letter issued grant for discov refusing continuance do not affect the pump Rule of Civil Procedure ery under Federal Any analysis. error in district court’s 56(f).2 This fails as well. The contention request judicial to rule for failure on judicial court notice of the took district and, therefore, was harmless is not notice pain pump received fact that Medtronic’s De reversible. See Sanchez Aerovias approval as demonstrated premarket Mexico, C.V., S.A. De F.3d may facts records. A court consider Cir.2010). (9th on to a a motion extraneous dismiss, into converting the motion without V. judgment, if facts summary such one recognize may harsh to We seem judicially noticeable under Federal are deny compensation person alleges to a who City Lee v. Los of Evidence 201. Rule injury a medical But serious from device. (9th Cir.

Angeles, 250 F.3d 688-89 Supreme is the direction from the 2001). judicial A take notice court like the one us. We cases before subject to reasonable a fact “is required to followthe Court. accurately ... can be dispute because it To the extent the claims are readily determined from sources re- theory on the state law based reasonably be accuracy cannot whose about Medtronic to warn consumers quired 201(b). Be questioned.” Fed.R.Evid. dangerous pumps pain condition its accuracy of FDA records cannot cause an do so receiving first order to without reasonably questioned, premarket FDA, state law from the establishes is a pump status of Medtronic’s approval requirement require- different from the Funk v. subject judicial notice. See fact 360k; ments of the FDCA. See U.S.C. (5th Corp., F.3d Cir. Stryker 325, 128 999. To Riegel, 552 U.S. at 2011) judicial FDA let (affirming notice of Stengels’ claims are based the extent the approval). The granting premarket ter theory them that Medtronic caused on court thus did not abuse its discre district duty injury by comply failing to fact considering in connection tion FDA, their report information to to dismiss. with motions threaten to skew the delicate bal- to be statutory objectives sought Finally, contend ance Buckman, ruling on achieved the FDCA. See the district court erred Congress has judicial notice of 121 S.Ct. 1012. request to take U.S. their pro- premarket approval letter correction and a docu established the Medtronic’s important get- ultimate as an balance between showing pump that the was cess ment as patients who need it as soon ting help in But the court ly recalled 2008. district will patients and who judicial possible protecting need notice of the to take did help. who newly Those proposed use the correction letter because that document 56(f) 56(d) without to Rule Federal Rule were moved In the 2010 amendments to the 2. Procedure, change. provisions of substantial Rules of Civil congressional injured have benefitted from this Are individuals the malfunction us, balancing they remedy against are not but such devices without reap before them? insights. appears manufacturers of That Congress’s the benefit It is a today be the of this court Any conclusion change balance we must observe. the MDA holding explicitly must be made itself. Congress any preempts implicitly preempts Therefore, if we hold even some of remedy damages state of a violation be interpreted claims can requirement paralleling the MDA. escape they express preemption, cannot be conclusion, astonishing This in its com- interpreted implied to escape preemption. prehensiveness, equally astonishing is correctly The district court held that the light binding federal law as deter- futile, Stengels’ proposed amendment was mined States Supreme United and therefore did abuse its discretion Court. Alvarez, denying leave to amend. See F.3d at The law. In a case involving the defen- case, dant in our Court held: AFFIRMED. Nothing §in 360k denies Florida the right provide damages traditional NOONAN, Judge, dissenting: Circuit remedy for violations of common-law The issue that must this court address is parallel duties when those duties magnitude potential serious of its requirements. Even if it may be neces- implications great: is sary as a matter of Florida law prove From 2000 through more than that those violations were the result 150 new high-risk medical devices were conduct, negligent they or that created approved by the and Drug Food Admin- an unreasonable hazard for users of (FDA) through istration premarket product, such additional elements (known PMA) approval process, state-law cause of action would make an additional 600 devices were cleared narrower, state requirements not broad- 510(k) through demanding the less pro- er, requirement. than the federal While cess, specialty four medical areas such a requirement might narrower (cardiovascular care, neurology, obstet- “different from” in a rules rics and gynecology, orthopedics; sense, literal such difference would (Class graph High-Risk see Numbers surely provide strange reason for find- III) Medical Approved Devices ing of a state rule insofar as Cleared the FDA Cardiovascular it duplicates the federal rule. pres- Care, Neurology, Gyne- Obstetrics and damages ence of a remedy does not 2000-2011.). cology, and Orthopedics, amount to the additional or different “requirement” “Postmarketing necessary Surveillance of Medical rather, statute; merely Devices-Filling Gaps,” provides in the Frederic S. Resnic, M.D., another reason manufacturers and Sharon-Lise T. Nor- mand, Ph.D., (10.1056/ comply with existing “require- identical February ments” under federal law. NEJMplll4865). Lohr, 470, 495, Inc. v. 518 U.S. Has Congress Supreme or the Court (1996). 116 S.Ct. 135 L.Ed.2d 700 liability

created freedom from for the it, manufacturers of such sensitive devices As the Supreme puts “common only in nonexistent cases are preempted by the man- law duties” express not the subject ufacturers suit for damages? may terms of the “parallel” the MDA

1169 Riegel. damages do exert an addi- State “common law duties” cannot MDA. Such pull compliance tional with the MDA. may the states to zero because amount See id. remedy for their breach. provide a Buckman, 1012, 341, 121 531 U.S. S.Ct. Supreme Court also Literally, as majority, by in our case relied on out, may add an element the state points carefully predated Riegel and distin- cause action without de- of the state plaintiffs The in guished Lohr. Buckman re- parallel with the federal stroying the alleged had commit- manufacturer quirement. Id. Buckman, FDA. ted on the 531 U.S. fraud 347, charge 1012. That at 121 S.Ct. did of the statute magisterial exposition This a state cause of action. Fraud allege Court sets out what the by Supreme agency on a was not a tort that the federal consistently has held and Court Supreme traditionally penalized. Id. states had “To necessary the correct decision is what contrary, relationship between a pre- in the Nothing of case. statute our entity regulates federal and the it agency by “a a state of traditional provision vents in inherently federal character....” Id. remedy” for violation “state damages in “Accordingly—and contrast situa- parallel require- the federal duties” that implicating tions ‘federalism concerns and ments. primacy regulation the historic by exception preemption stated The safety,’ pre- ...—no matters of health in Lohr was restated Court sumption against pre-emption obtains in yet involving in another case Court Buckman, 348, this at 121 case.” U.S. “§ pre does not present defendant: 360k Lohr, 485, (quoting S.Ct. 1012 at U.S. damages from providing vent a State 2240). went on S.Ct. Court premised on a violation remedy for stamp claims in the case as “con- the state in regulations; the state duties of FDA flict[ing] with” the MDA and “therefore to, ‘parallel,’ case rather than add law.” impliedly pre-empted[] requirements.” Riegel Medtron omitted). (footnote Id. ic, 312, 330, 999, 128 S.Ct. 552 U.S. claims in Buck- fraud-on-the-FDA (2008) Lohr, (quoting 518 U.S. L.Ed.2d solely by man virtue “exist[ed] 2240). 495, 116 at S.Ct. requirements” FDCA and did disclosure Pellucidly, Supreme Court has twice tort “rely[] on traditional state the MDA and held states interpreted predated which federal enactments had damages remedy. provide a the lan- 353, 1012; question[ at in Id. S.Ct. ].” Lohr, “strange” if would be guage (con- 352-53, see also at 121 S.Ct. 1012 id. preserved state expressly Court remedies trasting preempted fraud-on- Buckman’s but such reme- from believed Lohr, the-FDA claims with the claims implicitly rejected the stat- dies were at U.S.

ute. “arose from the manufacturer’s pro- in the failure to use reasonable care case present court our comes Our product”). duction The claims in strange reading conclusion traditional, present case free- Buckman, U.S. 121 S.Ct. claims, those analogous tort standing Supreme disparaged where the Lohr. pull” on the of an “extraneous notion Lohr. Not Buckman limits pull” to “extraneous a word MDA. This reference dictum, invoke it do not show majority A it The but surely make-weight. was Riegel dem- application that it has here. conform with Lohr or stand after does not binding recognized that Lohr onstrates is still law has a cause of action Supreme the United States determined based on a manufacturer’s failure to reme- dy Court. give unreasonably or notice of an dan- gerous post-market. condition discovered requirements. The federal The federal Shovel, See Readenour Marion Power statutory on manufactur- imposes scheme 442, 448, (1986) 149 Ariz. 719 P.2d 1058 report- ers of medical devices a continuous (plaintiff manufacturer, argue could that that after ing obligation applies a device upon discovering unreasonably “an dan- goes to market. U.S.C. 360i. In its gerous any during condition at time Letter, Warning detailing regula- product’s history[,]” have should either tory history, the FDA noted Medtron- of already retrofitted “each the models July ic’s Educational Brief of 2003 was “a buyers sold or each of warn[ed] of the reportable correction under CFR danger”). existence the latent of That 806.10(a)(1).” Whatever information Med- Medtronic danger granu- discovered the physician customers, its gave tronic it had pain pump loma after the formation went reported not its action the FDA as a to market does defeat the Warning correction. The FDA Letter told cause of action under law. Arizona See id. Medtronic the incidents of formation of an inflammatory mass at catheter tip be- Whether the state law claim has ele- July tween November 2000 and 2006 “had application ments that further restrict its yet customers,” been communicated Lohr, is of no import. See U.S. at is, physicians. The FDA letter 116 S.Ct. 2240. The have Stengels told “disagrees Medtronic the FDA parallel a valid state law cause action. your the July conclusion that imposes Arizona law requirements a Educational Brief was not correction or parallel requirements labeling removal.” The new in law, provides a remedy Arizona Medtronic, FDA told not been had commu- damages for the violation of state re- physicians patients nicated to “whose al- quirement. ready SynchroMed pump implanted had The state damages. claim their within Stengel’s them.” doctor was in this amendment, proposed Stengels sought category physicians uninformed of the remedy damages inju- for the new information. ries Stengel suffered Richard as a con- These failures of Medtronic to report sequence of Medtronic’s failure to warn of are identified the FDA letter as acts in the danger posed by its pump. violation of the federal statute and the up, To sum seek amend regulations applying it. Under the FDA’s require- their to assert Arizona conduct, assessment Medtronic was parallel requirements ments that early violation federal law as as 2003 under the MDA and for which Arizona adequately because it failed to respond to provides remedy damages. indicating events posed its device amendments should be allowed. specific danger. parallel state claims. The Stengels Appendix sought to amend original complaint their to allege negligently that Medtronic Letter, failed The FDA Warning addressed to provide adequate warnings, “to July informa- CEO of set- tion, both, of the ting history risks hazards of out reports of the in- pain pump.” mass, The Arizona Supreme flammatory states:

1171 conveyed nor to cus- original labeling, conducted to or removal A correction posed by January communication risk to health tomers in a reduce a writing reported in inflammatory device was regarding masses. FDA, required 21 CFR as July Additionally, the 2003 Educational 806.10(a)(1). implant” Brief contained new “Post sent a your establishment July warnings suggest that that clinicians an enclosed “EDUCATION- letter with routinely patients monitor should BRIEF,” “Information entitled AL signs symptoms clinical or prodromal Mass,” Syn- Inflammatory about change in inflammatory mass such as Also (physicians). chroMed customers character, quality intensity pain; or of two articles reprints were enclosed reports pain, especially of new radicular 2002 issue of in the December published level of the at or near the dermatomal labeling for Medicine and revised Pain or tip; frequent large catheter escala- Manual. SynchroMed Technical daily drug tions of does to maintain the in 21 a “correction” CFR FDA defines effect; analgesic and dose escalations 806.2(d) modification, repair, “... may only temporarily that alleviate the destruction, relabeling, adjustment, increasing pain. These new patient’s (including patient monitoring) inspection in warnings were not included the Janu- physical its removal of a device without ary pump’s original 2001 letter or the to some other point of use from technical manual. July FDA believes location.” Brief, which was sent Educational Furthermore, journal articles includ- using SynchroMed to all customers July Educational Brief ed with the meets the definition of “correc- pumps, regard stated with to adverse event re- provided updated tion” that the letter porting regarding adverse events customers for devices that labeling to inflammatory were identified as of mass already in were distribution. (conveyed November 2000 to customers July believes that also letter). January The articles reportable Educational Brief is a also state that an additional 51 events 806.10(a)(1) correction under CFR were identified after the 2001 letter had specific infor- that the letter contained distributed to customers. The ar- been reduce the risk to mation intended to of new suggest ticles number For exam- posed by health the device. more than doubled in adverse events has July spe- 2003 Educational Brief ple, year noteworthy It is reporting. one inflammatory an cifically “[i]f states inspection of during the most recent course, clinical mass is detected in its firm your facility, your calculated the delivery prompt opioid discontinuation inflammatory current rate of masses the mass cause it to shrink or into approximately per events [redacted] surgical need for disappear without the figure, This implants. [redacted] specifically The letter also removal.” your yet has not been communicated to replacement, repo- catheter recommends customers, in- that the risk of suggests sitioning, proce- and other interventional occurring at or near flammatory masses dures, clinical depending patient’s on the used with tip of intrathecal catheters These recommendations condition. great- SynchroMed pumps [redacted] pump’s included were neither er than rate indicated the [redacted] January 2001 letter. CROSS, Petitioner-Appellant,

Terrell Warden, SISTO, Respondent-

D.K.

Appellee.

No. 08-17324. Appeals,

United States Court of

Ninth Circuit.

Argued Aug. and Submitted 2011. April

Filed

Case Details

Case Name: Stengel v. Medtronic, Inc.

Court Name: Court of Appeals for the Ninth Circuit

Date Published: Apr 16, 2012

Citation: 676 F.3d 1159

Docket Number: 10-17755

Court Abbreviation: 9th Cir.