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1001 G Street, N.W.
Suite 500 WestWashington, D.C. 20001tel. 202.434.4100 MEMORANDUM
April 15, 2009
(202) 434-4288
[email protected]
Wyeth v. Levine – U.S. Supreme Court Rejects FDAPreemption in Pharmaceutical Cases On March 4, 2009, the Supreme Court issued its long-awaited decision in Wyeth v. Levine, the controversial case addressing whether the Food and Drug Administration’s (FDA)approved labeling of prescription drugs shields drug manufacturers from state tort suits.1 In a6-3 opinion, the Court held that FDA’s approval of a prescription drug label did not preemptstate-law failure to warn claims given the facts of this case, although it left open the door openfor a finding of preemption under different circumstances. As a result of this decision,pharmaceutical companies should thoroughly document their interactions with FDA with respectto product labeling decisions and work to obtain clear FDA responses on whether proposedlabeling changes are, or are not, acceptable.
The Wyeth decision is part of a trilogy of FDA preemption cases taken up by the Supreme Court in the last year and signals a move towards limited availability of the implied preemptiondefense in the context of FDA regulated drugs. The case has also sparked speculation that theCourt’s decision may potentially be applied in other contexts of agency regulation, impactingconsumers who are suing for injuries caused by motor vehicles, chemicals, pesticides, andhousehold products, etc.2 As stakeholders begin to assess the impact of the decision, reviewingthe issues raised in Wyeth and other recent FDA preemption cases, as well as possible futurecongressional action, may provide important clues for what is to come regarding FDA’sregulation of the safety of products covered by the Federal Food, Drug, and Cosmetic Act(FDCA).
555 US ___ (2009), available at: http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf.
Thomas N. Tiedt, “Pharmaceutical Safety is Not Served by Federal Supremacy,” The Food and Drug Law Institute Update (September/October 2008) at 47; see also Adam Liptak, “No Legal Shield inDrug Labeling, Justices Rule” NY Times (March 4, 2009); see also High Court Hears Arguments onLimiting Drug Company Lawsuits,” The Online NewsHour with Jim Lehrer (November 3, 2008).
This document was delivered electronically.
Assessment of Wyeth v. LevinePage 2 An Overview of Wyeth v. Levine
This case involved Vermont guitarist, Diana Levine, who lost an arm due to gangrene caused by an improperly administered drug. In April of 2000, Levine suffered from nauseacaused by a migraine headache and visited a heath clinic for medical treatment. She was giventwo injections of Phenergan, an anti-nausea drug manufactured by Wyeth. The first dose wasgiven via intramuscular injection, the preferred method of administration identified byPhenergan’s labeling. When Levine’s nausea continued, she was given a second injection by“IV push,” a method through which the medication is administered directly into a vein in orderto promote faster relief. Unfortunately, the drug was accidentally injected into an artery, ratherthan a vein. As a result, the drug caused irreversible gangrene and led to the amputation ofLevine’s right hand and forearm.
Having settled with the health clinic, Levine sued Wyeth on claims of negligence and strict liability alleging that Phenergan’s label failed to sufficiently warn about the grave risksassociated with the IV push method. Although the label repeatedly emphasized the risk ofgangrene arising from inadvertent intra-arterial injection, the label did not specifically addressthe term “IV push,” nor prohibit its use. Levine argued that Wyeth should have modified thePhenergan labeling using FDA’s “Changes Being Effected” (CBE) regulations, which allow drugmanufacturers, in limited circumstances, to add new safety information to a label without FDAapproval while the agency reviews the change.3 Wyeth countered that based on FDA’s extensive review and approval of Phenergan’s label,4 Levine’s common law claims relating to the adequacy of the label are preempted.
Specifically, Wyeth argued that Phenergan has been an approved drug since the 1950s and FDAhad evaluated the risk of IV push administration many times, each time concluding the labelingwas adequate, even when Wyeth proposed stronger language to FDA.
The Vermont trial judge ruled in Levine’s favor, stating that FDA’s approval of Wyeth’s label did not prevent the manufacturer from adding to or strengthening warnings on the label. Ajury awarded Levine millions in damages. The decision was affirmed by the Supreme Court of The supplement procedures described in 21 C.F.R. §§ 314.70(c), 814.39(d) and 601.12(f)(2) (2008) are commonly referred to as “Changes Being Effected” (CBE) supplements and provide that aholder of a FDA approved drug, medical device, or biological product may file a supplementalapplication to amend labeling when there is newly acquired drug risk or efficacy information. See alsofootnote 15, infra. Since Congress passed the Federal Food and Drug Act of 1906, the FDA has controlled the standards for the labeling of prescription drugs and set extensive requirements in subsequent regulations.
Before a drug manufacturer can market a drug, it must submit a New Drug Application (NDA), as part ofwhich FDA will review the prescription drug label. The CBE regulations permit label changes withoutFDA approval only in limited circumstances where “new” risk or efficacy information is acquired. Seefootnote 3, supra. Assessment of Wyeth v. LevinePage 3 Vermont and certiorari was granted by the Supreme Court to address whether FDA’s labelingjudgments preempt Levine’s state-law tort claims.
Understanding the Fundamentals of Preemption
Wyeth v. Levine thus turns on the principle of preemption. The preemption defense is premised on the Supremacy Clause of the U.S. Constitution (Art. VI, clause 2) and provides thatwhen federal and state laws conflict, the federal law takes precedence. Importantly, federalpreemption of state action can occur in three ways. First, Congress may expressly preempt stateaction by language in the applicable legislation.5 Second, federal action may impliedly preemptstate action where Congress’ intent in enacting a federal law is to occupy the regulated fieldexclusively. Congress’ intent to occupy the field may be inferred if the scheme of federalregulation is “so pervasive as to make reasonable the inference that Congress left no room for theStates to supplement it.”6 Third, federal action may impliedly preempt state action when stateand federal law actually conflict. Such “conflict preemption” may be found where it isimpossible to comply with both state and federal law, or when the state law stands in the way ofimplementing Congress’ objectives.7 In this case, Wyeth conceded that Congress has not expressly preempted state tort actions in the FDCA, nor did Congress intend for the FDCA to occupy the entire field of prescriptiondrug regulation. Instead, Wyeth’s position, which was supported by FDA and the BushAdministration, was that the case involved the third type of preemption, implied conflictpreemption.8 In particular, Wyeth argued that it could not use the FDA-approved and required label and at the same time comply with the state common law duties that required stronger warningsabout the IV push method.9 Second, by penalizing drug companies for using FDA-approvedlabeling, Wyeth argued that state tort claims like Levine’s would obstruct the purpose of thelabeling regulations set forth by Congress in the FDCA by allowing juries to second-guess theexpert risk determinations of FDA.10 Indeed, FDA’s decision of what to include on drug labels,as well as FDA’s approval of a drug or medical device generally, requires careful balancing toensure that the benefits associated with the use of the product do not outweigh the risks. Ofcourse, taking any FDA approved drug always involves some risks.
Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517 (1992).
Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, 458 U.S. 141, 152-53 (1982) (internal citation Crosby v. National Foreign Trade Council, 530 U.S. 363, 372-73 (2000).
Brief of Petitioner at 29, Wyeth v. Levine, No. 06-1249, available at: http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_Petitioner.pdf.
Assessment of Wyeth v. LevinePage 4 Public Health Implications of the Preemption Doctrine
When oral arguments in Wyeth concluded in November 2008, stakeholders on both sides of the issue raised valid arguments for how the Supreme Court’s ruling could dramaticallyimpact public health. These policy viewpoints provide necessary context for understanding thepotential impact of this case.
Preemption opponents argued that preemption of pharmaceutical litigation would remove incentives for FDA and industry to improve product safety; in cases such as Levine’s,preemption would remove incentives to update product labels.11 Tort liability and trial discoveryalso disclose newly discovered dangers associated with certain drugs or instances ofmisrepresentation of drug safety risks.12 While frivolous lawsuits weaken this argument, FDAhas historically acknowledged that private tort suits complement FDA regulatory action byproviding a crucial back-end check on products once they have been approved.13 A decade ago,FDA stated that drug approvals set only minimal standards and states were free to provideadditional protections.14 Under the Bush administration, FDA made a controversial about-face,indicating that the agency’s labeling requirements are not mere minimum safety standards, butalso provide a ceiling.15 Continuing reports that FDA falls dramatically short in its post-approval surveillance of drugs provide further support for the claim that safety will be compromised if preemption David A. Kessler and David C. Vladeck, “A Critical Examination of the FDA’s Effort to Preempt Failure-to-Warn Claims,” 96 Geo. L.J. 462, 476 (2008) available at:http://www.georgetownlawjournal.com/issues/pdf/96-2/Kessler&Vladeck.PDF.
Tiedt, supra footnote 2, at 47.
See Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66378, See Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, 3934 (January 24, 2006) where FDA declared that it possessedpre-emptive power in the preamble to its new rules for drug labeling. The rules were updated on August22, 2008 (Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, andMedical Devices, 73 Fed. Reg. 49603), providing broader preemption authority. In its amicus curiaebrief in support of Wyeth, FDA stated that state-law claims that challenge labeling that FDA approvedafter being informed of the relevant risks are generally preempted as it threatens the agency’s authorityand ability to regulate labels under the FDCA. See “Brief for the United States as Amicus CuriaeSupporting Petitioner, Wyeth v. Levine,” No. 06-1249, available at:http://drugaddevicelaw.net/FDA%20Amicus%20Briefs/Levine%20SG-FDA%20brief%20on%20certioari.pdf; see also Terry Carter, “The Preemption Prescription,” ABAJournal (November 2008), (discussing FDA’s change in position on preemption), available at:http://abajournal.com/magazine/the_pre_emption_prescription/.
Assessment of Wyeth v. LevinePage 5 advocates prevail. The Government Accountability Office (GAO) reported that “FDA lacksclear and effective processes for making decisions about, and providing management oversightof, post-market safety issues.”16 Similar findings have been made by the Institute of Medicine inits report on the assessment of the U.S. drug safety system: “The [FDA] approval decision doesnot represent a singular moment of clarity about risks and benefits associated with a drug .”17Although not necessarily through fault of FDA, its approval of a new drug does not guaranteethat a drug’s benefits outweigh the safety risks once the drug is widely used. In numerousinstances, unforeseen risks or dangerous side effects are discovered once an approved drug hitsthe market.18 Thus, in the interest of public health, preemption opponents argued that FDAcannot provide the sole and final word on the safety and efficacy of a product as preemptioncould leave the agency “understaffed, underfunded and outgunned by the industries itregulates.”19 Preemption proponents similarly argued that public health will be compromised if manufacturers are unable to rely on FDA’s approval of their products or labels. First, the rulingfor Levine could cause FDA to be inundated with labeling revisions or labeling supplementsthrough its CBE regulations.20 Such an influx of change requests could make it difficult for thealready short-staffed agency to evaluate and respond to them appropriately.
Moreover, the credibility of drug warnings would be undermined if manufacturers are forced to over-warn about speculative risks in an effort to avoid liability. Exaggerated risks maycause individuals to forgo medical treatment they should be receiving. In their amicus curiaebrief in support of Wyeth, the Washington Legal Foundation and the American College ofEmergency Physicians noted that controversial warnings regarding the dangers of vaccines led toincreasing numbers of parents choosing to forgo vaccinating their children, resulting in a GAO, “Drug Safety Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process,” Report No. GAO 06-401 (2006), available at: http://www.gao.gov/new.items/d06402.pdf.
Tiedt, supra footnote 2, at 48 (quoting “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” Institute of Medicine, Committee on the Assessment of U.S. Drug Safety System(September 22, 2006)).
“Why Doctor’s should Worry about Preemption,” The New England Journal of Medicine (July 3, 2008) (citing Rosiglitazone, Rofecoxin, Dexenfluramine, Aprotinin as examples of drugs with safetyproblems post FDA approval). The New England Journal of Medicine also filed an amicus curiae brief insupport of Levine.
Carter, see footnote 15, supra. “Supreme Court Ruling in Wyeth Case May Make FDA More Cautions,” The Tan Sheet (November 10, 2008); “White House, PHARMA Urge High Court to Find Preemption in Drug Case,”Inside Washington’s FDA Week (June 13, 2008).
Assessment of Wyeth v. LevinePage 6 dramatic increase of measles outbreaks.21 State level lawsuits could thus make beneficial drugsless available to consumers and threaten FDA’s prescribed role as the expert body responsiblefor evaluating and regulating drugs. Wyeth argued, for example, that IV push was the mosteffective way to administer Phenergan for some patients.22 Allowing juries, rather than FDA, todetermine the adequacy of a drug label will not necessarily promote drug safety. Preemptionproponents explain that juries too often see only those consumers hurt by a drug, and not thosewho receive its benefits.23 A Review of the 2008 Supreme Court FDA Preemption Cases and the Decision in
Wyeth v. Levine
Wyeth v. Levine was the third Supreme Court case in the last year to address preemption in the context of FDA regulated products, indicating that the Court recognized the urgent need todefine the scope of the FDA preemption defense. In addition, the Supreme Court had indicatedan interest in two other FDA preemption cases in 2008 in which petitioners had applied forcertiorari.24 Preemption Upheld in Riegel v. Medtronic In February 2008, the Court ruled in Riegel v. Medtronic that an express preemption clause in the 1976 Medical Device Amendments (MDA) to the FDCA preempts state actionschallenging the safety and effectiveness of medical devices that have FDA approval.25 In this See “Brief for The Washington Legal Foundation and the American College of Emergency Physicians as Amicus Curiae Supporting Petitioner, Wyeth v. Levine,” No. 06-1249, available at:http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_PetitionerAmCuWLFAmeColofEmgncyPhy.pdf.
“Legal Side Effects: Can companies be sued even if they follow FDA instructions?” The Wall Street Journal (November 4, 2008), available at:http://online.wsj.com/article/SB122575828988095187.html.
See Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008), petition No. 08-437, finding FDA preemption of state-based failure to warn claims for the risk of suicide on labels for antidepressants Paxiland Zoloft. On March 9, 2009, the Supreme Court granted cert., vacated the appellate decision, andremanded for reconsideration in light of Wyeth v. Levine; See also Albertson’s v. Kanter (Farm-RaisedSalmon Cases), 42 Cal. 4th 1077, 175 P.3d 1170 (2008), petition No. 07-1327, finding no FDApreemption of California state-law claims addressing the failure to disclose the use of artificial coloringagents in farm-raised salmon. The Supreme Court denied cert. to the Farm-Raised Salmon Cases inJanuary 2009, heightening the anticipation of the decision in Wyeth v. Levine. 128 S. Ct. 999 (2008). In particular, the express preemption provision provides that “no State . . .
may establish or continue in effect with respect to a device . . . any requirement— (1) which is differentfrom, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates Assessment of Wyeth v. LevinePage 7 case, Charles Riegel and his wife sued Medtronic after he was severely injured by a ballooncatheter that burst during an angioplasty procedure. Writing for the 8-1 majority,26 Justice Scaliadenied his claims, focusing on the rigorous nature of the medical device pre-market approvalprocess, in which FDA reviews safety and efficacy of the device while balancing the potentialrisks and benefits. Key to the Court’s interpretation of the preemption clause was its finding thatstate negligence and strict liability tort claims impose requirements that are different from or inaddition to federal requirements. The Court also found that a state law that required a safer, buttherefore less effective, device than the model approved by FDA would disrupt the federalregulatory scheme established by Congress.
Because FDA had approved Phenergan’s label and similarly balanced the known risks and benefits associated with the drug’s label, Riegel initially appears instructive on the issue ofpreemption in Wyeth. Indeed, both medical devices and drugs undergo similar FDA balancingprocesses prior to their approval. The holding in Riegel, however, is limited as it only addressespreemption in the context of an express preemption clause in the medical device law.27 Unlikethe law governing medical devices, the FDCA contains no such express preemption clause fordrug products. Whether state tort litigation is impliedly preempted in Wyeth, therefore, is lessstraightforward than in Riegel.
Court Split in Warner-Lambert Co. v. Kent Next the Court took on the preemption prescription drug case of Warner-Lambert Co. v. Kent.28 In this case, Michigan residents sued Warner-Lambert for personal injuries arising fromits FDA-approved diabetes drug, Rezulin. Under Michigan law, prescription drug manufacturershave immunity from personal injury lawsuits if the drug was approved by FDA.29 The plaintiffsclaimed that this defense did not apply, however, because the statute provided an exception toimmunity if FDA approval was based on material misrepresentations or withholding ofinformation by the drug manufacturer. Warner-Lambert, now owned by Pfizer Inc. (Pfizer), (…continued)to the safety or effectiveness of the device or to any other matter included in a requirement applicable tothe device under this chapter.” 21 U.S.C. § 360k(a) Justice Ginsburg was the only Justice to dissent in Riegel v. Medtronic, stating that given the traditional primacy of state regulation of matters of health and safety, Congress did not intend for theMDA to radically curtail state common-law suits seeking compensation for injuries caused by defectivelydesigned or labeled medical devices.
In addition, the ruling was further limited to Class III medical devices that had undergone rigorous pre-market approval (PMA) with the FDA. In Medtronic, Inc. v. Lohr, 518 U. S. 470 (1996), afractured Court held that medical devices cleared under the less-rigorous Section 510(k) premarketnotification process were not covered by the express preemption provision.
See Mich. Comp. Laws § 600.2946(5).
Assessment of Wyeth v. LevinePage 8 argued that such state based “fraud-on-the-FDA” suits are impliedly preempted by federal lawbecause they conflict with the agency’s functions by permitting state courts to second-guessFDA’s product approval and fraud-detection processes.30 The Second Circuit held, however, that the implied preemption doctrine does not bar the fraud-on-the-FDA exception set forth in a Michigan statute.31 This ruling contrasted with theSixth Circuit case of Garcia v. Wyeth-Ayerst Laboratories, which reached the opposite resultwhen it interpreted the same Michigan statute.32 Yet in March 2008, the Supreme Court failed toprovide clarity on the Circuit split. With Chief Justice Roberts having to recuse himself becauseof his ownership of Pfizer stock, the divided Court affirmed the Second Circuit 4-4 and providedno accompanying opinion. The equally divided ruling has no precedental value and with noopinion, it left stakeholders guessing as to which Justices favored FDA preemption and whichdid not. The 4-4 decision did indicate, however, that unlike the nearly unanimous decision inRiegel, the Court is far less inclined to rule in favor of preemption when there has been noexpress preemption mandate by Congress.
Preemption Denied in Wyeth v. Levine Against this uncertain backdrop, in a 6-3 decision, the Supreme Court rejected Wyeth’s arguments that implied preemption should bar Levine’s state law failure to warn claims. Asmentioned above, Wyeth first argued that it could not use the FDA required label and at the sametime comply with the state common law duties that required stronger warnings about the IV pushmethod of administration of Phenergan. Second, Wyeth argued that state tort claims likeLevine’s would obstruct the purpose of the labeling regulations set forth by Congress in theFDCA by allowing juries to second-guess the expert risk determinations of FDA. Joined byJustices Kennedy, Souter, Ginsburg and Breyer,33 Justice Stevens wrote for the majority and Specifically, Warner-Lambert relied on the 2000 Supreme Court case of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) (holding that state law fraud-on-the-FDA claims arebarred by implied conflict preemption if the state tort statute requires actual proof of fraud). A unanimousSupreme Court explained, “State law fraud-on-the-FDA claims inevitably conflict with the FDA’sresponsibility to police fraud consistently with the Agency’s judgment and objectives.” 467 F.3d 85 (2d Cir. 2006). Unlike Buckman, the Second Circuit determined that the Michigan statute did not require proof that FDA was actually defrauded; rather the claims were rooted in traditionalstate tort law. Accordingly, the statute did not establish a specific cause of action for fraud on the FDAand thus did not attempt to police cases of fraud against the FDA.
385 F.3d 961 (6th Cir. 2004). The Sixth Circuit interpreted the Michigan statute differently as requiring proof of successful fraud on the FDA as a prerequisite to state tort liability and thus squarelypreempted by Buckman.
Justice Breyer also filed a concurring opinion emphasizing that the majority’s decision does not consider the preemptive effect of an agency regulation bearing the force of law. In other words, asdiscussed in detail below, the Court ruled that the statement of FDA preemption that appeared in thepreamble to the 2006 FDA regulation governing the content and format of prescription drug labeling (see Assessment of Wyeth v. LevinePage 9 rejected both arguments.34 Justice Thomas concurred in the judgment but wrote separately.35Justice Alito wrote the dissent and was joined by Chief Justice Roberts and Justice Scalia.
In addressing Wyeth’s first argument, the Court held that it was not impossible for Wyeth to comply with both state and federal law obligations. While generally a manufacturer may onlychange a drug label after FDA approves a supplemental application, the Court emphasized thatWyeth had a duty to adequately describe the risk associated with IV push and that the CBEregulations permitted Wyeth to provide additional warnings before receiving FDA approval.36 Wyeth had argued, however, that under the CBE regulations, as amended, a labeling change is not permitted unless a manufacturer has obtained “newly acquired information.”37Wyeth argued that “newly acquired information” means data of a “different type or greaterseverity or frequency than previously included in submissions to FDA.”38 Since the risk ofgangrene did not represent a change in the average frequency of this adverse event and FDA hadalready been aware of the risk of gangrene, Wyeth stated that there was no new information uponwhich to update the label. These arguments were echoed by Justice Alito in his dissent, wherehe emphasized that Phenergan’s label already warned about the risks of gangrene and that FDAhad specifically considered and reconsidered the strength of warnings.39 He further wrote thatthe agency’s ultimate decision was to retain IV push as one means of administering the drug,albeit with stringent warnings. Unfortunately, the physician’s assistant who administeredPhenergan ignored these and other warnings.
The Court majority referred to Wyeth’s arguments as a “cramped” reading of the CBE regulations, emphasizing that the regulations provide that a label may be updated based on “new (…continued)footnote 15, supra) did not bear the force of law. However, because “state tort law will sometimesinterfere with the FDA’s desire to create a drug label containing a specific set of cautions andinstructions,” Breyer wrote that FDA may seek to preempt state laws by passing “lawful specificregulations” indicating that a labeling requirement serves as a ceiling as well as a floor.
Slip. op. at 25 (holding of the case).
Justice Thomas agreed with the majority that in light of the CBE regulation, FDA’s approval of Phenergan’s label did not preempt state law failure to warn claims. While he further agreed that Levine’sclaims also did not obstruct the purposes and objectives of Congress, he disagreed with the majority’sapproach to assessing claims of implied or conflict preemption by looking beyond the statutory text offederal statutes passed by Congress.
See §§ 314.70(c)(6)(iii)(A), (C).
73 Fed. Reg. at 49603. See also footnote 15, supra.
See slip. op. at 9 (Alito, J., dissenting). Phenergan’s label in part stated that “inadvertent intra- arterial injection can result in gangrene of the affected extremity.” Assessment of Wyeth v. LevinePage 10 analysis of previously submitted data.”40 Thus, as amputations continued to occur, the Courtstated that Wyeth could have analyzed accumulated data and added a stronger warning withoutfirst obtaining FDA approval.41 The opinion is silent on what sort of labeling language wouldhave been appropriate, but emphasizes that manufacturers bear the responsibility for the contentof their labels at all times. In addition, the Court viewed FDA’s review of the risks associatedwith IV push very differently than the dissent, stating that FDA “gave no more than a passingattention” to the dangers posed by IV push. Justice Stevens explained that “absent clearevidence that the FDA would have not have approved a change to Phenergan’s label, we will notconclude that it was impossible for Wyeth to comply with both federal and state requirements.”42 The Court further found no merit in Wyeth’s second defense that Levine’s state law failure to warn claim would frustrate the purpose and objectives of the FDCA, which puts druglabeling decisions in the hands of FDA, an expert agency. The Court held that Wyeth’sargument was based on “an untenable interpretation of congressional intent and an overbroadview of an agency’s power to pre-empt state law.”43 In particular, the Court noted that unlike theexpress preemption clause that was controlling in Riegel, Congress had not enacted a similarexpress preemption provision during the 70 year-long history of the FDCA. While Wyeth andthe dissent argued that juries are ill-equipped to perform FDA’s cost-benefit-balancing function,the Court reiterated many of the arguments that preemption opponents have made, namely thatFDA has limited resources and that state law offers an important additional layer of consumerprotection that complements, rather than conflicts with, FDA regulation.
Finally, the Court disregarded Wyeth’s and the dissent’s argument that FDA’s interpretation of its own labeling rules should be given deference. The Court was particularlycritical of the preamble to the 2006 drug labeling rule44 where FDA articulated the FDCA’spreemptive effect. The Court found that the rule did not merit any deference because unlike anagency rule cited to by Wyeth and the dissent in Geier v. American Honda Motor Co. (529 U.S.
861 (2000)), FDA failed to provide notice and comment before finalizing the rule.45 In light ofthese procedural failures, the Court found “inherently suspect” both the preamble and FDA’s Approximately 20 incidents of gangrene resulting in amputation were reported prior to Levine’s See footnote 15, supra.
In Geier, the Department of Transportation (DOT) had promulgated a rule through formal rulemaking that provided car manufacturers with a range of choices among passive restraint devices.
The Court held that state tort claims premised on Honda’s failure to install airbags were impliedlypreempted because they conflicted with the federal regulation that specifically did not require airbags forall cars.
Assessment of Wyeth v. LevinePage 11 views on preemption.46 In addition, the position contrasted with FDA’s traditional recognition ofstate law remedies. Thus, the Court concluded that FDA’s 2006 regulation did not bear the forceof law and that although “some state-law claims might well frustrate the achievement ofcongressional objectives, this is not such a case.”47 Ultimately, the Wyeth decision makes clear that absent congressional intent to the contrary, the Court believes that state tort suits complement FDA regulation. Thus, the decisionwill likely limit the availability of the implied preemption defense in the context of FDAregulated drugs. The Court also indicated that there must be sufficient FDA oversight for animplied preemption argument to have prevailed. For example, if Wyeth had submitted a CBEsupplemental application that had been denied by FDA, it appears that the Court may have foundthe state law claims to be preempted. Given its reading of the facts, however, the majority didnot find that FDA had sufficiently considered and specifically rejected a stronger warning labelfor Phenergan. Thus, under the Court’s standard, manufacturers will have to increasinglyprovide “clear evidence”48 that FDA was fully informed about a drug’s risks and would haverejected a labeling change in order to succeed on implied preemption claims.
Possible Congressional Action and Expansion of the Wyeth Decision
The ruling against preemption in Wyeth v. Levine may be further strengthened, and possibly expanded, to cover products regulated by other agencies, by new Congressional action.
Aside from overturning regulations, there are two ways Congress may seek to overrule past andprevent future Supreme Court decisions upholding federal preemption, as well as FDA’s recentpreemption policy.49 First, Congress could insert anti-preemption clauses into any future billsinvolving products regulated by FDA. Congress successfully added such clauses when it passedthe Consumer Product Safety Improvement Act (CPSIA) in 2008. Preemption was addressed inseveral sections and the CPSIA specifically limits the ability of the Consumer Product SafetyCommission (CPSC) to issue opinions on whether its rules preempt common law tort suits.50 Second, stand-alone congressional measures prohibiting preemption of state tort suits in certain contexts have already been introduced. In the summer of 2008, Representatives Henry Id. at 24-25. In other words, had FDA’s 2006 preamble and regulation born the force of law like the rule promulgated Geier, it appears the Court would have given greater deference to FDA and mayhave found Levine’s claims impliedly preempted.
“Obama, Democratic Congress Could Change FDA Preemption Policy,” Inside Washington’s “CPSC Reform Act Imposes New Requirements, including Limiting Phthalates in Children’s Products,” Keller and Heckman LLP (August 22, 2008), available at:http://www.packaginglaw.com/index_news.cfm?ID=370.
Assessment of Wyeth v. LevinePage 12 Waxman (D-CA) and Frank Pallone (D-NJ) introduced the Medical Device Safety Act of 2008(HR 6381) to overrule Riegel.51 The legislation would have provided that existing federal lawgoverning medical device approvals would not “modify or otherwise affect” lawsuits brought instate courts. When Senator Edward Kennedy (D-MA) and Senator Patrick Leahy (D-VT)introduced the Senate version of the bill, then-Senator Barrack Obama (D-ILL) served as a co-sponsor.52 Although the legislation stalled in both the House and Senate, the bill was recentlyreintroduced this year by Pallone and Waxman.53 As Waxman defeated Representative JohnDingell (D-MI) in the race for House Energy and Commerce Committee Chair, he may be ableto gather greater support for the bill as he now has broad power over health care and FDAlegislation.54 The Bottom Line
The Wyeth decision makes clear that drug manufacturers, rather than FDA, bear the responsibility to monitor and update drug labeling when new risk information arises. The Court,however, provided little guidance on when newly acquired risk information triggers the burdento update product labeling. Thus, to protect themselves from liability, it may becomeincreasingly imperative for manufacturers seeking FDA approval for their products, labels, orboth, to create a comprehensive record of their application, demonstrating that FDA wasinformed of all known product risks and specifically evaluated all options prior to approval.
Manufacturers will also have to pay closer attention to reported adverse drug events andaccumulated risks, and when needed, unilaterally update drug labels while submittingsupplemental applications to FDA under the CBE regulations.
Full text of HR 6381, 110th Cong. (2008) is available at: http://www.house.gov/waxman/pdfs/bill_MDSA_2008.pdf.
“Kennedy, Colleagues Introduce Bill to Reverse Supreme Court Decision, Protect Consumers from Dangerous Medical Devices,” Senator Edward M. Kennedy News Release (July 31, 2008) availableat: http://kennedy.senate.gov/newsroom/press_release.cfm?id=9E5214E5-F445-49F5-BE9A-132B304980A2.
See “Health Leaders Introduce Legislation Reversing Supreme Court's Medical Device Decision” Committee on Energy and Commerce News Release (March 5, 2009).
The House Committee on Energy and Commerce has one of the broadest jurisdictions of any congressional committee. It maintains principal responsibility for legislative oversight relating totelecommunications, consumer protection, food and drug safety, public health, air quality andenvironmental health, the supply and delivery of energy, and interstate and foreign commerce in general.
This jurisdiction extends over five Cabinet-level departments and seven independent agencies, includingthe Energy Department, Health and Human Services, the Transportation Department, the Federal TradeCommission, the FDA, and the Federal Communications Commission.

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