Brueckner_wyeth v levine - us supreme court refuses to swallow big pharmas preemption pill:plaintiff magazine.qxd
APRIL 2009
Wyeth v. Levine: U.S. Supreme
Court refuses to swallow “Big
Pharma’s” preemption pill
The decision is being hailed as a
resounding victory for victims’ rights.

patient’s vein. The drug is corrosive and causes irreversible gangrene if it enters a heaved a collective sigh of relief when, on Levine v. Wyeth (2006) 944 A.2d 179, 185- IV-push injection of Phenergan that inad- vertently hit an artery. As a result, her wrote: “The litigation at issue here does against drug manufacturers off the litiga- tion map. In Wyeth v. Levine, 2009 WL her entire forearm. In addition to her ter- basis for federal preemption.” (Id. at rible pain and suffering, Ms. Levine lost profile cases decided this term, the Court her livelihood as a professional musician.
held 6-to-3 that federal law does not pre- returned a verdict for the plaintiff of $6.7 manufacturers for failing to warn of their million. During the trial, Ms. Levine pre- Court’s ruling did not conflict with the victims’ rights and for public health and United States Solicitor General’s Office, which filed an amicus brief in favor of A tragedy that could have been
deny review given this lack of a split. But Wyeth was filed on behalf of a profes- sional guitarist, Diana Levine, who lost an arm after an injection of the nausea drug Court, Wyeth attempted to avoid liability by arguing that Ms. Levine’s failure-to- The U.S. Supreme Court just
says “No”
whereby the drug is injected directly into a patient’s vein, or the “IV-drip” method, gument, holding that the jury’s verdict United States (as amicus) took the posi- did not conflict with the FDA’s labeling requirements because, under the agency’s “changes being effected” (“CBE”) regula- conflicted with the FDA’s decision to ap- For reprint permission, contact the publisher:
APRIL 2009
prove the drug’s warning label. (Because “preempts conflicting or contrary State to the FDCA and to FDA regulations, it law.”(Id. at *10 (quoting 71 Fed. Reg.
has remained a central premise of federal drug regulation that the manufacturer bears whether the plaintiff ’s claims were im- responsibility for the content of its label at all “merit deference” because it was not “an times. It is charged both with crafting an agency regulation with the force of law”; adequate label and with ensuring that its “mere assertion that state law is an obsta- authored by Justice Stevens, rejected this drug on the market.” (Ibid. (citations cle to achieving [the agency’s] statutory contention, holding that the mere fact of objectives.” (Id. at *11.) The Court also basis, the Court rejected Wyeth’s attempt to shirk its responsibility for the content label to warn the public of its risks. (See, to comment; it stated a position “at odds in his rejection of Wyeth’s argument that with what evidence we have of Congress’ Ms. Levine’s claims would “obstruct the purposes”; and, last but not least, “it re- verses the FDA’s own long-standing posi- federal preemption in cases involving the labeling regulation.” (Id. at *10.) The historic police powers of the States.
terms, stating, “Wyeth contends that the FDCA establishes both a floor and a ceil- FDA’s regulation of drug labeling during decades of coexistence.” (Id. at *11-12.) legislated. . .in a field which the States have traditionally occupied, . . .we start that all evidence of Congress’ purposes is preempt state law, and the FDA’s recently adopted position that state tort suits in- terfere with its statutory mandate is enti- tled to no weight.” (Id. at *13.) The majority’s opinion in Wyeth did (Id. at *5 (citations, internal quotations, jority went on to hold that the FDCA does ment, Justice Stevens noted that, “[o]f because, said Wyeth, “It is impossible for tion.” (Id. at *9.) “But,” he wrote, “absent both the state law duties underlying those clear evidence that the FDA would not have claims and its federal labeling duties.” (Id. approved a change to Phenergan’s label, we and state requirements.” (Ibid.) (empha- certain changes to its label before receiv- sis added). Justice Stevens cautioned that ing the agency’s approval.” (Id. *7-9.) ity for their drug labeling at all times.
the burden of proving such a “clear evi- dence” defense lies squarely on the drug for its “cramped reading” of the FDA’s manufacturer, (Ibid.), and that “[i]mpossi- regulatory framework. (Id. at *8.) “Wyeth suggests,” Justice Stevens wrote, “that the FDA’s view, as expressed in the preamble fense.” (Ibid.) In so ruling, Wyeth cut the to a 2006 labeling regulation, that its ap- bears primary responsibility for drug la- For reprint permission, contact the publisher:
APRIL 2009
Why Wyeth matters
not have the information that it needs to Holding drug companies accountable
their labels. And, without litigation, the The first – and most important – rea- son Wyeth matters is because it halted Big sate victims nor have any financial incen- Pharma’s attempt to wipe out consumers’ hicles. Geier’s holding has been decried id. at 491-96 (discussing how litigation gotten its way, no consumer would ever be who dissented in the case) as a radical – able to sue for failure-to-warn, regardless of the extent to which the drug’s label un- In short, an adverse ruling in Wyeth (criticizing the vague and “potentially Justice Stevens noted, the FDA itself has adequacy of prescription drug labels.
seek compensation for their injuries. The (See, id. at *12 n.11 (quoting, inter alia, “free-form judicial policymaking” en- ing that “the Agency suffers from serious earthed during the course of litigation.
gaged in by the Geier majority. (Id. at 911 (Stevens, J., dissenting).) In 2002, for ex- ulatory responsibilities.”).) Among other cision in Sprietsma v. Mercury Marine by the risk of litigation, at the direct ex- ited to the information that is submitted by the drug manufacturers themselves.
it lacked a propeller guard. And just last Luckily, this parade of horribles was year, in Altria v. Good (2008) 129 S. Ct.
after a drug’s label has been approved, stopped in its tracks. Wyeth makes crystal claims against manufacturers of so-called to reflect the newly discovered risks. As Public Justice explained in an amici brief “the [drug] manufacturer bears responsi- filed on behalf of editors and contribut- bility for the content of its label at all times.” (Id. at *8 (emphasis added).) Con- Breyer and Kennedy, who joined the ma- jority decision in Geier), rejected implied that, in many, many cases, drugs are left But that’s just the first reason Wyeth majority narrowly limited Geier to its even as the casualty statistics climb ever matters. As explained below, the decision Respondent, 2008 WL 3851616; see also tensive” history of the substantive regula- David A. Kessler & David C. Vladeck, A Limiting the scope of implied conflict
Critical Examination of the FDA’s Efforts to preemption
Preempt Failure-To-Warn Claims, 96 Geo.
Wyeth is also important because it went so far as to assert that implied con- entirely on the ground that it “leads to risks of prescription drugs. This informa- the illegitimate – and thus unconstitu- tion can, in turn, spur the agency to put tional – invalidation of state laws. . .” (Id. at *25 (Thomas, J., concurring in the prove the labels. But without this critical “feedback loop” generated by prescrip- For reprint permission, contact the publisher:
APRIL 2009
suade courts to find implied conflict pre- against the industry they purport to reg- bate, holding that “the [FDA’s] preamble emption, particularly in regulatory cases, like Geier, that invite courts to “[run ] guage in their regulations stating that, in amok with our potentially boundless . . .
the agency’s view, state law claims against based on frustration of purposes . . .” including any discussion of how state law (Geier, 529 U.S. at 907 (Stevens, J., dis- has interfered with the FDA’s regulation The Perils of Preemption, Trial Magazine rights and preservation of the civil justice Reaffirming the presumption against
Wyeth also should put the final nail Catherine M. Sharkey, Preemption by Pre- amble; Federal Agencies and the Federaliza- able in undercutting other agency’s at- tion of Tort Law, 56 DePaul L. Rev. 227 cases involving “the historic police power of the States.” In recent years, conserva- self, when it declared, in the preamble to cases involving state law damage claims.
(See, e.g., Altria v. Good, Brief of Wash- ington Legal Foundation as Amicus Curiae labels, and that state law failure-to-warn they would conflict with the agency’s la- ing Wyeth inapplicable to cases involving laid to rest”); Warner-Lambert v. Kent, the United States of America as Amicus sal of the FDA’s prior views on the mat- Wyeth majority’s stated distrust of “an Curiae in Support of Petitioners, 2007 agency’s mere assertion that state law is is no basis in the text of the Constitution purposes,” (Id. at *11), there will likely the agency’s ability to ensure the safety Wyeth’s refusal to defer to the FDA’s pre- in Altria v. Good, which applied a pre- ground that the FDA’s newly minted pre- “light” cigarettes. (See (2008) 129 S. Ct.
ence.” (See, e.g., Colacicco v. Apotex (3d Cir. 2008) 521 F.3d 253 (Colacicco, hap- Recognizing the value of the civil justice
tion against preemption yet again – this system
wake of Wyeth).) A number of other Finally, at a time when “tort reform” claims – Wyeth hopefully puts the issue to Court in Wyeth (See, 922 A.2d at 193) – Curbing federal preemption by
rejected the FDA’s preamble as inconsis- House, Wyeth provides a powerful re- regulatory fiat
minder of the importance of the civil jus- Wyeth also may help stem the tide of entitled to any weight. (See, e.g., Perry v. Novartis Pharmaceutical Corp. (E.D. Pa.
agency itself has “traditionally regarded For reprint permission, contact the publisher:
APRIL 2009
drug regulation.” (Id. at * 12.) The ma- jority went on to note that “State tort vide incentives for drug manufacturers to disclose safety risks promptly. They also risks), Wyeth’s ringing endorsement of come forward with information.” (Ibid.) larger audience. It is precisely this sort of public education that is needed to ensure this observation in terms of the FDA, his that the civil justice system continues to upholding an injury victim’s right to sue a play its role in making the world a safer manufacturer for failing to install propeller guards on its recreational motor boat engines. For reprint permission, contact the publisher:


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