By Kevin E. Noonan —
The Supreme Court handed down its decision in Wyeth v. Levine today, and in a 6-3 decision, declared that the labeling regulations and decisions by the Food and Drug Administration (FDA) did not preempt state tort liability based on "failure-to-warn" and strict liability theories.
As Justice Alito noted (albeit writing in dissent), this is a "tragic case." Diane Levine, a musician, went to a clinic to obtain treatment for migraine headaches and nausea, and while there, received Wyeth's Phenergan® drug (promethazine) by direct intravenous injection (in a procedure termed "IV push," indicating that the drug was not diluted with saline or other solution prior to administration). The drug's label contained a warning that administration by IV push was extremely risky, because inadvertent administration to an artery, or arterial contact due to extravasation into surrounding tissue, could lead to gangrene and the necessity to amputate the injected appendage. Unfortunately for Ms. Levine, this is what ensued and doctors needed to amputate one of her arms as a consequence of Phenergan® administration.
In addition to suing the clinic, physicians, and the physician assistant who actually administered the drug (that case settled before trial), Ms. Levine sued Wyeth on the grounds that the drug company was strictly liable and also that the FDA-approved labeling was inadequate and amounted to a failure to warn of the extent of the danger due to an ineffective label warning about the risks of administering the drug in the way the doctors had administered it. After denying Wyeth's summary judgment motions that Ms. Levine's claims were preempted by the federal Food, Drug and Cosmetics Act (FDCA) and FDA regulations, a Vermont jury found in favor of the plaintiff. In its judgment, the jury found that the (admitted) malpractice was not an intervening cause, that the inadequate label was a "but-for" and proximate cause, and also held Wyeth strictly liable. The Vermont Supreme Court affirmed the judgment; in its decision, Vermont ruled that FDA regulations provide "a floor, not a ceiling, for state regulation."
The Supreme Court granted certiorari specifically on the preemption question. In a decision by Justice Stevens, joined by Justices Breyer, Ginsberg, Kennedy, Souter, and Thomas (the latter concurring in the judgment but not in the Court's reasoning), the Court held that federal statutes and regulations did not preempt state tort law claims for injuries based on harm due to inadequate warnings to the public for FDA-approved drugs. The Court based its decision on two grounds:
1) There was no conflict or impediment for Wyeth to abide by both state and Federal law here, because FDA regulations permitted Wyeth to add stronger warnings to its label (
i.e., stronger than the FDA required) under a "changes being effected" program. In addition, there was no evidence that the FDA would have rejected stronger warning labels. Finally, according to the Court, FDA regulations provide that the manufacturer bears the responsibility for its label at all times, subject merely to approval by the FDA; Wyeth had argued that its failure to act was predicated on compliance with the FDA-approved label.
2) Permitting state law claims in such cases does not contravene Congressional intent, nor does the agency itself have the capacity to preempt state law. The Court found no evidence in legislative history of the FDCA that Congress intended preemption of state failure-to-warn actions. The only basis asserted by Wyeth (and advanced by the U.S. as amicus) was the preamble to a 2006 FDA regulation. The Court decided that the regulation did not merit deference, however, at least because the FDA did not offer interested parties the opportunity for notice and comment under its rulemaking authority; the court called this "inherently suspect." The Court also opined that preemption was at odds with the "available evidence of Congress's purposes" and that it "reverses the FDA's own longstanding position that state law is a complementary form of drug regulation."
Part of the factual predicate of the Court's decision is that it had been known for almost 50 years that Wyeth's Phenergan® drug could cause gangrene if improperly-administered, based on evidence of 20 amputations since the 1960s. Indeed, Wyeth itself had considered changing the label.
In performing its analysis, the majority held that the presumption is that Congress did not intend to preempt the "historic police powers" of the states, and that to find preemption required a "clear and manifest" Congressional intent. The Court looked first to the history of federal drug regulations, particularly for indications that Congress did not intend to preempt state law (for example, in the 1962 bill revising FDCA included a state law "savings" provision, and the 1976 law preempting state law for medical devices expressly did not include pharmaceuticals).
Turning to Wyeth's contention that it was precluded from making changes to its label once Phenergan® received FDA approval, the Court disagreed, saying:
There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency's approval. Among other things, this "changes being effected" (CBE) regulation provides that if a manufacturer is changing a label to "add or strengthen a contraindication, warning, precaution, or adverse reaction" or to "add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product," it may make the labeling change upon filing its supplemental application with the FDA; it need not wait for FDA approval. §§314.70(c)(6)(iii)(A), (C).
Under its interpretation of FDA regulations, the Court found that the "new information" required to change a label could include new interpretations of older information, such as the history of 20 amputees resulting from IV push Phenergan® administration. Under these circumstances, the Court found that Wyeth could have complied with both Federal law and regulations while at the same time applying a stronger warning label in compliance with state tort liability law. The Court recognized that the FDA could have rejected the label change, but there was no evidence that they did or would. (Interestingly, the majority declined an invitation from the Solicitor General to address the question of whether the FDA regulation precluded state law requirements, on the grounds that this question was not required for the Court to reach its decision.)
In this regard, Wyeth wasn't helped by evidence that Pfizer (ironically) had withdrawn another antinausea drug, Vistaril®, "several decades earlier" due to gangrene and amputation concerns. And the Court also evinced skepticism that the FDA would initiate an enforcement action against a manufacturer for strengthening a label warning, and no cases were cited where they have.
The majority completely rejected Wyeth's interpretation of FDA rules and regulations:
Wyeth's cramped reading of the CBE regulation and its broad reading of the FDCA's misbranding and unauthorized distribution provisions are premised on a more fundamental misunderstanding. Wyeth suggests that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling. Yet through many amendments to the FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is char
ged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market. See, e.g., 21 CFR §201.80(e) (requiring a manufacturer to revise its label "to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug"); §314.80(b) (placing responsibility for postmarketing surveillance on the manufacturer); 73 Fed. Reg. 49605 ("Manufacturers continue to have a responsibility under Federal law . . . to maintain their labeling and update the labeling with new safety information").
Indeed, prior to 2007, the FDA lacked the authority to order manufacturers to revise their labels. See 121 Stat. 924–926.
* * *
Thus, when the risk of gangrene from IV-push injection of Phenergan became apparent, Wyeth had a duty to provide a warning that adequately described that risk, and the CBE regulation permitted it to provide such a warning before receiving the FDA's approval.
Wyeth argued that the FDCA is intended by Congress to provide both a floor and a ceiling for drug regulation: at least, but no more than what the FDA approves. The Court disagreed, saying that "all evidence of Congress's purposes is to the contrary" including the fact that the original 1938 FDCA and subsequent amendments contained no Federal cause of action for consumer injury. Relying on Senate testimony, the Court found that Congress left lawsuits for consumer injury to the states, contradicting Wyeth's preemption arguments:
"The case for federal pre-emption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there [is] between them." Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U. S. 141, 166–167 (1989)
The Court also refused to give deference to statements by the FDA, in its regulations and in the U.S. amicus brief, that state law tort claims interfere with agency action and frustrate Congressional intent. The Court emphasized that it would consider the agency's expertise in the statutes it implements when it comes to preemption and frustration of Congressional purpose, but would not defer to the agency's conclusions. The standard the Court applied to whether and to what extent it would rely on and give weight to an agency's explanation of state law's impact on the federal scheme depends on its thoroughness, consistency and persuasiveness. The Court found that the preamble to the 2006 FDA regulation relied upon by Wyeth and the U.S. amicus "does not merit" this kind of deference, on both procedural and substantive grounds. First, the Court found that the preamble was not a part of the proposed regulation published for notice and comment in the Federal Register, and was added to the rule in the publication announcing final rule-making, something the Court found "inherently suspect." Second, the substance of the preamble was contrary to the entire history of earlier FDA positions, something supported by amicus briefs by two former FDA Commissioners. Finally, the Court noted that the FDA has limited resources, that the manufacturers have more and better information about their drugs, especially post-approval, and that the FDA traditionally used state law tort claims to supplement federal drug regulations. (In this regard, footnote 11 notes that the FDA is particularly inapt for monitoring post-approval adverse events and has imposed the responsibility on drug manufacturers to supply evidence thereof. State tort law liability provides a strong impetus for drug companies to monitor and comply with these requirements.)
Justice Breyer's concurrence emphasized that the Court did not consider the preemptive effect of a specific agency regulation bearing the force of law, and that under some circumstances state tort law could interfere with the Federal regulatory scheme. He concurred in the majority opinion because he did not believe that state tort law did so in this instance. However, he did opine that there is the possibility that the FDA could promulgate a lawful regulation establishing both a ceiling and a floor for label warnings that would have a preemptive effect, if based on the appropriate agency determinations.
Justice Thomas concurred in the result but not the reasoning; he took the 'true' conservative position that Federal preemption should be severely limited and exist only upon express Congressional intent:
In accordance with the text and structure of the Constitution, "[t]he powers delegated by the proposed constitution to the federal government, are few and defined" and "[t]hose which are to remain in the state governments, are numerous and indefinite." The Federalist No. 45, at 237–238.
To this effect he cited New York v. FERC, 535 U. S. 1, 18 (2002) that a "federal agency may pre-empt state law only when and if it is acting within the scope of its congressional delegated authority . . . [for] an agency literally has no power to act, let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it." He also cited FDA regulations that "require a drug manufacturer — after initial federal approval of a drug's label — to revise the federally approved label 'to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug.'" 21 CFR §201.80(e). The remainder of the concurrence argues against the Court's "purposes and objectives" preemption jurisprudence, which does not apply to the decision.
Justice Alito wrote in dissent, joined by Chief Justice Roberts and Justice Scalia. The majority characterized the dissent as selectively quoting the record and FDA statements to produce a fact pattern where the FDA gave the label change more attention than it actually did. The dissent "undertakes a study of Phenergan's labeling that is more elaborate than any FDA order" according to the majority. The dissents position was simple: the content of a drug label is up to the FDA, as an agency having expertise in crafting what it called "[t]he centerpiece of risk management," that "communicates to health care practitioners the agency's formal, authoritative conclusions regarding the conditions under which the product can be used safely and effectively," citing the preamble to the 2006 regulation. Justice Alito's dissenting opinion was based on the doctrine of "conflict preemption" that would preclude state law (as effected by the jury verdict) from "countermanding the FDA determination that a drug is safe." (The precedent the Justice cites for this determination is a case involving a medical device, where Congress enunciated an express preemption.) The opinion champions the Constitution's Supremacy Clause:
[T]he degree of a State's intrusion upon federal law is irrelevant — the Supremacy Clause applies with equal force to a state tort law that merely countermands a federal safety determination and to a state law that altogether prohibits [it]. . .
His reasoning, while almost cruel in this case, has a kernel of truth about the practical effects of the majority's opinion:
By their very nature, juries are ill-equipped to perform the FDA's cost-benefit-balancing function. As we explained in
Riegel, juries tend to focus on the risk of a particular product's design or warning label that arg
uably contributed to a particular plaintiff's injury, not on the overall benefits of that design or label; "the patients who reaped those benefits are not represented in court." 552 U. S., at ___ (slip op., at 12). Indeed, patients like respondent are the only ones whom tort juries ever see, and for a patient like respondent — who has already suffered a tragic accident — Phenergan's risks are no longer a matter of probabilities and potentialities.
In contrast, the FDA has the benefit of the long view. Its drug-approval determinations consider the interests of all potential users of a drug, including "those who would suffer without new medical [products]" if juries in all 50 States were free to contradict the FDA's expert determinations. Id., at ___ (slip op., at 13). And the FDA conveys its warnings with one voice, rather than whipsawing the medical community with 50 (or more) potentially conflicting ones. After today's ruling, however, parochialism may prevail.
The Court's decision is somewhat surprising, in view of the 4-4 deadlock (Chief Justice Roberts recusing himself) in a similar case (Warner-Lambert v. Kent) decided last fall. The way forward for Wyeth seems clear, however: as it has with medical devices, Congress could expressly preempt state tort law claims regarding pharmaceuticals, cosmetics, foodstuffs, and supplements regulated by the FDA. As with patent reform, any such efforts would be expected to be met by strong resistance, not only from the plaintiffs' bar but from consumer groups, public interest groups, and others. In addition to Federalism and other structural impediments to the exercise of preemption of a traditional state police power, the abject failure of the FDA to police post-approval events resulting in consumer injury (whether from drugs such as Vioxx®, Celebrex®, and Phenfen® produced and sold in this country, or generic versions produced abroad) would suggest that preemption efforts are unlikely to pass muster absent a broad increase in the FDA's authority and budget, results that have become less likely in the current economic climate.
ADDENDUM: The 2006 regulation preamble was written by Daniel Troy in his capacity as FDA chief counsel. A political appointee rather than a career government lawyer, Mr. Troy oversaw the filing of amicus briefs espousing preemption in a series of tort liability cases from 2002 through 2005, including appeals involving Pfizer's Zoloft and Paxil. This strategy having proved ineffective, in early 2006 Mr. Troy included the preamble to revisions to drug labeling regulations. Hat tip to Tamara Loomis from American lawyer.com for this information (see "Preemptive Strike").
Wyeth v. Levine (2009)Opinion by Justice Stevens, joined by Justices Kennedy, Souter, Ginsburg, and Breyer
Concurring opinion by Justice Breyer
Opinion concurring in the judgment by Justice Thomas
Dissenting opinion by Justice Alito, joined by Chief Justice Roberts and Justice Scalia
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