federal preemption

Yes, “Botch” is the right word.

by Greg Conko on March 5, 2009 · 2 comments

in Healthcare, Legal, Personal Liberty, Precaution & Risk, Regulation

I certainly take Alex’s point that libertarians can disagree about the appropriateness of federal preemption of state tort law. Indeed, Justice Thomas’s concurring opinion lays out a strong textual case against implied preemption of state law in all cases. However, there are a few points I was not able to make in yesterday’s post that better elucidate why preemption is better policy given the narrow facts presented in Wyeth v. Levine. And, Justice Alito’s dissenting opinion — after pointing out a few misleading statements of fact in Justice Stevens’s majority opinion — shows why, if one accepts the current state of implied preemption caselaw, the Court’s majority decision is bad law.

Stevens’s majority opinion asserts that, regardless of FDA’s regulation, “the manufacturer bears responsibility for the content of its label at all times.” It further argues that, FDA can’t keep track of all safety issues that arise after a drug is approved, that the agency never specifically made a determination regarding the safety of IV-push administration, and that Wyeth could have changed its label without FDA’s pre-approval after receiving information regarding the risk of arterial injection of Phenergan.

However, as Justice Alito’s dissent makes clear, FDA repeatedly and intensively investigated this exact question after cases of severe tissue damage connected to the use of Phenergan began to emerge after the drug’s approval in 1955, and the agency approved several changes to the drug’s label that boosted the warnings accordingly. Indeed, Levine and her attorneys conceded that, in 1988, Wyeth proposed a label change that “if followed, would have prevented the inadvertent administration of Phenergan into an artery,” but the FDA rejected that language. Further, no new evidence of Phenergan’s risks has emerged in decades.

The Court majority nevertheless concluded that there was some other conceivable way for Wyeth to have ramped up its warning short of Levine’s preferred route of ruling out IV-push injection altogether, which the FDA rejected. Thus, FDA regulation is a “floor” below which state law cannot fall, but that the agency’s drug labeling regulation should not preempt state tort laws that require a more strict approach.

Unfortunately, that conflicts with reasonable and long-standing Court precedent regarding implied conflict pre-emption of state laws elucidated most recently in Geier v. American Honda. As Justice Alito’s dissent makes clear, “the ordinary principles of conflict pre-emption turn solely on whether a State has upset the regulatory balance struck by the federal agency.” That is exactly what has happened here.

There is no such thing as a perfectly safe drug, but on balance most drugs offer more benefit than harm. Congress established the FDA and enacted the Food, Drug and Cosmetics Act and subsequent amendments giving the agency statutory authority over questions of safety and efficacy because it believed that a federal expert body could most effectively balance the benefits and risks of new medicines. FDA made a decision that permitting IV-push injection provides greater benefits than could be achieved with the alternative of deep tissue injection, and that those benefits outweighed the risks. Permitting state tort law to over-ride that determination upsets the regulatory balance struck by FDA.

Thus, contrary to Alex’s suggestion, allowing Ms. Levine’s claim here would in effect act as a ban – not one that removes the drug from the market, but one that removes one “safe and effective” use of the drug from its label. And, while physicians may prescribe a drug for an “off-label” use, if a use is not identified on the label, the manufacturer can’t tell anyone about it. That restricts the ability of doctors to receive information about possible uses, and it means that some patients will not be able to benefit from some drugs.

Finally, it is relevant, as Alex notes, that the existence of FDA regulation as a legal floor means that the tort system acts as a check on FDA decision-making, but only in one direction: toward greater regulation. Alex is right. “This IS one of these questions about what to do in the real world, where first-best solutions just aren’t politically possible” (emphasis added). So, I think it’s reasonable for we libertarians to support the less bad position that, if our society is going to create a regulatory gatekeeper for drugs and empower it to make risk-benefit balancing decisions on our behalf, then we should not permit lay juries to ratchet up that regulation in circumstances in which all reasonably available information about risks and benefits is internalized into the system.

Supreme Court Botches Preemption Case

by Greg Conko on March 4, 2009 · 7 comments

in Healthcare, Legal, Regulation

The Supreme Court handed down its decision this morning in the Wyeth v. Levine federal preemption case, holding, by a 6-3 majority, that “Federal law does not pre-empt [plaintiff Diana] Levine’s claim that [the Wyeth drug] Phenergan’s label did not contain an adequate warning about the IV-push method of administration.” Justice Stevens wrote the majority opinion, joined by Justices Kennedy, Souter, Ginsburg, and Breyr, and with Justice Thomas concurring in the judgment. Justice Alito wrote a compelling dissenting opinion, joined by Chief Justice Roberts and Justice Scalia. Guest blogger Bert Rein and I separately commented on the case here, here, here, and here.

According to Justice Stevens’ majority opinion, “The history of the [Food Drug and Cosmetics Act] shows that Congress did not intend to pre-empt state-law failure-to-warn actions.” Fair enough, but this isn’t a typical failure-to-warn case. As Justice Alito’s dissent notes, Ms. Levine alleged not only that the warning on Phenergan’s label wasn’t strong enough, but that Phenergan was “not reasonably safe for intravenous administration,” and that Phenergan’s label should have indicated that the drug “should not be used intravenously.” But, that’s a question regarding FDA’s approval of the product for that use, not merely the sufficiency of the warning.

Consequently, the decision reaches to the very core of FDA’s statutory competence. FDA made a regulatory decision that the benefits of IV injection outweighed the risks, and the agency permitted the product to be labeled accordingly. Furthermore, there are no allegations that Wyeth hid any information about the risks of IV injection, nor that any new information regarding the risks of IV injection have arisen that would call that decision into question since FDA made it. So, letting a Vermont jury penalize Wyeth for not ruling out IV injection on Phenergan’s label is tantamount to letting a group of laymen over-rule FDA’s expert opinion regarding safety.

It would have been one thing if new evidence of risk had arisen since FDA approved the label, or if Wyeth were accused of hiding information from the FDA or mis-representing the data it did provide. In such a case, exposing a drug manufacturer to tort liability would not be over-riding FDA’s expert judgment. But that is decidedly not the case here. Indeed, the negligent act that actually caused Ms. Levine’s unfortunate injury was not an IV push injection into a vein, but the physician’s assistant’s botched administration. The physician’s assistant injected Phenergan into Ms. Levine’s artery, in direct contravention of six label warnings against arterial injection. More or sterner warnings against arterial injection would not have prevented Ms. Levine’s injury.

Thus, the Supreme Court could have and should have held in Wyeth’s favor with a narrowly tailored opinion confined to the facts of this case. Doing so would not have insulated wrong-doers from punishment, but would have recognized that Congress gave FDA statutory authority over questions of safety and efficacy because it believed that only a federal expert body could effectively balance the benefits and risks of new medicines. So, not only is the majority’s decision bad policy, it’s also bad law.

Preemption in Wyeth v. Levine: Broader Implications

by Bert Rein on February 13, 2009 · 2 comments

in Healthcare, Legal, Precaution & Risk, Regulation

The Supreme Court’s pending, and perhaps imminent, decision on the preemptive effective of FDA drug labeling approvals in Wyeth v. Levine has stimulated a flood of legal and public policy debate on the roles that federal regulation and state-law based tort litigation should play in regulating pharmaceutical manufacturers. That debate, which is almost certain to continue in a legislative forum should Wyeth prevail before the Court, may determine the future of the now-lucrative litigation industry. More importantly, arguments made in the debate by those seeking to protect or expand litigation opportunities may exacerbate an onslaught of public policy initiatives that threaten the future viability of a private enterprise, research-based pharmaceutical industry.

The Wyeth v. Levine case itself presents a relatively narrow preemption issue. Ms. Levine lost her right forearm to gangrene when Wyeth’s drug Phenergan was improperly administered by intravenous push injection to deal with her severe migraine-related nausea. The drug entered an artery and caused gangrene. The administering clinic failed to observe a number of cautions prominently displayed on Phenergan’s label relating to the maximum total dosage, rate of administration, cessation of treatment on complaint of pain and extreme caution in avoiding exposure of Phenergan to arterial blood. Nevertheless, after settling her claim against the administering clinic, Ms. Levine successfully sued Wyeth under Vermont law for failing to totally foreclose push injection of Phenergan in its labeling and thus allegedly making the product unreasonably unsafe.

Wyeth’s constitutional preemption defense was two pronged. Wyeth first argued that, under federal law, it could not have complied with Vermont’s labeling standard. The FDA, in first approving Phenergan in 1955 and then repeatedly approving Wyeth’s evolving label, had determined that push injection – the fastest and most efficacious method of administration – was safe given the cautions included in the label. Wyeth’s post-approval experience had provided no additional information that would authorize a deviation from FDA’s position and any unauthorized deviation would put Wyeth in violation of federal law. Wyeth also argued that Congress had given FDA national authority to optimize prescription drug use by balancing benefit and risk and that state law – particularly case-by-case setting of labeling standards in jury trials – should not override FDA’s scientific risk assessments. Wyeth presented both arguments to the Supreme Court in seeking certiorari and in arguing the merits of its case.

Ms. Levine’s response to Wyeth was that FDA’s balancing determinations should be viewed as minimum standards subject to imposition of added safety requirements under state law. Congress had not included an express preemption clause in FDA’s prescription drug authority as it had, for example, in FDA’s medical device authority and thus a presumption against preemption should prevail. In any case, Ms. Levine argued, Vermont’s labeling standard only required Wyeth to compensate Ms. Levine and did not force Wyeth to change its federally-approved label.

The legal arguments of the parties, and the incremental approach typical of the Supreme Court, strongly suggest that the Court will issue a narrow legal ruling addressing FDA preemption only in the context of fully-informed FDA labeling decisions directly challenged in state tort actions. The Court is unlikely to rule on the consequences of allegedly fraudulent representations to the FDA or of pharmaceutical company failures to disclose or act upon new safety information available to the manufacturer after FDA approval. If other cases present those issues the Court will be able to deal with them on a full factual record.

Still, a number of organizations have filed amicus curiae (“friend of the Court”) briefs making “policy” rather than legal arguments regarding the importance of this case. Many, including the American Association for Justice (“AAJ”, formerly known as the Association of Trial Lawyers of America) have disregarded the narrow facts presented in Wyeth v. Levine to argue that preemption ought to be denied because of a need for additional tort-based supervision of the pharmaceutical industry. I will discuss the merits of these policy arguments in my next post.

[Editor's Note: Bert Rein, a founding partner in the Washington, DC law firm Wiley-Rein and a long-time friend of CEI, represents Wyeth in this case. This post appears by invitation.]