By Kurt R. Karst –
Your loyal and intrepid bloggers were in attendance at today's argument before the U.S. Supreme Court in Wyeth v. Levine. The case has been billed by some as the business case of the century; however, we think such hype is a little overblown, as even a decision against Wyeth would not mean the end of the world for defense attorneys in product liability litigation. The media feeding frenzy over the highly anticipated oral argument was given some chum late last week when Representative Henry Waxman (D-CA) issued a staff report critical of FDA’s current anti-preemption policy and Wyeth responded to the staff report in a 3-page letter.
For those of you not familiar with the facts of the case, Diana Levine, a Vermont bass player and author of children’s music, sought treatment for a severe migraine headache and associated nausea and dehydration and was administered Wyeth’s antihistamine PHENERGAN (promethazine HCl) via a delivery technique known as an “IV push” (as opposed to relying on gravity for an IV drip). PHENERGAN was inadvertently injected into one of Ms. Levine’s arteries, causing gangrene, and leading to the amputation of one of her arms. The FDA-approved PHENERGAN labeling warned against – but did not prohibit – IV push administration. Specifically, the PHENERGAN labeling states, among other things: “INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.”
Ms. Levine brought a common-law negligence claim against Wyeth in Washington County Superior Court on the theory that Wyeth should have revised PHENERGAN’s FDA-approved label to bar IV push administration. Wyeth countered that Ms. Levine’s state tort suit was impliedly preempted by federal law. The jury in the trial court proceeding returned a verdict in favor of Ms. Levine, and the court issued an opinion independently addressing preemption as a matter of law, concluding that the jury’s state-law-based judgment presented no obstacle to FDA’s regulatory objectives. Wyeth appealed to the Vermont Supreme Court, contending that the trial court erred by failing to hold that Ms. Levine’s common law claims were preempted, because: “(1) Wyeth would have been unable to comply with both Vermont’s common law duty to foreclose IV push injection and FDA’s directive, as evidenced by the drug’s approved label, to retain it; and (2) the claims would obstruct the full accomplishment of FDA’s risk-benefit objective to optimize use of Phenergan by imposition of a duty to foreclose IV push injection.”
In October 2006, a divided Vermont Supreme Court upheld the trial court’s ruling, finding that because FDA approval is not required to strengthen warnings, Wyeth could have complied with both state and federal law, that FDA labeling regulations create only minimum labeling requirements, and that state tort liability for approved labels would not frustrate the objective of promoting the public health that led Congress to enact the FDC Act. The Vermont Supreme Court did not afford any deference to recent FDA statements claiming that “FDA approval of labeling under the [FDC Act] . . . preempts conflicting or contrary State law,” and that “FDA interprets the [FDC Act] to establish both a ‘floor’ and a ‘ceiling,’ such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated or otherwise false or misleading.”
Wyeth appealed the Vermont Supreme Court decision to the U.S. Supreme Court. The question posed to U.S. Supreme Court in this case is:
Whether the prescription drug labeling judgments imposed on manufacturers by the [FDA] pursuant to FDA’s comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.
As additional backdrop for the case, keep in mind that earlier this year in a decisive win for medical device manufacturers, the Supreme Court ruled 8-1 in Riegel v. Medtronic that preemption principles and the 1976 Medical Device Amendments (“MDA”) bar common law claims on the basis of safety or effectiveness of devices approved by FDA under a Premarket Approval Application. However, unlike the MDA, which amended the FDC Act to include an express preemption provision (FDC Act § 521), the drug provisions of the FDC Act do not contain such a provision.
So on to today’s oral argument, which was argued on Wyeth’s behalf by Seth Waxman, on FDA’s behalf by Deputy Solicitor General Ed Kneedler, and on Ms. Levine’s behalf by David Frederick. . . .
The Justices showed a keen interest in the case, interrupting all three attorneys of record with questions before they barely spoke their opening sentences. One line of questioning by the Justices (initiated by Justice Ginsburg) raised the issue of whether the lack of an express drug preemption clause in the FDC Act (as opposed to existence of one with respect to medical devices - see Riegel) is of any significant import. Not surprisingly, Wyeth and FDA argued that such absence is not significant, as the U.S. Constitution’s Supremacy Clause is controlling, and that preemption should be found.
Mr. Frederick, who was heavily questioned by Chief Justice John Roberts and Associate Justices Antonin Scalia and Samuel Alito, at one point conceded that preemption would exist in this case had FDA considered and rejected the comparative risks of IV drip versus IV push administration. But according to Mr. Frederick, FDA was not provided with such information when the Agency approved PHENERGAN, and Wyeth, allegedly knowing the risks of IV push administration, should have presented FDA with such information. Mr. Waxman and Mr. Kneedler were adamant that FDA was informed and aware of the risks of IV push administration when the Agency approved PHENERGAN – and, in fact, FDA rejected Wyeth’s attempts to amending PHENERGAN’s labeling. Chief Justice John Roberts summed up this line of argument as follows: if FDA was aware of and considered the risks associated with IV push administration and approved the PHENERGAN labeling, then why wouldn’t preemption apply?
It is always difficult to prognosticate about Supreme Court decisions . . . and we are not willing at this juncture to say whether the Court will rule in favor of or against Wyeth. That being said, given the tenor of the Court’s questions, which dealt specifically with what FDA knew and what the submissions were, we believe that: (1) an outcome either way is likely to be narrowly focused; and (2) that a narrow outcome could result in additional litigation as to whether preemption is available in any specific set of facts (i.e., a sweeping proclamation of preemption involving all drug labeling is unlikely). But the Court’s opinion may not be issued for quite a while – perhaps not until mid-2009. And because it is now less than 24 hours before the election, we should also note for good measure that even if the Court rules for Wyeth, the legal pundits are already speculating that “a Democrat in the White House and a Democratic Congress could erase any preemption protection companies have won in the last eight years.” In other words, the debate is far from over. Stay tuned for more.