A view on Wyeth v. Levine

March 4, 2009 – 4:54 pm by Joshua Slatko

With the pharmaceutical industry’s effort to enshrine federal FDA pre-emption in the laws of the land taking a tumble after today’s Supreme Court ruling in Wyeth v. Levine, mass torts plaintiffs attorneys everywhere are licking their lips. We asked Will Sachse, a partner in the antitrust/competition and mass torts and product liability groups at Dechert LLP, how he thought today’s decision would affect the industry. Mr. Sachse probably isn’t licking his lips; he’s more often on the defense side of such suits, in particular having been a key member of a trial team in three trials involving nine diet drug plaintiffs that won defense verdicts in eight of the nine cases, with the ninth plaintiff receiving only nominal damages.

Med Ad News: What does the court’s ruling in Wyeth v. Levine mean for the pharma industry? Does this represent a radical shift in the pharma-tort landscape, or just a knockdown of a legal reach by pharma, or something else entirely?

Will Sachse: This is a disappointing result, but it does not mean the end of preemption. The Court rejected the broad argument that mere approval of a drug necessarily gives rise to preemption, but left open the possibility that in some cases, the regulatory history with respect to a particular drug may demonstrate that the FDA’s actions preempt state law tort claims. For example, the majority refused to find preemption “absent clear evidence that the FDA would not have approved a change to Phenergan’s label.” The dissent took great issue with the majority’s characterization of the specific regulatory record at issue, and in my opinion, had the better of the arguments. But the dispute between the majority and the dissent suggests that the regulatory record in the case was not as “clear” as it could have been. If the majority had been satisfied that the regulatory record provided “clear evidence” that the FDA considered and rejected the requested warning, the case may have come down differently. The opinion leaves the lower courts to continue to grapple with the question of what regulatory actions will preempt state law tort claims.

There are a number of broader public policy concerns raised by the decision, as pointed out by the concurring and dissenting opinions. First, who do you want making determinations as to whether a drug is safe and effective for a particular use? Who do you want deciding how best to communicate information regarding the risks and benefits of those drugs? Are these decisions decision better left in the hands of the FDA, who uses its expertise and employs a science-based, population-based, prospective balancing approach that takes into account not only the full panoply of risks but also the incredible benefits that these drugs have for a wide range of patients? Or is that decision better left in the hands of a lay jury that is faced with evaluating a specific risk that has befallen a specific person, and has to determine whether, in hindsight, the warning could have been written differently? The end result of this opinion may be that pharmaceutical companies are subject to a patchwork quilt of competing and conflicting requirements imposed by lay juries across the country, which undermines federal interests in uniform product labeling that accurately states risks and benefits for a particular drug without underwarning or overwarning about a particular risk.

Second, given the new administration’s pledge to ensure that regulatory agencies such as the FDA are robust regulators and enforcers, it remains to be seen whether the FDA’s enforcement strategies will coexist with or conflict with state law juries imposing liability for drugs that the FDA has deemed are safe and effective for particular uses and that carry warnings the FDA has deemed appropriate to accurately convey the risks and benefits of those uses.

Med Ad News: What, if anything, was surprising about the court’s decision? Why?

Will Sachse: It is surprising that the Court gave short shrift to the FDA’s own views as to whether its actions preempted state tort law, when in the past, both in the pharamceutical context and in the context of other regulated industries, the Court has been more deferential to such agency views.

Med Ad News: How do you think pharmaceutical companies might change their legal/regulatory strategies after this ruling?

Will Sachse: I believe that pharmaceutical companies will continue to raise preemption arguments where the record supports the defense. It remains to be seen the extent to which the FDA seeks to determine “whether and when state tort law acts as a help or a hindrance to achieving the safe drug-related medical care that Congress sought.” And it remains to be seen the role the pharmaceutical companies play in that inquiry.

Tags: law, Phenergan, Supreme Court, Wyeth