United States: Government Urges Reversal Of Third Circuit Fosamax Decision

Last Updated: October 10 2018
Article by Stephen J. McConnell

We would be hard pressed to think of a recent judicial decision we have blasted as hard or often as the Third Circuit's Fosamax opinion. We deemed it the worst case of 2017. It was bad enough that our hometown federal appellate court held that it was up to a jury whether the FDA would have rejected a stronger drug warning. It was worse that the court held that a defendant had to prove by clear and convincing evidence that the FDA would have rejected the warning. And it was still worse, and kind of weird, that the Third Circuit arrived at this holding in a case where the FDA actually had rejected a stronger warning. The result of the Fosamax decision was that summary judgement in favor of the defense on preemption became a pipe dream, and ultimate victory at trial became a lot tougher.

Right from the start, we thought Fosamax was reversal bait. The excellent certiorari briefing made us more sure of that. Then, when SCOTUS invited the government to lob in an amicus brief, we became still surer. Now that we have read the government's brief, we are even surer. Lawyers from the Solicitor General's office and the Department of Health and Human Services are on the brief. These lawyers are typically brilliant and the positions they stake out typically command a lot of respect from courts.

When we clerked, our Judge always paid a lot of attention to government amicus briefs. In the last SCOTUS case we worked on, the government's position turned out to be pretty much dispositive. We represented a father who had been tossed in the clink because he had failed to pay child support. It was a civil contempt proceeding that ushered him into jail. The state (South Carolina) did not provide him counsel because it wasn't a criminal case. We argued that however the case was styled, if imprisonment was a possibility, the right to counsel was implicated. The other side was represented by then Penn Law professor, now Third Circuit Judge, Stephanos Bibas, who was an amazingly effective advocate for what we thought was a weak position. We argued that counsel had to be provided and he argued not so. Then the SG's office filed a brief, and its answer split the difference: sometimes. Guess what SCOTUS decided? Sometimes won.

What do we have here with the government's Fosamax brief? The headline is that the government argues for reversal of Fosamax. It argues that the Third Circuit erred in holding that, under Wyeth v. Levine, a jury must resolve the preemption defense "As a factual matter subject to a clear-and-convincing evidence standard." Yay. But is there a 'sometimes' aspect to the government's position that makes us a bit uneasy? Yes, there is.

As always, the statement of the Question Presented sets the tone. Here is how the government frames the inquiry: "Whether a state failure-to-warn claim alleging the insufficiency of brand-name drug labeling is preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., when the Food and Drug Administration, after the drug manufacturer provided it with the relevant scientific data, rejected the manufacturer's application to modify its labeling to warn about the risk underlying the tort claim."

The first thing we notice is that the government is focusing on the fact that the FDA did actually reject a proposed warning. That rejection came in the form of a Complete Response Letter in 2009. The central point in the government's brief is that the meaning and effect of that Complete Response Letter presents legal questions that a judge, not jury, must resolve. It was a federal agency decision, and courts, not juries, interpret agency decisions. Even if factual findings are necessary to interpret the federal agency decision, such factual findings are decided by the court, not the jury.

The government's arguments on these points are compelling, and it is hard to see how reversal can be avoided. But how useful would reversal on this ground be for the rest of us? Whenever the FDA actually rejects an enhanced warning, there will be an agency decision, and the government's analysis would kick in and make the issue legal, not factual. But what if there is no rejection? What if the defendant wants to argue that there are other circumstances, not quite reaching the level of an actual agency rejection, that demonstrate that such rejection would have been inevitable? Are we still in fact-land, as opposed to legal-land? The ruling in Fosamax might end up a little narrower than we'd like.

Let's not dwell on these questions for now. No point in being a nervous Nellie. There are other goodies in the government's brief. For instance, while the Third Circuit in Fosamax speculated that possibly the FDA's rejection was a result of dissatisfaction with the specific language proposed by the pharmaceutical company, the government smacks that position down and restores the focus to the proper place: the state of the scientific evidence. Look again at the Question Presented. Hone in on this language: "relevant scientific data." The FDA looked at the data in the available literature and adverse events reports. "No sound basis thus exists for concluding that the FDA determined in May 2009 that the data was sufficient to warrant a warning but that it rejected petitioner's proposal because of petitioner's proposed text." If SCOTUS adopts this reasoning, as it should, plaintiffs will have one less arrow in their speculative quiver to stave off summary judgment on preemption.

Even better is how the government brief eviscerates the clear-and-convincing evidence standard. First, the brief makes the undeniable point that the Wyeth v. Levine decision simply did not address this issue. Thus, we are thrust upon first principles. This is a product liability case. It is a civil action for money damages, and "nothing warrants a higher standard of proof to resolve the preemption question here." Absent legislative specification, there is no basis to impose a higher evidentiary standard on defendants seeking to available themselves of SCOTUS preemption doctrine. We are not entirely fond of the government's explanation of the Wyeth "clear evidence" language, seeming to tie it into a presumption against preemption, but we are trying not to be churlish. In any event, we are content with the government's fundamental point that the Wyeth v. Levine "clear evidence" formulation was not intended "as a shorthand for a formal clear-and-convincing evidentiary standard, but merely to indicate that a manufacturer asserting preemption must show that a labeling charge was not warranted under the relevant statutory and regulatory framework."

Once the government shows that resolving the Fosamax case requires resolving a legal issue, that no factual findings are required, and that the preponderance of the evidence standard applies, the case becomes easy. The FDA rejected the proposed warning because the data was not yet in place to justify the warning. The Third Circuit got it wrong, the district court got it right, and the litigation should be over.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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