We just got this info handed to us. It’s second hand and not for attribution, but it’s the first thing approaching a blow-by-blow we’ve seen on the Wyeth v. Levine argument. Thanks to our anonymous source. You know who you are.

Our suppositions were correct in one respect, the arguing attorneys were Seth Waxman for Wyeth, Ed Kneedler (Deputy SG) for the government – arguing basically for the same positions as Wyeth – and David Frederick for Plaintiff.

Significant concession by plaintiff: that preemption would exist if the FDA directly considered and rejected the specific warning the plaintiff advocated. This concession should have the effect of nullifying the remaining “no tort preemption at all arguments” advanced both by plaintiff and moreso by some plaintiff’s side amici.

Defense Argument

Questions for Waxman: Justice Ginsburg, how does PMA (Premarket Approval for devices – the process found preemptive in Riegel) compare to NDA (New Drug Approval) for prescription
drugs?

Ginsburg, again: Why did Congress include express preemption provision but not drugs? Chief Justice Roberts later returned to this point.

Justice Scalia (more of a comment than a question): he “would be surprised” if states could regulate drugs in a way that goes beyond “what the FDA says in drug matters.”

As usual Scalia was active, including the question, “Who gets to decide? The FDA or juries?” A question that does not surprise us in the least, given plaintiff’s closing to the jury

Ginsburg was active, too: Did the FDA specifically considered risks and benefits of IV push administration (the use plaintiff claims should be contraindicated)?

Justice Alito: Was the FDA reasonable to permit IV push at all, since the drug was not lifesaving and the method had such a high risk?

Justices Breyer and Kennedy both questioned how “impossible” simultaneous compliance would be when Wyeth go back to the FDA and request a strengthened warning.

The answers were predictable and defense counsel was able to give them without getting crossways with the Court.

DoJ Argument (generally aligned with defense)

Questions for Kneedler:

Ginsburg: Has the Justice Department/FDA changed its position on preemption. He answered, “no,” of course.

The government’s view of the limits of preemption: the “same” standards shared by state and federal law, or if a drug is adulterated. The government’s position was that the FDA had in fact conducted a risks/benefit analysis of IV push administration.

Scalia: Would there be preemption where there was failure to report information relevant to the risk at issue in the suit? Answer, usually no.

There was general discussion about: (1) manufacturers’ reporting duties concerning new information, (2) what, if any, connection misbranding provisions of the FDCA had to product liability, and (3) the FDA’s new powers under the FDAAA.

Plaintiff Argument

Positions appeared contradictory. On the one hand: there was a duty to update labeling at any time that a manufacturer considered it inadequate, even if solely involving old information; on the other hand, the same duty is triggered by learning new information.

Then came the aforementioned concession – once the FDA has specifically considered and rejected a warning for a particular risk, there is preemption.

Plaintiff’s view of the facts, of course was that affirmative evidence didn’t establish such FDA consideration and that the only “reasonable” result was that IV push could not be allowed even
with the numerous warnings on the drug’s label.

Plaintiff claimed that affirmative FDA consideration should be in the nature of an affirmative defense, with the defendant manufacturer bearing the burden of proof, both as to FDA consideration and as to the pre-existing nature of the risk information.

This concession led to considerable questioning concerning the scope of preemption, with the issue of failure to disclose being reprised.

There was also discussion of the maximum defense position before the court – that preemption exists whenever there is an actual conflict with the label, with or without specific FDA consideration. Obviously, plaintiff’s counsel considered that well beyond the limited preemption he conceded could exist.

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Based on the above, we adhere to the position we had before the argument – there is preemption that requires reversal of this verdict, given the facts and the position plaintiff took in the trial court. However, the ruling is likely to be closely tied to the facts of the Levine case.

It’s likely to be a bridgehead – but whether it’s Dieppe or Normandy remains to be seen.