I was at the Warner-Lambert v. Kent argument this morning, which found several justices troubled about where to draw the Buckman preemption line--but also finds Justice Breyer remarkably critical of pharmaceutical product liability as a whole, suggesting that the respondents' ability to muddy the waters may lead the court to simply preempt broad swaths of pharmaceutical product liability. Throughout the argument, the specter of the Wyeth v. Levine case early next term led both sides to punt hard questions as a matter to be resolved down the road.
Carter Phillips, Sidley Austin, arguing for the petitioner Warner-Lambert, says that policing fraud on federal agencies is something entirely within the federal ambit, and that the
Scalia asks how far that principle goes: what if there were a tort action alleging conditions of FDA marketing were not met? Phillips punts the question: the petitioners are simply seeking a narrow ruling that Buckman applies. But, Scalia, says, Buckman's cause of action was FDA-specific. Phillips: But juries would be making the same sort of determinations that Buckman held impermissible.
Ginsburg (who perhaps tips her hand when she refers to the
petitioner as a "drug dealer") asks isn't the
Stevens questions the premises of Buckman: what is the evidence of burden to the government? Phillips: Buckman
held that we don't wait until there is serious interference with the
agency, we step in in advance. Stevens
asks about the bribery exception to the
Stevens: If this goes to litigation, what happens? Don't the plaintiffs have the burden of proving their case? Phillips: Yes, and the FDA didn't withdraw the drug. But there is still the problem of state courts pulling on federal prerogatives if that is litigated.
Daryl Joseffer, SG's office, argues for the government. (And if you want to feel old, watch the oral
argument of someone in a frock coat whom you supervised when he was a brand new
associate taking his first deposition.)
Souter takes up Ginsburg's question: is there the same issue if
regulatory compliance is a defense?
Joseffer: it depends on whether it implicates federal interest and asks
the jury to second-guess the regulatory decision. Preemption applies only to legal theories, not
evidence. Souter: so your objection is
to the plaintiffs being required to prove but-for withdrawal? Joseffer: not just that. It's the second-guessing of the approval
process. Souter: But why isn't that the
same as the compliance defense?
Joseffer: if it's a mere matter of evidence, no problem, but questioning
product-specific approval decisions.
Souter: but under
A good chunk of the arguments were taken up with
back-and-forth between Ginsburg and Scalia on the question of severability and
how to interpret
Allison Zieve, Public Citizen, for respondent plaintiffs:
the misrepresentation exception to the
Kennedy: but wouldn't discovery be intrusive upon the FDA? Zieve: No, because discovery would be the same as a typical product liability case.
This sets Justice Breyer off on a long speech: Why isn't that worse? You're alleging that the drugs have side-effects that hurt people. But there is a risk on the other side, the loss of the drug that can help people. On balance, is the drug going to save lives or cost lives? Who should make that decision? The FDA, or a jury of twelve people that sees only the hurt people? That is a decision for Congress, and Buckman holds that Congress said the agency decides. (Scalia smiles at this.)
Zieve tries to disagree: product liability simply
compensates injured patients, and thus complements FDA regulation. We're not seeking a regulatory remedy, just
compensation. Kennedy: but your premise
is that the drug should not have been sold.
Zieve, in response, picks up on Ginsburg's "invigorated defense"
Alito: Is the government wrong that having a jury
second-guess approval interferes with the regulatory mission? Zieve: In this case there is no interference,
because the drug is off the market. But
even as a general matter, there's no interference, because the effect of making
a showing in court has no regulatory effect.
It's the same as any other state tort litigation, which doesn't police
regulatory compliance either. Alito: But
wouldn't discovery into the internal decisionmaking of the FDA be problematic? Zieve: Plaintiffs seek that now, but
Scalia asks if there can be a distinction between drugs on the market and off the market; after all, if it is on the market, the FDA has incentive to retrospectively review the data in a way that it doesn't if it is off the market. Zieve: But all the FDA could do then is to sanction the manufacturer. Scalia: Wouldn't that solve your problem? You then get to show the exception applies. Zieve: But we can't force the FDA to make a finding, and the FDA finding doesn't get us compensation.
Breyer: But the drug will be withdrawn. What if a jury is wrong? Who's more likely to
be right? He is confused: you mean that
it is possible for the FDA to approve use, that the label is okay, the doctor
follows the label, and plaintiffs get compensation from the manufacturer for a
disclosed side effect? Zieve and Ginsburg
answer yes, and Zieve explains that the
On rebuttal, Phillips largely takes up the question of the appropriateness of severability. He blunders a bit when he argues that the FDA can order restitution to consumers after a drug is withdrawn and Stevens spanks him noting that that is hardly full remedial compensation for a wrongful death claim. But he closes noting that the FDA has full incentive to go after fraud, even post-withdrawal, and that Public Citizen petitioned the FDA to have Rezulin withdrawn on this sort of evidence, and the FDA rejected the petition.
Defense attorneys may be concerned that Phillips's argument
never gave a clear answer to the question of where to place the line between
every-day tort law and the