Saturday, December 08, 2007

The Supreme Court's Preemption Trilogy

There's never been a more interesting time to be a drug and device defense lawyer; this field is hopping. The Supreme Court has granted certiorari in two preemption cases, and a third, even bigger, issue is in the pipeline. This is the Supreme Court's preemption trilogy, in chronological order:

Riegel v. Medtronic

On Tuesday, December 4, the Supreme Court heard argument in Riegel v. Medtronic. The case asks whether product liability claims against manufacturers of medical devices approved by the FDA through the rigorous "pre-market approval" process are barred by the doctrine of express preemption. There's a chance, although remote, that the Court will choose instead to resolve the case based on the doctrine of implied preemption. There's a chance, though again not likely, that the Court will discuss, or analogize to, drug preemption in this device preemption case. But we're most likely to learn only about PMA device preemption.

In terms of timing, no one will be surprised to see a decision in Riegel any time after February, and it's essentially a lock that the decision will come down before the Supreme Court recesses for the Summer at the end of June.

For coverage of Riegel, see our earliers posts (1) about the death of the plaintiff and the question whether the appeal would survive the associated procedural irregularity (here, here, and here), (2) summarizing the arguments made in the defense briefs and linking to those briefs (here), (3) analyzing the Solicitor General's amicus curiae brief (here), (4) posting the transcript of the oral argument (here), and (5) summarizing the oral argument and giving our best guess of where the votes lie based on the Justices questions during oral argument (here).

But our coverage is hardly the only game in town.

Roger Parloff, at Fortune's Legal Pad, has posted on both the Riegel case generally and the weird wrinkle involving the plaintiff's death. The SCOTUS Blog has a "wiki" about the case, inviting the world to add and revise the discussion (here). The Mass Tort Litigation Blog links to a Federalist Society webcast about the case, in which Richard Epstein speculates that the Court might rule nine to zero in favor of preemption. (If his crystal ball proves accurate, the drinks are on us!) And the Wall Street Journal Law Blog posted about the case on the day of argument.

The popular press hasn't missed the party. On-line, we've seen CNBC, Bloomberg, and a host of others. And we've seen plenty of stories in the print media, too.

Warner-Lambert v. Kent

Next up is Warner-Lambert v. Kent. A Michigan statute gives drug manufacturers immunity from product liability lawsuits unless the manufacturer defrauded the FDA. An earlier Supreme Court case, Buckman v. Plaintiffs' Legal Committee, held that federal law preempts private parties' claims for fraud on the FDA. Where does that leave the fraud-on-the-FDA exception in the Michigan statute?

There are three main possibilities: (1) federal law does not preempt the fraud-on-the-FDA exception, so the whole Michigan statutory scheme remains intact, (2) federal law preempts only the fraud-on-the-FDA exception, leaving the immunity in place, but eliminating the exception, or (3) the immunity and the exception are so intertwined that federal law preempts the whole schmear, so the whole statutory scheme is thrown out and parties litigate under the existing case law, unchanged by the statute.

Once again, we've been all over this puppy, posting about the grant of certiorari (here), the implications of the case for states other than Michigan (here), how the Supreme Court could use Kent to clarify its preemption doctrine more generally (here), collecting other news about the case from around the web (here), analyzing whether drug companies will be inclined to move their corporate headquarters if the Supreme Court rules in favor of industry (here), and analyzing the Solicitor General's amicus brief (here).

The Supreme Court has not yet set Warner-Lambert v. Kent for argument. We expect the case to be argued in relatively early 2008, and we expect a decision in the Spring, but surely no later than the end of June.

Wyeth v. Levine

Last, but not least, the 600-pound gorilla: Wyeth v. Levine. Riegel affects only PMA-approved medical devices -- about 50 medical devices each year. Kent affects only states with statutes granting some kind of immunity subject to a fraud-on-the-FDA exception. That's eight states, and the immunities vary -- from essentially complete immunity from all liability (in Michigan) to limited immunity from liability for failure-to-warn claims (in Texas) to immunity only from punitive damages claims (in New Jersey and elsewhere). That ain't chicken feed, but it ain't the main course, either.

The main course is Wyeth v. Levine: Does federal law displace all product liability claims brought against all manufacturers of prescription drugs?

The argument (with which we agree) is that the FDA -- the expert federal agency expressly assigned the task -- judges the safety and efficacy of all prescription drugs and controls the labeling on the drugs. The FDA considers the health of the country as a whole, permitting drugs to be sold where the drugs' benefits outweigh their risks, even though some people will, of course, suffer unfortunate side effects. So long as the drug labeling (which the FDA controls) tells physicians about the risks and benefits of the drug, society benefits if the drug is available with the approved labeling.

Uniform regulation by an expert agency makes sense; having the agency's decisions second-guessed by lay juries, sitting in courtrooms in the presence of injured plaintiffs, does not.

That issue -- which affects essentially all claims against all drug companies in all 50 states -- is a showstopper.

The Supreme Court has not yet decided whether to hear Wyeth v. Levine. In May, the Court asked the Solicitor General to file an amicus curiae brief advising whether the government thinks the Court should accept the case. The SG has not yet filed that brief, but the smart money says we'll see it before the end of this month, which would give the Court time to hear argument in Levine, and decide it, this Term (before the end of June 2008). If the Supreme Court grants cert in Wyeth v. Levine, Riegel and Kent will look like small potatoes in comparison.

If the Supreme Court does not grant cert in Wyeth v. Levine, the federal appellate courts (and state supreme courts) will continue to wrestle with the broad drug preemption issue in many pending cases. (Ackermann v. Wyeth, argued in the Fifth Circuit last week, and Colacicco/McNellis, which will be argued in the Third Circuit on Monday, are just two examples.)

The legal and popular press have not yet focused on Wyeth v. Levine and similar cases -- but, when the Supreme Court agrees to decide that issue, katy bar the door.

In the meantime, here's Wyeth's cert petition in Levine and Levine's brief in opposition.

2 comments:

cartographer said...

This post needs a warning label for drug executives who might read it and get overexcited.

Not a chance that the Supreme Court will take a case arguing that, reading between the lines of the Food and Drug Act, Congress has prohibited mislabeling suits against drug manufacturers for seventy years, though somehow no one knew it before. Not even the Roberts Court. For one thing, even if they did rule that way, Congress would reinstate the right to sue in a heartbeat.

Calm down.

The Walrus said...

Careful what you wish for, you may be dusting off your resumes when pharma litigation drops off the face of the earth.