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Emerging Drugs & Devices
8/22/2008 4:12:56 PM EST
Tom Moylan
Will Levine Be The Final Word On Drug Preemption Or Just The End Of Round One?
Posted by Tom Moylan
LexisNexis Torts Law Center Staff

I’m not sure what the record is for the number of amicus briefs filed for one side in a Supreme Court case, but the ones filed last week in support a drug injury plaintiff must be in the Top Ten.

I reported in yesterday’s Mealey’s Emerging Drugs & Devices Report that 17 amicus briefs were filed in support of Diana Levine, the plaintiff who lost her arm when Wyeth’s Phenergan anti-nausea drug was administered in an off-label manner. Here’s who submitted briefs for Levine: 18 members of Congress (senators and congressmen). Forty-seven state attorneys general, including Vermont, whose state Supreme Court ruled that Levine’s warning claim wasn’t preempted by federal law.

Two former FDA commissioners chimed in. So did the National Conference of State Legislatures, which has taken great umbrage over the expansion of preemption generally under the George W. Bush Administration. Ten law professors filed a brief, and two others their own. Six former editors of the New England Journal of Medicine and four NEJM authors opposed preemption, the first time I’ve seen that.

Maybe it wasn’t surprising that the California Medical Association filed a brief — you know Cali’s rep — but the Texas Medical Association? Texas, home of George W., tort reform and the nation’s second state drug preemption law? And the Californians were joined on the same brief by the North Carolina Medical Society (reminder: N.C.’s not the most liberal member of the Union) and the Texas Medical Liability Trust, the latter a physician-owned malpractice insurer. I think it’s safe to say the Texas Trust doesn’t like litigation. But here, they’re supporting it.

Reading down the docket, I half expected a clerk’s entry at the end: APRIL FOOL! Except it’s August.

To be sure, Wyeth has amicus briefs, eight altogether. There are the usual suspects in a preemption case: The administration, the Product Liability Advisory Council, the Washington Legal Foundation, PhRMA, the Chamber. The only special guests were the Defense Research Institute and five economists.

It’s an old-fashioned showdown, folks, and I’ve already put in for a ringside seat Nov. 3. Got my Parker pen, my notepad and my popcorn.

The conventional wisdom (and I hate that phase) is that Antonin Scalia has the opinion finding preemption already written in his head. The only drama seems to be whether Ruth Bader Ginsberg will be alone on the dissent.

Still, while the Levine case on its face is the culmination of a years-long campaign to preempt drug liability claims, the argument can also be made that the Nov. 3 Supreme Court hearing and its expected pro-defense ruling is just the end of one battle and the beginning of another. There’s an undercurrent that plaintiff attorneys that “we’ll get it next year” when there might be a Democratic president and a more Democratic Congress amenable to anti-preemption legislation.

Sure, there’s been a lot of unproductive railing by Democratic-controlled congressional committees and a half-hearted attempted to insert anti-preemption language into the most recent FDCA bill. But there are signs of a sea change, of the pendulum heading back: In June, the House got a bill that would amend the FDCA to state that state tort remedies aren’t preempted, a so-called “repeal” of the Roberts Supreme Court’s Riegel v. Medtronic medical device preemption ruling in February. Ted Kennedy introduced a Senate version last month. And it’s obvious there’s going to be no action this year. That leaves next year.

Another sign of change is that Public Citizen, long the appellate champions against drug and device preemption, is off the plaintiff’s Levine brief, replaced with another firm. And finally, there is the sheer volume of those 17 amicus briefs. It’s like a new Special Ops team’s been recruited and they’re massing for the Spring Offensive.

To paraphrase James Earl Jones’ character “Field of Dreams,” preemption will come, Ray, preemption will most definitely come, preemption will most definitely come. But that might only mean a new arena: the legislative branch.

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