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Sunday, April 6th 2008

Pre-Emption For Big Pharma?

But We Can Still Sue Them Right?

I’m naive about the cases facing Johnson & Johnson over Ortho Evra. But that’s not important because what I am interested in is the potential that pre-emption may be upheld as a legitimate defense in drug liability suits.

This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.


In the fall, the Supreme Court will hear a…pre-emption case involving Wyeth, another drug company. Chris Seeger, a plaintiffs’ lawyer who has about 125 Ortho Evra cases, said he expected the court to rule in Wyeth’s favor.

To be clear a ruling for big pharma in the drug case would not remove their liability in whole. As in the recent Medtronic case which upheld pre-emption of FDA action over state laws,

The decision…does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.,

Here’s the majority opinion in that case.

I have mixed opinions on this protection for drug makers. I’ve blogged on many an example of what I think is the naivete of lay juries in pharmaceutical liability cases but I’m certainly not sure that the FDA is in the best position currently to enforce full disclosure on pharmaceutical companies. It certainly is an interesting Supreme Court opinion to keep our eyes open for. If the opinion comes down on the side of big pharma I’m wondering what that might’ve meant for the Vioxx cases if Merck hadn’t settled. Maybe nothing…I have no idea.

If anyone has an informed opinion on whether FDA pre-emption of state laws (so many of the Vioxx cases were filed in federal court) would’ve had any effect on the whole Vioxx mess then please comment.