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Cutter's Way


Pharmaceutical Executive

Pharmaceutical ExecutivePharmaceutical Executive-08-01-2008
Volume 0
Issue 0

FDA preemption is a hot issue for pharma, and it's likely to get hotter. But it's the wrong issue.

This year the Supreme Court has given itself three opportunities to rule on the question of whether FDA decisions trump the ability of consumers to sue pharma companies in state courts. The score so far: one minor loss for pharma and one pretty big win for medical devices, with a big case yet to come.

Patrick Clinton

But don't count on any relief, even if the Court comes down resoundingly on the industry's side later this year when it hears Wyeth v. Levine. Henry Waxman doesn't believe in preemption, as it's called. "The Supreme Court's decision strips consumers of the rights they've had for decades," Waxman told

reporters after the court ruled in Riegel v. Medtronic, the device case. He followed up by introducing a bill in Congress to eliminate preemption for devices, and it's a good bet he'll do something similar if the Court rules for Wyeth in Wyeth v. Levine.

When you think of it, it's kind of an odd idea that pharma companies should be liable for injuries caused by products that are properly manufactured, correctly labeled, and FDA approved. Waxman is right, the idea goes back decades—to 1955 and the "Cutter Incident," when a batch of polio vaccine manufactured by Cutter Laboratory proved to contain live virus, infecting 70,000, paralyzing 2,000, and killing 10.

At trial, Cutter argued that using current science it was unable to anticipate or even test for the problem that tainted the vaccine. The jury agreed, in a handwritten pencil note that accompanied their verdict finding for the plaintiff, according to Paul Offit, a medical professor who described the case in his 2005 book The Cutter Incident.

If the company did nothing wrong, why make it pay? According to Offit, the theory was laid out in an article in the Yale Law Review, published just months after the vaccine disaster. The article suggested that drug companies should pay, not because they deserved to pay, but because they could most efficiently distribute the cost of compensation back to the group of people who had benefited by the product—the patients who'd taken it.

That's not such a bad theory. The only problem is that it doesn't work in practice. The authors of the law review article envisioned an orderly process of compensating victims. What we have instead is a lottery, with juries basing their decisions on God-knows-what, a few folks who hit the jackpot, a lot of who come away undercompensated, and lawyers siphoning a significant share of the money.

Maybe it's time to get drug cases out of the courts entirely. There's a good model in the Vaccine Injury Compensation Program, a federal program launched in 1988 to lure manufacturers back into the vaccine arena, which had been ravaged by lawsuits. The program is not perfect: Critics say it is still more adversarial than it needs to be, and it is unpopular for relying on science when juries probably wouldn't—especially in regard to vaccines and autism. But it's relatively efficient, and it compensates victims without demonizing the industry.

We know patients will continue to be harmed by drugs, no matter how careful FDA and the industry are. That's not something anyone in the industry likes; but it's the reality for the indefinite future. As a society, we've agreed to live with that reality. Call me naive, but I think it's time for a system of victim compensation that acknowledges that choice.

Patrick Clinton



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