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The FDA doesn't want any low-down state court second-guessing it on drug labeling.Three years ago the widow of a man who had committed suicide while taking the antidepressant Zoloft filed suit against the maker, Pfizer. It was yet another tort case against a drug manufacturer claiming the company had failed to warn of possible dangers. But a funny thing happened on the way to the appeals court. The Food & Drug Administration filed a brief on behalf of Pfizer that in effect told the courts: Back off. The FDA had determined that Zoloft's labeling was appropriate. Do not entertain any claims to the contrary.
The case was tossed out, on other grounds. But the brief and several others marked a novel way for the FDA to try to block certain private tort suits against drug companies. The tactic has angered attorneys who want to use claims of bad labeling to win judgments. "Since 1938 the FDA hasn't regarded that its role is to stop plaintiffs from filing lawsuits, but now, suddenly, it does," says James T. O'Reilly, a food and drug law expert at the University of Cincinnati College of Law.
The battleground is the constitutional doctrine of preemption. When Congress preempts a field of regulation, there's no room left for state governments to horn in. For example, after the Tylenol poisonings in 1983 the FDA, empowered by Congress, required tamper-proof packaging for every medication sold over the counter, trumping any state packaging law.
But Congress often regulates some field without making explicit whether it intends to wipe the slate clean of state law. That keeps lawyers busy arguing about whether there was an "implied preemption." The FDA says it owns the labeling turf by dint of implied preemption. "This system cannot operate if other entities with less expertise and no congressional mandate have the ability to redecide what we've already decided," says Peter Pitts, the FDA's associate commissioner for external relations.
In 2002 the FDA intervened in a class action in southern California that alleged that GlaxoSmithKline's advertising failed to warn consumers that its antidepressant Paxil causes dependence and withdrawal symptoms. The agency's chief counsel, Daniel Troy, filed a brief saying that the FDA found that Paxil is not habit-forming and doesn't cause withdrawal symptoms--and, besides, the FDA is the exclusive authority in this matter. The judge in the case rejected the FDA's argument.
In another case the FDA argued that the former SmithKlineBeecham did not need to comply with a California law requiring toxicity warnings on over-the-counter nicotine products. Doing so would render products misbranded under federal law, the FDA said. But the court ruled against SmithKline, saying Congress had explicitly exempted the state law. The case is pending before the California Supreme Court.
Pitts says the FDA is perfectly capable of investigating new drugs and regulating their warning labels without getting any assistance from state juries on the subject. As he puts it: "Our willingness to invoke implied preemption can be traced to the growing propensity of bad scientific reasoning to seep into court cases involving FDA-regulated products."
The tort lawyers got vindication of a sort in March, when the FDA advised antidepressant makers to include stronger warnings of suicide risk. Maybe those juries aren't so ignorant after all?
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