Wyeth v. Levine – Are we in for a world of ubiquitous black box warnings?
The Supreme Court’s recent decision in Wyeth v. Levine held that FDA approval of a drug’s labeling does not preempt a state law tort claim for inadequate labeling. So what do you do if you’re counsel to a pharmaceutical company making physician-administered drugs? Put the biggest, scariest black box warning you can on every prescription drug you sell. There’s no downside! Physicians frequently don’t read labeling, relying instead on prior experience with the drug, or what they learn from pharmaceutical reps and colleagues. Patients rarely even see these labels, and instead hear only the doctor’s summary of risks. This course of action would provide a complete defense for the drug manufacturer so that tort liability will stop with the administering physician.
This seems absurd and counterintuitive; shouldn’t drug warning labels communicate actual dangers and not just be a proxy for a tort defense? FDA needs to step in and address this before physicians and patients have no way of knowing the actual dangers of these drugs.
March 24, 2009 11:39 am 2 Comments
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