Suits by injured consumers against drug companies and the regulation of drugs by the Food and Drug Administration have peacefully co-existed for many decades. But since the Bush Administration came to Washington, the FDA has taken the position that consumers should not be able to sue drug companies for harm caused by medications. Without citing any instance in which a verdict for a plaintiff has undermined federal regulation, the agency contends that lawsuits conflict with federal regulation by asking jurors to second-guess the FDA’s assessment of the safety of a drug and the adequacy of its label. Emboldened by the FDA’s new view that federal regulation of drug labels preempts a broad range of personal injury claims, drug companies have been making motions to dismiss or for summary judgment in cases throughout the country.
Today, a group of public interest organizations filed this amicus brief, written by my colleague Allison Zieve, opposing a drug company's preemption arguments in a case before the U.S. Court of Appeals for the Third Circuit. The case, Colacicco v. Apotex and GlaxoSmithKline, was brought by a man whose wife committed suicide a few weeks after she began to take an SSRI antidepressant. He claims that the defendants failed to warn of the risk of suicide associated with the drug. (The drug’s label now carries such a warning.)
Over at the new blog Tort Reform, Henry Greenspan offers the first part of a two-part series about the enactment of, and subsequent attempts to repeal, a Michigan statute that immunizes pharmaceutical companies from tort liability in that state.
My colleagues Allison Zieve and Brian Wolfman have taken an active role in litigation against the FDA’s preemption arguments; here’s an article they wrote earlier this year critiquing the FDA’s position. You can find other legal briefs in preemption cases here.
More generally, Catherine Sharkey of Columbia Law School has a soon-to-be published article, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, discussing the FDA drug labeling rule as an example (along with similar actions by NHTSA and the CPSC) of a broader federalization strategy.