Justices Rule Against Drug Company in Injury Case, Wash. Post, March 5, 2009.
The Supreme Court ruled yesterday in favor of a woman who had her arm amputated after an improper injection of an anti-nausea medication and said drugmakers could not rely on federal regulation to shield them from lawsuits brought under state consumer protection laws.The case is Wyeth v. Levine, No. 06-1249.
Analysis: A Warning to the FDA, SCOTUSblog, March 4, 2009.
Amid much critical commentary about the way federal drug regulators are doing their job, a Supreme Court majority on Wednesday provided a ringing endorsement of lawsuits in state courts to fill in for lapses at the national level — in particular, lawsuits that claim drugmakers have not given doctors and patients enough warning about side-effects. The six Justices who joined in upholding a verdict of nearly $6.8 million against the pharmacetical company Wyeth have sent their own warnings: to the industry, and to the Food and Drug Administration.
Justice John Paul Stevens’ opinion speaking for five Justices, and Justice Clarence Thomas’ separate opinion joining in the result, provided in combination a reinforcement of these ideas: that drug companies are primarily responsible for keeping their warning labels up to date and complete (and may pay for it if they don’t), and that the FDA not only needs to police the industry more closely — even if it lacks resources – but that it also had better have the clearest mandate from Congress before it tries to scuttle patients’ lawsuits in state courts.