Why Supreme Court OK’d Suits Over Drug Labels, But Not Medical Devices
Companies arguing that their federally regulated products are not subject to state court lawsuits could face difficulties absent an express congressional pronouncement after the U.S. Supreme Court’s ruling yesterday in a drug labeling case.
The decision in Wyeth v. Levine, which refused to shield drug companies from lawsuits over their warning labels, concerned implied pre-emption, the New York Times reports. The drug company Wyeth had argued it was not liable for providing insufficient warnings about its anti-nausea drug because federal regulations and policies had impliedly pre-empted state tort actions.
The Supreme Court is more sympathetic to express pre-emption arguments, the Times says. The court held last year in Riegel v. Medtronic that express language in a federal law protected medical device makers from many injury suits over products approved by the federal government.
Law professor Catherine Sharkey of New York University said yesterday’s decision means “there is certainly a thumb on the scale against the more aggressive arguments for implied pre-emption.”
A separate New York Times story points out that the Wyeth and Riegel rulings mean some injured consumers may sue the pharmaceutical companies but not makers of medical devices. Some lawmakers are planning to introduce a bill that would in effect overturn the Riegel ruling and allow suits alleging injury by medical devices.