Breaking News: The U.S. Supreme Court dashed pharma's hopes for a shield against state-court liability suits. In the much-publicized case of Wyeth v. Levine, the justices rejected Wyeth's claim that FDA approval of a drug--in this case, the antinausea treatment Phenergan--would pre-empt patient suits under state law.
The 6-3 decision marks the second time justices have rejected business groups' contention that federal regulation can supersede state liability, the Associated Press reports. It also marks the end of more than a year of intense debate in and around the pharma industry. Wyeth had argued that the FDA's review of a drug, and its subsequent regulation of drug safety and labeling, already hold drugmakers accountable for their products. Because federal law supersedes state regulation, that FDA oversight should be the last word for drugs.
But Levine's lawyers said that the FDA was always intended to be supplemented by state law. FDA was never designed to be the be-all and end-all of drug regulation, nor was it intended to keep patients from claiming injury in state court. And obviously, the Supreme Court agreed. We haven't seen the opinion yet, so we can't claim any insight into the justices' thinking on the subject. But we're sure that plenty of great legal scholars will be poring over it soon.
- read the AP story