Don't Lose YOUR Rights:
At Issue: Consumers, Packaging And Promises
A STATE jury's verdict
Injured as a result of a manufacturing defect
Strict FDA-imposed penalties for concealing information from the FDA
Full disclosure to the FDA information about the risk at issue, and the FDA was fully informed about the risk when FDA approved labeling
In the view of Georgetown law professor David Vladeck, "Part of the issue in this case is whether the FDA has the capacity to monitor effectively all the 11,000 drugs on the market, post-approval."
Leading the Supreme docket is an issue that by the business community's WISH list: immunity from lawsuits for drug companies.
The shield that drug companies argue protects them from suit is a legal doctrine called pre-emption — meaning that Congress can write laws that give the federal government the exclusive right to regulate in an area, barring states from getting into the act.
Pharmaceutical firms are regulated by the Food and Drug Administration, but that alone does not pre-empt state lawsuits — and for decades, courts have ruled that lawsuits can still go forward against drug companies for failing to adequately label and warn consumers and doctors about either the dangers of a drug or the dangers in administering it.