MAJOR RULINGS

The Supreme Court has ruled on liability immunity for drugmakers and medical device manufacturers in three cases since 2001.

2001 Buckman Co. vs. Plaintiffs' Legal Committee: All federal laws regulating products pre-empt, or bar, state law product liability lawsuits that attempt to modify those products' warning labels.

February 2008 Riegel vs. Medtronic Inc.: The Medical Device Amendments of 1976 to the federal Food, Drug, and Cosmetic Act expressly pre-empt state court product liability claims challenging the safety and effectiveness of an FDA-approved medical device (BI, Feb. 25).

March 2008 Warner-Lambert Co. L.L.C. et al. vs. Kimberly Kent et al.: A product liability case allowed under a Michigan law did not conflict with federal law, even though plaintiffs could not recover damages unless they proved a drugmaker defrauded the Food & Drug Administration. The case was allowed to proceed because the plaintiffs ultimately wanted to collect damages, not police the FDA (BI, March 10).