The US Supreme Court heard oral arguments this week in a case that could determine whether drug makers should receive a similar protection from lawsuits to the one the court granted to medical device makers last week.
The main issue, according to Justice Stephen Breyer, is whether a drug, “on balance,” will save people or hurt people. Breyer says he believes that the Food and Drug Administration, and not a jury, is solely responsible for policing the pharmaceutical industry. He expressed concern over allowing a jury of 12 people randomly selected to rule on such lawsuits.
If the Supreme Court rules along with Breyer, thousands of personal injury lawsuits filed against drug manufacturers could be thrown out.
The issue in this case, Warner-Lambert v. Kent, is restricted to examining a Michigan statute that prevents personal injury lawsuits against drug manufacturers unless the injured person can prove that the company purposely kept information from the FDA that would have then barred the drug from the marketplace. A majority of the arguments on Monday centered on whether (and how much) of the Michigan law should be struck down.
The Supreme Court, however, is also scheduled to hear arguments in Levine v. Wyeth. It is during this case that the will be asked to rule on whether FDA approval bars personal injury lawsuits.
Last week, the Supreme Court ruled 8-1 in favor of medical device maker Medtronic Inc. The court said that FDA approval of a medical device trumps state tort lawsuits filed against medical device makers for products that have already passed a rigorous FDA approval process.
The ruling may benefit other medical device manufacturers that have been named in products liability and wrongful death cases by injured patients.
U.S. Supreme Court considers extending protections to drug makers, International Herald Tribune, February 26, 2008
Top court rules for Medtronic in devices case, Washington Post, February 20, 2008
Related Web Resources:
Warner-Lambert Co. v. Kent, Oyez.org
Riegel v. Medtronic, Justia US Supreme Court Center
If you or someone you love has been injured by a medical device or by a dangerous or a defective drug in Massachusetts, one of our Boston, Massachusetts products liability lawyers can explore your legal options with you.
Contact Altman & Altman LLP today.