Consumer Law

Battle Lines Drawn on Immunity for Medical Device Companies

By Amanda

The front page of the New York Times business section today presents a pretty good overview of the expected fight in Congress to restore people's legal rights against medical device manufactures, a right taken away by the U.S. Supreme Court last year.  

The new congressional effort comes on the heals of a similar effort last year, where lawmakers introduced a bill that would allow lawsuits to be brought against negligent makers of medical devices that harm or kill people.

A boatload of legitimate and important cases are now being thrown out of court due to this misguided decision, and hopefully, key members of Congress will be doing something about this soon.  The Times reports,

"Those with lawsuits dismissed since the Supreme Court ruling include a woman burned internally by a device meant to reduce menstrual bleeding; a man who sustained internal injuries from a prostrate treatment device; and numerous patients who say they were injured by faulty joints or heart implants."

Not all of the courts are happy with the U.S. Supreme Court's decision.  On Tuesday, the Wisconsin Supreme Court (somewhat reluctantly) ruled against a man who had a faulty Medtronic defibrillator upholding Riegel v. Medtronic.   Justice Ann Walsh Bradley wrote,

?I write separately in order to express my concern that the United States Supreme Court's interpretation of the 1976 Medical Device Amendments does not adequately protect the safety of the citizens of Wisconsin. With one stroke of a pen, it has diminished the states' traditional authority over the development of the common law and substituted instead mandatory adherence to a regulatory standard that may be substandard.  I do not believe that such adherence was mandated by the express language of the amendments, although I acknowledge that I am bound by the Supreme Court's interpretation.?  

As the Times reports today, congressional leaders on this issue, as well as patient advocates and others, say the Supreme Court's medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

?Consumers face the worse of all possible worlds,? said David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog. ?The F.D.A. has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can?t sue companies for redress.?

Full post as published by ThePopTort on February 20, 2009 (boomark / email).