Bad Medical Devices and Pre-Emption

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
This fall, the US Supreme Court will hear cases involving medical devices that have caused injuries in spite of the fact that they were approved by the FDA. The Court already ruled in favor of pre-emption on February 29, 2008 in Riegel v. Medtronic. In that case, the court stated that if the FDA approves a medical device that later turns out to injure a person that person is barred or “pre-empted” from bringing a lawsuit in state court. This is obviously a huge victory for businesses, especially huge medical device companies. On the other hand, it is very unfair for those with valid claims whose pursuit of justice is now short-circuited by the Supreme Court’s decision.
One of the more interesting cases on the Supreme Court docket this fall is Wyeth v. Levine. Drug manufacturer Wyeth (the same company that produced the harmful diet drug Fen-Phen) will argue that it can’t be sued for mislabeling its drug Phenergan in spite of the fact that this mislabeling directly resulted in Ms. Levine’s loss of her right arm. Wyeth’s argument rests solely on the fact that the drug Phergan had been previously approved by the FDA and is therefore immune from any lawsuit brought in state court.
Aware of the injustice and inequity of the Supreme Court’s Riegel decision, Congress is working on legislation to fix it. The proposed legislation is called the Medical Device Safety Act of 2008.
In the Levine case, the issue boils down to this: Do the FDA and other federal regulatory agencies set minimal standards which states are free to strengthen or do federal agencies make judgments about safety standards that states are required to follow?
This will be a very important case for advocates of consumer justice. Will the Supreme Court bar injured victims, who, through no fault of their own, are severely injured by bad medical devices or will the Court side with the consumer recognizing that the courts are their only avenue to pursue justice?