A February 2008 decision by the Supreme Court stands as a barrier to patients who desire to sue for medical device liability. The Supreme Court ruling in Riegel v. Medtronic, Inc. holds that patients or their surviving heirs would be barred from suing makers of complex medical devices like the Medtronic’s heart device product, if the Food and Drug Administration (FDA) approved its sale.
Since that ruling, judges nationwide have applied the Supreme Court decision to a wide range of cases where manufacturers was being sued. The most recent dismissal was just last week by the Wisconsin Supreme Court.
But now members of Congress want to change the law. Lawmakers and patient advocate groups say that that February 2008 Supreme Court decision left patients legally powerless against the FDA’s oversight of products.
“Consumers face the worse of all possible worlds,” says David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog. “The FDA 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.”
Of the many medical device lawsuits dismissed since the Supreme Court decision, one included a woman burned internally by a device meant to reduce menstrual bleeding; in another a man sustained internal injuries from a prostate treatment device; and numerous patients say they were injured by faulty joint or heart implants.
Now being considered by the Supreme Court is whether to give the same type of legal protection to drug manufacturers. In the upcoming case, like the one decided in February 2008, the Bush Administration supported pre-empting many product liability lawsuits against FDA-approved products.
The Medical Devices Amendments of 1976 is the statute that created classifications under which the FDA approves medical devices. The 2008 Supreme Court decision referred to these statutes under its ruling that pre-empted product liability lawsuits against so-called Class III devices. Such devices receive the FDA’s highest level of safety scrutiny.
With the newly installed Congress in place, there is movement afoot in both the House of Representatives and in the Senate to pass new legislation that would allow lawsuits as a backstop to the FDA approval system.