From Reuters, in a case captioned Riegel v. Medtronic, Inc., the Supreme Court has ruled in favor of a medical device manufacturer and in so ruling made Federal pre-emption the law of the land. The court granted writs on the issue of “[w]hether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.” The court answered the question in the affirmative.
This judicial tort reform, specifically the preemption doctrine, is something that has been on the way for quite some time. It is the type of thing, the Federal government meddling in a state law issue, that conservatives claim to be against. But when it comes to protecting drug manufacturers, things like ideology are thrown to the wayside.
Scalia wrote the majority opinion for the Court, which says the FDA’s premarket approval of a medical device preempts a claim brought under a state’s negligence law, in that negligence cannot be proven because the device has been cleared as safe for use by the FDA. The FDA was given the authority to oversee approval of medical devices in a law passed by Congress in 1976. The law did not say that FDA approval of a medical device precluded a state law negligence claim and did not purport to give medical device manufacturers blanket immunity from negligence suits. A New York Times article states: two crucial figures in the passage of the original 1976 device law, Representative Henry Waxman, Democrat of California, and Senator Edward Kennedy, Democrat of Massachusetts, said Wednesday that the Riegel ruling was contrary to Congress’s intent and that they would introduce legislation to overturn it.
The medical device manufacturers provide much of the information that is used by the FDA to decide whether to approve a certain device. If the manufacturer provides information that is favorable to their product, such as studies that show their device is safe, but fails to include harmful information, can you say that company should be immune from lawsuits. This decisions will prevent plaintiffs’ lawyers from getting to the stage where they find out if this happened, because suits will be dismissed early in the game, before discovery has had a chance to proceed.
The threat of lawsuits give medical device companies an incentive to do things the right way. The threat prevents much harm. Now that threat is gone.
Justice Ginsberg cast the only dissenting vote and the story quotes the salient part of her dissent: “Congress, in my view, did not intend (for the 1976 law) to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices”.
Judicial Tort Reform from the highest court in the land. This decision impairs the right of injured individuals to seek justice through the legal system when someone negligently causes them harm. Not what our judicial system was set up to do.