The New York Times has a recap of the oral arguments heard yesterday by the Supreme Court in Riegel v. Medtronic. As Reg•Watch blogged yesterday, the issue is whether federal regulation preempts state common law claims against medical device manufacturers.

A case being argued before the Supreme Court today could affect the way consumers seek redress from companies when harmed by faulty drugs or medical devices. The case, Riegel v. Medtronic, "was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries," according to The Los Angeles Times.

Medtronic is arguing federal regulations serve as a shield which protects it from tort claims. Since FDA approved the medical device, Medtronic believes it bears no responsibility for injuries caused by its use.

As the LA Times reports, the case has broad ramifications: "The question in the catheter case is whether Congress intended to bar state common law claims when it gave the FDA authority to regulate medical devices in 1976."

In fact, Congress did legislate a regulatory system in which state regulations cannot supersede federal ones. Congress recognized 50 different sets of rules would be a nightmare for pharmaceutical and device companies seeking approval and would put consumers at greater risk.

But Medtronic is trying to compare apples and oranges. The positive law enacted by the U.S. Congress and state legislatures is different than the common law created by the courts in tort claims like this one.

The Bush administration has also been conflating these two types of law in its war on torts. A series of federal regulations have included language that preempts tort claims against companies in compliance with federal regulations. More on that here.

Update: The New York Times recaps oral arguments (12/05/2007)

Posted by Matt Madia, 10:28:54 AM