Riegel v. Medtronic -- Have You Lost the Right to Sue?

We represent multiple clients who have experienced unnecessary shocking due to Medtronic's faulty lead. One client, in particular, was shocked over thirty times.

What is more frightening is the fact that the Supreme Court recently held oral argument on whether federally approved medical devices are broadly shielded from product-liability lawsuits. If the Supreme Court agrees with this big business position, many people who are injured due to faulty medical devices will be left with no recourse. It seems that big business has bought the FDA since it recently admitted that it cannot keep up with advances in science! The report, from a subcommittee of the FDA's outside Science Board that included members and advisers from industry as well as academia, said the agency "cannot even keep up with the advances in science." An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities -- including food, drugs and medical devices -- in 2006.

In Riegel v. Medtronic. The Riegel case was brought by a New York man, Charles Riegel, who was injured when a Medtronic catheter burst during a 1996 angioplasty procedure. Riegel, who died in 2004, asserted the catheter had design flaws and that labeling instructions for the device were misleading.

Allison Zieve, a Washington-based attorney representing Riegel, labored to convince the justices that federal law allowed Riegel to sue Medtronic over the device, which had received so-called premarket approval from the Food and Drug Administration.

"It is clear that Congress didn't want any additional requirements", Justice Antonin Scalia said, indicating he thinks Congress wanted the FDA to regulate medical devices without interference from state regulators or courts.

A majority of the Supreme Court appeared to support this view.

The BIGGER QUESTIONS - if the FDA has admitted that it can't protect the people and companies can avoid liability by having its products FDA-approved, what protections are afforded to the users of these products? What incentives do medical device companies have to protect the end user?

February 7, 2008 12:25 PM