The United States Supreme Court, the nation’s highest court, will hear a case against Medtronic and other medical device manufacturers that could significantly affect lawsuits against all medical device manufacturers in the future.

How it began

In 1996, a patient named Charles Riegel had angioplasty, a procedure where a balloon catheter is inserted into an artery of the heart. The catheter, which was manufactured by Medtronic, burst during surgery and Mr. Riegel suffered severe and permanent injuries. He sued Medtronic for negligence, but both the trial and appellate courts ruled against him reasoning that he was pre-empted, or barred, from bringing a state action against the manufacturer.

Now, the U.S. Supreme Court will hear the case and decide whether a state action against a medical device company is pre-empted by language contained in federal regulatory laws that apply to medical devices. In short, since the Food and Drug Administration (FDA) – a federal agency – must approve the devices before they can be sold, can consumers sue manufacturers in state court?

Previous rulings

Medtronic believes that since the FDA has the final word on whether to approve these devices, federal law pre-empts it from state law claims about the product’s design or safety. In 1996, the Supreme Court ruled that lawsuits against manufacturers were allowed when the product went through a “fast track” approval process by the FDA. However, this process is used for new products that are similar to those already on the market. This case involves products that must go through the FDA’s “pre-market approval” process – a tougher standard that may take up to a year.

Both sides of the fence

On one side of the fence, consumer advocate groups say that manufacturers should be held responsible for the design and safety of their product – regardless of the FDA’s approval process – and that consumers who are injured by defective products should be able to sue manufacturers in state court.

On the other side, industry groups, backed by the Bush Administration, say that the FDA’s testing process should preclude consumers from bringing state claims against manufactures as it would subject manufactures to a bevy of different legal standards and increase the number of lawsuits filed.

While the Supreme Court heard arguments on December 4, 2007, their ruling will not likely be published for a few months.

Medtronic Incorporated is a Fortune 500 company that makes medical and surgical devices that diagnose, manage and treat diseases of the heart, brain, spine and ear, digestive system and urinary tract. Their U.S. headquarters are in Minneapolis, MN, but the company operates in 120 countries around the world.