Last week, the U.S. Supreme Court ruled that private lawsuits against medical device manufacturers are not permitted when the device in question complies with federal requirements. Essentially, the Court’s decision in Riegel v. Medtronic is another example of the U.S. Supreme Court’s attack on consumer rights, and will have far reaching negative effects for those who are seriously injured by dangerous and defective products . Charles Riegel received a balloon catheter manufactured by Medtronic which ruptured due to over inflation. He developed a heart block and was forced to undergo emergency surgery to save his life.
The Riegels brought a claim in federal court in New York, which was dismissed by the court, and upheld by the U.S. Circuit Court as being preempted by the Medical Devices Amendments (MDA). The MDA precludes lawsuits against manufacturers where the device in question complied with federal requirements. The problem with the Court’s decision, as noted by Justice Ginsberg in her dissenting opinion, is what if evidence of the product’s defect becomes known after the product has received premarket approval?
The Court stated in no uncertain terms its belief that juries are not capable of evaluating the risks associated with dangerous devices, with such language by Judge Scalia as the following: “The Dalkon Shield failure and its aftermath demonstrated the inability of the common law tort system to manage the risks associated with dangerous devices.” And this quote from the opinion is even more frightening for those who believe in our civil justice system as a means to hold manufacturers of defective products accountable: “A jury on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”
The Riegel decision should send a chill down the spine of citizens in this country who believe that the civil justice system is vital in the effort to require manufacturers to ensure that their products are safe for the public before they are placed on the open market.