Witnesses Voice Support for Medical Device Safety ActAug 7, 2009 | Parker Waichman LLP
Earlier this week, a Senate hearing was convened to discuss the Medical Device Safety Act of 2009. If it becomes law, the Medical Device Safety Act would restore important legal rights to victims of a defective medical device.
Patients lost many of those rights in 2008, when the U.S. Supreme Court issued a ruling in a case known as Reigel v. Medtronic. In an 8-1 vote, the Court bestowed legal immunity to the makers of defective devices. The justices held that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. Since then, scores of medical device product liability lawsuits have been dismissed by lower courts.
The Medical Device Safety Act would nullify Reigel v. Medtronic. On Tuesday during a hearing before the Senate Health, Education, Labor and Pensions Committee, several witnesses expressed support for the bill. According to Medpage Today, one such witness was Dr. William Maisel, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Maisel also chairs the FDA's Circulatory Advisory Committee.
According to Medpage Today, Dr. Maisel told lawmakers that FDA approval of a medical device does not guarantee its safety. He said it is "simply impossible" for the FDA to continue to monitor the safety of every medical device it has approved. Maisel also told the committee that under current law, if a patient it is injured by a faulty device, they often have to cover the costs of their resulting medical treatment, Medpage Today said. For patients on Medicare or Medicaid, the government gets stuck with the bill.
Another witness to testify at the hearing was Michael Mulvihill, who two years ago suffered 22 electric shocks within a span of 53 minutes when the lead on his Medtronic defibrillator fractured. That lead, called the Sprint Fidelis, was recalled in October 2007 because of a high fracture rate. According to Talk Radio News Service, Mulvihill said he hoped Medtronic would one day be held responsible for the injuries the defective leads caused thousands of patients to suffer.
Right now, people like Mulvihill have no legal recourse. As we reported previously, in January, Judge Richard Kyle dismissed over 1,400 product liability cases involving the Sprint Fidelis that were pending in the U.S. District Court in Minnesota, citing Reigel v. Medtronic. In his ruling, Judge Kyle wrote that, "The Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. . . . Plaintiffs' remedy, therefore, lies with Congress, and not with this Court."