Medtronic Sprint Fidelis Lead Victim Asks Lawmakers to Restore Consumers RightsJun 12, 2008 | Parker Waichman LLP A Pennsylvania woman went to Capitol Hill yesterday to ask lawmakers to overturn a Supreme Court ruling that has stripped consumers of their right to sue for injuries caused by defective medical devices. Bridget Robb was shocked more than two dozen times due to a defective Sprint Fidelis Lead attached to a Medtronic implantable defibrillator. Because the Supreme Court has taken away her right to sue the company, Robb said she was forced to go to Congress for justice.
Drug makers and medical device manufacturers have been waging an aggressive campaign in the courts to obtain protection against product liability suits. In February, medical device makers got their wish when the Supreme Court ruled that 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. Medtronic, which had brought the case before the Supreme Court, and the Bush Administration asserted that allowing state personal injury lawsuits against the makers of defective medical devices amounts to a state “requirement” different from FDA requirements because such complaints are based on state laws.
The Bush Administration recently sided with drugmakers in another preemption case involving a Wyeth drug that is going before the High Court in the fall. There is little reason to suspect that the court will act differently towards pharmaceutical companies.
The only way consumers will preserve their rights to sue over defective drugs and medical devices is if Congress passes a law restoring those rights. Yesterday, several victims of faulty devices appeared on before a Congressional committee yesterday, asking lawmakers to do just that.
One of them was 34-year-old Bridget Robb. Robb told lawmakers that she was shocked 31 times in 13 minutes by a recalled Medtronic Sprint Fidelis defibrillator lead. The Sprint Fidelis lead was recalled by Medtronic last year after it received reports of 5 fatalities linked to lead fractures.
According to Robb, her six-year-old daughter watched in horror as her mother's defibrillator shocked her heart multiple times. Robb said she did not know about the Medtronic Sprint Fidelis recall until she arrived at the Emergency Room, even though the company claims it sent certified letters to all patients who received the devices.
Despite her pain and suffering, Robb and thousands of others injured by defective medical devices cannot get compensation for injuries because of the Supreme Court ruling. Hopefully, lawmakers will be moved by these stories and take action to restore the legal rights of all consumers.