Two years ago, Michael Mulvihill of Bettendorf, Iowa, was driving with his wife to visit his son, daughter-in-law, and grandchildren when he saw a blue light flash before his eyes. He felt his body shaking but thought he’d simply hit some road debris. But he soon realized his heart defibrillator was firing, sending electrical shocks through his body while he was driving on the interstate.
After managing to pull over, Michael was taken to the hospital. A representative from Medtronic, the maker of his defibrillator, confirmed the device had malfunctioned, giving him 22 shocks in just 53 minutes. The wire that connects the defibrillator to the heart was recalled four months later after over a hundred reports of the lead malfunctioning had been reported to the Food and Drug Administration (FDA).
Michael had been diagnosed with an irregular heartbeat, and was implanted with his defibrillator in 2006 to control his heart rhythm and pulse. But the device intended to save his life nearly killed him and the anxiety from the episode led him to take early retirement because his job required so much interstate travel.
Unfortunately, his nightmare continues. Michael cannot hold the manufacturer of his device accountable for their faulty product because a U.S. Supreme Court decision last year gave the company complete immunity.
Yesterday, Michael testified before the U.S. Senate Health, Education, Labor, and Pensions Committee, and asked Congress to pass the Medical Device Safety Act (MDSA), which would restore the right of patients to hold manufacturers of medical devices accountable in court when their devices malfunction.
Michael also joined victims of faulty medical devices from eight states at a press conference where they shared their stories and the importance of this legislation. Mike and Joseph Collins of Georgetown, Texas were both implanted with a faulty device. Michele Meyer and Mark and Janis Baird of Minn., had children who died as a result of their devices malfunctioning. And Avery deGroh, of McHenry, Il., was only 3 when she received nine painful shocks from her faulty defibrillator.
MDSA was introduced in congress by Sen. Edward Kennedy (D-MA), Rep. Frank Pallone (D-NJ) and House Energy and Commerce Committee Chairman Henry Waxman (D-CA), and currently has 101 co-sponsors in the House and 23 co-sponsors in the Senate. This important legislation is critical in ensuring the safety of those patients who rely on these devices.
Both the Senate HELP Committee, and the House Energy and Commerce Health Subcommittee have held hearings on the legislation. The next step is for the Committees and Congress to move the legislation forward, so people like Mulvihill, Mike and Joseph Collins, and Avery deGroh can seek justice.