No one using a heart defibrillator ever wants to experience what Michael Mulvihill of Bettendorf, Iowa did two years ago. All of a sudden, while he was driving on the interstate with his wife in the car, he began to see blue flashing lights in his eyes and his body began to shake. His defibrillator was malfunctioning, sending painful shocks through his body. The device malfunction nearly killed Mulvihill and his wife; the man barely managed to pull the car over in the middle of a construction zone.
A representative from Medtronic confirmed the device had shocked Mulvihill 22 times in 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). However, because of a U.S. Supreme Court ruling last year, Mulvihill does not have any recourse to hold the manufacturer accountable.-AAJ
After the malfunction, Mulvill was forced to take an early retirement; his job required too much interstate driving. His family will have to make it on less than they’d planned.
In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that because the Food and Drug Administration (FDA) had approved a medical device through the pre-market approval process, patients injured by medical devices do not have any recourse to hold the manufacturers accountable. The Supreme Court ruled earlier this year in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts, creating a double standard between prescription drugs and medical devices. –AAJ
On August 4, Mulvihill testified about his life-threatening experience before the US Senate Health, Education, Labor, and Pensions Committee, asking Congress to pass the Medical Device Safety Act (MDSA), restoring patients’ right to hold device manufacturers accountable for the harms they cause when their devices malfunction, regardless of FDA approval.
Tragically, Mulvihill’s story is similar to hundreds of other patients who have been harmed by medical devices but have no legal recourse, while the profits of the companies that produce these faulty devices increase every day. Wyeth v. Levine affirmed patients’ rights to seek compensation from drug companies; it’s time for device manufacturers to answer to patients too.