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Sprint Fidelis Victim Asks Senate to Restore Patients’ Rights

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A victim of a faulty Medtronic Sprint Fidelis lead went to Capitol Hill on Tuesday to ask Senators to pass 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.

During a hearing before the Senate Health, Education, Labor and Pensions Committee, Michael Mulvihill, told lawmakers how suffered 22 electric shocks within a span of 53 minutes when the lead on his Medtronic defibrillator fractured two years ago. That lead,  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.

Patients llike Mulvihill lost their right to sue the makers of defective devices 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.  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.”

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