House Democrats seek to restore victims' right to sue over defective medical devices
The U.S. Supreme Court recently surprised lawmakers by re-evaluating thirty-year old legislation and finding that it was intended to grant immunity to manufacturers of medical devices. In its ruling, the Court concluded that all such devices are protected from suit, even if the FDA supervision of their manufacture and approval was inadequate. Michigan has a similar rule regarding FDA-approved medications, and a federal immunity-for-FDA-approved drugs claim is currently pending before the U.S. Supreme Court.
U.S. House Democrats are hoping to restore accountability for medical device manufacturers, although the manufacturers' special interests are maintaining an effective lobbying campaign among conservative Republicans, in particular. The most frequently cited example of a defective device that doesn't warrant manufacturer immunity is the Medtronic defibrillator lead known as the Sprint Fidelis. Defibrillator leads are included in the most dangerous Class III of medical devices, theoretically requiring the highest level of investigation and scrutiny prior to FDA approval.
Medtronic had originally produced a lead in the 1990s, and then created the Fidelis lead that was approved in 2004 without human testing. Approval is frequently achieved by a committee vote involving a majority of manufacturer's representatives and other persons with a vested interest in the approval process. The Fidelis lead was significantly thinner than its predecessor and immediately began to fracture and fail at an unacceptable rate. Removal and replacement of the recalled lead (it was implanted in almost a quarter-million patients) is a dangerous and sometimes fatal intervention--and Medtronic offers to pay only about $800.00 to offset the out-of-pocket expenses. Meanwhile, the families of patients who die during the procedure or who suffer debilitating consequences, have no alternative for compensation.
As many in Congress have noted, the FDA has proved spectacularly incapable of monitoring or supervising drug and medical device manufacture and approval, and either inept or unduly susceptible to influence. The right to pursue a lawsuit in appropriate cases is a significant deterrent and a needed protection under the circumstances. The FDA won't or can't protect American consumers from a very wealthy industry that won't or can't impose meaningful protections and standards. This is precisely the situation in which a carefully calibrated justice system can serve the public policy goal of protecting individuals and the public-at-large, by assuring accountability. Legal access should be reinstituted on a federal basis, even if Michigan consumers have been denied this protection.