Senate Hearing Held on Restoring Rights to Sue Medical Device Makers

A panel of U.S. Senators heard testimony on Tuesday from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent Supreme Court ruling that insulates manufacturers from product liability lawsuits for injuries caused by certain defective products that were approved by the FDA.

The hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions was the second in recent months over the Medical Device Safety Act of 2009, which seeks to clarify that FDA approval does not preempt lawsuits against medical device manufacturers, overturning the 2008 Supreme Court decision in Riegel vs. Medtronic.

As a consequence of that decision, thousands of pending medical device lawsuits have been dismissed, including cases filed on behalf of patients injured by the defective Medtronic Sprint Fidelis defibrillator lead that was recalled in October 2007. Although the design of the Medtronic lead makes it prone to fracture or break, a federal judge ruled earlier this year that patient claims for medical expenses and other compensation are now barred because the FDA approved the device.

“This has had catastrophic consequences for ordinary Americans. While the FDA approval of medical devices is important, it cannot be the sole protection for consumers,” said Senator Tom Harkin of Iowa. “I say that because FDA approval…is simply inadequate to replace the longstanding safety incentives and consumer protections provided by long-standing state tort law.”

Opponents of the legislation say that enacting the Medical Device Safety Act of 2009 would stifle innovation and cannot be a substitute for strengthening the FDA.

Consumer advocates who support the bill point to a recent Government Accountability Office (GAO) report that highlights how FDA oversight of medical devices is inadequate, arguing that they are not an effective guardian of patient safety. Removing potential exposure to liability for injuries caused by dangerous and defective products may further reduce the incentive for manufacturers to ensure the safety of their device and result in more cases where profits are placed ahead of patient safety.

At the Senate hearings this week, one patient, Michael Mulvihill of Iowa, testified that a Medtronic defibrillator implanted in his chest malfunctioned and applied more than 20 electrical shocks to his heart in the span of about one hour while he was driving. His injuries forced him into early retirement. Another family told of how their young daughter also received shocks from a defective defibrillator and had to have the device replaced. Medtronic, the manufacturer, has refused to pay their medical fees.