Restoring to Injured Patients the Right to Sue Medical Device Makers

One year after the US Supreme Court ruled that medical device makers cannot be sued for personal injury, products liability, or wrongful death if the Food and Drug Administration had previously approved the device, US lawmakers are taking steps to give back to defective medical device victims and their families the right to sue for damages. In the US Senate, Senators Patrick Leahy and Ted Kennedy intend to reintroduce a bill that they presented last year, while in the US House, Representatives Frank Pallone and Henry Waxman say they will introduce their own bill.

In the US Supreme Court case, Charles Riegel, who was injured during angioplasty surgery when a balloon catheter burst as it was being inserted in his body, had sued medical device maker Medtronic for products liability. His case, Riegel v. Medtronic, went all the way to the US Supreme Court, and in 2008, the Court affirmed a ruling by a lower court to throw out the lawsuit.

Following the Supreme Court decision, hundreds of people who were injured by defective medical devices are finding that they may have no legal recourse to recover damages. Earlier this month, the Wisconsin Supreme Court said that a man who had to have his Medtronic defibrillator removed because it could fail was not allowed to sue the medical device maker for products liability. Other plaintiffs whose defective medical device lawsuits have been thrown out include a man who says he was hurt by a prostate treatment device and a woman who sustained burn injuries from a device she was using to decrease menstrual bleeding.

Now, two cardiac specialists are warning that Medtronic’s Sprint fidelis lead, an electrical cable that allows a defibrillator to connect to a patient’s heart, may be failing in patients at a faster rate than what was previously thought and that this rate could increase as time goes by. Over 235,000 people were administered the medical device prior to a product recall and many of these patients are still using them. The problem with the Medtronic device is that it may fail to deliver a necessary, life-saving shock to a patient’s heart or unnecessarily send these jolts to the patient. Findings from this newest study will be published on the medical journal Web site Heart Rhythm next week.

Study Finds More Failure of Heart Device, New York Times, February 23, 2009
Effort Underway to Overturn Medical Device Lawsuit Ban,, February 20, 2009
Related Web Resources:
Estate of Riegel v Medtronic, Cornell University Law School

The manufacturers of defective products-especially if that defect can cause serious injury or deaths-must be held accountable and liable for their negligence and catastrophic mistakes. Our Boston products liability lawyers are committed to helping Massachusetts injury victims obtain the recovery they are owed.

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