Certain US lawmakers are taking steps to give back to US citizens the right to sue medical device makers for damages. In February 2008, the US Supreme Court issued a decision preventing patients and surviving family members from filing personal injury and wrongful death lawsuits against medical device manufacturers if the device had Food and Drug Administration approval.
The outcome of that particular case prevented a man, seriously injured when his Medtronic balloon catheter burst during an angioplasty procedure, and his wife from receiving products liability compensation. Since the Supreme Court’s ruling, more defective medical device lawsuits have been tossed out.
Just this week, a state supreme court ruled against a man who underwent surgery to take out his Medtronic defibrillator because there was a chance the device device’s battery could fail. Other personal injury lawsuits against medical device makers that have been dismissed since the Supreme Court ruling include a products liability case involving a man who sustained internal injuries because of a prostate treatment device, a woman who sustained internal burns from a device supposed to decrease menstrual bleeding, and a number of patients who are claiming injuries caused by heart implants or faulty joints.
Congressmen Henry Waxman (D-Ca) and Frank Pallone Jr. (D-New Jersey) are planning to reintroduce legislation to nullify the Supreme Court decision. In the US Senate,Senator Edward M Kennedy (D-Ma) and Patrick J. Leahy (D-Vt) are expected to reintroduce a similar bill.
Critics of the Supreme Court ruling say the decision does not take into account the fact that the FDA doesn’t always do a thorough job when approving medical devices for consumer use. For example, the Project on Government Oversight says the FDA has dramatically scaled back on inspections of “good laboratory practices” at places where early round testing of medical devices take place. The independent watchdog group also says there has been a decline in the federal enforcement of quality regulations at labs where medical devices are developed.
The Center for Devices and Radiological Health, which is the FDA division that oversees medical devices, has received complaints from its own scientists who claim managers have discouraged debate and that this has resulted in the approval of medical devices that are not entirely safe or effective.
Lawmakers Seek to Return Right to Sue Device Makers, New York Times, February 19, 2009
Report: FDA quietly scaled back quality enforcement at medical device testing lab, Chicago Tribune, February 18, 2009
Related Web Resources:
Supreme Court Shields Medical-Device Makers, The Washington Post, February 21, 2008
Read the Supreme Court Decision: Estate of Riegel v. Medtronic, Inc., Cornell University Law School
If you or someone you love sustained serious injuries because of a defective medical device, our Maryland personal injury law firm would like to talk to you.