Congressional Democrats Try to Restore to Injury Patients the Right to Sue Medical Device Manufacturers

March 13, 2009,
Now that the US Supreme Court has ruled in favor of allowing plaintiffs to sue drug makers over dangerous medicines, Congressional Democrats are pushing to restore to injured patients the right to sue the manufacturers of defective medical devices.

Last week, they reintroduced the Medical Device Safety Act. The bill allows for injury lawsuits against the manufacturers of replacement hips, heart devices, catheters, and other medical devices. 

Since February 2008, when the US Supreme Court issued its ruling in Riegel V. Medtronic, Inc., patients injured by defective or dangerous medical devices have found it more difficult to sue medical device manufacturers if the product had been FDA-approved. Charles Riegel sustained serious injuries when the Medtronic-made catheter he was using burst while he underwent a medical procedure. While he survived the procedure, he sustained permanent disabilities. He died in 2004.

Riegel's defective medical device lawsuit, pushed forward by his wife after his death, contended that the Medtronic catheter was defectively designed and did not come with the proper warning label. While Riegel survived the medical procedure, he sustained permanent disabilities. 

Riegel's products liability lawyers had argued that medical device makers cannot use FDA approval to block state lawsuits against them. The Supreme Court, however, determined otherwise and threw out Riegel's lawsuit. 

Since then, other injured patients have had their defective medical device lawsuits dismissed on similar grounds. One plaintiff claimed he had been injured by a device used to treat his prostate. Another woman filed a defective medical device lawsuit because she said a medical device that was supposed to help decrease menstrual bleeding caused her to suffer burn injuries instead.

Just because a drug or a medical device has been FDA-approved does not mean it is free from defects or is safe for use. Medical device makers and drug manufacturers are supposed to make sure that their products to do not hurt users. When failure to fulfill this obligation leads to injury or death, the device maker or drug manufacturer should be held liable in civil court for products liability.


Suing Medical Device Makers Gets Harder, CBS News, February 20, 2008 


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In Orange County, California, our defective medical device attorneys have represented products liability clients with complex cases in Southern California and throughout the United States. We know what is required to get you the outcome you deserve. Contact Howard Law, LLP today.