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Product Liability Protections Eroded By Highest Court

Posted by: Michael A. Kelly
March 21, 2008
Topic: Threats to Plaintiffs' Rights

As lawyers committed to protecting consumers rights, we are outraged by what is being done on a systematic basis to consumers' rights by big business, big Pharma, big corporations and the legislators and judges who they get elected and appointed.

The most recent example of the elimination of the rights of the average citizen is the U.S. Supreme Courts decision in Riegel v. Medtronic.

On February 20, 2008, the United States Supreme Court closed the doors of the courthouse to people harmed by defective medical devices where the product has undergone "premarket approval" by the FDA.

The decision terminated the serious injury claim of Charlie Riegel, who sustained serious injury when a balloon catheter burst while he was undergoing an angioplasty. Mr. Riegel and his wife brought an action against Medtronic alleging negligence in the manufacture, labelling and design of the device. Medtronic, which no longer makes the balloon catheter in question, claimed all fault was with the doctor.

The Court dismissed the case saying that federal law prohibits suing device manufacturers in state courts if the device was approved as safe by the FDA. The decision is expected to have negative ramifications for medical consumers in pending lawsuits against manufacturers of breast implants, defibrillators, artificial heart pumps and valves, drug-coated stints, spinal cord stimulators, and prosthetic hips and knees.

The Supreme Court has now effectively immunized all manufacturers from common law claims of product defect and negligence based on a contorted interpretation of the 1976 Amendments to the FDA Act. The amended provision provides that "no State may establish or continue in effect any requirement ... which is different from, or in addition to, any requirement applicable under this chapter to the device."

When manufacturers of medical devices are granted blanket immunity that protects them from all lawsuits, they no longer have any reason to make their products safe. They only need to seek FDA approval, not genuine product safety. History tell us the FDA grants its approval to deadly products on a regular basis; one need only look to Vioxx and Resulin, for evidence on the defective drugs side and Medtronic defibrillators on the device side.


With the U.S. Supreme Court handing medical device manufacturers complete freedom from accountability, the American public has absolutely no legal recourse for the harm caused by dangerous medical devices, even if they are defective.  At Walkup, we are committed to providing legal representation to those injured by defective products--the more obstacles big business sets up against injured persons and their right to recovery, the harder we work for our clients.


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