DEFECTIVE MEDICAL DEVICES

Millions of people rely on medical devices such as pacemakers, defibrillators, prosthetics and dialysis machines to live healthier and more effective lives. They put their lives in the hands of the companies that manufacture these devices, trusting that they have conducted the necessary tests and quality assurance to ensure that their products function properly. When manufacturers release defective products to the marketplace, they may be held responsible in a court of law.

The U.S. Food and Drug Administration (FDA) dictates the approval process for medical equipment, but it is ultimately the manufacturer’s responsibility to ensure the safety of its products. Flaws in design and manufacture sometimes lead to the production of defective medical devices. This, in turn, often leads to injury or death of the patients who use these devices.

The Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices. The amount of control the FDA exercises over the manufacturers depends on how likely the goods being produced are to cause injury. The FDA has promulgated standards and practices with which manufacturers must comply. Evidence of compliance may bolster a defendant’s case that it was not negligent, and evidence of failure to comply can support a plaintiff’s claim that the injury-causing product was defective. The FDA also prescribes labeling requirements for certain medical products. A manufacturer’s compliance with these requirements, however, does not itself relieve the manufacturer from failure-to-warn liability.

People filing state court lawsuits over the safety of federally-approved medical devices may face stricter legal hurdles, after a decision handed down by the U.S. Supreme Court in February 2008. In Riegel v. Medtronic, Inc., the Court held that the Medical Device Amendments of 1976 bars most state law claims challenging the safety or effectiveness of a medical device that received market approval from the U.S. Food and Drug Administration (FDA).

 

If you or a loved one has been injured by a medical device defect, please contact my office at 314-706-6013 for a free legal consultation to discuss your rights and how we can help you.