Manufacturers of products are required to take comprehensive measures to ensure that their products are safe for their intended uses. Failure to disclose any defects associated with a product is grounds for legal action. Manufacturers, however, do not protect your legal rights when you are severely injured by a defective device.



While technology has greatly advanced and saved lives, so has the potential for catastrophic injuries from the use of a medical device that is defective in either its design or manufacture. Unfortunately, the U.S. Supreme Court has virtually wiped out consumers' rights against companies that manufacture defective medical devices. The Court held that under the Medical Device Amendments of 1976 (MDA), if a medical device is approved by the FDA, there is no liability for the injuries caused by the defective device under state laws if the medical device had undergone the Food and Drug Administration's pre-market approval process.  Only one member of the Court disagreed.  Justice Ruth Bader Ginsburg wrote in her dissent that she doubted Congress meant to foreclose consumers injured by FDA-approved devices that "nevertheless prove unsafe...the MDA's failure to create any federal compensatory remedy for such consumers further suggests that Congress did not intend broadly to preempt [do away with] state common-law suits grounded on allegations independent of FDA requirements."  An expert testifying before a congressional committee noted that when the Federal Food, Drug and Cosmetics Act was passed, medical devices, for the most part, were simple instruments such as stethoscopes and scalpels in which defects would be readily apparent. The technology boom after World War II greatly increased the number and complexity of medical devices. The complexity and use of medical devices have increased exponentially over the past 60 years. As diverse as medical devices are, so are the range and complexity of problems that can arise from their use. These problems include mechanical failure, faulty design, poor manufacturing quality and adverse effects of materials implanted in the body. It is evident from the FDA annual lists of Safety Alerts that failure of medical devices is not uncommon. Yet consumer protection is once again deemed secondary to the profits of manufacturers. 

If you or someone you love were injured as a result of a defective medical device, please contact us online or call our experienced defective product lawyers at 1-850- 932-7733 for a free consultation. Our lawyers will fight to ensure that companies are held accountable and your rights are protected. Our goal is to help you regain the life you had before your catastrophic injuries.