How the Medical Device Industry Stays Unregulated

Michael Lin Baum is a lawyer who specializes in pharmaceutical litigation. Starting his career nearly 40 years ago, he is an experienced attorney who has represented thousands of people injured by prescription drugs and medical devices. In 2019, The National Trial Lawyers named Michael Lin Baum and his team Trial Team of the year in the mass torts category.

Several sophisticated medical devices come to the fore as technology continues to advance. Research has noted that about 10 percent of Americans have a medical device implanted in their bodies. Although medical devices come with their advantages, this industry is largely unregulated. According to research, some high-risk implanted devices are not subject to clinical trials and are grandfathered in. Many devices end up causing more harm than good. In fact, medical interventions have become the third leading cause of death in America.

Drugs usually have a more lengthy and rigid approval structure as they go through the Food and Drug Administration (FDA) agency. In contrast, the medical device industry is not subject to similar protocols.

Although the medical device industry became subject to the FDA in 1976, manufacturers of some medical devices still had permission to sell their devices without the requisite clinical testing that applies to drugs. Several medical devices were not subject to clinical testing as long as manufacturers could prove that the device they created is substantially equivalent to a device already in use.