Medical devices come in all shapes, sizes, and functionalities, and they can be lifesavers to people with certain conditions. Often, medical devices remain inside the body to prevent a debilitating condition from developing or worsening. With regulatory processes becoming less strict, however, dangerous products are making their way into the market. When these defective medical devices fail, the consequences can be devastating.
Such was the case for a Georgia woman who nearly died due to a defective filter. The patient had an IVC filter placed in her bloodstream to prevent blood clots; years later, she discovered that the device had fractured and debris was clogging her arteries and on its way to her heart. The debris was discovered when she went to the emergency room with arm pain and lightheadedness. Most of the debris was subsequently removed via surgery. However, a piece remains in the artery leading to her lungs. She and more than 3,000 others are suing the maker of the filter, Bard.
Many Devices Exempted from Human Testing
The IVC filter did not have to undergo a clinical trial before it was released. The Food and Drug Administration (FDA) oversees regulation for new and existing medical devices. By law, the agency must make the approval process the least burdensome it can, so many products are only tested on animals or machines before being made available. For some products, this approach makes sense – things like Q-tips and bandages are considered medical devices – but for other, riskier products such as replacement joints and mesh implants, these relatively lax regulations could put patients in danger.
Most medical devices have to go through a pre-market notification phase known as the 501(k) process before being put on the market. This allows new products to bypass the clinical trial phase by demonstrating that they are substantially equivalent to other products that are already available. Essentially, new devices can be made available for use without independently establishing their effectiveness, which can result in substandard products reaching the market.
Some products do not have to go through a premarket notification phase at all. Products that are considered less risky are often exempted from the 501(k) process. As an alternative, the FDA collects data from patients using the devices to determine if there is a safety risk. Medical records may not tell the full story, however, as doctors are not required to report incidents the same way hospitals are, and manufacturers can influence the data relating to their devices. Meanwhile, dozens of patients may be injured or killed before the agency realizes there is an issue.
There are currently more than 190,000 medical devices in use in the U.S., with more being released every day. The first quarter of 2018 saw more new devices approved than any other quarter since 2005. Without thorough regulation, patients may be exposed to defective products that can result in deadly injuries.
If you or a loved one has been harmed by a defective medical device, call the New Jersey medical product liability lawyers at Eichen Crutchlow Zaslow, LLP. Our knowledgeable, experienced lawyers will investigate who is responsible for your injury and determine whether medical malpractice was a factor. We are committed to recovering the maximum compensation for your suffering. With offices conveniently located in Edison, Red Bank, and Toms River, we serve clients throughout New Jersey. Call us today at 732-777-0100 or contact us online for a free consultation with a New Jersey medical product liability lawyer.