Before any new medical device can come to market in the United States, manufacturers must go through an approval process established by the Food and Drug Administration. This process is designed to ensure the health and safety of patients who receive treatment using any of the thousands of different medical devices available. So why are so many medical devices still failing, causing thousands of patients to suffer ill effects? Here’s how the FDA approval process works, how it doesn’t guarantee that a device won’t cause harm, and how you can get legal help if you’ve been hurt.
The FDA Device Approval Process
One way that many medical devices pass through the FDA is via the 501(K) process. This a fast-track procedure that device manufacturers often use for certain products they say are “substantially equivalent” to other devices already on the market.
When a device is determined to be “substantially equivalent” by the FDA, it may be granted 501(K) clearance. By making this claim about their device and receiving 501(K) clearance, company can release the product much more quickly than it would otherwise be able to do—and do so without performing nearly as many rigorous safety tests as other products. This often means the product goes to market without any additional testing for safety or effectiveness at all.
For a sense of how fast this process really is, in one 1996 Supreme Court case, it was found that the FDA’s review process was only taking about 20 hours on average per 501(K) device application. Compare that to the next-highest class of device, where the riskiest medical device applications took up to 1,200 hours of the FDA’s time on average to review. 501(K) is truly a fast-track process in comparison.
If a device does not qualify for 501(K) clearance, it would have to go through the “pre-market approval” or PMA process. Products that need PMA clearance must undergo strict testing, including clinical trials. This can take a lot of time and cost a lot of money—so there is a big incentive for manufacturers to seek 501(K) clearance instead.
Does FDA Approval Affect My Personal Injury Lawsuit?
Just because a device has made it through the fast-track 501(K) process doesn’t mean that the product is completely safe, unfortunately. Manufacturing defects happen, poor designs that cause patient harm can still slip onto the market, and other issues regularly result in medical device failures. Recent years have seen dozens of recalls of medical devices that had FDA approval, including hip and knee implants, hernia and surgical meshes, intrauterine devices (IUD) for birth control, surgical equipment, and more.
Thankfully, FDA approval does not preclude you from filing a lawsuit to recover from injuries caused by a defective medical device. Thousands upon thousands of patients who have suffered serious harm as a result of medical devices failing have filed lawsuits against manufacturers of devices that have (or had) FDA approval, seeking compensation for expenses such as:
- Revision (repeated) surgeries to repair or replace failing implants.
- Emergency medical treatment required due to a faulty medical device.
- Long-term care expenses due to chronic issues caused by defective medical devices.
- Physical therapy or rehabilitation to regain lost functionality.
- Skilled caregivers or in-home care due to disability.
- Lost wages from time spent away from work.
- Reduced earning capacity due to an inability to continue working.
Those who have been hurt by a defective medical device may also be able to receive compensation for pain and suffering. In some cases, it may even be possible to receive punitive damage awards, if it can be demonstrated that the company knew that a device was dangerous but tried to hide the fact or otherwise acted inappropriately.
Get Legal Help Today
If you’ve suffered harm due to a defective medical device, you’re not alone. At Wayne Wright LLP, we make it our job to stand up for the rights of those who have been hurt due to the greed of device manufacturers that rush dangerous products to market without regard for safety, and we want to help you get the justice that you and your family deserve.
To arrange a free, no-obligation consultation with one of our experienced legal professionals, call us by phone, use our contact form to send an email, or click the live chat box on this page right now.