If you’re dealing with a medical problem and your doctor suggests surgery, you shouldn’t have to worry about whether or not the medical devices used in that surgery will do you more harm than good. Unfortunately, with the current state of the industry, you should most certainly question the safety and reliability of any medical device that comes in contact with your body.
The big companies that produce popular medical devices like Essure, metal hip joints, and pelvic mesh are ultimately looking to protect their bottom line, which means they’re in it for a profit. While they may not be malicious in their quest for financial gain, their decisions to forgo expensive medical trials and time-consuming testing can ultimately cause future patients substantial harm.
If you were injured by a defective or dangerous medical device, you may need to question whether or not the device should have been approved for the market in the first place. Not all FDA work is about device regulation—much of it has to do with appeasing medical device manufacturers, which begs the question—who’s really at fault if you were harmed by a defective device? If the company responsible for creating a faulty medical device manipulated the FDA approval process, they could face hefty consequences.
The FDA & Medical Device Manufacturers
Although the FDA is supposed to monitor the medical devices on the market, the current process for healthcare products allows countless companies to pay their way through, bypassing very important roadblocks. Generally speaking, the FDA speeds the device approval process up, instead of slowing it down. But why would the FDA do this? In short, the FDA relies too heavily on the funds these medical device creators bring in.
According to Dr. Jeffrey Shuren, the head of the agency office in charge of device regulation for the FDA, the medical device industry is responsible for bringing in 35% of the funds that fuel the office’s work. Additionally, those contributions are hinged, by law, on the FDA’s ability to approve medical devices quickly. Medical device creators also supply ample funds to doctors and hospitals in consulting fees, according to the National Center for Health Research. All of this goes to say, the FDA relies on medical device manufacturers heavily, which is why so many dangerous, defective, and poorly tested devices make it into hospitals and medical offices each year.
In recent years, there have been countless patient claims against manufacturers for designing, building, and selling exceedingly dangerous products. Some products, like vaginal mesh, hit the market with hardly any clinical data to support their use, while other products make their way into distribution through the 510k pathway, which once allowed the FDA to hurry medical products into the market.
When medical devices forgo proper testing, clinical trials, medical review, and other forms of necessary regulation, dangerous products will undoubtedly make it onto the market. As our market currently stands, there are several dangerous and defective medical devices out in distribution, causing irreparable harm, painful injuries, and even death.
To learn more about the dangers of medical devices and their relation to the FDA, visit The New York Times.
Know Your Legal Rights
If you were harmed by a defective or dangerous medical device, you have a right to pursue legal action against the liable party, especially if that party was aware of the danger their device posed. Because medical device manufacturers are tied so closely to the FDA, they may feel entitled to certain privileges, and they may rush hazardous products onto the market well before they’ve been adequately designed, developed, or tested. If you were harmed as a result of this carelessness, our firm wants to help you fight for justice and compensation. Manufacturers should not be permitted to manipulate the FDA approval process, and if you were harmed because of any foul play, we’re prepared to support your claim.
Contact Decof, Barry, Mega & Quinn, P.C. to discuss your case with our experienced Rhode Island attorneys.