There is perhaps nothing more frightening for people than the prospect of having to undergo some type of surgical procedure to implant a medical device. However, those frightened of the operating room often find comfort in the thought that the medical device being implanted into their body has been rigorously tested and is otherwise perfectly safe.
The unfortunate reality, however, is that not all medical devices are subjected to the necessary battery of tests and, worse yet, may not be entirely safe for patients.
To illustrate, consider a lawsuit recently filed by a Texas man against one of the nation's largest medical device companies alleging that its plates used to help stabilize fractures in the leg are both dangerous and defective.
According to the lawsuit, the man was involved in a serious motorcycle accident back in 2007, in which he broke both bones in his lower leg. Here, the surgeons used a plate manufactured by Zimmer Inc. -- a medical device company whose worldwide earnings average nearly $4 billion a year -- to stabilize his leg.
Unfortunately, the plate broke during the man's recovery. However, acting on assurances from Zimmer that the device was safe, he decided to undergo surgery yet again to install the identical plate in his leg.
When the plate broke a second time, the man became understandably suspicious and began investigating the matter with the help of an attorney.
They allege in their complaint that Zimmer was not forthcoming with patients about potential issues with the plates, and failed to report the matter to the U.S. Food and Drug Administration, a dangerous practice they claim has been in place at the company for quite some time.
"Zimmer has a practice of not properly reporting adverse events or product failures to the FDA," said the man's attorney. "So the long and short of it is, because Zimmer doesn't follow the rules and hasn't followed the rules on reporting these devices to the FDA that don't work, there is no way to know [how safe devices are]."
The lawsuit also cites internal company documents calling the strength, thickness and testing of the plates into question.
For its part, Zimmer has denied that the plates are either defective or dangerous, stating that they received FDA approval over eight years ago and that they continue to be successfully deployed by surgeons across the U.S.
The man filing the lawsuit, a veteran and a family man, has since undergone a third surgery in an attempt to fix his leg. While surgeons had discussed the possibility of amputation beforehand, they were thankfully able to successfully implant a rod into his leg. However, his mobility is now severely limited.
"I did 10 years in the Marine Corps and seven in the Navy Reserve, military police for both of them," he said. "When you look up and you're in a wheelchair, then from wheelchair, you go from walker, to this [referencing a cane]. You're able to finally stand up. These people don't understand the half of what they've done to me."
If you have suffered serious personal injuries or lost a loved one because of a defective product, consider speaking with an experienced attorney to learn more about your rights and options for seeking justice.
Source: WFAA, "After plate in leg breaks again, military vet brings lawsuit against device company," Shelly Slater, Dec. 19, 2013