Tuesday, 20 of March of 2018

DePuy forced to recall additional devices

By Shapiro, Lewis, Appleton and Favaloro, Medical Malpractice Lawyer

What Happened:

DePuy Orthopaedics is being forced to recall yet another line of hip and other artificial joint implants. This time, the Johnson & Johnson subsidiary said that it would be pulling all of its unused custom orthopedic devices due to concerns raised by the FDA. The recall notice was issued on August 24, 2012, two years after the company issued its major ASR hip-implant recall.

Earlier this year DePuy agreed to stop manufacturing the custom devices after receiving a warning letter from the FDA. The regulatory agency said the implants had not been through clinical trials and were thus being sold without federal approval. DePuy argued that the devices were exempt from the normal application process given that the FDA had approved the original devices and the custom pieces were only being modified.

The FDA disagreed and wrote that, “Although the devices’ size and shape may vary with each patient’s anatomy, the standardized design characteristics do not vary among the devices manufactured.” The agency said that the fact that the final specifications may differ depending on the recipient does not mean that DePuy was excused from the usual FDA approval process.

The FDA went on to accuse DePuy of using poor quality control systems in the production of the different custom implants and ordered the company to recall any implants that had already been delivered to surgeons. Though more than 8,300 customized DePuy implants have been sold since 1999, the exact number of unused devices subject to this recall is unknown.

The news comes at a bad time for the medical device maker as DePuy is dealing with the huge global recall of 93,000 ASR hip-replacement and hip-resurfacing devices that was announced in August of 2010. The all-metal devices have been shown to fail within only a few years’ time, leading to painful and costly revision surgeries. Beyond the need for additional surgery, the DePuy hips have also caused metallosis due to the release of metal shavings created when the parts rub together. Some studies have shown that these metal pieces can cause damage to patient’s bladders and kidneys.

The ASR recall has precipitated a flood of lawsuits against the company. In the U.S. alone, more than 8,000 lawsuits have been filed against DePuy, with the first cases finally making their way to a settlement.

The Virginia Injury Lawyer’s Perspective:

If you or a loved one has been seriously injured by a dangerous or defective product, you should contact an experienced personal injury lawyer as soon as possible. There is a finite period of time to take legal action against those responsible for manufacturing the device and once the statute of limitations expires, you are barred from seeking compensation.

Attorneys with our Virginia personal injury law firm have helped many victims of dangerous and defective products recover damages from companies whose negligence or disregard for consumer safety led to injuries.

Helpful Info:

If you or a family member has been injured by a defective or dangerous product, you can begin to learn about your legal rights and options by reading this article.

Have Questions? 

We maintain a library of attorneys’ answers to frequently asked questions regarding recalled products.


About the Editors: The VA-NC medical malpractice attorneys at Shapiro, Lewis & Appleton include medical and surgical malpractice lawyers licensed in both Virginia and Carolina. Our attorneys have experience handling medical malpractice cases involving hospital and doctors’ mistakes, as well as nursing home abuse and neglect. Check out our case results to see our track record of success in medical malpractice lawsuits, and also be sure to read our free medical malpractice reports Top 10 Tips From a Medical Malpractice Insider and Top 5 Surgical Errors. Rick Shapiro and James Lewis have been listed among the Best Lawyers in America since 2008. They, along with fellow attorney Randy Appleton, have also been named Virginia Super Lawyers since 2010, an honor fewer than 5 percent of outstanding attorneys receive.