DePuy hip implant lawyers at Pintas & Mullins announce that plaintiffs suing Johnson & Johnson subsidiary DePuy over its defective hip implants are now asking the FDA to investigate the company’s cover-up of experts’ concerns over the devices.
Plaintiffs believe DePuy broke federal law in concealing expert testimonies over its defective metal-on-metal hip implants, which the company recalled in 2010 and pulled from markets completely in 2013. They allege that, between 2006 and 2010, DePuy violated federal reporting requirements by failing to alert the FDA about medical evidence that its ASR XL hip implants were unsafe.
The cover-ups were revealed during two bellwether trials regarding the ASR hip implants. Powerful testimony from DePuy executives illuminated the company’s fraudulent conduct which was previously sealed under protective court orders. DePuy sold over 33,000 ASR XL hip implants in 2010 alone, despite projections that it would prematurely fail in about 37% of those patients within five years. Other expert analyses estimated the all-metal implant would fail in as many as 60% of patients.
As this information has come to light, and as more and more patients experience premature device failure, litigation surrounding DePuy’s ASR XL system is growing considerably. About 11,000 ASR patients have sued DePuy, who are now urging the FDA to launch an investigation into the company’s reporting failure.
In the first bellwether DePuy was ordered to pay about $8.3 million to a California plaintiff who was seriously injured by the ASR. The jury found the implant’s design to be defective and DePuy to have acted negligently. Evidence from that trial revealed that DePuy rushed the faulty device onto U.S. markets, side-stepping numerous reports of poor patient outcomes in blatant violation of federal regulations.
The ASR hip system was officially recalled in August 2010 after extensive reports of serious side effects were reported to the FDA and DePuy. Many patients required painful revision surgeries to correct the device’s problems, while others continue to suffer from severe metal toxicity (metallosis) in their bloodstreams. Other side effects may include loosening of the device, pseudotumors (soft tissue accumulation), and cobalt or chromium poisoning or allergic reaction.
Many ASR plaintiffs believe that, had DePuy complied with the federal reporting requirements, many of their injuries would have been avoided. In the years leading up to the 2010 recall, many esteemed surgeons and hip implant developers warned DePuy that the all-metal device was dangerous and had a high potential to injure patients.
As far back as 2007 DePuy’s own engineers began notifying DePuy management that the ASR was in dire need of redesign. They stated that the devices shedded metal debris in high amounts. DePuy reportedly launched a secret initiative to redesign the ASR after these complaints, however, it was abandoned for monetary reasons. The company, however, failed to notify the surgical community and the FDA about the redesign concerns, resulting in blatant violations of federal law.
A year before the engineers’ complaint, a surgical investigator of an ASR clinical trial sent a letter to DePuy in which he stated that he did not trust the ASR and would no longer use it in human trials. At the time, in 2006, DePuy was trying to get a resurfacing device for the ASR approved by the FDA, and marketing executives urged employees to cover up the investigator’s complaints. The marketing executive’s email specifically stated that DePuy needed to “nip this one in the bud.”
In the ensuing years other surgeons reported similar concerns about the device, which also, unsurprisingly, went unreported, leaving the medical community and the public completely unaware of the very real dangers of this device. DePuy ASR lawyers at Pintas & Mullins will continue to report on any significant findings concerning this litigation. We are currently representing many victims of metal-on-metal hip device, including those implanted with DePuy’s ASR and Pinnacle hip systems.