A whistleblower lawsuit accusing DePuy Orthopaedics of marketing faulty metal-on-metal hip replacement products will move forward, after the U.S. Court of Appeals for the First Circuit overturned a lower court decision dismissing the case.
The whistleblower complaint was filed by two Britain-based orthopedic surgeons under the federal False Claims Act, which allows private individuals with knowledge of fraud against the U.S. government to file a “qui tam” lawsuit on behalf of the government. The relators accuse DePuy of selling defective hip devices to doctors who then sought reimbursement for the products through Medicaid and other government health insurance programs.
According to The National Law Review, the case was dismissed last year by U.S. District Judge F. Dennis Saylor IV of the District of Massachusetts, who found that the complaint failed to state a specific instance of fraud. However, the First Circuit allowed the lawsuit’s claim that sales of a defective DePuy hip replacement would violate the False Claims Act to move forward, and remanded the case back to the District of Massachusetts.
“In this context, where the complaint essentially alleges facts showing that it is statistically certain that DePuy caused third parties to submit many false claims to the government, we see little reason for Rule 9(b) to require relators to plead false claims with more particularity than they have done here,” the July 26th decision stated.
Both physicians involved in the whistleblower lawsuit are also acting as expert witnesses in a massive multidistrict litigation involving a metal-on-metal version of DePuy’s Pinnacle hip implant system, which is currently underway in the U.S. District Court, Northern District of Texas. Recipients of this Pinnacle hip configuration claim that its all-metal design allows dangerous amounts of toxic metal debris to shed from the implant and accumulate in recipients’ tissue and blood stream. This occurrence can result in metallosis, pain, loosening of the implant and premature device failure. They also claim that the all-metal Pinnacle should have been recalled, as it allegedly shares the same design flaws that prompted DePuy Orthopaedics to recall its ASR hip implants in August 2010.
More than 9,000 DePuy Pinnacle hip lawsuits are now pending in the Northern District of Texas. Three cases have already gone to trial, the first of which concluded in October 2014 with a verdict for the defense. The jury in a second trial awarded $500 million to five Pinnacle hip plaintiffs in March 2016, after finding that their metal-on-metal hip implants were defectively designed. However, the judge overseeing the case ultimately reduced that award to $151 million to comply with Texas law governing punitive damages.
A third Pinnacle hip trial concluded last February, after another Texas jury awarded more than $1 billion to six patients who were implanted with the all-metal version of the hip replacement system.
In May 2013, DePuy Orthopaedics announced that it would phase out metal-on-metal hip implants, including the device named in Pinnacle hip lawsuits. According to The New York Times, the company cited slowing sales, as well as a move by the U.S. Food & Drug Administration (FDA) to impose stricter regulations on sales of all-metal hips.