J&J and DePuy Looking to Have Qui Tam Pinnacle Lawsuit Dismissed

Boston, MAA hip replacement implant failure lawsuit that was dismissed back in February, only to be appealed by the plaintiffs to a higher court, remains firmly in the sights of defendants Johnson & Johnson (J&J) and DePuy Orthopaedics Inc (DePuy). Earlier this month, J&J together with DePuy urged a three-judge panel with the First Circuit to uphold the ruling of the lower court.

In the view of the defendants the lawsuit – brought under the auspices of the False Claims Act (FCA), lacked merit and was properly dismissed due to the lack of a primary prerequisite necessary for a FCA claim.

That prerequisite, according to the defendants, is the presence of a connection between a defective device and an actual false claim for payment.

Thousands of plaintiffs have brought a defective hip implant lawsuit against DePuy and J&J over their Pinnacle hip replacement joints, a metal-on-metal design that has also proven to be problematic with other manufacturers as well. Thought, initially to provide better wear under more robust use and a longer lifespan than first-generation hips fashioned from traditional materials, the metal hips were seen in practice to wear more quickly, releasing minute metal fragments into surrounding tissue causing inflammation and pain. Metal ions were also seen to enter the bloodstream, causing a condition known variously as metallurgical toxicity – a grievous health complication and risk for some patients.

Many hip replacement implant failure patients were required to undergo revision surgeries due to metallurgical toxicity. Others were required to undergo single, or even double procedures due to the early failure of the metal-on-metal implants.

DePuy pulled the troubled Pinnacle implants from the market, but that hasn’t stopped thousands of patients from filing lawsuits.

In briefs present to the First Circuit, DePuy suggested that two British doctors who served as relators in the FCA hip failure lawsuit improperly disclosed information from the multidistrict litigation file that currently houses upwards of 8,500 cases.

The DePuy Pinnacle MDL is Case No 2244. As of November 15, 2016 there were 8,661 lawsuits consolidated in the MDL. Earlier this month the third bellwether lawsuit related to the MDL brought a $1 billion verdict – half of which was for punitive damages – against J&J and DePuy.

The original FCA lawsuit was dismissed by US District Court Judge F. Dennis Saylor IV after finding that an allegation associated with a particular false claim was too vague. He noted that even though the case alleged fraudulent statements and misconduct related to the alleged failure of a certain device configuration that featured metal on metal, the complaint failed to specify if that had, indeed, been the device used to support the allegedly false claim, amongst other omissions.

The judge also rejected arguments that all of the claims that were made for reimbursement to government programs such as Medicare and Medicaid for the device at the center of the qui tam lawsuit were false, because the US Food and Drug Administration would have hesitated to approve the device, and surgeons would have declined using the device, had they known – as DePuy had – that the Pinnacle hips failed at alarming rates.

The case is Nargol et al. v. DePuy Orthopaedics Inc. et al., Case No. 16-1442, in the US Court of Appeals for the First Circuit.