New Orleans, LAReeling over the March 2016 jury verdict of $500 million against Johnson & Johnson subsidiary DePuy and its allegedly failed Pinnacle hip implants, the pharmaceutical giant is looking for some breathing room in multidistrict litigation so it can appeal the massive verdict.
The DePuy Pinnacle hip implant is a metal-on-metal implant system that has been found to fail prematurely, release minute particles of metal into surrounding tissue fostering inflammation and infection, and release metallic ions into the bloodstream causing metallurgic toxicity of the blood.
DePuy won the first bellwether trial a little under two years ago, in October 2014. However, the second bellwether trial went to the plaintiffs. With the third bellwether trial slated to begin in September, DePuy is asking for a stay of that trial while it undertakes an appeal of the $500 million Pinnacle verdict.
That verdict was worth $130 million in total compensatory damages with a further $360 million in punitive damages to five plaintiffs having received the Ultamet implant, described as a metal-on-metal version of the Pinnacle hip system.
Artificial hips were, historically, manufactured from porcelain and other heritage materials that were sometimes noisy and had other issues, but for the most part and for most patients succeeded in reaching the outer limits of an expected 15-year lifespan.
However, as baby boomers began to retire and the market for artificial joints exploded, manufacturers put a renewed focus on improving their products with an eye toward supporting a more active lifestyle via an artificial joint that would last even longer. Design improvements and the introduction of new materials such as metal were brought to the fore under a qualification for FDA 510(k) Clearance, a regulatory fast-track provided by the US Food and Drug Administration for products that are substantially similar to those already on the market.
While such products achieved an increase in market share for many manufacturers, design updates with new materials not subject to the normal clinical trial process proved to perform below expectations, resulting in early failures - and hip replacement lawsuits in kind.
Earlier this week, DePuy filed a writ of mandamus with the US Court of Appeals for the 5th Circuit, seeking a stay of the next bellwether trial involving no fewer than seven plaintiffs that’s set for September 6 - a little over two months from now.
“Mandamus relief is needed because pressing forward with another trial now - before this court has had an opportunity to review several critical legal and evidentiary rulings in the last trial that have broad implications for the remaining cases in the MDL proceeding - would corrupt the bellwether process,” DePuy told the appeals court.
In its submission, DePuy alleged that Judge Ed Kinkeade of the US District Court for Northern Texas abused the bellwether process.
“The petitioners won the [first] bellwether trial against a single plaintiff almost 2 years ago; yet, the MDL court has not entered judgment in that case,” DePuy continues, according to its submission to the Court. “Over petitioners’ objection, and without calling for briefing from the parties on the issue, the MDL court then consolidated five plaintiffs’ cases for trial shortly before the [second] bellwether trial was set to begin in January 2016. At trial, the MDL court rejected defendants’ dispositive motions wholesale, allowing plaintiffs to proceed with novel and far-flung theories, unsupported in law, that will likely recur in most if not all cases in the MDL proceeding - including that parent companies can be held liable for the acts of their subsidiaries on an ‘aiding and abetting’ theory and that a design defect can be proven not by singling out a specific flaw in a specific device but instead by arguing that an entire line of products should not have been sold by any of a range of manufacturers.”
DePuy’s petition to the Court, at this point, appears to descend into some potentially inflammatory claims: “The MDL court also allowed (again over petitioners’ objections) the injection of all manner of irrelevant and highly inflammatory evidence - including, for example, plaintiffs’ counsel’s gratuitous assertions that nonparty subsidiaries of J&J had made payments to ‘Saddam’s henchmen;’ hearsay assertions from a book about supposedly improper scientific articles planted in the literature by ‘Big Tobacco’ and other ‘industr[ies];’ allegations that the Pinnacle Ultamet poses a risk of cancer, even though no plaintiff alleged such an injury and no science supports it; references to an employee’s unproven allegations of racist treatment at DePuy; and a suggestion that the failure of a metal-on-metal implant in another, nonparty individual led him to commit suicide. Not surprisingly, the jury, awash in this flood of prejudicial evidence, returned a verdict in excess of $500 million - including $360 million in exemplary damages.
“Because the MDL court has indicated that it will consolidate the new bellwether cases for a multi-plaintiff trial and because it is likely to issue the same rulings on a slew of issues that petitioners intend to appeal, the order raises the prospect that petitioners could soon be facing twelve adverse verdicts, totaling potentially $1 billion and causing significant reputational harm, all before this court has ever had a chance to review any judgment in these proceedings.”
In sum, it appears that DePuy is asking for not only a stay of the September bellwether trial, but an overall pause in the MDL bellwether schedule until DePuy has the opportunity to appeal the $500 million Pinnacle verdict.
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