There have been a number of noteworthy developments in the national litigation efforts against DePuy and Johnson & Johnson over its failed Pinnacle metal-on-metal hip implants. There are currently more than 8,000 individual lawsuits pending in state and federal courts around the country alleging that the Pinnacle hip devices are defective due to metal wear debris generated by motion of the cobalt-chromium cup on the cobalt-chromium head of the implant. Most of the pending lawsuits have been filed in the multi-district litigation proceedings in Dallas, Texas and in coordinated JCCP proceedings in California state court.
The long term safety of metal-on-metal hip implants has been questioned for many years, especially after the recall of DePuy’s ASR metal hip implant as well as additional recalls and litigation involving other metal-on-metal hip implants manufactured by Biomet, Wright Medical, Zimmer, and Smith and Nephew. Numerous studies have been published over the years showing that patients with metal-on-metal hip implants are suffering serious tissue damage due to metal debris from the hip implant, and there are also serious concerns about the long-term health effects of patients having elevated levels of cobalt and chromium in their bloodstream. The FDA has also convened scientific panels to delve into these issues and have ordered manufacturers to conduct the long-term safety studies that the plaintiffs contend should have been completed long before the hip implant devices were placed into the bodies of hundreds of thousands of patients worldwide.
Government medical device regulators around the world have also been keenly aware of this emerging threat to patient safety and have been studying international joint registries and other available data to better define and understand what appears to be an alarming rate of device failures for patients implanted with MOM arthroplasty products.
Judge Kinkeade is the federal judge who oversees the Pinnacle MDL proceedings, which are based in Dallas, Texas. The first bellwether trial in that litigation resulted in a verdict in favor of DePuy in the fall of 2014. In that case, the plaintiff had bilateral hip Pinnacle hip implants that failed due to metallosis and required revision surgeries. The Defendants were able to presumably able to convince that federal jury that the unique positioning of the Pinnacle hip implants due to the patient’s anatomy led to the abnormal wear debris and resulting systemic and local tissue reaction rather than a defect in the Pinnacle hip implants. Following this loss by the plaintiffs, a great deal of effort was placed by the national leadership in the Pinnacle hip implant litigation to develop new experts and theories in the case to explain why the Pinnacle hip implant is defective and causes harm to patients.
In January of 2016, Judge Kinkeade began a second bellwether trial in the MDL proceedings. This was the first trial in any national hip implant litigation to include multiple plaintiff’s, as multi-plaintiff trials, while highly efficient and economical, are rarely granted as they are vehemently opposed by the defendants. This trial ultimately involved five plaintiff’s, all of whom were implanted with Pinnacle metal-on-metal hip implants manufactured by DePuy. A trial involving multiple plaintiffs provides tremendous benefits to the plaintiffs, as it prevents the Defendant, to some extent, from blaming other factors for the failure of the devices, especially an individual plaintiff’s medical history or alleged hypersensitivity to the implant. It is also difficult to blame the doctor or doctors for the failure of the implant(s).
Searcy Denney Partner Assists Pinnacle Bellwether
My partner Cal Warriner assisted in the preparation of expert witnesses for this trial as a member of the Plaintiff’s Steering Committee, including several trips to Europe to work with some of the leading experts on the causes of metal hip implant failures. He also had the pleasure of attending the first few days of trial, where the courtroom was filled to capacity, forcing some in attendance to watch a live feed from other roomed in the federal courthouse.
During the course of the trial, the jury heard testimony from 34 witnesses presented by the Plaintiffs and the Defendants. More than 1,100 exhibits were admitted into evidence, and the instructions to the jury from the judge spanned 40 pages with more than 100 questions that needed to be answered. During the course of the trial, there were numerous motions for mistrial made by DePuy and Johnson & Johnson. There were also 459 objections made for non-responsive answers by the Defendant’s witnesses versus only 10 similar objections with regard to testimony from witnesses for the Plaintiffs. In addition, the judge made 27 instructions to witnesses to respond to questions, with 26 of those instructions directed at defense witnesses and only 1 of those instructions to a witness for the plaintiffs.
On March 17, 2016, a federal court jury in Dallas rendered a verdict in the amount of $502 million after deliberating for nearly a week. The unprecedented MDL trial involving five different plaintiffs, rather than a single case, certainly created tremendous advantages for the Plaintiffs, which no doubt may have led, in part, to the sizeable verdict, an argument that DePuy will like argue on appeal. The verdict includes $360 million in punitive damages against DePuy and its parent company, Johnson & Johnson, after the jury found that these manufacturers committed fraud or gross negligence that caused harm to the plaintiffs.
During the many weeks of trial, there were daily motions for mistrial, which were denied by Judge Kinkeade, as well as numerous objections to the admissibility of documents and testimony as evidence and to the manner in which the trial was conducted. We anticipate that there will be significant post-trial motions seeking to set aside or reduce the verdict that will take months to resolve before Judge Kinkeade. Once those motions are completed, the verdict will be appealed to the intermediate federal appeals courts and likely the United States Supreme Court, a process that may take several years to resolve itself.
No money will be paid to the plaintiffs in this trial until all of the appeals are heard and resolved in their favor. Unfortunately, verdicts of this size and trials of this complexity are often overturned by the federal appeals courts.
Next Steps?
So, what impact does this verdict have on the more than 8,000 individual Pinnacle hip implant lawsuits that remain pending in the MDL and state court actions? The fact that the verdict was for the plaintiffs is very beneficial to all of the cases, especially after the tremendous loss for the plaintiffs in the first bellwether trial in the fall of 2014. The size of the verdict hurts the national litigation effort, as it is likely that the mega verdict will be reduced or overturned on appeal and can be perceived by the Defendants and their stockholders as merely an aberration. On the positive side, the successful use of the multi-plaintiff trial process in this case may serve as the new method for more expeditiously pushing hip implant cases to trial in the Pinnacle litigation as well as other hip implant litigations, and that is very positive for the plaintiffs as a whole.
What is probably most important for the future of the national litigation is what the MDL judge does next in the litigation. We are hopeful that he will start activating many of the pending 8,000 lawsuits for case-specific depositions in preparation for remand and transfer back to local courts for individual or small group trial settings. If that were to happen, I suspect that DePuy and Johnson & Johnson would likely seek to engage in settlement negotiations, as the risks of additional adverse verdicts and significantly increased defense costs are tremendous when they are having to actively litigate hundreds or thousands of individual lawsuits simultaneously (as opposed to the few dozen lawsuits that have been actively litigated thus far in the MDL in preparation for the first two MDL bellwether trials).
So far, DePuy and Johnson and Johnson have refused to engage in meaningful settlement discussions and thousands of plaintiffs with filed lawsuits have been waiting years for progress in their individual cases, so this next phase in the ligation over the next few months is of paramount importance.
