After an 8-week trial and twelve hours of deliberation over three days a Dallas jury returned a defense verdict in the first DePuy Pinnacle bellwether trial. The jury in this case concluded that the metal-on-metal Pinnacle hip was not defective and that the injuries suffered by the plaintiff, Kathleen Herlihy-Paoli, were not a result of product defects in her metal-on-metal Pinnacle implants.
The verdict came as a surprise to many observers, including myself, but it should be reminded that this trial was only the first of several bellwether test cases. This was not a class action case and the verdict is only binding in this case alone. There are still over 6,200 outstanding Pinnacle cases waiting to be tried.
Juries are different in each case and it is impossible to predict how they might rule. In this case the jury heard a vigorous defense from Johnson & Johnson lawyers differing from the defenses used earlier in the ASR cases. They argued aggressively that design flaws in the Pinnacle did not cause the plaintiff’s injuries; rather surgeon error was to blame for her ailments. The defense in this case also argued more forcefully that the Pinnacle had been “ thoroughly tested” and “closely monitored” for design defects and the company properly marketed the devices.
The jury in this bellwether case seemed to react to the defense’s argument that surgeon error was the cause of Herlihy-Paoli’s injuries. Arguing that the incompetence of orthopedic surgeons is to blame in over 6,200 cases will be a difficult strategy to maintain. It also blatantly ignores how metal-on-metal hip implants like the Pinnacle have been part of the greatest medical device failure in history. I have been representing victims who received theses dangerous devices since the earliest reports of failure began to surface, and from the beginning several facts have remained constant.
Patients who chose metal-on-metal implants did so because manufacturers had promised the new devices would be safer, last longer and allow for improved quality of life. What they got instead was exposure to metal poisoning, device failure, painful revisions, and life threatening complications. Patient’s health and safety had succumbed to lax oversight, outright negligence and the drive for corporate profits.
These metal-on-metal hip joints represent the greatest medical device failure in history. Aside from the Pinnacle and ASR, metallosis and premature failure have exposed other manufactures of metal-on-metal hip joints. Biomet, Zimmer, Stryker, Smith & Nephew, and Wright, are facing suits over metal-on-metal implants.
The largest manufacturer of metal-on-metal hip implants was DePuy Orthopedics, a division of Johnson & Johnson. They produced the Pinnacle and ASR hip replacement systems. In 2010 Johnson & Johnson recalled 93,000 of the ASR implants worldwide and the company faced thousands of lawsuits over the failure of the device. It was revealed in internal J&J documents that 37 percent of ASR hips had failed after 4.6 years. In 2012, the failure rate in Australia was 44 percent within seven years.
In a landmark settlement last year, J&J set aside $2.5 billion to settle 8,000 ASR cases in the U.S., and the eventual total cost of the settlement is predicted to be as high as $4 billion.
The Pinnacle line of hips wasn’t covered in the ASR settlement even though the Pinnacle hip was used as the basis in the design of the failed ASR implants.In 2005 DePuy’s parent company, Johnson & Johnson had helped obtain “fast track” 510k approval for the ASR by maintaining that both metal-on-metal hips featured “substantially similar” designs.
In spite of Pinnacle patients experiencing the same painful symptoms as ASR recipients, the Pinnacle was never recalled. DePuy Orthopedics quietly stopped producing the replacement joint and cited decreased demand as the reason. They might have also been wary of a 2013 ruling by the FDA that would have require them to submit new versions of the Pinnacle for pre-market approval.
Since then thousands of lawsuits have been filed against Johnson & Johnson over the ASR and Pinnacle implants. While they agreed to settle in the ASR cases, Johnson & Johnson seems committed to a vigorous long-term defense in the Pinnacle cases. But, for patients who have been injured from pinnacle implants it is important to not get discouraged and remember several important facts relating to the Dallas trial:
– In the second ASR trial in 2013, a state jury in Illinois delivered a verdict in favor of DePuy. This was in contrast to every other individual ASR trial prior to the settlement – which all favored the plaintiffs. This was also the only trial in which the jury concluded the design of the ASR was safe. Juries in every other ASR trial concluded the implant was deeply flawed.
– Mirroring earlier ASR trials – during this bellwether trial the plaintiff’s attorney introduced evidence clearly showing DePuy executives were being told as early as 2008 of a case of extensive tissue damage caused by the Pinnacle hip. Under cross-examination of DePuy President Andrew Ekdahl, it was also shown that as early as 2010, doctors were warning DePuy executives that the Pinnacle was failing at exceptionally high rates – yet the company continued to aggressively market the replacement hip.
– In this trial Pamela Plouhar, DePuy’s Clinical Research Vice-President, admitted that there was “no human study that looked at” the health effects of metal debris for the Pinnacle hips before 2001. When plaintiff lawyers pointed out that as early as 1974 research began suggesting problems with metal-on-metal implants, the only response that Plouhar could offer was to insist that DePuy had followed “industry standards.”
– The cobalt and chromium poisoning in Kathleen Herlihy-Paoli were absolutely consistent with other cases caused by faulty metal-on-metal implants. The injuries and infections she had as a result of that metal poisoning were also consistent.
It is early in the process and I urge patience to those injured by this faulty implant and now seeking justice. There are more bellwether trials to come and ultimately I believe that Johnson & Johnson will have to answer to each and every patient they have harmed. The Pinnacle was a dangerous and defective product and lives have been ruined solely because the company insisted on placing profits above the health of their patients.
My firm is continuing to accept and file hip implant lawsuits against many different manufacturers.
Admitted to both the California State Bar and the Florida State Bar, Joseph Saunders has also practiced in the United States District Court and the United States Court of Appeals. His philosophy is to provide aggressive, quality representation and seek fair compensation for individuals and their families who have suffered injury or death at the hands of insurance companies, large corporations, medical providers or governmental entities.