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2244 IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation
Northern District of Texas (Hon. James Edgar Kinkeade)
Still on appeal is the $247 million verdict awarded against the manufacturer of DePuy’s Pinnacle line of metal-on-metal hip implants, DePuy Orthopaedics Inc., and its parent company Johnson & Johnson (J&J), with $90 million in punitive damages against J&J and $78 million in punitive damages against DePuy. The appeal was argued on December 6, 2017.
This verdict is the third, consecutive multi-million dollar delivered against J&J in this multidistrict litigation (In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, MDL Docket No. 11-md-02244, Ramon Alicea, et al. v. DePuy Orthopaedics., Inc., et al., No. 15-03489, Uriel Barzel v. DePuy Orthopaedics, Inc., et al., No. 16-1245, Karen Kirschner v. DePuy Orthopaedics, Inc., et al., No. 16-1526, Hazel Miura v. DePuy Orthopaedics, Inc., et al., No. 13-4119, Michael A. Stevens v. DePuy Orthopaedics, Inc., et al., No. 14-1776, Eugene Stevens Jr. v. DePuy Orthopaedics, et al., No. 14-2341, N.D. Texas).
The jury unanimously found J&J and DePuy liable for a series of design and manufacturing defects, fraud and deceptive business practices. Further, they found both defendants acted with wanton, reckless or malicious conduct. More than $77 million was awarded for past and future medical expenses and pain and suffering to the six individual plaintiffs, each of whom is from New York. Additionally, the jury awarded four of the plaintiffs’ spouses damages for loss of consortium, totaling $1.7 million. The trial took two months, and is the fourth bellwether case in multidistrict litigation that includes more than 9,000 cases, all alleging design defects in DePuy’s Pinnacle Ultamet line of metal-on-metal hip implants.
The jurors heard the six plaintiffs tell of their suffering resulting from a range of injuries, including severe tissue damage that caused permanent muscle loss, intense pain, loss of hip movement and walking with a permanent limp. All six plaintiffs claimed that the Pinnacle product shed microscopic metal ions into their bodies, a phenomenon known as metallosis. Plaintiffs claimed the companies falsely promoted the device, most commonly used to treat joint failure caused by osteoarthritis, by saying it lasted longer than similar implants that include ceramic or plastic materials.
Specifically, the jury found J&J and DePuy liable for design defect, negligent design, inadequate warning, manufacturing defect, negligent manufacture, negligent misrepresentation, intentional misrepresentation to the surgeons who performed the initial hip implant surgeries on the plaintiffs, fraudulent concealment from the plaintiffs and from the surgeons and deceptive business practices as to the plaintiffs and the surgeons. Additionally, J&J was found liable for negligent undertaking of a duty to provide services to DePuy and for aiding and abetting DePuy in its tortious conduct. The jury did not find J&J or DePuy liable for intentional misrepresentation to the plaintiffs.
Previous Bellwether Trials
A bellwether trial is a preliminary, or “test” trial ordered by the federal court overseeing an MDL. These trials test jury reaction to a case or cases selected as representative of the MDL plaintiff pool. The outcome of an MDL’s bellwether trials may encourage an appropriate group settlement of all cases consolidated under that MDL, as large plaintiff verdicts may prompt defendants to consider settlement instead of incurring the risk of additional legal fees, court costs and judgments.
On December 1, 2016, in the third set of bellwether trials, a Texas federal jury awarded $40 million in compensatory damages and more than $1 billion in punitive damages to six plaintiffs who alleged that DePuy Orthopaedics Inc.’s Pinnacle metal-on-metal hip implants were defectively designed and that the company failed to warn doctors and consumers about complications possible from the device, which included pain and subsequent revision surgeries.
J&J prevailed in the first bellwether trial in 2014, and the second bellwether trial in March 2016 yielded a $500 million jury award to five plaintiffs. The court ordered that $140 million would be applied to collective compensatory damages with $360 million being awarded in punitive damages. After the trial, Judge Kinkeade reduced the $360,000,000 punitive damages award to $9,646,256 pursuant to a Texas statute capping punitive damages.
DePuy Reported to Know of Risk
As reported in our blog post, DePuy Knew of Metal-on-Metal Hip Implant Safety Risks, a senior engineer working for DePuy reported in 1995 that metal-on-metal constructions were “unpredictable” and parts prone to “catastrophic breakdown” five years before DePuy’s hips began to be implanted. Thousands of patients were later fitted with the implants, which experts say can deposit toxic ions into the bloodstream as they wear, known as metallosis, and were forced to undergo painful revision surgeries.
Dr. Graham Isaac, a senior engineer based in DePuy’s Yorkshire, UK factory, and now a “distinguished engineering fellow” at DePuy, warned in a 1995 report that testing showed metal implants were “working well for a period of time” before wearing down, prompting the “release of a large volume” of debris. In his 1995 memo, Dr. Isaac examined data on metal-on-metal hips produced by rival companies:
It is clear from the literature the survivorship of cobalt chromium [the materials used in metal implants], metal-on-metal prostheses in the past have been far from satisfactory. Manufacturing methods have improved. However, simulator testing of such components suggests their performance is as unpredictable as ever, working well for a period of time before suffering a sudden catastrophic breakdown of the bearing surface accompanied by a release of a large volume of wear debris.”
He also quoted an expert warning that the combination of metal with metal was “likely to give rise to toxic levels of metal under clinical conditions”.
Further, a 2010 e-mail from John Irving, a U.S. orthopaedic surgeon, forwarded internally to DePuy’s president, insisting that “it borders on unethical to continue to market” the Pinnacle type of metal-on-metal hips “until the issues are elucidated”. He accused the firm of a “head-in-the-sand response to this problem” and warned that “the products are harming patients” – three years before the implant was eventually discontinued.
DePuy ceased selling the metal-on-metal Pinnacle devices in 2013 after the U.S. Food and Drug Administration strengthened its artificial hip regulations.
2197 IN RE: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation
Northern District of Ohio (Hon. Jeffrey J. Helmick)
The MDL is still pending notwithstanding settlement whereby DePuy agreed to pay $2.5 billion to settle approximately 8,000 lawsuits by United States patients who had hip revision surgery as of August 31, 2013. The Third Settlement was extended to cover patients implanted with the Depuy ASR hip who received a revision surgery between January 31, 2015 and February 15, 2017.
In August 2010, Johnson & Johnson subsidiary, DePuy Orthopaedics, recalled all ASR Hip Resurfacing System and ASR XL Acetabular System devices sold since 2003. DePuy said the recall was due to unpublished National Joint Registry data showing a 12% revision rate for resurfacing at five years and an ASR XL revision rate of 13%. All hip prostheses fail in some patients, but the normal anticipated rate is about 1% per year. The FDA approved the Depuy ASR artificial hip for sale in 2005 by means of the 510(k) process. The FDA did not require the Depuy ASR hip to undergo clinical trials. Rather, Depuy submitted a section 510(k) premarket notification of intent to market the Depuy ASR Hip. By representing to the FDA that the Depuy ASR hip’s design was “substantially equivalent” to other hip products on the market, Depuy was able to avoid the important safety review required for premarket approval under FDA regulation, including vital clinical trials.
Metal debris from wear of the ASR hip implant built up over time, eventually causing a dangerous form of metal poisoning known as metallosis, which destroyed the soft tissues surrounding their joints, leaving some patients with long-term disability. Some patients also experienced severe pain and swelling at the implant site, as well as grinding, popping, and clicking noises when they walked. Ions of cobalt and chromium — the metals from which the hip implant was made — were also released into the blood and cerebral spinal fluid in some patients. Many patients have been required to undergo a second, and more painful, invasive and extensive revision or reconstructive surgery to remove the bad implant, and repair or rebuild the bone before installing a new implant, which subjects the patients to unnecessary surgical risks.
#DePuy #JNJ #pinnacle #hip #implant #recall #lawsuit #productliability
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