On November 13th, a U.S. District Court, Northern District of Texas federal jury began deliberating in the multiplaintiff DePuy Pinnacle hip bellwether trial after nine weeks of testimony (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 trial involves six consolidated hip replacement lawsuits filed on behalf of New York plaintiffs who allegedly suffered serious complications related to the premature failure of their Pinnacle device. During opening statements, the plaintiffs’ attorney asserted that DePuy and its parent company, Johnson & Johnson, brought the all-metal Pinnacle hip to market even though they knew the device was defectively manufactured. The attorney also argued that the defendants’ internal emails, a study commissioned by Johnson & Johnson, and marketing materials would prove that they had had employed deceptive means to induce surgeons to use metal-on-metal hip implants. DePuy has recently called upon Judge Kinkeade to declare a mistrial, alleging that plaintiffs had prejudiced the jury by making inappropriate references to other hip implant litigation.
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.
Johnson & Johnson 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 Orthopaedics and Johnson & Johnson appealed the decision and the plaintiffs filed their brief in response.
2197 IN RE: DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability
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.