DePuy Pinnacle Hip Bellwether Trials to Proceed Before Jury

A federal judge has blocked several last ditch efforts by DePuy Orthopaedics attorneys to stop a lawsuit over the Pinnacle hip replacement system from proceeding to trial next month. 

Three rulings were issued last month by U.S. District Judge Ed Kinkeade, who is presiding over the coordinated pretrial proceedings for thousands of DePuy Pinnacle hip lawsuits in the federal court system, rejecting motions by the manufacturer that sought to dismiss lawsuits filed by Kathleen Herlihy-Paoli and Toni M. Lay, which are scheduled for trial to begin on September 1.

The Herlihy-Paoli and Lay cases were selected as the first bellwether trials in the litigation, which are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout a large number of cases.

DePuy currently faces more than 6,500 hip replacement lawsuits over the Pinnacle implant in the federal court system, which are all centralized before Judge Kinkeade in the Northern District of Texas as part of an MDL, or multidistrict litigation.

All of the cases involve similar allegations that the Depuy Pinnacle metal-on-metal hip replacement system was defectively designed, indicating that the cobalt and chromium implants can shed metal debris into the body, causing metal blood poisoning, or metallosis, tumors, tissue death and eventually catastrophic hip implant failure.

After denying motion to exclude plaintiffs’ expert testimony (PDF), motion to quash plantiffs’ notices for deposition of two orthopedic surgeons (PDF) and motion to dismiss (PDF), the cases have been cleared to proceed before a jury.

Motions Found To Be Without Merit

In one of the motions, the DePuy attempted to declare expert witnesses designed by the plaintiff as unqualified to testify regarding the Pinnacle hip. The company argued that Dr. John Abramson is a family doctor who should not be permitted to provide expert witness testimony in the Pinnacle litigation. However, Judge Kinkeade noted in his analysis and rejection of the motion that the defense was significantly downplaying Dr. Abramson’s qualifications, and that he was testifying specifically on claims of deceptive marketing by DePuy over the safety and efficacy of the Pinnacle hip.

“In 1997, he was appointed a clinical instructor at Harvard Medical School, and in 2009, he was appointed lecturer in Harvard’s Department of Health Care Policy. While at Harvard, he taught and lectured extensively on the challenge to clinicians in trying to make informed decisions about parmacotherapy care and how to interpret and integrate medical literature and data into a risk/benefit analysis in choosing appropriate treatments for patients,” Judge Kinkeade pointed out. “He has written extensively about the integrity of information that doctors rely upon in making clinical decisions. In 2002 he left his clinical practice to conduct full-time research in this area and has written a book on this issue.”

Judge Kineade declared that Abramson was “more than qualified” to testify as an expert witness. He ruled the same way on a list of other expert witnesses DePuy’s attorneys objected against.

“DePuy has made no credible argument that any of the Plaintiffs’ expert testimony is being offered by unqualified experts or is unreliable or irrelevant,” the judge ruled.

The motion for summary judgment claimed that the plaintiffs did not have sufficient evidence to make a reasonable case. Judge Kinkeade rejected that as well, finding that a reasonable jury could return a verdict for the plaintiffs.

DePuy Metal-on-Metal Hip Problems

The metal-on-metal configuration of the DePuy Pinnacle hip was used as the basis for the approval of the controversial DePuy ASR hip implant in 2005, with the Johnson & Johnson subsidiary obtaining “fast track” 510k approval by maintaining that the DePuy ASR and DePuy Pinnacle metal-on-metal hips feature “substantially similar” designs.

A DePuy ASR recall was issued in August 2010, after the manufacturer acknowledged that the implant carried a higher-than-expected rate of failures. Johnson & Johnson recently agreed to pay more than $2.4 billion to settle DePuy ASR lawsuits filed on behalf of about 12,000 people who received the implants.

DePuy has already begun dispensing payments for ASR hip settlements, and some reports indicate they have paid out $250 million to plaintiffs so far. However, the manufacturer has indicated that it intends to defend against the lawsuits over DePuy Pinnacle hips.

Other manufacturers of metal-on-metal implants face similar allegations that they failed to adequately research the design or warn about the risk of problems. Additional MDLs have been established in the federal court system for Biomet M2A Magnum metal hip lawsuits and Wright Medical Conserve Cup metal hip lawsuits.

In January 2013, the FDA released new guidance for metal-on-metal hip replacements, indicating that doctors should only use the design if other artificial hip implants are not appropriate. The agency also determined that future metal-on-metal hip designs will be required to undergo extensive human clinical trials before they will be approved.