J&J Pinnacle Hip Implant Trial Underway
By Jof Enriquez,
Follow me on Twitter @jofenriq
The first trial over Johnson & Johnson’s Pinnacle hip implants alleged to have caused blood poisoning went underway in Dallas, and the outcome could greatly impact the other 6,000 or so cases filed against J&J.
Plaintiff Kathleen Herlihy-Paoli alleges that the artificial hips’ faulty design caused her to suffer pain shortly after they were implanted in 2009, and lab tests showed that she had alarmingly high levels of cobalt and chromium in her bloodstream from the metal-on-metal device, according to court filings obtained by Bloomberg. She had the two implants removed in 2011.
Herlihy-Paoli’s attorney Mark Lanier told jurors that J&J in 2001 ignored a specialist, Dr. Thomas Schmalzried, who said that metal ions could leach from the device, Bloomberg said in a follow-up report.
J&J subsidiary DePuy started selling Pinnacle products in 2005, but it announced in May 2013 that it would end sales of Pinnacle and other metal-on-metal hip replacements after an alert was issued by the FDA that this type of implant could fail more often than other types, according to Digital Journal. J&J and DePuy at that time denied that the decision to halt sales was based on safety concerns.
In his opening statement in court, Lanier showed jurors internal company documents dating from 2012 that showed that the Pinnacle artificial hips had a 15 percent failure after five years of use, yet J&J proceeded to engage in “marketing run amok” by telling doctors that the medical devices worked “99.9 percent of the time,” despite evidence to the contrary.
“They didn’t tell people they were basically guinea pigs,” Lanier told jurors, according to a separate Bloomberg report.
Under questioning, former DePuy president Andrew Ekdahl said that the company had issued risks and warnings associated with the product via a written brochure to doctors. He added that it was “common knowledge” among orthopedic surgeons that metal ions from metal-on-metal hip implants could leach into patients’ blood streams, Bloomberg reported.
In a statement, J&J’s lawyer Richard Sarver said that Herlihy-Paoli’s problems stemmed from the positioning of her hips, and not from design flaws of the implants, according to Claims Journal. Company officials assert in a statement that the devices were “thoroughly tested” and “closely monitored” for defects before they were marketed.
The 6,000 cases filed against J&J were consolidated earlier before U.S. District Judge Ed Kinkeade, who is also presiding over the Herlihy-Paoli trial.
According to HarrisMartin, Judge Kinkeade has “denied plaintiff efforts to bifurcate the issue of the amount of punitive damages, should jurors decide they’re warranted.” The defendants had earlier fought the motion because the plaintiffs “failed to identify a single concrete reason why bifurcation is appropriate in these cases.”
The consolidated Pinnacle cases are separate from the 8,000 suits that involved J&J’s ASR metal-on-metal hip replacements, which the company agreed to settle in November 2013 for $2.5 billion.
“The first trials in any of these consolidated litigations set the tone for the following cases,” Carl Tobias, a teacher of product liability law at the University of Richmond, told Bloomberg. “If J&J loses the first couple of these Pinnacle trials, they better start seriously thinking about coming up with a settlement similar to what they signed off on for the ASR hips.”