Issue: Defective metal hip implant
DePuy Fails to Take Responsibility for Implant Failures
From 2002 to 2012, DePuy Orthopaedics, a subsidiary of Johnson & Johnson (J&J), manufactured metal-on-metal hip implants sold under the brand name Pinnacle hip with a metal liner (called the Ultamet metal liner). In many patients, the metal-on-metal version of the Pinnacle hip implant has failed.
In May 2013, DePuy announced that it was taking all of its metal hip implants off the market. Earlier, in August 2010, J&J and DePuy recalled other DePuy metal hip implants, the ASR XL Acetabular and ASR Hip Resurfacing system, and a settlement program was created for patients with faulty ASR hip implants.
However, J&J and DePuy have not recalled the Pinnacle hip implant. The companies deny any legal or financial responsibility to patients who received Pinnacle metal implants and who have had had to undergo surgery to replace the defective artificial hip.
Common symptoms of a failing hip implant include:
- Pain in the groin, hip or leg;
- Swelling at or near the hip joint; or
- A limp or change in walking ability.
DePuy Pinnacle Hip Lawsuits
In complaints filed by Lieff Cabraser’s clients against J&J and DePuy, patients charge that the DePuy Pinnacle hip with the Ultramet metal liner suffers from design and manufacturing defects. These alleged defects cause excessive amounts of metallic particles, cobalt and chromium, to wear from the surface of the acetabular insert or from the implant’s femoral head.
As a result, microscopic shavings and metal debris are released into the tissue surrounding the patient’s artificial hip and into the bloodstream. This can lead to a condition called metallosis, or an excessive exposure to metal, which is characterized by a painful inflammatory reaction in the tissue and a high blood metal count. Ultimately, the hip implants fail and must be replaced (in a procedure called revision surgery).
The first trial against J&J and DePuy charging that the Pinnacle hip was a defective medical device commenced in September 2014.
On October 23, 2014, the jury returned a verdict for defendants. J&J had introduced evidence at the trial that the plaintiff’s implant had been improperly positioned, and thus the Pinnacle hip was not to blame for the plaintiff’s injuries.
Lieff Cabraser did not serve as the lawyers for the plaintiff in that trial. We continue to litigate Pinnacle hip injury cases against DePuy and J&J and to seek compensation for our clients’ injuries to the maximum amount allowed under the law.
Pinnacle Hip Injury Bellwether Trial Updates
November 2017 – Trial Ends with $247 Million Verdict for Injured Pinnacle Plaintiffs
On November 16, 2017, a jury in federal court in Texas reached a combined $247 million verdict for plaintiffs in a lawsuit against Johnson & Johnson and DePuy over injuries from the Pinnacle line of metal-on-metal hip implants. The result is the third consecutive hundred-million dollar plus verdict in the Pinnacle hip injury cases. As reported by Law360, “The unanimous jury found J&J and DePuy liable for a series of design and manufacturing defects, fraud and deceptive business practices, and found the companies had acted with wanton, reckless or malicious conduct. They awarded $90 million in punitive damages against J&J and $78 million in punitive damages against DePuy.”
An earlier bellwether trial of five Plaintiffs in the DePuy Pinnacle hip implant Multi-District Litigation began January 11, 2016 in federal court in Dallas before Judge Ed Kinkeade. (A bellwether trial is a case that the court and the parties select to test their arguments, with the goal of moving the overall larger litigation towards resolution.)
December 1, 2016 – Trial Ends with $1 Billion Verdict for Injured Plaintiffs
On December 1st, 2016, the jury found for the plaintiffs with a $1.04 billion verdict over injuries caused by dangerous and defective DePuy Pinnacle hip implants. You can read a detailed report on the verdict here.
The Court denied two Motions for Mistrial and 42 Rule 50 motions. The Court then read the 96-page Jury Charge with 33 questions related to the causes of actions and damage claims, including:
- Intentional Misrepresentation
- Fraudulent Concealment
- Compensatory Damages
- Punitive Damages
Each side had 90 minutes for closing arguments.
The defendants called Dr. Roger Emerson on causation issues and to discuss the historical development of hip implants. Dr. Emerson is a Yale- and Harvard-educated orthopedic surgeon who helped design Biomet products and received $8 million in royalties.
Thereafter, the parties rested their cases during this eleventh week of trial in Dallas. The closing arguments will take place Wednesday, November 30th.
The defense called Mary Beth Schmidt to testify. Ms. Schmidt is a simulator and wear testing expert with a Ph.D. in Biomedical Engineering. Ms. Schmidt was employed by J&J Professional Inc. for 5 years and also worked for a variety of other Johnson & Johnson subsidiaries.
Defense witness Dr. Patricia Campbell continued her testimony. Defendants then called Timothy Ulatowski, a regulatory expert who spent 37 years at the FDA.
Trial will be suspended next week for the Thanksgiving holiday. The trial is expected to conclude in the first half of December.
Tony Cutshall returned to the stand for cross-examination. Defendants called Dr. Patricia Campbell, an implant retrieval analysis expert.
On November 14, toxicology testimony concluded. On November 16, Defendants called Tony Cutshall, a DePuy employee of 27 years with an engineering background who was involved in development/compliance/medical affairs at the company.
During the week of November 7, Plaintiffs called a treating physician. Defendants called Dr. John Fisher, a Professor of Mechanical Engineering at the University of Leeds in England with a specialty in orthopedic tribology. Plaintiffs cross-examined Dr. Fisher.
On November 3, several plaintiffs and a treating doctor testified. Plaintiffs then rested their case, subject to taking witnesses out of turn. Defendants called Leanne Turner, B.S., a mechanical engineer and a 19-year DePuy employee who was involved in the development of the Pinnacle device. She currently is a device development team leader at the company.
On November 2, 2016, the Court issued an order setting the next bellwether trial for September 5, 2017. This trial will involve several plaintiffs from New York.
Pamela Plouhar’s examination by both sides concluded. Depositions of several of the Plaintiffs’ treating doctors were played via video. Plaintiffs called U.K. pathologist Dr. Nikos Athanasou, a medical doctor with a Ph.D. in cellular mechanism who teaches at Oxford and is a practicing pathologist. Defendants had no questions for Dr. Athanasou.
Plaintiffs continued their direct examination of Dr. Bernard Morrey, and then Dr. Pam Plouhar returned to the stand and concluded her testimony.
Examination of Dr. Tom Schmalzried by both sides continued via satellite transmission. Plaintiffs then called Dr. Bernard Morrey, an orthopedic surgeon with a Master’s degree in Biomechanics. Dr. Morrey is a Professor at the Mayo Clinic and Former Chair of their Orthopedic Department. He has expert knowledge regarding the performance of hip implants and the biological response to metal wear debris. He did not use metal on metal hips in his practice. He has also worked for NASA, and been a consultant to the NFL and the FDA.
Dr. Pam Plouhar, who was the DePuy V.P. for Clinical Research during times relevant to the litigation, was called adversely by the Plaintiffs to testify. Dr. Plouhar has a PhD in chemistry. Her testimony will continue later this week.
Dr. Antoni Nargol continued his testimony before the Court (see previous update below). It is anticipated that DePuy’s Vice-President for Clinical Research at times relevant to the litigation, Pam Plouhar, will begin testifying when the trial resumes Monday, October 17, 2016.
Dr. Antoni Nargol, an orthopedic surgeon who practices in England, was called to testify by plaintiffs. Dr. Nargol had been previously retained by DePuy to teach surgeons and participate in research about the ASR and Pinnacle hips, before sounding alarms about the products. Defendants had filed a brief seeking to exclude Dr. Nargol’s testimony. That request was denied by the Court.
Earlier, on October 11th, Andrew Ekdahl (Head of Marketing for DePuy during key periods relating to the litigation) returned to the stand as an adverse witness under cross-examination by plaintiffs.
Defendants again raised the argument to exclude the Deferred Prosecution Agreement (DPA) and the Foreign Corrupt Practices Act. Plaintiffs called Andrew Ekdahl to testify, Head of Marketing for DePuy during key periods relating to the litigation. Mr. Ekdahl was later promoted to World Wide President of DePuy; his current position is with Ethicon, a Johnson & Johnson subsidiary.
The ASR recall was then brought into evidence, followed by the Deferred Prosecution Agreement regarding the Federal Anti-Kickback Statute coming into evidence. Defendants made a motion for mistrial relating to the admission of the DPA evidence. Andrew Ekdahl remained on the witness stand the entire day. Court was adjourned until Tuesday 10/11, at which time Ekdahl will return to the stand.
Dr. Albert Burstein returned to the witness stand. The Court noted upcoming anticipated witnesses who will appear via remote satellite transmission: Plouhar on 10/13 from South Bend Indiana federal court; Schmalzaried on 10/18-10/19 from Los Angeles federal court; and McCormick on 10/24 from Minneapolis federal Court. The Court noted that the parties are operating under a time clock, with 75 hours per side. Dr. Burstein was cross examined, which testimony was followed by redirect and then re-cross examination.
The Court ruled on various Motions in Limine. Defendants moved for reconsideration of the satellite transmission; that motion was denied. Defendants also moved for reconsideration of the Court’s consolidation orders; that motion was also denied. Defendants again moved for a continuance, and that motion, too, was denied.
Opening statements were then presented, with each side having 90 minutes. The defendants moved for a mistrial, and that motion was denied. Then Plaintiffs’ expert Dr. Albert Burstein took the stand. Dr. Burstein is a biomechanical engineer with a focus on orthopedics — a hip implant design expert who has designed over 1,000 custom joints, and is a former professor at Cornell University and a former President of the American Society of Biomechanics. He has a Masters in Mechanical Engineering and a Ph.D. in Applied Mechanics, and is the former Editor of the Journal of Bone & Joint Surgery and an author of leading texts on Orthopedic Biomechanics. He has over 30 patents to his name.
The most recent Pinnacle Multi-District Litigation (MDL) bellwether trial began on September 26, 2016 before Judge Ed Kinkeade in the United States District Court for the Northern District of Texas.
There have previously been two Pinnacle MDL bellwether trials. The first trial resulted in a defense verdict in October 2014. The second trial consisted of five plaintiffs, and resulted in a $500 million plaintiffs’ verdict in March 2016. The Court has subsequently reduced that verdict to $151 million, based on Texas’s statutory damages limitations. DePuy is also appealing the recent plaintiffs’ verdict on various grounds, but the Fifth Circuit Court of Appeals declined to hear DePuy’s request to stay the upcoming bellwether trial during the appeal. Thus the next bellwether trial is proceeding despite DePuy’s ongoing appeal.
This newest bellwether trial consists of six plaintiffs from California. The jury selection process is taking place the week of September 26th, and the opening statements for the trial are set to begin on Monday, October 3, 2016. Each side will then have 70 hours to put on their case.
Per Texas law, U.S. District Court Judge Ed Kinkeade has reduced the $360 million punitive damages portion of the $496 million judgment against Johnson & Johnson’s DePuy Orthopaedics in five combined Pinnacle implant hip injury bellwether trials to keep it in line with the state’s $10 million limit on punitive damages. The reduction brings the total award in the case to approximately $150 million. The jury in the consolidated trial in Dallas had found the companies liable for serious health problems, including bone erosion and metal poisoning, that plaintiffs claimed were directly related to the metal-on-metal hip implants.
J&J and DePuy initiated a separate effort to stop further bellwether MDL trials relating to the approximately 8,000 additional Pinnacle hip injury cases, but Judge Kinkeade refused. The companies had previously agreed on the bellwether process, and “can’t grind the MDL to a halt now just because it lost one of the trials,” Judge Kinkeade said. “Only after losing the second bellwether trial did defendants object to the process,” the Judge continued. “There are more than 8,000 pending cases in this MDL; the court cannot grant a stay every time plaintiffs win a trial.” Judge Kinkeade further noted that pausing the claims would be unfair to everyone involved. The average plaintiff in the case is 68 years old this year, he said.
Jury in Second J&J DePuy Pinnacle Bellwether Trial Reaches $500 Million Verdict
In the second multidistrict bellwether trial over allegedly defective DePuy Pinnacle hip implants, a Texas jury awarded a $497.6 million in a verdict against Johnson & Johnson. The result for the five plaintiffs in the aggregate trial who sued over health problems from the metal hip implant devices included $360 million in punitive damages.
All the plaintiffs had received DePuy Pinnacle metal-on-metal hip implants and subsequently endured “serious health problems, including inflammation of surrounding tissues, bone erosion and metallosis.”
The parties have submitted their cases to the jury, and are now awaiting a jury verdict. For the past two months, Plaintiffs and Defendants have presented their cases at trial, calling various witnesses and experts to testify.
The experts that Plaintiffs called to testify included: Dr. Albert H. Burstein, Ph. D., a biomechanical engineer and hip implant design expert; Dr. Richard Kearns, a practicing orthopedic surgeon for over 35 years who performs 500 hip replacements per year; Dr. Nicholas Athanasou, a world renown orthopedic histopathologist and Professor of Musculosekletal Pathology at Oxford University; and Dr. Anthony Nargol, a non-retained Plaintiffs’ expert who is an orthopedic surgeon in the United Kingdom.
Various Plaintiffs and Plaintiffs’ relatives also testified, including Plaintiff Captain Robert Peterson, a retired Navy Seal who did four tours in Vietnam and received a Silver Star and Purple Heart; Plaintiff Don Greer, a 79 year old retired Board Certified Plastic Surgeon; and Plaintiff Greer’s son, Don Greer III, a former military combat pilot who received several bronze starts. Plaintiffs also cross-examined the key doctors who were involved in the design and sale of the Pinnacle Hip, including Dr. Thomas Schmalzried, who received over $20 million in royalties from DePuy, and who appeared only by video after refusing to attend trial in person.
Defendants called several doctors and surgeons to testify, including: Dr. Brian Haas, an Orthopedic surgeon who was a Primary Investigator for DePuy’s studies and received over $7.5 million in royalty/consulting payments; Dr. Scott Nelson, an orthopedic pathologist; Dr. Cato Laurencin, an orthopedic surgeon who was paid over $900,000 to testify; Dr. Edward Boyer, an emergency room doctor and medical toxicologist who received over $750,000 in compensation for this litigation. Defendants also called as a regulatory expert Timothy Ulatowski, a former Compliance Director at the FDA, and various members of the DePuy design team for the Pinnacle Hip, including Dr. William Griffin and Dr. Thomas Fehring.
Defendants filed several motions for mistrial throughout the trial, which the Court repeatedly denied. As of February 24th, there were 249 non-responsive objections sustained on Defendants’ witnesses or Plaintiffs’ adverse witnesses, while there were 10 such objections sustained on Plaintiffs’ witnesses. On March 10, the parties presented their closing arguments to the jury, and the Court once again denied Defendants’ mistrial motions. The jury is now deliberating.
The Pinnacle bellwether trials continued the week of January 19th with Plaintiffs continuing to present their case, including through testimony from one of the bellwether Plaintiffs and his family members; Dr. Tony Nargol, an orthopedic surgeon in the United Kingdom and a Plaintiffs’ expert; and Dr. Eric Matthew Heinrich, a defense expert and the surgeon for several Plaintiffs, who Plaintiffs called adversely.
Pretrial began the week of January 4th with the Court denying numerous pretrial motions by DePuy and Johnson & Johnson seeking to exclude evidence, including evidence of the recall of the DePuy ASR hip and of the Deferred Prosecution Agreement Johnson & Johnson entered into with the Department of Justice for kickbacks J&J’s subsidiaries paid to government officials abroad relating to medical devices. The Court also denied defense motions to split the trial. A nine-person jury was selected after the Court denied Defendants’ requests to shuffle the jury pool. The examination of witnesses and the presentation of evidence then commenced and continues to date. Plaintiffs have called several DePuy and Johnson & Johnson witnesses to testify thus far, including Andrew Ekdahl, the former World Wide President of DePuy who now serves as Company Group Chairman, and Dr. Pamela Plouhar, DePuy’s Vice President for Clinical Research during the relevant period.
Of note, the Court has ruled that Plaintiffs will be allowed to depose Johnson & Johnson’s current CEO, Alex Gorsky, on January 23rd. The Court has also denied several mistrial motions brought by Defendants to date. Finally, the Court has noted that it is considering setting the next set of DePuy Pinnacle cases for trial in the fall of 2016.