A once promising technology, metal-on-metal hip replacements were marketed as more durable than previous hip implant models. DePuy’s Articular Surface Replacement (ASR) hip systems were among the most popular metal-on-metal implants in the 2000s, but the devices weren’t as safe as advertised.
Recipients of ASR XL Acetabular and ASR Hip Resurfacing implants experienced severe complications that led to revision surgeries a decade earlier than advertised. DePuy eventually issued a worldwide recall of the ASR hip implants, but thousands of people hurt by the defective devices claimed the company failed to warn them of the risks.
Nearly 10,000 people have sued DePuy for damages related to ASR hip implants, and the company has agreed to a $4-billion settlement to resolve a large portion of the legal claims.
However, DePuy still faces more than 8,000 lawsuits involving its metal-on-metal Pinnacle hip replacements. DePuy continued to sell Pinnacle implants for almost three years after recalling the ASR implants. Patients who received Pinnacle implants also experienced unexpected side effects and sought compensation for the damages in court.
- Failure to warn
- Gross negligence and malice
- Willfully concealing the problems of the implant from the general public
Plaintiffs allege that both devices were defectively designed and that DePuy failed to provide adequate warning of safety risks. Studies have found that metal-on-metal hip systems have high failure rates that can lead to metallosis, infection, dislocation and immobility. Some plaintiffs claim that DePuy knew the hip implants were unsafe.
ASR Hip Implant Litigation
Thousands of lawsuits involving ASR hip implants were consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Ohio under Judge David A. Katz. Multidistrict litigation courts handle cases against similar defendants that involve similar facts.
A total of 9,939 lawsuits involving the DePuy hip implant were filed against DePuy in the Ohio MDL, and 1,480 were still pending in February 2016.
The first bellwether trials in the ASR MDL were scheduled to begin in 2013, but several cases were settled before the trials began. In March 2013, the first ASR lawsuit went before a jury in a lawsuit filed in the state of California.
Early Jury Verdicts
Loren Kransky was the first plaintiff who received an ASR hip replacement to see a jury. After a five-week trial in California, Los Angeles jurors ruled in favor of the plaintiff. The jury said the ASR system was defective in design and awarded Kransky $338,000 for medical expenses and $8 million for pain and suffering.
During the trial, lawyers revealed an internal Johnson & Johnson memo that estimated that 40 percent of patients who received an ASR implant would need a revision surgery within five years. Other court documents showed that Johnson & Johnson executives knew that the design of the hip implant was flawed and surgeons had warned the company to stop selling the product.
Hip replacement lawyers also presented evidence that Johnson & Johnson had thought about redesigning the hip system but decided to discontinue the implants because they were not making enough money.
About a month later, DePuy won a lawsuit filed by a Chicago woman who claimed that she was harmed by an ASR implant. Carol Strum received an ASR hip replacement in 2008 and had to have a revision surgery three years later.
In the lawsuit, defense lawyers argued that Strum received no pain relief after a revision surgery, indicating that she was overly sensitive to hip implants and that the ASR implant wasn’t defectively designed.
Major ASR Hip Replacement Settlements
In August 2013, Johnson & Johnson settled the claims of three Nevada women who received ASR implants from the same surgeon. Each case was settled for $200,000. Weeks later, Johnson & Johnson agreed to settle more than 7,000 lawsuits that claimed the ASR implants were defective.
The details of the agreement became public in November 2013. Johnson & Johnson set aside about $4 billion to settle about 8,000 claims. The settlement included plaintiffs who had revision surgery prior to August 31, 2013, according to court documents.
In March 2015, DePuy agreed to an additional settlement of $420 million to settle about 1,800 claims that weren’t covered under the previous settlement. The agreement compensated patients who had revision surgery between August 31, 2013 and January 31, 2015. The deadline to participate in the settlement was May 1, 2015.
Pinnacle Hip Lawsuits
DePuy continued to sell metal-on-metal hip replacement components in its Pinnacle system of products for more than two years after it recalled the ASR models. Patients complained that Pinnacle hip implants caused complications, such as metallosis and infections, that required revision surgeries, but DePuy never recalled the device.
The company discontinued the Pinnacle’s metal-on-metal components in 2013, but thousands of patients received the implant before then. A total of 8,896 lawsuits claiming the Pinnacle was a faulty product were consolidated in an MDL in the U.S. District Court for the Northern District of Texas under Judge Ed Kinkeade. As of February 2016, more than 8,500 cases were still pending.
DePuy Wins First Bellwether Trial
The first federal bellwether trials for Pinnacle claims began in September 2014. In the first case to go to trial, Kathleen Herlihy-Paoli claimed that medical debris from her all-metal hip implants forced her to have a revision surgery in 2011, two years after she received the hip replacements.
Blood tests indicated that Herlihy-Paoli’s blood had 85 times the normal level of cobalt. The plaintiff claimed that DePuy misrepresented the benefits of the hip replacements and failed to warn her of the risks.
DePuy claimed the implants were improperly implanted, and the devices weren’t to blame for the plaintiff’s problems. The jury sided with DePuy, finding the company was not at fault.
Verdicts in Favor of Pinnacle Patients
In the second bellwether trial, a jury awarded $502 million to a group of five patients who claimed their Pinnacle implants injured them. The case began in January 2016 and lasted two months. Judge Kinkeade had ruled that the five cases had enough in common that they could be consolidated into a single trial.
The plaintiffs each received Pinnacle Ultamet hip replacements that had to be surgically removed because they caused metal poisoning. The plaintiffs argued that Johnson & Johnson and DePuy knew of the faults in designs. The jurors agreed, awarding $142 million in actual damages and $360 million in punitive damages.
In December 2016, a Texas jury awarded $1 billion to six plaintiffs who said metal debris from the implants leeched into their blood and tissues and caused complications. The jury sided with plaintiffs who claimed that DePuy knew about the risks of its faulty Pinnacle implants but failed to warn the public.
The award included $30 million in compensation for plaintiffs and $1.04 billion in punitive damages which are awarded to discourage defendants from future misdeeds.
A fourth bellwether trial is underway in federal court in Dallas. MDL Judge Ed Kinkeade is presiding. On Oct. 16, Kinkeade ordered a criminal investigation into allegations of witness tampering, according to Reuters.
In an affidavit, orthopedic surgeon David Shein said a DePuy sales representative warned him about the “ramifications” for his medical practice in connection with his trial testimony, according to Texas Lawyer.
The trial involves more than 9,000 cases.
Chris Elkins is a writer and researcher for Drugwatch.com. He’s worked for various newspapers and has writing experience in sports, health communication and public relations fields. He graduated from the University of West Florida with a master’s degree in Strategic Communication and Leadership, a graduate-level certificate in Health Communication Leadership and a bachelor’s degree in Journalism.