Pharmaceutical giant Johnson & Johnson will pay more than $4 billion to resolve thousands of lawsuits from its recalled metal-on-metal hip implants.
Court approval is needed in this tentative plan representing one of the largest payouts for product liability claims involving a medical device.
This settlement will resolve more than 7,500 lawsuits in federal and state courts against J&J’s DePuy unit, said people requesting anonymity because they were not authorized to speak publicly about the settlement. Patients who have had hips replaced claimed in the cases that the implants were defective.
A J&J spokeswoman for the company’s DePuy Orthopaedics unit declined to comment on the possibility of a settlement. A settlement is expected to be announced next week in federal court in Toledo, Ohio.
The agreement will include the patients who have already been forced to have the device, the Articular Surface Replacement (ASR), removed and replaced with another artificial hip.
According to the proposed deal, each patient would receive about $350,000 in average compensation, although this figure will vary depending on patient’s age and medical condition.
The exact value of the settlement is not clear since lawyers for patients are estimating how many of the 12,000 lawsuits involve patients who had a replacement. It is believed that number may be 7,000 to 8,000 cases. Under the plan, patients who have not had a replacement would not receive compensation.
DePuy sold the ASR hip in 2010 and shortly after recalled by DePuy following reports of rising failure rates early on. The device had a metal ball and a metal cup and shedding metallic pieces into the body as it wears which caused damage tissue in many patients, pain and in some patients, caused crippling injuries.
DePuy has claimed that they acted appropriately in recalling the device when they did. However, it was disclosed during the trial that internal documents of a patient lawsuit this year showed that DePuy officials were long aware that hip had a flawed design and was failing prematurely at a rapid rate.
Many artificial hips last about 15 years before they wear out and need to be replaced. By 2008, data from orthopedic databases outside the U.S. also showed that the ASR was failing at high rates in patients after just a few years.
Internal DePuy projections estimate that the device will fail in 40 percent of those patients in five years, a rate of eight times higher than for many other hip devices.
For a long time it had been anticipated that DePuy would try to settle the case. Of the two lawsuits that have gone to trial, the company lost one lawsuit and won the other one.
However, it was facing the start of several new trials around the country with the prospect of large damage awards. The agreement “resolves a lot of litigation that could have dragged on for years and cost J&J much more money in the long run,” said Carl Tobias, who teaches product liability law at the University of Richmond in Virginia.
DePuy hip was first sold in 2003 inside the U.S. for use in an alternative hip replacement procedure called resurfacing. In 2005, DePuy starting selling another version in the U.S. for use in standard hip replacements using the same cup component as the resurfacing device. Only the standard version was sold in the U.S.; both were sold outside the U.S.
About 93,000 patients received an ASR, approximately one-third of them in the U.S.
The first design problems came to light in Australia and England only a few years after the device’s marketing began. But for years DePuy officials insisisted to the surgeons who complained about the device that patient problems were due to their surgical technique rather than the implant’s design.
It was last year that we reported to you that The New York Times stated that DePuy executives decided in 2009 to phase out the ASR and sell existing inventories weeks after the U.S. Food and Drug Administration (FDA) asked the company for more safety data regarding the implant.
The FDA also told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the U.S. due to concerns about “high concentration of metal ions” in the blood of patients who received it.
DePuy never disclosed the FDA ruling to regulators in other countries, where the resurfacing version of the implant was still being marketed.
It was reported that Andrew Ekdahl, head of DePuy’s orthopedic unit, oversaw the introduction of the hip and was warned by a company consultant in 2008 that the implant appeared to have a design flaw, according to internal DePuy documents disclosed during a trial earlier this year.
In 2010 when DePuy recalled the hip, it announced a program offering to pay the medical costs of a replacement procedure.
If this settlement is approved, it would resolve much of the litigation against DePuy involving the device, but still continues to face thousands of lawsuits involving the Pinnacle, another all-metal hip it no longer sells.
This settlement will be the second multibillion-dollar agreement this month for J&J, the world’s largest seller of health-care products. As we reported to you last week, New Brunswick, New Jersey-based J&J agreed on November 4 to pay $2.2 billion to resolve criminal and civil probes into the marketing of Risperdal and other medicines they sold off-label.
For more information regarding DePuy hip implants, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).