One year after Johnson & Johnson pulled 93,000 metal hip implants from the market, the company internally estimated that 37 percent of the devices would fail within 4.6 years, according to newly unsealed court records.
J&J faces 10,000 lawsuits over its ASR hips, which it pulled in August 2010 after citing U.K. joint registry data showing that more than 12 percent failed within five years. The estimate of triple the failure rate publicly cited by J&J came in documents unsealed Jan. 18 in the lawsuit of Loren Kransky in state court in Los Angeles.
Jurors are scheduled to hear opening statements on Jan. 25 in Kransky’s case, the first to go to trial against J&J, the world’s biggest seller of health-care products. J&J offered to pay more than $200,000 a case to settle most of the 10,000 lawsuits, according to five people familiar with the matter. The deal’s cost could exceed $2 billion if most plaintiffs accept the terms. Lawyers for hip recipients have so far rejected the offer, the people said.
The failure-rate estimate came in pretrial testimony of Paul Voorhorst, a biostatistician for J&J’s DePuy unit, which made the hips.
The J&J hips were made from a cobalt and chromium alloy used in two related models — the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revision, and 12 percent of the ASR Hip Resurfacing System failed.
In March 2011, the British Orthopaedic Association and the British Hip Society said preliminary data put the ASR XL’s failure rate in the U.K. as high as 49 percent after six years.
Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels. Patients who sued typically cite pain and say they are immobilized by joint dislocations, infections and bone fractures.
Claims by Kransky include failure to warn, negligent recall and manufacturing defect.