J&J Study Predicted 37% Hip-Failure Rate
One year after Johnson & Johnson (JNJ) 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.
urors 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. A plaintiff’s lawyer, Brian J. Devine, asked Voorhorst about a graph showing the company’s review of 554 implanted hips through September 2011, and how many would fail, requiring follow-up replacement surgery known as revisions.
“That means that 37 percent are expected to fail at 4.57 years, correct?” Devine asked Voorhorst.
“The estimated revision rate at that time would be 37 percent,” Voorhorst said. “That’s correct.”
