Johnson & Johnson’s (NYSE:JNJ) metal-on-metal hip implants stayed on the market in Europe and other countries after they were rejected for the U.S. market, according to a report from the New York Times.
The implants were sold to patients overseas for a year after they were prohibited for U.S. patients, until they were recalled in August 2010 amid concerns about high failure rates.
The devices were cleared by European regulators, whose standards are generally less stringent than those set by the FDA, but J&J was not required to disclose the FDA’s rejection letter to doctors, patients or regulators outside the U.S.
While perfectly within legal bounds, J&J’s decision not to reveal the FDA’s concerns may pose a problem for the company’s reputation and for ongoing lawsuits, FDA law specialist William Vodra told the Times.
J&J subsidiary DePuy Orthopedics began selling the articular surface replacement implants overseas in 2003. The company submitted results of clinical tests for the ASR device in 2007, and the FDA rejected the application in August 2009.
The FDA’s rejection letter is a confidential notice and hasn’t yet been made public.
DePuy announced plans to phase out its ASR implants amid declining sales in November 2009. Four months later, in March 2010, the company issued an alert.
DePuy also issued an alert about a related device, the ASR cup, which had gotten an FDA green light in 2005 as part of a standard hip implant. Both devices relied on an all-metal socket cup that some experts have said was poorly designed.
In August 2010, DePuy recalled both the ASR resurfacing implant and the related ASR cup due to a high rate of revision surgeries required to correct or remove defective implants.
The pair of devices were used on about 93,000 patients worldwide, according to the newspaper.
That could add up to a big nut for J&J to swallow, based on the experience of Sulzer Medica AG in 2001. That Swiss medical device maker’s recall of a hip implant, placed in about 31,000 patients, settled in 2002 for $1 billion (about 2,760 patients had revision surgeries attributed to that recall, according to Reuters). The DePuy ASR recall is three times the size of the Sulzer pullback.
Johnson & Johnson did not return requests for comment.