UPDATE: Withdrawn hip PMA was "purely a business decision," says J&J

February 16, 2012 by MassDevice staff

Johnson & Johnson responds to the latest ballyhoo over sales of its recalled metal-on-metal hip resurfacing implants, which were sold overseas for a year after being rejected for sale on the U.S. market.

Hip X-ray

Johnson & Johnson's (NYSE:JNJ) metal-on-metal hip resurfacing implants stayed on the market in Europe and other countries after they were rejected for sale on the U.S. market, according to a report from the New York Times.

The implants were sold to patients overseas for 1 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.

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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 in 2003. The company submitted results of clinical tests for the ASR resurfacing device in 2007, and the FDA rejected the application in August 2009. J&J withdrew its application.

"At the same time that the company received this FDA letter, market demand for hip resurfacing was declining rapidly," J&J spokeswoman Jessica Masuga told MassDevice in an email. "In weighing the significant resources that would be required to produce the new clinical data-set requested by FDA against the declining market interest in resurfacing, DePuy decided to withdraw the PMA.  This was purely a business decision."