UPDATE: Withdrawn hip PMA was “purely a business decision,” says J&J

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.

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."

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 the 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 the defective implants.

"DePuy issued a voluntary recall of the ASR hip system after receiving new information from the UK National Joint Registry as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System," Masuga told us. "This data showed a five-year revision rate of approximately 12% for the ASR hip resurfacing system and approximately 13% for the ASR XL acetabular system, which was not in line with data previously reported to DePuy."

The pair of implants were used on about 93,000 patients worldwide, the Times reported,

Lawsuits had already begun piling upgaining momentum after the recall announcement and consolidating into a multi-district case under an Ohio federal court judge by Dec. 2010. Some lawsuits allege that DePuy knew the devices were sub-par.

"Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need," Masuga told us. "DePuy is committed to working with patients and their health insurers to address medical costs directly associated with the recall. DePuy will also cover recall-related patient out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs."

Added to court costs, that could add up to a big nut for J&J to swallow, based on the experience of Sulzer Medica AG in 2001. The 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.

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