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A detailed review of safety studies caused the U.S. Food and Drug Administration (FDA) to reject Johnson & Johnson’s sale of an artificial hip in the U.S., but it didn’t stop the company from marketing it in Europe, according to a recent article by the New York Times.

Although the ASR Hip Resurfacing System was rejected by the FDA, the company gained permission to market a variation of the device in the U.S., known as the DePuy ASR XL Acetabular Hip System, under the FDA’s controversial 510(k) fast-track approval process, which only requires the device to be substantially equivalent to one that has been approved.

The agency sent the healthcare giant a confidential letter informing them that studies and clinical data submitted for the purpose of approval in the U.S., was inadequate to determine its effectiveness and safety. But, the company continued marketing the device overseas without notifying regulatory agencies. Further, the company failed to address the non-approval letter in financial reports or presentations to analysts.

DePuy orthopedic division of Johnson & Johnson began phasing out both of the ASR hip replacement systems in August of 2010, after data from the National Joint Registry of England and Wales suggested that the five-year failure rate linked to these devices was 13 percent (about 1 in 8 patients). At the time of the recall, more than 93,000 of the two hip systems had been implanted in people worldwide.

The handling of the ASR highlights how the F.D.A., by keeping its approval process confidential, may affect the health and safety of patients.

Since that time thousands of lawsuits have been filed against Johnson & Johnson in both state and federal courts throughout the United States by individuals who have experienced problems.

A spokeswoman for DePuy confirmed that the company had received the agency’s so-called non-approval letter. But, they declined to release the letter or to respond to questions.

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