Johnson & Johnson’s DePuy Orthopedics is once again the subject of scrutiny as new reports surface that the company marketed a metal hip implant to patients overseas, despite the fact that the FDA failed to grant approval for the device in the U.S.
According to a February 14th article published in The New York Times, the company had originally sought FDA approval for an artificial hip implant that used a metal cup and ball construction similar to its ASR hip device. In August 2009, FDA officials sent Johnson & Johnson a letter which stated that company studies and clinical data provided as part of the application process were insufficient to make an accurate assessment of the device’s safety and efficacy. The company was informed that additional clinical data would be necessary in order to pursue the application.
During this same period, concerns began to be raised worldwide regarding the company’s ASR metal hip implants after research studies indicated that the devices were potentially subject to premature failure. DePuy Orthopedics recalled the ASR hips in 2010 after the U.K. National Joint Registry presented data that suggested the devices had a failure rate of approximately 12 to 13%. Around this same time, the company withdrew its application for approval of the metal hip device that was being marketed overseas.
More recent statistics from researchers in the United Kingdom have suggested that as many as half of these devices will fail within 80 months of implantation. Earlier this month, the Medicines and Health products Regulatory Agency (MHRA) announced that it was launching an investigation into these devices after advisors to the agency alleged that the metal hips could be causing systemic toxicity in some patients. A new research paper is scheduled to be presented at the British Hip Society conference next month which suggests that defective metal hip implants may contribute to an increased risk of developing certain forms of cancer.
While Johnson & Johnson was not legally required to disclose the FDA’s decision as part of its overseas marketing strategy, its failure to do so may be considered questionable by some, particularly in light of the fact the company is currently facing several thousand lawsuits filed on behalf of patients who claim they were injured by one of these devices. It’s estimated that as many as 10,000 patients in the U.K and another 15,000 patients in the U.S. were affected by the DePuy hip recall. Reports of problems with these devices have also begun to surface in other European nations, including Denmark and the Czech Republic.
Patients who believe they are experiencing adverse side effects caused by a DePuy ASR hip are encouraged to speak with their doctor to determine whether additional surgery is necessary to correct the problems. Individuals who were injured by one of these devices are also urged to seek the advice of an experienced DePuy hip injury lawyer.
NadrichCohenLLP