Johnson & Johnson in the hot seat again, as the U.S. Food and Drug Administration (FDA) just issued a warning to Johnson & Johnson’s DePuy Orthopaedics for marketing a number of unapproved medical device components.
The drug and device giant’s subsidiary sold more than a dozen different orthopedic devices without ever having received required regulatory approval, said the FDA in a just-released warning letter, wrote the Asbury Park Press. The letter also said that DePuy had a quality system in place that was not in compliance with FDA mandates.
The letter, from Steven D. Silverman, FDA’s director of the office of compliance, was sent December 8, 2011 and followed an inspection that took place May 10, 2011 – June 7, 2011 said the Asbury Park Press. In his letter, Silverman said that DePuy manufactured 14 devices, that never received pre-market clearance or approval from the agency.
The products included devices for ankle, knee, hip, shoulder, elbow and wrist replacements.
The letter threatened possible regulatory action, including seizure, injunction and financial penalties and gave DePuy 15 business days to correct the violations.
DePuy said it believes that the devices in question were custom-made, surgeon requested devices meant for use in individual patients and to match specific anatomical needs, which would make them exempt from the FDA’s approval process, noted the Asbury Park Press. Regardless, said the FDA, the devices did not meet agency criteria, partly because once the devices were completed, they could have been made available to other physicians.
“The fact that the final specifications are tailored to match a patient’s anatomy does not preclude a clinical study or submission of a marketing application for the devices,” Silverman wrote, The Asbury Park Press, reported.
DePuy spokeswoman Lorie Gawreluk said custom medical devices have been an allowed exemptions to premarket review since 1976.
“While DePuy believes it had complied with FDA requirements, the company has made the decision at this time not to provide custom devices,” Gawreluk said.
The FDA also cited the device maker for its failure to comply with quality regulations, including that it did not have sufficient procedures in place to ensure devices met users’ needs, that it did not have appropriate procedures in place for complaint review, and it did not ensure the employee handling nonconformance issues was notified when a product was not in conformance, said the FDA, according to The Asbury Park Press.
Gawreluk replied that, “DePuy has implemented a number of actions to address concerns raised in the inspection, and has responded to all concerns raised in the Warning Letter.”
This is just one of the many battles that Johnson & Johnson has recently been faced with. As, DePuy has already been at the center of a massive recall of artificial hips after they were shown to fail at a higher-than-expected rate.
DePuy Orthopaedics Inc., is based in Warsaw, Indiana.