FDA says Johnson & Johnson subsidiary DePuy sold orthopaedic devices without approval
- APP
01/19/2012 - A Johnson & Johnson subsidiary sold more than a dozen types of orthopaedic devices without getting the necessary approval from regulators, the U.S. Food and Drug Administration said in a warning letter released this week.
DePuy Orthopaedics Inc., based in Warsaw, Ind., also had a quality system that didn’t comply with all of the FDA’s requirements, according to the warning letter.
New Brunswick-based Johnson & Johnson, the world’s biggest health company and one of New Jersey’s biggest employers, has seen several subsidiaries become the focus of FDA regulators in recent years.
Perhaps most notably was its McNeil Consumer Healthcare company, which last year closed one of its Tylenol plants after the company recalled millions of bottles of over-the-counter drugs and inspectors found several deficiencies in the manufacturing process. The plant, in Fort Washington, Pa., won’t reopen until regulators are assured the drugs made there are safe and effective.
DePuy also has been under scrutiny for a hip-replacement device, the ASR XL Acetabular Hip Replacement System. A United Kingdom database found the device failed in 13 percent of its patients, far higher than average. DePuy recalled the device and is paying for new surgeries.
The FDA letter from Steven D. Silverman, director of the office of compliance, was sent Dec. 8 as a result of an inspection from May 10, 2011 to June 7, 2011.
The letter said DePuy made 14 types of devices – from knee systems to hip systems – that didn’t receive pre-market clearance or approval from the FDA.
The company said it believed the devices were custom-made, requested by surgeons to match an individual patient’s anatomy and exempt from the approval process. But the agency said they didn’t meet the criteria, in part because once the devices were finished, they might have been available to other doctors.
“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.
Lorie Gawreluk, a DePuy spokeswoman, said custom medical devices have been exempt from pre-market review since 1976, and the company believed it complied with the FDA’s requirements.
“The company has made the decision at this time not to provide custom devices,” she said.
The agency also cited DePuy for failing to comply with quality regulations. Among the problems: The company didn’t have adequate procedures to ensure the devices conformed to the user’s needs; it didn’t have an adequate procedure to review complaints; and it didn’t ensure the employee in charge of nonconformance was notified when a product wasn’t in conformance, according to the FDA.
Gawreluk said: “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.”
If you or a loved one have been injured as a result of a defective hip replacement you may be entitled to compensation. Our experienced Hip Replacement Side Effects Lawsuit Attorneys are here to answer any questions you may have about a hip replacement lawsuit or a possible hip replacement class action lawsuit. Fill out the free hip replacement lawsuit case evalution form or contact our DePuy ASR Hip Replacement Recall Lawsuit Lawyers directly by calling toll-free: 1.800.856.6405. |
