Johnson & Johnson gets FDA warning over marketing joint replacement products without approval

Johnson & Johnson gets FDA warning on marketing

TRENTON, N.J. — A Johnson & Johnson business that makes joint replacements has been warned by the Food and Drug Administration that it’s illegally marketing two products.

The FDA notified Johnson & Johnson’s DePuy Orthopaedics Inc. that it is selling one product that was never approved for sale and is selling another product for uses that have not been specifically approved.

In a letter to the company, the FDA wrote that DePuy is marketing its Corail Hip System for two unapproved uses, and promoting those uses in an online brochure.

The agency also stated that it never approved the TruMatch Personalized Solution System. That’s a software system that uses high-tech scanning technology to create a detailed, 3-D view of a patient’s knee so a surgeon can properly position a knee implant.

The FDA has told DePuy, which is based in Warsaw, Ind., to stop selling the hip system for unapproved uses and to provide information that would be needed for the agency to approve the software system.

The FDA’s warning letter, addressed to DePuy President David Floyd, was posted on the agency’s website on Tuesday. The letter is dated Aug. 19.

It states that the Corail Hip System is approved for total hip replacement in patients with six specific types of damage to the hip. But a brochure on DePuy website claims the system can be used for treating two other conditions.

In early trading, Johnson & Johnson shares were down 78 cents at $58.08, while health-care stocks and the broader markets were all down sharply.

Mindy Tinsley, a spokeswoman for DePuy, said the company would provide comment later on Tuesday.

Johnson & Johnson is based in New Brunswick, N.J.