Johnson & Johnson has again run afoul of federal regulators, this time with its medical device subsidiary, DePuy Orthopaedics. The company has been warned recently that it is illegally marketing a hip implant and knee joint replacement product.
The FDA issued a warning letter to DePuy Orthopaedics, Inc. president David Floyd on August 19, which says that the marketing of the TruMatch Personalized Solutions System and the Corail Hip System are illegal. The Johnson & Johnson unit has 15 days to respond to the letter either by taking corrective action or giving a reason for why corrective action cannot be taken immediately. The company has also been ordered to halt marketing on both products, which the FDA considers to both be unapproved medical devices, until the situation is resolved.
TruMatch, a system that helps doctors shape knee replacement implants to better fit their patients, has not been approved for use in the U.S., according to the letter. The FDA claims DePuy never told them it intended to commercially distribute the product.
The FDA also accuses DePuy of getting the Corail hip implant approved quickly by giving inaccurate information regarding its design and use. The Corail system was approved under the FDA’s controversial 510(k) premarket approval system; an expedited process that requires that the medical device be functionally equivalent to a device already on the market in order to fast-track its approval. However, according to the warning letter, DePuy’s brochure on the device lists a number of claims about the device’s capabilities and specifications that were never approved by federal regulators.
The warning letter comes as Johnson & Johnson is under close scrutiny over quality control issues with its McNeil Healthcare pharmaceuticals subsidiary, which has had to issue two massive drug recalls this year and has suspended production.
On April 30, a recall was announced for nearly 40 liquid children’s medications made by McNeil Consumer Healthcare, including infant Tylenol, Benadryl, and Motrin. The products were recalled due to particulate contamination and irregularities in potency. As a result of the problems, the FDA issued a warning letter about quality control issues at the Johnson & Johnson manufacturing plant in Ft. Washington, Pennsylvania.
In addition, the company has issued a series of Johnson and Johnson drug recalls for a variety of drugs due to chemical contamination from wood pallets that give the drug a musty smell and have caused a number of people to fall ill. The problem is due to contamination by trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, which seeped into bottles from wood pallets treated with pesticide. The contaminated drugs had a moldy smell and made some users sick.
The DePuy unit itself has also faced a number of recent questions about the quality of the some other hip replacement systems. A DePuy ASR hip recall was issued earlier this year due to the high failure rate of the metal-on-metal hip implants.
In recent months, a number of DePuy hip lawsuits over faulty ASR Cup implants have been filed. It is expected that the number of cases will continue to grow as Depuy hip implant lawyers continue to investigate and review potential cases for individuals who have experienced problems and complications after hip replacement surgery involving the ASR cup.