The Johnson & Johnson/DePuy hip replacement recall is a mind-boggling fiasco, with the devices having been implanted in 93,000 patients. Many will likely need painful and expensive “revision” surgery.
But something even more amazing is another recall by Johnson & Johnson. It’s being referred to a “phantom recall,” in which J&J hired contractors to pose as customers and secretly buy back 88,000 packets of defective Motrin.
In fact, J&J is under fire for a long list of recalls. On Thursday, September 30, 2010, federal regulators told a congressional committee that Johnson & Johnson repeatedly did not investigate and fix problems with its medicines.
The hearing was the second one looking into problems at three manufacturing plants that are part of J&J’s McNeil Consumer Healthcare unit, according to an article Friday in the Wall Street Journal. The McNeil unit makes Tylenol and other over-the-counter medicines. The largest recall, which involved more than 135 million bottles of infants’ and children’s Tylenol and other medications, triggered the investigation, according to another newspaper.
Since September 2010, J&J has announced nine recalls of drugs for children and adults. They have also had recalls on Acuvue contact lenses, and on Tuesday, the FDA warned J&J against falsely claiming their mouthwash products remove plaque and prevent gum disease, according to the WSJ article. Additionally, the McNeil unit is under federal criminal investigation.
Before I go further, let’s review some facts of the hip replacement recall:
In August, the DePuy Orthopaedics company, a subsidiary of Johnson & Johnson, issued a voluntary recall of two hip replacement systems. The recall said that five years after implantation, about one in eight patients needed to have the “revision surgery.”
For more details on the DePuy hip devices, the recall, and symptoms you may experience, see this previous article.
If you have had a hip replacement and are experiencing pain, you likely will need the help of a hip-replacement attorney.
You may receive a letter from your doctor along with a Medical Release Form for you to fill out and sign. Do not sign anything. The form is from DePuy, and it releases all kinds of medical records to them – from physical therapy reports all the way down to telephone message slips.
Several red flags in the letter that suggest that this document is seeking information that can be used against you. I explain them in this previous article.
You may find it hard to believe that a company would use this seemingly harmless tactic to obtain your personal medical information. Which brings me back to the Johnson & Johnson hearing Thursday. Regarding the “phantom recall,” the FDA’s deputy commissioner, Dr. Joshua Sharfstein, testified that the FDA did not know J&J had instructed contractors to pose as regular customers while buying the product and to not alert store employees to their activity.
"Based on the documents I reviewed, I don't see any indication that the FDA was aware of the surreptitious, lying nature of the recall," Sharfstein said. These are harsh words from an FDA official.
Perhaps this fishing expedition for your medical records is not so surprising, given how J&J has handled other defective product problems.
For other information on the Johnson & Johnson recalls, see these reports:
National Public Radio (NPR)
If you are affected by the DePuy hip replacement recall, the attorneys of the Egerton Law firm can help you. We can review documents that you receive, explain their ramifications, and advise you on how to proceed. If you have already signed documents, we can tell you how to undo that.