Johnson & Johnson (J&J) is the largest pharmaceutical company and medical device maker in the world, with drug and equipment sales made across the globe that reap the company billions of dollars in profits annually.
Sometimes, though, and especially regarding its relationship with U.S. federal regulators, J&J appears to be more like a kid in school who is constantly caught and reprimanded by the teacher for cheating and taking unapproved shortcuts.
That can -- and has -- led to mass litigation concerning medical malpractice against the company and doctors that use its products, in a number of instances.
Readers might well remember some of J&J's recent woes. A manufacturing plant run by one of its subsidiaries -- McNeil Consumer Healthcare -- was closed outright by the FDA last year for irregularities regarding Tylenol products.
And then there is, of course, the celebrated DePuy hip-replacement litigation. J&J's product -- the ASR XL Acetabular Hip Replacement System -- has been found to be defective and resulted in thousands of patients suffering undue pain and subsequent surgeries.
And now DePuy is yet further embroiled in problems with government regulators for its failure to obtain the requisite approval on more than a dozen products it markets in the United States.
The FDA has just sent a warning letter to J&J concerning that, stating that the company did not get pre-market clearance on 14 orthopaedic devices it makes, primarily knee- and hip-system replacements.
Johnson & Johnson says it didn't require approval, because the products were custom devices made for particular patients.
The FDA rejects that claim out of hand, noting that the products could easily be sold to any physician. Moreover, the agency contends that J&J has failed dismally in complying with quality-control regulations concerning the products or implementing any system to review user complaints.
A J&J spokesperson says that the company 'has responded to all concerns raised in the Warning Letter."
Source: Asbury Park Press, "FDA says Johnson & Johnson subsidiary DePuy sold orthopaedic devices without approval" Jan. 18, 2012
