The world’s largest retailer of health-care products, Johnson & Johnson, is under attack for making false claims during the marketing of its hip replacement devices and vaginal mesh. The DePuy Orthopaedics ASR XL hip implant was recalled in August of 2010 and the Ethicon vaginal mesh POP kit was silently withdrawn from the market. J&J tried to fool the world by publicly stating they voluntarily withdrew these products due to their own self-monitoring. However, under the pressure of newly disclosed evidence in the California DePuy ASR XL trial and in the New Jersey Ethicon trial, J&J has finally admitted that the FDA forced these J&J products off the market. Ultimately, the U.S. Justice Department is sending a clear signal by launching a criminal investigation.
“Unfortunately, the FDA cowardly missed the opportunity to combatively set an example of these horrendous products by driving these products off the market with an FDA-sanctioned recall, despite clear evidence that these products had a clear track record of being the worst products of their kind,” says Attorney Daniel Nigh.
J&J made false claims during the marketing on the DePuy ASR XL device while the marketing claims for the vaginal mesh are being further investigated. The vaginal mesh, which is used in transvaginal surgeries and is also used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), and the DePuy device were approved through a controversial approval system known as a 510(k). Usually, this process does not include in-depth safety reviews for new controversial products before they hit the market. Preliminary safety reviews for both the DePuy hip device and surgical mesh were not conducted before being manufactured and distributed.
The probe is not the first of J&J’s legal woes. A court recently awarded Linda Gross from Atlantic City, New Jersey with $3.35 million dollars from damages caused by Prolift , a transvaginal surgical mesh manufactured by J&J subsidiary, Ethicon. In addition to the Prolift trial, mounting evidence in separate court cases for the DePuy ASR XL have suggested that J&J knew of the potentially serious health risks of the hip replacement device well before the recall in 2010.
In July 2012, the U.S. Food and Drug Administration stated that there is no definite advantage to using the vaginal mesh over alternative, non-mesh methods to treat POP and SUI. J&J has also stopped the distribution of four brands of transvaginal mesh manufactured by the company: Prolift, Prolift + M, TVT Secur, and Prosima.
DePuy has also been targeted for offering cash bonuses to encourage doctors to use their controversial implants. In 2007, the U.S. Department of Justice sued DePuy and four other hip implant manufacturing companies (Biomet, Inc., Smith and Nephew, Stryker Corporation, and Zimmer Holdings) for offering cash bonuses totaling almost $200 million to 940 orthopedic surgeons. In the end, DePuy essentially bought its way out of criminal charges and settled out of court with “deferred” charges and $311 million in fines. This clearly shows that DePuy and other companies will go as far as forking out money for bribes and forfeiting consumer health to maximize profit.
Krysta Loera is a writer and researcher with Ring of Fire.