January 1, 1970 · FLEMING | NOLEN | JEZ, L.L.P.
Within the last two months, we have learned how Johnson & Johnson handles its medical device business. It puts profits over patient safety. Johnson & Johnson has sold and marketed several devices with out obtaining the proper FDA clearance or approval. Clearly, this practice puts patients at risk.
Just last month is was reported that Johnson & Johnson sold medical devices, specifically hip implants, that were misbranded or sold without proper FDA approval. Then a few weeks later the NY Times reported that Johnson & Johnson put profits over patients by continuing to sell the DePuy ASR Hip Resurfacing System overseas after the FDA issued a non-approval letter for the device. Unfortunately, many patients have been negatively impacted by Johnson & Johnson’s negligent business practices.
The trend continues. Today, Bloomberg News reported that Johnson & Johnson marketed and sold the transvaginal surgical mesh device – Gynecare Prolift – without FDA approval. Johnson & Johnson began selling the Gynecare Prolift device in March 2005, however, the FDA did not learn of the product until 2007. Johnson & Johnson failed to submit the required 510k documentation to the FDA in 2005 but mentioned the Prolift implant in another 510K submission for the Prolift-M implant in 2007. Eventually, three years after being sold and marketed, Johnson & Johnson’s Gynecare Prolift obtained FDA clearance.
Johnson & Johnson’s disregard for patient safety has impacted hundreds of thousands of people who have been implanted with Johnson & Johnson’s hip implants and transvaginal surgical mesh implants. Johnson & Johnson’s disregard continues even today through its spokesman, who said, “our actions were responsible, appropriate and consistent with the FDA regulations.” This business as usual attitude will continue to put patients at risk.