Mesh implant sales continued despite FDA order
July 31, 2012
Though ordered to discontinue selling a vaginal mesh device, Johnson & Johnson purportedly disobeyed the Federal Drug Administration (FDA) order and continued selling the product. The FDA promulgated such an order in August of 2007, and informed the company to stop manufacturing the product until the agency could make a determination as to whether such a product was “substantially equivalent” to other such products on the market.
Johnson & Johnson began manufacturing the alleged defective products in 2005 (long before the FDA even learned that the product was on the market), and continued manufacturing the product into 2008 before the product was cleared for use. However, no sanctions were ever brought against the company.
Johnson & Johnson continually has done business in New Jersey throughout this period that the vaginal mesh device was being marketed and sold. Since Johnson & Johnson were able to continue in this business for such a significant period without sanctions, some experts have criticized the lack of enforcement power that the FDA has concerning such matters.
A problem with FDA enforcement is that products supposedly similar in design to other products already on the market can be fast tracked onto the market place if such products are substantially equal to the earlier approved device. There is also concern is that the company may decide to market such products again.
Attorneys that practice in the products liability can often take actions against companies, even when agencies do not have the apparent authority to do so successfully. Such attorneys can file products liability lawsuits in response to anyone being injured due to a defective product, and these same attorneys can financially punish such companies for placing a defective product on the market to begin with.
Source: DrugWatch, “Johnson & Johnson Continued Mesh Implant Sales After FDA Order to Stop,” July 20, 2012