The Honorable Carol E. Higbee has ordered Johnson & Johnson subsidiary Ethicon to produce all communications and correspondence between the transvaginal mesh manufacturer and the FDA regarding their regulation, Section 522.
Section 522, under the Federal Food, Drug, and Cosmetic Act, is a combination of earlier laws that allows the FDA to collect post-market research and surveillance information companies collect about the safety of their products. The FDA requires companies to research product safety before putting products on the market, but, according to Section 522, pre-market research cannot fully guarantee a product’s safety.
In January of this year, the FDA reportedly ordered 30 transvaginal mesh device manufacturers to produce 3 years of data on the safety and effectiveness of their devices and procedures. On June 4th, Ethicon announced it would voluntarily recall 4 of its transvaginal mesh devices, asking the FDA for 3 months to complete the process. The company also, at the same time, requested that the FDA put its 522 order on hold.
Click here to see a PDF of the request to recall from Ethicon to Judge Higbee.
However, Judge Higbee, in an August 8th Case Management Order, clearly stated that Ethicon must still release the 522 information to the plaintiffs in her multidistrict litigation.
Currently, there are five multidistrict litigations (MDLs) against major surgical transvaginal mesh manufacturers. While the process can be confusing, if you or a loved one have had a surgical mesh implant to correct organ prolapse or stress urinary incontinence and have since suffered much more serious side effects (including continued prolapse), you may be entitled to compensation. You may face mounting medical bills and an inability to work, which means you will need financial assistance to get you through this difficult time. Please contact the experienced lawyers at Strom Law, LLC, for help. We offer free consultations, and are currently accepting vaginal mesh cases nationwide. 803.252.4800.