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Transvaginal Lawsuit Upheld – But FDA Falls Short

Despite its attempts to have the judgment in a transvaginal lawsuit overturned, Johnson & Johnson subsidiary Ethicon is still on the hook for over $11 million. 

On 15 July, the Honorable Carol Higbee of the Atlantic City Superior Court in New Jersey rejected a motion by Ethicon's lawyers to overturn the award and grant a new trial in the transvaginal mesh lawsuit, filed by a South Dakota woman in 2008. Ultimately, the jury in that trial determined that Ethicon had “failed to warn” the patient's doctor about potential complications of its Gynecare Prolift product – and furthermore, had made “fraudulent misrepresentations” to the patient, according to a story in the New Jersey Law Journal.

The patient's transvaginal lawsuit was among the first to be filed, just before the U.S. Food and Drug Administration (FDA) acknowledged that the use of such products could have serious side effects. 

Of course, this isn't the end of it. Representatives for Ethicon have stated that appeals in this transvaginal lawsuit (currently, one of some 50,000 either pending or being heard) will continue.

In the meantime, the FDA – which approved the mesh for the treatment of pelvic organ prolapse (POP) via the infamous “501(k) Clearance” process – has recently reclassified this device and placed it into the “high risk” category, the agency has stopped short of instituting an outright ban on its use for this purpose. The same day Judge Higbee made her ruling against Ethicon, the FDA rejected a petition from the advocacy group Public Citizen to order a recall of all mesh devices and ban their sales going forward, at least for now.  According to a statement from the FDA, the government regulatory agency “...may consider future action against individual products or this product type as appropriate.” 

Public Citizen's Michael Carome, who drafted the original petition, is hopeful that eventually, some action may be taken. Nonetheless, he points out that “...as they do all too often, they're bowing to the interests of [corporations] and not acting in the interests of patients and public health.”

Learn more about Vaginal mesh lawsuits

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