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Pelvic Manufacturers Boston Scientific, Johnson & Johnson Hit with Verdicts

Two of the companies who are facing lawsuits across the country alleging injuries from defective pelvic mesh implants have been hit with verdicts in September.

On September 8, a jury in a Texas state court returned a verdict awarding $73 million to a woman claiming injuries from a mesh implant manufactured by Boston Scientific Corp., making it the largest verdict in the U.S., to date, against a transvaginal mesh manufacturer.

Just a few days earlier, on September 5, a jury in federal court in West Virginia awarded a $3.27 million verdict to a woman in a pelvic mesh lawsuit against Johnson & Johnson’s Ethicon unit.

As Reuters notes, neither of these verdicts will be binding on other litigation against Boston Scientific, Johnson & Johnson and other pelvic mesh manufacturers. However, they may help manufacturers and plaintiffs alike to “assess the strengths and weaknesses of the litigation as a whole as they decide whether to press forward with more trials or consider a settlement.”

Concerns about Pelvic Mesh Implants

Synthetic pelvic mesh kits – also called transvaginal mesh or surgical mesh – are medical devices that are used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The U.S. Food and Drug Administration (FDA) approved the products for SUI treatment in 1996 and for POP treatment in 2002.

However, within only a few years after these products became widely used, concerns arose. By July 2011, the FDA issued a warning that there are “clear risks associated with the transvaginal placement of mesh to treat POP.”

In early 2014, the FDA proposed reclassifying surgical mesh implants as high-risk devices, which would force manufacturers to submit data proving the mesh implant’s safety and effectiveness before the products could be sold in the U.S.

Thousands of lawsuits across the country have been filed against pelvic mesh manufacturers, including many that were filed in federal court and consolidated in the U.S. District Court for the Southern District of West Virginia.

These multidistrict litigation cases have involved claims against C.R. Bard, Inc. (MDL No. 2187), American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326), Ethicon (MDL No. 2327), Coloplast Corp. (MDL No. 2387) and Cook Medical, Inc. (MDL No. 2440).

It should be noted that, in April 2014, Endo International’s American Medical Systems unit settled what it described as “a substantial majority” of the pelvic mesh lawsuits against the company for $830 million.

A Closer Look at Recent Pelvic Mesh Verdicts

As Reuters reports, the verdict in the Texas case against Boston Scientific is the first verdict to go against the manufacturer, which is facing more than 23,000 lawsuits relating to its pelvic mesh products.

In the Texas case, a 42-year-old woman claimed to suffer constant pelvic pain and permanent nerve damage after receiving an Obtryx sling four years ago to treat urinary leakage. The woman alleged that Boston Scientific knowingly designed and marketed a defective product, according to Reuters.

The jury awarded the woman $23 million in compensatory damages and $50 million in punitive damages based on its finding that Boston Scientific was “grossly negligent,” Reuters reports. According to a company spokesperson, Boston Scientific planned to appeal the verdict.

In the West Virginia case against Johnson & Johnson’s Ethicon unit, a 52-year-old woman claimed to suffer several complications, including pelvic pain, after being implanted with a Gynecare TVT Obturator, according to Reuters. A company spokesperson told Reuters that it, too, intended to appeal the verdict.

As the news outlet reports, Johnson & Johnson’s Ethicon unit was previously hit with an $11 million pelvic mesh verdict in a New Jersey state court in 2013 and a $1.2 million verdict in Texas state court in April of this year.