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Johnson & Johnson Agreed to $120M Vaginal Mesh Settlement

— February 1, 2016

Medical device manufacturer Johnson & Johnson agreed to $120M vaginal mesh settlement. The settlement resolves 2,000 – 3,000 vaginal mesh cases. This is a huge move in the years-long litigation in which tens of thousands of women claim constant pain and organ damage as a result of eroded mesh products.

Medical device manufacturer Johnson and Johnson agreed to $120M vaginal mesh settlement. The settlement resolves 2,000 – 3,000 vaginal mesh cases. This is a huge move in the years-long litigation in which tens of thousands of women claim constant pain and organ damage as a result of eroded mesh products.

Ernie Knewitz, J&J spokesperson said, “From time to time we have appropriately agreed to resolve some cases. We will not discuss the terms, nor discuss our ongoing litigation strategy.”

That’s a wise move considering the medical device giant still has 42,400 more vaginal mesh cases queued up against it. The overall financial hit, beyond the $120M, is hard to estimate, as the average payouts on the remaining cases will vary.

This is the first time J&J and its Ethicon division agreed to settle so many mesh cases. Previously, only a small number of cases have reached this point. October 2015 filings with the Securities and Exchange Commission (SEC) show that the company has earmarked an undisclosed amount for the yet-to-be resolved mesh cases facing the company.

In a statement sure to tug at the strings of even the hardest of hearts, J&J said the financial risk it faces as a result of the mesh cases is not “material.” This is akin to saying that the hit is “only a mosquito bite.”

A Costly Itch

If only most of our bank accounts could absorb such hits without causing us pain. This immaterial financial setback has already cost J&J $2.2B in 2013, $1.2B in 2014 and $141M in 2015. That’s a $3.5B itch, by my calculations.

Of all the mesh manufacturers, J&J has the most for which to answer. Litigation of vaginal mesh cases began in 2011 with at least 100,000 cases spread over a half-dozen plus companies. Two notable companies, C.R. Bard, Inc. and Boston Scientific Corp., settled several cases as well as reserving over $1B to handle others.


Plaintiffs’ complaints with J&J/Ethicon’s mesh include shrinking after implantation. This causes constant pain as well as organ damage.

Unwilling to Talk

Carl Tobias, teacher of product-liability law at Virginia’s University of Richmond, said that J&J has declined to join discussions between other mesh manufacturers and plaintiffs’ attorneys. The discussions are aimed at developing a global resolution of the mesh litigation.

According to Tobias, “J&J still has a ton of cases to deal with, but this settlement may encourage other lawyers to consider taking their offer.”

One “request” to collaborate was inescapable, however. In 2012, the FDA ordered J&J, Bard, Boston Scientific and others to join in a study of the rates of complications and organ damage associated with mesh products. On January 4, the FDA upped the ante, declaring surgical mesh used in transvaginal repair of pelvic organ prolapse (POP) a high-risk (Class III) device. It was formerly a moderate-risk (Class II) device.

The agency gave mesh manufacturers 30 months to prove the safety and efficacy of their mesh products. This includes submitting the products for premarket approval (PMA) review. Vaginal mesh was originally approved through the FDA’s 510(k) process. This less-restrictive process forgoes clinical trials and only makes companies prove that the product is substantially equivalent to one already on the market.

All new mesh products for treatment of POP must also pass the PMA-level review. It’s important to note that the FDA’s reclassification does not affect mesh products used for abdominal repair of POP and treatment of stress urinary incontinence.

So far, J&J has won and lost cases in the vaginal mesh litigation. J&J/Ethicon was found liable by juries for injuries caused by mesh in California, New Jersey and Texas. A jury in Philadelphia awarded a plaintiff a $12.5M judgment against J&J/Ethicon for injuries to her bladder caused by the company’s Prolift product. In 2014, a West Virginia plaintiff lost in a case involving mesh that was used to treat incontinence.

Federal Judge Joseph Goodwin Assigned

U.S. District Judge Joseph Goodwin (Charleston, WV) was assigned in 2012 to oversee federal mesh cases nationwide. According to Tobias, Judge Goodwin has been urging manufacturers to settle.

Boston Scientific, based in Massachusetts, still has 30,000 mesh suits against it. The company agreed to a $119M settlement in April 2015, which covered roughly 3,000 of those cases.

C.R. Bard had settled around 6,400 cases in October 2015, leaving with 12,850 unresolved. In August, the company agreed pay more than $200 million to resolve at least 3,000 more cases.

The case is In Re Ethicon Inc. Pelvic Repair System Products Liability Litigation, 12-MDL-2327, U.S. District Court, Southern District of West Virginia (Charleston).


J&J to Pay $120 Million in Its First Big Mesh Settlement

FDA Reclassifies Vaginal Mesh as a High-Risk Device

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