Transvaginal Mesh Verdicts and Settlements

The first transvaginal mesh lawsuits went to trial in 2012 and 2013. Since then, multiple transvaginal mesh producers have lost multimillion-dollar lawsuits. Many companies have agreed to large legal settlements to avoid facing plaintiffs in courtrooms, but others have delayed proceedings and settlements.

Juries have sided with numerous plaintiffs who accused companies of designing defective products, fraudulently promoting the safety of the devices and failing to warn of potential complications. Despite multiple settlements, thousands of lawsuits are still pending in federal and state courts. It’s unclear whether companies will try to resolve remaining claims or fight them.

“(Settlements are) hard to predict,” lawyer Laura Yaeger told Drugwatch. “It depends on a number of factors, including the pace of litigation, the type of cases – stress urinary incontinence (SUI) versus pelvic organ prolapse – and the strategy the defense takes.”

C.R. Bard was the first manufacturer to lose a transvaginal mesh lawsuit. The company withdrew its Avaulta Plus vaginal mesh from the market in July 2012, weeks before losing a $3.6 million verdict to a woman who experienced complications from the company’s device.

More than 100,000 lawsuits were consolidated in multidistrict litigation courts in West Virginia. Judge Joseph Goodwin presides over six MDLs involving separate manufacturers. Many of these claims have been dismissed, settled or received jury verdicts in courts.

Mentor also faces lawsuits involving its bladder sling in a Georgia MDL. The Georgia MDL is separate from the others because it was established years earlier. It stopped accepting cases in 2016, according to a judicial order.

Johnson & Johnson lost the first federal mesh lawsuit in February 2013, and American Medical Systems became the first company to agree to a large settlement in July 2013. Less than a month later, Bard lost the second federal lawsuit involving transvaginal mesh.

Five companies began settlement discussions in October 2013. Johnson & Johnson was the only company that did not participate. It remains the company with the most lawsuits pending against it.

A group of companies, including Coloplast and Caldera Medical, agreed to an $11.75 million class-action settlement to resolve 2,000 mesh claims in California courts in 2016.

By 2017, almost every company in the federal MDLs had agreed to settlements. Boston Scientific, Bard and AMS settled thousands of claims, and other companies settled hundreds. Cook Medical has not agreed to any settlements, and the company has not faced a trial. More than 100 lawsuits against the company have been dismissed for being meritless.

“I wish I had a crystal ball so I could tell clients when and if they will have a settlement,” Yaeger said. “However, there is no way to predict it. Judge Goodwin is really pushing the litigation. That’s a good sign. He’s making everybody toe the line.”

Judge Goodwin has warned device makers to cut their losses, urging them to settle outstanding claims and avoid massive court costs and verdict losses.

Of all the mesh manufacturers, J&J’s Ethicon has been the slowest to offer settlements. The company also faces the highest number of federal lawsuits. Despite multiple trial losses, Johnson & Johnson has refused to agree to a large settlement.

It settled four lawsuits for an undisclosed amount in January 2015. One month later, it settled 111 lawsuits involving OBTape, a bladder sling that was marketed by Mentor Corporation. The product was discontinued in 2006, and Johnson & Johnson bought Mentor in 2009. The OBTape lawsuits were also settled for undisclosed amounts.

The company has been quietly settling groups of cases handled by plaintiff’s firms for undisclosed amounts. For example, on June 11, 2019, the Johnson Law Group entered into an agreement with Ethicon, according to Pretrial Order #340.

As of June 19, 2019, about 2,791 cases remained in the MDL.

In addition to personal injury settlements, J&J has had to pay $9.9 million to Washington state for “failure to include serious risks in the instructions and marketing materials for surgical mesh devices,” according to the Washington State Office of the Attorney General.

A judge ordered Ethicon to pay nearly $344 million to the State of California for “endangering patients through deceptive marketing of pelvic mesh products.” Though an appellate judge reduced the verdict by $44 million in April 2022, Ethicon was still on the hook for $300 million.

After losing a state lawsuit for $3.6 million in 2012 and a federal lawsuit for $2 million in 2013, Bard settled a pair of cases for undisclosed amounts. In October 2014, Bard settled more than 500 lawsuits for $21 million, but the judge presiding over the MDL was disturbed by Bard’s slow pace.

In December 2014, Judge Goodwin told Bard to settle additional cases or face billions in jury verdicts. In August 2015, Bard settled another 3,000 cases for $200 million and a number of others for confidential amounts.

Weeks before Bard’s first federal lawsuit in 2013, American Medical Systems agreed to settle an unspecified number of claims for $54.5 million. The settlement agreement involved lawsuits filed in both state and federal courts. A month earlier, AMS had estimated that its liability for transvaginal mesh claims was $159.8 million.

In May 2014, AMS reached another agreement with multiple plaintiffs’ law firms to settle approximately 20,000 mesh claims for up to $830 million. The settlement resolved the majority of the 25,000 lawsuits pending against AMS in state and federal courts.

In September 2014, it increased its reserves to $1.6 billion, according to Reuters.

According to Bloomberg, American Medical Systems’ parent company, Endo International, set aside $775 million to settle 22,000 claims in August 2017. In total, the company has spent about $2.6 billion to settle its mesh cases.

Boston Scientific lost multiple jury verdicts before settling 3,000 mesh lawsuits for $119 million in April 2015. Claimants received about $40,000 per case. The company’s CEO said that Boston Scientific would continue to fight the remaining legal claims against it, including more than 15,000 claims in the federal MDL. One month later, the company lost another mesh lawsuit.

In December 2017, the company settled an additional 350 lawsuits for an undisclosed amount.

In early 2018, Boston Scientific CFO Dan Brennan announced the company was setting aside $800 million to settle more mesh claims, the Star Tribune reported.

According to the company’s 2018 annual report, as of Feb. 5, 2019, Boston Scientific had “entered into master settlement agreements in principle or are in the final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 50,000 cases and claims.”

In March 2021, the company agreed to pay $188.7 million to settle claims by 47 states and Washington, D.C. that it deceptively marketed its transvaginal mesh products to consumers.

Coloplast faced the second fewest lawsuits in the West Virginia MDL. The first lawsuit against Coloplast was scheduled to begin in December 2013, but the company announced that it would settle about 400 mesh lawsuits for $16 million in January 2014. The claimants reportedly received about $40,000.

Coloplast increased its legal budget to $448 million in September 2015 after courts ordered the company to move forward on litigation involving 200 cases. Less than 500 cases were pending against Coloplast in 2017.

As of June 19, 2019, only 114 cases remain.

Bard, Boston Scientific and Ethicon had thousands of cases pending against them as of June 2019. Cook Medical had 1 case pending. AMS, now part of Endo, had 182 cases in the MDL after resolving tens of thousands of cases.

Transvaginal mesh manufacturers have lost hundreds of millions of dollars in jury verdicts, and they’ve paid about $8 billion to settle tens of thousands of claims. The size of jury verdicts in state courts has been climbing. More verdicts and confidential settlements could be pending.

Only 6,371 cases remained active in the West Virginia MDL as of June 2019.