Transvaginal Mesh Settlement
More than 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. Many of these cases remain unresolved, but the multimillion-dollar settlements and verdicts that have been reached to date bode well for mesh victims who await resolution of their cases.
Endo agreed to pay $775 million to resolve the remaining lawsuits filed over its vaginal mesh implants.
In addition, the punitive damages handed down by juries in some verdicts support the claim by women that manufacturers showed egregious misconduct in their failure to warn patients about mesh side effects.
In August 2017, Endo agreed to pay $775 million to resolve the remaining 22,000 lawsuits filed over its vaginal mesh implants.
Johnson & Johnson
Johnson & Johnson faces more vaginal mesh lawsuits than any other manufacturer. Here are results from some of the lawsuits that have turned out in favor of mesh victims:
- In April 2017, a Philadelphia jury awarded $20 million to a woman who claimed she was in constant pain because of her TVT-Secur transvaginal mesh, a product of Johnson & Johnson subsidiary Ethicon. A spokesperson for Ethicon said the company would appeal the decision, but it was the fifth major loss over the mesh products since 2014.
- $13.5 million verdict awarded to Sharon Carlino of New Jersey in February 2016. According to the lawsuit, Carlino received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence and it left her with constant pain and discomfort. Two surgical attempts to fix the device did not rid her of pain. $10 million of the verdict came in the form of punitive damages. The jury said that Carlino’s doctor would not have used the Ethicon mesh had the device risks been known.
- $4.4 million jury award to Florida resident Tessa Taylor in February 2016. The jury found that ObTape sling (made by J&J subsidiary Mentor) caused Taylor’s back pain, bladder pain, and difficulty urinating over a 7 year period. Taylor received the mesh to treat urinary incontinence, but she was re-diagnosed with the condition in spite of the device. $4 million of the verdict was for punitive damages to “discourage others from behaving in a similar way.”
- J&J agreed to pay $120 million to settle 2,000-3,000 mesh lawsuits in January 2016. The settlement marked the first serious attempt by J&J to settle a significant number of mesh lawsuits. A regulatory filing at the time showed that J&J still faced more than 42,000 mesh cases.
- $12.5 million verdict awarded to Indiana resident Patricia Hammons, including $7 million in punitive damages. Hammons was implanted with Ethicon’s Prolift device, which she says caused severe pain, sexual difficulties, and incontinence–even after corrective surgery.
- $5 million settlement reached in September with plaintiff Pamela Wicker, implanted with Ethicon’s Prolift mesh device. Wicker claims that Prolift eroded inside of her and necessitated numerous surgeries to remove the device. A law professor said that the large settlement showed the costs of dealing with mesh litigation would be a lot higher than expected.
- $5.7 million verdict awarded to Coleen Perry in March 2015 by a California jury. Perry was implanted with the J&J/Ethicon TVT Abbrevo and says she expects to have pain the rest of her life. The jury found that the TVT Abbrevo has design problems and that Ethicon failed to warn about potential health risks. The verdict included $5 million in punitive damages for conduct that amounted to “malice.”
- Two confidential settlements involving 115 mesh victims were reached in January 2015. One of the settlements resolved 4 cases in Missouri over Ethicon’s Prolift mesh device and the other resolved 111 cases in Georgia over the ObTape Transobturator Sling (made by J&J subsidiary Mentor). The Missouri women claimed that the mesh in Ethicon’s Prolift insert shrinks and damages organs, causing constant pain and making sexual intercourse difficult, while the Georgia women alleged that ObTape causes permanent injuries.
- $3.25 million verdict awarded to plaintiff Jo Husky over the J&J/Ethicon Gynecare TVT-O mesh device. The verdict was reached by a West Virginia jury in September 2014 following a two-week trial. Jurors found that the TVT-O was faulty and that Ethicon failed to warn of side effects.
- $1.2 million verdict awarded to Linda Batiste, implanted with the Gynecare TVT Obturator (TVT-O) mesh sling (made by J&J unit Ethicon) in April 2013. The jury concluded that the device’s design was flawed.
- $11.1 million verdict (including $3.35 million in compensation and $7.76 million in punitive damages) awarded to Linda Gross of South Dakota, who was implanted with J&J’s Gynecare Prolift vaginal mesh device. A New Jersey jury reached the verdict in February 2013, saying that J&J fraudulently misled Gross about device risks.
New Jersey-based C.R. Bard has moved to settle some of the vaginal mesh lawsuits that it faces, but more than 10,000 cases remain unresolved. A few notable verdicts and settlements include:
- In its second large-scale mesh settlement, Bard agreed to pay more than $200 million (~$67,000 per case) in August 2015 to resolve an estimated 3,000 cases. Legal experts said that the payout was made to avoid a string of multi-million dollar verdicts that could lead to bankruptcy for Bard.
- Bard agreed to pay more than $21 million to settle over 500 mesh lawsuits in October 2014 (an average payout of $43,000 per claim). It was the company’ first large-scale resolution of mesh claims.
- $2 million verdict returned in an August 2013 trial. The plaintiff, Donna Cisson, was implanted with a device from Bard’s Avaulta line of devices to treat pelvic organ prolapse. She had several follow-up surgeries to remove the mesh due to pain, bleeding, and bladder problems. Cisson’s lawyers said that Bard put profits ahead of patient safety. $1.75 million of the $2 million was punitive damages.
- $5.5 million jury verdict awarded to Elaine Houghton, recipient of Bard’s Avaulta Plus mesh implant, in July 2012. Houghton reportedly received the implant in 2008 and subsequently underwent 9 surgeries to correct device-related problems such as incontinence and pelvic pain. The award was reduced to $3.6 million in November 2015 after it was found that the doctor was partly at fault.
Endo/American Medical Systems
Endo International plc (Endo) acquired device maker American Medical Systems Holdings, Inc. (AMS) in 2011. Endo has agreed to pay out roughly $2.6 billion to settle cases claiming injuries from its vaginal mesh devices, which include the Perigee, Apogee and Elevate implants. The company has stopped making AMS transvaginal mesh.
The following settlements demonstrates Endo’s efforts to resolve mesh implants made by AMS:
- $775 million settlement to resolve 22,000 mesh lawsuits in August 2017. This settlement resolves the remaining lawsuits against AMS mesh implants.
- Approximately 450 mesh lawsuits resolved through two separate settlements in April and May 2015.
- $400+ million to settle more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. With the move, Endo said that it resolved “substantially all” the remaining lawsuits against its AMS unit. The $400 million was in addition to $1.2 billion already pledged by Endo to cover mesh litigation.
- $830 million settlement to resolve around 20,000 mesh lawsuits (~40,000 per case) in May 2014. The settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny. “The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo said in a statement at the time.
- $55 million paid in June 2013 to settle an undisclosed number of lawsuits, according to a filing with the U.S. Securities and Exchange Commission.
Marlborough, Massachusetts-based Boston Scientific is one of the top vaginal mesh manufacturers. After some early mesh cases returned huge jury verdicts against the manufacturer, including the largest single verdict of all mesh lawsuits tried thus far, Boston Scientific has moved to settle remaining cases but still faces approximately 20,000 mesh lawsuits.
- In October 2016, a West Virginia judge upheld a $14.3 million jury award for three plaintiffs who suffered injuries from Boston Scientific’s Obtryx pelvic mesh devices.
- In October 2015, Boston Scientific announced it had settled around 6,000 mesh lawsuits for a total of $457 million through the 3rd quarter of that year. The news, based on a filing with the SEC, did not provide a breakdown of individual compensation per plaintiff.
- $100 million awarded in May 2015 to a woman implanted with Boston Scientific’s Pinnacle and Advantage Fit mesh devices. It was the largest amount of damages ever handed out in a transvaginal mesh trial, although a judge later reduced the award to $10 million. The plaintiff claims she suffered bladder infections and pain from the mesh that required her to undergo corrective surgeries.
- $119 million to settle approximately 3,000 mesh cases in April 2015 (~$40,000 per case). Boston Scientific said it reached the settlement agreement “solely by way of compromise” and that it planned to “continue to contest these claims vigorously.”
- $18.5 million paid to four women implanted with Boston Scientific’s Obtryx mesh. The women, who received between $3.25 and $4.25 million apiece, allegedly suffered nerve damage, infection, and painful sex from the devices. A jury found that Boston Scientific defectively designed and negligently manufactured the devices. The verdict, reached on November 20, 2014, was the second major mesh verdict in a week returned against the manufacturer.
- $26.7 million paid to four women implanted with the company’s Pinnacle mesh device (about $6.5 million/apiece). Plaintiffs claim to have suffered pain, bleeding, and infection from the devices, and lawyers accused Boston Scientific of inadequately testing the Pinnacle before it went to market. The verdict was reached on November 13, 2014.
- $73 million jury verdict paid to plaintiff Martha Salazar in September 2014. Salazar, implanted with an Obtryx sling to treat urinary leakage, claims to have permanent nerve damage and constant pelvic pain from the device. The award, which included $50 million in punitive damages, was later reduced to $34.5 million by the court.
Coloplast A/S is a Danish medical device manufacturer best known for making ostomy and urine bags for post-surgical use. The company currently faces around 2,000 vaginal mesh lawsuits in a consolidated federal multidistrict litigation–down from a peak of more than 2,400 cases.
- A $16 million settlement was reached between Coloplast and about 400 vaginal mesh plaintiffs in spring 2014. The settlement works out to ~$40,000 for each claimant.
Medtronic Inc., one of the three largest medical device makers, agreed to buy Covidien Plc in 2014 in an effort to help it compete with Johnson & Johnson. Medtronic said in a June 2015 SEC filing that its Covidien unit was involved in nearly 11,500 mesh lawsuits.
- $180 million was set aside by Medtronic in 2015 to settle an undisclosed number of mesh cases.
Neomedic International is a Spanish medical device maker with U.S. headquarters in Coral Gables, Florida. The company, which specializes in pelvic floor products, faces around 130 mesh lawsuits as part of a federal mass tort centralized in West Virginia.
- Neomedic paid $2.19 million to settle an undisclosed number of mesh lawsuits in December 2015. Neomedic reserved the right to walk away from the agreement if at least 90 percent of claimants did not opt into the settlement. The agreement covered the Contrasure Needleless Sling System, the Needleless Sling System, the Remeex System/TRT Remeex System, the KIM System, the Uplift device, and the Surelift device.
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