Thousands of women who received transvaginal mesh implants to treat conditions called pelvic organ prolapse (POP) and stress urinary incontinence (SUI) say they suffered severe pain, organ damage and other complications because of the devices.
Since 2012, women who have sued companies over transvaginal mesh have won at least 20 verdicts in state and federal courts totaling around $300 million. By March 2017, multiple companies had settled thousands of claims for millions.
Some patients have won multimillion-dollar verdicts against manufacturers. One jury, for example, awarded $68 million to Mary McGinnis and her husband in 2018.
And there is no end in sight for court actions.
As of October 2018, six implant makers faced 44,237 lawsuits in multidistrict litigation (MDL) in West Virginia.
Johnson & Johnson’s Ethicon unit faces 20,060 lawsuits — the most of any manufacturer — followed by Boston Scientific at 14,908, Bard at 6,057 and American Medical at 2,809.
Legal Actions Combined in West Virginia
At one time there were about 100,000 lawsuits pending in federal court before U.S. District Judge Joseph R. Goodwin in West Virginia. Many have settled, gone to trial or have been dismissed.
In February 2012, the federal courts agreed to consolidate cases against three companies into MDLs in the Southern District of West Virginia, where one transvaginal mesh MDL already existed.
|Company||Pending Actions||Total Actions|
|American Medical Systems||2,809||21,290|
ObTape Multidistrict Litigation
Before the Judicial Panel on Multidistrict Litigation formed the main mesh MDL in West Virginia, the first transvaginal mesh lawsuits involved a device called ObTape manufactured by Mentor. In 2008, the judicial panel combined several of these cases into a multidistrict litigation.
A total of 857 lawsuits were included in this one MDL between 2008 and 2017.
In 2016, the judge overseeing the MDL asked the judicial panel to stop adding cases to the ObTape MDL. He said the MDL had received too many lawsuits that did not have enough evidence to stand up in court and cases that had missed the time limit for filing a lawsuit.
The judicial panel has not closed the ObTape MDL. Women seeking compensation for ObTape injuries can also still file claims in state courts.
Injuries Include Erosion, Infection and Pain
Women who received the device for prolapse or stress urinary incontinence and filed lawsuits say they suffered from painful injuries.
Those women had problems such as sitting, walking, having sex and participating in other activities, according to lawsuits. The complications were so bad that many women had to suffer through multiple revision surgeries to remove the implants.
- This occurs when implants damage vaginal walls or internal organs.
- Studies show that bacteria can grow on implants and cause infections.
- The device may damage nerves, cut through tissues or shrink, causing scarring and pain — including painful intercourse.
- Urinary problems
- The devices may block the bladder, making it difficult to urinate.
- Recurring prolapse
- Even after mesh surgery, the implant can fail and cause recurring prolapse.
- Recurring incontinence
- Some women experience new or worsened incontinence of the bladder or rectum.
Allegations Against Manufacturers
Women who filed lawsuits claim that manufacturers “had a legal duty to ensure the safety and effectiveness of their pelvic mesh products” but instead provided patients with “false and misleading information” about how safe and effective the products supposedly were. The products were cleared for use based on “weak evidence,” according to a 2017 study in BMJ.
- Intentionally misleading the U.S. Food and Drug Administration, the medical community, patients and the public about the true safety and effectiveness of the products.
- Failing to properly test devices.
- Failure to research the risks of the products.
- Failing to create safe and effective methods to remove the materials.
- Failing to adequately warn people of potential complications and injuries.
Settlements & Verdicts
So far, manufacturers have paid out billions in settlements and jury verdicts. As of June 2017, at least 18 bellwether cases in the West Virginia MDLs had been tried, settled, dismissed or delayed.
People who filed lawsuits have won verdicts totaling more than $49 million in 10 of the bellwether trials. J&J subsidiary Ethicon has won the only defense verdict of any of the companies in the MDLs.
- May 2014
Coloplast settled 400 lawsuits
Bard settled 500 lawsuits
Ethicon (Johnson & Johnson) settled four lawsuits
Boston Scientific settled 3,000 claims
- August 2015
Neomedic settled 112 claims
Remaining 22,000 AMS claims settled
Boston Scientific settled about 350 claims
J&J, Bard and Boston Scientific each lost multiple bellwether trials, and the MDL court has urged those companies to settle more lawsuits. So far, J&J has agreed to settle only four lawsuits and continued to defend itself in court.
- Mary and Thomas McGinnis
- A New Jersey jury awarded Mary and Thomas McGinnis a total of $68 million in April 2018 in her lawsuit against C.R. Bard Inc. Mary McGinnis had been injured after being implanted with an Avaulta Solo and an Align Transobturator. The award to the Raleigh, N.C., couple was comprised of $33 in compensatory damages and $35 million in punitive damages. "I've very grateful," Mary McGinnis said as she left the courtroom with her husband, according to northjersey.com. "This case was fought for all the victims of mesh, whom I hold in my heart."
- Blankenship, Campbell, Tyree and Wilson v. Boston Scientific
- Jeanie Blankenship, Carol Sue Campbell, Jacquelyn Tyree and Chris Rene Wilson had each been implanted with the Boston Scientific Obtryx product. In 2014, a New Jersey jury held Boston Scientific responsible for the women’s medical bills and suffering. The four women shared $14.5 million for their injuries and another $4 million in punitive damages. That total $18.5 million award was upheld by an appellate court in February 2018.
- DuBois-Jean, Dotres, Nunez and Betancourt v. Boston Scientific
- Margarette DuBois-Jean, Margarita Dotres, Maria Nunez and Juana Betancourt all claimed the company had been negligent in the Pinnacle mesh’s defective design. In 2014, a Florida jury awarded each of the women more than $6 million in November 2014, but Boston Scientific appealed. In October 2017, the 11th Circuit Court of Appeals upheld the $26.7 million verdict.
- Hammons v. Ethicon
- Patricia Hammons won a $12.5 million award after she sued J&J for injuries one of its products products caused. Hammons’ Prolift implant failed and she had multiple revision surgeries. The jury awarded Hammons $5.5 million for her injuries and $7 million in punitive damages. A state appeals court upheld the verdict in June 2018.
- Engleman v. Ethicon
- Peggy Engleman won a $20 million jury verdict after she said Ethicon’s TVT-Secur device caused serious complications and the company did not warn her. The device caused pain, bleeding and infections that required multiple surgeries to fix, her lawsuit said.
- Hyrmoc v. Ethicon
- Elizabeth Hyrmoc won $4 million for pain and suffering and $10 million for punitive damages against J&J’s Ethicon subsidiary. The New Jersey jury also awarded $1 million for loss of conjugal affection. Hyrmoc received Ehticon’s Prolift and transvaginal tape for incontinence and had several corrective surgeries for pain and other complications.
In 2015, an insurance company for a device maker, Caldera Medical Inc., filed a class-action suit against its client over a coverage dispute. Federal Insurance Co. took Caldera to court as the company faced 2,184 claims from women who alleged injuries from the products.
In 2016, the companies set aside a settlement fund of $11.75 million for these claimants. On March 3, 2017, U.S. District Judge Stephen Wilson approved the settlement, which had grown to $12.25 million. “The settlement is made in good faith; and is fair, reasonable, adequate, and consistent with due process,” Wilson wrote in his order.
The case is Federal Insurance Company v. Caldera Medical, Inc. and the case number is 2:15-CV-00393. The deadline to submit a claim was May 2, 2016.
Please seek the advice of a medical professional before making health care decisions.