Women who received transvaginal mesh implants thought they were receiving devices that would provide relief from pelvic organ prolapse or stress urinary incontinence. Hundreds of thousands of women claim they weren’t warned that the devices could cause severe pain, organ damage and other complications.
Procedures to fix transvaginal mesh complications are painful and expensive. The damage from mesh can be permanent. Some women are unable to sit comfortably or have sex without experiencing pain.
The devices they received were never recalled, and the companies that made them didn’t offer compensation for their injuries. So the women and their families were forced to seek justice in court. They have strong cases, too.
Transvaginal mesh devices were never tested with thorough clinical trials. The U.S. Food and Drug Administration approved them using a fast track process called the 510(k) program. The first implant to treat stress urinary incontinence was approved in 1996, and the first one to treat pelvic organ prolapse was approved in 2002.
By 2008, the FDA announced that it had received thousands of complaints from patients and physicians. The mesh devices were eroding inside of women, perforating organs and causing severe pain. In 2011, the FDA provided updated information, saying complications weren’t rare. The next year, the FDA ordered companies to monitor the safety of the devices. That’s when several companies removed the products from the market.
At that time, thousands of women had already filed lawsuits against the manufacturers. The lawsuits revealed that some companies knew about the problems with the devices, but they sold them anyway.
More than a dozen plaintiffs have won multimillion dollar verdicts against mesh manufacturers. They claimed that the products were defective, and the companies didn’t warn of the risks.
Those plaintiffs include Christine Scott and her husband. They won a $2 million jury award in 2013 in the first Avaulta mesh verdict in federal multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia. The product was made by Bard, based in Covington, Georgia. The couple alleged that the implant caused bleeding, pain, bladder spasms and painful sexual intercourse and also required several surgeries to remove the mesh. The jury also heard extensive testimony and saw other evidence from both sides about how mesh implants are designed to work in the body and about Bard’s testing and marketing efforts.
Multiple companies have settled thousands of claims, but 60,199 lawsuits were still pending as of March 2017.
Patients Say Manufacturers Misled Them
Women who filed transvaginal mesh lawsuits allege that mesh 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 the products’ effectiveness and safety.
Plaintiffs say they were never warned that mesh can erode through the vaginal walls or other organs within weeks or months after surgery. The injuries caused by mesh erosion and other complications caused severe pain and hindered regular activities, such as sitting, walking and sexual intercourse. The complications forced many women to undergo multiple revision surgeries to remove the mesh.
The physical and emotional harm affected women’s work, relationships and daily activities. They sought compensation for those harms in court.
Lawsuits accuse mesh manufacturers of:
- Actively and intentionally misrepresenting the safety and effectiveness of transvaginal mesh products
- Failing to conduct proper testing and research to determine the risks of surgical mesh to treat female pelvic floor disorders
- Failing to establish safe and effective methods for removal of transvaginal mesh
- Failing to adequately warn of potential complications and injury
Lawsuits claim the mesh implants caused:
- Extreme Pain
- Dyspareunia (pain during sexual intercourse)
- Recurrence of urinary incontinence
Blankenship, Campbell, Tyree and Wilson Claimed Organ Damage
Four lawsuits filed by four different plaintiffs were consolidated into a single trial in federal court in November 2014. Jeanie Blankenship, Carol Sue Campbell, Jacquelyn Tyree and Chris Rene Wilson claimed the Boston Scientific Obtryx implant that they received eroded, perforated their organs and caused severe pain. A New Jersey jury held Boston Scientific responsible for their medical bills and suffering. The four women split $14.5 in compensation and $4 million in punitive damages.
Hammons Sought Compensation for Revision Surgeries, Pain and Suffering
Patricia Hammons sued Johnson & Johnson after her Prolift implant failed, causing pain and medical problems. Hammons was forced to have numerous revision surgeries. During her trial, a Johnson & Johnson employee testified that the company didn’t create a plan to remove the mesh from patients. A jury ruled that the company was negligent and misrepresented the safety of the device. Hammons was awarded $5.5 million in compensation and $7 million in punitive damages.
Women and Husbands Seek Compensation for Mesh Injuries
Device manufacturers named in mesh lawsuits never recalled transvaginal mesh devices or offered compensation for injuries. So women were forced to seek compensation through the legal system.
Women have sought compensation for:
- Medical expenses, including the costs of additional surgeries
- Lost wages
- Lost spousal consortium
- Lower quality of life
- Pain and suffering
Husbands of women harmed by transvaginal mesh have been included in lawsuits. They seek compensation for loss of consortium. Loss of consortium refers to a loss of a relationship or normal marital relations.
Numerous women and their husbands have won lawsuit verdicts and received millions of dollars in compensation for their injuries. Some lawsuits have also awarded plaintiffs punitive damages, which are designed to discourage companies from wrongdoing.
ObTape Lawsuits in Georgia MDL
The first transvaginal mesh lawsuits involved a bladder sling called ObTape that was manufactured by Mentor. Its design was based on a bladder sling called ProteGen, but ProteGen was recalled in 1999 because of design flaws. Mentor sold ObTape from 2003 to 2006, but it never initiated a recall.
Women harmed by ObTape filed lawsuits against Mentor, seeking compensation for injuries. In 2008, the Judicial Panel on Multidistrict Litigation transferred cases involving ObTape to a multidistrict litigation court in the Middle District of Georgia. Judge Clay Land has overseen the litigation for almost a decade. A total of 857 lawsuits were filed in the court between 2008 and 2017.
Courts consolidate cases into multidistrict litigation when there are a large number of cases involving similar facts and the same defendant. Moving them to a centralized location reduces court costs and improves efficiency.
Johnson & Johnson bought Mentor in 2009, and the company has settled more than 100 lawsuits involving ObTape. In 2016, Judge Land asked the Judicial Panel on Multidistrict Litigation to stop transferring cases to the MDL. He said the MDL had received too many meritless lawsuits and cases that had exceeded the statute of limitations. The JPMDL has not closed the MDL, yet. Women seeking compensation for ObTape injuries can still file claims in state courts.
Mesh Lawsuits in the Southern District of West Virginia
By 2012, companies that manufactured transvaginal mesh products faced more than 650 lawsuits in state courts. In January of that year, plaintiffs’ lawyers asked the Judicial Panel on Multidistrict Litigation to consolidate the cases. In February, the panel agreed to consolidate cases against three companies into MDLs in the Southern District of West Virginia, where one MDL already exisisted. Three more MDLs were eventually formed.
The companies involved in the MDLs include:
C.R. Bard – Consolidated in October
American Medical Systems – Consolidated in February
Boston Scientific – Consolidated in February
Ethicon (Johnson & Johnson) – Consolidated in February
Coloplast – Consolidated in August
Cook Medical Inc. – Consolidated in June
Neomedic – Consolidated in February
Chief Judge Joseph R. Goodwin oversees each of the MDLs. The first bellwether trials in the MDLs began in July 2012. C.R. Bard lost the first trial, and Johnson & Johnson lost the next trial in February 2013. In July 2013, American Medical Systems avoided a trial by agreeing to a small settlement, and Bard lost its second bellwether trial.
Multiple companies have agreed to legal settlements in the last four years, including:
Settled 20,000 claims in May 2014
Settled 3,500 lawsuits between 2014-2015
Settled 400 lawsuits in January 2014
Johnson & Johnson
Settled four lawsuits in January 2015
Boston Scientific settled
Settled 3,000 claims in April 2015
Settled 112 claims in December 2015
Neomedic’s settlement resolved the majority of the legal claims against the company. The Neomedic MDL was terminated in January 2017. Cook is the only mesh manufacturer in an MDL that hasn’t faced a trial or agreed to a settlement. More than 100 claims against Cook have been dismissed since the MDL began. The judge found that the claims were made without merit.
Cases in Transvaginal Mesh MDLs as of March 2017
|Company||Pending Actions||Total Actions|
|American Medical Systems||4,245||20,819|
Johnson & Johnson, Bard and Boston Scientific each lost multiple cases that went to trial, and Judge Goodwin has urged the companies to settle more lawsuits. Coloplast has also been ordered to take action on pending cases.
After multiple settlements and verdicts were announced in 2015, mesh litigation made little progress in 2016. Judge Goodwin has continued to urge plaintiffs and defendants to move forward with settlement talks. Multiple trials are scheduled for 2017.
State Lawsuits Involving Transvaginal Mesh
When a lawyer files a lawsuit on behalf of a client, they can choose to file in state court or a federal MDL. Sometimes, state judges request that cases be transferred out of state court and into the MDL. Other times, state courts hear the cases, especially if the facts are unique to that state.
Several plaintiffs have won large verdicts in state court. The first mesh lawsuit that went to trial was held in California in 2012. Christine Scott won a $5.5 million verdict against Bard and her surgeon. Scott and her husband claimed her mesh implant caused her to feel severe pain, lose control of her bowel movements and experience dyspareunia (pain during intercourse). The jury ruled that Bard was negligent in its design and marketing.
Johnson & Johnson and Boston Scientific have also lost verdicts in state courts. Other companies have settled cases before they went to trial in state court.
The largest settlement involved a class-action agreement in 2016. Caldera Medical and several other companies, including Coloplast, agreed to resolve 2,000 claims for an estimated $11.75 million. The majority of mesh cases are handled in federal MDLs, but thousands are still pending in state courts.
Advice from a Transvaginal Mesh Lawyer
Laura Yaeger has represented thousands of individuals who have been harmed by manufacturers of dangerous drugs and medical devices. She is an advocate for transvaginal mesh victims, and she has a proven track record of success in complex litigation.
Today, she handles mass tort litigation, including cases related to transvaginal mesh, for Morgan & Morgan — a personal injury law firm serving clients from across the country.
“I’ve talked to hundreds and hundreds of women, they’re always very difficult conversations. You really can’t say anything to make their lives better. Their lives in some ways have been completely ruined. Even if we can get them justice – and have the manufacturers pay for their injuries – they’ll never be made whole again. That’s the most difficult part.”
– Attorney Laura Yaeger, transvaginal mesh victim advocate
Although lawyers who handle transvaginal mesh cases can’t repair the damage that mesh caused, they can help people harmed by mesh get compensation for their injuries.
“If a woman is injured from the mesh, and they would like to be compensated for their injuries, they have a certain time limit to file a claim,” Yaeger said. “If they have been harmed, they need to think about whether they want to move forward and have someone protect their interests. If they don’t do it soon, they may never be able to get compensation for their injuries.”
Transvaginal mesh lawsuits have become a part of one of the largest mass torts in U.S. history. A mass tort is a civil action involving multiple plaintiffs and corporate defendants. Device makers have not made the effort to willingly pay for the damage caused by their mesh implants. So women and their families have sought justice though the legal system. Thousands of women have received compensation after filing a lawsuit.