2018 Vaginal Mesh Lawsuit News: An exposé on CBS’s 60 Minutes highlighted more than 48,000 transvaginal mesh lawsuits against Boston Scientific, with more than 100,000 TVM lawsuits total in federal courts against manufacturers like Johnson & Johnson (Ethicon) and C. R. Bard. If you have had problems after undergoing mesh surgery, discuss your legal options with a lawyer today.
In the U.S. and around the world, thousands of women have been harmed by transvaginal mesh implants, with many requiring multiple surgeries to have the mesh removed. Vaginal mesh was widely used to treat pelvic organ prolapse and other pelvic floor disorders, despite a lack of long term data concerning its safety, and around 10% of patients have experienced complications, often severe. The debilitating pain and potentially permanent side effects, in addition to financial concerns and emotional difficulties, have left many patients seeking justice.
Thousands of lawsuits have been filed against the pharmaceutical companies responsible for manufacturing and distributing these devices, with some ending in multimillion dollar settlements. Of those that have progressed to trial verdicts, juries have frequently found in favor of plaintiffs and awarded compensation for pain and suffering. Many such verdicts have been contested by the pharmaceutical companies in question, with some decisions later reversed in higher courts.
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FDA Approval and Actions
Surgical mesh has been used since at least the 1950s, initially for the hernia repair and other reconstructive surgeries. In the 1970s, many gynecologists began to use surgical mesh to treat pelvic organ prolapse (POP) – a condition in which tissues in the pelvic floor weakened or stretched, often in response to pregnancy and childbirth – as well as stress urinary incontinence (SUI). As time went on, the use of gynecological mesh increased, with thousands of women receiving pelvic mesh implants.
In 1976, the amended Federal Food, Drug, and Cosmetic act gave the FDA authority to regulate medical devices; however, devices that were already on the market at the time of the amended act were subject to a different classification process than new medical devices developed after the passage of the act. As such, surgical mesh was classified as a Class II medical device, which did not require premarket approval.
As women began to report problems they had with their gynecological mesh, the U.S. Food and Drug Administration (FDA) looked closer at the adverse event records. After studying the thousands of reports that came in between 2005 and 2010, the FDA eventually issued a notice changing the classification of vaginal mesh from a Class II to a Class III medical device, requiring premarket approval for surgical mesh devices going forward.
FDA Timeline of Urogynecological Mesh Actions
- October 2008: Public health notification about more than 1,000 reports during the preceding three years related to gynecological mesh
- July 2011: FDA safety communication update on serious transvaginal mesh complications, with more than 2,800 additional reports submitted between January 2008 and December 2010
- May 2014: FDA published a proposed order requiring premarket approval for surgical mesh used in transvaginal pelvic organ prolapse repair
- January 2017: The proposed premarket approval requirement went into effect, with updated rules published in the Federal Register
- September 2017: Another FDA safety communication related specifically to synthetic materials used to make Boston Scientific’s composite mesh
Lawsuits Against Ethicon (J&J)
Ethicon, a division of Johnson & Johnson, has been the subject of thousands of vaginal mesh lawsuits, with many women naming its Gynecare TVT Abbrevo product as responsible for their injuries. Despite the multitude of lawsuits concerning Abbrevo, this product continues to be sold. Other transvaginal mesh recalls have since been issued by Ethicon, although the manufacturer has not admitted that safety concerns were behind this decision.
Transvaginal mesh lawsuits list a variety of claims, depending mostly on the complications experienced by the women filing the suits. In many cases, women who experience any of these severe side effects have limited treatment options, which may include additional surgeries to remove the pelvic mesh and repair damaged tissue.
Transvaginal Mesh Lawsuit Side Effect Claims
- Infection, pain, discomfort, allergic reaction, or irritation near the surgery site
- Difficulty urinating, incontinence and involuntary urination
- Pain during everyday activities, including urination and sexual intercourse (dyspareunia)
- Organ perforation or mesh erosion into nearby organs and tissue (e.g., bowel, bladder or vaginal epithelium)
- Recurrent pelvic organ prolapse
Important: If you experience these or any other symptoms after your transvaginal mesh surgery, talk to your doctor or healthcare provider right away to understand your treatment options.
Due to the volume of lawsuits against Ethicon, these cases have been consolidated into multidistrict litigation overseen by U.S. District Judge Joseph R. Goodwin. Collectively, they are known as MDL No. 2327. Approximately 40,000 cases in this MDL are still pending. Ethicon has set aside an undisclosed amount of money to cover their litigation expenses, as well as settlements and court decisions.
Note: Many of the composite mesh products (or similar brands like Atrium C-QUR mesh, Ethicon Physiomesh, and Composix Kugel Mesh) at the center of these legal claims are also the subject of hernia mesh lawsuits. If you or a loved one has had hernia surgery and experienced a complication like bowel perforation, bowel obstruction or hernia recurrence, connect with a law firm that specializes in defective product cases today.
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Gross v. Ethicon
In February 2013, a jury awarded $11 million in compensatory and punitive damages to a South Dakota couple. Linda Gross required 18 surgeries (including nine to remove the mesh implant) after Ethicon’s Gynecare Prolift device caused her to experience chronic pain. In March 2015, this verdict was affirmed in the Appellate Division. Ethicon petitioned for this affirmation to be reviewed, but their request was denied by the New Jersey Supreme Court in December 2015.
Batiste v. McNabb
In April 2014, a jury in Texas awarded $1.2 million in compensatory damages after finding that Ethicon’s TVT-O vaginal mesh had a dangerous design defect. But this verdict was later reversed and the plaintiff’s award stripped when a Texas appellate court concluded in November 2015 that there was not sufficient evidence to prove a design defect caused the plaintiff’s injuries.
Huskey v. Ethicon
In September 2014, $3.27 million was awarded to a woman injured by Ethicon’s TVT-O vaginal mesh. The West Virginia federal jury concluded Ethicon’s device was faulty, and sufficient warnings about the risks of the mesh had not been provided.
Bellew v. Ethicon
In March 2015, Ethicon settled a case relating to its Gynecare Prolift mesh device on the fifth day of the trial. Ethicon has not disclosed details of the settlement.
Cavness v. Kowalczyk et al
In October 2015, a Texas jury ruled in favor of Ethicon in the first of many lawsuits blaming its Gynecare Prosima device for pain and suffering. The jury decided a design defect was not to blame for the plaintiff’s pain, despite the product having being pulled from the market by its manufacturer.
Engleman v. Ethicon
In April 2017, a Philadelphia jury awarded a New Jersey woman $2.5 million in damages. They also hit Ethicon with punitive damages of $17.5 million. The plaintiff experienced severe pain after being fitted with Gynecare TVT-Secur mesh for incontinence, and required multiple surgeries to have it removed.
In its first large transvaginal mesh settlement, Ethicon paid $120 million dollars in January 2016 to resolve as many as 3,000 cases. Judge Goodwin has allegedly advised Ethicon to settle more cases in MDL No. 2317.
Other Mesh Lawsuits (Boston Scientific, Bard, etc.)
Ethicon is not the only producer of transvaginal mesh facing a multitude of lawsuits related to their products. Boston Scientific and C. R. Bard are amongst the other mesh manufacturers hit hard by mesh litigation.
Boston Scientific Mesh Lawsuits
As of May 2018, there are currently more than 48,000 lawsuits in federal and state courts against Boston Scientific due to its synthetic mesh implants. While Boston Scientific has settled some of the lawsuits against it – such as a $119 million settlement in 2015 that resolved approximately 3,000 claims – there are still thousands of outstanding cases pending against the company.
C. R. Bard Mesh Lawsuits
C. R. Bard has also been named as a defendant in tens of thousands of transvaginal mesh lawsuits, and has paid more than $200 million in settlements to date related to its Avaulta brand and other mesh products.
Foreign Mesh Lawsuits
These cases are not limited to the United States alone. A civil case brought by 450 Australian women against Johnson & Johnson will begin in July 2017. A further 300 women have filed a class action lawsuit against American Medical Systems. In the United Kingdom, manufacturers of transvaginal mesh and the National Health Service are being sued by more than 800 women. Thousands more class action and civil lawsuits are in progress or are expected to be filed around the world, with the global cost of transvaginal mesh legal action already reaching billions of dollars.
Filing a Vaginal Mesh Lawsuit
If you or someone you care about has experienced complications as a result of transvaginal mesh, you may be entitled to file a claim.
Plaintiffs have claimed that pharmaceutical companies responsible for manufacturing mesh devices failed to provide adequate warnings about the risks and potential side effects. Many argue these companies deliberately misrepresented the safety of their mesh products.
Both women and their spouses have sought compensation for the negative impact the mesh has had on their lives, including:
- Pain and suffering
- Loss of consortium (loss of marital relations)
- Medical expenses, including
- Loss of wages
- Lower quality of life
The statute of limitations for filing a transvaginal mesh lawsuit varies significantly between states. Plaintiffs have 1 – 10 years from the time they become aware of their injuries to file a claim, depending on product liability laws where they live. That’s why it’s important to speak to a lawyer specializing in vaginal mesh cases to understand your rights and find out what’s best for you and your family.
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