Vaginal Mesh Lawsuits in 2023

Vaginal mesh litigation has become one of the most significant mass torts in recent history, involving thousands of lawsuits against multiple transvaginal mesh (TVM) product manufacturers. This article provides a history of the vaginal mesh litigation and gives you the lay of the land for bringing a vaginal mesh lawsuit in 2023.


UPDATES:

September 1, 2023: Boston Scientific Corp. has settled a lawsuit in a Georgia federal court over allegations related to its pelvic mesh product, Obtryx. The lawsuit claimed that the mesh caused debilitating pain and complications.

The terms of the settlement were not disclosed, and the agreement is expected to be finalized within 90 days. The plaintiff filed the suit in 2022, contending that the mesh led to chronic pain and nerve damage. The lawsuit further alleged that Boston Scientific was aware of the risks associated with the product, as indicated by FDA warnings in 2011, but continued to market it as safe. This settlement follows previous legal actions involving Boston Scientific’s surgical mesh products.

Defendants do not want to let these cases go to trial if they are not sure they can win.  Because it restarts the energy in the litigation.

August 14, 2023: The 8th Circuit Court of Appeals recently upheld a decision dismissing a woman’s vaginal mesh lawsuit because she filed her expert opinion too late. Had the woman gotten her expert report submitted within the deadline, this would have been a viable case, but the failure ultimately led to the dismissal of her claims because without expert testimony these cases cannot proceed.

March 24, 2023: The 11th Circuit U.S. Court of Appeals has upheld a $500,000 verdict in a pelvic mesh case against Coloplast Corp. The court determined that the evidence supported the jury’s finding that the mesh device could cause the claimed injury and specifically caused the plaintiff’s injury. The plaintiff, who suffered from stress urinary incontinence and pelvic organ prolapse, received two different mesh implants, one by Coloplast and one by Boston Scientific Corp., which led to complications including erosion, pain, and bleeding. The court rejected Coloplast’s argument that there was insufficient evidence for general causation and that the mesh’s benefits outweighed its risks. It also ruled that expert testimony supported the verdict, emphasizing that the jury considered substantial evidence regarding the potentially harmful effects of polypropylene mesh. The decision affirmed the jury’s conclusion that the mesh’s risks outweighed its benefits, and it clarified that the ruling did not establish automatic liability for prescription-only products but was based on the specific evidence presented during the trial.


Origins of Vaginal Mesh Use and Problems

Transvaginal mesh is a medical device used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. These conditions occur when the pelvic muscles and tissues weaken, causing organs like the bladder, uterus, or rectum to descend into the vagina. To address this issue, surgeons began using surgical mesh in the 1970s for the abdominal repair of POP. In the 1990s, the use of mesh was expanded to treat SUI through a transvaginal approach.

The U.S. Food and Drug Administration (FDA) cleared the first TVM product for marketing in 1996 through the 510(k) clearance process, which allows medical devices to be approved without clinical trials if they are considered substantially equivalent to an existing approved device. This paved the way for other manufacturers to enter the market, and by the 2000s, several companies were producing TVM products.

However, soon after the introduction of TVM products, patients and healthcare professionals began reporting complications associated with their use. Some of these complications included mesh erosion (where the mesh wears through the vaginal wall), organ perforation, infection, chronic pain, and urinary problems. These complications often required multiple revision surgeries, causing significant physical and emotional distress for the affected women.

Vaginal Mesh Complications

Women have been through a lot with the defects in how these vaginal mesh products.  Vaginal mesh complications can be severe and life-altering, affecting patients’ physical and emotional well-being. Some common complications associated with vaginal mesh implants include:

  1. Mesh erosion: The mesh can erode through the vaginal tissue or other surrounding organs, causing pain and discomfort, often requiring additional surgeries to repair or remove the mesh
  2. Pain: A critical element of damages in these lawsuits is the chronic pain, usually in the pelvic region, that women have during intercourse or even while sitting or walking
  3. Infection: Mesh implants can lead to infections, which may require antibiotic treatment or even surgery to remove the infected mesh
  4. Organ perforation: In some cases, the mesh may puncture nearby organs, such as the bladder, bowel, or blood vessels, requiring immediate medical attention and possibly additional surgeries
  5. Urinary problems: Women may develop urinary incontinence, retention, or recurrent urinary tract infections due to the mesh implant
  6. Vaginal scarring or shrinkage: The mesh can cause scarring or shrinkage of the vaginal tissue, leading to discomfort or pain, particularly during sexual intercourse
  7. Recurrence of pelvic organ prolapse (POP) or stress urinary incontinence (SUI): In some instances, the original condition for which the mesh was implanted may recur, necessitating further treatment or surgery
  8. Emotional and psychological distress: Dealing with the physical complications of a vaginal mesh implant can lead to pain and suffering, and jury’s have compensate victims for that emotional and psychological distress

FDA Warnings and Public Awareness

In response to the growing number of reports about TVM complications, the FDA issued a Public Health Notification in 2008, warning healthcare providers and patients about the potential risks of TVM devices. The notification also urged manufacturers to provide more comprehensive information about these risks in their product labeling.

In 2011, the FDA released an updated safety communication, stating that serious complications associated with TVM products for POP repair were not rare and that there was no evidence to prove that TVM was more effective than non-mesh methods for treating POP. This announcement attracted significant media attention and raised public awareness about the potential dangers of TVM devices.

Beginning of Vaginal Mesh Litigation

The first transvaginal mesh lawsuit was filed in 2009, marking the beginning of the vaginal mesh litigation. In the following years, thousands of lawsuits were filed against various TVM manufacturers, including Johnson & Johnson (Ethicon), C.R. Bard, Boston Scientific, American Medical Systems (AMS), Coloplast, and others.

These lawsuits alleged that TVM manufacturers were negligent in their design, testing, and marketing of the devices, and failed to warn healthcare providers and patients about the potential risks and complications associated with their use. The plaintiffs sought compensation for their physical and emotional suffering, medical expenses, and lost wages.

MDL Class Action and Bellwether Trials

Due to the growing number of vaginal mesh lawsuits, the Judicial Panel on Multidistrict Litigation (JPML) consolidated federal cases into several multidistrict litigations (MDLs) in 2012. Each MDL targeted a specific manufacturer, streamlining the pretrial process and allowing for more efficient handling of the cases.

Lawsuits involving vaginal mesh were consolidated into seven multidistrict litigations (MDLs) against C.R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp., Ethicon, Inc., Coloplast Corp., Cook Medical, Inc., and Neomedic. This coordinated litigation expanded to encompass over 100,000 cases, making it one of the largest mass tort litigations in the history of the United States.

The United States Judicial Panel on Multidistrict Litigation assigned these MDLs to U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia’s Charleston courthouse. At this point, only a small fraction of the original cases are still ongoing.  But new vaginal mesh lawsuits are still being filed in 2023.

Bellwether trials, which are test cases intended to gauge the strengths and weaknesses of both sides’ arguments and potentially guide settlement negotiations, were held in several of these MDLs. Some of the notable bellwether trial verdicts included:

  • In 2012, a jury awarded $3.6 million to a plaintiff in a case against C.R. Bard, finding the company liable for the plaintiff’s injuries caused by their TVM product.
  • In 2013, a jury awarded $11.1 million to a plaintiff in a case against Johnson & Johnson’s Ethicon, which included punitive damages for the company’s negligence in manufacturing and marketing their TVM product.
  • In 2014, a jury awarded $26.7 million to four plaintiffs in a case against Boston Scientific, holding the company responsible for the injuries caused by their TVM devices.
    These bellwether trial verdicts demonstrated that plaintiffs had strong cases against TVM manufacturers, and as a result, some manufacturers began to explore settlement options to resolve the pending lawsuits.
  • In 2016, a New Jersey jury awarded a woman and her husband $33 million in compensatory damages, including medical expenses, and an additional $35 million in punitive damages after finding C.R. Bard responsible for design and failure-to-warn defects under North Carolina products liability law, the home state of the plaintiffs. However, the verdict was overturned in 2021 due to an evidence error by the trial judge.
  • In 2017, a jury awarded a record $57.1 million to a woman in her 50s who had a vaginal mesh implanted in 2007, followed by a second device implanted two months later, which eroded through her urethra three times, each time necessitating surgery; the verdict included $50 million in punitive damages.

Settlements and Continued Litigation

Several TVM manufacturers decided to settle a substantial number of lawsuits to avoid further litigation and the potential for large jury verdicts. Some notable settlements included:

  • In 2013, AMS agreed to settle around 20,000 lawsuits for a total of $1.6 billion
  • In 2014, Coloplast settled approximately 400 lawsuits for $16 million
  • In 2015, C.R. Bard settled more than 3,000 lawsuits for a total of $200 million
  • In 2018, Boston Scientific settled around 50,000 lawsuits for a total of $189 million

Despite these settlements, thousands of vaginal mesh lawsuits remained pending against various manufacturers. In 2019, the JPML established a new MDL to handle the influx of new cases, consolidating them against multiple manufacturers, including Johnson & Johnson, C.R. Bard, and Boston Scientific.

  • Over $300 million for consumer class action against Johnson and Johnson

FDA Actions and Regulatory Changes

In response to the ongoing concerns regarding the safety and effectiveness of TVM products, the FDA took several actions to increase regulatory oversight and improve patient safety:

  • In 2012, the FDA ordered manufacturers of TVM products to conduct post-market surveillance studies to assess the safety and effectiveness of their devices
  • In 2016, the FDA reclassified TVM devices for POP repair from class II (moderate risk) to class III (high risk), requiring manufacturers to submit premarket approval applications for these devices (no more backdoor product approvals)
  • In 2019, the FDA – finally! – ordered all manufacturers of TVM devices for POP repair to stop selling and distributing their products in the United States, citing insufficient evidence of their safety and effectiveness

Vaginal Mesh Litigation in 2023

As of today, vaginal mesh litigation is ongoing, with thousands of lawsuits pending against various manufacturers. While many cases have been resolved through settlements, some manufacturers continue to litigate and defend their TVM products in court and victims continue to file these transvaginal mesh lawsuits.

The FDA’s regulatory actions and the increased scrutiny of TVM devices have led to significant changes in the medical community’s approach to treating POP and SUI. Many healthcare providers now opt for non-mesh alternatives for POP repair and use TVM products more cautiously for SUI treatment.

Current Status of Vaginal Mesh Class Action Lawsuits

In the early days of the litigation, the transvaginal mesh lawsuits pending in federal courts were consolidated into seven separate class action MDLs. Each MDL involved claims against a specific vaginal mesh manufacturer: (1) C.R. Bard (2) Boston Scientific Corp. (3) American Medical Systems (4) Ethicon (5) Coloplast (6) Cook Medical, and (7) Neomedic. At their peak, there were around 100,000 plaintiffs with cases pending in these 7 class action MDLs. The chart below shows the number of plaintiffs in the 4 biggest transvaginal mesh class actions:

COMPANY TOTAL CASES
C.R. Bard 15,868
American Medical Systems 21,367
Boston Scientific 26,617
Ethicon 40,761

As of 2023, 95% of the cases pending in these vaginal mesh class action MDLs have been resolved through settlement and are no longer pending. Billions in settlement compensation have been paid out to victims. Vaginal mesh lawsuits continue to get filed as new women are injured by these mesh implants, but these new cases are not being handled in the class action MDLs.

Who is Eligible to File a Transvaginal Mesh Lawsuit in 2023?

Even though most of the cases in the vaginal mesh class action lawsuits have been settled, it is not too late to file a vaginal mesh lawsuit. As of April 2023, large numbers of vaginal mesh product liability lawsuits continued to get filed in courts across the country. The current vaginal mesh plaintiffs primarily include women who had a transvaginal mesh implanted and suffered complications or injuries directly related to the implant within the last few years.

One of the primary concerns for prospective vaginal mesh plaintiffs looking to file a lawsuit in 2023 is whether the applicable statute of limitations has expired on their claim. Each state has its own statute of limitations for personal injury cases, but in most states the SOL is around 2-3 years. Whatever the applicable SOL period is in your state, it doesn’t begin to run until your vaginal mesh injury or complication first occurred. As long as the first occurrence of your vaginal mesh complications occurred with the last 1 or 2 years, you will probably not have to worry about the statute of limitations.

Can You Join a Vaginal Mesh Class Action?

The vaginal mesh class action MDLs have mostly been settled and are now closed to new cases. However, if you were injured by complications related to a vaginal mesh or pelvic mesh, you can still file a product liability lawsuit against the implant manufacturer. Your lawsuit will not be consolidated into a class action MDL. Instead, your case would just proceed on its own against the defendant.

Potential Settlement Amounts of Vaginal Mesh Lawsuits

Based on prior settlements and verdicts in earlier vaginal mesh lawsuits and in the class action MDL settlements, we have a pretty good idea of what the potential settlement value of a good vaginal mesh case could be. Our lawyers estimate that a successful vaginal mesh injury lawsuit in 2023 would have a settlement payout value of around $150,000 to $450,000.  How much your vaginal mesh case is worth and where it falls in this settlement range would depend on various factors including the severity of the physical injuries and the age of the plaintiff.

Contact Us About a Vaginal Mesh Lawsuit

Our national product liability lawyers are currently accepting new vaginal mesh lawsuits from women who suffered complications and injuries related to a vaginal, transvaginal, or pelvic mesh implant. Contact us at 800-553-8083 for a free consultation or contact us online.

 

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