Transvaginal Mesh Lawsuit
$1.2 Million Verdict against Johnson & Johnson TVT-O Sling
On April 3rd, 2014, a Dallas, Texas jury awarded $1.2 million against Johnson and Johnson, one of the TVM manufacturers of the TVT-O bladder sling. This verdict was the first time a jury had the opportunity to decide whether J & J’s TVT-O bladder sling product was defectively designed. After hearing evidence for two weeks, the jury found that the medical device was defectively designed. The 64 year old plaintiff, Linda Batiste, is a former nurse who suffered serious pelvic pain and suffering after the TVT-O implant eroded inside her. Although the FDA ordered J & J and other vaginal mesh implant manufacturers to study rates of injuries to linked to mesh devices, the TVT-O device is still on the medical device market being implanted in women.
TVM MDL Bellwether Trial Schedule
The bellwether trials against each of seven (7) manufacturers are updated as follows:
- Donna Cisson v. Bard, Inc. - $2 Million Verdict – August 15, 2013
- Wanda Queen v. Bard, Inc. 2:11-cv-00012 - Settled August 21, 2013
- Carolyn Jones v. Bard, Inc. 2:11-cv-00114 - Settled.
- To Be Announced – MDL Trial starting January 30, 2015.
- Carolyn Lewis v. Johnson & Johnson, et al. Defense Judgment
- Huskey v. Ethicon, et al. to begin August 25, 2014
- Edwards v. Ethicon, et al. to follow
- Dianne Bellew v. Ethicon, Inc., et al. (Prolift) December 4, 2014
- Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) to follow
- Canterbury, et al. v. Boston Scientific Corp. Trial begins October 14, 2014.
- Member cases: Billings, Hendricks, Sexton, Moore, Tyree, Campbell, Blankenship, Pugh, Workman, Wilson
1 – 5. The following cases have been resolved and their trials (scheduled for June 2, 2014, July 7, 2014, and August 19, 2014) cancelled: Serrano 2:12-cv-03719; Jilovec 2:12-cv-05561; Weiler 2:12-cv-05836; Fontes 2:12-cv-02472; and Najor 2:12-cv-6722. 6. Pattison v. AMS, 2:12-cv-7154, remains scheduled for August 19, 2014.
There are no bellwether trials scheduled for the following MDLs:
- MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation
- MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation
- MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation
Judge Upholds Bard Two Million Dollar Transvaginal Mesh Verdict - On October 18, 2013, U.S. District Judge Joseph R. Goodwin denied C.R. Bard’s attempt to reverse the $2 million dollar verdict for Donna Cisson. The judge’s well reasoned opinion noted sufficient evidence was produced that Bard knew materials in the polypropylene mesh were not for human use and surreptitiously obtained the mesh materials from the polypropylene manufacturer through a third party. Plaintiffs’ attorneys argued that the design and polypropylene material used in the Bard Avaulta Plus led to Cisson suffering injuries that included inflammation, extrusion, erosion, and excessive scarring. As a result, Cisson suffered pain during intercourse, while sitting, and during gynecological exams.
Use of Dangerous Polypropylene Key Issue in Verdict
During the trial, sufficient evidence was presented that revealed:
- Bard knew the plastic used in the mesh was not fit for human use, and
- Bard knew about the problems for at least a decade (10 years). The company has since removed Bard Avaulta mesh from the market.
The jury found Bard liable for Cisson’s injuries and awarded $250,000 in compensatory damages, as well as another $1.75 million in punitive damages. After trial, Bard argued that the jury was not shown evidence that could reasonably lead to that conclusion.
Bard’s Knowledge of Danger
The plaintiffs produced a Material Safety Data Sheet (MSDS) in Bard’s possession from Chevron Phillips regarding the polypropylene used in the Avaulta mesh that warned: “MEDICAL APPLICATION CAUTION: Do not use this Chevron Phillips Chemical Company LP material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
Bard’s Conscious Indifference
Judge Goodwin’s opinion noted, “I find that a reasonable jury could find by clear and convincing evidence that Bard’s conduct exhibited an entire want of care raising the presumption of conscious indifference to the consequences,” Further, “Bard was thus on notice that products made from polypropylene resin should not be permanently implanted in the human body. However, Bard failed to ask Phillips about the MSDS warning. In fact, Bard intentionally avoided alerting Phillips that it was surreptitiously purchasing Phillip’s polypropylene resin via third parties.”
Judge Goodwin detailed Bard’s scheme to cover up that the manufacturer was buying the product to use in female bodies. At one point the supplier, Shakespeare Co.. refused to sell the material to Bard after the Phillips MSDS warning was revealed. Bard was so brazen as to offer to indemnify Shakespeare. However, Shakespeare Co. made it clear that “under no circumstance” would the company sell Bard the material for medical device use.
Bard Failure to Conduct Human Tests
The Judge further opined that there is evidence to suggest that Bard understood the dangers of using polypropylene for tissue repair, including;
- a higher risk of erosion and infection;
- a greater amount of scar tissue formation around the mesh; and
- a tendency to unravel, creating a sharp ‘fishing line’ effect, which can slice through patient’s tissue,
Judge Goodwin further admonished. “However, even with this knowledge, Bard conducted no human tests before placing the Avaulta Plus on the market.
C.R. Bard Settles First New Jersey Trial
The first New Jersey Bard Avaulta mesh case scheduled for trial September 23, 2013, was settled under confidential terms. The plaintiff, Melanie Virgil, a 56 year old Colorado teacher, underwent numerous surgeries for complications associated with Avaulta mesh.
C.R. Bard Settles Second Bellwether Trial
C.R. Bard agreed to a confidential settlement of the second MDL transvaginal mesh bellwether trial. Wanda Queen, the plaintiff in the second Bard lawsuit claimed to have suffered injuries with the Avaulta Solo Anterior Synthetic Support System mesh implanted in North Carolina and required numerous surgeries to revise and remove the product.
The third bellwether trial in the federal litigation is scheduled to begin on November 8, 2013. C.R. Bard and other manufacturers are facing over 20,000 lawsuits in the U.S. District Court for the Southern District of West Virginia before Judge Joseph Goodwin. The plaintiffs allege that Bard’s transvaginal mesh caused injuries, including, physical pain, permanent injury, physical disfigurement, and loss of consortium.
August 15, 2013 – $ 2 Million Verdict in Bard MDL Bellwether Trial
The jury in the first Bard MDL bellwether trial in West Virginia returned a verdict in favor of the plaintiffs, finding for the plaintiffs on both design defect and failure to warn, and awarding $250,000 in compensatory damages. The jury also determined that punitive damages were warranted, and returned a punitive damages verdict of $1.75 million.
The trial involved a Bard Avaulta Plus posterior mesh that had been implanted in plaintiff Donna Cisson, 55, in 2009. The plaintiffs alleged that women continue to complain with the Avaulta Plus implant even after the mesh is removed because the arms of the implant are firmly implanted in the levator ani muscles, which provide support for the pelvic floor and aids in urination and defecation. The mesh will shrink and cause the muscles to spasm and the mesh arms serve as a saw cutting the pelvic floor muscles causing a woman’s ongoing pain, long after the center portion of the mesh is removed. Some surgeons feel it is too dangerous to retrieve the mesh arms used to anchor the mesh in place due to the deep placement in the tissues. Additionally, the Avaulta Plus posterior implant is a version of the Avaulta Solo implant coated with porcine collagen. The manufacturer’s theory was that the porcine collagen would decrease the risk of erosion, however, that has not been the desired result for many women.
Clean Contaminated Field
Another complication with TVM is its passage through the vaginal area where incisions are cut and steel tools are used to pull the plastic mesh into the pelvic region. The vagina is a clean contaminated field that can never be sterilized. If infection is introduced during the passage, there will be erosion of the mesh. This is unlike a hernia mesh, which is never pulled blindly through a contaminated area.
Mesh Inserted by Blind Passage of Trocars
The blind passage of trocars through the area with important blood vessels and muscles, the side-to-side attachment, puncture of the levator ani area and mesh shrinkage affects normal sexual functioning and pain.
Mesh Inserted through a Contaminated Area
The instructions for use (IFU) or warning label that accompanied the product simply stated, “Potential adverse reports, are those associated with any permanently implanted materials.” The warning is inadequate as it fails to mention that the mesh is implanted in the vagina, which is not a sterile environment. As such, the mesh is pushed through a contaminated area, unlike a clean area into which the hernia mesh is inserted.”
Massive Mesh Volume
Polypropylene mesh has more complications than polypropylene sutures as the sheer volume in the Avaulta mesh overwhelms the amount of mesh you might find in a suture. Some medical personnel state,”the more mesh, the more mess.”
February 28, 2013 - $11.11 Million Verdict in 2nd TVMesh Trial
A New Jersey jury returned a $3.35 million compensatory and $7.76 punitive verdict to a South Dakota nurse in a transvaginal mesh case against Johnson & Johnson, claiming that J & J failed to adequately warn the nurse’s doctor of the potential dangers of a vaginal mesh implant made by the company’s Ethicon subsidiary and for misrepresenting the product in brochures. The nurse filed her lawsuit after having surgery in 2006 to insert a Gynecare Prolift for pelvic prolapse, but later developed a variety of problems, including mesh erosion, scar tissue, inflammation and neurologic compromise to her pelvic structures and tissue. She repeatedly sought medical treatment including 18 operations to repair the damage caused by the mesh. The suit was filed in 2008 and the trial began in January 2013 ending with a plaintiffs verdict after six weeks of testimony from experts, scientists, J & J company representatives, doctors and fact witness. This sends a strong message to Transvaginal Mesh manufacturers about the safety of their implants.
Approximately 20,000 other transvaginal mesh claims are filed in federal court MDLs against Ethicon, C.R. Bard Inc, Boston Scientific Corp, Coloplast, and Endo Health Solutions’ American Medical Systems Inc. Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from five surgical mesh manufacturers. These complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are usually placed transvaginally for minimally invasive placement. Complications include:
- erosion through the vaginal tissue
- urinary problems and/or incontinence
- recurrence of prolapse
- bowel, bladder, and blood vessel perforation during insertion
- dyspareunia or pain during sexual intercourse
Treatment of the complications includes additional surgical procedures to revise or remove the mesh, IV therapy, blood transfusions, and drainage of hematomas or abscesses from infection.
July 23, 2012 – $5.5 Million Verdict in 1st TVMesh Trial
For the first time in the nation, a jury awarded a California couple $5.5 million against Bard, one of the TVMesh manufacturers, claiming they knew their product was unsafe. The TVMesh claimant was an active runner and had the mesh implanted to correct her leaking bladder. But, the TVMesh began cutting her colon, and tissue continues to grow through the tiny holes in the mesh. She has already had eight surgeries and does not know how many more she will need. The jury awarded the TVMesh claimant $5 million and her husband $500,000, claiming the mesh has ruined their love life. It’s a landmark victory, the first of its kind in the country.
In July 1, 2012, Bard Medical stopped selling the Avaulta Mesh in the United States because the FDA wanted more clinical trials done. But, it’s still sold in other countries. Claims against sling, tape and mesh products are moving forward at a rapid pace.
On June 4, 2012: Johnson and Johnson/Ethicon withdrew four mesh products from the US Market, including its controversial Gynecare Prolift, Prolift+ M, TVT Secur and Prosima systems,. In a letter filed with U.S. District Judge Goodwin, Ethicon also will advise healthcare providers to select alternative treatments for their patients.
History of Warnings:
Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.
Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.
In October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the huge number of complications experienced by women, including erosion of the vaginal tissues. Ironically, a majority of the transvaginal mesh are based upon this recalled defective device!
On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).
On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.
On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.
On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.
Transvaginal Mesh Products & Manufacturers include:
- Prolift +M
- Gynemesh/Gynemesh PS
- TVT-Obturator (TVT-O)
- TVT-SECUR (TVT-S)
C. R. Bard
- Avaulta Plus™ BioSynthetic Support System
- Avaulta Solo™ Synthetic Support System
- Faslata® Allograft
- Pelvicol® Tissue
- PelviSoft® Biomesh
- Pelvitex™ Polypropylene Mesh
American Medical Systems
- Obtryx® Curved Single
- Obtryx® Mesh Sling
- Obtryx Transobturator Mid-Urethral Sling System
- Prefyx Mid U™ Mesh Sling System
- Prefyx PPS™ System
- Uphold Vaginal Support System
- Pinnacle Pelvic Floor Repair Kit
- Advantage Transvaginal Mid-Urethral Sling System
- Advantage Fit System
- Solyx SIS System
- T-Sling-Universal Polypropylene Sling
- Aris-Transobturator Sling System
- Supris-Suprapubic Sling System
- Novasilk-Synthetic Flat Mesh
- Suspend-Tutoplast Processed Fascia Lata
- Exair-Prolapse Repair System
- Axis-Tutoplast Processed Dermis