Transvaginal Mesh Lawsuits
Bellwether Trials Began Against Boston Scientific, Scheduled Against C. R. Bard and Ethicon
Transvaginal mesh trials began against Boston Scientific and are scheduled over the next three months against C.R. Bard and Ethicon/Johnson and Johnson. The verdicts in the bellwether trials assist in the evaluation and resolution of the remaining cases in litigation. Over 66,000 pelvic mesh cases against seven manufacturers are consolidated in the MDL. Ethicon lawsuits are in the majority, with close to 22,000, followed by American Medical Systems nearing 19,000, Boston Scientific lawsuits approximate 14,000, and C.R. Bard lawsuits number over 10,000. Coloplast, Cook and Neomedic lawsuits are in smaller numbers.
TVM MDL Bellwether Trial Schedule
In multidistrict litigation, exemplar cases, called bellwether cases, are chosen by the lawyers and Judge. The bellwether trials are updated as follows:
- Hendricks, et al. v. Boston Scientific Corp. Trial began November 3, 2014.
- Member cases: Moore, Tyree, Campbell, Blankenship, Pugh, Wilson
- Eghnayem v. Boston Scientific (Florida Pinnacle) Trial began November 3, 2014.
- Member cases: Dortes, Betancourt, Nunez
MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation
- Carolyn Lewis v. Ethicon, et al. Defense Judgment
- Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
- Dianne Bellew v. Ethicon, Inc., et al. (Prolift) Trial begins December 4, 2014
- Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) dismissed
- Donna Cisson v. Bard, Inc. - $2 Million Verdict
- Wanda Queen v. Bard, Inc. 2:11-cv-00012 - Settled.
- Carolyn Jones v. Bard, Inc. 2:11-cv-00114 - Settled.
- To Be Announced – Trials starting January 30, 2015.
MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Product Liability Litigation
- 1 – 5. The following cases have been resolved and their trials 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, is continued until further notice by the court.
- Bellwether Trials To Be Named: April 20, 2015 8:30 am, May 18, 2015 at 8:30 am, June 8, 2015
There are no bellwether trials scheduled in MDL No. 2387 Coloplast or MDL 2511 Neomedic
The plaintiffs have won seven trials and the defendants have won three. An undisclosed number of plaintiffs have entered into confidential settlement agreements. A brief summary of the verdicts follows:
July 20, 2012: $5.5 million was awarded to Christine Scott against C.R. Bard by a California jury. Ms. Scott had nine revision surgeries after the Avaulta Plus mesh was implanted in 2008.
February 2013: $11.11 million was awarded to Linda Gross against Ethicon and Johnson & Johnson by a New Jersey jury. Ms. Gross, a nurse, had eighteen revision surgeries after the Prolift mesh was implanted. $7.76 million of the award is punitive damages.
August 15, 2013: $2 million was awarded to Donna Cisson against C.R. Bard in the MDL in West Virginia. Ms. Cisson had three removal surgeries after the Avaulta mesh was implanted.
February 18, 2014: Nothing was awarded to Carolyn Lewis against Ethicon and Johnson & Johnson in the MDL. Ms. Lewis was implanted with a TVT-O sling and the Judge directed a verdict in favor of the defendants after presentation of Ms. Lewis’ evidence.
April 4, 2014: $1.2 million was awarded to Linda Batiste by a Dallas jury against Ethicon, Inc. and Johnson & Johnson. Batiste was implanted with a TVT-O sling in January 2011.
July 28, 2014: Nothing was awarded to Diane Albright from a Massachusetts jury in her suit against Boston Scientific. Ms. Albright suffered from injuries after implantation of Pinnacle mesh.
August 29, 2014: Nothing was awarded to Maria Cardenas from a Massachusetts jury in her suit against Boston Scientific. Ms. Albright suffered from injuries after implantation of an Obtryx sling.
September 5, 2014: $3.27 million was awarded to Jo Huskey by an MDL jury against Ethicon and Johnson and Johnson. Ms. Huskey had removal surgery after implantation of the TVT-O sling.
September 8, 2014: $73.465 million was awarded to Martha Salazar against Boston Scientific by a Texas jury. Ms. Salazer underwent four additional mesh removal surgeries after her Obtryx transobturator mid-urethral sling was implanted in January 2011. $50 Million of the award was punitive damages and was reduced to $11 Million post verdict in accordance with Texas Tort Reform laws.
Transvaginal Mesh Adverse Events
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.
Judge Reduces Boston Scientific Verdict to $34 Million
Due to Texas Tort Reform, the judge in the Boston Scientific state court verdict was compelled to reduce the punitive damages verdict to $11 million in accordance with Texas law. This does not affect the jury’s findings of the $50 million dollar punitive damages award designed to punish Boston Scientific for gross negligence.
$73.465 Million Verdict against Boston Scientific
September 8, 2014 – $73.465 million was awarded to Martha Salazar in her transvaginal mesh lawsuit against Boston Scientific in a Texas courtroom. In Salazar v. Boston Scientific, a jury found the company liable for injuries the 42 year old lady suffered, including, irreversible nerve damage which causes her to walk with a limp, dyspareunia and pain. After the implant surgery, Ms. Salazer underwent four additional mesh related removal surgeries. The award includes $50 million in punitive damages to punish the company for gross negligence.
Ms. Salazar was implanted with an Obtryx transobturator mid-urethral sling, a polypropylene mesh used to treat stress urinary incontinence (SUI). Ms. Salazer’s doctor performed the surgery in January 2011 to relieve her of leaking urine as she exercised, coughed or sneezed.
In complete contrast, Boston Scientific won two cases in the past few months and those juries in Massachusetts awarded no money to two women claiming their injuries were caused by defective transvaginal mesh devices.
$3.27 Million Verdict against Johnson & Johnson TVT-O Sling
September 5, 2014 – $3.27 million was awarded in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division. In Huskey v. Ethicon, a jury found that Jo Huskey suffered injuries from a Gynecare TVT-Obturator pelvic mesh tape implant. Also known as a “sling,” the TVT-O is a medical device utilized in stress urinary incontinence (SUI).
The sling includes a mechanism to place a mesh tape under the urethra to provide support to the urethra. The jury in the MDL found the manufacturer was liable on the issues of defective design, failure to warn and negligence. Note that punitive damages were not allowed by Judge Goodwin in this case, so the jury verdict does not contain a large damage award to punish the company.
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