Transvaginal Mesh Lawsuit
J&J, Ethicon Deceptively Marketed Pelvic Mesh
$344 Million Judgment
Johnson & Johnson and its subsidiary, Ethicon, must pay the state attorney general approximately $344 million for deceptively marketing their transvaginal mesh devices as safe. On January 20, 2020, San Diego County Superior Court Judge Eddie Sturgen issued the $343.99 million judgment following a lengthy trial that began on July 15. California Attorney General Xavier Bercerra filed the action, seeking damages under California’s unfair competition and false advertising laws. The claims arose from the sale of 42,000 Ethicon pelvic mesh devices in the state from 2008 to 2014.
J&J, Ethicon Settle 41 States ‘ TVM Claims
$117 Million Settlement
On October 18, 2019, Johnson & Johnson and Ethicon Inc. agreed to pay nearly $117 million to 41 states and the District of Columbia to settle allegations that they touted the benefits of their transvaginal surgical mesh devices while concealing the risks. The settlement requires the companies to fully disclose the device’s risks and accurate information on promotional material and “information for use” package inserts.
Over the past decade over $8 billion in personal-injury settlements between several manufacturers and tens of thousands of women in the United States. In 2019, the Food and Drug Administration, after years of complaints, stopped the sale of pelvic mesh to treat a condition called pelvic organ prolapse. Johnson & Johnson had stopped selling pelvic mesh to treat that condition in 2012, but it and other manufacturers still sell similar products to treat urinary incontinence in women.
Transvaginal Mesh Verdicts
TVM litigation has been a mega mass tort with over 100,000 claimants. There have been many large verdicts of significantly injured women damaged by the devices publicized. Most of these cases are appealed with no compensation for the clients pending appeals. Many cases are dismissed with clients receiving no recovery. Many claimants choose to forego the exorbitant costs and risks of receiving nothing after years of litigation in exchange for settling for smaller awards. We are still helping claimants based on certain medical evidence. The verdicts, settlements, manufacturers, products, and jurisdictions follows:
- 6/19: $500,000 – Dunfee v. Ethicon/JJ (Prolift) PA
- 5/19: $80+ million – Mesigian v. Ethicon/JJ PA
- 4/19: $120 million – McFarland v. Ethicon/JJ (TVT-O) PA
- 1/19: $41 million – Emmett v. Ethicon/JJ (Prolift & TVT-O) PA
- 4/18: $68 million – McGinnis v. Bard (Solo & Align) NJ
- 3/18: $35 million – Kaiser v. Ethicon/JJ (Prolift) IN
- 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT Secur) PA
- 5/17: $2.16 million – Betz v. Ethicon (Prolift) PA
- 4/17: $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
- 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT) PA
- 2/16: $0 – Sherrer v. Boston Scientific (Solyx & Bard Align) MO
- 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) PA
- 10/15: $0 – Martha Carlson v. Boston Scientific (Uphold) NC
- 10/15: $0 – Carol Cavness v. Ethicon/JJ (Prosima) TX
- 5/15: $100 million – Deborah Barda v. BSC (Pinnacle, Advantage Fit) DL
- 3/15: $5.7 million – Coleen Perry – Ethicon/JJ (Abbrevo) CA
- 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) CA
- 3/15: Settled – Bellew v. Ethicon (Prolift) MDL
- 2/15: Settled – Wise v. Bard (Avaulta, Avaulta Plus) MDL
- 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific (Pinnacle) MDL FL
- 11/14: $6.7+ million – Margarita Dotres – Boston Scientific (Pinnacle) MDL FL
- 11/14: $6.7+ million – Mania Nunez – Boston Scientific (Pinnacle) MDL FL
- 11/14: $6.5+ million – Juana Betancourt – Boston Scientific (Pinnacle) MDL FL
- 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific (Obtryx) MDL
- 11/14: $4.75 million – Chris Wilson – Boston Scientific (Obtryx) MDL
- 11/14: $4.25 million – Carol Campbell – Boston Scientific (Obtryx) MDL
- 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific (Obtryx) MDL
- 9/14: $73.465 million – Martha Salazar – Boston Scientific (Obtryx) TX
- 9/14: $3.27 million – Jo Huskey – Ethicon/JJ (TVT-O) MDL WV
- 8/14: $0 – Maria Cardenas – Boston Scientific (Obtryx) MA
- 7/14: $0 – Diane Albright – Boston Scientific (Pinnacle) MA
- 4/14: $1.2 million – Linda Batiste – Ethicon/JJ (TVT-O) TX
- 2/14: $0 – Carolyn Lewis – Ethicon/JJ (TVT-O) MDL
- 8/13: $2 million – Donna Cisson – C.R. Bard (Avaulta) MDL
- 2/13: $11.11 million – Linda Gross – Ethicon/JJ (Prolift) NJ
- 7/12: $5.5 million – Christine Scott – C.R. Bard (Avaulta Plus) CA
$500,000 Mesh Verdict
$500,000 was awarded to transvaginal mesh plaintiff, Linda Dunfee, by a jury in the Philadelphia County Court of Common Pleas on June 28, 2019. The jury found that design defects in Ethicon’s Prolift mesh resulted in Ms. Dunfee’s pain and suffering. The jury did not award any punitive damages against Ethicon/Johnson and Johnson. Although this verdict is much less than previous awards in Philadelphia, the defendant vows to appeal the verdict.
$80+ Million Mesh Verdict
$80.025 million was awarded to transvaginal mesh plaintiffs Patricia and George Mesigian on May 19, 2019. Patricia was implanted with Prolift mesh in 2008 to treat organ prolapse, but the mesh eroded causing pain, infections, inflammation and scar tissue which required several revision surgeries. The award included $50 million in punitive damages and $30 million in compensatory damages.
$120 Million Mesh Verdict
$120 Million was awarded to a transvaginal mesh plaintiff on April 24, 2019. The jury found that Ethicon, the Johnson and Johnson subsidiary, negligently designed the pelvic mesh implant forcing Susan McFarland to suffer with incontinence and chronic pain that prevented her from having sex with her husband for over ten years. The TVT-O implanted in 2008 sawed through the soft tissue in Susan’s pelvis and was exposed in her vagina. She was eventually forced to undergo a second surgery to remove a portion of the implant. This is the second trial for the McFarland couple as the first jury deadlocked in September 2018, resulting in a retrial.
$41 Million Mesh Verdict
$41 Million was awarded to a transvaginal mesh plaintiff by a jury on January 31, 2019. The Philadelphia jury found against Johnson & Johnson’s subsidiary, Ethicon Inc., and rendered a $41 million verdict. The jury found that defects in the plaintiff’s pelvic mesh implant manufactured by JJ/Ethicon left Suzanne Emmett with permanent injuries after three products sawed into her vagina. The three pelvic mesh devices were implanted after she suffered organ prolapse. The mesh repeatedly eroded into her vagina, leaving her with urinary incontinence, painful bladder contractions and pain during sex. Suzanne underwent nine surgical procedures and over 40 nerve treatments, including injections. Mr. Emmett, Suzanne’s husband’s had evidence that his privates were cut like a piece of barbed wire during sex.
$35 Million Mesh Verdict
$35 million was awarded to Barbara Kaiser by a Gary, Indiana jury consisting of $10 million in compensatory damages and $25 million in punitives. Ms. Kaiser was implanted with a Prolift mesh in 2009 and suffered with pain and underwent a surgical revision of the implant. This follows $57.1 million awarded against Johnson & Johnson and Ethicon to Ella Ebaugh, who was implanted with TVT-Secur transvaginal mesh that eroded through her urethra, caused her internal injuries and permanently damaged her urinary system leaving her incontinent. The jury verdict included $7.1 million in compensatory damages and $50 million in punitive damages. The Philadelphia Court of Common Pleas verdict was delivered September 7, 2017, marking the fifth TVM verdict against the mesh manufacturers.
$20 million was awarded to a woman who suffered after multiple surgeries to remove a TVT-Secur mesh implant. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded $2.5 in compensatory damages and $17.5 million in punitive damages. Plaintiff, Peggy Engleman’s mesh failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On May 26, 2017, Sharon Beltz was awarded $2.16 million for injuries caused by Ethicon’s Prolift implanted in 2006. Johnson and Johnson vows to appeal the cases to a higher court.
Pelvic Mesh Ordered Off the Market
On April 16, 2019, the FDA ordered the manufacturers of pelvic synthetic surgical mesh products to stop selling and distributing their products in the United States immediately. Reported side effects include permanent incontinence, severe discomfort and an inability to have sex. The mesh is made from polypropylene, which is the same material as fishing line. The FDA said it determined that “the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices.” The statement adds that if patients have experienced no problems with the mesh, no action needs to be taken to remove the devices. Additional information for patients and health care providers about the use of surgical mesh for transvaginal pelvic organ prolapse is provided in the links.
Ethicon Mesh off the Market
- Prosima and
- (Gynemesh PS and
Ethicon TVT Gynecare Mesh
- Gynecare TVT Retropubic (TVT)
- Abdominal (TVT-A) System,
- Gynecare TVT Obturator System (TVT-Obturator),
- Gynecare TVT Abbrevo Continence System (TVT-Abbrevo), and/or
- Gynecare TVT Exact Continence System (TVT-Exact),
Bard Mesh Verdict – $68 Million
A New Jersey state jury rendered a verdict against C.R. Bard Inc.in the total amount of $68 million in damages on Friday the 13th of April, 2018. The breakdown calculations of the award include $23 million in compensatory damages to plaintiff Mary McGinnis, $10 million to her husband, Thomas McGinnis, and $35 million in punitive damages. The New Jersey jury heard evidence that the manufacturer knew that two of its pelvic mesh products implanted in Mary were unsafe and failed to warn doctors about potential risks related to devices that caused overwhelming and debilitating pain and suffering. Bard vows to appeal the verdict.
MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Cases are being prepared for trials, dismissals or remands. Total Cases: 38,956 Total Closed: 7718 Past verdicts and settlements include:
- Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
- Edwards v. Ethicon, Inc., et al., 2:12-cv-09972- Dismissed
- Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
- Carolyn Lewis v. Ethicon, et al. Defense Judgment
- Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
- Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) Dismissed
MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL. Total Cases: 21,127 Total Closed: 17,248
MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation– Cases are being prepared for trials, dismissals or remands. The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs. Total Cases: 15,491 Total Closed: 10,452 Past verdicts and settlements include:
- Wise, et al. v. C. R. Bard, Inc. – Settled
- 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
MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – Settlements in process with no trials scheduled. Total Cases: 25,029 Total Closed: 15,101
Past verdicts include:
- Jeanie Blankenship – $4.25 million + $1 million punitive damages
- Chris Wilson – $3.75 million + $1 million punitive damages
- Carol Campbell – $3.25 million + $1 million punitive damages
- Jacquelyn Tyree – $3.25 million + $1 million punitive damages
- Juana Betancourt – $6.5 + million
- Mania Nunez – $6.7 + million; and
- Margarita Dotres – $6.7 + million;
- Amal Eghnayem – $6.7 + million
MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials have been scheduled. The following cases were dismissed: Ailey v. Cook Inc., Watkins v. Cook Inc., et al. Hovey v. Cook Inc., et al. Total Cases: 629 Total Closed: 123
MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no bellwether trials scheduled and the judge is conducting settlement conferences. Total Cases: 2610 Total Closed: 2397
MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There are no bellwether trials scheduled. Settlement Program entered 11/2015. Total Cases: 137 Total Closed: 125
On February 10, 2016, $13.5 million was awarded by a Philadelphia jury in Carlino v. Ethicon. $10 million of that award was for punitive damages. The plaintiff suffered through three TVT sling revision and removal mesh surgeries following her Ethicon/Johnson and Johnson implant.
This follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. A Philadephia jury found that Patricia Hammons suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction.
On February 2, 2016, a Kansas City, Missouri jury awarded nothing to the plaintiff in a Boston Scientific Solyx and C.R. Bard Align case. On October 16th, 2015, the jury awarded nothing to the plaintiff in Martha Carlson v. Boston Scientific in Statesville, North Carolina. On October 5th, 2015, the jury awarded nothing for the plaintiff in Carol Cavness v. Ethicon/ Johnson and Johnson in Dallas, Texas.
As of August 3rd, 2016, eighteen (18) transvaginal mesh plaintiffs have won trials and the defendants have won six (6). Following the failed status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million and numerous confidential settlements. Boston Scientific, Coloplast, AMS and Bard have begun offering settlements.
A California jury awarded $5.7 million to Coleen Perry, who was implanted with an Abbrevo sling device. Ms. Perry experienced pain after surgery, but the sling could only be partially surgically removed because the mesh had grown into the tissues. The jury unanimously awarded $5 million in punitive damages finding Ethicon acted with malice.
Trial began March 2, 2015 in Bellew v. Ethicon in the MDL and settled March 6, 2015 for an undisclosed amount. This case involved removal of a Prolift mesh, a product which had been taken off the medical device market.
Bard Bellwether Case Settles Before Trial
Wise v. Bard, the bellwether case set for trial February 18, 2015, was settled right before trial for a confidential amount. On February 12, 2015, Judge Goodwin appointed Ellen Reisman as Special Master to facilitate settlement negotiations in the Bard MDL. Christine Scott, the first Bard Avaulta Plus plaintiff who endured nine mesh revision surgeries stated, “Thank God, we can finally get the word out to women.”
$26.7 Million and $18.5 Million Verdicts Against Boston Scientific
$26.7 million and $18.5 million verdicts against Boston Scientific were awarded in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014, a Charleston, West Virginia jury awarded $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.
The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include:
- Amal Eghnayem – $6.7 + million;
- Margarita Dotres – $6.7 + million;
- Mania Nunez – $6.7 + million; and
- Juana Betancourt – $6.5 + million
The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market. The individual awards for the women in the Obtryx sling trial include:
- Jeanie Blankenship – $4.25 million + $1 million punitive damages;
- Chris Wilson – $3.75 million + $1 million punitive damages;
- Carol Campbell – $3.25 million + $1 million punitive damages;
- Jacquelyn Tyree – $3.25 million + $1 million punitive damages
Transvaginal Mesh Adverse Events
Click the TVM video link which contains medical legal animation, diagrams and warnings about TVM implants and the transvaginal mesh litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations
Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:<
- erosion through the vaginal tissue
- mesh contraction
- mesh extrusion
- infection and abscess
- blood loss
- chronic and acute nerve damage
- pudendal nerve damage
- pelvic floor damage
- scar tissue
- chronic pelvic pain
- urinary problems and/or incontinence
- recurrence of prolapse
- bowel, bladder, and blood vessel perforation
- dyspareunia or pain during sexual intercourse
Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications.
In July 1, 2012, Bard stopped selling the Avaulta Meshin the United States because the FDA required additional clinical trials and testing.
On June 4, 2012: Johnson and Johnson/Ethicon withdrewfour mesh products from the US Market, including its controversialGynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.
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.
However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that 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
- 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