(July 10, 2018) – In 31 transvaginal mesh (TVM) trials so far, 22 have concluded with verdicts in favor of plaintiffs. Eleven (or half) of those verdicts have gone against Johnson & Johnson and Ethicon, which has seen its mesh losses mount faster than any other TVM manufacturer. J&J has lost five verdicts over its Gynecare Prolift mesh, three for its TVT-O mesh, one for TVT-Abbrevo, one for TVT-Secur, and one for its polypropylene tape used to treat stress urinary incontinence (SUI).
Related: Transvaginal Mesh Lawsuit
In 2016, the FDA reclassified transvaginal mesh for prolapse repair (but not SUI) as Class III (high risk) medical devices. The reclassification made TVM implants ineligible for FDA’s 510(k) clearance program. That program had previously allowed mesh products on the market without prior clinical trial testing on human beings. But 510(k) clearance does not amount to FDA approval. TVM or pelvic mesh devices are not FDA approved.
Johnson & Johnson, Ethicon Mesh Losses Mount
Besides fighting TVM cases in the courts, Johnson & Johnson and other defendants have also quietly settled hundreds of them. As with most settlements, terms are not disclosed and the companies that pay admit no wrongdoing.
Johnson & Johnson (Ethicon) Trials have yielded at least eleven (11) wins for plaintiffs so far. These include:
March 8, 2018 – $35 Million for Plaintiff (Gynecare Prolift)
A U.S. District Court for Northern Indiana jury hit Johnson & Johnson’s Ethicon with a $35 million verdict over its Prolift pelvic mesh. ($10 million in damages and $25 million in punitive damages). Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012 after learning that the Prolift mesh her doctor implanted in 2009 to treat pelvic organ prolapse might be causing her low pelvic pain. The lawsuit petition accused J&J and Ethicon of concealing Prolift problems that included high failure, injury and complication rates, as well as “frequent and often debilitating re-operations.” Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” said the complaint.
The Kaisers also alleged that “[Ethicon] consistently under-reported and withheld information (about) Prolift’s propensity to fail and cause injury and complications, and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large.”
The Kaisers also alleged. “Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective. . .”
Dec. 14, 2017 – $15 Million for Plaintiff (Prolift)
A New Jersey woman was awarded $15 million by a Bergen County (New York) Superior Court jury in her transvaginal mesh lawsuit. The verdict followed 2 ½ weeks of trial testimony and nearly a day of jury deliberation. The woman testified that she had been in constant pain since receiving an Ethicon mesh implant. Jurors found the Johnson & Johnson subsidiary had failed to adequately warn her of the risks associated with Ethicon’s Prolift mesh implant. They awarded her $4 million in compensatory damages and $10 million in punitive damages, as well as awarding her husband $1 million for his loss of conjugal affection.
The jury also found Ethicon had failed to provide the woman with adequate safety warnings in regards to the TVT-O mesh implant, but they determined the Prolift mesh alone was responsible for her injuries. (Case No. L-13686-14)
September 6, 2017 – $57 Million for Plaintiff (TVT-Secur)
A Philadelphia jury awarded a woman $57.1 million in damages over a TVT-Secur mesh implant. Ella Ebaugh accused Johnson & Johnson unit Ethicon of making a defective pelvic mesh implant that scarred her urethra and left her incontinent. Her award included $50 million in punitive damages. The jury unanimously backed her claims that two negligently and defectively designed mesh devices had “mutilated” her urethra and left her with little control over her urinary flow.
May 26, 2017 – $2.16 Million for Plaintiff (Prolift)
A Pennsylvania jury awarded $2.16 million to a woman who suffered serious complications from Ethicon, Inc.’s Gynecare Prolift mesh. The verdict came in the Philadelphia Court of Common Pleas. It was the fourth straight loss for Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit. (Case No. 130603835)
April 28, 2017 – $20 Million for Plaintiff (TVT-Secur)
A state-court jury in Philadelphia ordered Johnson & Johnson to pay a New Jersey woman $20 million over a TVT-Secur pelvic mesh. The woman blames J&J’s vaginal-mesh inserts for leaving her in constant pain. The jury concluded that the TVT-Secur was defectively designed and caused Margaret Engleman’s injuries. They awarded her $2.5 million in damages and then hit J&J and Ethicon with $17.5 million in punitive damages.
February 2016 – $13.5 Million for Plaintiff (Polypropylene tape)
A jury in Philadelphia hit Johnson & Johnson subsidiary Ethicon with a $13.5 verdict in the second case involving its pelvic mesh products to go to trial in the city. The Philadelphia Court of Common Pleas jury awarded Sharon Carlino $3.5 million in compensatory damages, $10 million in punitive damages. It found Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective. It also found that Ethicon failed to adequately warn of its risks. Ms. Carlino required three revision surgeries to remove the eroded mesh.
March 4, 2015 – $5.7 Million for Plaintiff (TVT Abbrevo)
A California jury in Los Angeles hit Johnson & Johnson’s Ethicon Inc. unit with a $5.7 million verdict. The jury sided with a woman who claimed her doctor had given her an older, heavier version of a pelvic mesh product that will cause her a lifetime of pain. The jury awarded plaintiff Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages. Ms. Perry had been implanted with Ethicon’s TVT Abbrevo mesh.
December 2015 – $12.5 Million for Plaintiff (Prolift)
A Philadelphia jury ruled Johnson & Johnson must pay $5.5 million to a Pennsylvania woman over its Ethicon unit’s Gynecare Prolift mesh implant. The jury found J&J liable based on the negligence of its scientists in relation to its Prolift pelvic mesh implant. They cited the mesh as the root cause of plaintiff Patricia Hammons’ inability to have sex after it was implanted. The jury later added $7 million in punitive damages.
A Pennsylvania state court judge ruled in 2014 that Johnson & Johnson and other pelvic mesh makers like Boston Scientific and Bard will need to challenge more than 860 product liability lawsuits on a case-by-case basis.
September 2014: $3.3 Million for Plaintiff (TVT-O)
In West Virginia, a federal jury in the MDL court hit Ethicon with a $3.3 million verdict over its TVT-O transvaginal sling. The jury found in favor of plaintiff Jo Huskey on all counts, which included strict liability, design defect, failure to warn, negligence.
April 3, 2014: $1.2 Million for Plaintiff (TVT-O)
A Dallas jury ordered Johnson & Johnson to pay a Texas woman $1.2 million for a defective plastic sling – the TVT-O – which J & J’s Ethicon division makes and markets for stress urinary incontinence. Freese & Goss and Matthews & Associates represented the woman, Ms. Linda Batiste.
February 2013 – $11.11 Million for Plaintiff (Prolift)
A New Jersey jury awarded Linda Gross an $11.11 million verdict in her lawsuit against Johnson & Johnson’s Ethicon over the company’s Prolift vaginal mesh product. Ms. Gross suffered 18 surgeries in repeated attempts to remove the failed mesh and resultant scar tissue. The jury found J&J had failed to warn patients and doctors about the risks of its mesh products and that the company made fraudulent misrepresentations.
Johnson & Johnson TVM Court Wins
Johnson & Johnson settled at least one Prolift trial which had reached the MDL courtroom, and it has won two TVM trials so far. In February 2014, company lawyers were able to have Judge Goodwyn dismiss the case of a Texas woman against Ethicon and J&J (Lewis v. Ethicon/JJ) in a TVT-O case, and a Texas jury awarded nothing in a Nov. 2015 case over a Prosima device that reached trial (Cavness v. Ethicon/JJ). J&J also settled with the plaintiff in at least one TVM case which reached trial in March 2015 (Bellew v. Ethicon/JJ).
Transvaginal Mesh Lawsuits
Today, many thousands of TVM cases remain unresolved, parked in various state courts across the U.S. and in the federal MDL in West Virginia. The overseer of the federal MDL court, Justice Joseph Goodwyn, announced in June 2018 that he will no longer accept new mesh cases. Judge Goodwin has overseen several MDL trials and still has more than 100,000 cases on his books. He has urged the defendants to settle, some have occasionally obliged, but the sheer number of cases in the MDL makes it the largest federal court docket for mass tort litigation since asbestos.