Before the first pelvic mesh case went to trial, plaintiffs’ lawyers had a question to answer. Would the implanting physician be held liable for the injury alongside the manufacturer for making a defective product?
You would then have a defective product and medical malpractice case to try simultaneously. But that created a problem.
The doctors could blame the manufacturers of defective mesh. The mesh maker could blame the doctors for a poor placement or nerve injury that caused persistent pain. The jury might be confused and blame neither.
Choosing to simplify these cases, which were being filed in multidistrict litigation (MDL) in West Virginia, the MDL executive committee decided the implanting doctors would be brought into the fold to testify against the manufacturers.
They, too, would claim they had no idea that the medical devices were faulty and could cause permanent and life-altering complications. It would make the failure-to-warn claim that much easier to win instead of getting lost in the blame game - doctors blaming manufacturers, manufacturers blaming doctors.
And in most cases, it had the added benefit of being true.
The pelvic mesh MDL closed to new cases in June 2018 after amassing and settling nearly all 108,000 claims.
Future trials for the newly injured will be heard in various state courts, and something else has changed.
Almost a decade after polypropylene pelvic mesh made it onto the marketplace; it’s a stretch for any doctor to say he had no idea it could injure patients with mesh erosion, infections, chronic pain, nerve injury, and perforating organs.
In a legal precedent, a team of lawyers now plans to add medical malpractice claims to the defective product lawsuits filed around the country. There is no faster way to get the attention of implanting physicians and perhaps curtail this largely experimental practice, cleared through the Food and Drug Administration with no clinical trials.
Being sued for performing a medical procedure considered the “Gold Standard” is the worst nightmare for doctors, who discussed the fear of medical malpractice suits as early as the 2016 meeting of the annual American Urogynecologist Society (AUGS).
On February 22, 2022, jurors in a Dallas courtroom will hear the medical malpractice based on negligence case against Dr. Charmaine Oladell. (Dallas County Court of Law, case No CC-19-05461-D, County Court 4).
Plaintiff J. S. claims her permanent injuries were caused by an Abbrevo TOT (obturator) made by Ethicon.
The plaintiff firm is Ben Martin of Martin Baughman of Dallas, TX, specializing in severe, permanent, life-altering nerve injury cases caused by the placement of polypropylene pelvic mesh.
Ethicon is accused of negligence for selling a faulty medical device and failing to warn the end-user, the doctor. Ethicon also faces fraudulent concealment and breach of express warranty.
This case is one of the first to name the implanting doctor as a defendant, and Martin Baughman plans to introduce more medical malpractice claims attached to future product liability lawsuits.
J.S. received a TVT-O (obturator) Abbrevo sling made by Ethicon, a subsidiary of Johnson & Johnson.
Implanted by Dr. Oladell in March 2019 to treat stress urinary incontinence, J.S. soon developed postoperative leg and perineal pain.
Dr. Oladell referred her to Dr. Geoffrey Nuss, a urologist, for a revision. In April 2019, both doctors performed a partial mesh removal, with Dr. Nuss removing 2 cm of the urethral portion. After being told they’d gotten as much as possible, maybe up to half, J.S. later found that only one-sixth of the pelvic mesh was removed.
In July 2019, J.S. underwent an additional surgery to remove the embedded arms of the Abbrevo under the care of mesh removal expert Dr. Dionysios Veronikis in St. Louis, MO.
J.S. says she still suffers perineal and leg pain from the initial implantation. The complaint says those injuries, along with mental anguish, physical impairment, economic damages, and medical expenses, as well as loss of earning capacity, will continue into her future.
The complaint accuse Ethicon of selling a defective medical device and failing to warn about its risks, and common law fraud by claiming their mesh products had been tested and found safe and effective.
“Defendants’ wrongful conduct constitutes fraud and deceit and was committed and perpetrated negligently, willfully, wantonly, and/or purposefully on Plaintiff.”
Dr. Oladell is accused of being negligent in failing to warn her patient she had mesh in her body and for implanting it in the first place. In doing so she breached the standard of care says the complaint.
According to the complaint, had Ethicon not concealed or misrepresented information to the plaintiff and medical community, other surgeons might not have been induced to prescribe and/or use their pelvic mesh products.
“Product Liability Defendants took unconscionable advantage of their dominant position of knowledge regarding plaintiff and engaged in constructive fraud in their relationship with plaintiff. Plaintiff and Defendant Charmaine Oladell reasonably relied on their representations.”
Gross negligence is among the seven counts facing Ethicon, claiming the company sold Abbrevo without doing adequate testing and with the knowledge their product can shrink, disintegrate, degrade, and cause severe and debilitating injuries.
“Product Liability Defendants’ conduct as described herein shows willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care which raises the presumption of conscious indifference to consequences, thereby justifying an award of punitive damages.”
Abbrevo is one of a family of pelvic meshes made by Ethicon (Johnson & Johnson) used to treat stress urinary incontinence (SUI). TVT Abbrevo is a shortened 12 cm polypropylene transobturator mid-urethral sling using less mesh through the thigh muscles when compared to a full-length sling.
Still, on the market, Abbrevo was the pelvic mesh that was the focus of the Coleen Perry trial in Bakersfield, California, in 2015. Perry claimed Abbrevo led to her permanent injuries.
Eventually, the jury agreed and awarded her $700,000 in compensatory damages and $5 million in punitive damages. Jurors found that Abbrevo was defective in its design and its instructions to doctors, the end-users.
Some members of the American Urogynecologic Society (AUGS) have called for the withdrawal of TVT-O from the marketplace because of the potential for injury. That’s because doctors should understand that inserting a medical device into the obturator internus muscle can produce a specific neurological pain syndrome that far exceeds what anyone could imagine.
Instead of acknowledging this, the manufacturer refers to this elective procedure as “minimally invasive.”
“Minimally invasive” should not include nerve injuries from adjacent muscles producing catastrophic neuropathic pain syndromes that can happen either immediately after implantation or months to years later.
Even AUGS admitted in a joint position statement with the International Urogynecological Association (IUGA) that “extra pelvic pain” is possible and has been chronicled in the medical literature as far back as 2010. Neuropathic pain caused by the transobturator sling may take months to become symptomatic.
Pelvic mesh manufacturers still produce pelvic mesh to treat incontinence, including Boston Scientific, Coloplast, and Ethicon (Johnson & Johnson).
Lawyers say that even today, mesh makers have not warned physicians about the risk of nerve damage that can occur even when the pelvic mesh is correctly placed through the obturator.
Mesh is supposed to be a permanent implant, and managing life-altering pain has become the way of life for some women implanted with it.
Neurological injuries following the implantation of a polypropylene sling, combined with medical malpractice and defective product cases, will soon be seen going forward across the country.
The cost of future care for these patients will run into the millions.
Snowden v Ethicon, J&J and Charmaine Oladell, M.D. Petition, filed 8-30-2019
MND, Ethicon Abbrevo - A TVT Family Member, January 2015
MND, October 6, 2021, AUGS Mischaracterizes Mesh Litigation
MND, Navigating Neuralgias in New Pelvic Mesh Litigation, August 23, 2021
MND, Ethicon on Hot Seat in California Courtroom, Perry v Ethicon Begins, January 26, 2015
MND, Perry v. Ethicon: Sales Rep, Doc in the Dark about Pelvic Mesh Dangers, January 30, 2015
MND, Perry Hammered About Her Medical Past in Transvaginal Mesh Trial, February 12, 2015
MND, Closing Arguments: Perry v Ethicon Mesh Trial, February 27, 2015
MND, Defense Closing and Rebuttal in Perry v. Ethicon Pelvic Mesh Trial in Hands of Jury, March 2, 2015
MND, Verdict In! $5.7 Million for Ms. Perry in her Pelvic Mesh Trial, March 5, 2015