Before the first pelvic mesh case went to trial, the plaintiff’s lawyers had a question to answer. Would the implanting physician be held liable for medical malpractice 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.
Then 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 become confused and blame neither.
Choosing to simplify these cases, which were being amassed in multidistrict litigation (MDL) in West Virginia, the executive committee of the pelvic mesh MDL decided that the implanting doctors would be brought into the fold to testify against the manufacturers.
Doctors 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 physicians (end users) 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 107,000 claims. Now trials for the newly injured will be conducted in individual states. Something else had changed.
Doctors increasingly cannot claim they have no idea that mesh potentially causes injury. There has been mainstream media coverage over the trials and their outcomes for almost a decade.
More than a decade after polypropylene pelvic mesh made it onto the marketplace, it’s a stretch for any doctor to say he has no idea it has the potential to injure patients with mesh erosion, infections, chronic pain, nerve injury, and perforating organs.
Being sued for performing a medical procedure considered the “Gold Standard” is the worst nightmare for doctors, who publicly discussed being hit with medical malpractice suits as early as the 2016 meeting of the American Urogynecologist Society (AUGS).
Now, in a legal precedent, a team of lawyers 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 that was cleared for the market with no clinical trials.
Second Wave of Transvaginal Mesh Litigation
The first such lawsuit was filed in August 2019. Dr. Charmaine K. Oladell, M.D., was hit with a lawsuit from a woman injured by a TVT-O sling in Dallas County (Case No. CC-1904584-D). Ethicon (Johnson & Johnson) was the manufacturer of the TVT-O, which was implanted in 2013 in a Texas hospital.
Ethicon was 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.
Dr. Oladell is accused of failing to diagnose nerve complications associated with the mesh and misrepresenting to her patient that a revision surgery removing part of the mesh was the same as complete mesh removal.
TVT-O (transvaginal tape obturator) is one of a family of pelvic meshes made by Ethicon. TVT-O is called a “sling” and treats stress urinary incontinence (SUI). Still, with the TVT-O, the mesh is passed through the obturator space, flush with nerves and considerable potential for injury.
Another TVT-O lawsuit
In June 2021, two gynecologists were hit with medical malpractice lawsuits by a woman who claimed grievous injuries from the implantation of her TVT-O device. The cases were filed in New York (Index No. EF2021-00001618).
The plaintiff alleges the two gynecologists, Dr. John Barrett and Dr. Jonathan Oliva, caused the injuries and then failed to disclose to the woman that the risks of chronic disabling pain were a possibility, failed to foresee the risks, and then failed to deliver care in a timely manner.
Before the lawsuit can be filed, the issue must go before a medical review panel. Regardless of the decision by the review panel, plaintiff attorneys can sue the doctors.
Some members of the American Urogynecologic Society (AUGS) have called to withdraw the 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 implant or months to years later.
Lawyers recommend you be very selective in the cases you accept and focus on specific neurological injuries following the sling procedure. Combining medical malpractice and defective product cases can result in millions for the plaintiff when considering the amount of care the permanently injured woman will require in the future.
Pelvic mesh manufacturers still producing pelvic mesh include 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 if the pelvic mesh is correctly placed through the obturator.
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. Specifically, that neuropathic pain caused by the transobturator sling calling it “latent injuries,” may take months to become symptomatic.
Mesh is supposed to be a permanent implant and managing life-altering pain has become the way of life for some women. 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 future care of these patients will run into millions of dollars. ##