THE FIRST WEBINAR- June 8, 2018 – Many questions came into the first webinar conducted by Mesh Medical Device News Desk (MND) and Monheit Marketing this past Wednesday. (Monheit advertises and markets MND).
Questions concerned the multidistrict litigation (MDL) and the bellwether pelvic mesh trials that were supposed to set values for settlements; the slow pace of receiving settlement dollars; the fact that some law firms are notoriously bad at contacting their clients; and which hernia meshes are being litigated.
All of the four participants agreed – it is vitally important for every patient who has had a mesh complication to report it to the U.S. Food and Drug Administration’s (FDA) MedWatch database. Know your lot number, mesh manufacture, and type of mesh. Follow-up with the FDA to make sure your report has been filed, get the number and make sure it accurately reflects what you said.
It’s especially important because the FDA tends to disregard complication reports filed by law firms. When a patient reports to MedWatch, it is much less likely to be dismissed and is the only way the agency can get a big picture of the number of actual number of hernia and pelvic mesh injuries in the U.S.
Dr. Robert Bendavid, Shouldice Hospital hernia surgeon
of Shouldice Hospital in Toronto, told the 100 or so who were listening that pain complications from hernia surgery range from about 12 to 30% of cases while approximately 11 percent experience a recurrence.
Shouldice Hospital remains a non-mesh hospital in about 99% of cases, he said. Occasionally a patient who is obese or a smoker might require a mesh reinforcement to repair their hernia.
It is not uncommon, said Dr. Bendavid, for young males who have bilateral hernia repairs to come back in ten years experiencing difficulty with fertility due to mesh erosion into the vas deferens. He demonstrated with microscopic slides of the mesh eroding into the vas.
Calling doctors who work with industry and are financially compensated, “collaborative surgeons,” Dr. Bendavid said the only requirement of the medical profession is to disclose the financial arrangement. There is no need to tell anyone how much a doctor may be compensated, which we see from discovery can be in the millions of dollars.
Few surgeons have experience in mesh removal, he said. There are just a handful of experienced mesh explantation surgeons in the U.S. and abroad who are well practiced in mesh removal. Dr. Bendavid says you want a surgeon who has done 40 to 50 procedures ideally. It is no small affair to take mesh out. It’s incredibly difficult.
The patient may be advised it’s all removed to lessen the anxiety but this is not a realistic outcome because mesh is designed to be permanent. It may be attached to vital organs, the bowel, the bladder, and a doctor may have to trim close to the organs but can’t remove it.
Today’s polypropylene (PP) plastic mesh used for both hernia and pelvic organ repair, have been around since the 1940s and 1950s, said Dr. Bendavid.
In his lab, with hundreds of explanted hernia meshes, he finds the ingrowth of nerves in the mesh pores a condition called SIN, surreptitious irreversible neuralgia (SIN) syndrome which brings pain.
Bruce Rosenberg, patient advocate
told those listening that hernia mesh patients should have a Dopplar Curvelinear Ultrasound as the best way to see what mesh is doing in the body. He cited the work of Dr. David Jamadar and his work with Doppler images.
Is there an informed consent for hernia mesh patients, I asked.
Everything is covered said Rosenberg, and nearly every patient signs, but at the last minute when he is on the gurney. Rosenberg believes most patients would run away if they knew there was a chance they might be permanently debilitated or have to have a testicle removed.
He added if a mesh is infected it’s almost impossible to solve the infection.
Entrapment of nerves are reversible but the injuries may be permanent said Rosenberg. Even if the patient undergoes a neurectomy (cutting a nerve) or a neurolosis (moving the nerve) the pain can come back.
Bruce advised patients to be candid with their doctors and tell them about problems with sex, ejaculation, pain diarrhea, constipation, so they can get the full picture about a possible mesh complication. The road to recovery is a long one there are no magic bullets. Hernia surgery can take a year and a patient needs to be mindful or not returning to extreme activity in that time period.
Joseph Fantini, Rosen Law
talked about the difference between a Mass Tort and a Class Action. A mass tort, such as the pelvic mesh litigation, means that the Judicial Panel of Multidistrict Litigation appoints one court to oversee a large number of similar cases. In the case of pelvic mesh, the JPML decided to amass cases in federal court in Charleston, West Virginia before Judge Joseph Goodwin. That was in early 2012.
In an MDL, bellwether trials gauge the relative worth of the claims. Then the injured can either go to trial or be considered for settlements. In a Class Action one person heads the class and generally recovery for each person is the same.
Why didn’t this MDL lead to mass settlements?
In a sense it did. Boston Scientific is almost settled. The RICO case, filed by the Mostyn law firm, is being settled, for example.
Joseph Saunders, Sanders & Walker
Pinellas Park, FL has been on the Steering Committee of mesh litigation since the beginning of the MDL.
He discussed the status of the MDLs for hernia mesh – the Physiomesh (Ethicon) MDL is established in North Georgia, while the C-Qur (Atrium Medical) is in federal court in New Hampshire.
Other hernia meshes involved in litigation are Parietex (Medtronic), Proceed (Ethicon), Prolene, Prolene 3D (both Ethicon), See pending MDLs filed in the JPML website here.
Currently there are about 50,000 hernia mesh cases ready to go and the inventory is expected to swell to more than 100,000 cases which are all being investigated.
Still, upward of one million hernia surgeries are performed in the U.S. every year with more than 90% of them using PP mesh, which means more injuries will no doubt be reported.
Why are medical societies still heralding mesh? The reason is money. With medical societies in financial arrangements with manufacturers, money drives the use of mesh. And for the practitioner, it’s simply is more profitable than a multi-hour-long repair using native tissue. In a cyclical relationship, medical societies are there to support the use of mesh as the Gold Standard by calling it the “standard of care.”
Many mesh–injured women blame their law firms for being money hungry too, but Saunders says for his and other firms, the money is just going one way – out! Most have not yet seen any return on their cases yet. That’s one reason many law firms, who were the first to jump in, are the first to jump out.
Saunders insists it would take decades to try the huge number of cases if they had been filed in state courts originally, so the MDL made sense, however after six years, Judge Joseph Goodwin is winding down his MDL and by this summer he wants the remaining cases returned to their state courts.
Why does it take so long for settlement money to be dispersed? Saunders said the MDL is not a good or efficient process to get financial recovery. He admitted some law firms took more cases than they could ever have worked up for trial, which he hinted might not have been ethical. Many firms with many cases have never taken a single one to trial.
Trial is expensive, Saunders says at least $150,000 to take a case to trial and many hours to work it up a case to be trial-ready. Many firms took the shortcut of settling instead. Then again, not all cases should be tried – maybe there is a statute of limitations problem, or the woman is obese, or she smokes (two conditions that might necessitate the use of mesh).
Lien negotiations, in some instances, takes as much work for the plaintiffs’ lawyer to negotiate down as to prepare the case. During that negotiation a number of things are considered - the number of revisions (with anesthesia), the number of revisions in the doctor’s office. Whether the woman is a smoker or obese will be considered. Smokers typically recover less than non-smokers.
Saunders says the philosophy has been to get the doctors to help the plaintiffs. He asks them, “If you had known the mesh would cause permanent life-long pain, would you have that discussion with the patient? You didn’t know that did you?”
Generally the doctor will say,"No, I didn’t know," going to the failure-to-warn claim.
MND has reported that in many cases, women have not heard from their lawyer ever! With massive transvaginal mesh advertising, some cases were captured, then sold to another firm. Some women do not even know who represents them. We’ve seen cases where the plaintiff moves, the firm has not contacted her, and her case falls between the cracks. She is dropped. Is that her fault?
Always remain vigilant with your case, even if your law firm is not.
The Boston Scientific RICO case has been shelved and is in the process of being settled, was another question by readers.
This webinar was not recorded and there are plans in place to narrow focus another webinar through attorney Michael Monheit very soon. ###