Because of watching six separate pelvic mesh trials I have a unique perspective of what has worked and what hasn't worked. I hope the following observations and analysis will prove helpful to both lawyers and women who are suffering from complications arising from pelvic mesh implants.
Kimberly Adkins Trial
The implanting doctor was not available to testify because he has dementia. The Plaintiff’s lawyer mentioned this towards the end of the trial.
Kim Adkins did not recall what warnings and risks her implanting doctor told her about.
She was asked on cross examination whether she would have consented to have the mesh implanted had she been told about certain risks that were specified the IFU or product information brochure that was included with the mesh kit. She testified that had she known of certain risks outlined in the IFU that she would not have consented to have the mesh implanted.
Defendants’ lawyer argued to the jury that there was no factual causation, as Ms. Adkins would not have elected to have the mesh implanted had her implanting doctor told her of risks mentioned in the production information brochure.
The jury found on the verdict slip that the mesh was defective and that Ms. Adkins had been injured as a result of the defective mesh. But the jury did not award Ms. Adkins any damages at all because the jury concluded that there was no factual causation – presumably because Ms. Adkins testified that she would not have had the mesh implanted had she known of the risks identified in the product brochure.
The trial judge granted Plaintiff’s lawyer’s motion for a new trial on damages as the jury was required minimally to award Ms. Adkins money damages at least for her revision surgery, since the mesh had to be excised or taken out of her vagina, which is one of the stated complications for mesh surgery.
This case demonstrated the difficulty of the plaintiff not recalling what she was told about the risks, her implanting doctor not being able to testify as to what risks he told her since he has dementia, and finally, and perhaps most importantly, Ms. Adkins’ testimony that she would not have gone forward with the mesh implantation had she been told of the risks identified in the product brochure.
Routinely, women considering mesh implants for stress urinary incontinence are not warned that mesh is permanent, cannot be removed totally, that there are risks of serious harm (such as painful sex – aka dyspareunia, pelvic pain, erosion of mesh into vagina or other organs such as urethra or bladder, need for revision surgery where some of the eroded mesh is removed, bleeding and return of incontinence even more severe than previously suffered before the mesh was implanted), and that the risks are likely.
Women are rarely told of permanence, severity and likelihood of risks – so had Ms. Adkins testified that she would not have proceeded with the vaginal mesh implant had she been told of the permanence, severity and likelihood of the risks she would have been fine and the jury could have found causation. However, since she testified that the stated risks in the product brochure had not been told to her, and that had her implanting doctor told her of the risks stated in the product brochure she would not have consented to have the mesh implanted, that is what got her into trouble and led to the jury concluding that there was no factual causation.
My impression is that where the implanting doctor is not available to testify as to what risks he warned his patient of, and the patient cannot recall what she was told about the risks, there can be causation problems if the plaintiff does not recall being warned of the risks identified in the product brochure. It is not advisable for a plaintiff to state that she would not have decided to have the mesh implanted had her implanting doctor warned her of the risks stated in the product brochure. That will lead to factual causation problems.
Failure to warn is only one of the theories of liability. As long as the product is found to be defective (the benefits are outweighed by the risks), and the defective mesh caused harm to the plaintiff, regardless of a failure to warn the plaintiff should recover under a defective product theory.
The Adkins case is still being appealed, and to date there has not been a retrial as to Ms. Adkins’ damages from her erosion surgery and whatever other complications she suffered from the pelvic mesh implanted to help alleviate her stress urinary incontinence.
Ella Ebaugh Trial
This time there were women trying the case for the Plaintiff, Ella Ebaugh, and the lead Plaintiff’s attorney did an excellent job showing images she claimed evidence that the pelvic mesh mangled Ms. Ebaugh’s urethra, causing urine to gush out across the room like a geyser hose. Plaintiff's counsel claimed that during an exam by Plaintiff’s expert witness, Dr. Tom Margolis, when he tested her for urinary incontinence, her urine shot across the room like gushing out from a hose. The visual created by these descriptions and images had a profound impact on the jury which awarded Ms. Ebaugh a record $57 million.
Ms. Ebaugh had three erosions and five perforations of her urethra. The photos showed blue inside her urethra – something that was able to be viewed using a scope that was placed inside the urethra. This made a dramatic impact on the jury. Ms. Ebaugh had multiple erosion surgeries – four surgeries and three corrective procedures. Some of the mesh was removed from her urethra.
The case did not include a failure to warn as a theory of liability.
Design defect and negligence were theories of liability in the case. The felt tips failed in their intended purpose to hold the pelvic mesh in place, when the mesh eroded into areas that the mesh was not supposed to be.
The mesh had small pores, which caused scar plating and fibrosis. Had the mesh been made of larger pores the tissue could have grown through and around the mesh. The scar plating caused the mesh to shrink and contract. The chronic inflammation as the body’s reaction to a foreign body is a lifelong complication of the mesh. The reaction does not fade over time.
There was a safer alternative, the Burch procedure, which uses stitches to hold up the vagina and support the urethra.
Plaintiff would have to suffer from pain and incontinence the rest of her life.
She could not enjoy her daughter’s wedding. Her having 5 vaginal births caused her pelvic floor muscles to weaken, causing her to suffer from urinary incontinence.
She feels like she’s on fire down there, in constant pain whether she sits or stands.
The serious risk of permanently injuring women led the jury to conclude that the mesh was a defective product – worth a $57 million verdict, a record breaking amount.
Susan McFarland Trial
This time Defendants had skilled women attorneys taking the lead role in defending Johnson & Johnson and Ethicon, with opening and closing statements, and during direct and cross examination. It made a greater impact on the jury. It appeared as if the defense lawyers were getting better compared with earlier trials I had witnessed. Using women lawyers is more effective in my opinion as pelvic mesh and complications from stress urinary incontinence surgery are women’s issues.
There were excellent cross examinations made of the defense experts by Plaintiff's lawyers, and a strong closing argument by the lead female Plaintiff's trial attorney.
However, in my opinion, what led to a mistrial because three jurors did not believe the mesh caused Ms. McFarland’s injuries, was that her implanting physician, and a number of other treating doctors such as urologists, concluded that her injuries were caused by vaginal atrophy.
Hearing doctor after doctor opine that Ms. McFarland had vaginal atrophy and her complications could have been less severe had she used estrogen cream – something she stopped doing after her sister had breast cancer – made it seem as if her atrophy and not the pelvic mesh was the cause of her complications, which included painful sex aka dyspareunia.
While Plaintiff’s expert, Dr. Tom Margolis, did a great job of testifying that not everyone with vaginal atrophy has complications like that suffered by Susan McFarland, apparently three out of 12 jurors believed the opinions of her treating doctors that the mesh was not the cause of her problems, but instead, her vaginal atrophy was the culprit.
It is hard to find the perfect plaintiff. Many women past the age of menopause are the very women suffering from stress urinary incontinence and/or pelvic organ prolapse as their pelvic floor muscles weaken from child birth or the absence of estrogen, which is part of the aging process for every woman.
However, not every woman suffering from vaginal atrophy suffers the types of severe complications experienced by women that have pelvic mesh implants. Yet it is clearly an uphill battle to convince a jury of that.