First, why so little? Why no punitive damages? Why no damages for loss of consortium claim of Linda Dunfee's husband?
All of the pelvic mesh trials I have watched - where the plaintiffs have won -- have had verdicts in the millions of dollars and have included awards of punitive damages. Why not this case, and why so little?
First, the judge obviously matters. While the judge was a good one in many respects (for example, he explained the reasoning behind many of his rulings, something judges rarely do), some of his rulings were in my opinion outrageous.
For example, unlike many other pelvic mesh trials I have watched, Judge Charles Cunningham, the presiding judge over the Linda Dunfee trial, did not allow the Plaintiff's attorneys to present Defendant's damaging company emails where one of them stated callously that the women injured by pelvic mesh should try sodomy (where they are experiencing painful sex aka dyspareunia), another email described sex with a woman that has a mesh implant being like having sex with a wire brush, and another email had the inventor of the Prolift stating that he would not like to have the Prolift implanted in his own wife.
Despite the highly probative value of these company emails Judge Cunningham ruled that the prejudicial impact outweighed the probative value, and refused to allow Plaintiff's attorneys to present these emails during the case and the rebuttal closing argument of the Plaintiff's attorney, Elia Robertson.
After Plaintiff's counsel took on the judge and objected to his rulings keeping out these damaging emails (made Defendants look very bad), Judge Cunningham relented somewhat and allowed Attorney Philip Pasquarello to question Defendants' expert, Dr. Salil Khandwala, an obstetrician-gynecologist in Dearborn, Michigan, regarding the email where the inventor of the Prolift, Professor Bernard Jacquetin, said he would not want it implanted in his own wife.
However, unfortunately for the Plaintiff's case, Dr. Khadwala testified that the email did not necessarily relate to the Prolift.
Elia Robertson asked the scientific and engineering project lead, Scott Ciarrocca, "did Professor Jacquetin ever tell you that he would not want to have the Prolift implanted in his own wife? From when you started as project lead until you were transitioned to another project?"
Judge Cunningham sustained Defense objection to this question, but the jury heard the question.
In other mesh cases Plaintiff's counsel made much of the fact that the inventor of the Prolift did not want it implanted in his own wife. Judge Cunningham did not consider himself bound by what prior judges allowed in other mesh cases, finding that these company emails were highly prejudicial, and that their probative value was outweighed by prejudicial impact.
Judge Cunningham stated Professor Jacquetin may have been facetious, maybe he was not even married, and there was no evidence what kind of relationship Professor Jacquetin had with his wife.
In my opinion, the judge's rulings were outrageous and clearly erroneous, the probative value is clear, even the inventor did not want the Prolift implanted in his own wife. What could be more probative than that?
When Elia Robertson made the mistake of waiting until her rebuttal closing argument to mention the email from Professor Jacquetin, Judge Cunningham said she took a chance in not raising this evidence in her initial closing statement, said he did not have to allow her any rebuttal argument at all, that it was in his discretion, and he ruled that this evidence crossed the line where its probative value was outweighed by its prejudicial impact. Defense had objected when, on the morning of the Plaintiff's rebuttal, the defense attorneys were given copies of slides Elia Robertson intended to use in her rebuttal argument.
A hard lesson that could not have helped Plaintiff's case.
Lesson to be learned: Lead with your best evidence in your initial closing statement, do not wait to get in the last word on key evidence in your rebuttal argument, or you risk that the judge will not allow the evidence in at all.
Bias by the Trial Judge
The trial judge made an outrageous statement when the defense complained about Elia Robertson stating if the Prolift is so safe and effective, why isn't it still on the market.
Defense said the company voluntarily stopped selling the Prolift in 2012, that Ms. Robertson should not have said the Prolift was pulled from the market, can only say it is not on the market.
Judge Cunningham asked the defense if they wanted him to tell the jury that there is no evidence that the Prolift is off the market because it's not safe. That it was removed from the market for reasons that had nothing to do with product safety.
That is simply outrageous. Elia Robertson then told the judge that the Prolift would still be used if the FDA had not recently (just a few months ago) stated that mesh kits could not be used and were not warranted (suitable) for repairing prolapse given the poor safety profile, bad side effects and complication rates associated with such mesh implant kits.
The fact that Judge Cunningham suggested telling the jury that the Prolift was not removed from the market because of patient safety concerns is simply outrageous given that Judge Cunningham knew that the FDA had recently ordered that all mesh kits not be used for prolapse repairs.
It appears that Judge Cunningham was biased against the Plaintiffs, occasionally chastising Plaintiff's counsel for making arguments or comments, and another lawyer from Plaintiff's law firm for merely nodding his head during argument by Philip Pasquarello. That lawyer, I believe, was a partner at Plaintiff's law firm named Michael Trunk. Attorney Trunk told the judge he was just nodding his head, and did not think anything he could do would have any impact on the way the judge was ruling. Judge Cunningham then said that was good.
The judge did not want any comments or gestures from the peanut gallery, telling the lawyers if they wanted to make argument to come before him. At one point, Plaintiff's counsel did come before him when the judge said this, and proceeded to make argument, telling the court reporter to reference that he was making an appearance in the case.
Other factors that did not help
When Philip Pasquarello was cross examining Defendant's expert, Dr. Khandwala, he kept reading from various emails and/or Ethicon/Gynamesh company documents, and asking Dr. Khandwala whether he had read this or that correctly. Defense kept objecting to this mode of questioning, stating that it was empty simply reading various documents to Dr. Khandwala without asking how they may have impacted his opinions. While Judge Cunningham allowed this mode of questioning for hours, over continued objections by Kim Bueno, one of Defendants' many attorneys (there were at least 6 sitting in the courtroom doing who knows what during the entire trial), Judge Cunningham granted Ms. Bueno's request to bifurcate the rest of Pasquarello's cross examination, so she would be allowed to ask her questions of Dr. Khandwala.
I have never seen a judge bifurcate a cross examination mid-stream like that, but again, it was annoying to anyone listening to Pasquarello's cross examination to hear him simply reading long portions of various documents and not asking anything other than whether he had read them correctly. It seemed to be putting the jury to sleep, I know I thought it torturous to listen to him. Elia Robertson and other attorneys I have seen in the past have done such things when showing expert witnesses various medical records, but I have never seen any lawyer read long portions of company documents without asking any substantive questions about them.
The Plaintiff, Linda Dunfee, did not have any medical visits with her doctors related to the dyspareunia and erosions since 2015 even though she had been to her doctors over 80 times since then, for various other ailments, including having a lap band, other cosmetic procedures, and even treatment for bee bites.
Linda Dunfee responded that she had been to the emergency room a number of times but the Plaintiff and Defendants had not presented any medical records evidencing those emergency room visits. Further, Linda Dunfee testified to having sharp pain like a knife in her crotch, but this statement was no where found in any of her medical records.
This was ameliorated somewhat by Plaintiff's expert's testimony, where Dr. Richard Bercik, an obstetrician-gynecologist in New Haven, Connecticut, affiliated with the Yale School of Medicine, where he is a full time assistant professor, testified that Linda Dunfee may not have sought additional treatment for her dyspareunia and erosions since 2015 because she had accepted her "new norm" and did not think further consultations with medical doctors would help her. Dr. Bercik noted that each time Linda Dunfee is examined, those examinations are extremely painful for her, and would not necessarily lead to any improvement of her situation.
The testimony of Linda Dunfee and her husband conflicted as to their ability to have sex with deep penetration, her husband described them doing this, while Ms. Dunfee's testimony seemed to describe other types of sexual activity besides intercourse. There was also a discrepancy as to the type of services that Ms. Dunfee was not able to perform around the house such as lifting heavy laundry, so it was not clear what the evidence was as to the value of Thomas Dunfee's loss of consortium claim.
Personally, I found their testimony credible, they kept it real, and it was quite moving. However, I could see how the jury may have found conflicting testimony hard to evaluate. Both Plaintiffs were impeached with their deposition transcripts where their in-trial testimony did not always line up with their deposition testimony.
Elia Robertson downplayed these discrepancies in her closing statement, arguing what difference did it make whether Tom Dunfee remembered accurately about his wife's inability to lift the laundry 10 years earlier, and what difference did it make whether Linda Dunfee recalled accurately what type of pads she wore for incontinence 10 years earlier, where her medical records indisputably evidenced that she suffered with de novo (new, since the mesh implant) dyspareunia (aka painful sex) for over 10 years.
There was a tape recording made of the defense physical examination where supposedly Ms. Dunfee told the examining doctor that she and her husband were still having sexual intercourse. Ms. Dunfee denied recalling making such a statement to this defense exam doctor, and the Defendants did not call him to testify at the trial. Hence, Judge Cunningham did not allow Defendants to use this testimony, which Linda Dunfee rejected, in the defense closing statements, because it was uncorroborated hearsay.
Another issue was whether Ms. Dunfee was using estrogen cream vaginally as prescribed by her treating doctor, Dr. Carl Della Badia, who is an obstetrician-gynecologist in Philadelphia, who claimed he had prescribed Linda Dunfee with vaginal estrogen cream "for life" because she was in menopause following a hysterectomy and because she had a mesh implant. Defense argued the reason the mesh eroded multiple times was because the tissue was thinner because of a lack of estrogen, which made the mesh closer to the surface.
Defense argued Linda Dunfee was responsible for the mesh erosions because she failed to use the vaginal estrogen cream as prescribed by her doctors. The Plaintiff's expert, Dr. Richard Bercik, and Linda Dunfee, herself, both denied that she was ever prescribed vaginal estrogen cream for life by Dr. Della Badia. Plaintiff took systemic estrogen tablets/pills for a time, and later took a natural organic estrogen therapy that would not pose a risk of breast cancer.
Elia Robertson argued that Linda Dunfee got an erosion, she took vaginal estrogen cream, and the first erosion healed. When she got a second erosion, she restarted using vaginal estrogen cream, but was told by her doctor that her erosion was too large and would not heal without revision surgery to remove the eroded mesh that was in her vagina. Ms. Robertson argued that Ms. Dunfee still had erosions while taking systemic estrogen pills, but the defense argued that only the vaginal estrogen cream was effective in preventing erosions.
The defense argued that the Prolift did what it was supposed to do, which is to support Ms. Dunfee's anterior (front) prolapse condition, where her bladder was coming down into her vagina. This condition is also known as a cystocele. Elia Robertson argued her prolapse was asymptomatic and did not justify the Prolift mesh implant, stating that curing the mild prolapse was outweighed by the deleterious side effects, where Ms. Dunfee could no longer have sexual intercourse for the rest of her life. She compared this to cutting off a finger to remove a splinter, the splinter was gone, but at what cost.
With all of these points in issue, the jury did not find Defendant's conduct warranted punitive damages. Elia Robertson argued the Defendants rushed the Prolift to market without testing it on a single live human being, said cadavers could not experience pain with sex. Elia Robertson argued the mesh in a live woman roped and curled.
Linda Dunfee gave Elia Robertson during the trial a photograph of the actual mesh that was removed after the revision surgery. Ms. Robertson gave the photo to the defense, who showed the photo to the jury during examination of defense expert Dr. Salil Khandwala after Plaintiffs had rested their case. The photo did not appear to show the mesh removed to be in a curled or roped condition. Ms. Robertson argued that it was like that when it was inside Ms. Dunfee's body, and described the removed mesh as "disgusting" in her closing argument.
Philip Pasquarello, during his cross examination of the defense expert, Dr. Salil Khandwalra, had the doctor use a model he brought to the court, to perform an actual implant using the Prolift kit, the cannulas and tunnelers -- which were described by Plaintiff attorneys as "a contraption" -- and left the Prolift mesh in the cannulas for his entire 2-hour cross examination.
Attorney Pasquarello claimed to have forgotten to ask Dr. Khandwalra to do the most important part, which is to remove the mesh from the cannulas. Dr. Khandwalra stated that Philip Pasquarello had cleverly caused the mesh to be inside the cannulas for 2 hours, something that would never be done in a real life operation, where the entire procedure takes only 45 minutes, and where the actual mesh implant part of the procedure only takes about 15 minutes.
Still, it appeared that the mesh had, indeed, roped and curled after being passed through cannulas that were smaller in diameter than the mesh that passed through those cannulas.
The jury was told to look at the mesh arms as they passed by the model that was left beside the jury box. Plaintiff's expert, Dr. Bercik, said the mesh had to have curled when it was placed into a smaller round cannulla which had a smaller diameter. The defense attorneys argued during closing statement that the mesh removed from Linda Dunfee did not have a roped or curled condition in the photo that was displayed to the jury during the closing statement.
With this conflicting evidence, the jury came down with a much smaller verdict than normal, only $500,000. Still a sizable sum, but clearly far less than the $120 million verdict handed down in the Susan McFarland case, and the $80.025 million verdict handed down in the Patricia Jill Mesigian case.
Keep in mind, however, that the type and severity of the damages suffered varies from case to case, some women have the mesh eroding into their urethra or other pelvic organs, have a greater number of erosion revision surgeries, and may have many UTI's (uterine tract infections) that are attributable to the mesh.
Plaintiff Linda Dunfee only had two categories of damages: dyspareunia and erosions. This case is an excellent example of what one jury found that a claim involving life long dyspareunia, where the woman could no longer have intercourse, was worth financially, albeit Ms. Dunfee also arguably had 3 erosions.
In the Linda Dunfee case her own treating doctor and her own expert witness, Dr. Bercik, testified that her "yeast infections" were not caused by the mesh implants. However, Elia Robertson pointed out that the symptoms she was experiencing, burning, pain, etc. were caused by her erosions and mirrored symptoms associated with urinary tract infections.
The greatest category of damage in my opinion was her inability to have deep penetration intercourse, which is something she had enjoyed with her husband of more than 40 years. Had she known she would never be able to have intercourse again she testified she would not have agreed to have the Prolift implanted, particularly as her anterior prolapse was not very symptomatic.
The trial judge did not allow the Plaintiffs to introduce evidence of the risks stated in the IFU, or product information brochure, and that is because Judge New had ruled pretrial that there was no failure to warn claim because the implanting doctor testified that he knew the risks of the Prolift included erosions and dyspareunia.
Linda Dunfee signed multiple consent forms, some of which specifically stated these risks. The risk of dyspareunia is not mentioned in the product information brochure, and Elia Robertson tried to get Judge Cunningham several times during the trial to allow her to mention the IFU, said the IFU still exists despite Judge New's pretrial ruling.
The implanting doctor testified before the trial at his deposition that the risks were commonly known from the medical literature and that he did not rely exclusively on the IFU to know what risks were associated with the product.
Judge Cunningham ruled that Plaintiff cannot put before the jury any information regarding the content of the IFU. Elia Robertson tried to persuade Judge Cunningham not to take this position, stating that a component of the New Jersey statute regarding design defects states that instructions are a component of a design defect case, so the IFU is not solely relevant to a failure to warn claim, which was stricken by Judge New when granting Defendant's summary judgment motion.
Ms. Robertson told the judge that the defenses in a strict liability design defect case include characteristics of the product which are known to a typical purchaser or user, and how the ordinary consumer or user knew about those characteristics. Since one of those ways is what is set forth in the IFU, she deemed the IFU to be relevant to a design defect case regardless of the failure to warn claim having been previously thrown out on summary judgment.
The IFU falsely states that pain is transient, even though it is now known that there is a risk of lifelong pain which is permanent. The judge told the Plaintiff lawyers not to assume the door is opened to bring up the contents of the IFU without running it by him first.