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Blog: Prolift Mesh Trial of
Linda Dunfee - Overview & Comments
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.
Dr. Salil Khandwala
Testimony of Defense Expert, Dr. Salil Khandwala
He is paid $10,000 for a full day of trial testimony.
He claimed the mesh does not shrink. He was shown Ethicon power point slides which state "factors related to mesh shrinkage."
The power point deck states the ideal mesh is light weight, partially absorbable. The Ultrapro and Prolift +M both contain partially absorbable mesh, the Prolift has no absorbable mesh in it.
The arms are needed to prevent lateral recurrence of the prolapse.
In Ms. Dunfee's case, she has pain and erosions in the area of the left arms, which cannot be removed, they are a permanent implant.
Small pores lead to fibrotic bridging, increased shrinkage and mesh contraction.
Qualities of idea mesh include: no shrinkage, no rigidity, no vaginal distortion, maintain normal sexual function, no chronic pain, less erosion.
His mantra is "show me the medical literature," "show me the evidence," he does not consider company emails evidence.
He does not consider the French TVM study a failure.
A study states that the retraction phenomenon is impossible to forecast, and is highly variable.
Gynemesh PS was considered to be an improvement, which is why it was chosen for the Prolift.
Vaginal tissue has to retract as a natural part of the healing process, the tissue contracts and shrinks. He does not think the mesh shrinks, rather that the tissue surrounding the mesh shrinks.
All surgery in the vagina has a risk of dyspareunia. Not good to leave any organs dangling out, need to fix prolapse.
Less complications to fix mesh exposure than to re-operate after a Sacrocolpopexy, which is much more complicated. He thinks there is a higher failure rate with native tissue repairs.
He was shown an internal Ethicon document stating you cannot increase the price of Ultrapro, with Gynamesh PS you can get a much higher price for the product.
It is no good business to release Vipro and Ultrapro together on the market at one time.
Every surgery has problems and complications. The Prolift is not a simple procedure.
He does not advise hysterectomy concomittant (at the same time) with prolapse surgery.
He offers native tissue repairs to his patients. You do not need to augment all prolapses with mesh.
He has prescribed estrogen for life, twice a week, for post-menopausal women, where there are no contraindications.
He does not state this in his expert report, simply mentions treating exposures with estrogen.
He was deposed in May of 2019, a month prior to the trial, and was asked 7 questions about estrogen use, and did not testify at his deposition about prescribing estrogen for life.
He did an unpublished study of his own patients, comparing Prolift +M and the Prolift. He's the only person that knows this data. Out of 157 of his patients using the Prolift, he has seen a 2.2 % exposure rate. For the Prolift +M, out of 250 of his patients, he has seen a 2.2%-5.4% erosion rate. He has seen a de novo dyspareunia rate of 15.8% for Prolift +M users, 6% for Prolift users.
Dr. Richard Bercik
Plaintiff Expert Witness
Dr. Richard Bercik
He is paid $800 per hour, $8,000 per day of trial testimony.
He has been paid by Kline & Specter to testify against other mesh manufacturers including Boston Scientific, BARD and Mentor Worldwide, and also on medical malpractice cases. He has testified that the Prolift used to repair POP (pelvic organ prolapse) and SUI (stress urinary incontinence) devices are defective.
He has never been approached by a mesh manufacturer, he knows of no doctors that testify on both sides of a medical device product liability case.
His exam of Linda Dunfee and his interview of her was billed by Yale University, his employer, he did not bill Kline & Specter.
He does not know how much Yale University billed Kline & Specter.
He's worked 20-25 cases for Kline & Specter. He was paid $391,511.
He has not provided invoices for other law firms besides his work for Kline & Specter.
He submitted an invoice to Kline & Specter in March of 2019 for $13,120, no invoice submitted since then.
He has spent at least 10-15 hours since then reviewing and preparing for trial with Elia Robertson.
For his travel time and review time he is paid $800 per hour. He was retained for this case in December of 2018, he does not recall the exact date.
It's a regular part of his business to treat complications from mesh.
Linda Dunfee had an erosion with granulation tissue at the apex (top) of her vagina.
Dr. Montgomery suggested she use estrogen vaginal cream, that doctor knew she was on HRT (hormone replacement therapy). He wanted her to apply the cream topically in her vagina to treat her erosion, gave her a few weeks worth of samples.
There is no evidence Linda Dunfee filled her prescriptions for Estrace.
She was seen by a nurse, Crystal Bianci, an independent nurse practitioner, who said there is no evidence of dryness or irritation.
Her doctor, Dr. Carl Della Badia, prescribed Premarin cream, he recommended she use it 3x per week and to return in 3 months, he noted she had a small erosion.
She filled her first prescription for Premarin cream on 6/10/2010.
The mesh erosion healed nicely. She was taking systemic estrogen at that time.
A second erosion was noted 5/10/2012, at the apex, on the left side. There was no evidence she filled her prescription for Estrace cream, which was prescribed 3x/week.
Dr. Della Badia noted in his treatment notes dated 5/22/2013 that Linda Dunfee had vaginal bleeding related to a mesh erosion. Pain on deep penetration was the main problem reported.
She did not have atrophy or vaginal dryness, which can also lead to dyspareunia.
Dr. Bercik's patients have a 2-3% erosion rate, but only a 1-year follow-up.
His patients' overall complications rate is about 5%, again only 1-year follow-up after surgery.
Cross-examination by Attorney Joe O'Neil:
Dr. Bercik emailed Sean Bush, an Ethicon sales representative, telling him he did not like a regional manager named Joseph Steele, said he wanted to be involved in research for the Prolift+M, said company did not value loyalty.
Exams were painful for Ms. Dunfee, she accepted her pain with sex as a new norm. She did not have atrophy or dryness.
No strong argument that she could avoid erosions by using vaginal estrogen cream.
It might help with bleeding post-intercourse.
He wanted to do clinical trials for Prolift +M, thought some dissolvable mesh would leave less material in the body, have bigger pores, and better tissue integration, less foreign body response.
Ultrapro was available even before the Prolift was put on the market.
Dr. Bercik is not anti-mesh, he still uses mesh for abdominal repairs and for SUI.
There is pain with the arms of the Prolift, which cause severe dyspareunia, chronic and long lasting. Pain was a big issue, deep dyspareunia around the deep arms of the Prolift.
He stopped using Prolift because of the severity of the complications.
He received $391,000 over a 5 year period, working on 20-25 cases for Kline & Specter.
Linda Dunfee has had yeast infections, he does not think she had that diagnosed. Her irritation symptoms, including discharge, bleeding, and odor could be attributable to her erosions, she did not have these symptoms pre-implant of the Prolift.
Ms. Dunfee's second erosion did not heal using estrogen cream because it was too large. Dr. Marty Weisberg testified that no estrogen cream could cure an erosion more than 1/2 cm, and Dr. Bercik agrees with him.
You can develop an erosion even using vaginal estrogen cream.
The scar tissue from the hysterectomy is not causing Ms. Dunfee's pain with sex. The scar on the left anterior side, where the Prolift arms are located, is where her scar is located.
Her condition is permanent, she will continue to have pain, there is a 50% chance that physical therapy might help reduce pain.
Dr. Bercik thinks Prolift +M is also defective.
Plaintiff Linda Dunfee Testimony
When she was 51 years old Linda Dunfee had lap band surgery for weight loss. She has suffered from chronic back pain and arthritis, off and on.
For two years after she had the lap band she could not eat healthy food, lettuce would get stuck, and she had nausea.
In October of 2012 she had her lap band removed, it was removed laparoscopically.
She had a gastric sleeve procedure in August of 2017, where a small portion of her stomach was taken out.
In March of 2018 she had lipo suction and in February of 2018 she had a face lift.
She had 108 doctor visits since her last visit to Dr. McKinney in July of 2015.
23 of those visits she received bio-identical pellets, made of yams and sweet potatoes, implants once every 3 months.
23 of those visits were to her chiropractor. She had a car accident in May of 2018, and had physical therapy after that.
She has stabbing pain in her crotch, probably the mesh contracting.
She had a defense medical exam with Dr. Elerchman. She does not recall a conversation with him where she allegedly told him she had sexual intercourse twice a week.
She learned what an erosion was in 2015. When she signed a consent form in 2007, she did not know what an erosion was.
The consent forms she signed did not state the frequency of an erosion, nor did they say she was likely to have two erosions.
She'd recall, she never was told the Prolift could cause sexual dysfunction. There was no reference to pain with sex. Recurrent pain was not mentioned.
The problems she experienced were: 3 erosions, in 2009 and 2011, pain with sex, more pain with deep penetration, lack of intimacy with her husband Tom, who does not want to cause her pain, she can't do things as much, more than just sex.
She has had pain with sex for 10 years, vaginal discharge, odor and bleeding when she had erosions, the symptoms improved after the revision surgery.
She thought she might be having a yeast infection.
She has had stabbing pain, pelvic pain, which did not resolve after her revision surgery.
Once or twice a week she tries to have sex with her husband, but totally different from pre-implant encounters. They do different things, not as pleasurable for her, no vaginal orgasms, she feels distant from her husband, he helps her through everything, he's a good man, would not leave her.
The mesh arms are causing her pain. She never saw the Prolift before her surgery.
She thought the implant would dissolve and disappear.
Dr. Elerchman examined her with a speculam, put fingers inside her. She felt a little pain during the exam.
She would not have had a mesh implant, she did not need it, she would not have put herself through the pain.
Testimony of Thomas Dunfee - Loss of Consortium Claim
He's 59 years old, resides in Deptford, New Jersey. From Southwest Philadelphia originally.
Was a line backer, played football, had a two year scholarship.
They have been married 42 years, have 3 children, Dana age 30, Daniel age 26 & Tommy age 20.
They used to go hiking, biking, walk the boardwalk, go on mountain walks, she's always in pain, lost doing all these activities together.
They had an excellent sex life, pleasured each other, 3-4x per week, great times for 42 years.
They had sex to completion, and she enjoyed it too. Since June of 2007 their sex life has been robbed. no spontaneous sex life any more.
He can't push himself on her. Once or twice she pleasured him "more or less", now no sex till completion.
He tells her he loves her morning and night.
He feels the mesh, had blood on the head of his penis, said "what the hell was that." Felt like pin holes with blood coming out, he said "what's up there?" This incident where he was stabbed occurred in 2015.
He wants to enjoy his wife. He wants her back 100%, she's sore and in pain all the time.
My comments: He was keeping it real, seemed very credible, it is surprising to me that the jury gave him no money for loss of consortium.
It is hard to believe that the jury would not award him anything, based on his testimony.
He saw a lawyer television ad in 2015, told his wife to look into this, she did not know she had mesh in her body. The lawyer advertisement described symptoms like his wife was having.
He does laundry and shopping, not afraid to do them.
Elia Robertson, Esq.
Plaintiff Closing Statement
Send a message to the folks in Somerville, New Jersey. That's the headquarters of Johnson & Johnson. Tell them to stop hurting women. Stop putting products on the market without adequate testing.
Defense objected to this, and judge agreed it was improper, told jury it was not proper to use formulas in calculating damages:
1/1000 of $10 is 1 cent. 1 cent doesn't hurt, J & J has a net worth of approaching $62 Billion, make them hear you.
Pick a person for foreperson with a loud voice.
J & J failed Linda. There was a rush to market without sending the canulla and tunneler tools to France for the TVM group of French surgeons to test them in their patients in a clinical trial.
No test of the Prolift and tools on a single live woman, dead bodies do not feel pain from inserting cannulas, cannot feel pain with sex.
Mr. Ciarrocca cut and pasted material from a different product - Gynamesh PS -- in his clinical expert report for the Prolift, a different product because of the cannulas and tunneler tools. Mr. Ciarrocca was very casual about admitting he had done this. What difference does it make - we are dealing with live women, patient safety is at stake, that's why it is wrong to cut and paste language from a different product's clinical expert report when you are submitting a clinical expert report for the Prolift.
Mr. Ciarrocca admitted he never read the clinical studies cited in the Prolift clinical expert report. One was related to a mesh with similar complications to what was experienced with Gynamesh-PS.
Mr. Ciarrocca never called the medical director, Charlotte Owens, saying why isn't the information from the French TVM group in the Prolift clinical expert report. He told her that she might like to include it and when the clinical expert report did not include this information Mr. Ciarrocca never asked Charlotte Owens why it's not in the Prolift clinical expert report.
Mr. Ciarrocca admitted the company had concern about competitor products beating theirs to the market. Why didn't he hit pause and instead hit fast forward, why the company didn't send canullas to France for the French surgeons to test on live women.
The Dr. Elerchman charade - the defense doctor that actually examined Linda Dunfee, he was never called to testify at the trial, Ms. Robertson only found out a day ago he would not be coming to testify.
Linda Dunfee testified that the size of the snippet of mesh removed from her during the revision surgery as shown in the photo, was the size of a nickel. The photo was not to scale, makes the size of the mesh removed seem larger than it really was.
Charlotte Owens was available to both sides and neither side called her as a witness at the trial, she was in the control of both parties. Even though Elia Robertson said in her opening statement that she would be bringing in Charlotte Owens as a witness, she did not keep her promise.
Judge said stretching language in cases to suit their position - that's called advocacy. That is why he likes to ask lawyers to show him and highlight what language in the case they are relying on.
Plaintiff said she didn't know the mesh was in her body until 2015.
Why didn't the defense call Dr. Ellerchman to testify when he examined Linda Dunfee?
Judge ruled that the transcript of conversations between Linda Dunfee and Dr. Ellerchman is out, just heresay, Ms. Dunfee said no, that didn't happen when asked if she told Dr. Ellerchman that she was able to have sex twice a week.
Rebuttal argument of Elia Robertson:
Because the Defendants' closing (see next section) ended close to the normal time the jury is excused for the day Judge Cunningham asked the jury whether any of them minded having a half hour rebuttal (amount of time Elia Robertson asked for), and two jurors raised their hands, so the jury was excused until the next morning.
The defense complained about Robertson getting half an hour, with overnight to prepare, but the judge allowed it anyway, defense the next day complained about the many slides Robertson gave them that she wanted to use in her rebuttal, but the judge allowed them except for the one email of Professor Jacquetin, the Prolift inventor, saying he wouldn't want the Prolift implanted in his wife. Judge Cunningham thought it crossed the line because of prejudicial impact outweighing probative value.
Robertson argued she should be allowed since the email had been shown to the jury by Pasquarello during his cross examination of defense expert, Dr. Khandwala. Judge Cunninham said she took a chance not mentioning it in her closing argument, she has no right to rebuttal, it is within his discretion to allow, and he would not allow it.
The Prolift failed according to their own protocol, pre-launch.
Effectiveness means nothing when someone is suffering from severe permanent injuries.
Pre-launch studies showed back in 2006 that there was a 17% shrinkage rate, 17% de novo dyspareunia rate.
Why was this the most studied, post-launch? Because of the many problems associated with it, it's not on the market any more.
It's not safe, studied and tested. They tested Gynamesh, not the tools (canullas and tunnelers). They did not test the arms.
The French arm of the TVM study had a 36% complication rate.
The U.S. arm had a 14.1 erosion rate.
The French arm failed by their own protocol. They had all they needed to tell them, stop, it's failing.
They didn't test the cannulas or the arms, cadavers cannot feel pain.
Dr. Khandwala said the arms lay flat in the tissue, in contraction to what Mr. Ciarrocca said.
Mr. Ciarrocca testified that it is impossible because the mesh is wider than the cannulas.
Dr. Khandwala said some of the mesh lays flat in the cavity, and this other part doesn't.
There is a roping of the arms, period, that is what was happening.
A roping, curling of the arms, which is what is causing Ms. Dunfee's problems.
The only doctor that examined Ms. Dunfee and came here to talk with you testified to this.
Defense said Plaintiffs changed their story, they can't remember what happened a decade ago, based on her memory and her husband's memory. Defendants want you to excuse their conduct because Ms. Dunfee went to a doctor to treat her bug bites.
Because Plaintiffs try and attempt to have sexual intercourse, this excuses their conduct.
The medical records show that for 10 years Ms. Dunfee told her doctors that she was having pain with sex, she was reporting her complaints in real time, which is still happening to her today.
It is a fact that she has suffered from dyspareunia for more than 10 years, a fact that mesh eroded into her vagina twice (3 times), this is not in dispute, not up for debate.
Medical records don't lie, don't lose sight of this.
There is no alternative explanation for what is causing her pain with sex or erosions.
Dr. Bercik found palpated pain at the mesh arm and vaginal distortion, things only a mesh device could cause.
The lap band procedure is a distraction.
Dr. Bercik had low complication rates with the Prolift because he only had one year follow-up. Erosions take place over years.
Defendants showed one email about Dr. Bercik wanting to participate in a clinical trial. What about all the emails from Defendants and what they said?
He is still implanting Ethicon products today, he has no ulterior motive for not wanting to implant the Prolift.
He is mad about the product and what it did to women, as he should be.
He earned $300,000, for work he did for Kline & Specter. The numbers Kim Bueno told you are made up, lawyers' statements are not evidence.
Defendants claim Ms. Dunfee was not compliant with use of vaginal estrogen cream. Well, there are Express Script mail order documents showing that the cream was delivered to Ms. Dunfee's house.
In May of 2012, and in May of 2015. And it didn't work when she used it, she still got erosions.
Estrogen does not cause an erosion, mesh does.
The picture means nothing, no expert said what this picture means, no pathologist was called. It looks disgusting.
Saying a complication is not a defect is insulting to your intelligence.
Concerning punitive damages, do not ignore the company's words before this lawsuit, evidencing why they acted recklessly.
Ms. Dunfee is not looking for sympathy, she is looking for justice, and its about time.
Kim Bueno, Esq.
Defense Closing Statement
A complication is not a defect. Just because Linda experienced an erosion and pain with sex after her Prolift procedure does not mean she is entitled to receive any money.
You have to find that there was a design defect in the Prolift and that this defect caused Linda Dunfee's injuries.
"Show me the evidence." That is the Plaintiff's burden.
The Prolift was effective for prolapse repair, it supports the pelvic organs - Efficacy.
There are higher rates of recurrence with native tissue repairs. Need for re-operations, prolapse comes back.
Dr. Khandwala testified that out of 315 of his patients (in his unpublished study) 97.8% of the time there was anatomic success for the treated compartment.
There was a 93.4% overall anatomic success rate with his patients.
No surgery is free of risk. Do the benefits outweigh the risks?
Ms. Dunfee has only two complaints: erosions and pain with sex.
There are low complication rates in some studies, what's the real rate? It's
a known risk.
Dr. Bercik said the pore size is to blame for the erosion, that pores collapse and become almost non-existent, that the pores are too small, leading to scar formation, tissues cannot integrate and incorporate - this is just a theory.
The mesh removed from Ms. Dunfee at the site of her erosion was not roped or curled, the photo speaks for itself.
When Dr. Bercik implanted women with the Prolift there was an overall complication rate of only 5%, and an erosion rate of only 2-3%. Why so low a rate of erosion if the small pore size is causing erosions.
In the Lowman article, there is a 16.7% de novo dyspareunia rate. Dr. Khandwala testified that there are higher dyspareunia rates with native tissue repairs.
There is a risk of pain with sex whenever there is an incision made into the vagina. Plaintiff claims her pain with sex is caused by the arms and tools, that there was anatomical distortion of her vagina, a ridge was formed which caused pain with deep penetration sex.
Yet the part of the arm which twists, curls, ropes and frays is not in the vaginal compartment, it is cut off.
The arms of the Prolift come out of the groin, some goes from the muscles outside and is cut off, the area inside the pelvis lays flat because that part never passes through the canullas.
The ridge within the vaginal compartment, that part has not passed through the canullas.
Dr. Della Badia, an obgyn for 30 years, could feel the mesh, said it was where it was supposed to be.
There was no shrinking, roping or curling, only Dr. Bercik found this.
The "IDI" slides where top 20 surgeons gave feedback, J & J asked them for their opinions to find out what could be improved, how could they do better, they said the cannulas were the best tools, the mesh and tools, were great too. The Gynamesh PS was tested, had a proven track record. It was studied and tested.
The TVM group tested the Gynamesh PS on over 600 patients, with an 80-90% success rate.
What difference does it make what studies are included in the clinical expert report of the Prolift? [This is an outrageous claim, why have a clinical expert report at all to show product safety if it does not matter what studies are included within it, patient safety is at issue, that's what difference it makes.]
There were continued studies after the Prolift was launched on the market, it is more studied than any other prolapse repair device, there are 98 results from post-launch studies.
It is the Plaintiff's burden to show that the Ultrapro was a feasible alternative design that if used would have prevented her injuries, that's on the verdict slip.
If use Ultrapro, less complications, that's a great idea. No evidence that it would have prevented Ms. Dunfee's injuries.
Great idea, less mesh. Not show it's a feasible alternative, clinical studies had not yet been done for the Ultrapro, needed more animal and human testing.
Not ready to launch Ultrapro on the market in 2007, when the Prolift was implanted in Ms. Dunfee.
There are similar complication rates with Ultrapro, not have less complication rates than the Prolift.
Plaintiff has the burden to show Ultrapro would not have injured Ms. Dunfee.
Plaintiff's burden to show there was a safer alternative design. [Actually, per the verdict slip, it is Defendant's burden to show that the Ultrapro would not have been a safer alternative.]
Dr. Bercik opined in his testimony that he believes that both the Prolift and Ultrapro are defective products in his opinion.
Dr. Elliot's testimony was presented via video, which was taken back on November 21, 2015. Why didn't Plaintiff bring him in live? There is data since then that shows otherwise, additional clinical studies since then, showing that Ultrapro and Prolift have similar complication rates.
Ms. Dunfee had a one hour discussion with Dr. McKinney where he told her about the risks of recurrence, erosion, sexual dysfunction, recurrent pain, this took place on December 11, 2006, Ms. Dunfee then had 6 months before implant to think about whether she wanted the implant. [This was an assumption of risk argument, which is improper.]
Dr. Bercik put in 350 Prolifts in his patients, in late 2009 or early 2010, he stopped putting in the Prolift. There was an email from Dr. Bercik where he desired to participate in clinical research of the Prolift +M, where Yale could be the clinical site, states he has been a loyal user of the Prolift.
The email states that Gynecare does not value loyalty or stand by its promises.
Since then, Dr. Bercik has earned $391,000 on the 20-25 cases he has been an expert in cases against manufacturers of mesh devices, he earns $800/hour. Kim Bueno claimed he has earned $1,043,057 [Plaintiff disputes this, says amount is $391,000]. He is the go to guy for Kline & Specter. He has been paid $55,000 so far in this case.
Dr. Khandwala was paid $1 million by Ethicon, this money went to his hospital, for work he does, and for his clinical studies.
Ms. Dunfee was not compliant with using vaginal estrogen cream that was prescribed, when there is a graft (mesh implant), her doctor testified that he prescribes this 2x/week for life, in post menopausal women, to keep the vaginal tissue healthy.
It is not enough to take systemic estrogen (oral HRT pills).
Ms. Dunfee claims she has pain like a knife stabbing her in the crotch, this is no where in her medical records.
The verdict form will include questions related to statute of limitations, she has two years from when she should have reasonably known and discovered that her injury was caused by the conduct of another.
She filed the lawsuit October 26, 2015, so if she knew before October 23, 2013 that her injuries were caused by conduct of another then the lawsuit is not timely. [Elia Robertson said in her rebuttal, how could Linda Dunfee know when Defendants are still claiming their product is not defective?]
Punitive damages are designed to punish, only the worst type of wrong doing, where there is clear and convincing evidence, which means no serous or substantial doubt, a wanton disregard of the Plaintiff's rights, malicious intentional wrongdoing, where there is a high probability would hurt another, evil minded, trying to hurt women.
Putting profits over patient safety - that is all Plaintiff is claiming.
The IDI's show that Ethicon and J & J were seeking feedback and criticism, to make their product better and safer for women, more clinical testing was done post-launch.
The profits made in Pennsylvania related to sales of the Prolift between 2005-2012 were only $115,117, from 953 units that were sold over a 7 year period, that is only $16,000 per year, this is a stipulated fact.
Not fair to consider the worldwide market for the Prolift.
My comments: Apparently, these arguments swayed the jury, as no punitive damages were awarded, which is a first in a case I have seen, where the Plaintiff won but no punitive damages were awarded.
A complication does not equal a defect.
Not warranted to throw money at Mrs. Dunfee like Monopoly money. Say the truth, not based on sympathy, emotion, bias or prejudice, apply the evidence.
Composition of Jury
The jury was comprised of 7 men, 8 women. 5 of the women were black, 2 were white, and 1 appeared to be Hispanic.
4 men were white, 3 were black, and 1 was light skinned of unknown race.
One alternate ended up on the jury because one juror needed to attend the sentencing of a man that murdered his wife.
Another juror was excused earlier because of health concerns.
In the end there was still one alternate left.
The jury seemed attentive and engaged for the most part. The judge had a good sense of humor.
The courtroom was the smallest I have ever seen used for a major trial.
Thoughts about the attorneys
Elia Robertson - one of the best I have seen in these cases, she had a lot of tough breaks, didn't let anything phase her.
Kim Bueno - very nice personality, smiles a lot, but doing much better not to smile inappropriately, she was very effective in her closing statement, rather tough in her cross examination of the Plaintiff.
My opinion has generally been that women are far more effective in handling cases of this nature, involving women's issues. Some men have shined, particularly Daniel Thornburgh in the Kim Atkins case.
Final thoughts about the case
Prepare Plaintiff to state all her damages she believes she is still suffering from the mesh, make sure all are documented in the medical records.
Make sure your expert has both case specific and general expert opinions in his report so won't be an issue of beyond the scope raised.
Ask Plaintiff if she has any photos or whether the mesh excised has been preserved. Don't wait until trial.
Make your best arguments in your closing, don't save for rebuttal since judge may not allow.
Don't read from documents and just ask witness, have I read that correctly? Too much is boring and annoying.
Make sure husband of Plaintiff will not give any information that indicates he or his wife knew the mesh was defective or causing injuries more than 2 years before the lawsuit has been filed. Good argument to state how could Plaintiffs know mesh was defective when Defendants are still claiming their mesh product is safe and effective.
Plaintiff did not even know mesh was in her, did not even know what an erosion was. This may sound incredible, but I have seen this in a number of cases.
Good preparation before depositions and trial testimony as to what Plaintiff can no longer do because of her injuries, such as activities, chores around the house, etc.