Preview Newsletter
Ethicon Media Monitoring 4/16/2018
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How Profiteers Lure Women Into Often-Unneeded Surgery
Apr 14, 2018 | The New York Times
By Matthew Goldstein and Jessica Silver-Greenberg
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NYT on Profiteers Who Lure Women into Unnecessary Mesh Surgery
Apr 15, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
The New York Times published a front page story April 15th about the people who allegedly prey on unsuspecting women with transvaginal mesh, allegedly to have additional surgeries to increase the value of their settlement. -
Pelvic mesh case: $68M award from Bergen jury
Apr 13, 2018 | NorthJersey.com
By Richard Cowen
A jury has returned another huge verdict in a product liability case involving pelvic mesh implants, this time awarding a Raleigh, North Carolina couple $33 million in compensatory damages and $35 million in punitive damages. -
C.R. Bard Must Pay Punitive $35 Million in Vaginal-Mesh Case
Apr 13, 2018 | Bloomberg
By Jef Feeley
C.R. Bard Inc. was ordered to pay $35 million in punitive damages to a woman who blamed her injuries on the company’s vaginal mesh inserts in the medical supplier’s first case over the controversial devices to go to trial in New Jersey. -
Bard Hit With $35M Punitive Damages In NJ Mesh Case
Apr 16, 2018 | Law 360
By Bill Wichert
C.R. Bard Inc. was slammed Friday with $35 million in punitive damages in a New Jersey state lawsuit alleging its pelvic mesh devices caused a woman debilitating pain, a day after jurors hit the company with a $33 million verdict in compensatory damages. -
UPDATE: New Jersey jury hits BD subsidiary Bard with $68m pelvic mesh verdict
Apr 13, 2018 | Mass Device
By Brad Perriello
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard was reportedly hit yesterday with a $33 million verdict in a product liability lawsuit brought over its Avaulta and Align pelvic mesh products. -
$35M Punitives Award Brings Bard Pelvic Mesh Verdict to $68M
Apr 13, 2018 | New Jersey Law Journal
By Charles Toutant
A jury in Bergen County, New Jersey, on Friday awarded $35 million in punitive damages in a suit against C.R. Bard over defective pelvic mesh products. -
Jury awards woman $23 million in C.R. Bard implant trial in New Jersey
Apr 13, 2018 | Legal News Line
By John Sammon
A jury by 7-1 vote on April 12 ruled that $23 million in damages be awarded to plaintiff Mary McGinnis after deciding a pelvic mesh implant caused the 70-year-old North Carolina woman to suffer inflammation, severe pain, loss of lifestyle and mounting medical bills when the mesh had to be removed over subsequent surgeries.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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How Profiteers Lure Women Into Often-Unneeded Surgery
Apr 14, 2018 | The New York Times
By Matthew Goldstein and Jessica Silver-Greenberg
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NYT on Profiteers Who Lure Women into Unnecessary Mesh Surgery
Apr 15, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
The New York Times published a front page story April 15th about the people who allegedly prey on unsuspecting women with transvaginal mesh, allegedly to have additional surgeries to increase the value of their settlement.
Mesh News Desk has found this to be a problem, (see MND story on profiteers here) but in context it represents a fraction of the women who have had implants and been injured by their doctors and ultimately by mesh manufacturers, which the evidence showed, popularized polypropylene mesh implants for profit. Please take the time to comment on the story here.Here is my response:Glad the Times is finally paying attention to the biggest medical scandal targeting women in our lifetime but the story demands context – the real profiteering starts at the top. While despicable few women have fallen prey to these individuals whose stories are covered on Mesh News Desk. The big boys – BSC, JNJ, AMS, Bard launched their polypropylene “experimental” devices with no clinical trials, to any doctor willing to make his business more profitable. They knew this blind procedure with plastic mesh would hurt patients, evidence has shown. Then the big boys paid millions to certain “consultants” training and selling other docs to get them into the fold. The profiteering dollars didn’t stop there. Medical societies had their hands and wallets opened to dollars from industry to host their annual conferences, where again, the profiteers appeared like a trade show pushing profitability. Safety? No clinical trials, No alternatives to mesh (there are), just put the stuff in. Even today, doctors are telling women “It’s not the same mesh”…. It is! Its polypropylene, and permanent implant for both hernia and pelvic. Juries hearing the evidence – the destroying documents, the dummy companies set up to buy raw polypropylene when the petroleum industry stopped selling it to medical device makers, the insider emails – Juries are leveling huge punitive damages to send a clear message they don’t like the reckless preying for profit
https://www.meshmedicaldevicenewsdesk.com/nyt-on-profiteers-who-lure-women-into-unnecessary-mesh-surgery/
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Pelvic mesh case: $68M award from Bergen jury
Apr 13, 2018 | NorthJersey.com
By Richard Cowen
A jury has returned another huge verdict in a product liability case involving pelvic mesh implants, this time awarding a Raleigh, North Carolina couple $33 million in compensatory damages and $35 million in punitive damages.
The jury found that two pelvic mesh devices developed and sold by New Jersey-based C.R. Bard Inc. were faulty, and that the plaintiff, Mary McGinnis, was never adequately informed of the risks. Late Thursday, the jury awarded McGinnis and her husband, Thomas, compensatory damages of $33 million. On Friday, the jury returned to decide if punitive damages were warranted, and awarded the couple an additional $35 million.
"They rushed this product to market, and I think the jury was repulsed by that," said Adam Slater, the attorney for the plaintiffs. "I think this jury sent a message: Change what you're doing, because there are consequences."
C.R. Bard, a subsidiary of global medical supplier Becton-Dickinson of Franklin Lakes, says it will appeal the verdict. In a statement, the company said McGinnis knew of the inherent risks in having the vaginal implants.
"We are disappointed with the outcome of the trial and we plan to appeal," said Troy Kirkpatrick, a company spokesman. "Any implantable medical device carries inherent risks as well as clinical benefits. While we appreciate that Mrs. McGinnis is dissatisfied with the outcome of her procedure, it is important to note that thousands of women over many years have benefited from these products and have improved lives because of them."
The jury verdict was the latest huge award in a product liability case involving pelvic mesh implants, which are meant to treat organ prolapse, a common problem that women face after menopause. Thousands of lawsuits have been filed against the manufacturers of these devices, and although few cases have come to trial, juries have consistently sided with the plaintiffs and delivered huge awards.
"I've very grateful," Mary McGinnis said as she left the courtroom with her husband. "This case was fought for all the victims of mesh, whom I hold in my heart."
In awarding punitive damages, the jury found that the C.R. Bard had acted either with "malicious intent" or "wanton and willful disregard" for McGinnis' health when they put the products on the market in 2008. The jury held C.R. Bard liable for two products that McGinnis had implanted in March of 2009: an Avaulta Solo mesh, and an Align Transobturator. Both products have been taken off the market.
The jury of five men and three women deliberated for about three hours on Friday before returning with punitive damages.
Slater, during his summation on Friday morning, had urged the jury to come back with punitive damages and send a message to the company: "You can do better," he said.
"Why did this all happen? Because they were chasing a market," Slater told the jury,. "They knew in 2008 that the properties of the mesh was causing harm."
Lori Cohen, the attorney for C.R. Bard, said both mesh products that McGinnis received, an Avaulta Solo and an Align Transobturator, were subjected to extensive testing and met all industry standards when they were put on the market.
"There was no malicious intent, no evil-minded act" on the part of the company, Cohen told the jury.
This was on the second pelvic case heard in Bergen County. Last December, a jury awarded Elizabeth Hrymoc of South River $5 million in compensatory damages, and levied $10 million in punitive damages against the manufacturer in her case, Ethicon,a division of Johnson & Johnson.
McGinnis had the synthetic mesh devices, implanted in her vagina in March of 2009 to relieve the symptoms of organ prolapse, a condition that is common among women past their child-bearing years in which the vagina walls weaken. The mesh is supposed to act like a basket to support the internal organs and keep pressure off the bladder.
The trial, which was held before Superior Court Judge James J. DeLuca, began on March 19 and lasted nearly a month. The judge, after polling the jury and accepting the verdict, thanked them for their service, which he said was rendered "diligently."
None of the jurors would talk about the case to reporters as they left the courthouse.
https://www.northjersey.com/story/news/2018/04/13/pelvic-mesh-case-68-million-dollar-award-bergen-jury/512520002/
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C.R. Bard Must Pay Punitive $35 Million in Vaginal-Mesh Case
Apr 13, 2018 | Bloomberg
By Jef Feeley
C.R. Bard Inc. was ordered to pay $35 million in punitive damages to a woman who blamed her injuries on the company’s vaginal mesh inserts in the medical supplier’s first case over the controversial devices to go to trial in New Jersey.
The punishment award handed down Friday brings to $68 million the amount that Bard must pay to Mary McGinnis and her husband. McGinnis said Bard inserts designed to bolster organs and address incontinence issues were defective and left her in permanent pain.
The verdict comes as Murray Hill, New Jersey-based Bard is pushing to resolve a raft of suits over its mesh inserts, which have been criticized by women for damaging organs and robbing them of normal sex lives. Bard has settled more than 13,000 cases since 2014, according to its regulatory filings.
As of September 2017, the company still faced more than 3,000 suits over allegedly defective inserts that were the target of litigation. Those cases are consolidated before a federal judge in West Virginia. The company also faces about 150 suits in state courts in New Jersey.
A spokesman for Bard said the company is disappointed with the outcome and plans to appeal.
“Any implantable medical device carries inherent risks as well as clinical benefits,” Troy Kirkpatrick, the spokesman, said in an emailed statement. “While we understand that Mrs. McGinnis was dissatisfied with the outcome of her procedure, it is important to note that thousands of women over many years have benefited from these products and have improved lives because of them.”
Adam Slater, McGinnis’s lawyer, said in a telephone interview that the jury “sent a message that people in New Jersey won’t give companies a pass on unethical conduct.”
McGinnis alleged Bard’s Avaulta and Align implants shrank after being implanted, causing nerve damage and leaving her unable to have intercourse, according to court filings. McGinnis suffered through four surgeries in hopes of having all the mesh removed from her body, Slater said.
Bard took the Avaulta implants off the market in 2012 and did the same with the Align inserts in 2016. Those moves came after the U.S. Food and Drug Administration in 2010 ordered Bard and other mesh-insert makers, including Johnson & Johnson and Boston Scientific Corp., to study injury rates tied to the devices. J&J also pulled four lines of mesh insert from the market.
Bard has been accused in some women’s suits of using a form of mesh in the devices that the mesh’s manufacturer had warned wasn’t suitable for human implantation. Bard officials countered that the mesh was a safe substance from which to make the inserts.
Last year, medical-devices company Becton, Dickinson & Co. acquired Bard for $24 billion to combine two of the world’s biggest health-care suppliers. Kristen Cardillo, a Becton spokeswoman, didn’t return a call for comment.
The case is Mary McGinnis v. C.R. Bard, Inc., Docket No.: BER-L-17717-14, New Jersey Superior Court (Hackensack).
https://www.bloomberg.com/news/articles/2018-04-13/bard-ordered-to-pay-35-million-punitive-damages-in-mesh-case
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Bard Hit With $35M Punitive Damages In NJ Mesh Case
Apr 16, 2018 | Law 360
By Bill Wichert
C.R. Bard Inc. was slammed Friday with $35 million in punitive damages in a New Jersey state lawsuit alleging its pelvic mesh devices caused a woman debilitating pain, a day after jurors hit the company with a $33 million verdict in compensatory damages.
After more than three hours of deliberations, the jury found that the additional punitive damages were warranted because Bard acted maliciously or in wanton and willful disregard of the rights of plaintiff Mary McGinnis and her husband.
“This case has always been about the mesh victims that have always lived in my heart,” McGinnis told reporters outside the Hackensack courtroom after the punitive damages verdict was handed down.
A Bard spokesman did not immediately respond to requests for comment on Friday.
The award follows the jury’s decision on Thursday that McGinnis’ injuries were caused by the defective design of the company's Avaulta Solo Support System and Align Trans-Obturator Urethral Support System and the inadequate warnings for the devices.
The jury awarded compensatory damages of $23 million for McGinnis and $10 million for her husband and fellow plaintiff, Thomas.
Following the punitive damages verdict, Adam Slater of Mazie Slater Katz & Freeman LLC, an attorney representing the couple, said outside the courtroom that the jury told Bard that “they’re not just a business and that they have a tremendous responsibility because they’re injecting themselves into the care of human beings.”“And I think they told Bard, ‘You need to do a much better job of caring about the people whose lives you affect and you have to de-emphasize the financial numbers and the profit margins and the ambition of moving up in a company,’ because that’s what drove … these products onto the market,” Slater told reporters Friday.
A few hours earlier, Slater urged jurors to deliver such a message to the company, calling on them to punish Bard for its misconduct and tell the company, “You can’t do business like this anymore. These are people’s lives.”
“Speak to them and tell them, ‘Don’t do this again,’” Slater said during his closing argument in the punitive damages phase of the nearly four-week trial. “They need to hear from you forcefully.”
Slater argued that Bard acted with wanton and willful disregard of the health and safety of patients by selling products the company knew would harm women and not providing adequate warnings to physicians.
“They deliberately went through red light after red light," Slater said. “They knew women were gonna be harmed."
But Bard attorney Lori G. Cohen of Greenberg Traurig LLP said Friday that the evidence does not support a punitive damages award, saying the company believed in patient safety and complied with all industry standards with respect to the products. She also noted that Bard sought feedback from physicians.“You have sent your message,” Cohen told the jury in her closing argument, adding that “the time to stop is now in terms of punitive damages.”
The plaintiffs have stressed that Bard did not perform clinical studies on the devices, but Cohen said such studies were not mandatory. She pointed to evidence that, consistent with industry standards, the vast majority of medical devices come to market without clinical trials.
Cohen had asserted during the trial that Bard relied on information related to similar devices and, given that trove of research, new clinical studies were neither needed nor required. Bard also conducted extensive testing of the Avaulta Solo and the Align, Cohen has said.
Cohen added Friday that “when a company follows rules, requirements, complies with all standards, plaintiffs can’t meet the burden of showing evil, deliberate misconduct that’s needed for this phase." She said Bard officials "have not acted maliciously, intentionally, deliberately to harm anyone."
Slater countered, however, that Bard was not bound by such industry standards. “You can reject those as being inadequate,” Slater said.
McGinnis, who filed the lawsuit in 2011, had the devices implanted in March 2009. She underwent the Avaulta Solo procedure to support her bladder, and the Align system was designed to treat stress urinary incontinence, court documents state.
McGinnis has alleged that, before her procedure, Bard knew about problems with the devices, and that her surgeon, Dr. Elizabeth Barbee, would not have implanted the devices in her if Bard had warned the physician about certain risks.During his closing argument Friday, Slater played video clips from Barbee’s deposition, including one in which she said debilitating complications related to the Avaulta Solo were not disclosed to her by a Bard representative and were somewhat glossed over during training sessions.
After playing that clip, Slater said of Bard officials: “They didn’t tell Doctor Barbee the truth.”
“Bard needs to know: Don't sell as much if the cost is gonna be human suffering," Slater soon added.
But Cohen noted during the trial that McGinnis signed an informed consent document before the initial procedure, arguing that she was notified by Barbee — following warnings provided by Bard — about the risks of medical issues that McGinnis is now attributing to the company's products.
“Dr. Barbee had what she needed to do a very good consent form and explain well … to Ms. McGinnis what she needed to know,” Cohen said Friday in her closing argument.
Before the attorneys presented their closing arguments Friday, Cohen objected to various acts that allegedly occurred in the courtroom on Thursday after the jury handed down its compensatory damages verdict.
Cohen said the “most concerning” issue was that McGinnis allegedly said “thank you” to multiple jurors as they left the courtroom, noting that the trial was not yet finished and that “there’s grave concern always about jury tampering.”
“It can be unintentional jury tampering,” Cohen said. “It can be anything that can impact the jury and prejudice one party or the other.”
If the court planned to proceed with the punitive damages phase, Bard demanded a mistrial as to the entire matter, including the compensatory damages phase, according to Cohen.
Slater argued that McGinnis’ purported statements were “not designed to influence anybody” and instead “just a normal show of gratitude.”
Judge DeLuca denied the mistrial bid, noting in part that McGinnis’ alleged remarks were made after the compensatory damages verdict was delivered.
“Those reactions in the courtroom, from my point of view, are normal, not intended to influence the jury,” the judge said.
Mary and Thomas McGinnis are represented by Adam Slater and Cheryll A. Calderon of Mazie Slater Katz & Freeman LLC.
Bard is represented by Lori G. Cohen and Cliff Merrell of Greenberg Traurig LLP and Melissa A. Geist of Reed Smith LLP.
The case is Mary McGinnis et al. v. C.R. Bard Inc. et al., case number L-17543-14, in the Superior Court of New Jersey, County of Bergen.
https://www.law360.com/articles/1033164/bard-hit-with-35m-punitive-damages-in-nj-mesh-case
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UPDATE: New Jersey jury hits BD subsidiary Bard with $68m pelvic mesh verdict
Apr 13, 2018 | Mass Device
By Brad Perriello
Updated to include a $35 million in punitive damage verdict released today.
Becton Dickinson & Co. (NYSE:BDX) subsidiary C.R. Bard was reportedly hit yesterday with a $33 million verdict in a product liability lawsuit brought over its Avaulta and Align pelvic mesh products.
A New Jersey jury in the Bergen County Superior Court awarded $23 million in compensatory damages to plaintiff Mary McGinnis and $10 million to her husband, Thomas McGinnis, Courtroom View Network reported.
Bard was also hit with $35 million in punitive damages today, according to the CVN report.
The jury found that the Avaulta and Align meshes implanted to treat McGinnis’s bladder prolapse and stress urinary incontinence were defectively designed and left her in chronic pain, CVN reported. Bard argued that it tested Avaulta extensively and that McGinnis had other medical issues that caused her injuries. By 2016 the company had removed both products from the market, according to CVN.
Back in 2012 Bard lost a $5.5 million Avaulta verdict in California state court and another $2 million Avaulta case West Virginia the next year; in February 2016 Bard and co-defendant Boston Scientific (NYSE:BSX) won out in another suit brought over their respective Align and Solyx mesh devices.
BD closed its $24 billion acquisition of Bard late last year.
https://www.massdevice.com/new-jersey-jury-hits-bd-subsidiary-bard-with-33m-pelvic-mesh-verdict/
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$35M Punitives Award Brings Bard Pelvic Mesh Verdict to $68M
Apr 13, 2018 | New Jersey Law Journal
By Charles Toutant
A jury in Bergen County, New Jersey, on Friday awarded $35 million in punitive damages in a suit against C.R. Bard over defective pelvic mesh products. With Thursday’s $33 million award for compensatory damagesfrom the same jury, the total award to Mary McGinniss and her husband comes to $68 million.
The jury found that Bard’s Avaulta Solo Prolapse Repair System and the Align Transobturator Stress Urinary Incontinence Repair System were defectively designed and failed to contain adequate warnings. The jury found that as a result of the defects in these two medical devices, Mary McGinniss underwent several surgeries and has been left with permanent pain and serious injuries.
The verdict came after a trial before Superior Court Judge James DeLuca in Hackensack, New Jersey. The case is the first bellwether trial against Bard in New Jersey’s mass tort program. According to the New Jersey judiciary’s website, 154 pelvic mesh cases against Bard are pending before DeLuca.
The jury’s compensatory verdict awarded Mary McGinniss $23 million in compensatory damages and $10 million to her husband, Thomas, for loss of consortium.
The plaintiffs were represented by Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, New Jersey.
Slater said the standard for punitive damages was met because “the company knew these products were going to harm women based on the track record for similar products. Then when they … were harming women, they kept selling the product and continued to tell doctors these products were safe.”
Mary McGinniss suffered severe scarring and pain and went though multiple operations in attempts to remove the deteriorating product from her body. She experiences severe pain during intercourse and will suffer “chronic inflammation for the rest of her life,” said Slater.
The jury consisted of nine men and three women.
With the close of the case, “virtually every important issue is decided” in the Bard pelvic mesh litigation, Slater said. “Trying these cases is more streamlined—it allows us to try these cases quicker.” Asked if the verdict would prompt Bard to settle other mesh cases, Slater said, “they can always come and settle, but until that time, we’ll keep trying these cases.”
Bard was represented by Lori Cohen of Greenberg Traurig in Atlanta. A Bard spokesman, Troy Kirkpatrick, said in an email, “We do not believe this verdict is supported by the facts or the law, and plan to appeal.”
The $68 million total in the McGinniss case after the addition of punitive damages is topped by only two other pelvic mesh verdicts nationwide, according to the website Drugwatch.com.
In May 2015, a Delaware jury awarded $100 million to Deborah Barba on claims that Boston Scientific’s Pinnacle and Advantage Fit mesh implants were defectively designed after the devices eroded and caused vaginal scarring, constant pain and other complications.
In Barba’s case, an appellate judge deemed the award excessive and reduced it to $10 million, according to Drugwatch.com.
And in September 2014, a Texas state jury awarded $73.5 million to Martha Salazar after finding Boston Scientific was negligent for failing to warn doctors and patients of risks associated with the Obtryx bladder sling. An appeals court later reduced the award to $34.6 million, Drugwatch.com reported.
And ALM publication The Legal Intelligencer reported in September 2017 a $57.1 million verdict against Johnson & Johnson subsidiary Ethicon in a pelvic mesh trial in Philadelphia.
Bard settled more than 500 pelvic mesh lawsuits for $21 million in 2014, and resolved another 3,000 cases for $200 million in 2015.
Bard has also seen verdicts in individual pelvic mesh suits for $5 million, $3.6 million and $2 million in recent years, according to Drugwatch.com.
https://www.law.com/njlawjournal/2018/04/13/35m-punitives-award-brings-bard-pelvic-mesh-verdict-to-68m/
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Jury awards woman $23 million in C.R. Bard implant trial in New Jersey
Apr 13, 2018 | Legal News Line
By John Sammon
A jury by 7-1 vote on April 12 ruled that $23 million in damages be awarded to plaintiff Mary McGinnis after deciding a pelvic mesh implant caused the 70-year-old North Carolina woman to suffer inflammation, severe pain, loss of lifestyle and mounting medical bills when the mesh had to be removed over subsequent surgeries.
The judgment against New Jersey-based C.R. Bard, maker of the Avaulta and Align pelvic mesh implants, included an additional $10 million (again 7-1 vote) to go to McGinnis' husband Tom for his suffering because of his wife’s ordeal. The jury majority found the implant devices installed in McGinnis’ pelvic region in 2009 were defective and that warnings of possible complications were inadequate.
On the inadequate warnings count, the jury vote was a unanimous 8-0.
New Jersey Superior Court of Bergen County Judge James DeLuca, because of the 7-1 vote on most of the charges including proof of injury, asked the jury and attorneys to return Friday, April 13 for a punitive damages phase of trial.
“In light of the verdict, there will be a second phase," DeLuca said.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
Adam Slater of Mazie, Slater, Katz & Freeman of Roseland, New Jersey, McGinnis' attorney, had tears in his eyes as the jury verdicts were read.
During closing remarks on April 11, attorneys for C.R. Bard said Mary McGinnis’ own personal arthritis caused her physical pain and not a pelvic mesh implant; while the plaintiff maintained it was the implant, which was allegedly unsafe and untested, that caused McGinnis' pain.
Made of clear polypropylene, the device has a small central mesh with attaching thin arms and comes in a box kit. C.R. Bard first put the devices on the market in 2007.
McGinnis’ lawsuit, in addition to the physical suffering, lifestyle damage and medical bills, alleged that C.R. Bard officials were negligent and more eager to sell their products and realize a profit than they were in doing the proper background clinical trials and ignored health risk warnings.
C.R. Bard’s attorney, Lori Cohen of Greenberg Traurig, told the jury the plaintiff could not prove the Avaulta and Align devices had caused the harm to her that she alleged.
“They have to prove that C.R. Bard acted unreasonably in the design and failure to warn,” Cohen said. “Did they prove causation and harm? In our opinion, absolutely not.”
Instead, Cohen said McGinnis’ pain symptoms were a result of long-term arthritic progressive conditions that pre-dated the implant, including hip, groin, thigh, back and leg issues that over a number of years caused her to visit doctors 176 times.
Cohen added that a big part of McGinnis’ testimony alleged a loss of sexual intimacy with her husband because of her vaginal pain, but this was caused by a rectocele (prolapse condition) left for a time untreated and not as a result of the implant.
“This was a window (discovery) we opened for the first time,” Cohen said.
In a slide exhibition, Cohen faulted doctors who treated McGinnis, including the implant surgeon Dr. Elizabeth Barbee, a North Carolina gynecologist, for allegedly causing “buttonholing” during the procedure, an undetected tear in tissue that leads to erosion.
Surgical treatments after the implant to remove the mesh allegedly exacerbated the woman’s condition, in one case from missing three exposure areas of the implant resulting in the need for an additional and unnecessary surgery.
“These were causing a cascade of issues,” Cohen said.
Cohen said accusations by the plaintiff that the implant devices were too heavy and had a too small pore size were groundless. She said the materials had five decades of clinical use and that C.R. Bard had provided adequate warning to users and the devices had been “extensively” tested by the company.
“There was no defect, no failure to warn, no causation,” she said. “Our response is no, no, no.”
Slater, however, equated what C.R. Bard did to driving through red traffic lights.
“What you’re going to do is put this in someone’s body for the rest of her (McGinnis’) life,” he said. “They (C.R. Bard) knew about pore collapse and that it would cause scar plating. They had no evidence how the arms would perform and they were so tight. During a vaginal exam, the pain was so bad Mary (McGinnis) cried out on the table. That is the case in a nutshell.”
Slater said it was undisputed the implant later contracted inside the body and causing severe pain.
He called attention to the testimony of Roger Darois, former C.R. Bard vice president of research and technology. Darois testified that information the company was using polypropylene resin materials supplied by Phillips Sumika Polypropylene Co. for medical implants had been withheld from Phillips because if officials of that company found out, they might choke off the supply due to safety concerns.
“It was said in an email to purchase the material through a third party to avoid a supply issue,” Slater said. "There’s only one reason you hide something - you don’t want someone to know.”
Slater said C.R. Bard employees knew the products were unsafe in September of 2008 and that the mesh could cause scar plating, contraction, erosion, pain and dyspareunia (painful intercourse).
Slater told the jury a materials data safety sheet warned against using the material in permanent implants in the human body and said alternative methods, including the use of suturing instead of implants, had resulted in very low rates of re-operation.
“These meshes were not needed,” he said.
Slater exhibited a slide that showed a bloody portion of McGinnis’ extracted implant.
“That’s what came out of Mary,” he said. “The arm and the Avaulta fused together. Does that look safe? It cemented itself into the pubic bone. Did they fully warn of this? It was never warned about.”
Slater said C.R. Bard’s testing of the product was inadequate and that Barbee, who had been trained by C.R. Bard on how to implant the devices, had not been adequately warned of the possible complications. Barbee said during testimony she would not use the products today because of the risk.
“Barbee was recruited by a C.R. Bard sales representative who failed to warn her,” Slater said. “That’s what she testified. She followed their training. What do they do? They blame her. She (Barbee) would not have used the products if she’d known these things.”
Slater said the failure to warn was causation and his client had suffered as a result.
“It comes down to a patient (McGinnis) and her husband,” Slater said. “They trusted; they’re the consequences of this."
https://legalnewsline.com/stories/511388896-jury-awards-woman-23-million-in-c-r-bard-implant-trial-in-new-jersey
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