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Ethicon 9/10
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Judge upholds $3.3 million verdict in Ethicon transvaginal mesh suit
Sep 9, 2015 | Thompson Reuters Blog
By Ronald V. Baker
Jo Huskey’s suit was one of the first to go to trial as a bellwether proceeding in the 26,000-case-strong Ethicon Inc. Pelvic Repair System Products Liability Litigation proceeding, MDL No. 2327. -
Vaginal mesh slings for incontinence fail in about 3 percent
Sep 9, 2015 | Reuters
By Lisa Rapaport
About one in 30 women who get a common type of vaginal surgery to address urinary incontinence will need repeat procedures within 10 years to remove or replace mesh slings inserted to prevent leaking urine, a study finds. -
Dangers of Vaginal Mesh Surgery for Incontinence May Be Overstated: Study
Sep 9, 2015 | Health Day News
By Dennis Thompson
Surgical mesh appears to be relatively safe for treating urinary incontinence in women, despite concerns raised by U.S. regulators, a new report contends. -
Surgery rate to fix vaginal mesh problems low, says London-led study
Sep 10, 2015 | CTV
By Sheryl Ubelacker
Despite a growing number of lawsuits linked to the use of vaginal mesh implants, the proportion of women who need reparative surgery for complications from the device is relatively low -- at least for those treated for stress incontinence, an Ontario study suggests. -
One in 30 require further surgery after vaginal mesh treatment: study
Sep 9, 2015 | CTV News
Canadian women who received vaginal mesh slings to treat incontinence had a one in 30 chance they would need to have that mesh removed or undergo further surgery within 10 years, a new study has found. -
Low rate secondary surgeries for removal, revision of vaginal mesh slings for stress urinary incontinence
Sep 9, 2015 | Medical Xpress
A follow-up of nearly 60,000 women who received a synthetic vaginal mesh sling for the treatment of stress urinary incontinence finds the risk is low for needing a second surgery for mesh removal or revision (about 1 in 30 women ten years after surgery), according to a study published online by JAMA Surgery. -
NBC: C.R. Bard Forged Documents on Controversial Blood Clot Filter to Gain FDA Approval
Sep 9, 2015 | Mesh Medical Device News Desk
By Jane Akre
This week, NBC News investigated a blood clot filter made by C.R. Bard, and the questionable way the controversial medical device was approved for market. Bard also makes a number of pelvic meshes which are the focus of thousands of defective product lawsuits.
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Judge upholds $3.3 million verdict in Ethicon transvaginal mesh suit
Sep 9, 2015 | Thompson Reuters Blog
By Ronald V. Baker
A $3.27 million jury award to an Ethicon Inc. transvaginal mesh plaintiff has been upheld by the federal judge heading the multidistrict proceeding for suits over the devices, who cited insufficient evidence to overturn the jury’s findings.
The Aug. 19 ruling by Judge Joseph R. Goodwin of the Southern District of West Virginia came on a motion by Johnson & Johnson’s Ethicon Inc. subsidiary for judgment as a matter of law or alternately, a new trial.
Jo Huskey’s suit was one of the first to go to trial as a bellwether proceeding in the 26,000-case-strong Ethicon Inc. Pelvic Repair System Products Liability Litigation proceeding, MDL No. 2327.
In 2014 a federal jury in Charleston, W.Va., awarded Huskey $3.27 million on her claim that the Ethicon TVT Obturator system polypropylene-based mesh she had implanted in 2011 required removal after nine months.
Huskey alleged that soon after the device was implanted to alleviate symptoms of pelvic organ prolapse, she began to experience pain. A month after the implantation, her surgeon found that the mesh had eroded into her vaginal tissue. The device was explanted in November 2011. Huskey and her husband sued Ethicon in 2012, seeking damages for the injuries and pain she experienced before and after its removal.
After a two-week trial in the District Court, jurors found Ethicon liable for selling faulty devices and failing to warn patients and their doctors that users were at risk for pain, bleeding and infection.
Ruling on Ethicon’s renewed motion for judgment as a matter of law (Judge Goodwin rejected one the company filed at the conclusion of Huskey’s case), the judge declined to disturb the verdict, saying a “reasonable jury could find in favor of the plaintiffs on each of their claims.” Huskey’s evidence on the defective design claim “is particularly strong and is capable of upholding the verdict on its own,” he said.
Judge Goodwin noted that although Ethicon presented expert testimony from Dr. David Robinson, its former worldwide medical director, who said the TVT-O represented an improvement over then-available female pelvic devices, Huskey offered testimony from at least three other experts who challenged the device’s risk-benefit value.
The judge said plaintiffs’ expert Dr. Bruce Rosenzweig, a urogynecologist, testified that polypropylene mesh can degrade, shrink and deform, resulting in “chronic foreign-body reaction and chronic inflammation.” Such problems cannot always be reversed by removing the mesh because resulting remnant scarring and nerve irritation, Rosenzweig said.
Judge Goodwin noted that before deciding the case, jurors “heard evidence indicating that these risks posed by the TVT-O could have been avoided, or at least reduced, in several ways.” Among these approaches, he said, was one noted by plaintiffs’ expert, biomedical engineering specialist Scott A. Guelcher, who said reducing the amount of mesh used can lessen the foreign-body reaction.
Urologist Jerry G. Blaivas also testified for Huskey that pain symptoms can persist even when visible exposed mesh is removed from a patient implanted with TVT-O, the judge noted.
Rosenzweig said rejection issues likely stem from the fact that TVT-O mesh is “laser-cut” and stiffer than other mechanically-cut mesh products, Judge Goodwin said, adding that Rosenzweig described insertion of the mesh near a woman’s obturator space as “inappropriate” and “especially concerning” because nerves and muscles in the area can be irritated by foreign-body reaction.
Design defect
Judge Goodwin said that while Ethicon produced evidence of the TVT-O’s usefulness and benefits, the plaintiffs countered with evidence of the device’s high injury risk. He noted Huskey offered suggestions on how Ethicon could have mitigated those risks through use of other designs.
“Taking the evidence as a whole and viewing it in the light most favorable to the plaintiffs, it is clear that reasonable persons could balance the risks and benefits against Ethicon,” the judge said.
Defect and failure-to-warn claims
Judge Goodwin also rejected Ethicon’s argument that Huskey failed her state law duty to prove a specific defect had caused her injuries. The plaintiff did identify specific defects in the TVT-O and “provided evidence that these defects proximately caused Mrs. Huskey’s injuries, at least in part,” he concluded.
Regarding the failure-to-warn claim, the judge said, Huskey presented sufficient evidence at trial that her surgeon, Dr. Gretchen Byrkit, “would have acted differently had she been warned about the TVT-O’s increased risks for active women.”
H uskey et al. v. Ethicon Inc. et al., No. 2:12-cv-5201, 2015 WL 4944339 (S.D. W. Va., Charleston Div. Aug. 19, 2015).
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Vaginal mesh slings for incontinence fail in about 3 percent
Sep 9, 2015 | Reuters
By Lisa Rapaport
About one in 30 women who get a common type of vaginal surgery to address urinary incontinence will need repeat procedures within 10 years to remove or replace mesh slings inserted to prevent leaking urine, a study finds.
This risk is considered low, the authors note.
Patients fared best when they had slings inserted by surgeons who did the highest volume of these procedures. These patients were 37 percent less likely to need repeat procedures, the study found.
Women should make sure they know what their surgeon’s past experience has been, lead researcher Dr. Blayne Welk of Western University in London, Ontario said in an email.
Millions of women develop urinary stress incontinence when muscles and tissues that support the bladder weaken. Simple actions such as coughing, running or lifting heavy objects can put pressure on the bladder and cause urine to leak. The risk increases with age, obesity, and multiple vaginal childbirths.
In the U.S., an estimated one in seven women will get surgery for urinary stress incontinence during their lifetime, Welk and colleagues note in JAMA Surgery.
While long-term follow up of some of the first women to get the slings found few complications after more than 17 years, some previous research has linked the devices to chronic pain, fistulas, and mesh erosions into the urethra or vagina, the researchers note.
Treatment of these complications can require repeat surgeries to remove or replace the devices, a possibility that regulators in the U.S. and Canada have highlighted in warnings to consumers and advised surgeons to explain to patients considering these procedures. In the U.S., more than 50,000 women have joined class action lawsuits related to complications with vaginal mesh.
Given the warnings, Welk and colleagues set out to examine reoperation rates and to assess how the surgeon’s training and experience might influence the results. Overall, they looked at data on 59,887 women who had mesh slings implanted by nearly 1,000 different surgeons between 2002 and 2012.
After an average follow-up of five years, 1,307 women, or 2.2 percent, had needed a reoperation. However, when women were followed for 10 years, that rate rose to 3.3 percent.
In other words, Welk said, the risk of reoperation for mesh removal or revision 10 years after the procedure is one in 30.
The surgeons’ specialty – for example, gynecology versus urology - didn’t affect the outcomes of surgery, but their volume of cases did. When the researchers looked at surgeons' total number of procedures, those in the top 25 percent outperformed the rest.
The authors admit that they were lacking data on the severity of pre-surgery incontinence, smoking history or type of mesh used in the procedures. The study also limited its analysis of complications to those serious enough to require repeat surgeries.
Many complications, while not life-threatening, can still affect a patient’s quality of life, said Dr. Quoc-Dien Trinh, who co-wrote an editorial with colleague Dr. Christian Meyer at Brigham and Women’s Hospital and Harvard Medical School in Boston.
The findings highlight the importance of seeking surgeons who have done high volumes of the procedure, Trinh said by email.
“This paper shows that there is merit in asking that question specifically in the context of mesh surgeries, and it has been shown to be a generally reliable metric of surgical quality of care,” Trinh said.
More complicated is the choice patients face when no surgeons close to home have done high volumes of these procedures, Trinh added. It may be easy to find a high volume surgeon in large cities, but in less populated areas it might mean traveling hundreds of miles.
“Ultimately, patients need to strike a balance between convenience and quality,” Trinh said.
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Dangers of Vaginal Mesh Surgery for Incontinence May Be Overstated: Study
Sep 9, 2015 | Health Day News
By Dennis Thompson
Surgical mesh appears to be relatively safe for treating urinary incontinence in women, despite concerns raised by U.S. regulators, a new report contends.
Only one out of every 30 women who receive a synthetic vaginal mesh sling to treat stress incontinence will suffer a complication that requires a second surgery, according to a decade-long follow-up study of nearly 60,000 Canadian women.
"If a person has a sling in, 97 percent of them will do just fine and will have a good outcome potentially up to 10 years, in terms of their risk for future surgery," said study author Dr. Blayne Welk, an assistant professor of urology at Western University's Schulich School of Medicine & Dentistry in Ontario.
The researchers also found that women can greatly reduce their risk of complications by choosing a surgeon who performs these mesh implants on a regular basis.
"You want to go to someone who's doing this routinely," said Dr. Harvey Winkler, co-chief of the division of female pelvic medicine and reconstructive surgery at North Shore-LIJ Health System in Great Neck, N.Y. "When he's putting this sling in, it's just another day at the office for him," added Winkler, who was not involved with the study.
Stress incontinence occurs when tiny amounts of urine leak due to coughing, laughing, sneezing or other movements that place stress on the bladder.
The U.S. Food and Drug Administration has released several warnings in recent years related to the safety of vaginal mesh, according to background information in the article.
The mesh devices can cause pain, infection, bleeding, pain during intercourse and urinary problems, according to the agency. And surgery to remove or fix the mesh does not always clear up these symptoms.
Most recently, the FDA said in April 2014 it plans to reclassify surgical mesh as a "high-risk" device for fixing pelvic organ prolapse, in which weak or failing muscles allow pelvic organs such as the bladder, bowel and uterus to drop below their normal position and bulge (prolapse) into the vagina.
In the United States, more than 50,000 women have joined class-action lawsuits for complications resulting from incontinence and prolapse procedures involving surgical mesh, the researchers said.
Welk and Winkler argued that the FDA has done a poor job separating the risk of surgical mesh used for incontinence from the greater risk posed by mesh used to treat prolapse.
Surgical mesh is much more often used to treat incontinence than pelvic organ prolapse, Welk said. During this 10-year study, only about 5,000 women received mesh implants to treat prolapse, while nearly 60,000 received mesh for incontinence.
Winkler explained that incontinence treatment requires just a small strip of synthetic mesh that is inserted to support the urethra, while surgeons must use larger pieces of mesh to treat prolapse.
To assess the safety of mesh in treating incontinence, Welk's team tracked the number of Ontario women who needed a follow-up surgery to remove or fix a mesh implant. The study, which was published online Sept. 9 in the journal JAMA Surgery, included almost 60,000 women who had the procedure April 2002 through December 2012.
Overall, just over 1,300 women -- or 2.2 percent -- needed a follow-up surgery within an average of about a year after receiving a mesh implant for stress urinary incontinence, the findings showed.
By the end of the decade-long study period, there was a slightly more than 3 percent cumulative risk of complications, the investigators found.
Patients of "low-volume" surgeons were 37 percent more likely to require a follow-up surgery, when compared to women who received treatment by a surgeon who regularly performs this procedure, the researchers said.
However, Welk pointed out that the study's definition of a high-volume surgeon included doctors who perform an average of 17 sling procedures each year.
"It's not something where you have to do hundreds of these a year," Welk said. "That translates to one or two per month, which isn't out of the range of possibility for the average gynecologist or urologist."
The results show that incontinence surgery using the synthetic mesh is safe, and that women who have undergone the procedure can feel reassured, Winkler said.
"I have three friends of mine within a block of me who have the sling in," he said. "People should not lie awake at night worrying that the mesh is going to cause them problems."
However, the study did find that women who receive multiple mesh-based procedures for urinary incontinence had an almost fivefold increased risk of complications that would require a second surgery.
The study was supported by grants from the Ontario government and received no funding from medical device makers.
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Surgery rate to fix vaginal mesh problems low, says London-led study
Sep 10, 2015 | CTV
By Sheryl Ubelacker
Despite a growing number of lawsuits linked to the use of vaginal mesh implants, the proportion of women who need reparative surgery for complications from the device is relatively low -- at least for those treated for stress incontinence, an Ontario study suggests.
A study by the Institute for Clinical Evaluative Sciences (ICES) found that about three per cent of women treated with a transvaginal mesh sling for stress incontinence -- the kind of urine leakage typically brought on by laughing, coughing, sneezing or exercise -- have needed surgery to remove or alter the implant.
"Our study shows that, after 10 years of followup, one in 30 Ontario women required mesh revision or removal surgery," said principal researcher Dr. Blayne Welk, a urologist at St. Joseph's Hospital in London, Ont., and an adjunct scientist at ICES
Vaginal mesh implants are made from a polymer plastic and work by supporting the urethra, the tube through which urine flows, he said. "When there's activity, the urethra can't move and urine can't leak out."
The implants, the most common surgical intervention for female stress incontinence over the past 20 years, are also used to treat pelvic organ prolapse (POP), in which the bladder and uterus have begun to sag.
But in some cases, the slings can cause complications, such as chronic pelvic, genital or groin pain and an inability to properly urinate. Among the most serious adverse effects are infection, tissue erosion and organ perforation.
The 2002-2012 study, published Wednesday in the journal JAMA Surgery, examined health records for almost 60,000 Ontario women who received a vaginal mesh implant for stress incontinence. Researchers found that 1,307 were required to have the device removed or altered in some way as a result of complications.
Welk said the study showed that surgeons who performed a lower number of implants had a 37 per cent increased likelihood of a patient having complications, compared to their higher-volume counterparts.
But he said he was heartened to see the rate of removal/revision surgery was less than three per cent.
"As a surgeon, I find it reassuring that the rate's relatively low, and I think the most important thing that statistic does is help us educate our patients on the risk of this surgery. And it reaffirms the fact that complications are rare, but they're not unheard of. They do happen with this procedure."
Paul Miller, a partner in the Toronto law firm Will Davidson LLP, said he was surprised at the study's one-in-30 finding, given that thousands of women in Canada and the United States have been or are plaintiffs in class-action and individual lawsuits against manufacturers of the mesh slings.
"I'm surprised it was such a low number, actually," Miller said Wednesday. "I was surprised considering the number of clients."
His firm is representing about 225 women, who overall are suing seven different manufacturers of the devices. About 35 cases against the company American Medical Systems were settled out of court in December for an undisclosed amount. That company is also facing a class-action lawsuit in Canada.
Miller said an estimated 5,000 to 7,000 Canadian women who had vaginal mesh implants for stress urinary incontinence or pelvic organ prolapse are plaintiffs in lawsuits due to complications.
In the U.S., 50,000 to 70,000 women fitted with the slings have also brought suit against manufacturers, which include Johnson and Johnson, Ethicon, Boston Scientific and Atrium.
"One of the things I hear from women all the time -- and it's the saddest thing -- is that 'the doctor says it's in my head. It's not the mesh. There's no problem with the mesh,"' said Miller.
"That is a problem that women are encountering."
The US. Food and Drug Administration and Health Canada have both issued warnings about the risk of complications from mesh slings, including painful intercourse and urination, vaginal and urinary tract infections, and injuries to the bladder, bowel and vagina.
In 2011, the FDA strengthened its warning, saying serious complications associated with surgical mesh for transvaginal repair of POP are not rare. The agency also said vaginal mesh procedures do not necessarily improve quality of life for patients over standard surgeries and instead can expose them to greater risk.
The ICES researchers say their findings support the regulatory agencies' statements suggesting that patients should be counselled that serious complications can occur with mesh-based stress urinary incontinence procedures and that surgeons should achieve expertise in their chosen procedure.
"The most important thing for women to realize is they should talk to their surgeon about their experience and their background with the product that they're using and make sure they're happy with their surgeon's ability to manage potential complications, if they should come up," said Welk.
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One in 30 require further surgery after vaginal mesh treatment: study
Sep 9, 2015 | CTV News
Canadian women who received vaginal mesh slings to treat incontinence had a one in 30 chance they would need to have that mesh removed or undergo further surgery within 10 years, a new study has found.
Overall, the authors say the risk of needing a second surgery to treat complications from vaginal mesh is “low.”
But they note that the women in their study who received additional slings when the initial one fails had a nearly five-fold increased risk of complications that required even more surgery
The study, from researchers at the Institute for Clinical Evaluative Sciences (ICES), is the first to measure the rate of mesh removal or revision among Canadian women.
Researchers looked at nearly 60,000 women in Ontario who had undergone surgery between 2002 and 2012 to treat “stress urinary incontinence” – a condition in which women leak urine when they cough, sneeze, or are physically active.
For some women, pelvic floor muscle exercises can help with the condition as can some lifestyle changes. But for others, the condition is so disruptive, surgery is recommended.
Over the past 20 years, vaginal mesh slings have become the most common surgical treatment for the condition. The slings, made of a polypropylene material, are surgically implanted in the vaginal wall to create a sort of "hammock" under the urethra or bladder neck. The sling supports the urethra and helps to keep it closed.
But in some women, the slings can erode, leading to vaginal or leg pain, or trouble emptying the bladder. These complications can be challenging to treat, and often require further surgery.
In the United States, more than 50,000 women have joined class-action lawsuits for vaginal mesh complications.
“Our study shows that after 10 years of follow-up, one in 30 Ontario women required mesh revision or removal surgery,” said senior author Dr. Blayne Welk, a urologist and adjunct scientist at ICES Western.
Women who have had surgeries to implant a second or third mesh implant had a much higher risk for complications. The authors say that finding should “temper the enthusiasm” of previous studies that suggest the use of multiple slings is safe and effective.
Health Canada and the U.S. FDA have acknowledged the risks of vaginal mesh. The majority of this risk has been attributed to the use of vaginal mesh for prolapse surgery, but the authors say stress incontinence mesh can lead to complications as well.
The researchers found that surgeon experience was a notable factor in the risk for complications. The patients of surgeons who did the most mesh incontinence surgeries had a 27 per cent lower chance of needing mesh removal or revision than other patients.
The researchers say their findings support statements from Health Canada and the FDA that advise that patients be counselled that serious complications can occur with mesh-based stress urinary incontinence procedures and that surgeons should achieve expertise in the procedure.
The full study results appear in the journal JAMA Surgery.
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Sep 9, 2015 | Medical Xpress
A follow-up of nearly 60,000 women who received a synthetic vaginal mesh sling for the treatment of stress urinary incontinence finds the risk is low for needing a second surgery for mesh removal or revision (about 1 in 30 women ten years after surgery), according to a study published online by JAMA Surgery.
Female stress urinary incontinence (SUI) is a common condition that is often treated with surgery when conservative management options are unsuccessful. An estimated 1 in 7 women will undergo surgery for SUI during their lifetime. Synthetic mesh slings are the most common surgical treatment. However, the U.S. Food and Drug Administration has released warnings related to the safety of vaginal mesh (used for procedures to treat SUI and pelvic organ prolapse). In the United States, more than 50,000 women have joined class action lawsuits for transvaginal mesh complications resulting from SUI and prolapse procedures, according to background information in the article.
Blayne Welk, M.D., M.Sc., of Western University, St. Joseph's Health Care, London, Ontario, and colleagues measured the incidence of mesh removal or revision after SUI procedures and determined whether significant surgeon and patient risk factors exist. The study included all adult women undergoing a procedure for SUI with synthetic mesh in Ontario, Canada, from April 2002 through December 2012 (n = 59,887).
Overall, 1,307 women (2.2 percent) underwent mesh removal or revision a median of 0.94 years after receiving a mesh implant for SUI. Patients of high-volume surgeons (75th percentile of yearly mesh-based procedures) had a significantly lower risk for experiencing the composite outcome (surgical procedures related to removal or revision of mesh slings). Gynecologists were not significantly associated with more complications compared with urologists. Multiple mesh-based SUI procedures increased the risk for complications.
"These findings support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure. Multiple mesh-based procedures for SUI are a novel risk factor associated with an almost 5-fold higher rate of mesh removal or revision, and the safety of this practice should be studied further," the authors write.
The researchers note that although the FDA in the past has treated all vaginal mesh implants as equivalent, the intervention rates for mesh-based complications in procedures for SUI appear to be lower than those associated with procedures for pelvic organ prolapse.
"The results of Welk et al suggest that treatment of stress urinary incontinence would be better served by a high-volume surgeon; however, for such a common procedure, this solution may be impractical or impossible," write Christian P. Meyer, M.D., and Quoc-Dien Trinh, M.D., of Brigham and Women's Hospital, Harvard Medical School, Boston.
"Should patients be expected to travel hundreds of miles for surgery by a designated high-volume surgeon? Similarly, if the community urologist or gynecologist is not to perform such procedures, then what are they supposed to do? A more reasonable approach to achieve quality surgical care for common procedures may come from structured proctoring and/or coaching models and from mandatory outcomes reporting. Although physicians may not openly welcome these initiatives, they ultimately will help to establish surgical audits and improve outcomes. In all likelihood, such programs will be mandatory in the near future and tied to reimbursements. Ultimately, we surgeons should be the drivers for change rather than wait for payers or regulators to impose punitive measures."
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NBC: C.R. Bard Forged Documents on Controversial Blood Clot Filter to Gain FDA Approval
Sep 9, 2015 | Mesh Medical Device News Desk
By Jane Akre
This week, NBC News investigated a blood clot filter made by C.R. Bard, and the questionable way the controversial medical device was approved for market. Bard also makes a number of pelvic meshes which are the focus of thousands of defective product lawsuits.
The Recovery blood-clot filter, is associated with 27 deaths so far and other complications. It was cleared by the U.S. Food and Drug Administration in 2002. See the story here.
After her car accident, Dodie Froehlich received the Recovery in the large vein in the body to block clots. Bard is one of 11 companies that makes these filters in the U.S. Instead a one-inch piece of metal from the Recovery pierced her heart. She survived. Others did not.
Forged Documents?
NBC unveils that a regulatory specialist, Kay Fuller did not sign the FDA application document in 2002, even though her name appears on the document.After the Recovery was initially rejected by the FDA, Bard hired Fuller to try again. Bard refused to give her the safety testing she requested. She said she would not sign an FDA application until safety concerns were addressed. With no response to her request, Fuller resigned from Bard. She talked to NBC News.
As of 2006 there are at least 20,000 patients walking around with a Recovery blood-clot filter in their body.
The Cissons enter court, Aaugust 2013
Bard and Cisson Trial
C.R. Bard was showed to have falsified documents in the pelvic mesh trial of Donna Cisson. The raw material used to create the Avaulta mesh was a polypropylene (PP) resin in pellet form which was purchased from petroleum company Phillips Sumika. The PP was spun into a monofilament which makes up the mesh of the Avaulta Plus.
A Material Data Safety Sheet from Chevron Phillips clearly stated the material should not be used in medical applications especially
“involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”E-mails presented at trial by Cisson’s attorney, Henry Garrard, showed Bard created a dummy company, Red Oaks, to buy the polypropylene pellets so the supplier would not link Bard to the polypropylene purchase, therefore the creation of a medical device. See MND coverage here.
Cisson was awarded $2 million by a Charleston, WV jury in August, 2013. Bard has appealed her case. See the MND coverage of her trial conclusion here.
A year earlier in a Bakersfield, California court, Christine Scott was awarded $5.5 million by a jury over her pelvic mesh injuries. Her implanting physician was found to be responsible for a portion of the award for damages.
The Cisson case was the first bellwether against C.R. Bard in multidistrict litigation in Charleston, WV. As of today, Bard is facing 12,521 product liability cases over its pelvic mesh as well as numerous other pelvic mesh actions filed in state courts around the country. #
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