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Ethicon Media Monitoring 3/12/2018
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Johnson & Johnson Hit With $35M Verdict In Pelvic Mesh Trial
Mar 9, 2018 | Law 360
By Emily Field
An Indiana federal jury on Friday slammed a Johnson & Johnson unit with a $35 million verdict in favor of a woman who claimed she was harmed by a pelvic mesh device, finding that the mesh implant was negligently designed and the company failed to warn of its risks. -
Johnson & Johnson Hit With $35M Verdict in Pelvic Mesh Case
Mar 10, 2018 | The National Law Journal
By P.J. Dannunzio
A federal jury in northern Indiana hit Johnson & Johnson with a $35 million verdict in a lawsuit over an "unreasonably dangerous" pelvic mesh implant, a team of lawyers has announced. -
US jury awards mesh victim almost £30m over ‘unreasonably dangerous’ implant which has been used in Scotland
Mar 11, 2018 | The Sunday Post
By Marion Scott
A US jury has awarded a mesh victim almost £30million over what was described in court as an “unreasonably dangerous” implant that was used in Scotland. -
Study: 21% of Transvaginal Mesh Patients Needed Surgery Again
Mar 12, 2018 | Drugwatch
By Kristin Compton
Almost one-third of patients who had transvaginal mesh surgery needed surgery again, a new study revealed. -
Ethicon Loses $35 Million Prolift Pelvic Mesh Case in Indiana!
Mar 12, 2018 | Mesh Medical Device Newsdesk
Once again Ethicon has challenged a mesh-injured woman in court and once again, the healthcare giant has lost! -
'It needs to be stopped': Vaginal mesh patients ask Chief Medical Officer to listen to their stories
Mar 11, 2018 | thejournal.ie
PATIENTS WHO SUFFERED complications after surgeries using transvaginal mesh implants have asked the Chief Medical Officer to engage with them as part of his review of the use of these devices in Ireland. -
Do you have a FOFO? Find out more in the latest MedTalk Podcast — Episode 7
Mar 12, 2018 | EPM Magazine
The team discuss the government’s latest plan to review three public health scandals. Fliss and Reece delve into the details of what the plan means for products such as vaginal mesh and sodium valproate. -
Loyola University Medical Center, doctor allegedly failed to properly perform surgical procedure
Mar 11, 2018 | Cook County Record
By Louie Torres
A woman is suing Loyola University Medical Center and Dr. Cynthia Brincat for allegedly taking insufficient measures to prevent injuries.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Johnson & Johnson Hit With $35M Verdict In Pelvic Mesh Trial
Mar 9, 2018 | Law 360
By Emily Field
Law360 (March 9, 2018, 6:37 PM EST) -- An Indiana federal jury on Friday slammed a Johnson & Johnson unit with a $35 million verdict in favor of a woman who claimed she was harmed by a pelvic mesh device, finding that the mesh implant was negligently designed and the company failed to warn of its risks.
The verdict came after nearly two weeks of a trial that started on Feb. 26, according to a statement from Indiana resident Barbara Kaiser’s attorneys. The nine members of the jury found that J&J's subsidiary Ethicon Inc. deliberately failed to warn of the risks of the Prolift pelvic mesh device and sold a product that was defective and in unreasonably dangerous condition, according to the statement.
"Ethicon defended an indefensible product and the jury stood up for Barb Kaiser,” Thomas Plouff of Costello McMahon Burke & Murphy Ltd., an attorney for Kaiser, said in a statement. “They were asked to send a message to Ethicon to deter future wrongdoing and they did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful complications from mesh in their pelvic area."
The verdict includes $10 million in compensatory damages and $25 million in punitive damages, according to the statement. A copy of the verdict form was not immediately available on Friday.
In January 2009, Kaiser was implanted with the Prolift device to treat her pelvic organ prolapse, according to a 2012 complaint. Two years later, she learned from a doctor that her complaints of low pelvic pain could be tied to the implant, the complaint said.
Kaiser suffered painful sexual intercourse, groin pain and bladder spasms, according to the statement.
In the complaint, Kaiser alleged that contrary to the company’s marketing to the medical community and patients, the Prolift device has high failure, injury and complication rates and has caused severe injuries to a “significant” number of women.
She also cited a 2011 safety alert from the U.S. Food and Drug Administration warning health care providers and patients that serious complications associated with surgical mesh for treating pelvic organ prolapse are not rare and it was not clear that treating transvaginal pelvic organ prolapse with mesh was more effective than traditional repairs that didn’t use mesh.
“During a hearing in September 2011 in Gaithersburg, Maryland, an FDA review team concluded there was insufficient scientific evidence as to the safety and efficacy of transvaginal surgical mesh used to treat pelvic organ prolapse, including defendants’ Prolift,” Kaiser said in the complaint.
She claimed that the company failed to use adequate testing and research to evaluate the risks and benefits of the Prolift device, according to the complaint.
“Defendants failed to design and establish a safe, effective procedure for removal of their Prolift in the event of a failure, injury or complication associated with the device,” Kaiser said.
"Ethicon intends to appeal this verdict as we believe it contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications," a spokeswoman for the company told Law360 on Friday. "Pelvic organ prolapse is a serious and debilitating condition with limited treatment options. Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for some women."
Kaiser is represented by Thomas Plouff of Costello McMahon Burke & Murphy Ltd., Jeff Kuntz of Wagstaff & Cartmell LLP, and Edward Wallace of Wexler & Wallace LLP.
J&J is represented by Jennifer L. Steinmetz of Tucker Ellis LLP, Mary Nold Larimore of Ice Miller LLP, and Amy M. Pepke and Jordan N. Walker of Butler Snow LLP.
The case is Kaiser et al v. Johnson & Johnson et al., case number 2:17-cv-00114, in the U.S. District Court for the Northern District of Indiana.
--Editing by Stephen Berg.
Update: This story was updated to include comment from Ethicon.https://www.law360.com/articles/1020607/johnson-johnson-hit-with-35m-verdict-in-pelvic-mesh-trial
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Johnson & Johnson Hit With $35M Verdict in Pelvic Mesh Case
Mar 10, 2018 | The National Law Journal
By P.J. Dannunzio
A federal jury in northern Indiana hit Johnson & Johnson with a $35 million verdict in a lawsuit over an "unreasonably dangerous" pelvic mesh implant, a team of lawyers has announced.
Access to full text unavailable – subscription required. For full story: https://www.law.com/nationallawjournal/2018/03/09/johnson-johnson-hit-with-35m-verdict-in-pelvic-mesh-case/?slreturn=20180212031620
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Mar 11, 2018 | The Sunday Post
By Marion Scott
A US jury has awarded a mesh victim almost £30million over what was described in court as an “unreasonably dangerous” implant that was used in Scotland.
A federal jury in Indiana awarded Barbara Kaiser and her husband Anton the damages on Friday over injuries they claimed were caused by the Prolift mesh implant.
The plastic polypropylene implant, developed by Johnson & Johnson firm Ethicon, was used in Scottish hospitals to treat pelvic organ prolapse.
Barbara was implanted with mesh in January 2009, in Minster Community Hospital, and went on to suffer the same painful side effects thousands of other victims have reported around the world.
In evidence, the surgeon who operated on Mrs Kaiser said that he may not have started using the device had he known of the complications.
The Kaiser’s lawyer Thomas Plouff said: “Ethicon defended an indefensible product and the jury stood up for Barbara Kaiser.
“They were asked to send a message to Ethicon to deter future wrongdoing, and they did.”
The jury awarded almost £8 million in damages, and a further £20 million in punitive damages against Ethicon.
J&J intends appealing the verdict and spokeswoman Mindy Tinsley said: “We believe it contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications.”
Scottish Mesh Survivor Elaine Holmes said last night: “The world is waking up to the reality that mesh causes life changing injuries.”
Thanks to campaigners, mesh is no longer to be used to treat pelvic organ prolapse in Scotland.
https://www.sundaypost.com/fp/us-jury-awards-mesh-victim-almost-30m-in-damages-over-unreasonably-dangerous-implant-which-has-been-used-in-scotland/
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Study: 21% of Transvaginal Mesh Patients Needed Surgery Again
Mar 12, 2018 | Drugwatch
By Kristin Compton
Almost one-third of patients who had transvaginal mesh surgery needed surgery again, a new study revealed.
The study followed women for up to 25 years after transvaginal prolapse repair with synthetic mesh. More than 20 percent of the women reported having to undergo a later surgery.
Women more likely to need another surgery included:
Younger women
Women with apical mesh placed
Women who experienced urinary tract injury during the surgery16% of Patients ‘Very Unsatisfied’ with Transvaginal Mesh Surgery Results
Researchers collected medical information and data from patients’ medical records.
The patients in the study had vaginal prolapse surgery using synthetic mesh. The surgeries took place between May 1991 and October 2010.
Researchers used written surveys and pelvic exams to assess patients’ symptoms. They also evaluated patients’ satisfaction with the surgery.
Among 804 possible patients, 158 were eligible for inclusion in the study.
A total of 54 patients — or 34 percent — experienced mesh-related complications.
Thirty-three patients — or 21 percent — needed another operation.
Researchers received 43 questionnaires ranking patient satisfaction.
16 percent reported that their symptoms became worse after surgery42 percent were “very satisfied” with their surgical results
16 percent were “very unsatisfied”
Authors of the study shared the results at a Society of Urodynamics meeting in Austin, Texas.
The conference focused on female pelvic medicine and urogenital reconstruction. It took place over a period of five days from Feb. 27 to March 3, 2018.
https://www.drugwatch.com/2018/03/09/study-21-transvaginal-mesh-patients-needed-surgery/
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Ethicon Loses $35 Million Prolift Pelvic Mesh Case in Indiana!
Mar 12, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 9, 2018 ~ Once again Ethicon has challenged a mesh-injured woman in court and once again, the healthcare giant has lost!
The product liability trial of Kaiser v Ethicon began in Hammond, Indiana, February 26th.
One of the earliest pelvic mesh product liability cases filed eight years ago in multidistrict litigation in Charleston, WV, the case was remanded back to federal court to the Northern District of Indiana before the Honorable Judge Philip P. Simon to finally be resolved. On Thursday, March 8, the jury delivered its verdict in Kaiser’s favor – $35 mllion with $25 million in punitive damages.
The six women, three men jury returned the verdict after approximately six hours of deliberation on Thursday night.
In doing so they determined that Johnson & Johnson and its Ethicon medical device division, marketed, sold and recruited physicians worldwide to implant the Prolift pelvic mesh, an “unreasonably dangerous” pelvic mesh, defective in its design and in its warnings to end user physicians.
Kaiser, 69, was represented by attorneys Ed Wallace (Wexler Wallace, Jeff Kuntz (Wagstaff Cartmell) and Indiana attorney Thomas O. Plouff, of Costello, McMahon & Burke, & Murphy Ltd., who said in a press release:
“Ethicon defended an indefensible product and the jury stood up for Barb Kaiser. They were asked to send a message to Ethicon to deter future wrong doing and they did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful complications from mesh in their pelvic area.”
This was not the first trial for Prolift, a large, controversial polypropylene medical device used to treat pelvic organ prolapse (POP), that J&J quietly removed from the market in June 2012, along with three other pelvic meshes, to avoid conducting three-years of post-market surveillance.
See Prolift trials, Gross, Hrymoc, and Hammons below.
PLAINTIFF BARBARA KAISER
Plaintiff Barbara Kaiser, was implanted with Ethicon’s Prolift mesh on January 27, 2009. She was being treated for prolapse as well as SUI (stress urinary incontinence) and Dr. Gregory Bales of Munster Community Hospital in Munster, Indiana decided the extra-large Prolift, with its six polypropylene arms should be the mesh of choice.
Kaiser suffers dyspareunia (painful sex), pelvic pain, levator myalgia, bladder spasms and groin pain. She underwent one attempted revision surgery.
The lawsuit claimed the polypropylene implant is incompatible with humans and leads to an immune reaction and severe adverse reactions.
“Defendants knew that the pelvic mesh products were not safe for their intended purposes and that the pelvic mesh products would cause, and did cause, serious medical problems, and in some patients, catastrophic and permanent injuries,” the complaint said.
Canadian Pathologist Vladimir Iakovlev was among the experts who appeared at trial. He studies the effects of mesh on the body.
Ethicon said it was not to blame for the alleged injuries. J&J continues to stand by its product, said a company spokeswoman.
Bales, in his deposition, said he was probably one of the early users of Prolift, which came onto the market in March 2005. Bales said he had performed a couple hundred procedures with either total Prolift System or the Anterior Prolift System which incorporates the bladder.
Dr. Bales received some of his training on Prolift by Vince Lucente MD, a urogynecologist who has made millions as a consultant to Ethicon and has trained new doctors on the procedure and product.
Lucente’s name has been heard in the previous mesh trials of Linda Gross and Joan Budke where Dr. Lucente trained their doctors as well on the Prolift.
Dr. Bales admitted in his deposition that had he known about the complications associated with the use of Prolift, he “may not have started using the Prolift.”
Dr. Bales admitted that the “majority of the times the reps would be present” referring to sales representatives from various vendors are in the operating room.
Ms. Kaiser later learned from Raphael Albert, MD that her complaints of lower pelvic pain could be related to the Prolift.
REMANDED
The Kaiser case was one of the earliest ones filed in U.S. District Court in Charleston, West Virginia where a pelvic mesh multidistrict litigation consolidated thousands of cases for trial.
The Kaiser case No. 2:12-cv-00887, was remanded to the Northern District of Indiana with a new case number 2:17-cv-00114 on March 15, 2017.
Lawyer Ed Wallace, one attorney for Ms. Kaiser says, “This is one of the first cases remanded and yes it will start to happen with others, hopefully.” Judge Goodwin has announced he wants the pelvic mesh MDL (multidistrict litigation) to be resolved.
Because Ms. Kaiser was implanted in Indiana, the Indiana’s Products Liability Act must be followed.
It requires the plaintiff to show a product is defective and unreasonably dangerous through design defect, its manufacturing defect or a failure to warn, all counts in the Kaiser claim along with negligence, strict liability defective product, common law fraud, fraudulent concealment, constructive fraud, negligent infliction of emotional distress, breach of express warranty, breach of implied warranty and gross negligence.
Ethicon claimed that Ms. Kaiser’s claims were untimely under the two-year statute of limitations. Judge Goodwin denied Ethicon’s motion for Summary Judgment.
TRIAL PREPARATION
In January of last year, Plaintiffs asked the court to exclude evidence related to the FDA and its 510(k) clearance process that allows most medical devices on the market with no clinical trials to assure safety and efficacy. There was no mention of the FDA at this trial and no introduction of evidence about spoliation, that is, the destruction of documents by J&J that were on a litigation hold for pelvic mesh cases.
Plaintiffs felt any mention of the U.S Food and Drug Administration (FDA) might add legitimacy to the device that had skirted through safety assurances through the fast-track 510(k) clearance-to-sell process.
To explain how the majority of medical devices make it to market would have required an extraordinary amount of time to delve into the FDA’s process that requires a manufacturer name a “predicate device” already in commerce that is similar to compare the new device to with no clinical trials needed.
For its part, the defendant wanted to exclude the “522 letters.” In January 2012, the FDA issued a mandate to mesh makers which required them to show the safety of their POP meshes in order to stay on the market.
What resulted was a mass, yet quiet removal of most POP meshes from the market including the Prolift, relieving the mesh makers of conducting expensive clinical trials proving the products were safe.
Never mind the thousands of women, like Barbara Kaiser, who live today with POP polypropylene meshes placed in their pelvic region and its consequence.
In January 2016, the FDA moved to reclassify POP mesh as a high risk device, requiring clinical trials to prove safety and efficacy. To date no new POP meshes have attempted to clear that hurdle. ###
LEARN MORE:
MND, December 14, 2017, Jury in Hrymoc Pelvic Mesh Trial Returns $15 Million to Plaintiff
https://www.meshmedicaldevicenewsdesk.com/hrymoc-product-liability-mesh-trial-jury/MND Prolift Pelvic Mesh found Defectively Designed, December 21, 2015
https://www.meshmedicaldevicenewsdesk.com/prolift-pelvic-mesh-found-defectively-designed-plantiff-awarded-5-5-million-punitives-to-be-determined/MND, Gross $11.1 Million Jury Verdict Survives Final J&J Challenge
https://www.meshmedicaldevicenewsdesk.com/linda-gross-11-1-m-jury-verdict-survives-final-jj-challenge/Radar- Documentary on Prolift, The Netherlands, February 22, 2017
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/MND December 22, 2015, Philadelphia Prolift Mesh Case Yields $12.5 million Verdict for Plaintiff
https://www.meshmedicaldevicenewsdesk.com/philadelphia-prolift-mesh-case-yields-12-5-million-verdict-for-plaintiff/MND, February 22, 2017 Documentary: J&J Knew Risks of Prolift
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/MND, December 21, 2015, Prolift Pelvic Mesh Found Defectively Designed
https://www.meshmedicaldevicenewsdesk.com/documentary-jj-knew-risks-prolift/MND, January 9 2015, The Launch of Prolift Pelvic Mesh- What the Company Knew, Budke Trial
https://www.meshmedicaldevicenewsdesk.com/the-launch-of-prolift-pelvic-mesh-what-the-company-knew/MND, January 23, 2018, Australia Pulls Ethicon TVT Mesh Devices from the Market
https://www.meshmedicaldevicenewsdesk.com/australia-pulls-ethicon-tvt-mesh-devices-market/MND, June 5, 2012, Four J&J Vaginal Meshes Named Will be Removed from Market
https://www.meshmedicaldevicenewsdesk.com/four-jj-vaginal-meshes-named-will-be-removed-from-market/MND, Jan. 2012, Mesh Makers who Received 522 PostMarket Surveillance Orders
https://www.meshmedicaldevicenewsdesk.com/mesh-makers-who-received-fda-letter-requiring-follow-up-tests/https://www.meshmedicaldevicenewsdesk.com/ethicon-prolift-pelvic-mesh-case-begin-monday-indiana/
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'It needs to be stopped': Vaginal mesh patients ask Chief Medical Officer to listen to their stories
Mar 11, 2018 | thejournal.ie
The HSE said Dr Holohan’s review will be completed in the coming months but did not confirm whether he would be engaging with patients.
PATIENTS WHO SUFFERED complications after surgeries using transvaginal mesh implants have asked the Chief Medical Officer to engage with them as part of his review of the use of these devices in Ireland.
Thousands of women across the world have reported painful complications after having a mesh implant inserted. These devices, made with polypropylene – a type of plastic – are used in surgeries to address stress urinary incontinence and pelvic prolapse, conditions women can suffer after natural childbirth.
TheJournal.ie first highlighted that women in Ireland were reporting negative side effects from the devices in September last year. Since then, more than 200 patients who claim to have been impacted have joined the support group Mesh Survivors Ireland.
At least 30 of these women are currently pursuing legal action, either against the HSE or their consultants.
In November, Health Minister Simon Harris asked the Chief Medical Officer Dr Tony Holohan to examine the use of transvaginal mesh devices in Ireland.
More than a dozen women who have suffered complications after their surgeries have now written to Holohan asking him to engage with them and consider their experiences as part of his research.
These complications include chronic pain and recurrent urinary tract infections and have been life-changing in many cases. Some women have reported that the mesh device moved and eroded through the walls of their vaginas, causing pain and resulting in further surgeries to remove sections of the mesh.
Life-changing
60-year-old Christine had her implant inserted in 2009 to treat stress urinary incontinence.
“It was sold to me as a fix in a day, it was supposed to be the gold standard,” she said.
The procedure successfully treated her incontinence, but within months she started to experience pain and urinary tract infections. In 2011 she spoke to a consultant urologist who did a removal surgery.
“He said taking it out could leave me incontinent again and it was shocking, I knew every toilet around Dublin, I had to double up on pads, I was only short of wearing a nappy,” she said.
“I couldn’t sit, I couldn’t walk. I remember one day up at the shop I was talking to a guy, I was wearing doubled up pads, and we were having a bit of a laugh and chatting, and when I came home I was wet down to my knees. It had never been that bad beforehand.”
Christine later had another procedure to fix her incontinence, which involved using muscle taken from her stomach to hold up her bladder. This operation was one of the preferred options for stress urinary incontinence before mesh slings were introduced as a treatment in Ireland in the late 90s.
She also had a second mesh removal surgery in January 2013, though she said she is not sure all of it has been removed.
The devices are designed to strengthen the walls of the bladder and natural tissue grows into the mesh. This makes full removal extremely difficult without damage to the surrounding tissue and organs.
Christine still suffers from regular infections.
“I’ve had two already in the last three weeks, and two lots of antibiotics. I’m worried that I’ll end up with sepsis or something like that. I could have an antibiotic every two to three weeks and that’s not good for you.
“It’s very life limiting, it drains you and I have to take to the bed. It’s very unfair.”
Christine has reported her complications to the HPRA and is hoping the Chief Medical Officer will tell surgeons to stop using these devices.
“It needs to be stopped, they can’t continue to do it. Hundreds of women have the same symptoms as I have – that’s not a coincidence.”
‘Extremely concerned’
A number of other countries have stopped using certain mesh devices, and in January the English government launched a retrospective review of all women who had a vaginal mesh surgery since 2015.
The UK’s health watchdog NICE had already recently recommended a ban of one of these devices – the type commonly used to treat pelvic prolapse – advising that doctors only use it for research purposes.
The watchdog said there were “serious but well-recognised safety concerns” around the use of this product.
In a statement to TheJournal.ie, the Department of Health said: “The minister is extremely concerned to ensure that both the current use of transvaginal mesh implants in surgical procedures in Ireland, and the ongoing clinical management of women who have had these procedures in the past, are in line with international best practice”.
“He has requested the Chief Medical Officer to prepare a report for him on the many clinical and technical issues involved. That work is underway and is anticipated to be completed within the coming months. Clearly this will be informed by emerging evidence and the concerns being raised.”
https://www.thejournal.ie/vaginal-mesh-chief-medical-officer-3895189-Mar2018/
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Do you have a FOFO? Find out more in the latest MedTalk Podcast — Episode 7
Mar 12, 2018 | EPM Magazine
This episode sees the editors (as well as their not-so-invisible fact checker!) come together to chat about the latest developments in the worlds of medtech, digital health, medical plastics and pharma.
The team discuss the government’s latest plan to review three public health scandals. Fliss and Reece delve into the details of what the plan means for products such as vaginal mesh and sodium valproate.
Dave plugs Med-Tech Innovation Expo and why it is the event to be at in April for the medical manufacturing and engineering communities.
Lastly, Fliss takes the Fear of Finding Out (FOFO) quiz to see if she has a fear of finding out bad news about her health.
You can listen to the latest episode on Soundcloud or iTunes.
https://www.epmmagazine.com/opinion/medtalk-podcast-episode-7/
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Loyola University Medical Center, doctor allegedly failed to properly perform surgical procedure
Mar 11, 2018 | Cook County Record
By Louie Torres
CHICAGO — A woman is suing Loyola University Medical Center and Dr. Cynthia Brincat for allegedly taking insufficient measures to prevent injuries.
Eileen Roe filed a complaint on Feb. 7 in Cook County Circuit Court, alleging she suffered serious physical injuries as a result of a vaginal mesh procedure she underwent.
The plaintiff seeks judgement against the defendants in an amount that exceeds the jurisdictional limits of this court. She is represented by Michael F. Sullivan of Sukhman Yagoda LLP in Chicago.
Cook County Circuit Court case number 2018L001376
https://cookcountyrecord.com/stories/511348027-loyola-university-medical-center-doctor-allegedly-failed-to-properly-perform-surgical-procedure
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