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Ethicon 6/10
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Better care, fewer women suffering crippling, lifelong pain following a simple operation. Scotland plans sweeping reforms. Changes welcomed by campaigning journalist
Oct 5, 2015 | Wisbech Standard/ Cambs Times
By Kath Sansom
Three out of four mesh products used in women’s gynaecology operations will no longer be used in Scotland after new measures were outlined to protect patients. -
Shona Robison to give evidence in mesh implants review
Oct 6, 2015 | Glasgow South and Eastwood Extra
The procedure can be used to treat women suffering from prolapse and bladder problems but an independent review was ordered after women who had been left suffering from painful complications took their case to Holyrood. -
J&J Wins 1st Trial Over Prosima Pelvic Mesh
Oct 5, 2015 | Law360
By Jess Davis
A Texas state court jury on Monday cleared Johnson & Johnson of liability in the first trial over the company's Prosima pelvic mesh device, rejecting claims the device was defectively designed and that the company didn't adequately warn consumers about the risks involved. -
Defense Verdict Issued in Texas Ethicon Gynecare Prosima Transvaginal Mesh Action
Oct 5, 2015 | HarrisMartin Publishing
A Texas jury has reached a defense verdict in favor of Ethicon and Johnson & Johnson, rejecting claims that the plaintiff suffered multiple injuries as a result of Ethicon’s Gynecare Prosima Pelvic Floor Repair System, which was implanted to treat her pelvic organ prolapse. -
Scotland Limits Use of Pelvic Mesh Implants
Oct 5, 2015 | Mesh Medical Device news Desk
By Jane Akre
According to a story in Scotland’s The Daily Record,here, on Friday, the Health Secretary of Scotland published an interim report on the use of transvaginal mesh. -
Cavness v. Ethicon – First Jury Vote for Ethicon 10-2, Mesh Not Defectively Designed
Oct 6, 2015 | Mesh Medical Device News Desk
By Jane Akre
In its second day of deliberations, the 12-member jury in Cavness v. Kowalczyk (et al., case # DC-14-04220) decided for the Defendant Johnson & Johnson, 10-2. -
Monday Morning- Jury Still Out in Cavness Pelvic Mesh Trial Against J&J
Oct 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
The jury had question about 11 am Central time for Judge Ken Molberg in his Dallas court. The jury had a question they relayed to Judge Ken Molberg in a jury note.
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Oct 5, 2015 | Wisbech Standard/ Cambs Times
By Kath Sansom
Three out of four mesh products used in women’s gynaecology operations will no longer be used in Scotland after new measures were outlined to protect patients.
The news has been welcomed by mesh injured women and campaigners around the world who are looking to Scotland to lead the way in banning mesh products.
The safety review was launched after women spoke out about being left crippled for life and in agony.
The Scottish report has recommended surgeons no longer use the TVTO mesh for stress urinary incontinence and two types of mesh used for prolapsed organ surgery.
They will still be able to use TVT mesh but only after a woman has undergone rigorous talks with a physiotherapist, surgeon and nursing team.Elaine Holmes and Olive McIlroy from Hear Our Voice Scottish campaign
Scotland looks set to make the changes despite Government watchdog body, the MHRA, saying the surgery is safe,
Canadian hernia surgeon Dr Robert Bendavid, who has not worked for two years to research complications, write reports and give talks to health professionals on the dangers of mesh used in all areas of the body, said: “This is definitely a major victory.
“Let the good news spread. The measures put in place will slowly snuff out the practice. The advantage of this decision will be the ripple effect it must have.”
New Zealand mesh injured campaigner Carmel Berry has entered the Scottish report to New Zealand’s Health Select Committee as evidence to get the mesh suspended there.Dr Robert Bendavid, among authors of reports outlining mesh complications
She said: “I hope they will see this as a critical document in their consideration of the petition.”
She added it was time for medical regulatory bodies globally to “wake up and realise the scale of this problem.”
Lana Keeton, an American patient advocate and president of Truth in Medicine, said: “Finally some sanity in a world of unethical surgeons profiting from harm to their patients.”
Hear Our Voice campaigner Elaine Holmes, from Glasgow, said: “We’re now confident no other woman will be left unaware of the horrific side-effects of mesh implants.Reporter Kath Sansom pictured on Sky News where she talks about the campaign Sling The Mesh
“We called for a total ban on mesh products as we believe time will show just how dangerous they are. But we’re happy to support the review recommendations as long as they and our petition points are put in place and actioned before any suspension is lifted.
Fellow campaigner Olive McIlroy, from Renfrew, said: “We’re also happy doctors will no longer be able to urn to mesh products as a first option but rather as a last option.
“We strongly believe doctors failed their patients in the past by not reporting adverse incidents, which allowed mesh manufacturers to continue to state their products were safe when clearly they were causing injury.”
Sling the Mesh campaigner Kath Sansom said: “This is a big step in helping prevent other women suffering. I hope England follows suit and also adds a National Register so there is hard evidence about how many women suffer.”Sling The Mesh Facebook campaign
Scottish health secretary Shona Robison welcomed the interim report and said: ““We know that these procedures, in some cases, can have serious consequences and life changing side effects.
“Our advice to boards around suspending the use of mesh remains in place. We need to see the final report before we consider any changes that could potentially be made. We also need to be confident the recommendations for improved safeguards have been agreed and implemented.
Chairman of the Independent Review, Dr Lesley Wilkie, said: “This report points the way forward for improving services for women.
“The report recommends improvements in clinical governance ensuring above all that women with these conditions can be assured that the treatment which they receive within the NHS is evidence based, audited and likely to produce a good result.”
The changes mean doctors will not be able to use mesh implants unless authorised by a multi-disciplinary medical team.
They must report adverse incidents or face possible sanctions - victims say the scale of the problems has been covered up by doctors failing to properly record complications.
An MHRA spokesperson said: “The MHRA continues to sympathise greatly with women who have suffered complications after surgery.
“We are committed to helping to address the serious concerns that have been raised by some patients and have undertaken a great deal of work to continuously assess findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.
“What we have seen, and continue to see, is that the greater proportion of the clinical community and patients support the use of these devices in the UK in the treatment of distressing conditions of incontinence and organ prolapse.
“We note that the Interim Report finds that for the majority of woman, serious complications do not occur and we will continue to work in collaboration with patients, the NHS, professional bodies and international partners to ensure emerging issues are detected and acted upon quickly.”
The MHRA, however, uses the BSUG database where only 20 to 30 per cent of surgeons admit to reporting problems, which makes complication rates appear lower.
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Shona Robison to give evidence in mesh implants review
Oct 6, 2015 | Glasgow South and Eastwood Extra
The procedure can be used to treat women suffering from prolapse and bladder problems but an independent review was ordered after women who had been left suffering from painful complications took their case to Holyrood.Shona Robison is to give evidence to MSPs on the Scottish Parliament's Public Petitions Committee
Both Ms Robison and Dr Lesley Wilkie, chair of the independent review of transvaginal mesh implants, will give evidence to MSPs on the Scottish Parliament's Public Petitions Committee today.
It comes after an interim report was published last week called for better training to be put in place to ensure medical staff are more aware of the complications women can suffer after mesh implant surgery.
The report expressed ''serious concerns that some women who had adverse events found they were not believed'', adding this added to their distress and meant they had to wait longer for help.
About 11,000 women in Scotland have had the implant procedure but MSPs have been told that as many as one in five implants can go wrong, with the interim report noting mesh implants ''carry a risk of complications which in some cases are life-changing and cannot be corrected''.
The Scottish Government has already suspended the use of mesh implants, with Ms Robison making clear last week that this remains in place.
Elaine Holmes and Olive McIlroy, of Scottish Mesh Survivors, the group which took the issue to Holyrood, want a public inquiry to be held or independent research to be carried out into the safety of mesh devices.
Dr Wilkie said last week the interim report " points the way forward for improving services for women in the treatment of these conditions"
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J&J Wins 1st Trial Over Prosima Pelvic Mesh
Oct 5, 2015 | Law360
By Jess Davis
A Texas state court jury on Monday cleared Johnson & Johnson of liability in the first trial over the company's Prosima pelvic mesh device, rejecting claims the device was defectively designed and that the company didn't adequately warn consumers about the risks involved.
J&J has defended the efficacy of its product and said it more than adequately warned doctors about the inherent risks of using the Prosima pelvic mesh device. (Credit: AP)
In a 10-2 verdict, Dallas County District Court jurors rejected plaintiff Carol Cavness' claim that the Prosima device was defectively designed and that J&J's Ethicon Inc. unit had failed to give adequate warnings about the risks associated with the mesh device. Cavness, who had the device implanted in 2012 and says she has suffered debilitating pain and other medical problems since then, had asked jurors to award $9.56 million in actual damages and a substantial punitive damages award that would send a message to J&J about its decision to market the Prosima device.
Jurors deliberated for about seven hours following seven days of testimony.
"We're pretty shocked," David Matthews of Matthews & Associates, Cavness' attorney, said after the verdict.
Matthews said it's "sad" Johnson & Johnson took the strategy of attacking Cavness' past medical history instead of addressing her concerns about the Prosima device.
"I think they never defended the product at all," Matthews said. "I think there's a lot of information still to come to light about the Prosima."
Ethicon spokesman Matthew Johnson said in a statement Monday the jury's decision "reflects the facts in this case."
"Ethicon acted appropriately and responsibly in the research, development and marketing of the product and Prosima was not the cause of the plaintiff’s continuing medical problems," Johnson said. "We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events. We have always made patient safety a top priority and will continue to do so."
Cavness alleged after she was implanted with the mesh in 2012, she suffered debilitating pain and has spent three and a half years in and out of hospitals and undergoing multiple surgeries, along with depression and anxiety and other medical problems related to the mesh.
She argued J&J knew before it ever launched Prosima that the device was risky and carried with it the threat of permanent damage to women who were treated with it, but that the money-hungry company pushed the device to market to avoid losing ground to competitors.
"This is an epidemic," Matthews said in his closing argument. "These meshes are health care disasters. Does anyone really think this product was pulled from the market because of sales? This product was pulled because it's dangerous."
J&J has defended the efficacy of its product and said it more than adequately warned doctors about the inherent risks of using the device. It said Cavness' injuries are not the result of an adverse reaction to the Prosima but instead were caused by a pelvic floor disorder that was triggered by the same on-the-job injury that initially led her to seek surgery for pelvic organ prolapse.
"Mesh is not, was not and will not be the cause of her pain," said William Gage of Butler Snow LLP, an attorney for J&J. "There is no proximate cause."
After the verdict was read, several jurors said they were frustrated by the questions they had to answer. Two jurors said the jury thought they would get questions about whether Cavness had mesh remaining in her, not whether the product was defectively designed. Deliberations were heated, and around noon today, the jury thought they might not be able to come to a consensus, the jurors said.
Juror Godwin Egbobawaye said many of the jurors shed tears during deliberation out of sympathy with Cavness, but ultimately did not think she proved the Prosima device was the proximate cause of her injuries.
The Dallas trial is the country's first involving Prosima. Other J&J pelvic mesh products have racked up a mixed verdict in state court and bellwether federal trials. The company faces tens of thousands of lawsuits in federal multidistrict litigation, and is set for several state court trials in Texas in the next six months involving its mesh products.
In 2013, a New Jersey state court ordered J&J to pay a total of $11.1 million — $7.76 million of which was punitive damages — to a woman who said she was injured by a Gynecare Prolift pelvic sling made by Ethicon.
The first bellwether in the federal MDL involving J&J was a win for the company, when a federal judge in February 2014 found the plaintiff failed to present sufficient evidence to support her claim a defect in the TVT device caused her injury. That ruling was affirmed by the Fourth Circuit.
In September 2014, another federal jury found the TVT-O mesh device to be defective and awarded $3.27 million in actual damages, with no punitive damages.
In Dallas, before the same judge who presided over Cavness' trial, a jury in April 2014found J&J's TVT-O mesh was defectively designed, but that J&J provided sufficient warning of the known risks. The jury awarded $1.2 million in compensatory damages, with no punitive damages.
A Dallas appellate court in September heard oral arguments in J&J's appeal of that verdict, with the company arguing there was insufficient evidence establishing the plaintiff’s injuries were caused by the TVT-O device.
Cavness is represented by Bill Blankenship of William F. Blankenship III PC, Tim Goss and Rich Freese of Freese & Goss PLLC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.
Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP, Kat Gallagher of Beck Redden LLP, Carol Traylor and Ashley Parrish of Cantey Hanger LLP and Scott Stolley of Cherry Petersen Landry Albert LLP.
The case is Cavness v. Kowalczyk et al., case number DC-14-04220, in the 95th District Court of Dallas County, Texas. -
Defense Verdict Issued in Texas Ethicon Gynecare Prosima Transvaginal Mesh Action
Oct 5, 2015 | HarrisMartin Publishing
A Texas jury has reached a defense verdict in favor of Ethicon and Johnson & Johnson, rejecting claims that the plaintiff suffered multiple injuries as a result of Ethicon’s Gynecare Prosima Pelvic Floor Repair System, which was implanted to treat her pelvic organ prolapse.
According to the court docket, the jury, sitting in the 95th Judicial District Court of Texas, began deliberations on Oct. 2 and rendered the verdict on Oct. 5. Judge Ken Molberg presided over the trial, which began on Sept. 21.
In April 2012, Dr. Teresa Kowalczyk implanted Carol Cavness with the Gynecare Prosima Pelvic ...
Subscription required, for full article please see: http://harrismartin.com/article/19971/defense-verdict-issued-in-texas-ethicon-gynecare-prosima-transvaginal-mesh-action/
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Scotland Limits Use of Pelvic Mesh Implants
Oct 5, 2015 | Mesh Medical Device news Desk
By Jane Akre
According to a story in Scotland’s The Daily Record,here, on Friday, the Health Secretary of Scotland published an interim report on the use of transvaginal mesh.
It says three of the four procedures doctors routinely recommend to treat incontinence and pelvic organ prolapse will no longer be used.
The reforms are outlined in a safety review by the government largely encouraged by a series of reports by Marion Scott and the Sunday Mail as well as Scottish Mesh Survivors patient group. Their Hear Our Voice campaign carried to testimony before a Parliamentary Committee on the dangers of mesh implants.
See background stories here and here.
WHAT’S CHANGED
What will change is using pelvic mesh to treat prolapse will not be approved, even though the U.S. version of the FDA, the MHRA, insists the procedure is safe and the benefits outweigh the risks.
Mesh procedures to treat stress urinary incontinence (SUI) also will not be routinely offered as a first line of care unless they are authorized by a multi-disciplinary medical team.
Hundreds of women in Scotland had complained to Parliament that their complications or adverse events were not being reported to the government. As a result, now that those incidents must be reported or the doctor will face possible sanctions.
Marion Scott tells Mesh News, “The mesh victims played a huge role in writing the patient information leaflets and they have ensured all possible side effects ate explained clearly. The SUI leaflet has already been done and they are working on the POP leaflet as we speak. This is a great example of what can be achieved. I’m so proud of all these incredible women who put their own pain to one side and pushed for these changes so no other women need suffer. They really are incredible.”
There is still voluntary reporting in the U.S. and the complications recorded by the U.S Food and Drug Administration are thought to represent one to ten percent of real-life complications.
Reporter Marion Scott began her series of investigations beginning in March 2013 for the Sunday Mail where the injuries from pelvic mesh became front page news. Women told the paper they had dire complications including an inability to walk and function and still faced dozens of surgeries. As in the States, many patients were told the problems were in their head and they should get mental health treatment.
That too was taken into consideration by the independent reviewers who urged surgeons to increase their “listening and empathy” skills.
The campaigners had asked for a total ban on mesh products but Elaine Holmes told the Daily Record “We’re happy to support the review recommendations as long as they and our petition points are put in place and actioned before any suspension is lifted.”
She added that the safety of patients is finally being put first.
Marion Scott, Daily Mail reporter
Marion Scott tells Mesh News Desk,
“This is a momentous step forward and will ensure the devices which have caused the most damage will no longer be used and the one procedure that is left will only be used as a last resort rather than the first. Doctors will have to go in front of a panel to justify each and every use of the one SUI procedure left available, using retropubic tapes, and it will only be carried out as a last resort and when patients are fully informed of all the risks. Doctors will also face possible sanctions if they fail to report adverse incidents as there is a strong feeling over their failure to report previously. We reckon the new restrictions will have wide reaching effect.
“It has been a hard fought battle by women who have all suffered horrific injury. They are the true heroines of the piece. None of this will help them as their injuries are permanent. But they could not stand back and allow any other women to be injured.
“Thanks for all your support Jane. We just hope other countries will follow suit. I fully believe mesh will eventually be recognised as one of the biggest medical scandals of all time. Keep up the good fight. “
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Cavness v. Ethicon – First Jury Vote for Ethicon 10-2, Mesh Not Defectively Designed
Oct 6, 2015 | Mesh Medical Device News Desk
By Jane Akre
In its second day of deliberations, the 12-member jury in Cavness v. Kowalczyk (et al., case # DC-14-04220) decided for the Defendant Johnson & Johnson, 10-2.
In doing so, jurors found the Prosima pelvic mesh, made by Ethicon (J&J) is not defective in its design and in its instructions to doctors, the end users.
This is the first trial win for Johnson & Johnson after suffering $21.5 million in losses in four previous pelvic mesh trials.
Heated debate in the Cavness jury room resulted from confusion about the questions jurors had to answer about Design Defect of the Prosima pelvic mesh, and whether the Instructions to doctors were defective or inadequate.
Jurors told patient advocate, Joleen Chambers, the questions were “too legalese” for them and they were unclear how the questions related to the evidence shown in the case. The female jury foreman, who reportedly took 100 pages of notes, and another woman voted for Ms. Cavness. The other jurors voted ‘No’ to both questions.
Plaintiff, Carol Cavnes, 60, broke down in the courtroom and was ushered out. The two female jurors reportedly were also crying.
JURY QUESTIONS
Chambers says jurors told her if one word was changed it would have changed the whole thing. Friday jurors were convinced they would render a quick decision, but that reportedly changed when they saw the jury questions, which they say, did not coincide with what they heard at trial.
At trial, jurors heard about the injuries Ms. Cavness suffered and what the company knew prior to marketing Prosima.
Defense had asked for specific language in the two jury questions. Once Judge Molberg realized that, he spoke to the jury this morning asking them to change their thoughts about the definition of “Proximate Cause” to let jurors know they could find for the Plaintiff based on causation.
Molberg defined that as the cause which was a substantial factor in bringing about an injury and without such cause the injury would not have occurred.
Judge Ken Molberg, 95th Judicial District, TX
“In order to be a proximate cause, the act or omission complained of must be such that a medical device manufacturing company, using ordinary care, would have foreseen the injury or some similar injury might reasonably result there from. There may be more than one proximate cause of an injury,” he said.
Around 11 am Central Time, Judge Molberg told jurors if they had answered either question, they should re-deliberate using the definition he just gave “because it is the proper legal definition.” That was all he could say to them about legal theory.
One male juror told Chambers the deliberations were very difficult. He said he learned a lot about female anatomy quickly. He learned you can have an injury and it could reappear later. He too said the language in the question made no sense given what they were told during trial.
DESIGN DEFECT
Other pelvic mesh trials have focused on the polypropylene material used to form the woven plastic and how the resin makers specifically warned against using the raw polypropylene resin for use in implantable medical devices. The Material Safety Data Sheet, which contains the warning, was not presented in this trial.
This is the first trial win for J&J and its Ethicon division, maker of pelvic mesh implants.
On Friday, the Plaintiffs asked for $9.5 million in actual damages against J&J plus punitive damage awards.
Judge Ken Molberg, who had a previous appointment, had to leave while the jury deliberated today.
Judge Emily Tobolosky told the court the jury wanted to deliver a statement along with the verdict. Attorneys for Plaintiff Cavness did not want to hear the statement while the Defendant’s lawyers had no problem with the statement, which was not disclosed.
The jury decision came back just about 4 pm Central Time.
BACKGROUND
The Cavness case is the sixth product liability case filed against Ethicon over its pelvic mesh. Four cases that have gone to trial include Linda Batiste ($1.2 million) Jo Huskey ($3.57 million), Linda Gross ($11.1 million) and Coleen Perry ($5.7 million). The Carolyn Lewis case was dismissed after Judge Joseph Goodwin granted J&J a directed verdict last year.
Other cases naming Ethicon/ J&J have settled including Budke and Wicker, as well as a few cases in Missouri.
So far, two juries have found the TVT-O, mesh used for incontinence, and made of the same mesh as the Prosima, to have been defectively designed and manufactured.
At this writing, J&J faces 28,960 cases filed in multidistrict litigation in federal court in Charleston, WV. Thousands of other cases are filed in state courts and around the world. J&J has vowed to take the pelvic mesh litigation to trial rather than settle, as several other manufactures have begun doing.
Ethicon knew the mesh used in the Prosima could prompt an immune system response that would cause degradation of pelvic tissue, but that information was withheld, says her complaint. Instead the company called the mesh “safe and effective” in its marketing efforts.
“Contrary to the representations and marketing of defendants J&J and Ethicon, the pelvic mesh products have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating revision surgeries, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women,” Cavness’ complaint states.
The Plaintiff’s complaint says implanting physician, Dr. Kowalczyk, failed to disclose the risks associated with the implantation and instead recommended it as a safe and effective.
Cavness was seeking compensatory damages for disfigurement, impairment, past and future medical expenses and mental anguish. Punitive damages were allowed, reports CVN, after Judge Ken Molberg denied Ethicon’s motion to deny punitive damages against the company.
The suit also included claims against the physician who implanted the mesh in Cavness, Teresa Kowalczyk. The doctor was negligent in the care and treatment to her patient and did not act as a reasonably prudent physician in caring for her patient, says the complaint.
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Monday Morning- Jury Still Out in Cavness Pelvic Mesh Trial Against J&J
Oct 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
The jury had question about 11 am Central time for Judge Ken Molberg in his Dallas court. The jury had a question they relayed to Judge Ken Molberg in a jury note.
What is Proximate Cause?
The judge answered.
“On page 3 of the charge of the court you will find a definition of proximate cause. You are to disregard that definition and substitute it with this definition.
Proximate cause means a cause which was a substantial factor in bring about an injury and without such cause the injury would not have occurred. In order to be a proximate cause, the act or omission complained of must be such that a medical device manufacturing company using ordinary care would have foreseen the injury or some similar injury might reasonably result there from.
There may be more than one proximate cause of an injury.
Ordinary care means that degree of care a medical device manufacturing company or ordinary prudence would use under same or similar circumstances.
If you have answered either question one or two you should redeliberate using the definition I have given you in the supplemental charge because it is a proper legal definition. It is the only answer I can give you at this time.
Signed this fifth day of October 2015. That is the answer to your question, you should disregard the previous definition of proximate cause please return to the jury room to resume deliberations.
Mesh News Desk will be watching the proceedings via Courtroom View Network which has provided a live feed from the courtroom during the entire two week trial. Thanks to CVN for the access!! www.cvn.com
BACKGROUND
On Friday, attorneys for Carol Cavness, 60, asked Johnson & Johnson to award $9.5 million in actual damages, including a sizable punitive damage award to send a message to the company about its Prosima pelvic mesh, which has since been taken off the market.
Ms. Cavness, 60, alleges she was injured by the Prosima pelvic mesh used to treat prolapse. Experts brought to trial on her behalf says she is permanently injured and some of the polypropylene mesh remains behind in her body to cause future injuries. Plaintiff attorneys’ brought life can plan experts to trial to show the financial needs she will have in the future due to the injuries from the Prosima mesh, which is made by Ethicon, a division of Johnson & Johnson. This is the first product liability trial for Prosima.
J&J is facing 30,000 other defective mesh product liability trials ahead.
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