Preview Newsletter
Ethicon Media Monitoring 5/19/2017
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$20M Awarded in Ethicon TVT Mesh Lawsuit
May 18, 2017 | The Legal Examiner
By Andrew D'Arcy
A state court jury in Philadelphia has returned a $20 million verdict against Johnson & Johnson’s Ethicon division, including punitive damages designed to punish the manufacturer over problems with the Ethicon TVT-Secur transvaginal mesh. -
Kavaler Expert Witness for J&J on Stand in Beltz Mesh Trial
May 18, 2017 | Mesh Medical Device Newsdesk
Dr. Elizabeth Kavaler, a urogynecologist, appeared as an expert witness for Ethicon, a division of Johnson & Johnson, in a Philadelphia product liability trial over transvaginal mesh Wednesday. -
Minister Says Expert Will Look at Mesh Implants Review
May 18, 2017 | BBC
Health Secretary Shona Robison has asked an expert to examine a review into the safety of mesh implants. -
Chairing Mesh Implant Review Was Mission Impossible, MSPs Told
May 18, 2017 | Aberdeen Evening Express
Leading an independent review into mesh implant surgery was "mission impossible", MSPs have been told. -
The Do’s and Don’ts of Post-Baby Recovery
May 18, 2017 |
By June Kellum Fakkert
French women have a secret to bouncing back and feeling great post-baby: They embrace postpartum physical therapy.
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$20M Awarded in Ethicon TVT Mesh Lawsuit
May 18, 2017 | The Legal Examiner
By Andrew D'Arcy
A state court jury in Philadelphia has returned a $20 million verdict against Johnson & Johnson’s Ethicon division, including punitive damages designed to punish the manufacturer over problems with the Ethicon TVT-Secur transvaginal mesh. The 12-member jury hearing the case returned the verdict after testimony was given by Plaintiff Margaret Engleman, demonstrating she suffered life-altering injuries when the mesh eroded inside of her.
Two prior trials in Philadelphia have resulted in damage awards against Ethicon that totaled approximately $26 million. A 2015 case led to a $12.5 million verdict for an Indiana woman and a 2016 case led to a $13.5 million verdict for a New Jersey woman. The pelvic mesh mass tort has another 183 cases pending.
Ethicon and other transvaginal mesh manufacturers have faced tens of thousands of similar claims brought by women throughout the United States, each involving allegations that the mesh used for repair of pelvic organ prolapse and female stress urinary incontinence migrated through the vagina, causing infections and other painful injuries. Many of the manufacturers have reached vaginal mesh settlements to avoid potential jury verdicts.
The U.S. Food and Drug Administration (FDA) issued warnings concerning transvaginal mesh implants in 2008 and 2011. In 2011, the federal regulator updated its prior notification to include that complications tied to transvaginal mesh were “not rare,” that transvaginal mesh does not appear to have any clear benefits for patients diagnosed with pelvic organ prolapse (POP) when compared to non-mesh methods, and that transvaginal mesh devices may also present additional risks that may include infection, incontinence, mesh erosion, pain, recurrence of prolapse, and urinary problems. Perforation of the bowels, bladder, and blood vessels were also associated with transvaginal mesh device implants.
To address these concerns, the FDA reclassified transvaginal mesh from a moderate to a high-risk device. This means that transvaginal mesh device makers must go through the agency’s stricter pre-market approval process, which mandates medical device companies to submit data proving their devices are both safe and effective.
Three additional Ethicon mesh trials are scheduled over the next two months, and the manufacturer has indicated that it intends to appeal last week’s verdict.
http://atlanticcity.legalexaminer.com/fda-prescription-drugs/20m-awarded-in-ethicon-tvt-mesh-lawsuit/
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Kavaler Expert Witness for J&J on Stand in Beltz Mesh Trial
May 18, 2017 | Mesh Medical Device Newsdesk
Dr. Elizabeth Kavaler, a urogynecologist, appeared as an expert witness for Ethicon, a division of Johnson & Johnson, in a Philadelphia product liability trial over transvaginal mesh Wednesday.
The defense presented her as a medical expert in the case of Beltz v. Ethicon.
She has been presented as a defense expert witness in the trial of Linda Gross, and Joan Budke, women injured from their pelvic mesh implants (Budke’s injury was fatal), as well as other plaintiff actions on behalf of Johnson & Johnson.Dr. Elizabeth Kavaler, a New York city based urogynecologist, appeared again Wednesday as a medical expert for Ethicon in the case of Beltz v. Ethicon. Beltz etal vs Ethicon Women’s Health and Urology, Case ID: 130603835).
On September 20, 2006, Sharon Beltz was implanted with the Ethicon Prolift +M System to treat pelvic organ prolapse. Her surgeon was Dr. Heather Van Raatle, MD at St. Lukes Hospital in Bethlehem, PA.
On that same day, Beltz was implanted with the Gynecare (Ethicon) TVT System to treat incontinence.
The Beltz trial began in the Philadelphia Court of Common Pleas on May 8th, and the jury is now listening to the defense side of events.
FROM THE GROSS TRIAL
In the Linda Gross trial, Dr. Kavaler testified that pelvic mesh does not move around within the pelvic area.
“It does not have a life of its own,” she said. See Mesh News Desk coverage here.
Dr. Kavaler had conducted a medical exam on Ms. Gross.
In August 2013, the Gross case resulted in an $11.1 million verdict for the South Dakota nurse.
J&J appealed and has exhausted the appeals process and the award should finally be awarded to the family soon.
Kavaler has been an expert witness for at least 25 cases for Johnson & Johnson and Ethicon concerning pelvic mesh made by the healthcare giant.
Plaintiff attorney, Adam Slater recounted her deposition where she said she “was a big mesh user.”
That is what got her the attention of Dr. Vincent Lucente, an Ethicon consultant, who introduced her to Ethicon. Dr. Kavaler was driven to the company headquarters and attended a dinner in the Meat Packing District in New York City where she said she wanted to talk to other doctors.
After first being contacted by Ethicon in 2009 she began teaching courses for the company on the use of another mesh, Prosima. She was also hired to proctor a cadaver lab.
Kavaler admitted during the Gross trial that Ethicon was not informing surgeons about mesh complications, mesh removals or even what to expect when a polypropylene mesh goes wrong.
According to sources close to the case, the first witness on behalf of Ms. Beltz was Dr. Daniel Elliott, urologist from the Mayo Clinic, by video. He also appeared in the Hammons trial.
Medical expert Dr. Tom Margolis, MD also appeared. He is one of the few doctors in the country specializing in pelvic mesh complications and revisions at his San Francisco area office. See it here.
A HISTORY OF LOSSES
So far J&J has suffered a string of losses in this venue. The last three trials resulted in wins for the Plaintiff including – $12.5 million (Hammons), $13.5 million (Carlino) and on April 28th $20 million for Ms. Engleman.
Read the MND story of the Engleman trial here. MDN on Carlino here. Read the MND story on Hammons case here.
There are nearly 200 pelvic mesh product liability cases filed in this Philadelphia state court waiting for trial.
Most name as a defendant Ethicon, Johnson & Johnson or Gynecare, all divisions of J&J. Boston Scientific, another mesh manufacturer, is also named in a number of other product liability cases filed here.
The Beltz case could go to the jury this week. ###
http://www.meshmedicaldevicenewsdesk.com/kavaler-expert-witness-jj-stand-beltz-mesh-trial/
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Minister Says Expert Will Look at Mesh Implants Review
May 18, 2017 | BBC
Health Secretary Shona Robison has asked an expert to examine a review into the safety of mesh implants.
Many women have questioned the safety of the implants, which are used to treat incontinence, after suffering debilitating side effects.
Two patients sitting on the original review group quit in protest at what they said was a watered-down report.
Now independent expert Alison Britten, a professor of healthcare and medical law, will examine the final report.
Ms Robison told Holyrood's public petitions committee that Prof Britten, from Glasgow Caledonian University, would examine the process by which the report came to its conclusions.
She told MSPs: "Professor Britten will produce a report on how the independent review process was undertaken and importantly what lessons can be learned in the future."
The report concluded procedures should not be offered routinely to women with pelvic organ prolapse.
It recommended patients be offered a range of treatments and given the information to make "informed choices".
The report also said reporting of adverse events should be mandatory.
Ms Robison confirmed the recommendations would continue to be implemented despite calls from campaigners for an all-out ban.
The health secretary said the government did not have the power to ban the procedures as that lay with UK regulatory body the Medicines and Healthcare Products Regulatory Agency.
In other evidence, the chairwoman of the independent review Tracey Gillies apologised for failing to unite all panel members around the review's controversial final report.
'Impossible mission'
Ms Gillies took over as chairwoman of the independent review of transvaginal mesh implants in its final stages towards the end of last year.
It emerged she had no conversations with previous chairwoman Lesley Wilkie, who resigned for personal reasons.
Her evidence was punctuated by cries of "shame on you" and "rubbish" from a packed public gallery which included some women who had suffered painful and debilitating complications as a result of the procedure.
Ms Gillies said her task had been "almost mission impossible from the beginning".
She said: "It was clear that there were strongly-held views of difference at the point that I came in, so one could say more fool me for agreeing to chair this.
"This is not something that most people would have ... welcomed would be the wrong word, but it's clearly going to be a very difficult thing and I personally have reflected and feel disappointed that I have not achieved what I would have set out to do, which would have been to bring this in in consensus.
Olive McIlroy and Elaine Holmes - who had both suffered complications as a result of the surgery - quit the review group earlier this year, saying they felt "dismayed and disgusted" at the publication of the independent report.
It was claimed that parts of the final report had been removed.
Following their resignations, it emerged that a consultant also quit the expert group over concerns about the final draft of the report.
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
http://www.bbc.com/news/uk-scotland-39964844
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Chairing Mesh Implant Review Was Mission Impossible, MSPs Told
May 18, 2017 | Aberdeen Evening Express
Leading an independent review into mesh implant surgery was “mission impossible”, MSPs have been told.
Chair Tracey Gillies apologised for failing to unite all panel members around the review’s controversial final report.
Holyrood’s Public Petitions Committee heard a “review of a review” is to be set up to see what lessons can be learned from the process, which was branded a “whitewash” by opposition parties and mesh survivors.
Two of those survivors, Olive McIlroy and Elaine Holmes, resigned from the panel, claiming the report had been ”diluted”, and a clinician member also withdrew.
Ms Gillies took over as chair of the independent review of transvaginal mesh implants in its final stages towards the end of last year.
It emerged she had no conversations with previous chair Lesley Wilkie, who resigned for personal reasons.
Her evidence was punctuated by cries of “shame on you” and “rubbish” from a packed public gallery, many of whom had suffered painful and debilitating complications as a result of the procedure, including Ms McIlroy and Ms Holmes.
Ms Gillies said her task had been “almost mission impossible from the beginning”.
She said: “It was clear that there were strongly-held views of difference at the point that I came in, so one could say more fool me for agreeing to chair this.
“This is not something that most people would have … welcomed would be the wrong word, but it’s clearly going to be a very difficult thing and I personally have reflected and feel disappointed that I have not achieved what I would have set out to do, which would have been to bring this in in consensus.
“I hear the voices from behind me and I feel very sorry … that I have not achieved something which brought something together where people felt they were able to stay as part of that to the end and I am personally sorry that that has not happened, and if that is any fault of mine then I would want to acknowledge that.”
Responding to claims the report was a “whitewash”, she added: “I’ve done my best from the place that I started in to try to include the views as I heard them and to try to make sure that we produced a report that considered the evidence as we’d been asked to do, and actually produced a report that was credible and tried to set out as much of the evidence as possible.”
Health Secretary Shona Robison told the committee she had commissioned Glasgow Caledonian University Professor Alison Britton to “produce a report on how the independent review process was undertaken and importantly what lessons can be learned in the future”.
She said the review was not about revisiting the evidence but would look at concerns raised about the process.
The report concluded procedures must not be offered routinely to women with pelvic organ prolapse, recommended patients should be offered a range of treatments and must be given the information to make ”informed choices”, and said the reporting of adverse events must be mandatory.
Ms Robison confirmed the recommendations would continue to be implemented despite calls from campaigners for an all-out ban.
The Health Secretary repeated that the government did not have the power to ban the procedures as that lay with UK regulatory body the Medicines and Healthcare Products Regulatory Agency.
Speaking after the meeting, committee convener Johann Lamont said: “The committee has previously heard from campaigners enduring chronic health conditions, expressing their fears that issues around mesh implant devices are not being properly addressed.
“It is deeply concerning that the evidence we heard produced more questions than answers.
“As we continue to seek to respond to the issues highlighted to us, the committee wants to hear from people who have comments on the independent review.
“We particularly want to hear evidence from all who were members of the review and intend to seek a debate in parliament to gauge views from across the political spectrum.
“It is vital that an outcome is reached in which patients can have confidence.”
https://www.eveningexpress.co.uk/pipe/news/scotland/chairing-mesh-implant-review-was-mission-impossible-msps-told/
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The Do’s and Don’ts of Post-Baby Recovery
May 18, 2017 |
By June Kellum Fakkert
French women have a secret to bouncing back and feeling great post-baby: They embrace postpartum physical therapy.
Six weeks after birth, French women begin “la rééducation périnéale” (perineal reeducation), a set of guided exercises that help get the muscles back to optimal functioning. After 10 to 20 sessions of therapy, women complete another round for the abdominal muscles.
In the United States, a woman’s postpartum body is given comparatively little attention, and many new moms may feel embarrassed to discuss issues they encounter.
Rachel Parrotta is a physical therapist at Shift Integrative in New York who specializes in women’s health and pelvic floor recovery. For her French clients, postpartum physical therapy is standard practice, says Parrotta, but the majority of her American clients seek treatment only if they have a problem.
To help new mothers heal properly after giving birth, Parrotta shared some guidelines for what women should and shouldn’t do in caring for their bodies.
Do…
Learn How the Pelvis Works
This is something women should do before giving birth. Pelvic floor exercises, commonly known as Kegels, require some practice and muscle coordination, and can be hard to perform correctly when the muscles are in a weakened state. Therefore, it is better to learn proper methods of care and exercise while pregnant, rather than after delivery.
Parrotta has also encountered many women who perform the exercises incorrectly. For example, bearing down instead of pulling upward when doing Kegels can worsen postpartum issues like pelvic organ prolapse.
Practice Coordination
Before giving birth, women should check themselves in the mirror or with a finger to be sure they can contract and release their pelvic floor muscles. Learning to coordinate these muscles is key, and once the brain has mastered this technique, it will be much easier to do after delivery.
Another reason to practice during pregnancy is that after the baby’s arrival, life becomes one big learning curve, especially for first-time parents. Learning ahead of time means there’s one less thing to focus on.
Engage the Abdominals Correctly
During pregnancy, women should also learn how to correctly engage their abdominal muscles. This will help throughout the pregnancy and prevent many issues related to weakness and separation of the abdominals (diastasis recti) after birth.
Parrotta recommends that women cultivate the habit of good abdominal engagement in their daily activities, such as when lifting children or groceries.
Use the Bathroom Properly
Still a rather taboo subject in the United States, having correct bathroom posture is important—especially before and after birth.
Our common form of sitting with the legs and torso at a 90-degree angle can cause women to bear down, which presses the pelvic organs down toward the vaginal canal.
Parrotta recommends using a stepping stool or specially designed products like the Squatty Potty to elevate the knees above the hips.
Check for Diastasis Recti
An issue women commonly encounter after birth is weakness and separation of the abdominal muscles, a condition called diastasis recti. This can make her abdomen continue to protrude months after birth and may cause injury, lower back pain, and pelvic instability.
Women can do a self-check for this along the midline of the body (linea alba) by seeing how many fingers they can fit in the gap. A gap larger than two finger-widths is considered too much. A physical therapist will also check the tension of the abdominal muscles. If there is not enough tension, it may indicate weak tissue.
Don’t…Be Embarrassed to Ask for Help
Issues like urinary or fecal incontinence after birth can feel awkward to discuss, even with a doctor or physical therapist, but getting help for these problems is important.
Women should raise any concerns about symptoms such as incontinence, pelvic pressure, or pain with their doctor, and ask for a referral for physical therapy.
Exercise Too Soon
Many women feel pressure to “get their body back” soon after childbirth. However, too much, too soon can cause issues, some of which may not manifest until months or even years later.
Even something as innocuous as pushing a stroller up an incline a few weeks after birth can lead to problems. While Parrotta does not give her clients hard and fast rules, she recommends easing into exercise and making sure the core and pelvic floor muscles are able to support whatever they do.
It’s also very important to do movements correctly because incorrect form—such as bearing down during a workout—can have unintended consequences.
Believe Leaking Urine is Unavoidable
arrotta has heard from women who’ve been told by mothers, grandmothers, and even doctors that it’s normal to leak urine after giving birth. However, if you are still leaking urine six weeks postpartum, she recommends getting help. Physical therapy can do a lot to treat this, she said.
Rush to Surgery for Diastasis Recti
Parrotta has heard of some doctors who’ve told women that the only way to fix diastasis recti is with surgery.
Physical therapy can do a lot to heal the gap by helping a woman engage the deepest abdominal muscle (the transversus abdominis) in addition to more superficial muscles.
A physical therapist can also use myofascial release (a technique using gentle, targeted pressure) around the ribs to soften stiff tissues that can affect the abdomen.
Neglect Care for the Pelvis After C-section
Women who have a cesarean delivery can still have issues with their pelvic floor muscles, even though the baby did not pass through the pelvis. One sign can be pain during intercourse.
Parrotta said that the majority of her clients who’ve had C-sections have pelvic muscles that are too tight and high, which can result from the scar tissue pulling upward and together. Physical therapy can help lengthen the muscles and soften scar tissue.
http://www.theepochtimes.com/n3/2248960-the-dos-and-donts-of-post-baby-recovery/
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