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Ethicon Media Monitoring 10/5/2015
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Jury Asked To Award $9.5M Damages In J&J Pelvic Mesh Case
Oct 2, 2015 | Law360
By Jess Davis
A Texas woman on Friday asked jurors to find Johnson & Johnson's Prosima pelvic mesh device was defectively designed and that the company failed to warn doctors about the device's risks, and to award $9.5 million in actual damages against J&J, in the first trial involving the device. -
Three of the four mesh procedures routinely used in Scottish hospitals will no longer be recommended
Oct 4, 2015 | Daily Record
By Marion Scott
THREE of the four mesh procedures routinely used in Scottish hospitals will no longer be recommended under a raft of new measures designed to protect patients. -
J&J PROSIMA Pelvic Mesh Case Goes to the Jury!
Oct 2, 2015 | Mesh Medical News Desk
By Jane Akre
About 3 pm Central Time, the case of Cavness v. Ethicon rested and went to a Dallas jury for deliberation. -
Study: 1-in-30 Women Develop Vaginal Mesh Complications
Oct 2, 2015 | Top Class Actions
By Joanne Szabo
Concerns are growing over the risk of serious transvaginal mesh complications. -
Management of sling complications
Oct 5, 2015 | BellaOnline
By Denise Howard
Stress urinary incontinence is a common problem that will require surgery in 1/11 women. The most popular procedure is the mid-urethra sling and its wide availability has made it possible for many women to be cured.
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Jury Asked To Award $9.5M Damages In J&J Pelvic Mesh Case
Oct 2, 2015 | Law360
By Jess Davis
A Texas woman on Friday asked jurors to find Johnson & Johnson's Prosima pelvic mesh device was defectively designed and that the company failed to warn doctors about the device's risks, and to award $9.5 million in actual damages against J&J, in the first trial involving the device.
In the Dallas County District Court case, plaintiff Carol Cavness also asked for a sizeable punitive damages award that would send J&J and its Ethicon Inc. unit a message about the Prosima device, how the company researched and marketed the device and what the company did after scientific studies showed the device carried serious complications and the risk of lifelong injury. Cavness had the Prosima device implanted in 2012 to treat pelvic organ prolapse and says she has suffered chronic pain, depression and anxiety and other medical problems related to the mesh.
"This is an epidemic," said David Matthews of Matthews & Associates, an attorney for Cavness. "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."
Matthews told jurors they should consider internal J&J documents showing that before Prosima launched, consultants the company paid as "key opinion leaders" said the Prosima device was no more effective than a surgical procedure used for decades that treated pelvic organ prolapse with natural tissue instead of mesh, but carried with it significant risks and that it would be "reckless" to launch it.
Cavness asked jurors to award $6 million for future pain and suffering, $2 million for past physical pain and mental anguish, $935,000 in future lost wages because the side effects of the surgery have made it impossible for her to continue working as an airplane mechanic, $570,000 in future medical care and $61,000 in lost wages. She also asked jurors to award punitive damages large enough to send a message to J&J to stop gambling with patient safety.
Matthews also told jurors J&J was trying to portray Cavness as "damaged goods," and that her injuries don't matter.
J&J focused its defense throughout trial and in closings not on the Prosima device itself but on the theory Cavness suffers from pelvic floor disorder and that all her injuries are attributable to a disorder that was likely caused by a muscle tear, not the mesh. It said there's no evidence Cavness had any mesh remaining in her body after an explant procedure three months after the implant.
"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."Gage told jurors Cavness tore a muscle in her pelvic floor at work — the same day that she noticed the pelvic organ prolapse that was treated with the Prosima implant days later — and that the pain she has suffered since then was never about the mesh. He suggested the doctors who have been treating Cavness had a kind of tunnel vision focused so sharply on the mesh implant as a potential source of her pain that they didn't consider alternate causes.
Gage said doctors, including the doctor that implanted the Prosima in Cavness, had plentiful warning about the potential side effects of Prosima. And he said no safer alternative design existed at the time the product was launched."It's the best thing we've got at the time," Gage said. "Yes, it's not perfect and people are going to get hurt, hopefully infrequently. This is medicine; it's not perfection."
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. -
Three of the four mesh procedures routinely used in Scottish hospitals will no longer be recommended
Oct 4, 2015 | Daily Record
By Marion Scott
THREE of the four mesh procedures routinely used in Scottish hospitals will no longer be recommended under a raft of new measures designed to protect patients.
Wholesale reform of medical procedures around mesh implants is detailed in a safety review launched after the Sunday Mail revealed hundreds of women had been left crippled and in agony after surgery.
Mesh victims who joined the Hear Our Voice campaign welcomed the findings of the review yesterday,
saying the revised guidelines will save others enduring similar torment.The expert review group launched by the Scottish Government have decided using mesh to treat pelvic organ prolapse should not be approved for patients – despite UK health watchdog the MHRA insisting the potential benefits outweigh any risks.
Procedures using implants to treat bladder problems will also no longer be recommended for routine use in Scotland.
The changes mean doctors will not be able to use mesh implants unless authorised by a multi-
disciplinary medical team.And they are being warned that they must report adverse incidents or face possible sanctions after victims claimed the scale of the problems has been hidden by doctors failing to properly record complications.
The Sunday Mail first reported the awful legacy endured by some patients in March 2013 and since then we have campaigned for action to ensure people are properly informed of the risks of mesh implants.
Many patients had to have more than a dozen further operations as surgeons tried in vain to remove mesh from their bodies.
Some were told their agony was all “in their head” while others were sent for psychological treatment rather than the surgery they needed.
The review states: “The independent review expressed serious concern that some women who had adverse events found they were not believed, adding to their distress and increasing the time before any remedial intervention could take place.”
It urges surgeons to improve their knowledge about mesh complications and their “listening and empathy” skills.
Hear Our Voice campaigner Elaine Holmes, from Newton Mearns, Glasgow, said: “We’re now confident no other woman will be left unaware of the horrific side-effects of mesh implants.
“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.
“Our aim has always been to ensure women were properly educated about these devices, something we were denied, and we believe we have achieved that.
“The review has taken many months of hard work but we believe the safety of patients is finally being placed first and foremost.”
Fellow campaigner Olive McIlroy, from Renfrew, said: “We’re also happy doctors will no longer be able turn 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.”The campaigners, who last year won an Unsung Hero gong at our Great Scot Awards, will travel to Holyrood on Tuesday to see Health Secretary Shona Robison address the public petitions committee on the mesh report.
Robison will explain why she is backing the recommendations made by the Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants.
Following completion of the final review, due at the start of next year, the Health Secretary will expect health boards to follow the new recommendations.
Robison yesterday said: “I welcome the interim report and the recommendations that it puts forward. From those initial findings, it is clear that the service which women who suffer from these conditions receive must be improved.
“It is also clear that the whole process of treating women with these distressing conditions – the clinical governance – needs to be changed.”
Despite almost 400 Scottish women facing repeated surgeries and taking legal action, just a handful of doctors reported adverse incidents to the MHRA.
Last June, former health secretary Alex Neil introduced a suspension of mesh and said he was proud
Scotland was leading the way across the world.Labour MSP Neil Findlay, who campaigned on behalf of patients, said: “These women are true heroines and I must congratulate them for their strength and determination to ensure no others suffer the injuries which have blighted their lives.
“Their tenacity has at last made doctors realise that they cannot carry out procedures on patients without fully informing them of the possible side-effects.”
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J&J PROSIMA Pelvic Mesh Case Goes to the Jury!
Oct 2, 2015 | Mesh Medical News Desk
By Jane Akre
About 3 pm Central Time, the case of Cavness v. Ethicon rested and went to a Dallas jury for deliberation. (Carol Cavness v. Kowalczyk et al., case # DC-14-04220).
The 12 jurors will have to decide if the Prosima pelvic mesh, used to treat pelvic organ prolapse, is defective in its design and its manufacture and if the manufacturer, J&J’s Ethicon division, failed to inform the end user doctors about its dangers, that is, whether it was also defective in its instructions.
Previous trials have resulted in $15.87 million in judgments against Johnson & Johnson, which makes the Prosima. J&J has vowed to continue to try these cases rather than settle, as three other mesh makers have begun doing.
JURY INSTRUCTIONS
Before Judge Molberg this morning, both sides discussed jury instructions. Among the 20 or so questions for the jury to consider, the Defense wanted to change some of the language. Defense suggested to Judge Molberg the instructions should say the Prosima is an unavoidably unsafe product because it is implanted surgically. That suggestion was overruled.
Defense wanted the jury to be told the manufacturer does not have a duty to warn the patient about the rate of severity of adverse events because the device is a prescription device. That was overruled.
Also Defense wanted the jury to consider when there is reasonable disagreement in the scientific community, it should not representat a liability for the manufacturer. That too was overruled.
BACKGROUND
The case began Monday, September 2 in the 95th Judicial District Court of Dallas County before Judge Ken Molberg who has presided over two other pelvic mesh cases, both of which resulted in jury awards for the plaintiff.
In the case of Linda Batiste, her case against Ethicon over its TVT-O, the jury found the mesh to be defective and awarded her $1.2 million. In the case of Maria Salazar, the jury found for Ms. Salazar and awarded her $74 million over her Boston Scientific pelvic mesh. That amount was later reduced to half due to a state caps on jury awards.
Friday verdicts are not uncommon and at this writing everyone is sitting in the courtroom waiting.
Cavness is represented by Tim Goss and Richard Freese of Freese & Goss PLLC, Bill Blankenship of William F. Blankenship III PC, 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 and Kathleen Gallagher of Beck Redden LLP.
Thanks goes out to Courtroom View Network for access to a live feed in the courtroom proceedings.
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Study: 1-in-30 Women Develop Vaginal Mesh Complications
Oct 2, 2015 | Top Class Actions
By Joanne Szabo
Concerns are growing over the risk of serious transvaginal mesh complications.
As transvaginal mesh lawsuits are on the rise, new research suggests that approximately one-out-of-every-30 women implanted with a vaginal bladder sling will eventually require removal or replacement.
New Transvaginal Mesh Studies
A recent study published by JAMA Surgery, a medical journal, shows that over 2 percent of women with a synthetic transvaginal mesh implant suffer from complications, which can be very serious.
The study also shows that more than three percent of these women will need to have the vaginal bladder sling either removed or replaced within ten years of the initial implantation.
Additionally, the report indicates that women who went to less experienced surgeons in the area of transvaginal mesh procedures were more likely to suffer from mesh complications than women who went to more experienced doctors.
The vaginal mesh study states that women who went to surgeons who performed a lower volume of transvaginal mesh implants had a 37 percent increased risk of suffering from transvaginal mesh complications.
The transvaginal mesh report studied data from nearly 60,000 women who had received transvaginal mesh implants to treat stress urinary incontinence (SUI).
Out of the 1,307 of the women observed in the study, or about 2.2 percent, suffered from transvaginal mesh complications. The study also found that that 3.29 percent of the women in the study had to either have their mesh removed or replaced within a 10 year period after implantation.
Transvaginal Mesh Implants
A transvaginal mesh implant is used for treating stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women who have usually undergone hysterectomy, menopause, or childbirth.
Unfortunately, the product has reportedly contributed to serious complications, such as mesh erosion and organ perforation. These complications require the sling to be removed and/or replaced for the safety of the patient.
Transvaginal insertion of these mesh implants is quicker and easier than abdominal insertion, but the serious complications associated with some of these products has caused thousands of women to file transvaginal mesh lawsuits. Hundreds of thousands of women have already had mesh products implanted and may be at risk.
Transvaginal Mesh Implant Lawsuits
In 2008, the U.S. Food and Drug Administration (FDA) reported reeiving hundreds of complaints about transvaginal mesh implant complications. By 2011, the number of transvaginal mesh complications reports increased to thousands.
In the FDA’s investigation of this issue, it was noted that there may be no additional benefits tied with transvaginal mesh implants than any other SUI treatment alternatives.
Presently, more than 70,000 women are pursuing transvaginal mesh lawsuits against the medical device manufacturers. These mesh lawsuits allege that the companies sold unreasonably dangerous and defective products, given the alleged risk of serious complications and the lack of significant benefit when compared to treatment alternatives.
Several transvaginal mesh lawsuits have already gone before juries, resulting in multi-million dollar damage awards for the plaintiffs who experienced transvaginal mesh complications.
If you or someone you know has suffered from transvaginal mesh or bladder sling complications, you may be able to file a transvaginal mesh lawsuit.
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Management of sling complications
Oct 5, 2015 | BellaOnline
By Denise Howard
Stress urinary incontinence is a common problem that will require surgery in 1/11 women. The most popular procedure is the mid-urethra sling and its wide availability has made it possible for many women to be cured. All surgeries are not successful and even in those that are, there can be some bumps in the road. So what happens if you have any of the sling complications?
First, it is important to remember that the chance of success is high, so the majority of women undergoing surgery will not have any problems. The most common problems faced after sling surgery include the inability to void completely, a urinary tract infection, failure of the procedure, mesh erosion or exposure, or subsequent voiding dysfunction. All of these can be managed with minimal long term effects.
The possibility of difficulty voiding should have been discussed before the surgery. This happens. Some women can’t void at all while others can only void partially. This usually resolves in 1-2 weeks but you should be prepared to either perform intermittent self catherization or go home with a catheter in place to continuously drain the bladder. If the issue has not resolved in 2-3 weeks at the most, then your surgeon can take you back to the surgical suite to loosen the sling. If the incomplete problem persists for much longer then the sling may need to be cut. Some women experience this incomplete voiding months and years after the procedure and removal of the sling is also a possibility.
Ideally, you will have a 100% cure after the sling surgery however this doesn’t always occur. 75% or more improvement can certainly be considered a success, especially if you have gone from leaking a lot to only losing a few drops. If, however, there is not perceptible improvement then let your doctor know as soon as possible. There is a way to go back to surgery to attempt some type of tightening but the window of opportunity is narrow.Urinary tract infections are common after bladder procedures and these are usually treated with oral antibiotics. Voiding dysfunction including urinary frequency, urgency and even urge incontinence are potential risks that cannot be avoided. If the dysfunction involves incomplete emptying then cutting or removing the sling is an option. Finally mesh erosions or exposure into the genital region are usually managed by the use of estrogen cream in postmenopausal women or cutting and burying the exposed mesh. Major complications are rare but are managed in conjunction with the appropriate clinical expert based on the scenario.
Sling surgery is an excellent option for those who suffer from stress urinary incontinence which has not responded to conservative measures. Nothing in life is free and no treatment is without risks. Take the time to choose the right provider and partner with them to make sure you fully understand the treatment recommendations, the planned procedure, the potential complications and risks as well as the postsurgical expectations.
I hope this article has provided you with information that will help you make wise choices, so you may:
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