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J&J Pelvic Device Gets 1st Court Test In Dallas Trial
Sep 18, 2015 | Law360
By Jess Davis
A pelvic mesh device made by Johnson & Johnson’s Ethicon Inc. unit to treat pelvic organ prolapse will get its first courtroom test on Monday, as Dallas jurors are set to hear a trial alleging the Gynecare Prosima Pelvic Floor Repair System was defectively designed. -
J&J Tries to Overturn Batiste’s $1.2 Million Verdict
Sep 20, 2015 | Mesh Medical Device News Desk
By Jane Akre
Linda Batiste was awarded $1.2 million by a Dallas jury last year as compensation for the injuries she suffered from her defective pelvic mesh implant made by Johnson & Johnson (J&J). Now the healthcare giant wants that award overturned. -
Ladies, you're not presupposed to leak whereas exercising! Ignore what CrossFit says
Sep 19, 2015 | Jackson Observer
A infamous video launched two years in the past was alleged to be a present of solidarity for ladies who leak throughout exercises. The issue is, ladies do not should leak in the event that they tackle the basis concern. Too dangerous CrossFit missed the entire level. -
Mesh outcomes linked to provider volume
Sep 18, 2015 | Urology Times
By Lisette Hilton
One in 30 women treated for stress urinary incontinence (SUI) with synthetic mesh slings might require mesh removal or revision 10 years post-SUI mesh surgery.
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J&J Pelvic Device Gets 1st Court Test In Dallas Trial
Sep 18, 2015 | Law360
By Jess Davis
A pelvic mesh device made byJohnson & Johnson’s Ethicon Inc. unit to treat pelvic organ prolapse will get its first courtroom test on Monday, as Dallas jurors are set to hear a trial alleging the Gynecare Prosima Pelvic Floor Repair System was defectively designed.
The case is a rematch of sorts for the plaintiffs’ lawyers and J&J after an April 2014 trial before the same Dallas district court judge ended in a $1.2 million verdict and a finding Ethicon’s TVT-O pelvic mesh device had been defectively designed.
Most of the litigation involving Ethicon's pelvic mesh products, including the handful of cases that have previously reached trial, focused on the TVT family of devices, used to treat stress urinary incontinence. The Prosima is a treatment for pelvic organ prolapse, which occurs when the supportive muscles and tissues of the pelvis become weak and causes the organs inside the pelvis to drop from their natural positions.
The suit claims the Prosima device was unreasonably dangerous, not reasonably safe for its intended use and that alternative and safer devices were available. The suit also claims J&J and Ethicon failed to warn patients of the dangers and risk associated with the pelvic mesh products.
Here, Law360 takes a look at what’s at issue in the suit and reviews J&J’s history of wins and losses in pelvic mesh cases around the country.
Cavness v. Kowalczyk et al.
In the trial set to begin Monday, Cavness is seeking to hold J&J and the doctor who performed her surgery, Teresa Kowalczyk, liable for what she says were serious bodily injuries that followed the April 2012 surgery where she had the Prosima device implanted.
The trial will pit some of the same plaintiffs lawyers and defense counsel against one another in the same courtroom where last year a jury found J&J defectively designed its TVT-O mesh.
Cavness filed suit in 2014, alleging after the surgery, she required a partial explant of the device, and had pain, discomfort, difficulty peeing, continued incontinence, discharge, scarring, infection, odor and bleeding. She says she incurred substantial medical bills, was unable to work for an extended period and that her marriage and emotional health also suffered.
She contends the device was unreasonably dangerous as designed and that safer alternatives were available, claiming the pelvic mesh is biologically incompatible with human tissue and promotes an immune response that leads to degradation of pelvic tissue and can contribute to severe adverse reactions. She also alleges J&J suppressed information about the product failures in other patients and continued to “mislead the public into believing that the pelvic mesh products and the procedures for implantation were safe and effective.”
Cavness is seeking damages for past and future physical pain and mental anguish, disfigurement, physical impairment, lost earning capacity and medical expenses. In pre-trial hearings, Dallas County District Judge Ken Molberg denied Ethicon’s motion for partial summary judgment on punitive damages, so Cavness will seek a punitive award, her lawyer said.
“Ms Cavness has been permanently injured, and we will show the jury the severity and life-altering effects of this mesh,” David Matthews of Matthews & Associates said Friday.
J&J, which denies liability, has argued that before pelvic mesh products were available to women who had prolapse and incontinence, other surgical options had “unacceptably high rates of recurrence” and that its Prosima device provided a more durable repair compared with other surgical options.
"We empathize with Ms. Cavness' medical situation, along 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 conditions,” spokesman Caleb Weaver said Friday.
Weaver said Prosima has been clinically demonstrated to be effective and have a low rate of post-operative complications when used with appropriate patient selection and proper surgical technique. He said the company will “vigorously defend itself,” and that the evidence will show the company “acted appropriately and responsibly in the research, development and marketing of its Prosima device.”
J&J's Mixed Record In Previous Mesh Trials
J&J and other manufacturers of pelvic mesh, including C.R. Bard Inc. and Boston Scientific Corp. have faced tens of thousands of lawsuits alleging their pelvic mesh products are defective, about 70,000 of which are consolidated in multi-district litigation in West Virginia federal court.
In 2013, a New Jersey state court ordered J&J to pay a total of $11.1 million — $7.76 of which was punitive damages — to a woman who said she was injured by a Gynecare Prolift pelvic sling.
But 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.
Judge Molberg in Dallas presided over a 12-day April 2014 trial involving TVT-O mesh. The jury in that case determined the mesh was defectively designed, but said J&J provided sufficient warning of the known risks. It awarded $1.2 million in compensatory damages, with no punitive damages. An appellate court in Dallas last week heard J&J’s argument there wasinsufficient evidence establishing the plaintiff’s injuries were caused by the TVT-O device.
The next J&J trial in federal court, involving the TVT-O device, ended in September 2014 with a $3.27 million award of compensatory damages to the plaintiff, with no punitive damages.
In March, a California state court jury awarded $5.7 million against J&J in a suit over its TVT-Abbrevo device, with $5 million of that figure coming from punitive damages.
Judge Molberg also oversaw a pelvic mesh trial against Boston Scientific Corp. in September 2014 that ended with what was at the time the largest verdict in any pelvic mesh trial -- a $73 million awarded that included $50 million in punitive damages. Judge Molberg reduced the amount of the punitive damages awarded to about $11 million and Boston Scientific has appealed the judgment.
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 and Kathleen Gallagher of Beck Redden LLP. The doctor is represented by Philipa Remington and Cathryn Paton of Thiebaud Remington Thornton Bailey LLP.
The case is Cavness v. Kowalczyk et al., case number DC-14-04220, in the 95th District Court of Dallas County, Texas. -
J&J Tries to Overturn Batiste’s $1.2 Million Verdict
Sep 20, 2015 | Mesh Medical Device News Desk
By Jane Akre
Linda Batiste was awarded $1.2 million by a Dallas jury last year as compensation for the injuries she suffered from her defective pelvic mesh implant made by Johnson & Johnson (J&J). Now the healthcare giant wants that award overturned.
The 65-year-old Batiste died from cancer last month. She never saw her compensation award which is to be paid to her family whenever J&J runs out of appeals.
Law360 reports that one of those appeals was presented before a judicial panel at the Fifth Court of Appeals in Dallas, September 16.
Attorney Stephen Brody spoke on behalf of J&J. Besides failing to establish the TVT-O mesh was defectively designed, Brody said Plaintiffs failed to prove her injuries were caused by the mesh used as a treatment for stress urinary incontinence.
Batiste had numerous health problems and J&J told jurors at trial her mesh injures were caused by previous surgeries.
Representing Batiste to the appellate panel, attorney Sarah Turman-Vedral argued the expert doctor at trial, M. Tom Margolis MD, who removed Batiste’s mesh and is considered a mesh removal specialist, testified her injuries resulted from her TVT-O implant.
The Batiste trial was the first to show the TVT-O was defectively designed. Transvaginal tape-obturator requires the polypropylene mesh to hammock the urethra and then exit through a woman’s obturator space which includes up to eight layers of muscle, ligaments and tissue.
In Huskey v. Ethicon, (here) jurors also found the TVT-O to be defectively designed. The mesh medical device remains on the market.
At trial, attorneys for Batiste showed jurors there were safer alternatives to TVT-O that could have been used by her doctor, but Brody for J&J argued on appeal Plaintiffs did not prove those meshes had less risk than TVT-O. Turman-Vedral countered some alternatives, shown to jurors, are not yet approved for use by the U.S. Food and Drug Administration.
The Batiste case was tried under Texas law which requires Plaintiffs show another product existed that was a safer alternative to the defective product used – creating a higher burden for the Plaintiff.
According to Law 360 (subscription required) here:
“Justice Bob Fillmore asked Turman-Vedral several times to point out the specific evidence that Batiste’s injuries were caused by the TVT mesh the jury found to be defective. Justice Bill Whitehill said he didn’t know how to draw a line between evidence that injuries like those Batiste suffered can result from a design defect and evidence that Batiste’s injuries were in fact caused by that defect. “The J&J argument directly echoes the directed verdict it achieved in the case of Carolyn Lewis in February 2014. See MND coverage here andhere.
At the end of the Plaintiffs’ case in Lewis, J&J asked for and received a directed verdict in its favor because of alleged failures in the Plaintiffs’ case. Brody’s letter arguing the failings of the Lewis case can be found here.
The Lewis case was also tried under Texas law, though heard before Judge Joseph Goodwin in multidistrict litigation proceedings in Charleston, WV where more than 83,000 pelvic mesh product liability lawsuits are consolidated.
Besides Brody, J&J attorneys included Charles Lifland of O’Melveny & Myers LLP and Scott Stolley of Cherry Petersen Landry & Albert LLP.
Batiste attorneys included Peter de la Cerda of Edwards & de la Cerda PLLC, Richard A. Capshaw of Capshaw & Associates, Tim Goss and Sara Turman-Vedral of Freese & Goss PLLC and David P. Matthews of Matthews and Associates.
The case is Johnson & Johnson et al. v. Batiste, case number 05-14-00864-CV, in the Texas Court of Appeals for the Fifth District. -
Ladies, you're not presupposed to leak whereas exercising! Ignore what CrossFit says
Sep 19, 2015 | Jackson Observer
A infamous video launched two years in the past was alleged to be a present of solidarity for ladies who leak throughout exercises. The issue is, ladies do not should leak in the event that they tackle the basis concern. Too dangerous CrossFit missed the entire level.
A pair years in the past, a was launched by CrossFit entitled “Do You Pee Throughout Exercises?” Host Rory McKernan opened with an instantly alarming assertion: “We’ve seen blood right now and now we see urine and that’s what it takes if you wish to be the fittest lady on the planet.”
It might seem that a minimum of one facet of those ladies’s bodily health is less than snuff if their exercises end in a puddle of urine on the ground, however McKernan and the ladies he interviews appear to seek out it amusing.
To make issues worse, a lady who claims to be a gynecologist speaks into the digital camera: “Women, in my skilled opinion as a gynecologist, it’s OK to pee throughout double-unders. I’m certainly one of them. Ten double-unders and I’m standing in a puddle. It ain’t fairly.” (A double-under is when a skipping rope passes twice beneath you for every leap.)
That is imagined to be a present of solidarity for ladies who expertise Stress Urinary Incontinence (SUI) whereas exercising. In actuality, it does ladies an awesome disservice by telling them to not fear about pelvic flooring weak spot and subsequent leakage.
states: “It’s a false impression to assume that it’s regular to have urinary leakage after childbirth. It’s a false impression to assume that there’s nothing you are able to do about urinary leakage.”
Pelvic physiotherapist Janice Taylor defined to me that there’s an appalling lack of knowledge inside North America’s medical group in terms of pelvic well being, particularly when in comparison with France, the place ladies obtain six weeks of government-funded pelvic flooring physiotherapy after childbirth. Right here, ladies are given no details about find out how to strengthen their pelvic flooring, and lots of settle for the truth that they may leak for years, notably throughout train, regardless that it’s a completely preventable drawback.
Sports activities instructors train athletes the right way to stretch, heat up, breathe into, and brace many elements of their our bodies, whereas typically neglecting their pelvic flooring, which is a weak area for each men and women. Many gyms encourage workouts corresponding to sit-ups, which Taylor believes are horrible for ladies, as it could over-strengthen the abs to the purpose of making damaging downward strain on the pelvic flooring.
Unsurprisingly, the video tries to show the issue right into a moneymaking enterprise. McKernan asks the top of Rogue Health (CrossFit’s official supplier of kit) if there’s “some type of particular product we might design for ladies with urination issues?” The reply is not any, however there are answers on the market, and that’s the place CrossFit actually missed the ball.
What can a pelvic physiotherapist do for ladies affected by SUI? :
What might have been a chance to debate an often-ignored facet of girls’s health and to be a pacesetter in educating each athletes and the general public about what could be completed for this widespread drawback was squandered as a nasty joke, made in very poor style.
In the event you’re thinking about studying extra, take a look at , or learn this text by the , written in response to the CrossFit video, that accommodates nice assets.
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Mesh outcomes linked to provider volume
Sep 18, 2015 | Urology Times
By Lisette Hilton
One in 30 women treated for stress urinary incontinence (SUI) with synthetic mesh slings might require mesh removal or revision 10 years post-SUI mesh surgery.
In addition, women who go to lower-volume surgeons have a 37% increased complication risk compared to patients whose surgeons are more experienced in the procedure, according to a new study.
These findings support the FDA’s warnings about vaginal mesh safety, write the authors, who measured the incidence of mesh removal or revision after SUI in nearly 60,000 women treated in Canada from April 1, 2002 through Dec. 31, 2012.
First author Blayne Welk, MD, MSc, of the University of Western Ontario, London, ON, found that high-volume surgeons, who were in the 75th or higher percentile of yearly mesh-based procedures, were less likely to perform a simultaneous hysterectomy, were more likely to work in an academic center, and saw the patient less frequently in the year prior to the procedure, according to the findings, which were published online in JAMA Surgery(Sept. 9, 2015).
Among the other findings: Overall, 2.2% of the women, or 1,307, had mesh removal or revision a median 0.94 years after receiving the mesh implants. Women who had their initial surgeries done by high-volume surgeons had a significantly lower risk of having surgical procedures related to removal or revision of the mesh slings.
Urologists and gynecologists in the study had similar complication rates. But multiple mesh-based SUI procedures were associated with an increased complication risk.
“This is a demonstration that the volume-outcomes relationship matters in all circumstances, not just for complex cancer surgeries requiring lengthy hospitalizations. ‘Practice makes perfect,' ” Quoc-Dien Trinh, MD, assistant professor of urology at Harvard Medical School, Boston, told Urology Times.
Dr. Trinh is co-author of an accompanying study commentary in JAMA Surgery, in which he and Christian P. Meyer, MD, research fellow at the Center for Surgery and Public Health at Harvard, wrote: “Should patients be expected to travel hundreds of miles for surgery by a designated high-volume surgeon? Similarly, if the community urologist or gynecologist is not to perform such procedures, then what are they supposed to do? A more reasonable approach to achieve quality surgical care for common procedures may come from structured proctoring and/or coaching models and from mandatory outcomes reporting.
“Although physicians may not openly welcome these initiatives, they ultimately will help to establish surgical audits and improve outcomes. In all likelihood, such programs will be mandatory in the near future and tied to reimbursements. Ultimately, we surgeons should be the drivers for change rather than wait for payers or regulators to impose punitive measures.”
Dr. Trinh said some in the field have taken a big step in launching quality improvement initiatives, including Michigan Urological Surgery Improvement Collaborative, which specifically addresses prostate cancer care.
“We need similar initiatives for the full breadth of urological procedures, including procedures for stress urinary incontinence,” he said.
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