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Ethicon Media Monitoring 12/12/2018
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FDA advisory panel to mull transvaginal mesh
Dec 11, 2018 | Mass Device
By Sarah Faulkner
The FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse. -
Exiting the MDL – Arizona Woman Files TVM Case in State Court
Dec 11, 2018 | Mesh Medical Device News Desk
By Jane Akre
A woman who was significantly injured by the Solyx Transvaginal Mesh Sling has accused the sling manufacturer, Boston Scientific Corporation, of failing to warn about severe neurological injuries caused by the defective device. -
Emmett Prolift, TOT Mesh Trial Underway in Philadelphia
Dec 11, 2018 | Mesh Medical Device News Desk
By Jane Akre
After a lengthy jury selection, the case of Suzanne M. Emmett from Lancaster Pennsylvania finally got underway against Johnson & Johnson and its Ethicon medical device division. -
J&J Starts Settling Suits Over Pinnacle Hip Defect Claims
Dec 11, 2018 | Bloomberg
By Jef Feeley and Margaret Cronin Fisk
...The company is using the same tactic to resolve lawsuits over its vaginal mesh inserts.
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FDA advisory panel to mull transvaginal mesh
Dec 11, 2018 | Mass Device
By Sarah Faulkner
The FDA plans to hold an advisory committee meeting in February 2019 to discuss the safety and efficacy of surgical transvaginal mesh as a treatment for pelvic organ prolapse.
According to a document from the U.S. regulatory watchdog, the committee will be tasked with assessing the benefits and risks of placing mesh transvaginally in the anterior vaginal compartment, as well as clarifying the appropriate patient group and physician training needed for those products.
The meeting will be open to the public, the FDA said, and the agency is requesting comments.
Earlier this year, reports surfaced that Johnson & Johnson (NYSE:JNJ) tried to stop health authorities in France from publishing a report that warned against the use of untested pelvic mesh devices.
Also this year, Ireland temporarily suspended all transvaginal mesh procedures for the treatment of stress urinary incontinence or pelvic organ prolapse at Health Service Executive funded hospitals.
The country said that the suspension will stay in place “until a set of conditions to mitigate the risks of injury are met.”
Ireland’s Minister for Health, Simon Harris, said that the Department Chief Medical Officer requested the suspension following a review by the Dept. of Health, HSE and the Health Products Regulatory Agency.
https://www.massdevice.com/fda-advisory-panel-to-mull-transvaginal-mesh/
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Exiting the MDL – Arizona Woman Files TVM Case in State Court
Dec 11, 2018 | Mesh Medical Device News Desk
By Jane Akre
A woman who was significantly injured by the Solyx Transvaginal Mesh Sling has accused the sling manufacturer, Boston Scientific Corporation, of failing to warn about severe neurological injuries caused by the defective device.
The lawsuit was filed by Jamie H., a woman who was living in Arizona when she was implanted with the Solyx Sling, a transvaginal mesh device manufactured by Boston Scientific Corporation.
The transobturator sling was implanted on November 28, 2016 in Phoenix, Arizona by Dr. Daniel Jaffee, to treat stress urinary incontinence, a condition that affects up to 17% of women over age 40 as a complication of child birth.
The plaintiff has been diagnosed with pudendal neuralgia and complex regional pain syndrome (CRPS) and has undergone revision surgery of the sling by a mesh removal specialist, Dr. Michael Hibner.
Boston Scientific Corporation is accused of negligence for selling a defective medical device and failing to warn about the risk of the device.
The Solyx is called by Boston Scientific an “innovative mid-urethral sling” in that it is similar to the transobturator pathway and its attachment ends are permanently embedded into the obturator muscle. The Solyx is 9 cm in length, according to Boston Scientific.
Over 100,000 transvaginal mesh cases have been filed to date, and most of those have been pending since 2012 in federal multi-district litigation in the United States District Court for the Southern District of West Virginia. Earlier this year, the judge overseeing the litigation, Judge Joseph R. Goodwin, ordered that no new cases be filed in the MDL, allowing new plaintiffs to proceed with filing in their home states and elsewhere.
The lawsuit was filed on November 16, 2018 in Superior Court of Arizona, in the County of Maricopa (Case # CV213-014430).
The plaintiff is represented by attorney Greg Vigna, MD, JD, PLC, a national pharmaceutical injury attorney in Santa Barbara, California, and local counsel Lincoln Combs, Esq.
Greg Vigna, MD, JD, a physician and catastrophic injury attorney, represents women with pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome caused by the transobturator sling.
The Transvaginal Mesh (TVM) Multidistrict Litigation (MDL) in West Virginia is now closed to new cases. Dr. Vigna has associated with leading national pharmaceutical injury attorneys experienced in the TVM MDL, and local attorneys to prosecute new cases against the manufacturers of the device in State Courts across the country.
https://www.meshmedicaldevicenewsdesk.com/exiting-the-mdl-arizona-woman-files-tvm-case-in-state-court/
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Emmett Prolift, TOT Mesh Trial Underway in Philadelphia
Dec 11, 2018 | Mesh Medical Device News Desk
By Jane Akre
After a lengthy jury selection, the case of Suzanne M. Emmett from Lancaster Pennsylvania finally got underway against Johnson & Johnson and its Ethicon medical device division.
The case is being heard in the Philadelphia Court of Common Pleas, before Judge Emmett. [Case No. 01495].
Emmett was implanted with a Prolift mesh used to treat pelvic organ prolapse (POP) as well as a TVT-O (obturator) to treat stress urinary incontinence. They were implanted by Dr. Patricia Reddy at Pinnacle Health in Harrisburg, PA on May 14, 2007.Dr. Patricia Reddy, implanting physician
Since then she has experienced ten mesh erosions, nine revision surgeries, and several Botox injections with multiple silver nitrate applications. Prolift was removed from the market by J&J in mid 2012.
In 2008 she had corrective surgery with Dr. Vincent Lucente from Allentown, PA.
Her complaint says today she suffers permanent injury, mental and physical pain and economic loss. She still works in the insurance industry.
Ms. Emmett is represented by Kila Baldwin and Elia Robertson of Kline Specter.
Defense attorneys are Tarek Ismail, Anita Modak Truran and Joe O’Neil.
TRIAL UNDERWAY
The case opened last week Monday 3rd and called Dr. Thomas Margolis. He was questioned last week and then lawyers played the videotaped deposition of Dr. Daniel Elliot.
Dr. Margolis has served as an expert witness for plaintiffs in dozens of pelvic mesh trials.
His interview appeared on Mesh News Desk in 2011. He is considered one of the top mesh removal doctors in the country.
He told MND (here) that problems with mesh started with the invention of mesh kits, which are “ten times as bad” as the original mesh sold in sheets and cut to fit the patients.
“They were their own death knell. They were so big and problematic. They got the attention of the FDA. They took a bad idea and exploded it.” Dr. M. Tom Margolis referring to mesh makers.
Dr. Margolis, believes there are many options before surgery to correct pelvic organ problems, and that transvaginal placement of mesh introduces bacteria because it is a “clean, contaminated field.”
He has appeared as an expert at the Ebaugh trial, also heard in the Philadelphia Court of Common Pleas, Jo Huskey, Carolyn Lewis, Ana Martinez, McFarland, Beltz, Cavness, Batiste, and Ms. Perry, among others.
Dr. Daniel Elliott is a urologist with the Mayo Clinic in Rochester, MN. He told MND in 2014 that his department never used mesh kits used transvaginally.Instead, they perform standard repairs such as the anterior and posterior colporophy with absorbable stitches and not synthetic mesh. He is referring to the urology department alone, not for urogynecologists associated with Mayo,who in some cases, do use synthetic mesh implants.
Read Dr. Elliotts’ 2014 MND interview here.
In October, Ethicon filed a protective order to prevent lawyers to re-depose Dr. Patricia Reddy. Ethicon argued that since Dr. Reddy hadn’t treated Ms. Emmett since 2007.
The original deposition was conducted June 21, 2018. In it she was she was trained on a Prolift implant by Dr. Lucente at his facility in the Lehigh Valley. She was also trained on transobturator tape or TVT-O. Altogether she was trained on four Gynecare devices by Dr. Lucente.
Trials have shown that Dr. Lucente is a consultant to Johnson & Johnson and has been compensated millions in return.
During the deposition Dr. Reddy affirmed that today she would stand by her decision to use mesh to treat Ms. Emmett.
Dr. Reddy, a board certified gynecologist continues to practice medicine in York County, Pennsylvania.
https://www.meshmedicaldevicenewsdesk.com/emmett-prolift-tot-mesh-trial-underway-in-philadelphia/
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J&J Starts Settling Suits Over Pinnacle Hip Defect Claims
Dec 11, 2018 | Bloomberg
By Jef Feeley and Margaret Cronin Fisk
Johnson & Johnson has begun settling consumers’ claims that it sold artificial hips knowing they were defective, marking the first settlements in the seven-year-old litigation.
A federal judge in Texas overseeing the cases said about 3,300 of 10,000 “have settled or are in the process of settling,’’ according to a Dec. 9 court filing. Terms of the accords weren’t made public.
J&J is set to face a trial Jan. 14 in Dallas where five recipients of the Pinnacle hip will press claims that the world’s largest health-care products company failed to warn customers about the devices’ risks. A similar 2016 case produced a $1 billion verdict for multiple plaintiffs.
Mindy Tinsley, a spokeswoman for J&J’s DePuy medical device unit, which made the hips, declined to comment on the settlements. Mike Papantonio, a lawyer representing hip patients, didn’t return a call seeking comment. Mark Lanier, another attorney for hip plaintiffs, declined to comment.
Over the last two years, juries in federal court in Dallas have ordered the company to pay at least $1.7 billion in damages over the hips. Several awards, including the one for $1 billion, were later reduced or thrown out on appeal.
The hip recipients argued DePuy officials rushed the Pinnacle hips to market with little testing and misled doctors about the device’s safety profile, assuring them there was little risk of metal poisoning or tissue damage. J&J has denied these claims and said it developed and marketed the hips responsibly.
The Pinnacle devices aren’t covered by New Brunswick, New Jersey-based J&J’s $2.5 billion settlement of claims over its ASR line of artificial hips. J&J recalled 93,000 of those implants worldwide in August 2010, saying 12 percent failed within five years.
The Pinnacle lawsuits have been consolidated before U.S. District Judge Ed Kinkeade. Kinkeade, who has been overseeing the cases since 2011 and will preside over the Jan. 14 trial, said that instead of negotiating a global settlement, J&J is settling individual lawyers’ inventories of Pinnacle cases. The company is using the same tactic to resolve lawsuits over its vaginal mesh inserts.
“Defendants’ domino confidential settlements have left the court without necessary information about the total or projected value of settlement,’’ the judge wrote.
The information on the settlements came in an order by Kinkeade granting a request by plaintiffs to increase the amount of money reserved in all Pinnacle accords to cover the fees and expenses of lawyers who have been guiding the consolidated cases. The judge increased those holdbacks to 25 percent of each settlement to insure sufficient funds are available for those purposes.
The Pinnacle case is In Re DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-2244, U.S District Court, Northern District of Texas (Dallas).
https://www.bloomberg.com/news/articles/2018-12-11/j-j-starts-settling-lawsuits-over-pinnacle-hip-defect-claims
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