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Ethicon Media Monitoring 3/13/2019
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Pa. Justices Won't Boot Philly Judge From Mesh Trial
Mar 12, 2019 | Law 360
By Matt Fair
The Pennsylvania Supreme Court on Tuesday rejected a Johnson & Johnson unit’s bid to have a Philadelphia County judge removed from overseeing pelvic mesh injury trials, including a case set to begin this week, based on his mother’s pending lawsuit against a separate J&J subsidiary. -
Mesh Surgery- What is a Qualifying Procedure?
Mar 13, 2019 | Mesh Medical Device News Desk
By Jane Akre
For those women with a “Mesh in Place” that is no revision, there is a way to stay in the pelvic mesh litigation.
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Pa. Justices Won't Boot Philly Judge From Mesh Trial
Mar 12, 2019 | Law 360
By Matt Fair
The Pennsylvania Supreme Court on Tuesday rejected a Johnson & Johnson unit’s bid to have a Philadelphia County judge removed from overseeing pelvic mesh injury trials, including a case set to begin this week, based on his mother’s pending lawsuit against a separate J&J subsidiary.
J&J subsidiary Ethicon Inc. told the court in an emergency petition last week that Judge Kenneth Powell had displayed an unwillingness to fully consider its arguments regarding recusal even as he continued to be assigned to oversee mesh cases as part of a mass tort program in Philadelphia County.
While Ethicon said that Judge Powell’s continued role in ongoing mesh trials allowed a buildup of “prejudice-tainted adjudications,” the justices denied the company’s bid for his recusal in a one-page order on Tuesday afternoon.
Shanin Specter, an attorney with Kline & Specter PC representing the plaintiff in the latest mesh case, slammed J&J’s conduct in a statement to Law360 on Tuesday afternoon.
“Johnson & Johnson is a bully, a felon and a mass tortfeasor,” he said. “Their contemptible motion was beyond the bounds of fair advocacy. It disparaged one of the most highly regarded trial judges in Pennsylvania and was an assault on the independence of the judiciary.”
Ethicon asked the state’s high court last Thursday to have Judge Powell removed from a case, currently undergoing jury selection in Philadelphia, over alleged defects in a mesh implant received by Blair County resident Susan McFarland to treat her urinary stress incontinence.
The case is the latest in a string of eight trials that Ethicon has faced in Philadelphia over its mesh products in recent years, six of which have resulted in damage awards against the company.
The McFarland case is set to begin anew this week after jurors deadlocked last fall on whether defects they agreed were in the mesh product had been the main factor in the woman’s injuries.
In two prior cases that Judge Powell has overseen as part of the litigation, Ethicon has asked for him to recuse himself based on the potential conflict of interest created by a lawsuit the judge has admitted his mother is pursuing against another J&J unit in Philadelphia County over injures from the anticoagulant medication Xarelto.
In both of the cases, however, the judge has denied Ethicon’s motion.
Ethicon argued to the justices that Judge Powell had shot down the recusal bids without full briefing or argument, and that he had displayed a history of nondisclosure about his mother’s case.
The company argued that Judge Powell had presided over a trial that ended in May 2017 without disclosing his mother’s claims against J&J, and that Ethicon only sought his recusal in a later case after learning about the conflict on its own.
“In the face of mandatory disclosure, nondisclosure — and particularly sustained nondisclosure — raises an appearance of impropriety,” the company said in its filing to the justices.
Attorneys on the plaintiff’s side pointed to Judge Powell’s stated belief that “his mother’s lawsuit would have no impact on his capacity to be fair and impartial.”
Ethicon’s petition to the Supreme Court comes on top of motions it has filed this month asking two other judges in Philadelphia County to consider removing Judge Powell from presiding over mesh litigation.
In the first, which was denied last Tuesday, the company said that a separate judge should hold an in camera evidentiary hearing to consider whether Judge Powell should be recused.
In the second, which remains pending, the company asked Judge Arnold New, who supervises the pelvic mesh mass tort program, to bar Judge Powell from the McFarland case and any future mesh cases.
A spokeswoman for Ethicon declined to comment.
Ethicon is represented by Kenneth Murphy, D. Alicia Hickok, Melissa Merk and William Carr of Drinker Biddle & Reath LLP, Kate Skagerberg of Beck Redden LLP, and Adam Spicer, Paul Rosenblatt and Jordan Walker of Butler Snow LLP.
The plaintiffs are represented by Tracie Palmer, Kila Baldwin, Lee Balefsky, Charles “Chip” Becker, Christine Clarke, Ruxandra Laidacker, Braden Lepisto and Elia Robertson of Kline & Specter PC.
The case is Susan McFarland v. Ethicon Inc et al., case number 20 EM 2019, before the Pennsylvania Supreme Court.https://www.law360.com/articles/1138261/pa-justices-won-t-boot-philly-judge-from-mesh-trial
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Mesh Surgery- What is a Qualifying Procedure?
Mar 13, 2019 | Mesh Medical Device News Desk
By Jane Akre
For those women with a “Mesh in Place” that is no revision, there is a way to stay in the pelvic mesh litigation.
What is a Qualifying Procedure?
Last year, a federal judge overseeing the multidistrict pelvic litigation mesh moved to dismiss hundreds of cases of women who had not undergone a Johnson & Johnson (Ethicon) mesh removal surgery.
These are known as “mesh in place” cases and Ethicon wanted them removed from the docket stating they should no longer have a claim. At its height, the federal court in Charleston, West Virginia was home to more than 104-thousand pelvic mesh cases filed against seven manufacturers.
Since 2012 when the multidistrict litigation was filed (MDL), cases have slowly been dropped from the court as they settle or go to trial.
Ethicon, which had more cases than any other manufacturer (40,545) no longer wanted to settle mesh in place cases for the products it still has on the market – the Gynecare TVT products including TVT and TVT-O, Abbrevo and TVT Exact. The J&J motion was granted by Judge Goodwin.
See Pretrial Order #293 in Ethicon MDL 2327.
Why leave a controversial mesh in place?
Some women were unable to have polypropylene pelvic mesh removed – maybe she could not undergo surgery, maybe she could not afford surgery, or maybe a doctor told her she was not a candidate for removal. Also some women with no pain initially develop complications later. Regardless, hundreds of women did not undergo mesh removal surgery.
As a result, in July Judge Joseph Goodwin dismissed 500 of those women from multidistrict litigation, leaving the door opening to refile their case if they had something called a “Qualifying Procedure.”
What is a Qualifying Procedure?
While Ethicon limited refilling a case in the MDL to “medically necessary Revision Surgery,” Judge Goodwin broadened the definition of a “revision” surgery, suggesting other qualifying procedures could substitute.
These include:Office removal of the mesh, also known as a partial removal. Many mesh surgeons do not suggest a partial removal for various reasons, largely a partial can cause more problems than it solves. An alternative to a full mesh removal would include more than one office partial revision/removal of the mesh.A revision surgery should mean removal of mesh, scar tissue, repair of fistulas and under general anesthesia, regional or MAC anesthesia.These patients also need to have accompanying treatments of trigger point injections, vaginal physical therapy, or utilization of vaginal Valium.At least six medical records need to have demonstrated the need for these therapies which must be performed by a competent, licensed physician.A litigation funding company can have no relationship with the physician or facility performing the procedure or the surgery will not be considered.Ethicon agreed that in consideration for allowing her to dismiss her case without prejudice ( it can then be refiled later) procedures must take place within five years of the date of dismissal of her case for it to be a viable case, though Ethicon adds it is not waiving any applicable statute of limitations.
Trials Ahead in the WV Court
The one remaining case from Wave 7, Ms. A. Sutphin, is scheduled to be tried in Charleston, West Virginia in April. She was implanted with a TVT-O.
Wave 10 Ethicon cases are currently being settled, remanded out of the MDL, or prepared for litigation with deadline exhausted for trial preparation by June 2019. There are 1,256 woman implanted with an Ethicon pelvic mesh currently slated for Wave 10. PTO #320, Ethicon 2327.
Ethicon Wave 11- PTO #328 – Discovery date ends in September of this year and the trials should commence shortly afterward unless the cases are settled. There are 6,557 women listed in Ethicon’s Wave 11.
Exhibit B of Wave 11 is made up of 551 women and includes cases filed against Boston Scientific, Mentor Worldwide, C.R. Bard, Coloplast, American Medical Systems, as well as Ethicon.
https://www.meshmedicaldevicenewsdesk.com/mesh-surgery-what-is-a-qualifying-procedure/
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