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Ethicon Media Monitoring 5/12/2017
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Protest Targets J&J CEO on Day of Annual Shareholder Meeting
May 11, 2017 | New Brunswick Today
By Dave Schatz
Members of the Mesh Awareness Movement (MAM) want Johnson & Johnson’s (J&J’s) shareholders “to know they are investing in criminal behavior,” according to a statement. -
Beltz Pelvic Mesh Trial in Philadelphia- Will it be Fourth PA Court Loss for J&J?
May 11, 2017 | Mesh Medical Device Newsdesk
The case of Sharon Beltz began with jury selection Monday in the Philadelphia Court of Common Pleas, the same venue where there have been three straight losses for J&J over its transvaginal mesh, which includes $34.5 million in punitive damages -
J&J Hit With $20M Verdict in Third Pelvic Mesh Trial
May 11, 2017 | The Legal Intelligencer
By Zack Needles
Benjamin Anderson of Anderson Law Offices, Cleveland; Daniel J. Thornburgh, of Aylstock, Witkin, Kreis and Overholtz, Pensacola, Florida; Chris Gomez of Kline & Specter, Philadelphia; Martin P. Schrama and Stefanie Colella-Walsh of Stark & Stark, Princeton, New Jersey. -
Boston Scientific Prevails on Appeal on Warning Claim in Transvaginal Mesh Case
May 11, 2017 | HarrisMartin Publishing
A federal appellate court has upheld an award of summary judgment to Boston Scientific Corp. on a failure to warn claim in a transvaginal mesh action, finding the plaintiff failed to provide evidence that her implanting physician was inadequately warned of the risks.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Protest Targets J&J CEO on Day of Annual Shareholder Meeting
May 11, 2017 | New Brunswick Today
By Dave Schatz
NEW BRUNSWICK, NJ–Members of the Mesh Awareness Movement (MAM) want Johnson & Johnson’s (J&J’s) shareholders “to know they are investing in criminal behavior,” according to a statement.
The group, a grassroots effort to bring awareness to the harmful effects of mesh on the human body, held a rally against J&J in New Brunswick on April 27, during its annual meeting of shareholders.
MAM has a Facebook group that's grown from about 20 to 700 people in just a year-and-a-half, according to co-founder Tammy Jackson, who said others have contacted her but aren't keen on taking part in social media due to their attorneys' advice.
Jackson said a couple woman in the group were recently offered $189 by the pharma giant to settle their cases, but declined, while five others she knows personally accepted $4,000, and seven received $200,000, in the past six to seven months.
“It’s hard to get people so badly injured to travel across the country and stand all day,” said Jackson, a 50-year-old resident of Kentucky, and former nurse, adding she also brought chairs to the rally for some of the women.
Yet during the hour-plus meeting of shareholders inside the State Theatre, where audio was streamed live on the internet, the women held a protest outside the theatre and say they feel their voices were heard.
Their chants included:“No more mesh…”“Stop the harm, No more profits.”“You are not going to be able to hide from us.”“Profit over lives.”
Jackson has had 17 mesh removal and reconstruction surgeries over the past four years, she said.
“Trying to remove mesh out of your pelvic is like removing rebar out of concrete," said Jackson. "Your bladder is angry."
J&J says "we are nothing more than a 'cost of doing business.' We say, we are a hundred thousand severely and permanently injured people who could just as easily be your wife, mother or sister," continues MAM’s statement.
"It doesn’t matter to [J&J] that they’ll have to spend, for example, $2.5 Billion in Litigation, Verdicts, Penalties and fines because they’ve already made $25.1 Billion,” added the statement.
Jackson’s 10-year-old daughter was interviewed for a documentary about patient safety while in the Garden State with her mother and father for the rally.
She told the producers, “I would say quit making mesh and help my mommy,” according to Jackson, who said many MAM members were also interviewed for the film.
“Where's the media?” wondered one MAM member during the rally. “They need to tape this -- we should flood the TV stations.”
One journalist, Jane Akre, operates the Mesh Medical Device News Desk (MMDND), and was present for J&J's annual meeting of shareholders on the morning of April 27.
She thought the presentation to J&J's stock holders was "rehearsed" and highlighted "the health of J&J's stock," as Alex Gorsky, J&J's chief executive officer, repeated the words "sustainable" or "people come first."
Yet across the street, she writes, via an "orderly, heart-felt display," some 30 women and their families rallied.
But their signs indicated they didn't feel like they came first: “The Johnson & Johnson Credo: ‘Research must be carried on, innovative programs developed and mistakes paid for.' Pay the mesh injured for your mistake!”
“Mr. Alex Gorsky” was targeted by another sign that continued, “The highest form of ignorance is when you reject that which you know nothing about.”
A sign urged Gorsky to “Talk to the mesh injured,” while the message on another read: “#SerialKiller CEO. It’s time for you to go!”
"Each [woman] represents at least 10,000 [pelvic] mesh implanted women who can’t make it to a mesh rally, because they are too sick or broke from fighting to regain their health! And that doesn’t even begin to include the one million hernia mesh implants a year!” wrote Akre.
"All use polypropylene! Some day in the not so distant future, we may come to recognize that this cheap plastic is not an ideal, bio-compatible material for an implant, I believe."
"The legal facts have shown that [J&J] knew these mesh devices were unsafe, but they quickly put them on the market anyway... bypassing proper FDA approval, failing to conduct thorough testing and withholding serious risks and warnings,” continues MAM’s statement.
"Little did I know that [during the shareholders meeting], a Philadelphia jury was delivering the third verdict for a plaintiff in another mesh trial – $20 million, which included $17.5 million in punitive damages!"
Akre wondered whether J&J might now be considering a "multi-billion dollar global settlement" and whether "fighting mesh-injured women in court" is worth it.
The pharma giant is facing $34.5 million in punitive damages, plus other amounts awarded by juries in three separate mesh trials in Philadelphia state court, according to reports.
Akre noted that after half a decade of writing reports for MMDND, media coverage of mesh issues is gaining some traction.
"Internationally, the media is less afraid to report of Pharmaceutical Giants," she writes citing front page stories in Scotland, Australia, New Zealand and the UK, for instance.
Though Akre provided coverage of the April 27 MAM rally, she said very few reporters were there.
“It was a powerful day," said one woman who took part in the event.
"J&J had a line of buses on the other side of the street to block the view of the rally. [The company] rented those buses with money they earned from harming us,” she added, saying that she felt like J&J owned New Brunswick.
J&J did not respond to a request for comment.
http://newbrunswicktoday.com/article/protest-targets-jj-ceo-day-annual-shareholder-meeting
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Beltz Pelvic Mesh Trial in Philadelphia- Will it be Fourth PA Court Loss for J&J?
May 11, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, May 11, 2017 ~ The case of Sharon Beltz began with jury selection Monday in the Philadelphia Court of Common Pleas, the same venue where there have been three straight losses for J&J over its transvaginal mesh, which includes $34.5 million in punitive damages
Does this comport with the company’s model of “sustainability”?
The Prolift +M and TVT are the focus of the Beltz case.
In the Philadelphia Court of Common Pleas there are nearly 200 product liability cases filed naming primarily Ethicon, a division of Johnson & Johnson. A fewer number of cases name defendant Boston Scientific.
Among them is the case of Sharon Beltz, which began this week. (See Beltz etal vs Ethicon Women’s Health and Urology, Case ID: 130603835).
Beltz is suing Johnson & Johnson’s Ethicon medical device division along with Secant Medical that knits the Prolene polypropylene filaments and Prodesco, Inc of Perkasie, Pennsylvania, which did business under the fictitious name of Secant Medical. Secant Medical manufactured and sold the mesh components of the J&J pelvic mesh products.
THE COMPLAINT
On September 20, 2006, Ms. Beltz was implanted with the Ethicon Prolift +M System to treat pelvic organ prolapse as well as the TVT (tension-free vaginal tape)-O. 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.
Beltz says she has suffered permanent catastrophic injury, undergone corrective surgery, “has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including, but not limited to, obligations for medical services and expenses.”
See the Beltz Complaint.
The Complaint reminds readers that even an Ethicon sponsored study, published in the August 2010 Journal of the American College of Obstetricians and Gynecologists concluded there is a high 15.6% vaginal mesh erosion rate with Prolift. “With no difference in overall objective and subjective cure rates.”
See MND story here.
Prolift +M, and three other meshes were removed from the market by J&J in 2012. See MND story here.
The manufacturer has consistently under-reported and withheld information about the failure rate and propensity to cause injury and complications, says the complaint.
In all the defendant deceived the medical community and plaintiffs showing a “callous, reckless willful, and depraved indifference to the health, safety and welfare,” of the plaintiff.
Beltz had corrective surgery November 5, 2011 and then another revision surgery by Dr. Van Rattle.
Ms. Beltz alleges defective manufacture and design of the meshes, Common law fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express warranty, Breach of implied warranty, violation of consumer protection law, gross negligence, loss of consortium,
Beltz is represented by Kline & Specter, the same firm that has overseen a series of plaintiff wins in the same Philadelphia Court of Common Pleas. Ethicon is represented by Drinker Biddle & Reath LLP and Butler Snow, Thomas Combs & Spann and O’Melveny & Myers.
These are defective product cases which alleges the mesh was defectively manufactured and its instructions to end user doctors were insufficient. Punitive damages are allowed.
THE WITNESSES
According to sources close to the case, the first witness is Dr. Daniel Elliott, urologist from the Mayo Clinic, by video, same a the Hammons trial.
Later in the week Plaintiffs causation expert will be M Tom Margolis, MD. Dr. Margolis has been an expert medical witness in a number of mesh trials. 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.
The defense expert is Dr. Elizabeth Kavaler, MD from the Gross and Budke case.
J&J in this PA Court – A HISTORY OF LOSSES
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.
Altogether, the three cases represent $34.5 million in punitive damages, intended to punish a company. Juries decided on the punitive damages after listening to evidence from both sides.
Here is the Philadelphia Court of Common Pleas website which has 182 pelvic mesh cases listed for trial, primarily naming Ethicon Women’s Health and Urology, Johnson & Johnson. A few cases name defendant Boston Scientific, Inc.
Monday, May 15th there is a Pelvic Mesh Meeting scheduled in the Complex Litigation Center. ###
http://www.meshmedicaldevicenewsdesk.com/beltz-pelvic-mesh-trial-philadelphia-will-fourth-pa-court-loss-jj/
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J&J Hit With $20M Verdict in Third Pelvic Mesh Trial
May 11, 2017 | The Legal Intelligencer
By Zack Needles
Date of Verdict:
April 28.
Court and Case No.:
C.P. Philadelphia No. 021103888.
Judge:
Arnold L. New.
Type of Action:
Products liability.
Injuries:
Chronic pain; urinary dysfunction.
Plaintiffs Counsel:
Benjamin Anderson of Anderson Law Offices, Cleveland; Daniel J. Thornburgh, of Aylstock, Witkin, Kreis and Overholtz, Pensacola, Florida; Chris Gomez of Kline & Specter, Philadelphia; Martin P. Schrama and Stefanie Colella-Walsh of Stark & Stark, Princeton, New Jersey.
Defense Counsel:
Kenneth A. Murphy and Melissa A. Merk of Drinker Biddle & Reath, Philadelphia; Rita A. Maimbourg and Julie Callsen of Tucker Ellis, Cleveland; Nils B. Snell of Butler Snow, Fort Washington; James M. Campbell of Campbell, Campbell, Edwards & Conroy, Boston.
Plaintiffs Expert:
Dr. Bruce Rosenzweig, gynecology, Chicago.
Defense Expert:
Dr. Brian Flynn, urology, Aurora, Colorado; Janet Tomezsko, urogynecology, Skokie, Illinois.
Comment:
A 12-member Philadelphia jury handed up a $20 million verdict—including $17.5 million in punitive damages—against Johnson & Johnson subsidiary Ethicon in the third pelvic mesh case to go to trial in the city.
It was also the third multimillion-dollar plaintiff's verdict from Philadelphia's pelvic-mesh mass tort program and the latest in a line of megaverdicts against Johnson & Johnson and its subsidiaries across the country over a variety of products.
The verdict in Engleman v. Ethicon, which also included $2.5 million in compensatory damages, was awarded April 28 in the Philadelphia Court of Common Pleas to a New Jersey woman who alleged she suffered life-altering injuries when the mesh eroded inside of her.
Plaintiff Margaret "Peggy" Engleman, of Cinnaminson, New Jersey, alleged in court papers that she had Ethicon's TVT-Secur mesh implanted to help with her stress urinary incontinence, but her doctor discovered erosions in the material just two months later.
Engleman said in her pretrial memorandum that the eroding mesh began causing her pain and she was eventually forced to undergo three separate surgeries, under anesthesia, to remove the material. However, portions of the mesh remain in her body and she has developed chronic pain and urinary dysfunction, according to the memorandum.
Engleman alleged in court papers that TVT-Secur was "defective in design, warnings and instructions" and that Johnson & Johnson released the product to the public despite knowing that there was a significant risk that the mesh would erode inside patients.
Ethicon argued in its own pretrial memorandum that Engleman offered no evidence that the company "failed to warn of risks not within the common knowledge of pelvic floor surgeons."
"Under New Jersey law, a manufacturer has no duty to warn of risks that are within the common knowledge of physicians," the company said in its memorandum.
But Engleman's attorney, Benjamin Anderson of Anderson Law Offices in Cleveland, said he thought the jury turned in his client's favor when a former consultant for Johnson & Johnson learned for the first time, while being cross-examined, about an internal study circulated within the company warning of the dangers of pelvic mesh.
The jury ultimately agreed with the plaintiffs that TVT-Secur mesh was defective in design and that Ethicon failed to adequately warn of its risks.
According to Anderson, the jury unanimously found that the statute of limitations had not expired; 11 of 12 jurors found the mesh was defectively designed while 10 of 12 found that the design defect caused Engleman's injuries; the failure-to-warn verdict was unanimous, as was the failure-to-warn causation finding; 11 of 12 jurors agreed to the $2.5 million compensatory damages award; 10 of 12 agreed that punitive damages should be awarded and 11 of 12 agreed that to the amount of those damages.
"Their punitive damages award is a reflection, we believe, of how despicable this conduct was, how offensive this was," Anderson said.
An Ethicon spokeswoman said in a statement, "We believe the evidence showed Ethicon's TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff's continuing medical problems. Therefore, we are disappointed with today's verdict and feel we have strong grounds for appeal."
The verdict in Engleman came just over 14 months after a Philadelphia jury unanimously handed up an award of $3.5 million in compensatory damages and $10 million in punitive damages in Carlino v. Ethicon.
Before that, in December 2015, a jury handed up a $12.5 million award to a woman making similar claims about an Ethicon-made pelvic mesh device.
http://www.thelegalintelligencer.com/id=1202785981917/JJ-Hit-With-20M-Verdict-in-Third-Pelvic-Mesh-Trial
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Boston Scientific Prevails on Appeal on Warning Claim in Transvaginal Mesh Case
May 11, 2017 | HarrisMartin Publishing
BALTIMORE — A federal appellate court has upheld an award of summary judgment to Boston Scientific Corp. on a failure to warn claim in a transvaginal mesh action, finding the plaintiff failed to provide evidence that her implanting physician was inadequately warned of the risks.
In a May 9 opinion, the 4th Circuit U.S. Court of Appeals explained that the plaintiff failed to establish that either she or her implanting physician actually read the alleged inadequate warning in the device’s Directions For Use (DFU).
Martha Carlson was implanted with a BSC Uphold Vaginal Support System to treat her pelvic organ ...
Access to full text unavailable – subscription required. For full story:
https://harrismartin.com/article/22277/boston-scientific-prevails-on-appeal-on-warning-claim-in-transvaginal-mesh-case/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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