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Ethicon Media Monitoring 01/27/2017
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4th Circ. Backs $3M Pelvic Mesh Verdict
Jan 26, 2017 | Law 360
By Emily Field
he Fourth Circuit on Thursday upheld a $3.27 million jury verdict handed down two years ago in a bellwether trial over Johnson & Johnson subsidiary Ethicon Inc.’s allegedly defective transvaginal pelvic mesh implants, finding that the woman who brought the suit showed sufficient evidence that the mesh caused her injuries. -
Missouri Supreme Court denies J & J's requests to delay talcum trials
Jan 26, 2017 | Seeking Alpha
By Douglas W. House
... J&J's attorneys have also been busy with a multitude of product liability lawsuits over a transvaginal mesh product, Abbrevo, marketed by its Ethicon unit. -
Endo Axing 90 Employees in Restructuring
Jan 26, 2017 | Genetic Engineering & Biotechnology News
... One key factor in the losses: Endo has laid out more than $1 billion pretax since 2015 to settle lawsuits related to its vaginal mesh implants for pelvic organ prolapse “and other litigation matters”—$931.496 million in January–September 2016, nearly double the $525.875 million shelled out during Q1–Q3 2015.
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4th Circ. Backs $3M Pelvic Mesh Verdict
Jan 26, 2017 | Law 360
By Emily Field
Law360, New York (January 26, 2017, 5:18 PM EST) -- The Fourth Circuit on Thursday upheld a $3.27 million jury verdict handed down two years ago in a bellwether trial over Johnson & Johnson subsidiary Ethicon Inc.’s allegedly defective transvaginal pelvic mesh implants, finding that the woman who brought the suit showed sufficient evidence that the mesh caused her injuries.
In a published opinion, the Fourth Circuit rejected Ethicon’s argument that Jo Huskey had failed to prove there was a specific flaw in the design of her TVT-O sling, finding that the record belied that assertion as she offered sufficient evidence for a reasonable jury to find that the company’s use of heavyweight polypropylene mesh in the sling caused her severe scarring and pelvic pain.
"We're very pleased with the ruling and excited for Jo Huskey and the team that worked on the case," Edward A. Wallace of Wexler Wallace LLP told Law360 on Thursday. "Given the length that the court went to explain its reasoning, we hope it can be used to demonstrate to Ethicon that it needs to go ahead and resolve all of these cases for all of these women."
Huskey’s expert witnesses had testified about the body’s reaction to heavyweight polypropylene. One witness was also a former Ethicon employee, Dr. Brigitte Hellhammer, who testified that she had no reason to believe that lightweight mesh couldn’t effectively treat stress urinary incontinence.
“Drawing all inferences in the Huskeys’ favor, a reasonable jury could conclude from this expert testimony that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect that caused Mrs. Huskey’s inflammation and pelvic pain,” the panel said.
Huskey sued Ethicon in 2012, claiming the polypropylene mesh in her TVT-O sling eroded, causing her severe, ongoing pain as the mesh could not be entirely removed through surgery. Her husband, Allen, also sued for loss of consortium.
The suit was the first bellwether case to go to trial in the massive multidistrict litigation against Ethicon over its mesh implants. The trial concluded on Sept. 5, 2014, with the jury deliberating for about three hours before returning its compensatory damages verdict.
U.S. Judge Joseph Goodwin solidified the jury’s verdict in August 2015, refusing to throw out the verdict as a matter of law, or alternatively to allow a new trial, finding that the plaintiffs had brought sufficient evidence that Ethicon failed to warn Huskey’s doctor of certain risks in implanting the company’s TVT-O polypropylene mesh product, and even stronger evidence that there were defects in the product’s design.
The panel also rejected Ethicon’s argument that a product liability doctrine known as “comment k” — which holds some products, such as vaccines, are unavoidably unsafe though not unreasonably dangerous — provided a shield from Huskey’s claims.
Huskey is an Illinois resident and courts in that state determine on a case-by-case basis if a specific product is covered by that doctrine, the panel noted.
Much of the same trial evidence that indicated the use of heavyweight polypropylene mesh constituted a design defect also suggested that “comment k” doesn’t shield Ethicon, the panel said.
For one, a jury could reasonably infer from Hellhammer’s testimony that if Ethicon had used a lightweight mesh, the TVT-O would have stayed effective and patients would have a lower risk of reacting to the mesh, the panel said.
“Taken together, the expert testimony allowed the jury to infer that Ethicon could have designed the TVT-O with lightweight mesh without sacrificing any performance,” the panel said.
A spokeswoman for Ethicon told Law360 that its company is reviewing its options.
" The verdict in the Huskey trial was not supported by the evidence and we believed we had strong grounds for this appeal," the spokeswoman wrote in an email Thursday. "Ethicon’s TVT-O midurethral sling was properly designed and Ethicon acted appropriately and responsibly in the research, development, and marketing of this device for the treatment of stress urinary incontinence.”
Huskey is represented by Edward A. Wallace and Mark R. Miller of Wexler Wallace LLP, Fidelma L. Fitzpatrick of Motley Rice LLC, and Jeffrey Kuntz and Adam Davis of Wagstaff & Cartmell LLP.
Ethicon and J&J are represented by Christy D. Jones of Butler Snow O'Mara Stevens & Cannada PLLC, David B. Thomas and Philip J. Combs of Thomas Combs & Spann PLLC and Charles C. Lifland, Stephen D. Brody and David K. Roberts of O’MELVENY & MYERS LLP
The case is Huskey et al. v. Ethicon Inc. et al., case number 15-2118 in the U.S. Court of Appeals for the Fourth Circuit.
--Additional reporting by Steven Trader. Editing by Kelly Duncan.https://www.law360.com/trials/articles/885170/4th-circ-backs-3m-pelvic-mesh-verdict
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Missouri Supreme Court denies J & J's requests to delay talcum trials
Jan 26, 2017 | Seeking Alpha
By Douglas W. House
Johnson & Johnson (JNJ -0.7%) has received some bad news from Missouri. The state's Supreme Court has denied its requests to delay trials over allegations that its talcum powder-based products caused some women to develop ovarian cancer. The ruling gives the green light for the next trial, set to start on February 6 in St. Louis.
Attorneys representing the company and Imerys Talc America, the talc producer, also asked the Court to deny the St. Louis Circuit Court jurisdiction over the matter since most of the plaintiffs are not residents of Missouri but that request was rejected two days ago.
Last year, St. Louis juries awarded plaintiffs $70M, $72M and $55M in three separate cases. They accused the company of suppressing and dismissing research that showed a link between the genital use of talcum powder in products like Johnson's Baby Powder and Shower to Shower and a heightened risk of developing ovarian cancer.
J&J's attorneys have also been busy with a multitude of product liability lawsuits over a transvaginal mesh product, Abbrevo, marketed by its Ethicon unit. Plaintiffs allege that the product erodes over time causing organ damage and pain. The company and fellow mesh makers Boston Scientific and C.R. Bard face over 70K personal injury cases at the federal level and thousands more at the state level
http://seekingalpha.com/news/3238023-missouri-supreme-court-denies-j-and-js-requests-delay-talcum-trials
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Endo Axing 90 Employees in Restructuring
Jan 26, 2017 | Genetic Engineering & Biotechnology News
Endo International said today it will eliminate 90 full-time positions in a restructuring designed to lower costs, increase efficiency—and bring the company back into the black following recent losses and a plunge in its stock price.
Endo said its restructuring would primarily affect its corporate and branded pharmaceutical R&D operations at its U.S. headquarters in Malvern, PA, as well as in Chestnut Ridge, NY, where Par Pharmaceutical was headquartered until it was acquired by Endo in 2015.
The restructuring, Endo said, was intended to better align those operations with its recently restructured Generics and U.S Branded Pharmaceutical business segments.
Endo acknowledged that it will incur approximately $15 million to $20 million in cash charges related to the restructuring—but expects to generate approximately $40 million to $50 million in annual pretax cost savings by the fourth quarter.
The company added that it expects to spend part of these cost savings in its core product franchises and new product development programs for both the Branded and Generics segments.
“In a competitive and challenging healthcare environment, these difficult but necessary steps are intended to best position Endo for long-term success,” Endo president and CEO Paul V. Campanelli said in a statement. “These actions will serve to strengthen our Company and permit us to provide additional support for our core franchises and development programs.”
In recent months, Endo completed a restructuring of its generics unit and in October streamlined its Global Supply Chain organization with the goal of better supporting the Branded and Generics businesses. The company also eliminated its field sales force for U.S. Branded pain drugs, and realigned the rest of the unit’s operations, while refocusing the branded segment on its specialty drug business.
Today’s announced restructuring comes 4 months after Campanelli was promoted to his current position from president of Par Pharmaceutical, now Endo's generic and OTC drugs business, which accounted for approximately 60% of Endo's total revenues through the first half of 2016.
During the third quarter of 2016, Endo shrunk its net loss from continuing operations to $191.496 million from $803.706 million from the year-ago quarter, while revenues rose 18.6% year-over-year to $884.335 million, reflecting the addition of sales from Par Pharmaceutical, which Endo acquired in 2015.
Over the first 9 months of 2017, Endo racked up $109.553 million in income from continuing operations, an improvement over the $744.108 million continuing-operations loss recorded during January–September 2015.
One key factor in the losses: Endo has laid out more than $1 billion pretax since 2015 to settle lawsuits related to its vaginal mesh implants for pelvic organ prolapse “and other litigation matters”—$931.496 million in January–September 2016, nearly double the $525.875 million shelled out during Q1–Q3 2015. In March, Endo shut down its Astora Women’s Health unit after it was unable to find a buyer
Just this week, Endo moved to resolve another controversy by settling U.S. Federal Trade Commission charges that the company entered into illegal “pay-for-delay” patent infringement settlements intended to block lower-cost generic versions of its two top-selling drugs, Opana® ER (oxymorphone hydrochloride extended release) and Lidoderm® (lidocaine patch 5%). Endo will pay no fines and admit no wrongdoing under an agreement with the FTC.
Over the past year Endo’s shares have plunged 79% to $11.89 at the closing of trading yesterday from $57.84 on January 25, 2016.
http://www.genengnews.com/gen-news-highlights/endo-axing-90-employees-in-restructuring/81253776
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