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Ethicon 3/11
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Ethicon Settles Bellwether Pelvic Mesh Case Mid-Trial
Mar 10, 2015 | Law 360
By Kurt Orzeck
Johnson & Johnson subsidiary Ethicon Inc. has settled a bellwether case in multidistrict litigation over alleged transvaginal mesh injuries on the fifth day of trial, and after another jury issued a $5.7 million verdict in a related suit, an Ethicon spokesman confirmed Tuesday. -
Lawsuits Move Forward, Brought By Women Hurt By Vaginal Mesh
Mar 10, 2015 | WBUR Common Health
By Rachel Zimmerman
...Meanwhile, myriad lawsuits brought by women who say they were harmed by the mesh implants, made by a Ethicon, a subsidiary of the drug giant Johnson & Johnson, continue... -
Judge Denies Request for New Mesh Trial
Mar 10, 2015 | West Virginia Record
By Kyla Asbury
A federal judge has denied a motion requesting a reduction in punitive damages in a lawsuit against C.R. Bard Inc. for its vaginal mesh products. -
Here Is How Much Lawsuits Cost J&J Every Year
Mar 10, 2015 | Forbes
Johnson & Johnson was recently asked by a jury in the state of California to pay $5.7 million in damages to settle a lawsuit pertaining to transvaginal meshes.
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Ethicon Settles Bellwether Pelvic Mesh Case Mid-Trial
Mar 10, 2015 | Law 360
By Kurt Orzeck
Johnson & Johnson subsidiary Ethicon Inc. has settled a bellwether case in multidistrict litigation over alleged transvaginal mesh injuries on the fifth day of trial, and after another jury issued a $5.7 million verdict in a related suit, an Ethicon spokesman confirmed Tuesday.
Ethicon spokesman Matthew Johnson said the company and plaintiff Dianne M. Bellew had agreed to resolve the matter, although he declined to provide any details of the deal. On Friday, the fifth day of the trial, jurors were told the case had concluded, according to a district judge daybook entry from that day.
Bellew claimed she suffered inflammation, chronic pain and other complications as a result of a surgically implanted mesh product manufactured by Ethicon. She allegedly had four subsequent operations to remove and revise the mesh, according to court papers.
The bellwether case resides in one of seven massive MDLs assigned to U.S. District Judge Joseph R. Goodwin by the Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence, court filings said. More than 70,000 cases were consolidated into the MDLs.
Tens of thousands of plaintiffs have sued pelvic mesh makers over complications with the products, alleging the mesh, which is put in place to manage stress urinary incontinence and pelvic organ prolapse, is responsible for a litany of injuries.
In West Virginia, a federal jury in September hit Ethicon with a $3.3 million verdict over its TVT-O transvaginal sling, finding in favor of plaintiff Jo Huskey on all counts, including strict liability, design defect, failure to warn and negligence. Punitive damages were not awarded.
And other companies that make pelvic mesh products have also been hit with big-dollar verdicts by juries that sided with the plaintiffs who complained of erosion of the mesh that caused severe pain and necessitated more surgeries, among other injuries, court records show.
Boston Scientific Corp. was dinged for $73 million in September by a Texas state jury that found the company’s Obtryx-brand transvaginal sling was defectively designed and caused severe injuries, the company’s first loss in pelvic mesh litigation.
And a West Virginia judge in January refused to dismantle a $2 million verdict against C.R. Bard Inc. despite the company’s protests that the August verdict wasn’t supported by enough evidence.
But Ethicon has had some success in the pelvic mesh litigation. Earlier this month, the Fourth Circuit refused to undo the company’s win in multidistrict litigation, finding that plaintiff Carolyn Lewis hadn’t sufficiently shown that a different warning by Ethicon as to the TVT’s alleged risks would have changed her doctor’s decision to prescribe the device. Lewis had appealed a lower court’s ruling that granted summary judgment to Ethicon on her failure-to-warn claim.
A California jury on Thursday saddled Ethicon with a $5.7 million verdict, siding with a woman who claimed her doctor had given her an older, heavier version of a pelvic mesh product that will cause her a lifetime of pain. The jury awarded plaintiff Coleen Perry $700,000 in compensatory damages and $5 million in punitive damages after deliberating for three days, court records showed.
Ethicon and J&J will appeal the verdict, a spokesman for Ethicon said in a statement Thursday.
Attorneys for Bellew didn't immediately respond to requests for comment Tuesday.
Bellew is represented by Bryan F. Aylstock, Daniel Thornburgh and Renee Baggett ofAylstock Witkin Kreis and Overholtz PLC, Adam M. Slater of Mazie Slater Katz & Freeman LLC, and Benjamin H. Anderson of Anderson Law Offices LLC.
Ethicon is represented by Christy D. Jones of Butler Snow LLP and David B. Thomas ofThomas Combs & Spann PLLC.
The case is Dianne M. Bellew v. Ethicon Inc., case number 2:13-cv-22473, in the U.S. District Court for the Southern District of West Virginia at Charleston. -
Lawsuits Move Forward, Brought By Women Hurt By Vaginal Mesh
Mar 10, 2015 | WBUR Common Health
By Rachel Zimmerman
With all of the complications related to vaginal mesh — which we reported on several years ago — the influential doctors group the American College of Obstetricians and Gynecologists recently issued an article, “What Is New in the Use of Mesh in Vaginal Surgery?” offering data published in the past year on the topic.
One notable point about the implants, used to lift sagging pelvic organs back into place, is that removing a vaginal mesh implant that has been causing problems doesn’t always fix the problems. The article, by John R. Fischer, M.D. of the Department of Obstetrics and Gynecology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, says:
Complications from placement of permanent synthetic mesh for vaginal prolapse repair are well-documented, but there is little to guide physicians regarding outcomes after surgical removal of trans-vaginal mesh. This is a retrospective review of patients who underwent excision of trans-vaginal mesh owing to complications. The most common issues were pelvic and vaginal pain, mesh exposure, and a bulge sensation…After removal, 51% of patients reported complete resolution of their symptoms, with mesh exposure mostly likely to respond to treatment. Of those who presented with pain, 51% reported persistent pain after excision.
Fischer concludes: “…of the many symptoms that are treated with mesh excision, persistent pain may be the most difficult. Patients with a history of chronic pain may not be ideal candidates for the use of synthetic mesh.”
Dr. Peter Rosenblatt, Director of Urogynecology at Mount Auburn Hospital in Cambridge, Mass., says that use of the mesh implants has, indeed, gone down. In an email, he writes:
There has certainly been a decline in the use of transvaginal mesh to treat prolapse, although many pelvic reconstructive surgeons still offer this treatment to patients who are at high risk of failure from traditional surgical repair of pelvic organ prolapse. The FDA safety update in 2011 raised concerns that some of the complications that are unique to these procedures, especially erosion (or more accurately “exposure”) of the mesh through the vaginal wall, are “not rare” and that physicians needed to counsel their patients about the potential risks of using mesh. Surgeons and their patients should weigh these risks versus the potential benefits of transvaginal mesh, which includes improved anatomic success rates. There is also no question that the ubiquitous and never-ending television ads by law firms have instilled a real sense of fear and apprehension among women who are suffering with these problems.
Meanwhile, myriad lawsuits brought by women who say they were harmed by the mesh implants, made by a Ethicon, a subsidiary of the drug giant Johnson & Johnson, continue.
Earlier this month, a California jury returned a $5.7 million verdict in favor of the plaintiff in a vaginal mesh case, according to a local TV news report.
And a West Virginia jury last year awarded $3.27 million to a woman who underwent surgery to remove a vaginal mesh device, reports the National Law Journal.
Lawyers for the device maker say they are appealing,, according to their website.
In 2013, Reuters reported that a New Jersey jury said J & J should pay $3.35 million to a woman who said she suffered from years of chronic pain and 18 surgeries related to a vaginal mesh implant. From the Reuters report:
A jury…said Johnson & Johnson should pay a South Dakota woman $3.35 million for failing to adequately warn her doctor of the potential dangers of a vaginal mesh implant made by the company’s Ethicon subsidiary, and for misrepresenting the product in brochures…
The lawsuit, in state Superior Court in Atlantic City, New Jersey, was brought by Linda Gross, 47, of Watertown, South Dakota, in November 2008. It alleged that the Gyncare Prolift vaginal mesh was not safe and that J&J and Ethicon were liable, among other things, for “their defective design, manufacture, warnings and instructions.”
The Ethicon product, before being taken off the U.S. market last year, was used to treat pelvic organ collapse, a condition for which the plaintiff, a nurse, was treated in November 2008…
Gross, a nurse, filed her lawsuit after having surgery in 2006 to install a Gyncare Prolift for pelvic prolapse. She alleged the surgery led to a variety of problems, including mesh erosion, scar tissue, inflammation and “neurologic compromise to … structures and tissue.”
The report also says that in addition to the lawsuits against J & J and its Ethicon division, “about 11,000 other claims have been filed against a variety of manufacturers of vaginal mesh…The defendants in those cases are Ethicon, C.R. Bard Inc, Boston Scientific Corp, Coloplast, and Endo Health Solutions’ American Medical Systems Inc.”
In our reporting on mesh, women complained of a range of problems, including the material eroding “through the vaginal lining, causing infections and nerve damage, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and a halt to their sex lives.”
Correction: An earlier version of this story incorrectly reported the date of the New Jersey jury verdict in the vaginal mesh case there. The verdict was in 2013, not last week. We regret the error. This post was updated at 3:55 p.m.
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Judge Denies Request for New Mesh Trial
Mar 10, 2015 | West Virginia Record
By Kyla Asbury
A federal judge has denied a motion requesting a reduction in punitive damages in a lawsuit against C.R. Bard Inc. for its vaginal mesh products.
Bard had filed a motion for a new trial and a motion to reduce the $1.75 million punitive damages.
In his opinion, District Judge Joseph R. Goodwin said Bard’s arguments advanced in support of a new trial are unpersuasive.
“Crucially, none of the objections raised by Bard constitutes an error ‘so grievous as to have rendered the trial unfair,’” Goodwin’s opinion states.
On the contrary, the evidentiary decisions made during the trial ensured that the jury would hear the most probative evidence from each side without being confused and misled by superfluous and complicated testimony, according to the opinion.
Because of this, Goodwin denied the motion for a new trial and denied Bard’s subsequent requests.
The case was the first jury trial within the seven MDLs assigned to Goodwin by the Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat pelvic organ prolapse and stress urinary incontinence, according to the opinion.
“In the seven MDLs, there are more than 70,000 cases currently pending, approximately 10,000 of which are in the C.R. Bard Inc.”
This particular case concerns Donna Cisson, who was implanted with transvaginal surgical mesh—specifically, the Avaulta Plus Posterior Biosynthetic Support System manufactured by Bard to treat pelvic organ prolapse—in May 2009, and after receiving the implant, she experienced “significant mental and physical pain and suffering.”
On March 10, 2011, Cisson and her husband filed the lawsuit against Bard for various causes of action and trial began July 29, 2013.
The trial lasted 14 days and, on Aug. 15, 2013, the jury returned a verdict in favor of Cisson on her design defect and failure to warn claims.
The jury awarded Cisson $250,000 in compensatory damages and $1.75 million in punitive damages.
Goodwin stated that after the trial, he considered and denied Bard’s renewed motion for judgment as a matter of law, finding that the plaintiffs’ claims had sufficient evidentiary basis such that the jury’s verdict was reasonable under Federal Rule of Civil Procedure 50.
“In a final attempt to absolve itself of the jury’s verdict, Bard has moved for a new trial pursuant to Federal Rule of Civil Procedure 59(a)(1),” according to Goodwin’s opinion.
Anxious to submit its case to the Fourth Circuit Court of Appeals, Bard recently requested a ruling on this motion, which Goodwin denied.
Goodwin stated that Bard attempted to minimize Cisson’s physical injuries, calling them “non-life threatening,” but the court cited trial facts of Cisson’s “life-altering” pain that is “permanent in nature” as evidence of Bard’s reprehensible conduct.
Goodwin also stated that Bard’s continuous indifference and reckless disregard of the harms caused to the plaintiff — by the use of the polypropylene resin in its device even after they were warned to avoid use in human bodies — as conduct that warranted the $1.75 million punitive damage award against it.
Goodwin also denied the plaintiff’s motion that would declare Georgia’s Tort Reform Act of 1987 unconstitutional.
According to the law, 75 percent of punitive damages must be paid to Georgia’s state treasury specifically for recoveries in product liability cases.
Cission and her husband were represented by Gary B. Blasingame, Henry G. Garrard III, Andrew Judson Hill III, Leanna Bankester Pittard and Josh B. Wages of Blasingame Burch Garrard & Ashley; Paul T. Farrell Jr. of Greene Ketchum Bailey Walker Farrell & Tweel; Allison Overbay Van Laningham of Van Laningham Duncan; and Anthony J. Majestro of Powell & Majestro.
C.R. Bard is represented by Melissa Foster Bird, Taylor Tapley Daly, Matthew B. Lerner, Richard B. North Jr., Amanda Naes Shelton, Anita Wallace Thomas, Marc E. Williams and Jane T. Davis of Nelson Mullins Riley & Scarborough; Lori G. Cohen, Ronald Merrell II, Michael A. Nicodema, Daniel I.A. Smulian, Eric W. Swanis and Philip M. Hymanson of Greenberg Traurig; Marilyn Ann Moberg of Reed Smith; and Deborah A. Moeller of Shook Hardy Bacon.
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Here Is How Much Lawsuits Cost J&J Every Year
Mar 10, 2015 | Forbes
Johnson & Johnson was recently asked by a jury in the state of California to pay $5.7 million in damages to settle a lawsuit pertaining to transvaginal meshes. Less than a month ago, it was announced that Boston Scientific will pay $600 million to J&J to settle a lawsuit related to the acquisition of Guidant Corp. At the end of 2013, a court ruled that J&J will have to pay $2.5 billion in damages to settle hip implant lawsuits. While in some cases the company has won, its financial statements suggest that the net outflow of cash pertaining to litigation expenses is significant. We usually don’t price in the impact of future lawsuits while estimating future cash flows for a company, or in this case J&J, due to the unpredictable nature of court cases. However, if history were to repeat itself and the lawsuits continue, pricing their impact would imply chipping off 7% to 8% of J&J’s value. Clearly, these lawsuits are expensive. However, we believe that their incidence, and net costs may go down going forward.
Our current price estimate for Johnson & Johnson stands at $101, which is at par with the market price.
J&J’s litigation expenses have averaged roughly $1.28 billion annually, and there is a clear pattern in the lawsuits filed against the company. Most of them seem to be related its medical devices & diagnostics subsidiaries. However, J&J has been divesting its medical devices & diagnostics assets. Last year, the company sold its diagnostics unit, Ortho-Clinical Diagnostics, to the Carlyle group for around $4 billion. The divestitures may continue and this year it could be Cordis that is to go. In fact, the wheel was set in motion last year when The Wall Street Journal reported that Cordis’ sale process is at an early stage. Medical devices & diagnostics business’ growth has slowed down significantly due to strong pricing pressure and competition from lesser known names. As J&J further streamlines its operations and focuses more on growing pharmaceuticals segment, we expect medical devices related litigation expenses to reduce significantly.
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