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Ethicon Media Monitoring 6/21/2018
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Hammons Prolift Case $12.8 Million Verdict Upheld
Jun 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
Patricia Hammons’ Prolift pelvic mesh trial against Ethicon, a division of Johnson & Johnson, handed her a $12.8 million jury verdict. Yesterday it survived the latest appeal filed by J&J. -
New Hampshire Lawmaker Asking FDA for Answers After 60 Minutes Report
Jun 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
A U.S. Senator from New Hampshire wants some answers from the Food and Drug Administration (FDA) following a controversial 60 Minutes report on Boston Scientific and the means it went to to secure a new supply of polypropylene (PP) from China to make its pelvic meshes. -
Boston Scientific wins bellwether pelvic mesh trial
Jun 20, 2018 | Medical Plastics News
A Massachusetts jury decided that the company was not at fault for side-effects allegedly caused by its Pinnacle Pelvic Floor Repair Kit or the Obtryx Sling System-Halo. -
Pa. court upholds $12.5 mln mesh verdict against J&J over BMS challenge
Jun 21, 2018 | Reuters
By Tina Bellon
A Pennsylvania appeals court has ruled that a recent U.S. Supreme Court decision limiting jurisdiction does not invalidate a $12.5 million jury award issued against Johnson & Johnson and its Ethicon Inc in a case alleging injuries from the companies’ transvaginal mesh. -
Products Liability/Mass Torts Winner—Kline & Specter
Jun 20, 2018 | The Legal Intelligencer
Kline & Specter had several victories last year in two major products liability/mass tort litigations docketed in the Philadelphia courts.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Hammons Prolift Case $12.8 Million Verdict Upheld
Jun 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
Patricia Hammons’ Prolift pelvic mesh trial against Ethicon, a division of Johnson & Johnson, handed her a $12.8 million jury verdict. Yesterday it survived the latest appeal filed by J&J.
Patricia Hammons was awarded $12.8 million dollars in her Pennsylvania case against Ethicon, a subsidiary of Johnson & Johnson. Of that award $7 million was in punitive damages.
On Tuesday, a state court panel refused Ethicon’s request to overturn the jury award.
The 82-page verdict, by Judge Victor P. Stabile, requires Ethicon to pay those damages to Hammons who had been implanted with a Prolift Pelvic Floor Repair kit mesh in 2009.
The Hammons trial was the first in the pelvic mesh mass tort litigation in the Philadelphia Court of Common Please. There are about 100 similar cases waiting to be heard in that venue.
Judge Stabile notes trial testimony by medical experts concluded the Prolift was defective because it was too heavy and made of plastic that can incite inflammatory responses.
At trial, Hammons’ surgeon testified if he had been adequately warned he would not have used the Prolift on Ms. Hammons. Jurors in the original trial found the Prolift was defective and the warnings to end user doctors was inadequate.
She was represented by Shanin Specter of Kline & Specter.
Ethicon immediately filed an appeal in the case.
The appeals process is not over. Ethicon can still file an appeal to the state Supreme Court.
Prolift cases have brought jury awards to plaintiffs starting with Linda Gross in New Jersey ($11.1 million) to the Kaiser case in Indiana ($35 million) in March, and $15 million in damages to New Jersey in the Hrymoc case against Ethicon.
Prolift entered the market in March 2005, even though testimony showed company doubts it was a safe and effective product. Ethicon quietly removed the polypropylene mesh from the market in mid 2012.
https://www.meshmedicaldevicenewsdesk.com/hammons-prolift-case-12-5-million-verdict-upheld/
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New Hampshire Lawmaker Asking FDA for Answers After 60 Minutes Report
Jun 20, 2018 | Mesh Medical Device News Desk
By Jane Akre
A U.S. Senator from New Hampshire wants some answers from the Food and Drug Administration (FDA) following a controversial 60 Minutes report on Boston Scientific and the means it went to to secure a new supply of polypropylene (PP) from China to make its pelvic meshes.
The report that aired May 13, (here) showed how the Massachusetts-based company, fearing it would run out raw resin for its Marlex polypropylene (PP) pelvic implants, contacted a known smuggler in China.
EMAI Plastics told company executives this was the real Marlex the company was used to using to make its Pinnacle and Obtryx meshes. But the story didn’t check out. The lot numbers didn’t match anything issued by the original supplier, Phillips Chevron, which reportedly informed Boston Scientific three times that the lot numbers on the bags from China were wrong.
“How did all this resin end up in China if it was made in Texas?” wrote a Boston Scientific compliance coordinator, internal company e-mails show.
No matter, the company executives purchased the raw PP resin and arranged for it to be smuggled into the U.S. in a way to evade U.S. customs agents.
It has been used to manufacture all of Boston Scientific’s pelvic mesh implants made from late 2012 forward.
Boston Scientific is just one of seven companies being sued by more than 104,000 women in one court in Charleston, West Virginia, making it the largest multi-district litigation since asbestos.BOSTON SCIENTIFIC REACTS
Boston Scientific replied that its plastic mesh is safe and the 60 Minutes story is “irresponsible and misleading.” The company CEO issued a videotaped press release.
“The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications,” BSC said in a statement.
Mesh News Desk covered the Boston Scientific/ Chinese smuggling issue extensively, here and here.
THE BROADCAST
In the May 13th segment, Dr. M. Tom Margolis told 60 Minutesthis is at best an experimental material.
“Implantation of this into anyone is human experiment but without consent because this is novel material. We don’t know how its effecting humans it’s never been tested before.”
“They don’t know where the material is coming from. Nobody knows who the original manufacturer is. Nobody knows and that’s a big deal right? You have to take record of every lot, was it contaminated? Has it been tested? And they don’t know any of those, any of those answers,” said plastics expert Chris DeArmitt, to 60 Minutes.
Perhaps the most startling confession within the segment was voiced by plastics engineer, Dr. Duane Priddy, who told 60 Minutes, “I can’t in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body.”
“It’s well known that it’s oxidatively unstable.” Dr. Priddy is not involved in pelvic mesh litigation.THE SENATOR’S LETTER TO FDA
In her letter to FDA administrator Scott Gottlieb, Sen. Shaheen said the PP Marlex product sourced from Chevron Phillips and the Chinese version “raise potential concerns relating to the FDA’s oversight of Boston Scientific’s production activities.”
The Senator questions the FDA’s own testing of the mesh products from China after 2012 when the FDA said “all samples met the appropriate specifications” of mesh made before.
“The claims made in this 60 Minutes report are deeply disturbing and raise important questions regarding the FDA’s oversight of this product,” says Sen. Shaheen.
“This product has led to painful experiences for many women across the country and they deserve answers about the manufacturing oversight process. Needless to say, a product this invasive should be subject to the utmost scrutiny to ensure the health and safety of the patient, both at the time of the product’s initial approval by FDA and through ongoing post-market oversight after the product is approved.”
She asks the following questions:
* When did FDA officials become aware that Boston Scientific had switched polypropylene suppliers, from Chevron Phillips Chemical Company to Chinese suppliers, and were FDA officials aware at that time that the Chevron Phillips Chemical Company had raised concerns about the use of Marlex polypropylene products in implantable medical devices?
*According to reporting from the Boston Globe, following notification of Boston Scientific’s change in polypropylene suppliers, the FDA “conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications.” Can you provide additional details on the scope of this finished product testing?
* The FDA’s response to the Boston Globe reporting indicates that “FDA concluded that the new resin does not raise new safety or effectiveness concerns.” Did the FDA obtain samples of the new polypropylene resin that was used following the supplier change and compare the physical properties of the resin itself with the Marlex polypropylene resin that was previously used to produce the device?
* The FDA’s response also suggests that in its review of the adverse event reporting database, FDA “did not find any indication that the change in resin led to an increase in adverse events.” Can you provide additional details on the types of patient circumstances that rise to the level of being included as “adverse events” for the purposes of adverse event reporting in the database?
Sen. Shaheen is the first woman in U.S. history to be elected both a U.S. Senator and Governor. She sits on the Senate Committees on Armed Services, Foreign Relations, Appropriations, and Small Business and Entrepreneurship.
https://www.meshmedicaldevicenewsdesk.com/new-hampshire-lawmaker-asking-fda-for-answers-after-60-minutes-report/
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Boston Scientific wins bellwether pelvic mesh trial
Jun 20, 2018 | Medical Plastics News
A Massachusetts jury decided that the company was not at fault for side-effects allegedly caused by its Pinnacle Pelvic Floor Repair Kit or the Obtryx Sling System-Halo.
The company was sued in 2012 by Ana Martinez who claimed Boston Scientific designed a defective product that can cause severe pain and failed to warn Martinez or her doctor about the long-term side-effects of the devices.
After surgery involving mesh, Martinez suffered from urinary incontinence, mesh erosion, and painful intercourse, according to her complaint.
Boston Scientific provided court documents and product warnings stating that mesh can fix incontinence but can also puncture organs, infections, bleeding, painful intercourse and urinary problems. The trial is the third win in Massachusetts for Boston Scientific, who has faced thousands of court cases regarding its pelvic mesh devices. The case involving Martinez was selected as a bellweather trial and could affect other cases in the US.
Boston Scientific hasn’t been as fortunate in previous cases, having to pay out $27 million to four women in 2014.
Boston Scientific was recently featured in a 60 Minutes report which unearthed claims that the company had used counterfeit plastic to produce its vaginal mesh product.
In response to the allegations, Boston Scientific stated: ““The show offered a one-sided view and commentary from clinicians and plastic experts involved with litigious actions. It is important to keep in mind that polypropylene-based (plastic) devices have been a mainstay in many medical procedures for more than 50 years, including hernia and tendon repair, sutures, and wound closure. Furthermore, our products meet rigorous internal safety standards, international standards, as well the standards of the FDA and other regulatory bodies.”
https://www.medicalplasticsnews.com/news/boston-scientific-wins-pelvic-mesh-trial/
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Pa. court upholds $12.5 mln mesh verdict against J&J over BMS challenge
Jun 21, 2018 | Reuters
By Tina Bellon
A Pennsylvania appeals court has ruled that a recent U.S. Supreme Court decision limiting jurisdiction does not invalidate a $12.5 million jury award issued against Johnson & Johnson and its Ethicon Inc in a case alleging injuries from the companies’ transvaginal mesh.
The New Jersey-based companies argued the high court’s June 2017 decision in Bristol-Myers Squibb v. Superior Court of California, which held state courts cannot hear claims against companies not based in the state when the alleged injuries did not occur there, meant Indiana resident Patricia Hammons could not sue them in Pennsylvania court.
https://www.reuters.com/article/products-ethicon/pa-court-upholds-12-5-mln-mesh-verdict-against-jj-over-bms-challenge-idUSL1N1TM2CG
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Products Liability/Mass Torts Winner—Kline & Specter
Jun 20, 2018 | The Legal Intelligencer
Kline & Specter had several victories last year in two major products liability/mass tort litigations docketed in the Philadelphia courts. These involved Risperdal, the antipsychotic drug found to be linked to gynecomastia, and vaginal mesh, a product that is surgically implanted to treat organ prolapse and urinary incontinence and that has been alleged to be defective, eroding and causing severe pain in some patients.
In one vaginal mesh case, the firm won a $57.1 million verdict, including $50 million in punitive damages, against defendant Ethicon, a Johnson & Johnson subsidiary. The firm also won a $20 million verdict against Ethicon, which included $17.5 million in punitives.
The firm also fought and won a battle to keep 120 vaginal mesh cases filed by out-of-state clients in the Philadelphia Court of Common Pleas, defeating Ethicon’s bid for removal under the U.S. Supreme Court’s landmark decision in Bristol-Myers Squibb v. Superior Court of California.
In addition, Kline & Specter successfully argued to the state Superior Court to allow for punitive damages against Janssen Pharmaceuticals, the division of Johnson & Johnson that makes Risperdal. Following arguments last year, the court held in January of this year that, when it comes to the question of whether they should be allowed to seek punitive damages at trial, plaintiffs could seek to have the law of their home state apply to their case.
Shanin Specter
What were some of the firm’s most satisfying successes in mass torts and products liability litigation in 2017, and why?
We won several large product liability verdicts in transvaginal mesh cases. We continue to litigate many product liability cases, including Risperdal and defectively designed automobiles, other machines and other products.
The U.S. Supreme Court’s decision in Bristol-Myers Squibb v. Superior Court of California has been called a game-changer for mass tort litigation. How formidable an obstacle will this ruling be for plaintiffs going forward?
In some circumstances it will force cases to trial in venues unaccustomed to product liability cases or on the home turf of the defendant. That’s a problem for some plaintiff’ firms and hence it’s a problem for those plaintiffs. We don’t worry about that as we’re used to trying and winning cases in difficult environments.
A prospective client in crisis calls and asks why your team should be retained—what is your answer?
Look at our track record. We have the most big verdicts and settlements of any Pennsylvania law firm.
What is the firm doing to ensure that future generations of litigators are ready to take the helm?
We give younger lawyers great opportunities to try cases. And they win. For example, two of our partners have won verdicts of $47 million and $57.1 million in the last year alone. Nothing is more important for a trial lawyer than simply trying and winning cases. That’s a timeless formula for success.
https://www.law.com/thelegalintelligencer/2018/06/20/products-liabilitymass-torts-winner-kline-specter/
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