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1. J&J's Vaginal-Mesh Costs May Rise If $5 Million Deal Is a Guide

   Apr 6, 2016 | Bloomberg

   By Jef Freeley
   
   
   Johnson & Johnson hasn’t disclosed how much it’s set aside to cover the risk from lawsuits by women who say they were injured by vaginal-mesh inserts, or what the company has already paid to settle such cases confidentially. But a $5 million settlement recently became public, giving a glimpse of how much it could cost to resolve the claims.
2. FDA Probes Allegations of 'Counterfeit' Boston Scientific Surgical Mesh

   Apr 6, 2016 | Health Care Business Daily News

   By Thomas Dworetzky
   
   
   Boston Scientific has found itself caught in a tangled web as accusations fly over the sourcing of the resin in its vaginal mesh, which lawyers now say "should be banned outright" by the FDA.

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Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Online Sources

1. J&J's Vaginal-Mesh Costs May Rise If $5 Million Deal Is a Guide

   Apr 6, 2016 | Bloomberg

   By Jef Freeley

   Johnson & Johnson hasn’t disclosed how much it’s set aside to cover the risk from lawsuits by women who say they were injured by vaginal-mesh inserts, or what the company has already paid to settle such cases confidentially. But a $5 million settlement recently became public, giving a glimpse of how much it could cost to resolve the claims.

   The accord was made part of the public record when the plaintiff’s lawyer asked a judge to approve his legal fees in the case. While it’s just one suit -- J&J still faces more than 46,000 such cases, according to its regulatory filings -- judges in New Jersey and West Virginia are pressing the company to resolve them.

   The case that was settled “presented unique circumstances,” J&J said in an e-mailed statement. While the estimated cost of the mesh litigation isn’t broken out, “the company appropriately discloses overall litigation expenses.”

   According to a court filing in Hackensack, New Jersey, the company agreed in September to pay $5 million to settle a lawsuit with Pamela Wicker, who claimed J&J’s Ethicon unit’s Prolift mesh eroded inside her, making sex painful and forcing her to endure multiple surgeries to remove the material. Before it settled, Wicker’s suit was to be the second so-called bellwether case that would help resolve the 8,700 such claims filed in New Jersey, according to court filings. In 2013, the first bellwether ended with an $11.1 million jury verdict against J&J.‘A Bad Sign’

   “This settlement is a bad sign because it shows investors it’s going to cost a lot more to deal with this liability than people expected,” said Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia.

   While J&J paid less to settle with Wicker than it lost by going to trial in the earlier case, her pay-out looks big when compared to what J&J has been said to have paid out in other settlements. In January, Bloomberg reported that J&J agreed to pay $120 million to resolve 2,000 to 3,000 mesh-related suits, citing people with knowledge of the agreement.

   The company has had a mixed record before juries in the mesh cases. It won several cases, but had losses in Texas, California and Pennsylvania. In February, a Philadelphia jury awarded $13.5 million to another woman who said she’d also been hurt by Prolift. And the New Jersey verdict for $11.1 million was upheld last month on appeal.Pending Appeals

   “From time to time we have agreed to resolve some cases,” New Brunswick, New Jersey-based J&J said. “We will not discuss the terms of resolutions, nor discuss our ongoing litigation strategy.”

   The company is appealing the Philadelphia verdict, and still reviewing whether to contest the New Jersey decision that was upheld. J&J pared litigation expenses to $141 million in 2015, down from $1.2 billion in 2014 and $2.2 billion in 2013.

   Wicker’s lawyer, Adam Slater, detailed the $5 million payment in a Nov. 3 filing seeking a judge’s approval for his $1.65 million legal fee that will come out of the accord. He declined to comment on the settlement, which hadn’t been made public until Judge Brian Marinotti approved the request.Device Makers

   Cases related to vaginal-mesh inserts, which bolster sagging organs and treat incontinence, have multiplied since they began in 2011, with more than 100,000 suits filed against more than a half-dozen device makers.

   J&J faces the most claims, and began pulling some product lines off the market in 2012 after the U.S. Food and Drug Administration ordered manufacturers including J&J, Boston Scientific Corp. and C.R. Bard Inc. to study injury rates. While Boston Scientific and Bard have also settled some cases, they continue to fight claims and defend the products. Each has set aside more than $1 billion to deal with claims over the inserts.

   In January, FDA officials tightened regulations after finding the inserts should be classified as higher-risk products when used to shore up organs.

   The Wicker case is Wicker v. Ethicon Inc., ATL-L-6951-10, Superior Court of New Jersey, Bergen County (Hackensack). The consolidated federal case is In Re Ethicon Inc. Pelvic Repair System Products Liability Litigation, 12-MDL-2327, U.S. District Court, Southern District of West Virginia (Charleston).

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2. FDA Probes Allegations of 'Counterfeit' Boston Scientific Surgical Mesh

   Apr 6, 2016 | Health Care Business Daily News

   By Thomas Dworetzky

   Boston Scientific has found itself caught in a tangled web as accusations fly over the sourcing of the resin in its vaginal mesh, which lawyers now say "should be banned outright" by the FDA. 
   
   The Houston-based Mostyn Law recently petitioned the FDA to recall Boston Scientific’s surgical mesh products, allegedly made of defective, counterfeit material from China. It revealed excerpts from Boston Scientific emails to illustrate the lengths the company went to regarding the material and has made racketeering charges. 

   “The FDA needs to do its job and ban this outright," attorney Amber Mostyn said in a statement. “Acknowledging there is a problem is not enough. It’s like a firefighter watching a building burn while warning us not to play with matches.” 
   
   “They knew they could not verify the authenticity of this plastic resin that they found in a warehouse in China from a known counterfeiter,” Mostyn continued. “They bought it anyway and have been implanting it potentially into tens of thousands of women.” 
   
   About 55,000 women receive Boston Scientific’s pelvic mesh annually. The company has $120 million in yearly revenues from the material. 
   
   "Boston Scientific does not use “counterfeit” or “adulterated” materials in our medical devices. The company rejects the allegations in the petition to the Food and Drug Administration filed by a Texas-based law firm on March 31, 2016," the company responded in a statement. 
   
   “At Boston Scientific, patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products,” spokesman Tom Keppelertold the Boston Globe. “We don’t believe the case has merit and intend to vigorously defend these claims.” 
   
   The FDA, for its part, took a measured approach to the allegations, stating that it "is aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material," it announced in a statement on the controversy. The agency noted that "it is not uncommon for a firm, based on its own appropriate evaluation of potential suppliers and raw material, to change the source of a raw material after the device has been cleared by the FDA, and such a change often does not require FDA premarket review." 
   
   The agency is now having Boston Scientific conduct additional tests on the material, which it noted, include "chemical characterization and toxicological risk assessment of the raw material alleged to be counterfeit, as well as chemical characterization and biocompatibility of the final finished urogynecologic surgical mesh." 

   For women who have had the mesh implanted, the FDA advised that so far the data on possible risks do not warrant removal. 
   
   The FDA had "strengthened" its requirements for surgical mesh for transvaginal repair of organ prolapse in January. “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said Dr. William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.” 

   The new orders are the result of thousands of reports of complications involving the use of mesh for transvaginal organ prolapse repair received over the last few years, stated the agency. 
   
   The recent counterfeiting accusation came about, claimed the law firm, when Boston Scientific ran out of FDA-approved supplies and “started using counterfeit resin from China with no history as to when it was made, how it was made, who made it, no title, and was smuggled out” in a series of transactions “mimicking an international drug deal.” 
   
   The company then, apparently started to search the globe for a source for polypropylene resin pellets, under the brand name Marlex – the product the FDA had approved for making those implants, alleged the law firm. 
   
   It found a Chinese supplier, but the Marlex was not documented as coming from the same U.S. manufacturer. In fact, that firm later stated that there was a fake lot number on a bag of pellets from the supplier. 
   
   Boston Scientific then shipped 37,400 pounds in four shipments, sent on different dates by air and sea to "avoid detection and limit losses if confiscated by customs agents," the petition claimed. 
   
   According to the document, one email from a Boston Scientific employee in China stated that, “for this material, we have lost all of the original paperwork so we can’t prove that was legally imported in the country. And if we don’t get rid of the original bags or the writing on the bags when we claim they are from China (we have to say they are from China since we don’t have the original paperwork attached), if it is caught by custom, we will be in trouble. Therefore the shipper told me it is better to consider to re-pack all of them or find a way to get rid of all of the words/writing on the bags.” 
   
   “Desperate [Boston Scientific] staff blindly waved its shoddy product on through,” the petition stated. 

   According to Mostyn Law, "tests also showed that the Chinese resin had high levels of selenium. Selenium is not present in Marlex resin." 
   
   The Mostyn Law class-action lawsuit is believed by the firm to the first invoking the Racketeering Influenced and Corrupt Organizations Act (RICO) against a company that makes vaginal surgical mesh.
   

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