Ethicon 3/18

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

Online Sources

1. Mesh Autoimmune Database and Registry

   Mar 17, 2016 | Mesh Medical Device News Desk

   By Jane Akre
   
   
   Her name is Hope Pagano and you may have read her profile (here) on the pages of Mesh Medical Device News Desk.
2. J&J Patients Won $498M Verdict With Rare Scope Of Evidence

   Mar 17, 2016 | Law360

   By Sindhu Sundar
   
   
   ...The court even allowed the patients to make references to the ongoing litigation over vaginal mesh devices sold by J&J's Ethicon Inc. unit, which is not involved in the Pinnacle litigation.

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

Online Sources

1. Mesh Autoimmune Database and Registry

   Mar 17, 2016 | Mesh Medical Device News Desk

   By Jane Akre

   Her name is Hope Pagano and you may have read her profile (here) on the pages of Mesh Medical Device News Desk.

   Hope, the mother of six and wife to Steven, mentioned to her doctor she had a little incontinence.   His treatment plan was to implant an Ethicon/ Johnson & Johnson TVT-Abbrevo sling.

   Besides pain and chronic infections, following her May 13, 2011 surgery, Hope developed new symptoms.

   Within three weeks she had fever, muscle fatigue, muscle aches, headaches, sensitivity to light and sound and brain fog.  Within eight months she was diagnosed through double stranded DNA (ds-DNA) and an ANA test with full blown Lupus.

   Lupus is an autoimmune disease that means the body is  attacking itself in some form. Essentially it is fighting off a foreign invader.  See more from the Lupus Foundation of  Americahere.

   Hope Pagano wants others, who have also developed autoimmune issues following their implant, to add their names to this registry.

   “There is strength in numbers,” she says.  “Only with proof in numbers will this be taken seriously.”

   Your Mesh News Desk editor has noted about half of those she speaks to have also complained of autoimmune complaints following their mesh implant. Also too are those complaints coming forward with following a hernia implant. Also below the original story on Hope are 54 comments, many complaining of similar symptoms post-mesh.

   However, these reports are considered anecdotal and not taken seriously by science.  Hard data is taken seriously. A registry is a way to start.

   Hope suggests you add your name (below), your email, the symptoms, how soon they developed after implant (not before) and the type of mesh you have. She also notes that the women implanted with the Essure birth control (here) are also reporting the emergency of autoimmune issues following the birth control device being implanted in their fallopian tubes.

   For those of you who want to remain anonymous, use another name but include the  other important information.

   There are no plans on how to use this data other than to see how many of you emerge so a pattern can be seen, the first step in taking a complaint seriously.

   Thank you for your participation!

   PS- Be Sure to add your voice to Mesh Problems (Facebook) questionnaire as well.!

   Thank you.
   https://www.facebook.com/groups/meshproblems/permalink/1194606963903579/?qa_ref=qd

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2. J&J Patients Won $498M Verdict With Rare Scope Of Evidence

   Mar 17, 2016 | Law360

   By Sindhu Sundar

   Johnson and Johnson suffered a withering $498 million blow in the second bellwether trial in multidistrict litigation over its unit DePuy Orthopaedics' Pinnacle hip implants, an explosive outcome that attorneys say was wrought in part because of the unusually broad scope of evidence the Texas federal court allowed the patients to present.
   

   The large Thursday verdict was in favor of all five patients, who allegedly suffer from metallosis after having the implants inserted, in the consolidated trial, in which J&J filed about a dozen mistrial motions to fight the court's admission of what it argued were "highly prejudicial and inadmissible" pieces of evidence unrelated to claims about the Pinnacle Acetabular Cup System implants at issue.
   
   Attorneys say that it is generally unusual for a court to allow such a wide range of evidence about a corporate defendant, particularly evidence relating to litigation involving a completely different device. It is likely that allowing a jury to consider such a broad scope of evidence over the course of the trial's two months helped ignite a large damages verdict, they said.
   
   "It's hard to know what the judge's rationale was for allowing the door so wide open for the introduction of this kind of evidence because I think it makes it much more difficult for the defendant if you're fighting too many fronts and fighting products that aren't even at issue," said Michael Walsh of defense firm Strasburger & Price LLP.
   
   "But there's no question that this type of outcome is the reason why J&J fought it so hard — there is such a prejudicial effect," he added. 
   
   Some of the evidence the court allowed the plaintiffs to introduce included J&J and DePuy's other legal skirmishes, such as DePuy's $84.7 million deferred prosecution agreement from 2007 over its marketing of hip and knee surgical implants. The court even allowed the patients to make references to the ongoing litigation over vaginal mesh devices sold by J&J's Ethicon Inc. unit, which is not involved in the Pinnacle litigation. 
   
   DePuy's 2007 deferred prosecution agreement with the U.S. Department of Justice involved allegations that from 2000 to 2006, the company paid surgeons through consulting agreements to encourage them to use its implant devices. J&J and DePuy said this agreement was irrelevant to the claims of the five patients in the second bellwether trial, arguing that there was no evidence that the plaintiffs' doctors had been in any way involved in these alleged arrangements.
   
   But the plaintiffs shot back and said it was relevant because the revising surgeon for at least one of them was a paid consultant for the defendants under similar programs. They argued also that the marketing practices at the heart of the 2007 agreement were relevant because they demonstrated the ways DePuy allegedly influenced surgeons to use its products. 
   
   In regards to the Ethicon vaginal mesh devices, the patients argued that that evidence was relevant because one of the witnesses for J&J was an executive at the company's research and development department for medical devices who oversaw both Ethicon and DePuy. 
   
   At issue was Pam Plouhar's testimony about the quality of the products under her oversight, including her testimony that "what we do in the end contributes to better patient care." The plaintiffs argued that contrary to a rosier picture her testimony painted, J&J's units have defectively designed products, including the vaginal mesh devices from Ethicon, which is also under Plouhar's oversight and currently facing its own host of legal issues.
   
   Nonetheless, J&J has vowed to appeal the verdict, with its attorney John Beisner of Skadden Arps Slate Meagher & Flom LLP saying Thursday that the lead plaintiffs' counsel in the case, Mark Lanier, "has a history of pushing the evidentiary envelope at trial to score substantial verdicts." 
   
   The MDL was consolidated in May 2011, when the U.S. Judicial Panel on Multidistrict Litigation centralized three actions and identified 54 potential tag-along actions. There are now more than 8,000 cases in the MDL, all involving Pinnacle devices that contain sockets with metal, ceramic or polyethylene lining, according to court documents.
   
   The defendants had taken issue with this consolidation, saying that combining the claims of five different plaintiffs in the second trial was likely to bias the jury as evidence relating to one plaintiff could unfairly shade the jury's perception of DePuy's conduct with respect to the other plaintiffs.
   
   But attorney for the patients Jayne Conroy of Simmons Hanly Conroy shot back, saying that U.S. District Judge Ed Kinkeade, who is presiding over the MDL, had made the decision to consolidate more than one plaintiff in the trial as a practical matter, considering the large case docket and the importance of trying claims that are truly representative of the large pool of plaintiffs.
   
   Specifically, the defendants argued that it was unfair to lump the claims of five patients whose implantation surgeries took place at different times along the span of several years — 2004 to 2010 — as the evidence about what the company knew and the science on the devices were different depending on the time period at issue.  
   
   Conroy disputed that argument also, saying the evidence relating to the plaintiffs' injuries and warnings available during their surgeries were more or less consistent since the company had warned only of potential hypersensitivity or allergic reactions to the products, not metallosis — the condition that all five plaintiffs allegedly suffered from and that is caused by the accumulation of metal debris in the body's tissues. 
   
   Ultimately, the judge did consolidate multiple cases for the trial and allowed the large breadth of evidence, which other experts not involved in the litigation believe likely influenced the jury's view of the case. But they see that more as an indication of the strength of the arguments and evidence presented by the patients. 
   
   "J&J threw everything they could at this, every witness they had," said Max Kennerly of Kennerly Loutey LLC. "Just based on the sheer volume and substance of the evidence that the jury heard before making this decision, that makes it a really strong verdict." 
   
   The plaintiffs are represented by W. Mark Lanier of The Lanier Law Firm, Larry Boyd, Wayne Fisher and Justin Presnal of Fisher Boyd Johnson & Huguenard LLP, Richard J. Arsenault of Neblett Beard & Arsenault, and Jayne Conroy of Simmons Hanly Conroy.
   
   Johnson & Johnson and DePuy are represented by Michael V. Powell and Seth M. Roberts of Locke Lord LLP and John H. Beisner, Stephen J. Harburg, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.
   
   The five cases consolidated for trial are Aoki v. Johnson & Johnson Services et al., case number 3:13-cv-01071, Christopher et al v. Johnson & Johnson Services Inc. et al., case number 3:14-cv-01994, Greer v. DePuy Orthopaedics Inc. et al., case number 3:12-cv-1672, Klusmann et al v. DePuy Orthopaedics Inc. et al., case number 3:11-cv-02800, and Peterson et al v. Johnson & Johnson Services Inc. et al., case number 3:11-cv-01941, all in the U.S. District Court for the Northern District of Texas.
   
   The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.
   

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