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Ethicon Media Monitoring 09/15/16
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Plaintiff’s Loss Overturned In Boston Scientific Pelvic Mesh Lawsuit
Sep 14, 2016 | Mass Device
By Brad Perrielo
The plaintiff in the 1st pelvic mesh lawsuit to go to trial against Boston Scientific (NYSE:BSX) won a new trial yesterday when a Massachusetts appeals court overturned a 2014 verdict dismissing the case. -
Boston Scientific Pinnacle Pelvic Mesh Verdict Overturned, Plaintiff Wins New Trial
Sep 14, 2016 | Mesh Medical Device Newsdesk
A decision by a Massachusetts Appeals Court means a mesh-injured woman from Ohio will win a new trial against Boston Scientific over her Pinnacle Pelvic Floor Repair Kit pelvic mesh implant she claims caused her injuries. -
New Trial Ordered in Mass. Boston Scientific Pinnacle Transvaginal Mesh Action
Sep 14, 2016 | HarrisMartin Publishing
A Massachusetts appellate court has ordered a new trial in a Boston Scientific Pinnacle transvaginal mesh action, ruling that the trial court erred in excluding “key evidence,” namely, a material safety data sheet caution and FDA letters regarding the device’s approval. -
Napoli Shkolnik mesh cases originated at controversial mass torts marketing firm – ex firm employee
Sep 14, 2016 | Reuters
By Alison Frankel
The prominent personal injury firm Napoli Shkolnik has just surfaced in the Chapter 11 bankruptcy of Excelium Management, a corporate sister of the controversial mass torts marketing company Law Firm Headquarters.
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Plaintiff’s Loss Overturned In Boston Scientific Pelvic Mesh Lawsuit
Sep 14, 2016 | Mass Device
By Brad Perrielo
The plaintiff in the 1st pelvic mesh lawsuit to go to trial against Boston Scientific (NYSE:BSX) won a new trial yesterday when a Massachusetts appeals court overturned a 2014 verdict dismissing the case.
Diane Albright alleged that the Pinnacle mesh implanted to treat her pelvic organ prolapse was improperly designed and caused her injuries after it was implanted in 2010. In July 2014, a jury in the Middlesex County Superior Court in Woburn, Mass., found that the device was properly designed and that the medical device company gave adequate warning about risks.
Albright appealed, arguing that Judge Diane Kottmyer improperly kept the jury from hearing about a warning on the material safety data sheet for the polypropylene Boston Scientific used in the mesh that it was not suitable for permanent implantation. The appeal also argued that Kotmyer should not have excluded a pair of letters from the FDA ordering the company to launch a post-market surveillance study of the Pinnacle device and later agreeing to suspend the trial after Boston Scientific said it planned to shelve the implant, according to court documents.
Yesterday the Massachusetts Appeals Court agreed, remanding the case for reconsideration in light of its judgment that the jury should have been allowed to see the MSDS warning and the FDA letters.
“We conclude that the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that [Boston Scientific Corp.], which had received the MSDS well before 2009, had notice or knowledge of the content of the caution,” Justice Gary Katzmann wrote. “When considered solely for the purpose of demonstrating notice or the extent of BSC’s knowledge, the caution was not hearsay.
“We conclude that, in the unique context of this lengthy trial, Albright ought to have been allowed to use the letters for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial. Such a limited use, to show bias or to rebut the witness’s opinion testimony, would be reasonable cross-examination,” Katzmann wrote.
“We add that the judge would have been well within her discretion to exclude all reference to the 510(k) clearance because of its potential to mislead the jury and confuse the issues. However, having permitted BSC to invoke the 510(k) clearance, it was error to preclude Albright from using the later-in-time (2012) letters in cross-examination of BSC experts or employees, who had addressed the FDA clearance, to rebut BSC’s claim that its product was, in essence, ‘cleared’ as a safe device,” he wrote.
http://www.massdevice.com/plaintiffs-loss-overturned-boston-scientific-pelvic-mesh-lawsuit/
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Boston Scientific Pinnacle Pelvic Mesh Verdict Overturned, Plaintiff Wins New Trial
Sep 14, 2016 | Mesh Medical Device Newsdesk
A decision by a Massachusetts Appeals Court means a mesh-injured woman from Ohio will win a new trial against Boston Scientific over her Pinnacle Pelvic Floor Repair Kit pelvic meshimplant she claims caused her injuries.
Yesterday, the court overturned the 2014 verdict against Diane Albright.
The jury in her 2014 trial in Massachusetts had concluded her Pinnacle pelvic mesh was not defective and the warnings to her doctor were adequate.
See the Mesh News Desk background story here and after the verdict here. Albright was represented by Fidelma Fitzpatrick of Motley Rice.
Lawyers for Albright immediately filed an appeal.
The judge withheld from jurors the Material Safety Data Sheet (MSDS), that is a document that gives detailed information about a chemical, its properties, safety, and environmental hazards. It is designed to keep workers who handle such materials safe and is required by OSHA, the Occupational Safety and Health Association.
It has been one of the most compelling pieces of evidence plaintiffs’ attorneys have shown at trial for several different types of mesh, all made of the polymer, polypropylene.
The MSDS said that devices made from polypropylene resin are “not suitable for permanent implantation.” Pinnacle, made from polypropylene, is a permanently implanted pelvic mesh.
Judge Kottmyer also did not let jurors see two letters from the Food and Drug Administration (FDA) that ordered post approval surveillance of Pinnacle. Instead, Boston Scientific took Pinnacle off the market in a voluntary recall in May 2011, three years after it was launched.
While the jury knew that the produce was cleared, the Plaintiffs were not allowed to present evidence about what was wrong with that 510(k) application process, a process that clears mesh for sale and not based on safety. That left the jury with the impression that the product was “legal” even though the Plaintiff vigorously argued that the product was not safe and was not effective.
According to court documents printed in MassDevice:
“We conclude that the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that [Boston Scientific Corp.], which had received the MSDS well before 2009, had notice or knowledge of the content of the caution,” Justice Gary Katzmann wrote. “When considered solely for the purpose of demonstrating notice or the extent of BSC’s knowledge, the caution was not hearsay.
“We conclude that, in the unique context of this lengthy trial, Albright ought to have been allowed to use the letters for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial. Such a limited use, to show bias or to rebut the witness’s opinion testimony, would be reasonable cross-examination,” Katzmann wrote.
“We add that the judge would have been well within her discretion to exclude all reference to the 510(k) clearance because of its potential to mislead the jury and confuse the issues. However, having permitted BSC to invoke the 510(k) clearance, it was error to preclude Albright from using the later-in-time (2012) letters in cross-examination of BSC experts or employees, who had addressed the FDA clearance, to rebut BSC’s claim that its product was, in essence, ‘cleared’ as a safe device,” he weot.
http://www.meshmedicaldevicenewsdesk.com/boston-scientific-pinnacle-pelvic-mesh-verdict-overturned-plaintiff-wins-new-trial/
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New Trial Ordered in Mass. Boston Scientific Pinnacle Transvaginal Mesh Action
Sep 14, 2016 | HarrisMartin Publishing
BOSTON — A Massachusetts appellate court has ordered a new trial in a Boston Scientific Pinnacle transvaginal mesh action, ruling that the trial court erred in excluding “key evidence,” namely, a material safety data sheet caution and FDA letters regarding the device’s approval.
In a Sept. 13 opinion, the Massachusetts Appeals Court held that in barring the evidence, the trial court aided BSC’s defense and handicapped the plaintiff’s case because the evidence “added necessary context to the § 510(k) clearance" of the device.
Ohio resident Diane Albright sued Massachusetts-based Boston Scientific Corp. in the Suffolk County Superior Court, seeking damages ...
Subscription required, for full story: http://harrismartin.com/article/21335/new-trial-ordered-in-mass-boston-scientific-pinnacle-transvaginal-mesh-action/
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Napoli Shkolnik mesh cases originated at controversial mass torts marketing firm – ex firm employee
Sep 14, 2016 | Reuters
By Alison Frankel
The prominent personal injury firm Napoli Shkolnik has just surfaced in the Chapter 11 bankruptcy of Excelium Management, a corporate sister of the controversial mass torts marketing company Law Firm Headquarters.
Law Firm HQ, as I’ve reported, is trying to stave off subpoenas by American Medical Systems, a defendant in the sprawling mesh litigation. AMS contends that Law Firm HQ improperly solicited women to file mesh claims and participated in a scheme to lure mesh clients into unnecessary surgery. The marketing company has said it helped women and that AMS is merely attempting to divert attention from its own wrongdoing in mesh cases, in which tens of thousands of women allege they were injured by medical devices implanted to treat urinary incontinence and pelvic organ prolapse. Law Firm HQ’s counsel in the subpoena fight has also said Excelium’s bankruptcy is not related to that dispute.
In a newly docketed letter to U.S. Bankruptcy Judge John Olson of Miami, who is overseeing the Excelium Chapter 11, former Law Firm HQ employee Stephanie Barraco alleges that Excelium may be engaged in potential bankruptcy fraud with funds the company expects to reap indirectly from Napoli Shkolnik via an intermediary law firm.
According to Barraco, who said she worked for the company and a predecessor for three years before resigning in August, Napoli Shkolnik is co-counsel with a firm called Bramzon & Associates Specialty Litigation Attorneys on hundreds of personal injury cases. I’ve previously reported that in 2015, Lonny Bramzon took over as the sole attorney of several Washington, D.C., law firms to which Law Firm HQ referred mesh cases it originated.
Barraco’s letter asserts that funds from the Napoli firm were previously transferred to Law Firm HQ’s corporate sister, Excelium, which filed for Chapter 11 bankruptcy on Aug. 24. But according to Barraco, on Aug. 25, Law Firm HQ exec Mitch Hammer informed employees in a meeting that “upwards of two million dollars” in fees coming from Napoli through Bramzon would be redirected to a new venture formed by Hammer and another Excelium principal. That venture, Key Legal Services, was registered in Washington, D.C., on Aug. 1.
Barraco, who said in her letter that she is owed more than $3,000 in back pay, also said she does not have documents to back her account of the meeting but told the court the session was recorded by Law Firm HQ’s security cameras. In a phone interview Wednesday, Barraco told me she decided to write to the bankruptcy judge because “I don’t like that they’re plotting to reroute the funds,” she said. “I felt like, ‘I’m telling on you because you are trying to screw me over.'”
Napoli Shkolnik founder Paul Napoli emphatically denied any relationship between his firm and Excelium or Law Firm HQ. He said Napoli Shkolnik began receiving referrals from Lonny Bramzon six or seven months ago. “I have no idea where his business comes from,” Napoli said. “My understanding is that he gets cases from Internet advertising.”
Napoli said emphatically that his firm does not owe any money to Excelium, let alone the millions of dollars Barraco mentioned in her letter. He also said that Napoli Shkolnik is in the early stages of litigating cases referred by Lonny Bramzon and that “in the scheme of things,” those cases are a “not significant” portion of his firm’s docket.
Excelium’s bankruptcy counsel Paul Decailly said in an email statement that Barraco alleges “some outlandish, though legally incorrect conclusions.” The lawyer said none of Barraco’s allegations “indicate any wrongdoing or fraud, or violate any rule or law” and that neither Excelium nor the other companies mentioned in Barraco’s letter has engaged in wrongdoing.
I left messages at two different telephone numbers for Bramzon but did not immediately hear back.
The bankruptcy judge in the Excelium case has scheduled an Oct. 4 hearing on Barraco’s letter.
http://blogs.reuters.com/alison-frankel/2016/09/14/napoli-shkolnik-mesh-cases-originated-at-controversial-mass-torts-marketing-firm-ex-firm-employee/
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