Ethicon Media Monitoring 11/14/16

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

Online Sources

1. Pelvic Mesh Maker Denied Access to Records of Litigation Funding Intermediary

   Nov 11, 2016 | The National Law Journal

   By Max Mitchell
   
   
   A federal judge has rejected efforts by a major defendant in the nationwide transvaginal mesh litigation aimed at preserving electronic records of a company that had acted as an intermediary between potential patients and third-party litigation funders.
2. Transvaginal Mesh Complication No Respecter of Borders

   Nov 11, 2016 | Lawyers And Settlements

   By Gordon Gibb
   
   
   Transvaginal mesh problems are no respecter of borders, in that Canadian women are having just as many problems with transvaginal mesh complications as those in the US.

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

Online Sources

1. Pelvic Mesh Maker Denied Access to Records of Litigation Funding Intermediary

   Nov 11, 2016 | The National Law Journal

   By Max Mitchell

   A federal judge has rejected efforts by a major defendant in the nationwide transvaginal mesh litigation aimed at preserving electronic records of a company that had acted as an intermediary between potential patients and third-party litigation funders.

   U.S. Magistrate Judge Cheryl A. Eifert of the Southern District of West Virginia on Thursday denied American Medical System's request to create a "mirror image" of the electronic records of Surgical Assistance and its owner, Wesley Blake Barber, in an effort to preserve any records that might be relevant to the pelvic mesh litigation. That litigation focuses on claims that the transvaginal mesh products the defendants sold were unsafe, and the companies hid information about the failure rates of the devices.

   American Medical Systems, which is one of seven medical device makers facing thousands of consolidated claims in West Virginia, has accused Surgical Assistance of being involved in a third-party funding "scheme" that included tacking "kickbacks" onto surgical fees to inflate the price of potentially unnecessary corrective procedures that some of the plaintiffs may have undergone.

   In making her decision to deny American Medical System's discovery request, Eifert said that, although Barber has admitted that his company regularly purged its pelvic mesh-related records and even wiped its hard drives in February, the defendant failed to show that the information was necessary, or that the company deleted any information after it received a subpoena to preserve it.

   "While information pertinent to damages is relevant and discoverable, the materials American Medical Systems expects to recover from a forensic examination of Surgical Assistance's hard drives is not critical to the case," Eifert said. "American Medical Systems has already conducted significant discovery on the issue of third-party funding of corrective surgeries and, by putting together evidence obtained from various sources, has largely identified the participants and reconstructed the process. Further, much of the information allegedly created or maintained by Surgical Assistance included materials available from other, more convenient sources."

   According to Eifert, American Medical Systems subpoenaed Surgical Assistance, contending it compiled information about women who received mesh implants and then sold those "leads" to potential funding companies and doctors, who would then perform the potentially unnecessary revision surgeries at inflated prices.

   Barber appeared for a deposition in June. He presented a small set of materials, and said that everything else that might have been relevant to the litigation had been purged before the subpoena was issued.

   According to Eifert, Barber testified in the deposition that Surgical Assistance acted as a "middleman" between potential patients and third-party litigation funders. According to Barber's testimony, the company set up call centers, screened potential plaintiffs interested in corrective surgeries, collected medical records and helped the patients set up medical appointments. The company also helped the patients with getting loans for the procedures from third-party funders, Barber testified, according to Eifert.

   Barber further testified that the company regularly deleted files related to each case once it was done setting up the medical appointments. He further noted that the company stopped its involvement with the pelvic mesh litigation in January to focus on another business venture, and all the hard drives were wiped one month later so they could be reused, Eifert said.

   American Medical Systems then asked the court for the preservation order and to imagine the company's electronic records, saying there was a real danger of future destruction. Surgical Assistance, however, contended that the discovery would be burdensome and would potentially expose trade secrets, and that the allegation of intentional destruction of records was pure speculation.

   In denying the defendant's discovery request, Eifert said American Medical Systems had already largely outlined the role third-party funders played in the litigation, and said the defendant failed to show Surgical Assistance intentionally tried to avoid complying with the subpoenas.

   Levin Simes attorney Amy Eskin and Motley Rice attorney Fidelma Fitzpatrick, who are co-lead counsels in the MDL, did not return a call for comment. Reed Smith attorney Barbara Binis, the lead defense counsel, also did not return a call seeking comment.

   http://www.nationallawjournal.com/home/id=1202772191935/Pelvic-Mesh-Maker-Denied-Access-to-Records-of-Litigation-Funding-Intermediary?mcode=1202615432992&curindex=2&slreturn=20161014020521
   

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2. Transvaginal Mesh Complication No Respecter of Borders

   Nov 11, 2016 | Lawyers And Settlements

   By Gordon Gibb

   Seattle, WA Transvaginal mesh problems are no respecter of borders, in that Canadian women are having just as many problems with transvaginal mesh complications as those in the US. In spite of the fact Canada has a much lower population overall than the US, there are still tens of thousands of women having undergone TVT sling and transvaginal mesh procedures, with hundreds more having filed lawsuits alleging problems with the devices.
   
   Women have revealed that pain and suffering can – and is – unbearable.
   
   The situation has resulted in serious complications for the US Food and Drug Administration (FDA) in the US, which in recent years has been compelled to admit receiving thousands of adverse event reports over a three-year period ending in December, 2010. The FDA has since increased the risk classification for transvaginal mesh, and some time ago announced that it was requiring all manufacturers of TVM mesh to conduct post-market studies in an effort to determine the safety and efficacy – or lack thereof, as the case may be – of transvaginal and TVT mesh.
   
   The situation has also left the FDA, having at one time approved TVM mesh as safe and effective within acceptable risk parameters, injecting increasing amounts of caution into the conversation without actually banning the devices. To that end, the FDA is of the view that use of transvaginal mesh may not necessarily be the most appropriate response to pelvic organ prolapse (POP) when compared with more traditional procedures involving more invasive surgery.
   
   Various plaintiffs in transvaginal mesh lawsuits allege the mesh products bind to, and become entwined with organ tissue to a degree that it can’t be safely removed. There have also been allegations of sharp edges of mesh protruding through the vaginal wall having migrated from the initial insertion position and point of deployment.

   Furthermore there have been allegations of synthetic mesh material breaking down, and causing inflammation to surrounding tissue. To that end a study tabled most recently at the 36th Annual Meeting of the American Urogynecologic Society in Seattle, Washington in October last year and published this past August in the American Journal of Obstetrics & Gynecology (Volume 215, Issue 2) concluded that in women reporting TVT side effects and transvaginal mesh complication, the mesh promoted inflammation that was found to persist for a period of years following implantation.
   
   Further, noted the study, “The increase in MMP-9 in mesh explants that were removed for exposure indicates degradation; the positive association between interleukin-10 and M2 macrophages in mesh explants that are removed for pain is consistent with fibrosis.”
   
   Not good news for vaginal sling patients and transvaginal mesh recipients from both sides of the border.

   https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/tvt-sling-transvaginal-mesh-34-21839.html
   

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