Ethicon Media Monitoring 11/21/2018

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

Online Sources

1. J&J Again Asks Pa. Mesh Judge To Recuse Over Family Ties

   Nov 20, 2018 | Law 360

   By Matt Fair
   
   
   After unsuccessfully pushing the issue in another case this year, a Johnson & Johnson unit is asking a Pennsylvania judge to step aside from an upcoming pelvic mesh injury trial based on concerns that his mother was pursuing her own product liability claims against the company.
2. FDA lays out plans to improve post-market medical device oversight

   Nov 20, 2018 | Mass Device

   By Fink Densford
   
   
   The FDA today laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.
3. Medical Device Safety Action Plan: FDA Sets Measure of Success Amid Funding Issues

   Nov 21, 2018 | Regulatory Focus

   By Ana Mulero
   
   
   The US Food and Drug Administration (FDA) dropped a bombshell of a statement on Tuesday, with updates on its medical device safety action plan ranging from “an important and ambitious new goal” and a shaky road for its planned nationwide device surveillance system.

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

Online Sources

1. J&J Again Asks Pa. Mesh Judge To Recuse Over Family Ties

   Nov 20, 2018 | Law 360

   By Matt Fair

   Law360 (November 20, 2018, 8:32 PM EST) -- After unsuccessfully pushing the issue in another case this year, a Johnson & Johnson unit is asking a Pennsylvania judge to step aside from an upcoming pelvic mesh injury trial based on concerns that his mother was pursuing her own product liability claims against the company.
   
   J&J unit Ethicon argued in a motion on Monday that Judge Kenneth Powell’s role presiding over a mesh trial slated to get underway in the Philadelphia County Court of Common Pleas next week could ultimately have a direct bearing on his mother’s own case pending before the court.
   
   “Your Honor will be called on to make rulings in this case that could bear on Your Honor’s mother’s case and place Your Honor in a difficult circumstance,” the company said.
   
   Ethicon had previously asked Judge Powell to recuse in a previous mesh case he was set to preside over in July that ultimately ended in a settlement.
   
   Before the settlement, however, the judge denied the recusal bid in a one-page order without explaining his rationale.
   
   The case slated to get underway next week involves claims from Lancaster County resident Suzanne Emmet alleging that defects in a mesh implant she received in the mid-2000s to treat her stress urinary incontinence resulted in the product sawing into her vagina, causing permanent scarring and pain.
   
   Without going into specifics about the case that Ethicon said it understood Judge Powell’s mother was pursuing, the company said the matter would “address legal and evidentiary issues that are likely to be similar to the ones at issue in the upcoming trial of this matter.”
   
   According to court records, a New Jersey resident named Helen Powell — with representation from the same attorneys representing the Emmet family — is pursuing a mesh case against Ethicon.
   
   Through staff, the judge declined to comment on the matter when contacted in his chambers on Tuesday.
   
   In response to the recusal bid, attorneys for the Emmets simply pointed to the judge’s prior ruling in July denying Ethicon’s request that he step aside.
   
   “This issue was already decided in a prior transvaginal mesh case,” said Kila Baldwin, an attorney with Kline & Specter PC representing the Emmets. “We are confident we will be starting trial next week as directed by [the supervising judge] who made the trial assignment here to Judge Powell.”
   
   Baldwin did not immediately respond to questions about whether her firm was also representing Judge Powell’s mother.
   
   Judge Powell has already presided over at least one mesh-related trial against Ethicon, a case that ended with a $13.7 million verdict against the company in February 2016.
   
   A representative for Ethicon did not immediately respond to a message seeking comment.
   
   Ethicon is represented by Kenneth Murphy, D. Alicia Hickok, Melissa Merk and Molly Flynn of Drinker Biddle & Reath LLP, Joseph O’Neil of Lavin O’Neil Cedrone & DiSipio, Anita Modak-Truran of Butler Snow LLP, and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
   
   The Emmets are represented by Thomas Kline, Kila Baldwin, Elia Robertson and Thomas Bosworth of Kline & Specter PC.
   
   The case is Suzanne Emmet et al. v. Ethicon Inc. et al., case number 130701495, before the Court of Common Pleas of Philadelphia County, Pennsylvania.

   https://www.law360.com/legalethics/articles/1103936/j-j-again-asks-pa-mesh-judge-to-recuse-over-family-ties
   

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2. FDA lays out plans to improve post-market medical device oversight

   Nov 20, 2018 | Mass Device

   By Fink Densford

   The FDA today laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.

   In an official posting, FDA head Dr. Scott Gottliebb and FDA Center for Devices and Radiological Health head Dr. Jeff Shuren laid out plans that they, and the agency, hope will address safety concerns that emerge after new devices hit the market and that will improve general overall safety in medical devices.

   To begin, the FDA said that it set an “ambitious new goal” in device safety: Ensuring that the FDA is consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices.

   The federal watchdog said that to attain this goal it will move beyond its existing post-market surveillance system, which it said is “largely passive and relies on device users to report problems to us,” into a new active surveillance system.

   The new system, which will operate around the FDA’s unique device identification system, will rely on real-world evidence and the “timely receipt” of safety information in an attempt to eliminate weaknesses inherent with the passive system, the FDA wrote.

   The agency said that as part of the development of a better post-market system, it is investing more resources in developing its National Evaluation System for health Technology, or NEST.

   “We’re now committing new resources to NEST to advance a more rapid build-out of this system,” FDA heads wrote in their posting. “In some cases, we already are receiving clinical evidence more quickly and more efficiently and are answering post-market questions we would not have been able to easily address in the past. NEST also will provide another source of information for medical device manufacturers to assess the safety and effectiveness of their devices and continue to develop innovative improvements. Importantly, it will help health care providers and patients stay better informed about the evolving benefit-risk profile of devices on the market and enable them to make more informed decisions.”

   The FDA said that to succeed in being the first in the world in terms of device safety will “rest in part on our ability to fully leverage NEST as an active surveillance and evaluation system.”

   The agency added that it has already “made strides” towards this endgame, having provided seed funding for the NEST coordinating center, or NESTcc, which now has agreements with 12 organizations representing more than 195 hospitals and nearly 4,000 outpatient clinics with access to 495 million patient records.

   Despite the strides, NEST will require “considerably more funding to fully meet its tremendous potential,” the group said, adding that it invested $3 million into NESTcc in September.

   To meet those needs fully, the agency said that the President’s budget for the fiscal year 2019 includes a request for an additional $46 million for CDRH to support NEST, as well as for post-market studies to address device-specific safety concerns.

   “If this funding becomes a reality, the FDA will continue to work with stakeholders to help make NEST financially self-sustaining in the long term,” the FDA wrote.

   The federal watchdog said that it will also continue to develop its Coordinated Registry Networks, with a focus on devices designed to treat women’s health issues. The FDA said that it is partnering with the American College of Obstetricians and Gynecologists, the American Urogynecologic Society, the National Library of Medicine on what it calls the Women’s Health Technologies CRN, or WHT-CRN, having targeted part of the additional $3 million in funding for NESTcc specifically for the product.

   So far, the project has developed core data sets in four clinical areas – stress urinary incontinence, pelvic floor disorders, uterine fibroids and long-acting reversible contraception and sterilization therapies, the FDA said.

   The next step in the project includes an implementation guide for participating registries to better extract clinical data, and assessing the feasibility of using EHRs to study meshes, the FDA wrote. It also announced the launch of an advisory committee meeting on February 12 looking to discuss the safety and efficacy of surgical meshes for treating transvaginal pelvic organ prolapse.

   A separate project, launched in September, will look to evaluate real-world data on the safety and performance of breast implants, the agency said.

   The agency added that it plans to unveil new actions intended to “fundamentally modernize” medical device review, particularly the 510(k) process, next week.

   “Ensuring the safety of medical devices on an ongoing basis requires a multi-layered effort. One element of this system is a vigilant post-market surveillance system for quick identification and evaluation of new or increased safety concerns. Robust oversight of safety also requires, timely public communication about safety issues and effective interventions to address concerns. The FDA also must foster innovation that spurs the development of safer, more effective technologies and assures timely patient access,” FDA heads wrote in the posting. “Doing all of these things, and more, will enable us to improve the safety, health and quality of life of patients and enable decision-making based on the best available evidence about medical devices.”

   Medtech industry group AdvaMed lauded the move from the FDA, with head Scott Whitaker calling the plan a “positive step.”

   “Patient safety is the number one priority of the medical technology industry, and we are always willing to look at new ways of ensuring patient safety — whether on the regulatory end with FDA, or on the manufacturing and distribution side with new tools for monitoring and preventing adverse events. This is a collective effort, and one we can continually improve when we work together. FDA’s latest updates to its Medical Device Safety Action Plan are another positive step in this collective effort, and we’re ready to work with the agency and other stakeholders on ways to support the continued safety and effectiveness of medical devices,” Whitaker wrote in an AdvaMed release posted today. “While we’re still reviewing the details of FDA’s updated Safety Plan, industry has long supported many of the programs highlighted, including development of the  National Evaluation System for health Technology to more efficiently generate better evidence on device performance and deployment of a unique device identification system to ensure companies can effectively identify their products through their distribution and use while ensuring patient access to the most innovative, life-saving technologies.”

   https://www.massdevice.com/fda-lays-out-plans-to-improve-post-market-medical-device-oversight/
   

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3. Medical Device Safety Action Plan: FDA Sets Measure of Success Amid Funding Issues

   Nov 21, 2018 | Regulatory Focus

   By Ana Mulero

   The US Food and Drug Administration (FDA) dropped a bombshell of a statement on Tuesday, with updates on its medical device safety action plan ranging from “an important and ambitious new goal” and a shaky road for its planned nationwide device surveillance system.
    
   The new goal to propel the safety action plan—released in April—is centered around ensuring that the agency is “consistently first among the world’s regulatory agencies to identify and act upon safety signals related to medical devices,” FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said in the statement.
    
   The agency prioritized regulatory reforms to shift away from a passive approach toward an active surveillance system as it has come under increasing pressure to reform its postmarket oversight approach partly due to medical device cybersecurity. A contentious debate emerged over the course of this journey about whether additional FDA authority is needed. The areas for which new purview is needed remain unclear, but the updates indicate FDA is seeking to impose additional postmarket safety requirements on devices cleared via 510(k) submissions.
    
   Yet “delivering on the goal to be first in the world to consistently identify and act on medical device safety signals will rest in part” on whether the agency is able to “fully leverage” the intended benefits of the currently under-developed National Evaluation System for health Technology (NEST) and resolve the funding issues which could hamper its success, according to Gottlieb and Shuren.
    
   The vision for the FDA-funded National Evaluation System for health Technology Coordinating Center (NESTcc) to establish an active surveillance system based on robust real-world evidence (RWE) was considered to be challenging from the get go among both agency staff and industry stakeholders, despite the steady flow of cash that has been going into this work since $3 million was granted to the Medical Device Innovation Consortium in 2016 seed funding for NEST.
    
   FDA saw a need to dip into internal agency funding for the additional $3 million in funding that was allocated to the NESTcc in September, agency spokesperson Deborah Kotz told Focus. This was in addition to the annual portion of the $30 million in funding granted under the latest reauthorization of the Medical Device User Fee Amendments to develop NEST over five years.
    
   “This new funding for NEST, which was provided in addition to the annual funding allocated by the latest user fee agreement, will allow us to continue supporting demonstration projects...for building out active surveillance capabilities,” Gottlieb and Shuren argued. NESTcc announced earlier this month it has selected a total of eight RWE test cases for its first round of projects.
    
   Current challenges in securing funding date back to inception of the idea for the system, NESTcc Chair Michelle McMurry-Heath previously toldFocus. McMurry-Heath, who also serves as the Johnson & Johnson’s worldwide VP of regulatory and clinical affairs and global head of evidence generation, was under CDRH’s employment when a regulatory science program led to the conclusion that lack of investments has hindered firms’ ability to experiment with novel technologies. 
    
   Several moving parts underpin the funding problem, including the road to a nationwide unique device identification (UDI) system being more fraught with implementation issues at the manufacturer level than previously anticipated—prompting FDA to issue various extensions on UDI compliance deadlines—and ensuring real-world data can be used as RWE to support regulatory decision-making. These form part of the larger efforts to shift away from not just a passive to an active surveillance system, but also from greater use of pre- to postmarket data.
    
   Gottlieb and Shuren argued use of RWE is among the “core pillars” of the medical device safety action plan. But the collectively charted course for implementing the new system nationwide is banking on whether NESTcc will be able to serve as a mechanism for agency officials to obtain a more holistic view of a total product lifecycle and as an RWE safety net for product developers.
    
   The goals have proven to be uniquely challenging. The “rapid built-out” of NEST for which FDA is investing new resources will require “considerably more funding to fully meet its tremendous potential,” Gottlieb and Shuren said. “Funding is the principal barrier to establishing this system.”
    
   A whopping $46 million was requested under the president’s budget for fiscal year 2019 in support of NEST’s development and related postmarket studies to tackle device-specific safety concerns. “The $46 million is the amount needed for FY19," Kotz confirmed with Focus. "If we don't get the funding, we won't be able to fully implement the system," she added. 
    
   The agency has already seen improvements in manufacturers’ readiness in submitting clinical evidence and answering postmarket questions that would have been difficult to address in the past, according to Gottlieb and Shuren. This speaks to the desire to continue full steam ahead despite remaining barriers, but the observed new industry behavior is merely an initial result of increased awareness in leveraging data sources as NESTcc has yet to become fully operational.
    
   Shuren—at the October annual meeting of the system that inspired NEST, MDEpiNet—offered his view on how success of NESTcc version 1.0 will be determined in 2019, such as broad applicability and whether it can provide answers on RWE and payer-related questions. CDRH is also strengthening coordinated registry networks (CRN) hosted under MDEpiNet as these are among the NESTcc data partners. It targeted part of the September $3 million in NESTcc funding to launch projects around using claims data and pilot the use of electronic health records to study urogynecologic mesh as part of its work on the Women’s Health Technologies CRN, Gottlieb and Shuren said. They also noted several other updates on women’s health.

   https://www.raps.org/news-and-articles/news-articles/2018/11/medical-device-safety-action-plan-fda-sets-measur
   

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