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|C.R. Bard Reaches $200 Million Transvaginal Mesh Settlement|
Kyla Gail Cole; Waters & Kraus, LLP;
September 15, 2015, previously published on September 14, 2015Transvaginal mesh maker C.R. Bard Inc. has reached an agreement to settle 3,000 vaginal mesh lawsuits for more than $200 million. The settlement averages out to $67,000 per case.
|Arbitrator Strikes Down ‘Vaccinate or Mask’ Policy at Sault Area Hospital as an Unreasonable Exercise of Management Rights|
Natalia Rodriguez; Borden Ladner Gervais LLP;
September 15, 2015, previously published on September 14, 2015On September 8, 2015, Arbitrator James Hayes released his decision in Sault Area Hospital v. Ontario Nurses' Association (“ONA”), striking down the Hospital's “Vaccinate or Mask” (the “VOM Policy”).
|DOJ Issues Memo Directing Prosecutors to Focus on Individual Accountability|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
September 14, 2015, previously published on September 11, 2015The U.S. Department of Justice (DOJ) issued a memorandum on Wednesday from Deputy Attorney General Sally Quillian Yates that reaffirms the Government’s commitment to prosecuting individuals and formally instructs prosecutors to focus on individual accountability when dealing with corporate...
|Exellus BlueCross BlueShield - Latest Victim of a “Sophisticated” Health Plan Cyberattack|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
September 14, 2015, previously published on September 11, 2015Exellus BlueCross BlueShield has announced that the personal information of at least 10 million members has been compromised in a “very sophisticated” cyberattack that occurred on December 23, 2013 and was discovered by the plan on August 5, 2015. According to a notification posted on...
|Amarin and Off-Label Drug Use: What it Means for the Pharmaceutical Industry|
Stephen G. Sozio; Jones Day;
September 14, 2015, previously published on September 2015The U.S. District Court for the Southern District of New York recently issued a significant decision in Amarin Pharma, Inc. et al v. United States Food & Drug Administration. Amarin sought and won a preliminary injunction against the FDA to stop it from pursuing a misbranding case against the...
|FDA Indicates Shared Nonproprietary Names Not Appropriate for All Biological Products, Including Biosimilars|
Edgar J. Asebey, Maureen Bennett, Colleen Heisey, Janet M. McNicholas, Christian Paul; Jones Day;
September 11, 2015, previously published on September 2015On August 28, 2015, the U.S. Food & Drug Administration ("FDA") released a draft guidance document describing its current position on biological product nonproprietary naming, including the need for biological products to bear a nonproprietary name to which is attached an...
|The TCPA & Healthcare: FCC Limits “House Calls” to Cellphones|
Richik Sarkar, Jane Marie Pine Wood; McDonald Hopkins LLC;
September 10, 2015, previously published on September 8, 2015The Federal Communications Commission (FCC) ruling this summer on the Telephone Consumer Protection Act (TCPA) had direct implications for many health care institutions - and recent case law continues to define the guidance with respect to health care related debt collection.
|HHS Proposes Revisions to the Common Rule for Protection of Human Research Subjects|
Edgar J. Asebey, Maureen Bennett, Michele R. Goodman, Glenn L. Krinsky, Heather O'Shea; Jones Day;
September 10, 2015, previously published on September 2, 2015On September 2, 2015, the U.S. Department of Health and Human Services ("HHS") and numerous other federal departments and agencies released the long-awaited proposed revisions to the Federal Policy for the Protection of Human Subjects, or "Common Rule," now published in the...
|U.S. District Court Issues Ruling on Preliminary Motion to Dismiss Interpreting 60-Day Overpayment Rule: Holds Identification Occurs when Providers Are "Put on Notice" of Potential Overpayment|
Lindsey Lonergan, Rebekah N. Plowman; Jones Day;
September 10, 2015, previously published on September 2015Compliance with the labyrinth of health care rules and regulations has always been a burdensome challenge for health care providers, and particularly for compliance officers who are frequently presented with potential overpayments that after months of investigation fail to reveal an actual...
|Legislators Request Power Morcellator Investigation|
Waters Kraus LLP;
September 10, 2015, previously published on September 9, 2015Twelve congressional members have asked the U.S. Government Accountability Office to conduct an investigation concerning the laparoscopic power morcellator - a device used in gynecologic surgeries that can spread undetected cancer cells throughout the body. A bipartisan group of lawmakers sent a...