Reed Smith is pleased to present a virtual life sciences CLE week from November 9 – 13, covering hot litigation and regulatory topics of interest to our pharmaceutical, biotech, and medical device clients. Sessions include: The ABCs of an MDL: Lessons learned through the lens of a case The benefits of arbitration for life sciences … Continue Reading
The CARES Act funding was a lifeline for many health care organizations and life sciences companies, but came with significant attached strings. Related fraud charges are already making headlines and bring with them the serious risk of False Claims Act litigation, which can have bet-the-company implications for companies. Please join us this Wednesday, August 5 … Continue Reading
On Wednesday, November 20, a three-judge panel of the U.S. Court of Appeals for the Eleventh Circuit heard oral argument in the closely watched False Claims Act (FCA) case of United States ex rel. Ruckh v. Salus Rehabilitation, Inc. The case involves questions regarding how to interpret and apply the FCA’s materiality standard set forth … Continue Reading
Issued in January 2018, the so-called Brand Memo reminded Department of Justice (DOJ) attorneys that “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation.” It also instructed DOJ attorneys that they “may not use noncompliance with guidance documents as a basis for proving violations of applicable law in affirmative … Continue Reading
Michael Granston, the Director of the Commercial Litigation Branch within the United States Department of Justice’s Fraud Section, recently issued an internal memorandum affirming his prior statements that the Department of Justice (DOJ) should consider seeking dismissal of meritless False Claims Act (FCA) suits brought by relators in qui tam cases. Under 31 U.S.C. § … Continue Reading
As covered in “Court Overturns $350 Million Judgment in FCA Case: Materiality, Scienter, and Causation Standards Preclude Liability by “’Zaps, Traps, and Zingers’”, Andy Bernasconi discusses a recent case, in which the Middle District of Florida issued a blistering opinion vacating a $350 million judgment in a False Claims Act (FCA) case and granting the … Continue Reading
On November 8, 2017, following many years of investigation, the U.S. Department of Justice dismissed a billion-dollar False Claims Act (FCA) case against our long-standing client HCR ManorCare, the industry leader in post-acute rehabilitation care. The DOJ alleged that HCR ManorCare delivered unnecessary therapy to patients covered under Medicare Part A in its skilled nursing … Continue Reading
Reed Smith’s Life Sciences Health Industry Group is proud to be hosting its third annual Life Sciences CLE Day at our Philadelphia office on Thursday, November 2. The day starts with breakfast and networking at 8:30 a.m. and sessions commence at 9 a.m. The event, which includes a working lunch, concludes at 4 p.m., with … Continue Reading
The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “12 Months in Health Care Law: A Roller Coaster Journey” on October 25, 2016 at 12:00 p.m. ET. Please join Reed Smith Partner Elizabeth Carder-Thompson as she presents her annual informative and entertaining review of many of the key regulatory … Continue Reading
A False Claims Act (“FCA”) retaliation claim, 31 U.S.C. 3730(h), filed January 26, 2016 in federal district court in Oregon, provides a perfect example of the type of challenging cases confronting health care employers today. Pediatrician Robert Dannenhoffer, MD, the former CEO of a joint venture between a hospital and physicians’ group, alleges that he … Continue Reading
On December 4, the U.S. Supreme Court granted certiorari in Universal Health Services, Inc. v. U.S. ex rel. Escobar, No. 15-7, raising the question of whether “implied certification” liability is permissible under the False Claims Act and, if so, under what circumstances. Under the implied certification theory, defendants are presumed to have certified that they … Continue Reading
A friendly reminder that the Reed Smith LSHI (Life Sciences Health Industry) Group will be hosting an upcoming November 18, 2015 Life Sciences 1/2 day CLE from 9:00 a.m. ET until 1:30 p.m. ET at their Philadelphia Office. All the details can be found in our previous post here. Registration and breakfast begin at 8:30 … Continue Reading
The Reed Smith Life Sciences Health Industry (LSHI) Group will be hosting an upcoming Life Sciences 1/2 day CLE on November 18, 2015 from 9:00 a.m. ET until 1:30 p.m. ET at their Philadelphia Office. Reed Smith presenters Stephen J. McConnell, James M. Beck, Michael T. Scott, Thomas H. Suddath, Jr., Amy M. Vanni and Rachel B. … Continue Reading
The February 2014 decision (discussed in an earlier blog post) in which the U.S. Court of Appeals for the Fourth Circuit dismissed the False Claims Act (FCA) charges brought in United States ex rel. Rostholder v. Omnicare, Inc. was confirmed on October 6, 2014, when the U.S. Supreme Court declined to review the Rostholder decision. … Continue Reading
Reed Smith Partner Larry Sher authored a post on the Drug and Device Law Blog about a recent decision in which the U.S. Court of Appeals for the Fourth Circuit affirmed the dismissal of a False Claims Act (“FCA”) case brought against Omnicare, United States ex rel. Rostholder v. Omnicare, Inc., No. 12-2431, 2014 WL 661351 … Continue Reading
On October 7, 2013, in evaluating a pending cert petition, the U.S. Supreme Court invited the Office of Solicitor General to provide its views regarding the level of specificity required when alleging activities in violation of the civil False Claims Act (FCA) (United States ex rel. Nathan v. Takeda Pharmaceuticals North America, No. 12-1349, order 10/7/13).… Continue Reading
This post was also written by Thomas W. Greeson. Providers and suppliers have until April 16, 2012 to comment on the proposed rule to implement provisions of Section 6402(a) of the Affordable Care Act that require “persons” receiving Medicare and Medicaid funds to report and return overpayments no later than 60 days after the date … Continue Reading
