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
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
The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Where Was This Made? Country-of-Origin Issues for Pharmaceutical & Medical Device Companies,” on July 19, 2016 at 12 p.m. ET. Drug and device manufacturers often struggle to correctly determine their products’ “country of origin” thanks to ever-changing global supply chains … Continue Reading
Last month, Lindsey provided readers of the Drug and Device Law blog with an overview of United Health Services, Inc. v. U.S. ex rel. Escobar, a False Claims Act (FCA) case that was bringing the implied certification theory of FCA liability before the U.S. Supreme Court for review. The FCA imposes liability on anyone who knowingly … Continue Reading
On May 26, the U.S. Supreme Court issued its ruling in Kellogg Brown & Root Services, Inc. v. United States ex rel Carter, No. 12-1497, __ S. Ct. __ (2015), in which a relator brought civil False Claims Act (FCA) claims against government contractors. The relator alleged that the contractors had made fraudulent payment claims … Continue Reading
Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading
The number of qui tam actions brought under the False Claims Act (FCA) has increased over the past several years. There are now more opportunities for potential allegations of FCA violations on the part of health care providers, and more eligible whistleblowers to bring those alleged violations to the government's attention. Given these circumstances, providers should take time to assess their current insurance coverage for defending and resolving FCA claims.… Continue Reading
As mentioned on our Health Industry Washington Watch blog, pharmaceutical and medical device manufacturers and group purchasing organizations (GPO) are currently in the process of submitting detailed 2013 payment and investment interest data to the Centers for Medicare & Medicaid Services. The submission of this data, as dictated by the Physician Payment Sunshine Act, is intended to highlight certain financial relationships between the manufacturers and GPOs and physicians. With some exceptions, this data will become public by September 1, 2014, at which time the Department of Health and Human Services' Office of the Inspector General, Department of Justice, and relators' attorneys will likely analyze the data to initiate investigations and support complaints under the federal False Claims Act.… Continue Reading
A recent decision by the United States District Court for the Southern District of Ohio may make it much harder for qui tam relators to rely upon stolen medical records or patient information in False Claims Act ("FCA") whistleblower actions. See Cabotage v. Ohio Hospital for Psychiatry, No. 11-cv-50 (S.D. Ohio July 27, 2012). In Cabotage, the district court held that a registered nurse was not permitted to support her allegations of FCA violations by relying on confidential protected health information that she surreptitiously removed from the hospital where she was employed.… Continue Reading
In yet another reminder about the importance of maintaining evidence on company-issued laptops, blackberries, or other electronic devices; the United States District Court for the Northern District of California recently sanctioned a qui tam relator for destroying more than 10,000 documents on his company-issued laptop. Moore v. Gilead Sciences, Inc., No. C 07-03850 SI, 2012 WL 669531 (N.D. Cal. Feb. 29, 2012).… Continue Reading
This post was written by Matthew R. Sheldon and Alexander Y. Thomas. The Second Circuit Court of Appeals is reviewing a lower court decision disqualifying a former in-house attorney from acting as a False Claims Act qui tam relator against his former employer. The relator was formerly general counsel to Unilab, a subsidiary of Quest … Continue Reading
On April 28, both the U.S. Senate and the U.S. House of Representatives took steps that would provide sweeping changes to the federal False Claims Act ("FCA"). The bills would significantly expand the scope of FCA liability while at the same time make it easier for qui tam relators to bring and maintain FCA suits on behalf of the government.
In short, the bills are answers to a DOJ and relator's counsel "wish list" that would eliminate 20 years of hard-fought defense jurisprudence. In addition, the House bill, for example, would eliminate the public disclosure jurisdictional bar and defense, which could allow a sworn federal agent to utilize information obtained in the course of official investigations to file FCA lawsuits as a relator, and to receive a portion of any financial recovery. The House bill would also eliminate any basic pleading standards by relators and allow relators' attorneys to file fishing expeditions without any substantive basis of allegation...… Continue Reading
