Tag Archives: Whistleblower

Erroneous Country of Origin Determinations May Result in Significant FCA Penalties for Medical Device Companies

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

Insurance Coverage for False Claims Act Lawsuits?

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

Supreme Court Invites Solicitor General Weigh In on Cert Petition Involving Specificity of False Claims Act Complaints

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

Whistleblower Cannot Rely on Stolen Patient Records

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

FCA Qui Tam Relator Sanctioned for Destroying Evidence on Company-Issued Laptop

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

Health Information Privacy and Incentives, Medicaid Funding, and Other Health Care Provisions in the American Recovery and Reinvestment Act

On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA"). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.… Continue Reading