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
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
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
The Reed Smith Life Sciences Health Industry Group (LSHI) recently released their “Winter 2015/2016 Webinar Course Offerings,” which once again features timely webinars and in-person programs on a wide variety of topics. Upcoming events include: January 19, 2016 – Webinar: The Good, the Bad and the Ugly: The Best and Worst Prescription Drug/Medical Device January 24, … 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
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
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
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
