Wendy C. Goldstein

Wendy C. Goldstein

Epstein Becker Green

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HEALTH REFORM: OIG Issues Updated Guidelines for Evaluating State False Claims Acts: Is More State Litigation on the Horizon?

On March 15, 2013, the U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) released the Updated OIG Guidelines for Evaluating State False Claims Acts (“2013 Guidelines”), which replaces the...more

4/1/2013 - Affordable Care Act Civil Monetary Penalty False Claims Act FERA Healthcare Medicaid OIG Qui Tam

Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution

In a long-awaited decision, on December 3, 2012, a divided panel (2–1) of the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz...more

12/13/2012 - Commercial Speech FDA FDCA Free Speech Marketing Off-Label Promotion Off-Label Use Pharmaceutical

Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct: Final Amendments to Be Issued

On November 21, 2012, the Massachusetts Public Health Council approved final amendments to 105 Mass. Code Regs. 970.000, the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law ("Massachusetts Marketing...more

12/5/2012 - Healthcare Professionals Manufacturers Medical Devices Pharmaceutical Preemption

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