Lawrence Sher

Lawrence Sher

Reed Smith

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Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

4/25/2016 - APIs China Country of Origin Department of Veterans Affairs Federal Supply Schedule (FSS) India Manufacturers Pharmaceutical Industry Prescription Drugs Supply Contracts Trade Agreements Act

The Supreme Court’s Recent Confirmation that Yearsley Derivative Sovereign Immunity Extends Beyond Public Works Projects

On January 20, 2016, the Supreme Court clarified the scope of “Yearsley immunity” – a form of derivative sovereign immunity available to qualifying government contractors – in its decision in Campbell-Ewald Co. v. Gomez....more

2/3/2016 - Campbell Ewald v Gomez Defense Strategies Federal Contractors Government Contractors Public Works Removal SCOTUS Sovereign Immunity

Medical Device Companies Face Severe FCA Penalties for TAA Violations

A spate of recent multi-million dollar settlements has shown that medical device manufacturers are subject to substantial liability under the False Claims Act (FCA) if they misstate the country of origin of their products in...more

3/19/2015 - Enforcement Actions False Claims Act (FCA) Manufacturers Medical Devices Trade Agreements Act

U.S. Supreme Court Upholds Fourth Circuit Victory for Omnicare, Inc. in High-profile, Precedent-setting False Claims Act Case

On October 6, 2014, the U.S. Supreme Court denied review of a groundbreaking Fourth Circuit decision affirming the dismissal of a novel False Claims Act suit against Reed Smith client Omnicare, Inc. In its February 2014...more

10/8/2014 - DOJ False Claims Act (FCA) Omnicare Prescription Drugs Qui Tam SCOTUS

Are Internal Compliance Investigations Privileged? D.C. District Court Rules No

U.S. District Court for the District of Columbia holds documents related to internal investigations of possible violations of corporate code of conduct not protected from disclosure under either attorney-client privilege or...more

3/17/2014 - Attorney-Client Privilege Chief Compliance Officers Compliance Corporate Counsel Disclosure Internal Investigations Work-Product Doctrine

Federal Appeals Court Rejects False Claims Act Suit Based on Drug Packaging cGMP Violations

Last Friday, 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...more

2/27/2014 - False Claims Act (FCA) Healthcare Omnicare Pharmaceutical Industry Prescription Drugs

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