Pharmaceutical Executives and In-House Counsel Beware: U.S. District Court Affirms Exclusion of Former Purdue Executives Under "Responsible Corporate Officer" Doctrine

This post was written by Elizabeth B. Carder-Thompson and Katie C. Pawlitz.

On December 13, 2010, the United States District Court for the District of Columbia affirmed the decision of Kathleen Sebelius, Secretary of the Department of Health and Human Services (the “Secretary”) excluding three former pharmaceutical executives for twelve years from participation in Medicare, Medicaid, and all other federal health care programs. The exclusion – the latest weapon in governmental assaults on pharmaceutical company wrongdoing – was imposed by the Office of Inspector General of the Department of Health and Human Services (“OIG”). The executives, who included the company’s former general counsel, were excluded notwithstanding the fact that they asserted no knowledge of the misbranding conduct for which their former employer, Purdue Frederick Company (“Purdue”), previously settled with the government.

The decision illustrates the government’s enhanced focus on individual liability and punishment in the context of fraud and abuse by health care entities, and it represents a significant development in enforcement activity in this area.

Now more than ever, we urge our health care clients – providers, suppliers, and manufacturers alike – to consider the potential impact of the OIG’s permissive exclusion authority when defending against allegations of fraud or abuse involving federal health care programs. To read our full alert, summarizing the court’s opinion and related background, click here.

Changes to Rule 26 Make It Easier To Work With Experts

This post was written by Meghan K. Landrum.

Recent changes to the Federal Rules of Civil Procedure (FRCP) Rule 26 make it easier to communicate with expert witnesses and to prepare them for deposition and trial testimony while still protecting attorney work product. While expert discovery has been a part of federal practice since 1993, the period dedicated to the discovery of attorney-expert communications and draft expert reports has become increasingly time consuming during pre-trial preparation. The amendments to Rule 26 address this development and attempt to create an atmosphere that encourages better communication between attorneys and their experts.

To learn more about the changes made to Rule 26 and the immediate impact this has on working with expert witnesses, read our full alert.

IRS Issues Guidance on Calculation of the Annual Fee Imposed on Manufacturers and Importers of Branded Prescription Drugs Under the Affordable Care Act

This post was written by Ruth Holzman, Angelo Ciavarella, Joe Metro, Jeffrey Kaylor, and Vicky Gormanly.

On November 29, 2010, the Internal Revenue Service (the “IRS”) issued Notice 2010-71, 2010-50 IRB (the “Notice”), which provides guidance on the calculation of the annual fee imposed on certain manufacturers and importers of branded prescription drugs for calendar years beginning after December 31, 2010, pursuant to the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the Affordable Care Act or the “ACA”). Reed Smith Tax and LSHI attorneys have prepared an analysis of the guidance which provides background on the annual fee and a summary of the information contained in the Notice. While the Notice provides a solid starting point for IRS guidance, there are nevertheless areas of ambiguity that companies will need to evaluate. Please click here to view our full alert.