Monthly Archives: July 2008

Welcome to Reed Smith’s Life Sciences Legal Update blog

Over the years, the lawyers at Reed Smith who represent clients in the life sciences and health industry have published newsletters like Product Liability Update and Health Law Monitor to keep clients informed about key litigation, transactional, and regulatory developments. We now have decided to take advantage of a blog format to make our content more accessible … Continue Reading

A PMA Device and a Sales Representative in the Operating Room – The Breadth of Riegel Preemption

A recent Virginia federal court decision demonstrates the powerful effect of the Riegel v. Medtronic precedent in product liability cases where PMA-devices are subject to claims-sounding in negligence or breach of duty related to the design, manufacturing, and labeling of the device. According to this court, however, the preemption defense of Riegel reaches only those allegations … Continue Reading

The “Medicare Improvements for Patients and Providers Act of 2008”: Delay and Reform of the Medicare DMEPOS Competitive Bidding Program

This post was also written by Robert J. Hill and Kathleen McGuan. I.  INTRODUCTION On July 15, 2008, the House and Senate overrode President Bush’s veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008” (“MIPPA”).1  Among many other things, MIPPA delays and reforms the Centers for Medicare & Medicaid Services’ (“CMS”) … Continue Reading

Pharmaceutical and Medical Device Preemption

Reed Smith partners James W. Wood and James C. Martin recently wrote an article regarding pharmaceutical and medical device preemption for the Washington Legal Foundation, discussing such cases as the Third Circuit’s Colacicco v. Apotex, Inc. case, as well as activity in the U.S. Supreme Court.… Continue Reading

A Media Campaign Questions the French Monopolistic Sale of Pharmaceutical Products

This post was written by Paule Drouault-Gardrat and Julie Gottenberg. Under French Law, pharmacies benefit from a monopoly on the sale of medicinal products. This monopoly covers reimbursed and non-reimbursed pharmaceutical products. Once they are de-reimbursed, the price setting is free. This is indeed a very important market for the approximately 23,000 French pharmacies, as the … Continue Reading

PhRMA Issues Revised Code on Interactions with Healthcare Professionals

This post was written by Christine E. Bloomquist, Gina M. Cavalier, and Matthew E. Wetzel. INTRODUCTION On July 10, 2008, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) issued a revised Code on Interactions with Healthcare Professionals (“HCPs”) (the “PhRMA Code”). The revised PhRMA Code, which becomes effective January 2009, contains several key changes that will impact significantly … Continue Reading
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