Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

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 (including search features and archives), and to make our delivery more efficient and environmentally conscious.

This site will have an inter-disciplinary scope, in keeping with the firm's recognition that legal issues are intertwined with business concerns, and rarely confine themselves to narrowly proscribed practice areas. It will be a collaborative effort by the firm’s Life Sciences Health Industry (LSHI) Group, which consists of 200 professionals, from many different practice areas, who are dedicated to serving clients who help save patients’ lives and preserve their health, whether through biotechnology, pharmaceuticals, medical devices, life sciences, or by delivering exceptional health care.

We also invite you to explore our companion blog, Health Industry Washington Watch, which focuses on legislative and regulatory developments affecting such areas as Medicare and Medicaid reimbursement; new benefits such as Medicare prescription drug coverage; and fraud and abuse developments.

We hope you will check our site often, and we welcome your feedback. To view more recent posts, please visit or return to our main page at http://www.lifescienceslegalupdate.com/.

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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 based on the safety and efficacy of the device itself, not on the alleged conduct of a company representative in the operating room during use of the device.

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This post was written by Debra A. McCurdy, Carol Loepere, Elizabeth Carder-Thompson, 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”) controversial competitive bidding program for certain categories of durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”), which had already gone into effect in 10 geographic areas on July 1, 2008. 

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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.

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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 current government follows a policy of dereimbursement.

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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 the sales and marketing efforts of pharmaceutical companies that choose to comply. The most important revisions are those relating to sales representatives’ ability to provide meals and logo items to HCPs. Specifically, the revised Code prohibits sales representatives from paying for off-site or restaurant meals for HCPs and their staff and prohibits the use of branded “reminder” items, such as mugs, notepads or pens. The following memorandum contains a description of these and other revisions and also details the potential impact of the revised Code on the pharmaceutical industry. In addition, attached to this memorandum is a chart summarizing the original and revised PhRMA Codes and highlighting the new provisions that will become effective next year.

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