Drug & Medical Device Newsletter

Spring 2005

Table of Contents

Good News and Bad News: Legislative and Regulatory Changes
Over the past six months, the pharmaceutical industry has faced some unprecedented challenges in both the regulatory and legislative sphere, making for some uncertainty as the industry looks to the future.  From the testimony of David Graham, a staff person with the FDA, regarding safety monitoring mechanisms to a new FDA focus on certain classes of drugs such as SSRIs used to treat depression and Cox-2 inhibitors used in the treatment of arthritis to political disputes over the importation of pharmaceutical products from Canada and other countries, the industry has been faced with the potential for a somewhat changed landscape in both the regulatory and legislative landscape.
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Mass Screenings: A Lesson from Asbestos Litigation
A lot of mass tort law in the United States has evolved from asbestos litigation since the early 1980s.  There are many problems for the defense bar that come directly from those early cases.  One of the biggest problems is the low threshold standard of proof needed to bundle low or no injury cases with cases where injury clearly occurred.
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Duty to Warn: Expanding Application of the Learned Intermediary Doctrine to Pharmacists
The learned intermediary doctrine has been adopted in some form by courts in all fifty states.  It is a defense tool in pharmaceutical litigation that provides an exception to the traditional rule in products liability law that manufacturers have a duty to warn the ultimate consumer, and it precludes manufacturer liability for failure to warn the consumer when an adequate warning has been given to a "learned intermediary."
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Ohio Enacts Broad Tort Reform for Products Liability Claims
On April 7, 2005, Amended Substitute Senate Bill 80 (“Senate Bill 80”) became effective in Ohio.  Senate Bill 80 is Ohio’s third attempt in the past decade to enact broad reforms to Ohio’s personal injury lawsuit system.  Senate Bill 80 applies, in general, to tort actions, including product liability claims.  This article focuses on the changes that Senate Bill 80 makes to products liability law in Ohio and the benefits these changes provide to defendants sued for products liability claims.
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