The Heparin Disaster: The Preemption Problem
6620 W. Central Ave. Suite 200, Toledo, OH 43617  (PH) 419-841-9623  (Toll Free) 1-888-841-9623  pamela@toledolaw.com
 

The Heparin Disaster



Wednesday, June 4, 2008  

The Preemption Problem

Baxter, along with other drug manufacturers, continues to advocate for complete immunity from the majority of suits involving unsafe medical drugs under a legal concept called “federal preemption.” (See Baxter’s “Response to Preemption Discussion to Quaid’s Lawsuit.” See also testimony of Dennis and Kimberly Quaid at the Committee on Oversight and Government Reform’s 5/14/08 hearing, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?” The full transcript and video of this hearing is available by clicking here.) Baxter and other drug manufacturers argue that regardless of misconduct or failures on their part, Americans injured by defective drugs should be stripped of their constitutional right to a trial by jury for most, if not all, legal claims, where the drugs are regulated or approved by the FDA.

This argument is not only legally and ethically problematic, but is based on the flawed assumption that the FDA has the resources, authority, and capability to ensure product safety. Unfortunately, as the heparin debacle as reminded us, such is not the case. Since the contaminated heparin recall, the significant shortcomings in the FDA’s ability to protect this county against unsafe drugs and medical devices, has been on the forefront of the news media, as well as the agenda of Congress. Reports exposing the depth of the problem continue. This week USA Today published an article entitled “Drug Companies Drain Scientific Brains from FDA,” which reports that the FDA continues to lose its most experienced scientific minds to major drug companies with more financial resources. This has led to staffing problems for the agency, which has a turnover rate twice that of other agencies.

A previous study conducted by USA Today and reported in an article entitled “FDA Advisers Tied to Industry,” found that “more than half of the experts hired to advise the government on the safety and effectiveness of medicine had financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions.”

With their undeniable influence at this and other levels of our government, it is no wonder that drug companies have gained support for federal preemption of medical drug and device lawsuits. It is also no wonder that Americans continue to die from unsafe drugs and medical devices.

Yet, our constitution gives every-day Americans injured through no fault of their own, a powerful weapon against corporate corruption and greed, the right to a jury trial. In a United States court of law, a regular American can hold even the wealthiest and most powerful corporation accountable. Attempts by Baxter and others to sacrifice that constitutional right for protection of its corporate profits, should be not be permitted.

Labels: , , , , , , , , , , , , , , ,


Backflip I Talk News Blinklist Simpy Spurl Technorati Squidoo Blinkbits Digg Delicious! Google Bookmarks Newsvine Stumbleupon




 



Digg is FREE

Powered by Blogger

Subscribe to
Posts [Atom]

 
 

© 2006-2008 Zoll, Kranz and Borgess, Attorneys at Law (419) 841-9623 pamela@toledolaw.com

Disclaimer             Blogger Template by: Web Design