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May 13, 2006 at 05:19:15

Bush Uses FDA To Shield Big Pharma From Lawsuits

by Evelyn Pringle     Page 3 of 7 page(s)

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Frist's PAC reimbursed Schering $10,809, the equivalent of a commercial first-class fare, but that was only a fraction of the cost of a charter flight, which would have cost 3 times that much. Besides, the cost was almost a wash because Schering had donated $10,000 to Frist's committee in 2003-04, according to USA Today.

Its also worth pointing out that Big Pharma was the largest contributor to the National Republican Senatorial Campaign Committee while Frist chaired the Committee.



The ever-growing number of lawsuits in state courts has created a nagging fear in drug makers. Local juries and elected judges in state courts are much more likely to go against drug giants than juries and appointed judges in federal courts which is a one of the main reasons why Big Pharma wants all cases moved to federal courts.

Vioxx set off the industry's worst nightmare when users or their heirs began filing lawsuits all over the US. According to the January 24, 2006, Associated Press, Merck currently faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the rest in state courts.

But Vioxx by far is not the only worry for Big Pharma. These days, every major drug company has litigation problems involving one or more FDA-approved products and a few prominent law firms have taken up the battle for plaintiff's in state courts.

For instance, since 1990, the Los Angeles based Baum Hedlund Law Firm has been handling SSRI (selective serotonin reuptake inhibitor) suicide/violence cases and served on the Plaintiffs' Steering Committee in the first SSRI-suicide litigation involving Prozac, the first SSRI approved by the FDA.

Baum Hedlund partner, Karen Barth Menziess, has been litigating claims involving injuries stemming from SSRIs such as Prozac, Paxil, Zoloft and, more recently, Lexapro/Celexa, for over a decade.

She heads a team of attorneys, who have successfully defeated Pfizer's and the FDA's preemption arguments in a number of cases, including Motus v Pfizer and Witczak v Pfizer.

In addition to her court activities, Ms Menziess has testified about the dangers of SSRIs before the California State Assembly and the FDA's Psychopharmacologic Drugs Advisory Committees and met with members of Congress regarding the risk of antidepressant induced suicidality and preemption issues.

Ms Menziess wrote an article discussing the ill-effects of preemption in Mealey's Emerg. Drugs & Devices 27 (2006), titled, "Preamble To FDA Final Rule: FDA's Latest Effort To Immunize Drug Manufacturers From Tort Liability At The Expense of Consumer Safety," and stated in part:

"Pharmaceutical industry lobbying efforts and zealot tort reformers have sired a new wave of brazen attempts to shield drug manufacturers from tort liability.

"The preemption language in the preamble to the Final Rule is but the latest attempt. Preemption has become the argument du jour and politically appointed regulatory officials the mouthpieces. The crafty messages sound of consumer protection, but are just the opposite. Limiting the liability of drug companies will not improve public safety.

"The FDA s purported position on preemption assumes that the FDA is infallible and that negligent misconduct by pharmaceutical companies should be the sole purview of FDA. Recent regulatory failures demonstrate that FDA is neither infallible nor does it have the capability of policing drug manufacturers negligent misconduct."

The Bush administration went up against a tough opponent in Baum Hedlund when it turned to the courts, and had the FDA file amicus briefs hoping the courts would rule in favor of preemption, but those attempts also failed.

Ms Menziess explains some of the history of the FDA's intervention into lawsuits she was involved in stating: "Until his resignation in late 2004, FDA Chief Counsel, Daniel Troy, was the pharmaceutical industry's 'inside man,' filing legal briefs on behalf of former clients such as Pfizer (the maker of Zoloft) and soliciting defense attorneys to submit their cases for government amicus brief consideration."

"Although the newly appointed Chief Counsel, Sheldon Bradshaw, lacks the blatant pharmaceutical industry ties that Troy had," she advises, "he clearly was not selected to his position because of a sudden change-of-heart in the political leadership or direction of the FDA."

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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