From the February 2008 Idaho Observer:


High court set to give the FDA and Big Pharma a license to kill

Supremes could also reopen doors for courts to award damages when drugs main and kill consumers

By Scott Thurston

On February 25, 2008, oral argument will be heard before the U.S. Supreme Court concerning a state citizenís ability to bring suit against a pharmaceutical company when injury and/or death occurs as a direct result of a drug approved by the Food and Drug Administration (FDA). The facts presented in Warner Lambert v. Kent, et al (2007) and the argument being offered by the lawyers representing pharmaceutical interests are quite revealing. After reading this article, you should have a clear understanding of the unholy alliance that exists between the pharmaceutical industry and the FDA, the government agency charged with protecting us from dangerous drugs.

Background

Under Michigan law as well as the laws of many other states, individuals may bring personal injury suits against manufacturers of FDA-approved prescription drugs only if the plaintiffs can show that FDA approval depended upon fraudulent submission or withholding of information. In 2000, 27 Michigan residents sued Warner-Lambert Co. (Desiano v. Warner-Lambert), claiming personal injury arising from using Rezulin, Warner-Lambertís FDA-approved drug for diabetes treatment. Warner-Lambert argues that Michigan law is preempted by federal law because, "permitting state courts to second-guess the FDAís product-approval and fraud-detection processes interferes with the agencyís essential functions and promotes regulatory uncertainty."

The Michigan plaintiffs claim that federal preemption does not apply to traditional state tort (wrongful death or injury) claims. The case was moved to 6th District Federal Court which ruled in favor of defendant Warner-Lambert by dismissing the case after ruling that the fraud provision of the Michigan law was unconstitutional.

In 2007, the 2nd Federal District in New York vacated the 6th in Desiano v. Warner-Lambert and ruled that the case could go forward.

It is believed that the U.S. Supreme Court granted Warner-Lambertís writ of certiorari to settle the split between the 6th District and 2nd District federal courts.

Landmark decision pending

The U.S. Supreme Courtís decision in this case concerns all Americans since it will clarify the scope of FDA autonomy in policing its own drug-approval process and a state citizenís freedom to assert state tort claims in areas regulated by federal entities.

The FDA subjects new prescription drugs to a highly-questionable and suspect review process before deciding whether to approve them for market. Michigan, along with several other states, defers to the FDAís regulatory "expertise" in the drug safety area by shielding drug manufacturers from product liability suits if the drug in question received FDA approval. However, Michigan law withdraws this defense if the injured party demonstrates that the manufacturer obtained FDA approval by omitting or fraudulently misrepresenting information. In a previous case (Buckman v. Plaintiffsí Legal Comm., 531 U.S. 341 2001), the U.S. Supreme Court held that "stand-alone" state law claims for fraud-on-the-FDA conflict with the FDAís authority to police such fraud. In determining whether the same federal preemption applies to the Michigan immunity exception, the U.S. Supreme Court will define the scope of the FDAís autonomy in policing its approval process. This will most likely result in the obstruction of a private citizenís ability to bring lawsuits relating to FDA-approved products as well as other areas of federal regulation.

Feds, Big Pharma v. Americans

Currently there are tens of thousands of pending cases involving drug manufacturers. The U.S. government and pharmaceutical industry representatives argue that liability based on state-court findings of fraud would burden the FDA with a flood of additional information from manufacturers and discovery requests from consumer litigants. They further argue that, "exposure to state-law claims could also inject excessive uncertainty into the approval process". 

If the Court holds in favor of Kent, the decision would advance traditional means of consumer protection through state tort claims. According to the American Association for Justice, state tort actions provide an essential companion to FDA drug-safety regulation because the FDA is overburdened, lacks authority to require companies to maintain post-marketing safety records, and "fails to adequately record reports of adverse reactions."

They further contend that, because fraud claims are governed by state law, complete federal preemption of drug-safety claims might leave many victims of drug-approval fraud without any legal remedy whatsoever.

Rezulin

In 1996, Warner-Lambert Co., a pharmaceutical manufacturer now owned by Pfizer, Inc., sought federal FDA approval of Rezulin (troglitazone), a prescription drug intended to treat type 2 diabetes mellitus. Despite recognizing risks of liver and cardiovascular problems associated with Rezulin, the FDA approved Rezulin in January, 1997, for use with insulin and/or other licensed diabetic drugs. In August, 1997, the FDA further approved the drugís "stand-alone" use.

From 1997 to 1999, after receiving several reports indicating harmful liver-related problems in Rezulin users, Warner-Lambert agreed to several labeling changes. In 1999, the FDA concluded that the benefits of Rezulin use without insulin no longer outweighed the risks. In March 2000, Warner-Lambert terminated sales of Rezulin in the U.S. Subsequent to Rezulinís withdrawal, 27 Michigan residents brought four independent product liability suits against Warner-Lambert, claiming damages under Michigan law for personal injury resulting from Rezulin use.

At trial, Warner-Lambert argued that it possessed a complete defense against the plaintiffsí claims based on Michigan state law that grants immunity from product liability for drug manufacturers whose drug and labeling were FDA-approved. However, the plaintiffs claimed that this defense did not apply based on a narrow exception to the statute, which withdraws the defense if the defendant obtained FDA approval through fraudulently withholding or misrepresenting information.

The Buckman test

Warner-Lambert asserts that the Supreme Courtís decision in Buckman (2004) compels the conclusion that Michiganís fraud-based immunity exception is preempted by federal law.

In Buckman, the U.S. Supreme Court held that state "fraud-on-the-FDA" claims were preempted by federal law because they disturbed FDAís attempts to balance several statutory objectives.

According to Warner-Lambert, the exception requires that a judge or jury inquire into fraud upon the FDA, an exclusively federal matter under Buckman.

The Michigan plaintiffs have responded that they believe the Court should apply a presumption against federal preemption because Michigan is exercising its historic police powers. The plaintiffs maintain that, unlike the special fraud-on-the-FDA claim at issue in Buckman, the Michigan immunity exception concerns product liability, a traditional field of state-law tort litigation.

Federal regulatory supremacy v. consumer protection

An outcome in this case will also clarify what is and will be considered by courts as the proper balance between victimsí interest in pursuing state-tort claims and the FDAís interest in controlling their drug review process. The Supreme Courtís decision concerning the scope of federal preemption under Buckman will, also, most likely apply beyond product liability to all conflicting state and federal regulatory regimes.

There is ample evidence to justify claims that Big Pharma and our own government are using Americans as laboratory rats to determine which new drugs are harmful and deadly while Big Pharma rakes in huge drug profits in the interim.

A portion of these profits then go to the FDA and individuals within that agency to insure the perpetuity of the game. Americans are being duped into paying Big Pharma to be used in the final and most important stage of their testing of new drugs approved by the FDA. This fact is evidenced by many public records and drug product liability cases such as the one discussed  here.

The uninformed public has unknowingly allowed itself to become  part of this Mengele-like approval process. And now Big Pharma wants to be insured from all legal liability resulting from the millions of dead and damaged (human) lab rats that have been or are still being unwittingly used as part of the FDA drug approval process.

Men or mice?

Personally, I donít foresee the U.S. Supreme Court ruling in favor of the (human) lab rats and against Big Pharma and its puppets in the FDA. It is more than likely that We the People will be robbed of yet another avenue of redress against the crimes of corrupt government and corporate killers. Many of us have come to expect that we will be treated as less than human beings by those who wield their power by virtue of  their ungodly gain.

It should be apparent to all who are seeking the truth that those charged with protecting us from deadly drugs are far more concerned about protecting the profits of their benefactors and securing the status quo than they are about a few million measly lab rats.