Janet's Conner

This Blog tell the Truth and will never not tell the Truth. Impeach Bush

Sunday, May 21, 2006

BUSH USES FDA TO SHIELD BIG PHARMA FROM LAWSUITS---PART II..................


This is Part II of a story telling you about how Bush is paying back the Big Pharmaceutical corporations that helped pay for his re-election, which he never won in the first place. Senator Frist (R-TN), helped to do this by attaching protective provisions to a Department of Defense appropriations report that gave the industry "unprecedented immunity."

MAKE SURE THAT YOU READ PART I, BECAUSE THIS "IS" AFFECTING US ALL IN ONE WAY OR ANOTHER. IT ALSO SHOWS HOW "CORRUPT" SENATOR FRIST IS................................


.....Vioxx set off the industry's worst nightmare when users or their heirs began filing lawsuites all over the U.S. 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 plaintiffs' 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 Beth 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 FDAs preemption arguments in a number of cases, including Motus v Pfizer and Witczak v Pfizer.

In addition to her court activities, Ms. Menzeiss has testified about the dangers of SSRIs before the California State Assembly and the FDA's Psychopharmalogical 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 and Devised 27 (2006), titled, "Preamble to FDA final Rule: FDAs 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 attempts. 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 FDAs 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 infalliable 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 FDAs 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."

"In fact," Ms. Menziess says, "following in his predecessor's footsteps, Bradshaw submitted a legal brief in support of Pfizer's federal preemption arguments."

The FDA filed its first brief in favor of a manufacturer of SSRIs in September 2002 in Motus v Pfizer, one of Baum Hedlund's cases in California, which was pending in the 9th Circuit Court of Appeals.

Daniel Troy, who was the FDAs Chief Counsel at the time, was contacted by Pfizer's national counsel, Malcolm Wheeler, in the summer of 2002 requesting that the government get involved in this private lawsuit to help Pfizer with its preemption argument related to Zoloft-induced suicidality.

Despite the fact that Pfizer had been one of his clients and Troy was paid over $358,000 for work he had conducted for Pfizer in the year he took office, Troy acquiesced, arguing that there was no impropriety in doing so because he did not become involved until after the required 1-year period in which government employees may not participate in official activities involving former clients.

From public accounts, it appears that the 1-year "grace period" elapsed less than a month before Troy entered the fray.

Troy argued in the FDA brief that, even though Pfizer never sought to strengthen Zoloft's warning label concerning suicidality, any warning, no matter how worded, that suggested a link between Zoloft and suicidality would have been false and misleading, would have misbranded the drug, and the FDA would have rejected any effort by Pfizer to use such a warning.

The 9th District Court never decided the preemption issue, instead ruling on another appeallate issue, which concluded the case on unrelated grounds.

Nevertheless, Menziess said that Pfizer has continued to use the brief in its battle against Zoloft-induced suicide cases, arguing that the lawsuits are federally preempted and should be dismissed.

But Judges across the US have been rejecting Pfizer's arguments, as well as the FDA brief itself. A federal judge in Texas pointed out that the law "allows, even encourages, manufacturers to be proactive when learning of new safety information related to their drug."

"Manufactureres, not the FDA, are tasked with responibility of taking proactive steps once a manufacturer learns of 'reasonable evidence of an association of a serious hazard with a drug,'" the judge stated.

A state court judge in California ordered the FDA brief stricken from the record, calling it "hearsay and irrelevant."

In an Illinois case, the judge said the brief "contains nothing more than legal argument by [FDA] counsel."

In a Zoloft suicide case in Minnesota, the court rejected Pfizer's arguments, stating the it "declines to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law." The same judge also called Pfizer's arguments "perverse" and a "public policy argument gone awry."

Ms. Menzeiss notes that the FDAs legal stance on preemption is "particularly egregious in the wake of congressional investigations involving FDA failures to protect the public health, in particular related to antidepressants."

Without state liability laws, she says, drug companies will be able to escape liability for injuries and deaths caused by drugs like SSRIs and Vioxx.

Baum Hedlund currently represents approximately 50 victims and their families in cases involving alleged antidepressant-induced suicide attempts, over one third of whom are children and adolescents.

As with Vioxx, the risks associated with SSRIs were also kept hidden. Ms. Menzeiss's litigation has evidence from as far back as the 1980s that people taking SSRIs were at a heightened risk of suicidality, and not just children, she notes.

In fact, in the early 1990's it was the FDA safety officer Dr. David Graham, of recent Vioxx fame, who raised concerns about the risk betwen antidepressants and suicidality, but no one listened, Ms. Menzeiss says.

Fourteen years later, the FDA finally ordered black box warnings labels on SSRIs alerting physicians about the increased risk of suicidality. Ms. Menzeiss describes the FDA during these years as "complacent, ignoring its own internal scientist when they raise concerns, and in the pocket's of industry."

She believes that the FDA would never have confronted the issue had it not been for the public outcry from victims, consumer groups, courageous experts willing to place their careers on the line, investigative reporters and pressure from certain members of Congress; and yes, "lawyers uncovering the drug industry's dirty little secrets through legal discovery and speaking out about the dangers."

Ms. Menzeiss points out that "the antidepressant contoversy and resultant congressional investigations, and later, the Vioxx public health debacle, have served to highlight deep-seeded problems within the FDA."

Over the past couple of years, a growing number of lawmakers have been turning up the heat on both the FDA and the industry in response to their combined failure to reveal the problems found in studies conducted on drugs like SSRIs and Vioxx.

At one point, Senator Charles Grassley (R-IOWA), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect industry profits and the careers of certain FDA officials.

"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grasley told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.

The results of a trial that took place in 2000, surfaced that showed that the FDA and Merck were aware that heart attacks were 5 times likely in patients taking Vioxx than among those taking a similar drug, Senator Grassley pointed out, but the FDA did nothing to change the labeling for nearly 2 years, he said, while Merck marketed its product on nightly TV.

On November 18, 2004, Senator Grassley drew enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr. Graham, testified that he determined that Vioxx may have caused tens of thousands of heart attacks and strokes, but that his superiors at the FDA pressured him to keep quiet.

"The estimates range from 88,000 to 139,000 Americans," Dr. Graham told the committee. "Of those, 30 to 40 percent probably died," he advised. "For the survivors," he added, "their lives were changed forever."

*This is the end of PART II..........Make sure that you come back for PART III


*I've been thinking about a recent article that I posted called "Unfit for Duty." If you haven't read it, take a look at it. It's about our troops who are being medicated and sent back onto the battlefield. A lot of them are taking Prozac, Zoloft and other anti-depressants. The sad part is that a lot of them are committing suicide and some homicides.

It makes me wonder if this wasn't done by Frist in order for the families of these troops not to be able to file lawsuits against the government for their deaths. I'm sure that it's for other reasons too, as a matter of fact, I know that it's been done for other reasons, but after posting "Unfit for Duty" and posting this article, it shows me what a bunch of creeps this administration and this Republican Congress are actually capable of. They don't care anything about the people. It's their supporters they care for. The ones that line their pockets!


Source: OpEdNews
Story By: Evelyn Pringle
May 13, 2006

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

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