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On Sept. 4, a federal court in Utah ruled against Eli Lilly which sought to absolve itself of Zyprexa liability.
The State of Utah sued Eli Lily alleging that the State had paid for inappropriate, unnecessary and unauthorized off-label use of Zyprexa, and that it was entitled to relief including the future costs of care for Medicaid recipients allegedly harmed by the drug.
Lilly invoked FDA's Preemption Rule which claims sole jurisdiction over drug safety issues.
This gift to the pharmaceutical industry was crafted by FDA's chief counsel, Daniel Troy, before he went back to a law firm representing pharmaceutical companies.
In effect, FDA preemption would deny citizens the right to seek relief for preventable harm caused by manufacturers' failure to warn about serious adverse effects linked to their FDA-approved prescription drugs.
The court rejected Lilly's effort to remove the case from state court jurisdiction underscoring the court's "presumption against preemption." In an almost conclusory fashion, the Utah district court cited the following precedents:
1. Supreme Court Justice Scalia’s bon mot in Alexander v. Sandoval, 532 U.S. 275, 291 (2001), that “[a]gencies may play the sorcerer's apprentice but not the sorcerer himself.” (In Sandoval, Scalia was referring to agencies’ power to create a federal
cause of action; here, the same metaphor is applied to agencies’ power to preempt state law.)
2. An earlier district court opinion from Louisiana which rejected FDA's assertion of preemption: “To take such drastic action based solely on a preamble inserted at the eleventh hour and drafted by an agency without the express or implied authority to abolish such remedies is Draconian and unacceptable.” More www.ahrp.org and http://ahrp.blogspot.com Daniel - Haszard www.zyprexa-victims.com
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http://fdanews.com/newsletter/article?issueId=10745&articleId=98697
RxTrials Institute Drug Pipeline Alert
Sept. 20, 2007 | Vol. 5 No. 185
Pharma Blog Watch
Zyprexa Side Effects Turn Psychiatrists Off (Pharmalot)
In his blog, Ed Silverman discusses the downturn in the number of prescriptions written for Eli Lilly’s antipsychotic drug Zyprexa with the news that the drug can cause weight gain and diabetes.
According to a recent survey by market-research firm Decision Resources, 86 percent of psychiatrists are writing fewer prescriptions for the drug.
-tell the truth don't be afraid-