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Congress of California Seniors v Pfizer, Inc. (maker of
Neurontin)
Amount At Issue: $$$ PENDING
Category: Drugs / Medical
Date Added to Site: 2/25/2003
Stage: Opposed

CASE OVERVIEW

Congress of California Seniors Take Pfizer to Court Over Off-Label
Promotion of Neurontin A class action has been filed against
pharmaceutical manufacturer Pfizer and its subsidiary Parke-Davis, on
behalf of members of the Congress of California Seniors and its
affiliates, alleging that the companies harmed consumers of the drug
Neurontin (gabapentin) by cir***venting drug approval regulations set up
by the U.S. Food and Drug Administration (FDA), and promoting
scientifically unproven "off-label" use of the drug. The action cites
violations of the California Unfair Competition Law in the companies'
efforts to deceive consumers by managing the publication of misleading
scientific articles and falsely and deceptively marketing Neurontin for
uses for which no valid scientific data existed. The action also asserts
that Parke-Davis violated California laws forbidding untrue and
misleading advertising. The action asks the court to order the companies
to immediately stop promoting Neurontin off-label use, to disgorge the
profits they received through illegal practices (which will be used for
redress for injuries to consumers), and to publish notice of the truth
regarding Neurontin.

The action alleges that in 1995 Parke-Davis decided that it did not want
to undertake the clinical trials that FDA requires in order to approve
new uses for a prescription drug because it would be too expensive and
time consuming. The company instead created an illegal promotional
campaign to get more patients to use the drug, Neurontin, which had only
been approved for epilepsy. Disguised as "medical education" for the
doctors or "consulting" for the company, that campaign allegedly
included illegal cash kickbacks to physicians and other sales ploys to
pump up sales of the drug for non-FDA approved uses.

The FDA gave Parke-Davis approval to market Neurontin as an epilepsy
drug in 1993. The company decided to launch a broad campaign to promote
the drug for treating at least 13 separate conditions, including
migraines, bipolar disorder and restless leg syndrome by hiring outside
firms to help exploit a loophole in government regulations that prohibit
the promotion of drugs for unapproved uses, except in published research
and medical education.

The action cites an internal Parke-Davis memo that reads: "Did it make
sense for Parke-Davis to do rigorous and expensive clinical trials to
prove to the FDA that Neurontin worked for the [other uses]? It did
not."

According to the action, Parke-Davis recruited and paid numerous
physicians to participate in sham studies that the company then
publicized to persuade other physicians to prescribe Neurontin in doses
far higher than FDA authorizes. In addition, the action charges, the
company paid physicians to attach their names to scientific articles
promoting the off-label use of Neurontin, even though the articles were


authored.

The action contends that Parke-Davis also recruited
physicians--including those who wrote high volumes of Neurontin
prescriptions--to act as consultants to the company, paying them to
attend meetings at hotels and resorts. In this scheme, physicians were
not required to provide consulting services, but instead sat through
presentations by the company which were designed to influence their
prescription-writing behavior.

The action notes that the off-label uses Parke-Davis promoted are not
medically accepted by the American Hospital Formulary Service Drug
Information, or any relevant peer-reviewed literature. Parke-Davis was
acquired by Pfizer when it bought Warner-Lambert in 2000. Parke-Davis
was successful in its off-label strategy. Published reports state that
78 percent of Neurontin prescriptions had been written for treatments
other than epilepsy, earning sales revenues of $1.3 billion.