The 47-page, five-count suit - filed this month on behalf of two South Florida women and a class of people in similar situations - says the patients were both prescribed Neurontin for conditions not approved by the federal Food and Drug Administration, which authorized the drug only as a supplementary treatment for epilepsy and certain nerve pain relating to shingles.
“The outrage is the deceptive practices of Warner-Lambert (now Pfizer) hurt people suffering from serious medical conditions”
Instead, the suit says, Warner Lambert and its Parke-Davis, Inc. subsidiary - both acquired by Pfizer in 2000 - launched, in the late 1990s, an illegal, deceptive and highly profitable scheme to get doctors to prescribe the drug as a primary medication for such unauthorized uses as bipolar disorder, nerve pain and neuropathy, among a host of other uses.
"The outrage is the deceptive practices of Warner-Lambert (now Pfizer) hurt people suffering from serious medical conditions," said Omar Malone, a lawyer with Freidin & Brown, who represents the women. "People rely on drug manufacturers to provide some measure of relief. And rather than provide relief through approved FDA medications, Warner-Lambert went behind the FDA's back to promote these drugs to the most vulnerable in our society. This drug was promoted big-time among people with bipolar syndrome, for instance. We have fielded hundreds of calls on this, including people who have suffered side effects, and expect to file more suits shortly."
The suit alleged Shirley Levin of Boca Raton and Ana Medero of Miami were prescribed Neurontin for neuropathy, an unapproved use. Malone said Levin spent nearly $5,000 out of pocket for the drug, and Madero spent $10,000 and suffered hallucinations and other side effects.
The suit was filed against Pfizer, Warner Lambert, which manufactured and marketed the drug through its Parke-Davis subsidiary before Pfizer acquired it in 2000, and Parke-Davis. The suit charges the defendants with violations of Florida's Deceptive and Unfair Trade Practices Act, negligence, unjust enrichment, breach of implied warranty of merchantability, and breach of implied warranty of fitness for a particular purpose.
Like the criminal charge that preceded the civil suit, the action provides a window into the manner in which drug companies use sophisticated tactics to promote drugs for unapproved uses to goose up their profits.
The government charged, and the suit alleges, that Pfizer goosed up sales for the drug through non-approved uses by flying doctors to lavish resorts, paying them kickbacks as consultants' and speakers' fees for unapproved uses, and fired salespeople if they didn't recruit enough doctors to prescribe Neurontin for pain. The government also said Pfizer suppressed a study revealing the drug to be less effective than a sugar pill placebo in treating bipolar disorder, leaving both doctors and patients uninformed.
The case against Neurontin goes back to 1996, when Warner-Lambert employee and whistleblower David Franklin revealed the scheme to the government.
Although Pfizer agreed to pay $430 million in criminal and criminal penalties in pleading guilty last May, that payment was a fraction of the drug manufacturer's $2.7 billion in sales from Neurontin in 2003, up from $97 million in 1997.
Since 1974, Freidin & Brown has represented seriously injured people in their claims for justice and compensation against insurance companies, large corporations, doctors, nursing homes and other wrongdoers.
(Ana Medero and Shirley Levin v. Pfizer, Inc., Warner-Lambert and Parke-Davis, Inc., Miami-Dade Circuit Court, 11th Judicial Circuit, Case No. 04-17021-Ca 32).
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