Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy
Mon, 26 Jul 2004
On July 23, 2004, a citizen's consumer protection lawsuit was filed against Pfizer Pharmaceuticals for concealment of evidence and deceptive marketing of the antidepressant Zoloft. The California law firm of Baum Hedlund has filed a suit against Pfizer on behalf of a doctor of public health / nurse and on behalf of "all California residents who have been misled about Zoloft." [press release below]
On May 14, 2004, Pfizer pleaded guilty in federal court to criminal fraud charges for the unlawful promotion and marketing of Neurontin by its predecessor, Warner-Lambert. Pfizer agreed to pay $430 million in settlement.
The New York, the law firm of Finkelstein & Partners, petitioned the US Attorney and the Judge who presided over the Neurontin case to consider the thousands of individuals who have been harmed - many died because their "doctors were fraudulently enticed to prescribe Neurontin." The letter noted that Pfizer "with full knowledge of the problem [ ] knowingly continued marketing the drug for unapproved, off-label conditions, thereby becoming criminally prosperous."
Andrew Finkelstein noted that the firm knew of 160 "Americans who, having never attempted any form of suicide before taking Neurontin, committed suicide while on the drug." Furthermore, he informed the court, he knew of "over two (2,000) Americans who, having never attempted suicide before taking Neurontin, were hospitalized following a suicide attempt while on the drug."
Finkelstein asked the court to hold Pfizer officials personally responsible:
"A prison sentence must be considered when so many lives have been damaged through a clear corporate program of criminal activity."
See, Finkelstein's letter: http://www.ahrp.org/SuitsDecisions/NeurontinPlea0504.pdf (780K pdf)
The United States Attorney states in the government's final Pfizer / Neurontin settlement:
"The Government notes that in a May 18, 2004 letter to the Court, an attorney, who stated that he represents thousands of former Neurontin users, objected to the proposed criminal resolution on, apparently, the ground that it does not go far enough. The United States believes that evaluation of thousands of claims by individual Neurontin users, each of whose experience is unique, would unduly complicate and prolong sentencing. See U.S.S.G. § 5E1.1(b)(2). Moreover, the proposed global settlement does not foreclose the rights of nongovernmental victims to seek redress." [p. 43]
See: United States of America v. Warner-Lambert [Pfizer], US Dist. Mass, CRIMINAL NO. 04-10150 RGS, June 2, 2004.
"Moreover, the proposed global settlement does not foreclose the rights of nongovernmental victims to seek redress." That statement refutes and invalidates the FDA-Bush administration policy that prevents individual citizens from seeking redress for medical injury from products approved by the FDA. [See today's follow-up AHRP Infomail]
The statement was signed by the Michael J. Sullivan, United States Attorney, District Of Massachusetts; Thomas E. Kanwit and Sara M. Bloom, Assistant U.S. Attorneys, U.S. Attorney's Office, Dist. of Massachusetts; and Jill Furman, Trial Attorney, Department of Justice.
FDA's failure to take action to protect public safety from hazardous drugs borders on criminal negligence.
The FDA has yet to require Pfizer to issue label warnings about the alarming suicide risk for patients prescribed Neurontin. Indeed, Finkelstein filed a Citizen Petition with the FDA (May 17, 2004) requesting the addition of postmarketing suicide report information to the Neurontin label.
The petition notes that FDA's Adverse Event Reporting System (AERS) database shows "a substantial increase in [ ] fatalities during the first six months of 2003. There were reports of "eight completed suicides from 1998 through 2002. Seventeen additional suicides recorded for the period between January - June 2003."
The disparity in numbers between actual drug-related harm--such as, suicides and suicide attempts--and the incidents voluntarily reported to FDA's MedWatch demonstrates that voluntarism doesn't work. There is a pressing need for mandatory reporting and disclosure of all serious adverse drug effects.
FDA's failure to perform its regulatory function responsibly - as it is mandated to do, to prevent drug-related harm--has resulted in hundreds of thousands of human casualties--far more than the casualties that resulted from the failure of US intelligence agencies to prevent 9/11.
Too many drugs are being prescribed without physicians' knowledge of the lethal risks.
In hospitals alone, 106,000 Americans die each year due to non-error adverse drug reactions.
In 1994, an estimated 2,216,000 (1,721,000 to 2,711,000) hospitalized patients had serious adverse drug reactions (ADRs) and 106,000 (76,000 to 137,000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.
See: JAMA April 15, 1998; 279(15):1200-5
BioMed Central Nephrology. December 22, 2003
Contact: Vera Hassner Sharav
July 23, 2004
FOR IMMEDIATE RELEASE
Baum Hedlund, A Professional Corporation
12100 Wilshire Blvd., Ste. 950
Los Angeles, CA 90025
Contact: Robin McCall, Media Relations
Day: (800) 827-0087 or (310) 207-3233
Evening and Weekend (818) 681-5697
Pfizer Conceals Evidence and Misleads Doctors and Patients About Safety
and Effectiveness of Zoloft
- Private Attorney General Steps in Because FDA Has Failed California Consumers
Los Angeles, California, July 23, 2004 -- Antidepressant litigation attorney Karen Barth Menzies and her partner, Ronald Goldman, filed suit today alleging Zoloft-maker, Pfizer, misled physicians and the public regarding Zoloft's safety and efficacy, particularly with regard to suicidality and withdrawal symptoms caused by the drug's use.
Today's consumer protection lawsuit was filed in Superior Court in downtown Los Angeles (case number BC318871). The suit details Pfizer's actions and omissions that downplayed Zoloft's risks and exaggerate Zoloft's alleged benefits. Pfizer did so, the complaint alleges, by suppressing evidence concerning: (1) Zoloft's lack of efficacy compared to placebos in treating conditions for which Zoloft is prescribed; (2) Zoloft's propensity to induce withdrawal and dependency; (3) the risk of increased suicidal and violent impulses in adult, child and adolescent Zoloft users; and (4) Zoloft's causing other side effects such as convulsions and psychosis.
The Plaintiff, Roberta Madison, is a nurse and doctor of Public Health. She has brought the action as a Private Attorney General on behalf of all California residents who have been misled about Zoloft. Last month, New York Attorney General Eliot Spitzer filed a similar lawsuit on behalf of all "aggrieved consumers" in the state of New York related to the drug Paxil. California's Unfair Competition Law provides that a private citizen may act as Attorney General on behalf of consumers.
Baum Hedlund is a national law firm representing thousands of antidepressant victims. Through its investigations on behalf of clients that suffered unwarned adverse side effects while using Zoloft, Baum Hedlund has obtained information supporting the complaint's allegations.
Karen Barth Menzies of Los Angeles based Baum Hedlund, stated:
"We are looking forward to working with Dr. Madison in this case to expose the fraud that has been perpetrated against the public by Pfizer. Pfizer has promoted the benefits as huge and the risks as minimal in an extremely deceptive way.
"We have been trying for years to raise public awareness about these issues. We believe that the truth has been suppressed for too long and as a result there has been an enormous waste of money, thousands of people have been harmed by these drugs and many lives have been shattered. We hope this lawsuit will be a significant step toward exposing the fraud.
"Once all the evidence comes out it will become clear that Pfizer was well aware of Zoloft's safety and efficacy issues for many years. Despite this knowledge, Pfizer has continued to market Zoloft as "highly effective," when only one out of five or Pfizer's own clinical trials for Zoloft's license application indicated superiority over placebos. We believe that the evidence will prove that the risks of Zoloft far outweigh any alleged benefits. Because of Pfizer's marketing practices and concealment of the truth, California healthcare providers have not been able to conduct accurate risk/benefit analyses when prescribing Zoloft. Additionally, we have seen many doctors who were unaware of Zoloft's serious side effects and consequently mis-diagnosed them. Where the public health is at stake, there is no room for secrecy and deception."
Public Relations Baum Hedlund RMcCall@BaumHedlundLaw.com 310-207-3233 firstname.lastname@example.org