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Zyprexa is the brand name for the drug olanzapine and is an atypical antipsychotic used in the treatment of schizophrenia and bipolar disorder. Zyprexa was developed and is manufactured, distributed, and marketed by Eli Lilly & Company (“Lilly”). Zyprexa is the leading atypical antipsychotic on the market and Lilly’s number one prescription product. Total Zyprexa sales in 2005 exceeded $4 billion.
PAL Member Litigation
In November 2006, PAL members joined a lawsuit against Lilly alleging widespread wrongful and illegal marketing, sales and promotional activities for the drug Zyprexa. Specifically, the lawsuit alleges that Lilly deceived physicians, consumers, health plans, and others regarding the safety of Zyprexa as well as the comparative efficacy of the drug to other antipsychotics. The lawsuit also claims that Lilly actively marketed and promoted Zyprexa for uses unapproved by the Food and Drug Administration (FDA) and for which it had never been proven safe or effective (“off-label uses”). These off-label uses included treatment of dementia and Alzheimer’s in the elderly as well as treatment of children suffering from depression, anxiety, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, sleep disorders, autism, mental retardation, Tourettes and anorexia nervosa. Lilly used a variety of tactics to promote the drug, including:
The case is pending in the U.S. District Court for the Eastern District of New York. In January 2006, Lilly filed a Motion to Dismiss. After hearing argument on April 21, 2006, the Court denied the motion. On June 28, 2006, the Court denied the Defendant's Motion for Summary Judgment
Update September 2008:
Plaintiff's Motion for Class Certification was filed in August 2007, leading to the filing of supplemental expert reports in January 2008, and an evidentiary hearing held over six days in March and April 2008. Judge Weinstein issued a lengthy proposed ruling on the certification of a TPP class in June, 2008, followed by a hearing on July 17, 2008. As a result, on September 5, 2008, the Court certified a nationwide class of third party payors (TPPs) who made payments for Zyprexa, whether on or off-label, from June 20, 2001 to June 20, 2005.
The Court declined to certify a consumer class at that time, but may consider it upon resubmission.
A certified third party payor sub-class, made up of all non-governmental entities to pay or reimburse all or part of the cost of Zyprexa from June 20, 2001 to June 20, 2005.
The court may consider future proposals to certify a proposed consumer sub-class, called a direct payor sub-class, which may include ‘all natural persons/individuals in the United States and its territories who, for purpose other than resale, purchased, reimbursed or paid, either in cash or as a percentage copayment, all or part of the price of Zyprexa prescribed, provided or administered to natural persons during the period from January 1, 1996 to the present.