The State of Connecticut Attorney General’s Office Press Release announced a landmark $25.1 million agreement with drug maker Eli Lilly and Company for allegedly marketing its antipsychotic drug Zyprexa for unapproved uses, and concealing the drug’s serious side effects, for more than a decade.  The Connecticut AG’s office sued Eli Lilly last year for corrupting physicians, pharmacies and administrators at nursing homes and youth detention centers as part of a massive illegal marketing campaign to promote Zyprexa for unapproved off-label uses, including for the treatment of children.  The lawsuit was filed pursuant to the Connecticut Unfair Trade Practices Act and the federal Racketeering Influenced and Corrupt Organizations Act (RICO).  The settlement also requires stronger standards for marketing and transparency to prevent Eli Lilly from rewarding physicians and others for their prescribing practices.

“This illicit multi-billion dollar drug marketing scheme corrupted health care at the expense of taxpayers, senior citizens, children and others who suffered serious side effects from Zyprexa,” AG Blumenthal said. “Eli Lilly was aided and abetted by so-called independent physicians paid handsomely to promote Zyprexa for unapproved off-label uses — ghost writing articles, downplaying dangers, and pitching the product.  Propelled by profits, Eli Lilly promoted Zyprexa recklessly – regardless of danger or FDA rules. Eli Lilly illegally marketed Zyprexa for unapproved uses in children to treat depression and Attention Deficit Disorder, and other uses never approved by the FDA. The result was catastrophic, causing severe weight gain, diabetes and cardiovascular problems in patients.  Eli Lilly promoted Zyprexa with deceitful determination for more than a decade with sham educational events, ghostwritten promotional articles and suspect studies. This meritless marketing misled countless physicians into accepting peer recommendations and prescribing Zyprexa for unapproved and unsafe uses.  More than the money, this settlement stops future harm, preventing practices that may deceive doctors and deprive patients of the right to make informed medical decisions. My office will continue the fight to hold accountable Eli Lilly — and others we are pursuing — who disregard deadly dangers to make a profit.”

Despite only limited studies on its efficacy and safety, and only limited federally approved use, Zyprexa has become the third best-selling drug in the world as a result of Eli Lilly’s illegal promotions.  The Food and Drug Administration (FDA) approved Zyprexa, or olanzapine, only for use in treatment of schizophrenia and bipolar mania. In order to maximize profits, Eli Lilly created illegal enterprises to promote Zyprexa for unapproved uses, while trying to avoid federal prohibitions against off-label drug marketing.  Doctors, falsely claiming independence, urged peers at “educational forums” to prescribe Zyprexa; ghostwriters published articles that promoted off-label prescribing, omitting details about serious side effects; and public officials in various states promoted Zyprexa for unapproved uses in adolescents at detention centers and nursing homes.  In reality, Eli Lilly paid these “independent” physicians and authors generously and concealed the financial arrangements by funneling compensation through its illegal enterprises and third parties. In some cases, Eli Lilly provided physicians and other participants tens of thousands of dollars in payments, grants and other compensation.  Eli Lilly also illegally promoted Zyprexa for the treatment of children suffering from depression, anxiety, Attention Deficit Disorder, Attention Deficit Hyperactivity Disorder, sleep disorders and generally as a mood stabilizer. Zyprexa has never been approved by the FDA for any use in children, not even for children with schizophrenia or bipolar disorder.

Through the Connecticut Medical Assistance Programs (CMAP), the state pays for part or all medical benefits for enrollees, including pregnant women and newborns, adults with disabilities, people age 65 and older, and people living in nursing homes.  Between 1996 and 2006, the CMAP spent millions on Zyprexa — and millions more to treat injuries related to the use of Zyprexa.

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Douglas K.W. Landau is admitted to practice in DC, VA, CT, FL, and NJ. Abrams Landau services clients in Washington DC, Pennsylvania, PA, Maryland, MD, Virginia, VA (including Northern Virginia, Fairfax county, Loudoun county, Herndon, Reston, and more), Connecticut, CT, Georgia, GA, Florida, FL, New Hampshire, NH, New York, NY, New Jersey, NJ, Maine, Massachusetts, MA, Rhode Island, RI, North Carolina, NC, and South Carolina, SC.

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