Attorney General Martha Coakley’s office, along with 32 other attorneys general, reached a record $62 million settlement with Eli Lilly and Company (Eli Lilly) resolving allegations of improper marketing of the atypical antipsychotic drug, Zyprexa.
It is the largest ever multi-state consumer protection-based pharmaceutical settlement, following closely on the heels of the May 2008, $58 million settlement agreement with Merck regarding its product, Vioxx.
Under this settlement, Massachusetts will receive $1,617,000 to fund local consumer education programs and for attorneys fees.
“While we are pleased with this monetary payment by Eli Lilly, it is the comprehensive injunctive relief that will ensure that Eli Lilly does not again mislead consumers or health care providers,” said Attorney General Coakley. “Too often pharmaceutical companies market drugs for improper uses not approved by the FDA. While prescription drugs can benefit consumers, they also can create risks and drive up health care costs when they are marketed irresponsibly by drug companies.”
The complaint, filed today in Suffolk Superior Court, alleges that Eli Lilly engaged in unfair and deceptive practices when it marketed Zyprexa for off-label uses and failed to adequately disclose the drug’s potential side effects to health care providers. In 2001, Eli Lilly began an aggressive marketing campaign called “Viva Zyprexa!” According to the complaint, as part of that campaign, the company unfairly marketed Zyprexa for a number of off-label uses. Eli Lilly illegally marketed Zyprexa for pediatric use, for use at high dosage levels, for treating symptoms rather than diagnosed conditions, and for treating patients suffering from dementia.
Following a twenty month investigation by the state attorneys general, Eli Lilly has agreed to change how it markets Zyprexa and to cease promoting its “off-label” uses, which are not approved by the U.S. Food and Drug Administration (FDA). While a physician may prescribe drugs for off-label uses, it is illegal for pharmaceutical manufacturers to market their products for off-label uses.
The consent judgment, also filed today in Suffolk Superior Court, contains comprehensive injunctive terms that will prohibit Eli Lilly from unfair and deceptive promotion of Zyprexa. The terms, which will remain in effect for six years, also prohibit the following:
misuse of grants and Continuing Medical Education (CME) to market Zyprexa;
inappropriate and conflict-creating payments to consultants and speakers to discuss off-label uses;
samples of Zyprexa for off-label use;
and false and misleading use of scientific data.
The Judgment will also protect consumers by requiring Eli Lilly to provide the attorneys general with an annual list of all health care providers and consultants who were paid more than $100 by Eli Lilly for promotional speaking or consulting, and require Eli Lilly to register all studies and post the results of those studies.
Zyprexa belongs to a class of drugs traditionally used to treat schizophrenia and commonly referred to as “atypical antipsychotics.” While these drugs may reduce the risk of symptoms associated with first-generation antipsychotics, they may also produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia, and other severe conditions.
Of the $1,617,00 settlement:
$1,130,730 will fund a cy press distribution to a non-profit or a state agency, with the express condition that the funds be used to benefit low income or disabled consumers for prescription medications, to fund programs directed at the treatment of mental illness, to promote initiatives that will lower health care costs for Massachusetts residents,or to fund other programs reasonably targeted to benefit a substantial number of persons affected by the covered conduct that is the subject of the consent judgment;
$350,000 will be distributed to the Commonwealth’s Consumer Aid Fund;
$136,570 will cover costs and attorneys fees.
The Massachusetts action was handled by Assistant Attorney General Emiley Zalesky Lockhart with assistance from Division Chief Quentin Palfrey from Attorney General Martha Coakley’s Health Care Division. In addition to Massachusetts and the District of Columbia, the participating states in the settlement are: Alabama, Arizona, California, Delaware, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, and Washington.
Source: Office of Attorney General Martha Coakley, USA