Published: October 08, 2008 10:01 pm            

Indiana gets $1.6M from Lilly settlement

Money part of deal reached on drug company’s improper marketing

TERRE HAUTE — Indiana will receive more than $1.6 million of $62 million that drug maker Eli Lilly & Co. will pay 32 states and the District of Columbia to settle an investigation of improper marketing of the antipsychotic drug Zyprexa.

The settlement, reached Tuesday, “is the largest ever settlement of its kind. It is the most ever in a multi-state consumer protection-based pharmaceutical action,” Greg Zoeller, chief deputy Indiana Attorney General, said Wednesday in a stop in Terre Haute at the Vigo County Courthouse to announce the settlement.

The amount paid to each state is based on population, Zoeller said. As an example, Pennsylvania will receive more than $2.2 million, while Wisconsin will receive more than $1.5 million. Indiana’s portion — $1,602,874 — will be used for future state consumer protection-based pharmaceutical action, Zoeller said.

“The agreement alleged that Eli Lilly illegally marketed the off-label uses for Zyprexa and may have failed to adequately disclose the drug’s potential side effects to doctors and medical providers,” Zoeller said.

“In 2001, Eli Lilly began an aggressive marketing campaign called ‘Viva Zyprexa.’ As part of that campaign, Lilly allegedly marketed Zyprexa for a number of off-label uses including pediatric use, for use at high dosage levels, for the treatment of symptoms rather than diagnosed conditions and in the elderly for the treatment and/or chemical restraint of patients suffering from dementia,” Zoeller said.

While a physician is allowed to prescribe drugs for off-label uses, Zoeller said the law prohibits pharmaceutical manufacturers from marketing their product for off-label uses. The drug is approved for schizophrenia and certain aspects of bipolar disorder, he said.

The Indianapolis-based company released a statement that said while there were no findings that the company violated state laws where the investigations took place, Lilly considered it in the company’s best interest to reach a settlement.

“We believe all of the parties involved share an interest in putting this dispute behind us,” said Robert A. Armitage, Lilly's senior vice president and general counsel. “From our standpoint, it’s certainly in the best interests of the company and the patients, caregivers and health-care professionals who continue to rely on this life-saving medication,” he said, adding that Zyprexa remains available to patients and on formularies for Medicaid programs in all 50 states.

“Lilly’s policies and practices already mirror most of the provisions included in the proposed consent decrees. This resolution reflects our commitment to continually build on a foundation of compliance, accuracy and transparency,” Armitage said.

Eli Lilly has agreed to cease promoting off-label uses and change its marketing practices. The agreement requires Lilly’s medical staff, rather than marketing staff, to be responsible for developing and approving medical content of all medical letters and references regarding Zyprexa, according to the Indiana Attorney General’s office.

Also, Lilly’s medical staff “is responsible for the identification, selection, approval and dissemination of article reprints containing more than an incidental reference to off-label information regarding Zyprexa, and that such information not be referred to or used in a promotional manner,” according to the Indiana Attorney General’s office.

Lilly can provide only product samples of Zyprexa to a health care provider whose clinical practice is consistent with the product’s current labeling.

“This agreement ensures that doctors prescribing Zyprexa are given accurate, objective and balanced information about the drug from Lilly’s medical staff rather than Lilly’s sales, marketing or other non-medical staff,” Zoeller said.

“I think the more transparent the side effects and the known problems and risks of these drugs, the better. It is a question of making sure that communication of all the information is provided to the medical community so that they can use their best judgment in making prescriptions to their patients,” he said.

Illinois and Oregon initiated the lawsuit, but Zoeller said Indiana was one of the early states to join. Zoeller, however, said there were not specific complaints made in Indiana.

“It has taken 18 months to resolve this, but we are happy with this agreement that has been reached and I think it is a positive for the state of Indiana,” he said.

The 32 states participating in the agreement are Alabama, Arizona, California, Delaware, Florida, Hawaii, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington and Wisconsin, as well as the District of Columbia.

Eleven other states (Louisiana, Mississippi, Montana, New Mexico, Pennsylvania, South Carolina, Utah, West Virginia, Connecticut, Arkansas and Idaho) have filed lawsuits over Zyprexa and are not covered by this agreement.

In March, Lilly entered into a $15 million settlement with the state of Alaska, which concluded an ongoing trial involving various issues surrounding Zyprexa. In addition, since 2005, Lilly has settled about 31,000 individual product liability lawsuits alleging that certain adverse events are associated with Zyprexa, according to the company’s Web site.

Since its initial approval by the FDA in 1996, Zyprexa has been prescribed for more than an estimated 26 million patients around the world, according to Lilly’s Web site.

Howard Greninger can be reached at (812) 231-4204 or howard.greninger@tribstar.com.

        

• Click to discuss this story with other readers on our forums.