Drug Manufacturer Eli Lilly Settles Zyprexa Legal Issues in Pennsylvania


Posted on Oct 29, 2008

According to the Associated Press, pharmaceutical drug giant Eli Lilly has finally settled a 32-state legal issue revolving around their drug Zyprexa. Although the drugmaker did not admit wrongdoing as part of the settlement, the company will split $62 million between the states, which include Pennsylvania.

Zyprexa is a drug used for the treatment of a number of mental disorders, including schizophrenia, depression, mania, and bipolar disorder. However, Eli Lily was accused of marketing the drug for other uses not yet approved by the Food and Drug Administration, such as pediatric care and dementia. The drug was also marketed for use at higher doses than those tested and approved by the FDA.  


As the law stands currently, doctors are allowed to prescribe drugs to patients for uses aside from those approved by the FDA, but the companies that manufacture the drugs may not advertise the drugs for situations outside of the approved uses - often referred to as "off-label" uses.

Some of the accusations also claimed that the drug's marketing of the drug did not accurately or thoroughly disclose the drug's side effects, which include weight gain, dry mouth, dizziness, insomnia, urinary retention, sedation, seizure, trouble swallowing, missed periods, runny nose, low blood pressure, impaired special orientation, apathy, increased appetite, and impaired judgment.

In addition to the cash settlement, the company also agreed to a handful of mandates moving forward. Aside from halting misleading claims and shady marketing efforts, Eil Lilly also agreed to make the medical staff - not the marketing staff - act more responsibly in regards to written content produced about Zyprexa.

Although Zyprexa has been profitable for the company - racking up $4.8 billion in sales just in the last year - the drug company has also struggled with over 31,000 product liability claims against the drug in the last two years. So far, the claims have led to $1.1 billion in legal fees and settlements.

Specifically in Pennsylvania, a number of different groups, from insurance companies to unions to individuals, are suing Eil Lilly for a number of reasons, ranging to the price of the drug to the marketing of off-label uses. A federal judge has granted the pkaintiffs a class-action lawsuit.

"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.

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