Zyprexa Targeted by Connecticut LawsuitMar 12, 2008 | Parker Waichman LLP
Zyprexa is the target of yet another lawsuit. Connecticut’s Attorney General, Richard Blumenthal, is suing Eli Lilly over the marketing of Zyprexa. He’s not the only one - at least nine other states are suing Eli Lilly for similar reasons; federal prosecutors are also involved and reportedly in talks over a large settlement with the drug giant. For its part, Connecticut is looking to recover over $190 million it spent on Zyprexa over many years on the grounds that Lilly illegally marketed the Zyprexa for unapproved uses and concealed risks associated with the drug. “The illegal marketing campaign exploited children and senior citizens—causing severe weight gain, diabetes, and cardiovascular problems,” Blumenthal said in a statement. “This scheme involved payments to public officials, bogus educational events, and ghostwritten promotional articles summarizing suspect studies.”
Lilly may be forced pay additional amounts of over $1 billion to state and federal governments stemming from that investigation. The U.S. Attorney's office for the Eastern District of Pennsylvania is investigating Zyprexa marketing and about 30 state attorneys general also have subpoenaed documents detailing Lilly's sales practices for Zyprexa as part of a civil investigation under state consumer protection laws. Lilly also faces other lawsuits from several states and some third-party payers accusing Lilly of promoting Zyprexa’s off-label use for treatments not approved by the U.S. Food and Drug Administration (FDA). A complaint filed in Utah, for instance, accuses Lilly of persuading doctors to prescribe Zyprexa for conditions such as Alzheimer's, dementia, and depression. Lilly representatives deny promoting these off-label uses.
Last month, two shareholders accused Eli Lilly of recklessly disregarding risks posed by illegal drug marketing practices related to its anti-psychotic drug Zyprexa. That complaint, filed by shareholders N.A. Lambrecht and Jeffrey Jannett in U.S. District Court for the Southern District of Indiana, notes that the FDA has taken a strong stance against off-label promotion.
A spokeswoman for Eli Lilly told the Associated Press that the claims in the lawsuit are without merit and the company markets drugs only for approved uses. Regarding the two shareholders who initiated the lawsuit last month, Lilly spokesman Phil Belt says that lawsuit was also groundless. Doctors are free to prescribe drugs for uses not approved by the FDA—off-label uses—however, pharmaceutical companies are prohibited by law from marketing drugs for non FDA-approved uses.
So far, Eli Lilly has paid over $1 billion to settle thousands of legal battles over Zyprexa and these suits are only the latest in a string of challenges over Zyprexa—an anti-psychotic drug approved for treating schizophrenia, acute mania, and bipolar disorder—which has generated both big money in sales and huge losses in litigation for Lilly. Many allege Lilly failed to warn consumers about the potential for diabetes or weight gain associated with Zyprexa, which realized sales of $4.8 billion last year, 25 percent of the company's total sales.
Meanwhile, the first of the trials is taking place in Alaska and according to today’s Anchorage Daily News, a former FDA official is testifying that Lilly downplayed risks associated with the Zyprexa.