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Oct 21, 2004 | Andrews Litigation Reporter Royster v. Eli Lilly & Co.

Pharmaceutical giant Eli Lilly & Co. has been named in a $280 million suit that claims a Florida man who used its schizophrenia drug Zyprexa for seven years is in danger of developing diabetes, hypoglycemia and similar ailments because Lilly never fully disclosed the associated risks.

Royster et al. v. Eli Lilly & Co., No. 04-4158, complaint filed (E.D.N.Y. Sept. 24, 2004).

In a suit filed in federal court in Brooklyn, N.Y., Helene Royster says her 23-year-old son Stephen "has developed, or is at an extremely high risk for developing" diabetes mellitus, pancreatitis, hyperglycemia, diabetic ketoacidosis and diabetic coma because Lilly has promoted Zyprexa as being safe and effective even though it knew or should have known the drug causes "unreasonably dangerous" side effects.

She says Stephen took Zyprexa from 1997 until discontinuing it earlier this year.

Seeking $40 million in compensatory and punitive damages on each of seven different causes of action, Royster says her son has been placed in danger due to Lilly's failure to conduct adequate pre- and post-market testing on the drug and its decision to under-report, underestimate, and downplay the drug's "serious and dangerous" side effects.

The suit asserts that Zyprexa has been one of Lilly's most popular drugs since receiving federal approval to be marketed as an atypical antipsychotic medication for schizophrenia in 1996 and, in 2000, for treatment of bipolar mania.

Royster says the drug, which reduces symptoms of schizophrenia by blocking various serotonin and dopamine receptors, has been shown in recent studies in Europe and Japan to cause severe and permanent injuries, including changes in patients' blood glucose levels. A 2002 study at Duke University, she says, documented "nearly 300" cases of diabetes in Zyprexa users.

The suit notes that while both British and Japanese pharmaceutical control agencies have issued public warnings about the risk of diabetes for Zyprexa users, Lilly itself has yet to issue such warnings. "There is no warning about the danger of developing diabetes on Zyprexa's label or product information in the United States," it adds.

Royster says her son has "endured or continues to suffer from mental anguish and psychological trauma of living with the knowledge" that he may have, or will soon develop, diabetes or any of the related ailments as a result of Lilly's improper conduct.

The suit includes causes of action for negligence, strict products liability, breach of express and implied warranties, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation.
The plaintiffs are represented by Jerrold S. Parker of Parker & Waichman in Great Neck, N.Y.
Company: Eli Lilly & Co.

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