PROZAC DATA WAS KEPT FROM TRIAL, SUIT SAYS
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Although that patent language directly contradicts Lilly's longtime position on Prozac, the Indianapolis-based drug company clearly saw great value in the drug described in the patent.

In December 1998, Lilly paid Sepracor $20 million for exclusive rights to the patent, a portion of which went to Teicher and McLean. Lilly also promised the inventors $70 million in milestone payments depending on the new drug's progress through ongoing clinical trials, and a percentage of sales if the drug is approved and sold.

Three months after that deal was struck, in March 1999, a federal jury in Honolulu began hearing a civil lawsuit Vickery filed on behalf of the two adult children of William and June Forsyth.

A wealthy couple, married for 37 years, the Forsyths had been going through a rough patch in their marriage in late 1992 and early 1993. William Forsyth, 63, began suffering panic attacks, and in February 1993 his doctor prescribed Prozac. After feeling wonderful the first day, Forsyth underwent a change for the worse and admitted himself to a psychiatric hospital. After a week, while continuing to take Prozac, he checked himself out.

On March 3, 1993, 11 days after he began taking Prozac, Forsyth fatally stabbed his wife multiple times with a serrated kitchen knife then impaled himself on the blade. Their children blamed the drug for what they said were their father's completely uncharacteristic acts.

Of some 200 lawsuits filed against Lilly asserting that the use of Prozac led to suicide or violence, the Forsyth case was only the second to yield a verdict. Lilly settled many of the others, and the only other one to reach a jury, in 1994, was widely reported to have been a victory for the company. In fact, it was settled in a secret agreement between Lilly and the plaintiffs.

Lilly obtained its long-sought courtroom victory in the Forsyth case when the jury said the drug could not be held responsible for the murder-suicide. In the suit filed yesterday, however, the Forsyths' children say the victory for Lilly was tainted by the failure to disclose its link to the new Prozac patent and should be set aside for a new trial.

A key element of Lilly's defense was its assertion that if Forsyth suffered from the severe form of agitation his children said led to the deaths, he would have experienced inner and outer restlessness. No one at the psychiatric hospital noticed restlessness in Forsyth before his release, and Lilly's lawyers and expert witnesses used that to rebut his children's case.

In the patent, however, the side effect is described purely as inner restlessness, a condition known as akathisia. Vickery said that difference is crucial because, if the patent had been disclosed at the trial, it would have been a powerful answer to Lilly's argument that outer restlessness characterized by relentless fidgeting was required as evidence of the side effect. It also might have challenged Lilly's overall assertions about suicide, he said.

For instance, a top Lilly scientist, Dr. Gary Tollefson, testified during the trial that it was his opinion "that there is absolutely no medically sound evidence of an association between any antidepressant medicine, including Prozac, and the induction of suicidal ideation or violence."

The new patent's language, and Lilly's purchase of exclusive rights to it, might have convinced the jury otherwise, Vickery said.

Vickery is basing the suit partly on a 1995 ruling by the US Court of Appeals for the 9th Circuit, which includes Hawaii. That case, Pumphrey v. K.W. Thompson Tool Co. of New Hampshire, involved the death of a man who dropped a handgun manufactured by Thompson. The gun fired, sending a bullet through his heart.

The court found that Thompson committed a fraud upon the court by failing to disclose that it had produced a video that showed the same type of gun fired accidentally when dropped. The court said the existence of the video should have been revealed by a Thompson lawyer who knew about it and attended the trial.

Vickery contends that Lilly acted similarly to Thompson because a patent lawyer for the drugmaker attended the Forsyth trial but never disclosed the language on suicide in the patent that Lilly licensed from Sepracor.

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