Suicide teen’s doctor should have warned of Prozac’s side effects, manufacturer says — (Naples Daily News)

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Naples Daily News

By CHRIS W. COLBY, cwcolby@naplesnews.com

February 25, 2005

The Prozac pills a federal lawsuit says led to Billy Willkomm’s death weren’t defective and didn’t cause the 19-year-old’s suicide, according to court papers filed by an attorney representing the antidepressant’s maker, Eli Lilly and Co.

In an answer and affirmative defenses to the lawsuit in U.S. District Court filed by Naples builder William J. Willkomm III, the attorney representing the Indianapolis-based drug company wrote Billy Willkomm may have misused the drug, which also could have been tampered with after it left Eli Lilly’s control.

Willkomm hanged himself on July 18, 2002, with a black Nintendo cord from a ladder at his parents’ home. There was no suicide note, but in the last of four cell-phone messages he left his younger sister, Kimberly, Billy said, “Kim you have nothing to do with it. I’m messed up in the head. It has nothing to do with you.”

The lawsuit blames the death on seven companies as producers or distributors of the drugs Billy took. The suit seeks $10 million in compensatory damages for “great mental anguish, emotional distress and loss of consortium” because of Billy’s death. It seeks another $10 million in punitive damages, plus $8,000 for funeral expenses.

The suit, filed July 16, 2004, in Fort Myers, claims the medicine Billy had taken since 2000 had worsened his mental illness and alleges the companies named in the suit failed to inform the public and medical community that Prozac “increased the risk of personality change and suicide among certain teenage males.”

The response filed Wednesday by Miami defense attorney Rafael Cruz-Alvarez argues the prescribing physician, not Lilly, had the duty to warn the Willkomms of possible side effects of the drug. The attorney also argues Willkomm’s claims are faulty because of the delay in filing the suit and may be barred by the statute of limitations. And the injuries Billy Willkomm suffered were caused by “an operation of nature or an act of God and are not the result of Lilly’s conduct.”

“Prozac is not a defective product in that its design, manufacture, inspection, packaging, warning and labeling conformed to the generally recognized state of the art at the time the product was designed, manufactured, packaged and labeled,” according to Cruz-Alvarez’s defense.

Any misuse of the product or dangers caused by its use were because of “acts of omissions” of others and were out of Lilly’s control, according to Cruz-Alvarez, who wouldn’t comment Thursday on the case or his defenses.

“The sole and/or partial proximate cause of damages claimed was due to the carelessness, recklessness, negligence, fault and/or strict liability of the plaintiffs,” according to the court papers.

The main defendant in the suit, Eli Lilly, was the first to patent and distribute Prozac in the United States in 1987. The safety of Prozac, an antidepressant, has been “thoroughly studied in clinical trials with more than 11,000 patients. There have been more than 3,500 publications on Prozac in medical/scientific journals,” according to the company’s Web site.

William Willkomm, a North Naples resident, filed the suit under the Florida Wrongful Death Act. His son, who had been an accomplished wrestler at Naples High School, was a University of Florida student. His doctor diagnosed him with mood-order depression when he was 16 as a result of a chemical imbalance in his brain. The symptoms included rapid mood swings, racing thoughts and feelings of despair. They would come unprovoked, often at night.

An autopsy revealed no drugs in his system or evidence to suggest his death wasn’t self-inflicted.