Eli Lilly and Co. entrusted the task of defending Prozac's reputation to a Lilly executive with broad political and public policy experience. Mitchell E. Daniels Jr. served as a top aide to President Ronald Reagan and was president of the Hudson Institute before joining Lilly in 1990.
He quickly found himself in pitched public relations battles with trial lawyers and the Church of Scientology.
The lawsuits and the religious sect charged that Prozac drove some people to commit suicidal acts and violence.
Lilly rejected the health claim, made in hundreds of lawsuits. However, Daniels said, "we took it as a deadly serious matter."

The reason: Lilly executives believed "the American litigation system is ludicrously out of control. Products and companies have been ruined without factual or scientific basis in the past," Daniels said.
The recent comments to The Indianapolis Star by Daniels, 51, who is now senior vice president of corporate strategy and policy, were the first a Lilly executive has made outside a courtroom about the decade- long Prozac litigation.
Early on, he said, "the purpose of the litigation was to try to cow Lilly, or intimidate Lilly, through publicity."
But by the mid-1990s, the number of lawsuits fell dramatically, Daniels said, as litigants realized "Lilly was not going to buckle under."

A key victory for Lilly came in December 1994, when the first Prozac case to go to trial produced a jury verdict in the company's favor.
"It showed Lilly was willing to go right to the wall on the facts and the science," Daniels said. "We weren't going to be run off, and it showed others this wasn't a fruitful line to take."
Daniels acknowledged the verdict was tainted by charges that Lilly struck a secret deal during the trial in Louisville, Ky., to pay off the plaintiffs.
"I sure wish we had just stayed pat" and not done the deal, he said. "We lost a good part of the advantage we would have gained by letting the process finish . . . without any cloud whatsoever."

The secret deal provoked separate lawsuits against Lilly and the plaintiffs' lead lawyer, Paul Smith of Dallas, filed by other trial lawyers with Prozac cases.
"When sharks turn on each other . . . it's an interesting phenomenon," Daniels commented.
He said Prozac users and the mental health community as a whole have benefited from Lilly's legal defense against the trial lawyers and Scientologists.
"If these people had killed Prozac in '91 and '92, there would have been a terrible human cost in people not seeking treatment or not having the safest and best treatment available to them. The entire view of depression in this country would have been set back years."
Daniels said Lilly's Prozac strategy wasn't affected by the suicide in May 1994 of Marilyn Tobias, the wife of Lilly's then-president, Randall Tobias. Tobias told a magazine in 1995 that his wife was depressed and had tried Prozac.

"It was a terrible personal tragedy, and that is all," Daniels said. "Our defense of the product never wavered for an instant."
Asked if there was any company reassessment of Prozac's safety profile, prompted by Marilyn Tobias' suicide, he replied simply, "There wasn't."
Daniels displays a wry memento of the legal fight over Prozac in his office in the 12th-floor executive suites. He was personally sued by the Church of Scientology for libel.
Lilly's lawyers gave Daniels a plaque displaying the newspaper quote that prompted the suit, the Virginia Supreme Court ruling in his favor, and a check for about $7,500 that the Church of Scientology was ordered to pay to Daniels and Lilly.
"I posted it as a reminder of those difficult days," Daniels said.

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Keywords: BUSINESS; DRUGS; OFFICIALS; LAWSUITS; ELI LILLY & CO; MITCHELL DANIELS; PROZAC; LAWSUITS
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