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Prozac on Trial

A book review By Carl T. Bogus

The Power to Harm: Mind, Medicine, and Murder on Trial
By John Cornwell.
Viking. 321 pp. $24.95.

Everyone in Joseph Wesbecker's life disappointed him. His father died in an accident when Wesbecker was only a year old. His mother was not up to the challenges of parenting and placed him in an orphanage. His first marriage was destroyed in part by arguments over what to do about the kids: a younger son with scoliosis, an older son repeatedly arrested for exposing his genitals to strangers. A second marriage ended over hostility with stepchildren. At age 47, Wesbecker was alone.

If anything, Wesbecker's occupational life was even worse. He hated -- even feared -- his job. The high-speed printing facility in Louisville, Kentucky, where Wesbecker worked repeatedly put him "on the folder," a cramped space surrounded by switches. There, subjected to noise and vibration comparable to being inside a jet engine, he was responsible for operating seven three-story-high presses. Wesbecker's co-workers teased him for begging to be given less stressful duties, and his superiors made him work multiple shifts.

Several years earlier Wesbecker made vague threats about harming his second wife's first husband and her daughter. In 1988 he started buying guns: an AK-47 assault rifle, several semiautomatic pistols, hundreds of rounds of ammunition. Wesbecker told a friend he was acquiring weapons "in case he needed them for his bosses"; he told the union president that he "could come in and wipe the whole place out." Wesbecker's threats -- like Wesbecker himself -- were treated with disdain.

He fought against his descent into mental illness. He made twenty-one visits to a psychiatrist, Dr. Lee Coleman, who tried a succession of medications. On August 10, 1989, Coleman put Wesbecker on Prozac, the antidepressant manufactured by Eli Lilly and Company that had been approved as a prescription drug by the F.D.A. two years earlier. But there were some things about Prozac that Lilly never told the F.D.A. and, consequently, that Coleman did not know.

Coleman did not know Lilly had reason to believe that Prozac might exacerbate "suicidal ideation." Suicidal ideation is associated not only with suicide but with acts of violence generally. Since a significant percentage of people suffering from depression experience suicidal ideation, it could reasonably be expected that perhaps 8 percent of people taking an antidepressant like Prozac would already be obsessed with suicidal thoughts. If Prozac did in fact intensify suicidal ideation in some patients, it had the potential of increasing both suicide and externally directed violence in a significant number of people.

Lilly knew that when given Prozac, previously friendly cats growled and hissed; rats became irritable; dogs became aggressive. One might expect that armed with this knowledge, Lilly would carefully explore these tendencies in people. Yet Lilly specifically excluded subjects suffering from suicidal ideation from its clinical trials. Moreover, if subjects on Prozac became agitated or developed suicidal symptoms, Lilly researchers recommended they also be given tranquilizers, thus masking how Prozac alone affected such patients.

In 1984 German authorities informed Lilly that they would not approve Prozac. Through a controversial re-evaluation of data -- Lilly reduced the number of subjects reported to have attempted suicide while on Prozac by deciding that investigators had erroneously concluded that subjects had in fact attempted suicide -- Lilly succeeded in having Prozac licensed in Germany, though German regulators required a warning that patients with suicidal risk should be subjected to "continuous observation."

But Lilly withheld this information from the F.D.A. -- and thus from U.S. doctors. When Wesbecker returned a month later, however, Coleman knew something was wrong. Wesbecker was agitated, suffered sudden alterations in mood and tended to answer questions with inappropriate responses. Coleman suggested he stop taking Prozac. "Don't take me off the Prozac," Wesbecker replied, "I feel it's helped me." Sobbing, he told Coleman that Prozac had made it possible for him to remember a terrible incident: A foreman had forced Wesbecker to perform fellatio on him in front of a third co-worker. Coleman was uncertain whether this was a real event or a delusion. Unable to persuade Wesbecker to go to a hospital for further diagnosis, Coleman instructed him to discontinue Prozac and return in two weeks.

Three days later Joseph Wesbecker arrived at the printing press at 8:37 a.m. and -- armed with his AK-47 and a handgun -- walked methodically through the plant shooting workers. To some he apologized ("I'm sorry, Dickie," he told one pressman before pumping five bullets into him); some he spared ("Hi, John...Get all the way back to the wall, stay the fuck out of my way"). He shot twenty people, killing eight, before shooting and killing himself.

The Power to Harm, by John Cornwell, a journalist for the London Sunday Times and director of the Science and Human Dimension Project at Cambridge University, is about the lawsuit that twenty-seven survivors, relatives and executors of the estates of victims brought against Eli Lilly, and the jury trial in state court in Louisville in the fall of 1994. As the first of more than 160 lawsuits involving Prozac to reach trial, it was an important case, and Lilly pulled out all the stops -- financial, legal and ethical -- to achieve a favorable result.

Plaintiffs argued that Prozac affected Wesbecker's already precarious condition the way a carelessly tossed cigarette affects a pile of leaves. Lilly -- which produces psychotropic drugs on the theory that mood and behavior can be chemically adjusted -- paradoxically tried to persuade the jury that Wesbecker's behavior was determined solely by his upbringing, experience and personality. In a relentless search to find anything in his life that may have contributed to his becoming a mass murderer, Lilly took nearly 400 depositions from Wesbecker's family, friends, neighbors, co-workers and doctors.

But Lilly did not rely on hard work alone: It found a way to subvert plaintiffs' will and compromise the evidence.

Plaintiffs' lawyers wanted to inform the jury that in 1985 Lilly had been criminally prosecuted for concealing information from the F.D.A. about another drug, an anti-inflammatory medication known as Oraflex. Both Lilly and its chief medical officer had pleaded guilty to criminal charges of failing to inform the F.D.A. that Oraflex patients in Britain had died or become ill from liver problems. Judge John Potter, who presided over the Louisville trial, initially held this evidence to be inadmissible in the Prozac case. But Lilly made the mistake of having witnesses testify about how seriously Lilly took its F.D.A. reporting obligations. Plaintiffs argued that the Oraflex story was now relevant to rebut these claims; Judge Potter reversed his ruling.

Then, Lilly and plaintiffs made a secret deal that apparently included a "high-low" arrangement. Under such an arrangement, defendant agrees to pay a set sum to plaintiff even if the jury ultimately decides it has no liability, while plaintiff agrees to accept no more than an agreed-upon sum even if the jury awards a larger amount. The deal in this case went further, however. Plaintiffs' attorneys agreed not to introduce the Oraflex evidence they had fought so hard to put before the jury. And, under penalty of forfeiting payments from Lilly, plaintiffs and their lawyers agreed to conceal the very existence of the deal not only from the public but from the court. When Judge Potter wanted to know why plaintiffs' lawyers did not introduce the Oraflex evidence, they told him they had decided to save it for the later, punitive-damage phase of the trial -- even though they and Lilly had secretly agreed that the issue of punitive damages would never be tried.

The jury, therefore, heard witnesses testify to Lilly's good citizenship with respect to F.D.A. reporting obligations, but it did not learn that Lilly had pleaded guilty to concealing data from the F.D.A. The jury found that Prozac was neither defective nor unreasonably dangerous. Plaintiffs did not appeal.

The existence of the deal came to light seven months later when, during the course of divorce litigation, one of the plaintiffs revealed that Lilly was paying him a substantial sum of money in three installments. Judge Potter scheduled a hearing in chambers to determine whether there had been fraud on the court. The results of that hearing have yet to be made public.

Cornwell does a workmanlike job of reporting the Joseph Wesbecker shootings and the history of the ensuing litigation, but his book is weakest on the most important questions raised by the case, namely: Does Prozac cause violent behavior in some patients? Did Prozac cause Wesbecker to shoot twenty people? How should the courts go about deciding such questions?

The last question is increasingly important. The F.D.A. is the first line of defense against dangerous drugs, but it is often at the mercy of pharmaceutical companies that test their own drugs and provide -- or conceal -- relevant data. The products liability system is, therefore, an essential adjunct to administrative regulation. Injured parties and lawyers working for contingent fees have the motivation and, through the discovery process, the tools to ferret out information that regulators never considered. But to make intelligent decisions the courts must rely on scientifically sound evidence.

Unfortunately, Cornwell fails to examine critically either the available scientific data or the evidence actually introduced at trial. Although he gives passing mention to an article by a Harvard Medical School psychiatrist who reported that six of his patients experienced strong suicidal ideation while on Prozac, and to several other incidents of patients who committed acts of violence while on Prozac, anecdotal evidence alone will not do. If Prozac is taken by an enormous patient population -- and it is the second-best-selling drug in the world -- it is inevitable that some people on Prozac will commit acts of violence, just as it is inevitable that some people who drink milk will do so.

Because products liability law is concerned with the product rather than the manufacturer's conduct, data that would help determine whether Prozac is unreasonably dangerous would generally be admissible even if it were collected after the incident in question. Indeed, one of the great benefits of the products liability system is that it not only uses but helps create scientific knowledge. Litigation drives research. Much of what we know about risks associated with Bendectin and Agent Orange, for instance, was learned after, and in large part because, they became the subject of litigation.

But if the system is to work properly, courts must require scientifically sound evidence. This is important both to insure fairness and to promote the public policy objectives of the system. It should not be enough to take a case to jury to show that Prozac makes animals aggressive; that Lilly constructed its clinical trials to obscure deliberately the question of whether Prozac exacerbates suicidal ideation and with it, presumably, acts of violence; and that a man on Prozac committed horrific acts. Neither the Kentucky court nor John Cornwell seems to have given this sufficient thought.

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