Paragraphs 25 & 26 read: "In early August, Mr. Finz filed a suit seeking $150 million from Lilly on behalf of
Rhonda Hala, a Long Island woman who was given Prozac to treat depression, which he said she had developed after a back injury left her slightly disabled." "While taking the drug, he said, 'she started to exhibit extreme and bizarre behavior. She attacked her doctor and herself, mutilating her chest, legs, stomach, anything to cut into the flesh.' Mr. Finz said that when she was taken off the drug, her violent behavior ended. But he said 'there is no part of her body left that isn't scarred and mutilated.'
http://query.nytimes.com/gst/fullpage.html?res=9C0CE7DA153AF935A2575BC0A966958260&sec=health&pagewanted=print August 16, 1990
HEALTH;
Eli Lilly Facing Million-Dollar Suits On Its Antidepressant Drug Prozac
By NATALIE ANGIER
LEAD: As reports mount that the nation's most widely prescribed antidepressant drug may spark violent or suicidal behavior in a fraction of patients, lawyers and former users of the medication are banding together to file multimillion-dollar lawsuits against the drug's maker.
As reports mount that the nation's most widely prescribed antidepressant drug may spark violent or suicidal behavior in a fraction of patients, lawyers and former users of the medication are banding together to file multimillion-dollar lawsuits against the drug's maker.
In the last three weeks, six lawsuits have been lodged against Eli Lilly & Company of Indianapolis, who manufactures Prozac, seeking a total of more than $300 million in punitive and compensatory damages. Lawyers working on the cases say that they and other lawyers are planning to file dozens of suits in the next few weeks.
Although the specifics vary from case to case, the plaintiffs of all six suits generally charge the maker of Prozac with failure to have tested the drug properly before introducing it on the market in 1987. The suits also contend that Eli Lilly was ''grossly negligent'' for not warning doctors strongly and clearly enough that the antidepressant may sometimes set off aggressive, violent or suicidal behavior.
The lawyers maintain that while their clients were taking Prozac, they became far more hostile, despairing and uncontrollable than they had ever been before, committing extreme acts of self-mutilation, attempting suicide and endangering their families. The lawyers attribute the violence to the psychiatric medication. They say that by presenting its product as relatively safe and free of significant side effects, Eli Lilly has made claims that are ''shocking, absurd and totally misleading,'' said Leonard L. Finz, who heads a New York firm specializing in product liability cases.
Lawyers Relying on Report
All lawyers are relying on a report published in the American Journal of Psychiatry in February by Dr. Martin H. Teicher and his colleagues at Harvard Medical School and McLean Hospital. In that paper, Dr. Teicher described six patients who were free of suicidal tendencies until they started on Prozac. His findings led him to predict that from 1.9 to 7.7 percent of Prozac users may be at risk for mania, obsession with suicide and dangerously violent behavior.
Spokesmen for Eli Lilly, while refusing to discuss the details of any cases under litigation, insist that Prozac was well tested before being marketed, and that it is remarkably safe.
''Certainly our product was adequately tested,'' said Edward West, director of corporate communications. ''Laboratory testing began in 1976. More than 11,000 people participated in clinical trials. To date, more than 2 million patients worldwide have been treated with Prozac. Our experience with Prozac does not show a cause-and-effect relationship between it and suicidal thoughts or acts. Our safety track record has been well established.''
In the last few months, the Food and Drug Administration has received about 10,000 reports from doctors, pharmacists and others of adverse reactions to Prozac. But Dr. Paul Leber, director of the division of neuropharmacological drug products at the agency, said that the vast majority of reported side effects, like agitation or insomnia, are relatively mild and are included on the list of warnings that accompany the drug's packaging.
Caution by F.D.A. Official
Of more severe reactions, he said it was hard to prove a cause-and-effect relationship.
''The trouble is that most of the symptoms described, like violence or suicidal tendencies, are symptoms well known to accompany depression,'' Dr. Leber said. ''To date, we don't see anything about this drug that is associated with an increased risk'' of violence or suicidal tendencies.
Dr. Leber and other experts note that, Prozac notwithstanding, depressed patients are at strong suicide risks. They said that no single treatment for depression was completely effective, and that a certain fraction of patients receiving Prozac or any other medication would be expected to fail to respond to the treatment and thus to continue being at risk for suicide. ''Ten percent of people with a lifelong depressive illnesses probably will kill themselves,'' said Dr. Leber.
Medical experts are mixed in their response to the recent lawsuits against Prozac. On one hand, psychiatrists and other doctors say that many of the latest complaints are exaggerated and misleading.
They insist that Prozac is an extremely valuable drug for treating depression, and say that it has far fewer side effects than do the older generation of antidepressant drugs. The lack of unpleasant side effects like weight gain, sluggishness, dry mouth and hypertension has lofted Prozac to its current position as the best-selling antidepressant.
But a growing number of experts worry that the ease of using Prozac, along with early hyperbolic reports that described Prozac as ''miracle drug,'' has led to its being overprescribed.
Hopes on Future Drug Use
''My main concern about Prozac is that, given the low incidence of side effects, the likelihood has increased that people would use it more casually, and that doctors would monitor its use less intensely,'' said Dr. Frederick K. Goodwin, director of the Alcohol, Drug Abuse and Mental Health Administration and the government's top psychiatrist. ''But this is a powerful drug, and any powerful drug will have powerful side effects. The backlash effect of all this adverse publicity probably will lead to a correction that won't hurt.''
Other doctors agree that if the publicity spurs doctors to be more judicious in prescribing Prozac and more vigilant in monitoring patients taking the drug, the new caution is for the best. But they said they would hate to see Prozac go the way of Bendectin, a drug marketed by Merrill-Dow to treat nausea associated with pregnancy.
In the early 1980's, several lawsuits were brought against the company, contending that the medication caused birth defects. Experts say that there was little or no scientific support for the claims, but as a result of the cost of the litigation, Merrill-Dow took Bendectin off the market.
Mr. West of Lilly said that while the company never comments on specific dollar figures for any particular product, sales for Prozac remain strong. ''There is no basis for even considering'' discontinuing the drug, he said.
Despite the difficulty of proving that Prozac causes violence, lawyers seem eager to pursue litigation. ''There's been a deluge of people coming to us,'' said Terry Hawkins, a lawyer with Morris, Hawkins & Dutton, in Louisville, Ky. ''Right now we're investigating eight or nine cases.''
Suits After Shooting Spree
Mr. Hawkins's firm represents three widows who are charging the pharmaceutical giant with partial responsibility for the deaths of their husbands. The men were among the eight people murdered and 12 others who were wounded when Joseph Wesbecker, an unemployed printer, went on a shooting spree last year at a printing plant in Louisville where he had worked. Mr. Wesbecker then turned the gun on himself.
An autopsy revealed that Mr. Wesbecker had ''therapeutic'' doses of Prozac in his blood at the time. He also had traces of other medications in his blood, as well as a history of mental disorders, but the lawyers in the case contend that Prozac transformed Mr. Wesbecker from a relatively innocuous if disturbed man into a homicidal maniac.
''We're looking at a man with a history of psychiatric problems, but he had never before done anything to carry them out,'' said Mr. Hawkins. ''He was never violent until he started on Prozac.''
The suits, filed on July 25, seek $50 million each in punitive damages from Lilly and unspecified amounts in compensatory damages.
The three other suits that have been filed involve former Prozac users who came close to committing suicide. In early August, Mr. Finz filed a suit seeking $150 million from Lilly on behalf of Rhonda Hala, a Long Island woman who was given Prozac to treat depression, which he said she had developed after a back injury left her slightly disabled.
While taking the drug, he said, ''she started to exhibit extreme and bizarre behavior. She attacked her doctor and herself, mutilating her chest, legs, stomach, anything to cut into the flesh.'' Mr. Finz said that when she was taken off the drug, her violent behavior ended. But he said ''there is no part of her body left that isn't scarred and mutilated.''
Other Suits Against Lilly
On Aug. 8, lawyers in Chicago filed a suit for a salesman in his early 50's, who had been treated for depression since 1985, but who never did anything violent until receiving Prozac in September 1989. Two months later, said his lawyer, Aron D. Robinson of Chicago, ''he attempted suicide by driving his car into the rear of a tractor-trailer.''
Another suit was filed on Aug. 7 in Indianapolis on behalf of Janet Sims, who says she was given Prozac to help her through her marital difficulties, but that she ended up being manic and obsessively suicidal. ''I ended up needing 15 electroshock treatments, just because I'd become suicidal from the Prozac,'' she said.
Dr. Teicher of Harvard says it is unclear why Prozac seems to occasionally spark violence or mania in patients. He says that all antidepressants can cause people to carry out their violent or suicidal fantasies. ''If patients were suicidal before taking antidepressants, their energy level may have been so low that they couldn't act on the impulse,'' he said. ''Sometimes antidepressants can energize them to go ahead and commit suicide before the drugs have a chance to relieve the depression itself.''
But Dr. Teicher believes Prozac is different than the older generation of antidepressants. ''In a small percentage of cases it will take people who aren't suicidal to become preoccupied with suicide,'' he said.
Speculation on Effects
He speculates that Prozac may on rare occasions have that effect because it influences the balance of serotonin, a chemical signal in the brain that is involved in emotion and aggressive behavior. The older antidepressants work largely through other signaling pathways in the brain, he said, affecting the neurotransmitters dopamine and norepinephrine, which do not seem to be as directly involved in modulating aggressive impulses.
''It's possible that the neurochemistry of people who do badly on Prozac is more sensitive, or out of balance in a very particular way,'' he said. ''But it's amazing how little we really do know about the serotonin system.'' But Dr. Teicher said many of his fellow psychiatrists have seen excellent results from Prozac.
''I hear mostly the bad news, and I have to keep on reminding myself that most people are doing tremendously well on the medication,'' he said. ''You have to put this in the perspective of 650,000 prescriptions being written every month.''
PROZAC' SIDE EFFECTS: 2 VIEWS
Lawsuits agaisnt Eli Lilly & Company allege that its antidepressant drug Prozac causes severe side effects, including suicidal and homicidal tendencies. The manufacturer says the drug has relatively few side effects. The Food and Drug Adminsitration says that violence or suicidal tendencies are not unknown among people with serious depression but are not among the adverse effects of the drug seen in clinical trials.
COMMON SIDE EFFECTS LISTED BY MANUFACTURER
* Nervous system complaints: anxiety, nervousness, insomnia.
* Drowsiness, fatigue; asthenia, the loss of strength or energy.
* Tremor.
* Sweating.
* Gastrointestinal complaints; anorexia, nausea and diarrhea.
* Dizziness and lightheadedness.
SEVERE SIDE EFFECTS ALLEGED IN LAWSUITS
* Suicidal tendencies, ideas and obsessions.
* Self-mutilation, attempted and actual suicide.
* Violent behavior; homicidal thoughts, behavior and actual homicide.
Sources: Eli Lilly & Company; Leonard L. Finz, Vernon Petri and Terry Howkins, plantiff's attorneys.