Santa Rosa Woman Wants Prozac Users Warned Of Possible Side Effects Legal Case Puts Drug To Precedent-Setting Test December Court Date— (The Santa Rosa Press Democrat)

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The Santa Rosa Press Democrat, (CA)

August 7, 1995

Author: James W. Sweeney, Staff Writer

A state law designed to protect consumers from deceptive advertising is being invoked in a novel legal case headed for trial in Sonoma County to challenge the use of a popular but controversial anti-depressant drug. Donna Christy of Santa Rosa, who survived a 1990 suicide attempt, contends her psychiatrist failed to fully disclose the potential side effects of using the drug, Prozac, to combat depression.

An arbitrator ruled in her favor, but the psychiatrist rejected the decision and demanded the case go to trial in Superior Court.   Both sides have described it as a test case that could extend the boundaries of consumer-protection law into the realm of medical malpractice cases.

However, it has been largely overshadowed by litigation in Kentucky stemming from a 1989 shooting rampage during which nine people were killed and 12 wounded. The gunman was using Prozac and relatives of the victim blamed it for the massacre.   Christy, a 36-year-old chiropractic assistant, says she wants to force doctors who prescribe the drug to thoroughly explain any potential adverse reactions.   “To me, it’s very cut and dried,” she said.  “I really don’t understand why they don’t agree to notify their patients of the side effects.”

Dr. Serge Abramovich, a psychiatrist who treated her in 1990 and 1991, disputes contentions the side effects of Prozac can include violent or suicidal behavior.  He declined to be interviewed for this article, citing the pending litigation, but issued a written statement saying the drug   “is a safe and effective medication” and neither the government nor the manufacturer requires any warning about suicide.

A judge refused to dismiss the lawsuit on motions filed by lawyers for Abramovich and Dr. Stephen Frye, a former Sonoma County mental health director who operates the clinic where Christy went for treatment in 1990 and 1991 after her marriage broke up.

Custody of children denied

She attempted suicide after about a month of therapy, taking a handful of tranquilizers. But she quickly called for help and court papers say her doctors question whether it was a true suicide attempt. However, papers say it was a factor in a judge’s decision to deny her custody of her two children.   Her lawsuit was filed in 1993 and the case was referred last year to an arbitrator, who sided with Christy in a non-binding decision issued last month.

Abramovich, however, rejected the arbitrator’s order to provide a written statement to his patients, saying there is divided opinion in the medical community and some studies  “t end to indicate that Prozac can increase depression in some patients and may result in suicidal ideation and violent behavior.”  The case is set for trial before a Superior Court judge in December.

In his written statement, Abramovich said  “there is no reliable scientific evidence that Prozac causes suicidal behavior” and  “I believe it is not appropriate for one relatively uninformed person, such as an arbitrator, to dictate how physicians in general and psychiatrists in particular should treat their patients.”    Prozac, made by Eli Lilly & Co., has been prescribed for about 16 million people since its introduction in 1987. It generates $1 billion in sales annually.

Variety of uses

In addition to its use as an anti-depressant, the Food and Drug Administration recently approved it for treating bulimia. Canadian researchers recommended it to relieve symptoms of premenstrual syndrome and some veterinarians have used it to treat dogs.   But it also has been the subject of heated disputes about its side effects with allegations and lawsuits beginning in 1991. Some researchers and the Church of Scientology contend the drug causes homicidal and suicidal tendencies in some users.

A special FDA panel rejected those claims but the debate has persisted, fueled by the Citizens Commission on Human Rights, an arm of Scientology, an organization that generally distrusts psychiatric medicine and offers its own program for depression.   Christy, a onetime volunteer for the human rights commission, and her lawyer are members of Scientology. Both deny the church played any role in her lawsuit.   “My religious association is nobody’s business but my own,” she said.

Would force disclosure

Her lawsuit is unique in that it seeks to force disclosure through a state law against false advertising. The key difference between that law and a traditional malpractice case is the issue of informed consent, or negligence.  “All you have to prove is there was a misrepresentation,” said James Jackson, a Glendale attorney representing Christy.    It’s really a powerful tool in the hands of a consumer.”    Legal experts said the false advertising approach is unusual but attorneys have been seeking a variety of avenues around the state’s medical malpractice law, which places strict limits on monetary damages and sets high thresholds of proof.

“A lot of us have speculated over the years that with these claims for drugs or HMOs or other medical services with TV commercials and the like you were setting yourself up exactly for that issue,” said Sheldon Davidow, a Napa attorney and insurance consultant.   Davidow, a former executive of The Doctors Company, the state’s largest provider of malpractice insurance, said he was unfamiliar with the details of the Christy case but “there are certainly issues there that may in fact be precedent setting.”    Jackson settled a similar case involving Prozac out of court after the judge refused a motion by the psychiatrist to dismiss the suit. In another case filed by Jackson, the judge did dismiss the suit and that ruling is on appeal.   A novice lawyer when he filed the case two years ago, Jackson said he got the idea for the consumer-protection suit from a fellow lawyer who built his practice around California’s lemon law, which regulates complaints about defective cars.

Suit evolves

In court papers, Abramovich’s attorneys have complained Jackson is pursuing the suit as “a test case” of a new theory for challenging medical treatment. The suit was rewritten several times following objections by Abramovich, but efforts to have it dismissed outright as an encroachment on a physician’s practice were unsuccessful.

Although there have been several lawsuits filed against Lilly and doctors who have prescribed the drug, only one has come to trial. A jury in Louisville ruled last year that Prozac was not to blame for Joseph Wesbecker’s shooting attack at a printing plant in 1989.   The judge in that case now is trying to have the verdict revised because he learned Lilly settled out-of-court with the plaintiffs before the case went to the jury.   Details of the settlement were confidential, but Judge John Potter said he believes the terms included an agreement to withhold from the jury evidence Lilly failed to tell federal regulators about adverse reactions by users during tests of another drug it makes, the arthritis remedy Oraflex.

Potter and Lilly are sparring before Kentucky appellate courts over his effort to list the case as settled rather than decided by a jury in favor of the Indianapolis-based pharmaceutical company.   An appeals court ruled for Lilly in June but the judge has asked the Kentucky Supreme Court to review the decision.   Lilly is not named as a defendant in the Santa Rosa case.

Record Number:  9508070028