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Lawsuits over antidepressants claim the drug is worse than the disease.

Jeremy Lown, a South Carolina teenager, suffered from Tourette's syndrome. To treat his uncontrollable tics and verbal outbursts, his neurologist prescribed the antidepressant Prozac. Three weeks after starting the medication, Jeremy hanged himself in the woods behind his house.

Vicky Jo "Brynn" Hartman of California was given a sample pack of Zoloft by her child's doctor. She was not diagnosed with--or even evaluated for--clinical depression, anxiety attacks, or any other psychological disorder. She merely mentioned she needed a "pick-me-up" to help with stress. Soon after starting the medication, she shot her husband, comedian Phil Hartman, and then herself.

Gary Piccirillo of Florida took Paxil for three years to treat bipolar disorder. When he tried to stop taking the drug in 2000, he experienced severe withdrawal symptoms including dizziness, sweating, nightmares, hallucinations, severe nausea, heart palpitations, and sensations like electric "zaps" and "jolts." He resumed the medication three weeks later, but continued to experience some of the symptoms. In 2001, he attempted suicide.

Once considered wonder drugs, these antidepressants have reportedly helped millions of people with depression and anxiety disorders. Yet the drugs have had disastrous consequences for others. The manufacturers insist the drugs have only mild side effects and are non-habit-forming. Plaintiff attorneys across the country disagree, and they are working to debunk the drug makers' claims and obtain compensation for people allegedly harmed by the drugs.

Claims have been filed across the country, charging that the drugs prompted users to behave violently. In 2001, a Wyoming jury awarded substantial damages to the relatives of Donald Schell, who killed his wife, daughter, granddaughter, and then himself while on Paxil. (Tobin v. GlaxoSmithKline, No. 00-CV-0025 (D. Wyo. June 6, 2001).) The suit filed by Jeremy Lown's family is scheduled for trial this month in South Carolina. Class action suits have been filed in California and in British Columbia, Canada, alleging that Paxil is addictive and leads to severe withdrawal symptoms.

Prozac (fluoxetine hydrochloride), Zoloft (sertraline hydrochloride), and Paxil (paroxetine hydrochloride) are selective serotonin reuptake inhibitors (SSRIs), medications that block serotonin--a neurotransmitter that controls mood--from being absorbed into brain cells. Leaving more serotonin in the gaps between cells, according to the makers' promotional material, allows more efficient transmission of electrical signals to the brain, which in turn increases the patient's feeling of well-being.

Since Eli Lilly and Co.'s Prozac was first approved in 1987--Pfizer, Inc.'s Zoloft followed in 1991 and GlaxoSmithKline's (GSK) Paxil, in 1992--the manufacturers have aggressively marketed SSRIs as safe and effective treatments for depression and a variety of other ills. The Food and Drug Administration (FDA) has approved the drugs to treat conditions such as panic attacks, post-traumatic stress disorder, obsessive-compulsive disorder, premenstrual dysphoric disorder, bulimia, and social anxiety disorder. Prozac has even been approved for children.

By 1997, Prozac was the fifth-most-prescribed drug in the United States; Zoloft was 11th; and Paxil, 17th.

Violence and suicide

In 1990, one of the first public reports of Prozac's propensity to induce suicide appeared in an American Journal of Psychiarty article by two Harvard psychiatrists and a registered nurse. (Martin H. Teicher et al., Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment, 147 Am. J. Psychiatry 207 (1990).)

One of the authors, Dr. Jonathan Cole, testified in a 2000 wrongful death case, "The SSRI drugs, as a class, clearly have the potential to cause, and in reasonable medical probability or certainty do cause, akathisia in some patients ... [which could] trigger or contribute to violent or suicidal behavior."

Akathisia is a neurological phenomenon characterized by intense internal restlessness, agitation, aggression, and suicide attempts. Some patients describe it as wanting to "jump out of their skin." They have reported it as a side effect of Prozac, Zoloft, and Paxil. The makers have defended the drugs for over a decade by saying that most patients taking SSRIs suffer from clinical depression--and that depressed people can be suicidal.

Now, though, plaintiff attorneys think that the companies' strategy--blaming the disease, not the drug--is unlikely to work in cases currently headed for trial. Attorney Arnold Vickery of Houston, who represents the Lown family in South Carolina, says he's noticed a changing pattern in his cases: "Most of them involve prescriptions by nonpsychiatrists for indications other than depression." Many of the patients in these cases did not suffer any form of mental illness, and yet they displayed the same suicidal tendencies as users who did.

For example, a case Vickery recently settled in Pennsylvania involved a woman who slashed her wrists and overdosed on sleeping pills after taking Prozac, which her general practitioner prescribed for weight loss. (Cassidy v. Eli Lilly & Co., No. CA-00821 (W.D. Pa. Nov. 26, 2002).) Vickery has filed a case in Tennessee in which a man hanged himself after taking Prozac, which his cardiologist had prescribed for chest pain. And in Georgia, Vickery has a case in which a woman shot herself after taking the Prozac her family doctor had prescribed for migraines.

"These are basically failure-to-warn, failure-to-test cases," said Vickery. "The drug makers have done nothing to alert doctors or patients that SSRI drugs, particularly in the first month, can trigger a suicide or homicide.

"Plus, they just haven't studied the issue," he added. "They've stuck their heads in the sand on it."

Significant verdict

A turning point in the litigation was the long-awaited Wyoming verdict for relatives of Donald Schell. Vickery introduced evidence showing that studies requested by GSK found that hundreds of volunteers had suffered adverse reactions to Paxil, including attempted suicide. (Documents from Paxil Case May Aid Plaintiffs Harmed by Antidepressants, TRIAL, Sept. 2001, at 84.)

"After the Wyoming verdict, lawyers started to think they could win these cases," said Bill Berke of Cape Coral, Florida, chair of ATLA's Paxil Litigation Group. He represents Piccirillo.

Bringing the potential dangers of these drugs to public attention is a major goal of SSRI litigation, plaintiff lawyers said. Vickery lost his first case, in Hawaii. That, he said, "was a heartbreaker. But ... we got out into the light of public scrutiny a bunch of internal documents about all these issues, so that everybody can know."

For example, in 1986 clinical trials, researchers found suicide rates of 12.5 patients per 1,000 taking Prozac, compared with 3.8 patients taking a non-SSRI antidepressant and 2.5 patients taking a placebo.

A 1995 study of suicides among British patients whose general practitioners prescribed antidepressants compared the rates of suicide for 10 drugs: Far more people killed themselves while on Prozac than on the others. The study found an annual rate of 187 suicides per 100,000 depressed patients taking Prozac, compared with 30 suicides per 100,000 depressed patients in general.

David Healy, a psychiatrist and author of several books on the subject, conducted extensive research on internal company documents as an expert witness for plaintiffs in several cases. He found reports of healthy-volunteer studies by SmithKline (GSK's predecessor) in which 25 percent of volunteers suffered from agitation and other symptoms of akathisia while taking Paxil.

Healy also found early drafts of Prozac's package insert that stated, "Mania and psychosis may be precipitated in susceptible patients by antidepressant therapy." The warning was not included in the final package insert for U.S sales. However, Germany's Bundes Gesundheit Amt (equivalent to the FDA) required that Eli Lilly include such a warning on its label for sales of the drug there, where it is called Fluctin. By 1999, the FDA had received reports of over 2,000 Prozac-associated suicides; 500 or more of the reports specifically referred to agitation and akathisia.

Now, one plaintiff is asking a new question: Can a simple test show whether a person will react adversely to these drugs? The case Vickery filed in a Georgia federal court on behalf of a suicide victim's widower claims that Eli Lilly failed to publicize research showing that some people are "poor metabolizers" of Prozac. The plaintiff asserts that a simple test can detect deficiency of an enzyme that normally metabolizes Prozac and similar drugs. When the enzyme does not process the drug properly, the drug's active ingredient can build up in the patient's system, leading to a higher risk of akathisia, violence, and suicide.

In a California case of a suicide allegedly induced by Zoloft, the FDA has filed an amicus brief arguing against the plaintiff's failure-to-warn claims. The agency said it would not have allowed Pfizer to put a warning about akathisia or suicide on the label--it would have considered that mislabeling.

Paxil-withdrawal suits

In addition to reports of violence and suicide, patients have begun to complain of severe withdrawal symptoms when trying to stop taking Paxil. Although GSK insists that the drug is non-habit-forming, some patients who quit taking it claim that they experience a range of side effects, such as flu-like symptoms or electric-shock sensations.

Many physicians recommend stopping any antidepressant by gradually reducing the dose. However, Paxil breaks down more quickly than Prozac, a process that can lead to jarring reactions when a patient misses a single dose or tries to stop the drug too quickly. Some patients experience such symptoms even when on a cessation program monitored by a physician. The World Heath Organization says that, of any antidepressant, Paxil has the highest rate of adverse experiences during withdrawal.

Healy's research into GSK's internal documents also found that in healthy-volunteer studies, as many as 85 percent of volunteers suffered agitation, bizarre dreams, and insomnia after stopping Paxil. As many as half showed symptoms of becoming physically dependent on the drug.

Karen Barth, a Los Angeles attorney who has worked with Vickery on several cases, says her firm is now bringing both individual and class action suits related to Paxil withdrawal symptoms.

"We kept getting contacted by individuals complaining of severe withdrawal problems," she said. In litigating cases that involved violence or suicide, "we had seen documents acknowledging a very serious concern about withdrawal related to Paxil. When we had hundreds of people telling us their story, and you start hearing the same story over and over again, you start saying, `Wow, we need to get some help for these people.'"

Barth's firm has filed a suit with over 400 named plaintiffs in Mississippi, and a smaller one in California. It is also working with other trial lawyers on a class action, filed in Los Angeles federal court, claiming that GSK "deliberately or recklessly failed to properly warn" of "serious and unexpected withdrawal symptoms." The suit also claims that GSK "falsely stated and continues to falsely state that Paxil is not habit-forming [or] addictive" in its advertising material. (In re Paxil Litig., No. CV-01-07937 MRP (CWx) (C.D. Cal. filed Aug. 24, 2001).)

The plaintiffs sought a court-ordered injunction against the print and TV advertisements. Judge Marianna Pfaelzer initially granted the preliminary injunction in August 2002, but she reversed her ruling when the FDA argued that it had reviewed and approved the ads. In January, the judge denied the plaintiffs' first motion for certification of a nationwide class, but she will allow them to refile. Barth said they will revise and refile this month, with a hearing expected in June.

Concern about and cases involving Paxil are not confined to this country. A Canadian firm in North Vancouver has filed a class action in the Supreme Court of British Columbia with similar allegations. Attorney Ken Baxter said that in addition to recovering damages for the patients, the suit aims to have GSK "adequately inform the public of the serious nature of possible withdrawal symptoms." He expects a certification hearing by fall.

Great Britain's Prescription Medicines Code of Practice Authority, the pharmaceutical industry's self-regulatory board, found that GSK violated the board's marketing code by downplaying the side effects of Paxil (sold there as Seroxat).

All three SSRI drugs are still on the market. As plaintiff attorneys pursue these cases, many see the issue as a puzzle.

"This is a drug that's supposed to help people with depression," said Vickery. "It's paradoxical that there are some people, even if it's a small percentage, who experience the exact opposite effect."
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Author:Jurand, Sara Hoffman
Publication:Trial
Date:Mar 1, 2003
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