Healthy Skepticism Library item: 2406
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: media release
Parents Blame Paxil for Their Daughter's Tragic Death
Pendley Law Firm 2005 Aug 31
http://www.pendleylawfirm.com
Keywords:
Paxil suicide Pendley litigation ssri
Notes:
Ralph Faggotter’s Comments: We are starting to see a rash of lawsuits in relation to SSRI type antidepressants which have been accused of inducing a variety of serious neurological and psychological effects in some individuals, including suicide and homicide. Expect to see more press releases and media reports like this over the next few years.
Full text:
August 31, 2005 Pendley Law Firm
FOR IMMEDIATE RELEASE 24110 Eden Street
Plaquemine, LA 70765
Contact: Chris Coffin
Phone: 225-687-6396
Email:ccoffin@pendleylawfirm.com
Web: www.pendleylawfirm.com
Parents Blame Paxil for Their Daughter’s Tragic Death
Peoria, Illinois, August 31, 2005 – Illinois residents Bonnie and William Mason filed a wrongful death lawsuit today in the Federal District Court for the Central District of Illinois, Peoria Division, against SmithKline Beecham Corp. d/b/a GlaxoSmithkline (“GSK”) alleging Paxil CR played a substantial role in the suicide death of their twenty three year-old daughter, Tricia Mason.
Tricia was prescribed Paxil CR, the controlled release form of the drug, by a nurse practitioner. Two days later, on March 2, 2003, she committed suicide by ingesting cyanide. Tricia, a resident of Normal, Illinois, was attending graduate school at Illinois State University (“ISU”), majoring in biotechnology. In addition, she worked at ISU as a lab research technician assisting with projects involving microbiology and molecular genetics.
Paxil was introduced into the U.S. market on December 29, 1992, and is a well known antidepressant medication in the same class as Zoloft and Prozac (selective serotonin reuptake inhibitors or “SSRIs”). Paxil is approved for marketing in the United States for conditions such as depression, obsessive compulsive disorder, panic disorder, and “social anxiety disorder,” but has been linked to an increased risk of suicide is some patients.
In January of this year, GSK was required to add a “black box” warning to its Paxil label alerting healthcare professionals and patients of the increased risk of suicidality in children and adolescents taking Paxil. Six months later, the U.S. Food and Drug Administration issued a Public Health Advisory titled “Suicidality in Adults Being Treated with Antidepressant Medications.” In it, the FDA warns that adults being treated with antidepressant medications such as Paxil should be closely monitored for increased suicidal thinking or behavior. The FDA is currently evaluating clinical trial data obtained from antidepressant manufacturers to further analyze the link between SSRIs and suicide.
A study published last week in the medical journal BMC Medicine found that suicide attempts are seven times more likely in individuals taking Paxil versus those on placebo. The researchers reached their conclusion after reviewing data from 16 previous studies where Paxil was compared to placebo.
In the lawsuit, Bonnie and William Mason claim that Paxil CR caused their daughter to experience severe side effects which, in turn, caused her to commit suicide. They allege that Tricia experienced Paxil-induced aggression, agitation, and a condition known as akathisia prior to taking her life. Akathisia is a neurological condition that causes extreme internal restlessness and psychological turmoil.
Christopher Coffin, the lead attorney representing the Masons, referred to Tricia’s death as “a shocking loss that could have been avoided had GlaxoSmithKline warned the medical community, including Tricia’s nurse practitioner, and Tricia about the suicidal risks associated with Paxil.” Coffin, who is also a registered nurse, stated “when a pharmaceutical company withholds information about serious dangers associated with its drug, it must be held accountable.”
The lawsuit was jointly filed by Kingery Durree Wakeman & Ryan of Peoria, Illinois; Christopher Coffin of Pendley Law Firm of Plaquemine, Louisiana; Baum Hedlund of Los Angeles, California; and The Law Office of Donald J. Farber of San Rafael, California.
FACT SHEET
Allegations in the Complaint include:
The Drug Paxil
13. The drug Paroxetine is manufactured, promoted, distributed, and marketed by GSK under the trade names Paxil and Paxil CR and is a member of a class of drugs known as “selective serotonin reuptake inhibitors” or “SSRIs.”
14. Like the other SSRIs, there is an association between Paxil and suicidal behavior for some patients who take the drug. Paxil can cause “side effects” or extrapyramidal reactions, including a dangerous condition called “akathisia” which is associated with acts of self-harm and/or violence. In addition, Paxil can cause some patients to become manic, hypomanic, or even psychotic.
15. As do other SSRI manufacturers, GSK touts Paxil as a cure for a chemical imbalance in the brain which is nothing short of speculation. As one renowned psychiatrist put it: “[SSRIs] are not correcting a biochemical imbalance, these drugs create severe imbalances in the brain … The idea that human suffering, psychological suffering, is biochemical is strictly a promotional campaign, perhaps the most successful in the history of the world, created by the drug companies. We do not even have a technology, a scientific technology, for measuring what happens inside the brain … it is literally a fabrication.”
16. Since the licensing of Paxil in 1992, the Federal Food and Drug Administration (“FDA”) has received reports under its voluntary reporting program of thousands of suicidal events, including suicide, related to the administration of SSRI drugs, including Paxil, in which the reporting physician or other health-care professional has listed the particular drug as “suspect.” By the FDA’s own estimates the reported cases are less than 10% of the represented incidents so that the deaths reported to the FDA stand proxy for more than 20,000 SSRI-related deaths (see website www.fda.gov). As a result, the public is at the mercy of the drug companies for which SSRI drugs represent a seven billion dollar annual market. During the clinical trials of Paxil, more than one clinical investigation determined that acts of self-harm were associated with Paxil.
17. The suicide-violence issue was well known to GSK for many years and well before Miss Mason’s death. This knowledge was first publicly brought to GSK’s attention in a February 1990 article by two highly reputed Harvard psychiatrists concerning the association between another SSRI antidepressant, fluoxetine and de novo suicidality.
18. Journal articles continued to appear in the medical literature throughout the 1990’s concerning the risks of SSRIs in relation to akathisia and suicidality. For instance, a doctor working for another SSRI manufacturer, Pfizer (the maker of Zoloft), wrote about the association and risk of violence and suicide for all SSRI drugs, including Paxil. See, Lane and Baldwin, “SSRI-Induced extrapyramidal side-effects and akathisia: implications for treatment,” Journal of Psychopharmacology, 12(2)(1998), pp. 192-214; Lane, “Selective Serotonin Reuptake Inhibitor-Induced Serotonin Syndrome: Review,” Journal of Clinical Psychopharmacology, 17(3)(1997), pp. 208-22. As Dr. Lane writes, these conditions are sometimes hard to detect and diagnose, although not so hard to treat. E.g. “SSRI-induced akathisia is a relatively rare event but is frequently unrecognized when it does occur . . . In addition to the obvious motor (objective) manifestations of ‘inability to sit still’, most researchers agree that akathisia has a strong psychological (subjective)
component. . . . The most outstanding feature of akathisia is the subjective distress. . . . It may be less of a question of patients experiencing fluoxetine-induced suicidal ideation, than patients feeling that ‘death is a welcome result’ when the acutely discomforting symptoms of akathisia are experienced on top of already distressing disorders.” For this reason, is it imperative that both physicians and their patients be forewarned and alerted about this serious risk.
19. GSK is required to warn about the serious hazards associated with its drugs as soon as there is “reasonable evidence of an association.” Despite its knowledge, GSK failed to do so until recently. GSK began warning of these risks in 2004 and 2005-through a change to its prescribing information Warnings Section or “label” as it is known in the industry. However, GSK could and should have issued these warnings long before Miss Mason’s death.
20. Before Tricia Mason’s death, GSK failed to inform either U.S. healthcare providers or patients of Paxil’s known risks as documented in its clinical trials and in the medical literature. Its U.S. package insert and marketing materials did not warn about the association with and risk of akathisia, did not warn about the risk of psychosis, and did not warn that Paxil is associated with acts of violence and/or self-harm.
21. GSK aggressively distributed and marketed Paxil, encouraging all types of healthcare providers (including those who have no specialized training or expertise in the mental health field such as the nurse practitioner who prescribed Paxil for Tricia Mason) to dispense and prescribe Paxil, not only for depression but also for other maladies.
22. GSK advertises Paxil both in professional medical publications and, more recently, in “direct to consumer” advertising. GSK has so aggressively marketed Paxil that its over-promotion has nullified what warnings GSK has given regarding this drug. Thus, GSK’s legal liability is predicated not only upon those things which it failed to tell prescribing physicians and patients but also on its affirmative misrepresentations.
About Pendley Law Firm:
Pendley Law Firm has been involved with SSRI litigation since 2000 and currently represents thousands of SSRI victims. The class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) includes, among others, Paxil, Zoloft and Prozac.
Christopher L. Coffin of Pendley Law Firm, a pharmaceutical litigator and registered nurse, testified before the FDA Psychopharmacologic Drugs Advisory Committee in 2004 regarding increased suicidality associated with the use of SSRIs. Evidence delivered and submitted to this committee caused FDA to issue a recommendation to SSRI manufacturers to include in their warning labels that patients taking SSRIs should be closely monitored for the emergence of suicidality.
Pendley Law Firm is one of four firms in the country that currently represent thousands of individuals who have suffered from symptoms, including increased suicidality, when discontinuing their use of Paxil. Mr. Coffin is on the “Plaintiffs’ Steering Committee” that leads this national litigation.
30
