On September 1, 2017, Baum Hedlund sent a letter to Apotex, the current manufacturer of Paxil and paroxetine, putting the company on notice that the Paxil label is inadequate. We encourage you to read this letter.
The Dolin paroxetine lawsuit returned a verdict worth $3 million and sent a message to generic drug makers: you will be held accountable if you fail to warn consumers about dangerous side effects.
“The Dolin verdict sent a clear message to GSK and other drug manufacturers that hiding data and manipulating science will not be tolerated,” says Paxil attorney R. Brent Wisner. “Brand drug manufacturers have the ability and responsibility to make their drug labels accurate. If you create a drug and know that it poses serious risks, regardless of whether consumers use the brand name or generic version of that drug, you have a duty to warn.”
Just as GSK was brought to justice for failing to warn consumers about dangerous Paxil side effects, so should Paxil (paroxetine) manufacturer Apotex.
If you would like to learn more about filing an Apotex lawsuit, we can help. Contact the law firm of Baum, Hedlund, Aristei & Goldman today for a free case evaluation by an experienced generic Paxil lawyer.
Can Generic Paxil Cause Someone to Commit Suicide?
All antidepressants like Paxil and generic paroxetine hcl carry a “black box” warning on the label, stating that these drugs can increase the risk of suicidal ideation and behavior in children, adolescents, and young adults up to the age of 24. But what about adults 25 and over? At the center of the Dolin generic Paxil suicide case were two basic questions:
- Can Paxil or generic Paxil (paroxetine) cause someone over the age of 24 to commit suicide? If so,
- Does the drug’s label properly warn physicians and their patients of this risk?
For now, let us address the first question, as its answer is of utmost importance to individuals who are considering filing a generic Paxil suicide lawsuit.
Paxil and “generic Paxil” (paroxetine) are prescribed to people diagnosed with a wide range of mental and emotional difficulties, including depression or anxiety. These disturbances may cause some people to experience suicidal ideation, attempt suicide, or cause individuals to harm themselves in some way.
With this in mind, it is natural to ask: “If such individuals commit suicide, or harm themselves in some way, how can you blame the drug?” People damaged by antidepressants, or who have seen their loved ones commit suicide or harm themselves while taking antidepressants, might well think that “mental illness” was solely to blame.
Jurors in the Dolin trial no doubt considered the same possibility. Nevertheless, after five weeks of testimony from psychiatrists and experts in pharmacology, the jurors were convinced that the current body of research and medical science pertaining to antidepressants, Paxil (paroxetine) and suicide proved the drug was to blame. Generic Paxil—paroxetine—can cause someone over 24 to take his, or her, life.
A 2017 Generic Paxil Suicide Lawsuit Resulted in a $3 Million Verdict
The most persuasive evidence introduced during the Dolin trial came directly from GlaxoSmithKline (GSK), the company that developed Paxil (paroxetine hydrochloride) and brought it to market in 1992. At that time, GSK was named SmithKline Beecham.
Jurors heard from Dr. David Ross, who worked for the U.S. Food and Drug Administration (FDA) for 10 years reviewing new drug applications submitted to the agency by pharmaceutical companies.
Dr. Ross testified about a suicide report on Paxil that GSK submitted to the FDA in 1991 following the Paxil clinical trials. In clinical trials, human subjects are given either the drug being tested or a placebo, which is used as a control in testing and has no therapeutic effect. Clinical trials are conducted to establish a drug’s safety and effectiveness.
According to Dr. Ross, GSK’s report on Paxil side effects (Plaintiff’s Exhibit 82) misrepresented the suicide data collected during clinical trials. Specifically, GSK reported a higher number of suicides and suicide attempts in the placebo group than actually took place during the trials.
GSK also reported a lower number of suicide attempts in the paroxetine group. These alterations made it appear as though those who took paroxetine faced about the same risk of suicide and suicidal behavior as those who took a placebo.
GSK actually made this claim to the FDA, to physicians at medical conferences, and in medical journals before and after Paxil received FDA approval.
At a December 1991 meeting of the American College of Neuropsychopharmacology, SmithKline Beecham employees presented a report claiming that “suicidal thoughts and behavior occurred less frequently with paroxetine than with either placebo or active controls [subjects taking a different antidepressant].”
In 1995, an SKB employee and two other psychiatrists published a paper in the journal European Neuropsychopharmacology which asserted that paroxetine hcl reduced suicides and suicide attempts. SKB encouraged its sales force to use this article in talking to physicians in order to allay concerns about a suicide risk caused by the drug.
However, as Dr. Ross testified, the data from Paxil’s clinical trials, when it was not altered, demonstrated that patients taking Paxil had nearly nine times the risk of committing or attempting suicide compared to those taking a placebo. Keep in mind, patients in both groups had about the same levels of depression, on average.
The increased risk was confirmed in 2006 by GSK’s internal analysis of its own suicide data. Patients taking Paxil were nearly seven times more likely to attempt suicide than those on placebo.
That same year, an FDA analysis of select clinical trials involving adults, found that taking Paxil resulted in a statistically significant 2.7 times increased risk of suicidal behavior compared to placebo for all indications.
Dr. Russell Katz, the FDA’s Director of Neurological Products, explained during an FDA Advisory Committee Meeting (Joint Meeting of the Peripheral Nervous and Central Nervous System Drugs Advisory Committee) in 2006, that statistically significant findings such as this are “operationally defined as causality.” In short, by the end of 2006, a clear picture had emerged: Taking Paxil can cause older adults, as well as children and young adults, to experience dangerous Paxil or paroxetine side effects, including suicidal behavior.
“Glaxo has known for two decades that Paxil can cause people of all ages to commit suicide. The company not only hid the risk, but stuck its head in the sand and ignored countless suicides that occurred in its clinical trials,” says Michael Baum, senior managing partner of Baum Hedlund and Paxil attorney. Baum adds that Paxil’s Black Box warning—which states there is a suicide risk for children, adolescents and young adults, but the risk ends at age 24—is “just wrong.”