What’s wrong with this picture?
Company A designs a drug. The company develops it, tests it on animals and ultimately humans, and sends the results of their research—or what they claim are the results—to the Food and Drug Administration (FDA). The FDA approves the drug to be marketed for the treatment of defined medical conditions in defined populations—for example, the treatment of colds in adults.
Sometime later, Company A loses its patent and generic versions of the drug manufactured by Company B, hit the market. A patient takes the generic version, has a horrible reaction and dies. It turns out lots of people who have taken the drug have died. But Company A says, “It’s not my fault the patient died. I didn’t make the generic drug the patient took. Company B did.” Company B says, “It’s not my fault. I didn’t design the drug. I have to make it exactly like Company A did. And I’m not allowed to change the label.”
The court says, “Sorry he’s dead, but legally no one’s at fault here. Company A didn’t make the product the man took. And it’s not their duty to warn consumers about a drug they didn’t make. But company B isn’t responsible. They’re required to make it and label it exactly like the branded drug and that’s what they did. Case dismissed.”
As a recent Law360 article illustrates, this just doesn’t pass the common sense test. Yet, unreasonable as it sounds, it is the very real catch-22 corner that several circuit court and Supreme Court rulings have backed most consumers of generic drugs into.
Hopefully, that will soon change. Thanks to the adept legal maneuvering and persuasive arguments of Baum, Hedlund, Aristei & Goldman, U.S. District Judge James B. Zagel in Illinois, is allowing a lawsuit to go forward that may open the door to holding a brand name drug maker liable for injuries caused by a generic drug. The action was brought by the widow of an Illinois man, Stewart Dolin, a prominent lawyer of Reed Smith, who took a generic version of the antidepressant Paxil in 2010, and, just six days later, committed suicide. The trial is scheduled to begin in January 2017.
To prevail, however, the plaintiff will need to first prove that Paxil can indeed cause suicidal behavior in an adult, even after just a few days of use. There is a great deal of evidence that it can. Antidepressant-triggered suicide, which we will refer to as antidepressant suicide, appears to be a proven Paxil drug reaction.
Before antidepressants like Paxil, known as selective serotonin reuptake inhibitors, or SSRIs, came on the market in the late 80s, antidepressant suicide was not a topic of everyday conversation. Today it is, thanks in many respects to lawsuits that have uncovered smoking gun documents that drug makers would have preferred remain buried. Internal company records demonstrate that the makers of several prominent SSRI antidepressants were aware, even before the drugs received FDA approval, that their drugs significantly increased antidepressant suicide risk.
Two experts who are familiar with those documents will testify for the plaintiff, Wendy Dolin, Mr. Dolin’s widow. Joseph Glenmullen is a psychiatry professor at Harvard Medical School. He has written extensively on antidepressant suicide in his books Prozac Backlash, The Antidepressant Solution, and Coming Off Antidepressants.
Dr. Glenmullen asserts that as early as 1989, the maker of Paxil, GlaxoSmithKline (GSK), knew that patients taking Paxil faced a significantly increased risk of suicidal tendencies, but GSK minimized these risks to the FDA.
Dr. David Healy is an internationally respected psychiatrist and psychopharmacologist and one of the foremost experts in plaintiff suicide trials involving psychotropic drugs. He is the author of a number of books, including Pharmageddon and The Antidepressant Era. He is an expert on SSRI-induced suicidality and akathisia, describing it as a sense of inner restlessness—a complex and highly destructive side-effect of various psychotropic drugs.
He says it can manifest as a physical inability to remain still, but can also be less obvious, presenting as anything from a constant and disturbing unease in the mind, through to an intense emotional turmoil.
Akathisia and suicide are strongly associated—a key fact in this case, since Ms. Dolin and other witnesses observed the sudden appearance of the unmistakable symptoms of akathisia in her husband shortly before his death
“I’d got home that night and Googled akathisia, Paxil, and suicide, and lo and behold, all this information pops up.”
– Wendy Dolin, plaintiff in generic Paxil lawsuit
It is well established that antidepressants can cause akathisia. Current drug labels for SSRI antidepressants warn that akathisia, agitation and insomnia have been reported in adult patients taking antidepressants and “such symptoms may represent precursors to emerging suicidality.”
In a 2003 study published in Psychotherapy and Psychosomatics, and again in a 2006 study published in the Public Library of Science, Medicine, Healy and several of his colleagues warned of the link between akathisia and antidepressant suicide, particularly Paxil suicide. “There is good evidence,” writes Healy, “that akathisia … can be linked to both suicide and violence.”
Generic Paxil Suicide
The jury in this case will not only have to find that Paxil was the probable cause of Mr. Dolin’s suicide. It will also need to find that GlaxoSmithKline was negligent in properly warning Mr. Dolin and his physician about the serious antidepressant suicide risk attached to Paxil. It is difficult to see how they could find otherwise. A GSK briefing document cited in Ms. Dolin’s complaint stated that suicidal behavior risk in adults taking Paxil was 6.7 times higher compared to those taking placebo. An FDA analysis found the risk to be nearly three times higher. Why this information was not prominently displayed on the label—for which GSK and GSK only bears ultimate legal responsibility—is a question that will surely be on the minds of the jurors. It is worth noting that television ads for Paxil from 2010 can still be viewed on YouTube. They mention decreased appetite, dry mouth and sleepiness among the possible Paxil side effects. But not a single word of caution that it might, in just a few days, cause you to kill yourself.
Setting a Legal Precedent
Should the jury rule in Ms. Dolin’s favor, this would send a strong message that consumers who are injured by generic products deserve some recourse. If GlaxoSmithKline appeals, it could eventually end up in the U.S. Supreme Court.