Eli Lilly Accused of Hiding Cymbalta “Brain Zap” Withdrawal and Other Symptoms
August 5, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Eli Lilly and Company , is involved in several lawsuits over its antidepressant Cymbalta, specifically that the company had inadequate warnings regarding the drug’s withdrawal symptoms. There have been as many as 5,000 claims regarding the withdrawal risks, which include vomiting, insomnia and electrical-shock sensations dubbed “brain zaps” in court filings.
On Tuesday, T. Matthew Leckman, an attorney representing Claudia Herrera, in a Los Angeles federal courtroom, said to the jury, “You’ll be asked to decide whether or not what she suffered was caused by Cymbalta withdrawal.”
As far back as January 29, 2013, Lilly was pushing a California judge to throw out a proposed class action suit regarding “brain zaps” and other side effects related to Cymbalta. The company argued that physicians had been properly educated on the risks. “Because plaintiffs received Cymbalta only through an intervening medical judgment,” stated Lilly’s motion, “by their prescribing physicians, they cannot establish the requisite link between Lilly’s alleged misrepresentations and their injuries.”
The suits argue that Lilly’s information aimed at consumers omitted the warning. In that particular ruling, lead plaintiff Jennifer Saavedra claimed that her attempts to stop taking Cymbalta were inhibited because of excruciating side effects that included severe nausea, tunnel vision and “electrical brain zaps.” As a result, she continued taking Cymbalta to stop the withdrawal symptoms.
In the more recent case this week, Lilly argues that the company provided adequate warnings about the drug’s withdrawal risks and that physicians would already be aware of them. “The label is written for doctors,” said Paul Schmidt, one of Lilly’s attorneys in an opening statement. “It is written for people with medical training so that they can make a judgment about the safety of the medicine.”
The attorneys pressing the suit argue that Cymbalta warnings say a few as 2 percent of patients suffer side effects, while studies indicate that more than 40 percent of patients receiving Cymbalta show withdrawal symptoms after quitting.
Leckman’s opening statement to the jury suggesting the case is about whether the symptoms were caused by Cymbalta withdrawal seems misleading. Withdrawal symptoms from antidepressants are very well known as even a cursory Internet search would indicate.
The Mayo Clinic website lists them as irritability, anxiety, insomnia or vivid dreams, headaches, dizziness, tiredness, flu-like symptoms, including achy muscles and chills, nausea and return of depression symptoms. The Mayo website doesn’t mention the “brain zaps,” although the Mental Health Daily website has a page dedicated to it, saying, “During withdrawal from antidepressant medications, ‘brain zaps’ are considered common symptoms to experience. It is believed that the severity and length of brain zaps may be related to whether a person discontinues ‘cold turkey’ as opposed to tapering off of their medication.”
That would at least suggest that the case may hinge more on whether the jury feels that Lilly wrote adequate warnings aimed at consumers, as opposed to those aimed at the patients’ physicians.
The Saavedra case, Saavedra v. Eli Lilly & Co., was denied class certification. Stephen McDonnell and Reed Smith, writing for JD Supra Business Advisor, said, “But the plaintiffs would still need to establish injury of some sort. Again, the theory was that the alleged misrepresentations caused the plaintiffs to pay a price premium. This time, instead of relying on a conjoint analysis, the plaintiffs claimed they could make their point via the defendant’s own internal documents. But Judge Wilson did not buy what the plaintiffs were selling. He assigned exactly the right value to the plaintiffs’ argument: zero.”
From 2004 to 2011, Lilly had brought in $18 billion in sales. It brought in $3.9 billion in 2013 before it lost patent protection. It brought in $561 million in the first half of this year.
The Saavedra suit argued that if people knew how difficult it was to stop taking the drug, they would not have taken it. “Disclosing the true risks of Cymbalta withdrawal in its marketing and risk disclosure materials would have been harmful to Lilly’s sales,” the lawsuit stated.
The most recent lawsuit between Herrera and Eli Lilly, is very similar to the Saavedra suit, with a potential 250 cases pending. Two more similar trials will start in Virginia at the end of this month.