By Donna Gregory Burch
Drugmaker Eli Lilly and Company has quietly settled hundreds of personal injury lawsuits involving patients who claim they experienced withdrawal symptoms while quitting Cymbalta.
When asked for an update on the cases, Robin McCall, media relations director for Baum, Hedlund, Aristei & Goldman, P.C., one of the firms handling the cases, wrote in an email, “All we can say is that the suit has been resolved.”
Lilly is also tight-lipped about the settlement, but provided the following written statement:
“Eli Lilly and Company has reached a comprehensive resolution of all personal injury lawsuits alleging symptoms from discontinuing Lilly’s medication, Cymbalta. Lilly has defended these cases vigorously and has won every case to reach a decision on the merits, including defense verdicts in every trial. To avoid continued legal costs, Lilly reached a resolution with plaintiffs in the remaining cases. Lilly remains committed to Cymbalta and its safety and benefits, which have been repeatedly affirmed by the U.S. Food and Drug Administration.”
No additional details on the settlement were provided.
More than 200 patients were suing Lilly, claiming the drugmaker didn’t fully disclose the severity of Cymbalta’s withdrawal symptoms. The plaintiffs in the cases said they experienced headaches, dizziness, nausea, nightmares, anxiety, mania, suicidal ideation, brain zaps (which feel like a lightning bolt going off inside the head) and other symptoms after they stopped taking Cymbalta.
Cymbalta is one of three drugs approved by the U.S. Food and Drug Administration to treat fibromyalgia. It’s also used for depression, anxiety, diabetic neuropathy and certain kinds of chronic pain.
As early as 2005, research indicated a high rate of what medical professionals call “adverse events” when patients stopped taking Cymbalta. This Lilly study found that 44 percent of patients involved in several short-term trials had “adverse events” when they suddenly stopped taking duloxetine (the generic name for Cymbalta). The most common withdrawal symptoms cited were dizziness, nausea, headache, paresthesia (tingling/numbness, usually in the limbs), vomiting, irritability and nightmares. About 10 percent of these patients had “severe” withdrawal symptoms.
A longer and larger Lilly trial involving 1,279 patients found that 50 percent of patients experienced withdrawal symptoms.
The crux of Baum Hedlund’s case involved Lilly’s physicians’ prescribing guide for Cymbalta, which says 1 percent or more of patients discontinuing the drug may experience side effects including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis and fatigue.
While the “1 percent or greater” figure is technically accurate, Baum Hedlund argued it far understated Cymbalta’s true rate of withdrawal symptoms.
“The label gives the impression that withdrawal is a rare event (somewhere around 1 percent) when in fact it is common (at least 44-50 percent),” said Baum Hedlund in an earlier interview. “We think Lilly played with semantics and the system in choosing its wording – it chose wording to minimize the risk while at the same time using language such as “or greater” as a “CYA” [cover your ass] measure. We believe the label is misleading, plain and simple. The testimony of the prescribing doctors in these cases proves it – they believed the risk was rare.”
Despite the discrepancy, Baum Hedlund had been unsuccessful at convincing a judge or jury that Lilly knowingly misled doctors and patients. Four cases heard in various federal courts last year ended in Lilly’s favor.
The lawsuits may be settled, but Cymbalta users are still dealing with the fallout of the drug’s withdrawal symptoms. The design and dosages of Cymbalta’s capsules make it challenging for patients to wean off slowly over time. Capsules come in 20mg, 30mg and 60mg strengths, meaning patients sometimes have to cut their doses in half while weaning. For some patients, that’s just too much of a reduction at one time.
In desperation, some patients are quitting Cymbalta by dumping out the contents of the capsules and then counting the tiny balls every day in an effort to slowly reduce their dosage over time.
Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She covers news, treatments, research and practical tips for living better with fibromyalgia on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.