Sept. 9, 2014, PLLR E-Newsletter
Cymbalta users sue over undisclosed withdrawal side effects
Courtney L. Davenport
Almost two dozen consumers who suffered moderate to severe side effects when they tried to stop using the antidepressant Cymbalta recently sued drugmaker Eli Lilly & Co. The plaintiffs claim the company knew the drug caused withdrawal symptoms in nearly half those who discontinued it but significantly downplayed the risks in warning labels.
Almost two dozen consumers who suffered moderate to severe side effects when they tried to stop using the antidepressant Cymbalta recently sued drugmaker Eli Lilly & Co. The plaintiffs claim the company knew the drug caused withdrawal symptoms in nearly half those who discontinued it but significantly downplayed the risks in warning labels. Seven individual suits and one class action were filed previously. The plaintiffs are seeking consolidation in an MDL. (In re Cymbalta Prods. Liab. Litig., Case Pending No. 99 (Jud. Panel on Multidistrict Litig. filed Aug. 15, 2014).)
“Lilly’s conduct in misleading prescribers and patients about the risk of withdrawal is appalling,” said Los Angeles attorney Brent Wisner, who represents some of the plaintiffs and has hundreds of cases waiting to be filed. “Cymbalta withdrawal likely affects over half of all Cymbalta users. That means there are potentially millions of people out there who have a valid claim against Lilly.”
The FDA approved Cymbalta (duloxetine) to treat depression in 2004 and later approved it to treat anxiety, fibromyalgia, and muscle pain. The prescription label warns that on “discontinuation,” at least 1 percent of users suffered side effects, including dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, sweating, mood swings, and vertigo. The label says nothing about how long symptoms last or what regimen patients should follow when they want to stop taking Cymbalta. The information given to providers contains only one sentence about how to wean patients off Cymbalta, telling them a gradual reduction is best.
But in 2012, Lilly gave the Institute for Safe Medication Practices (ISMP) the results of several early clinical trials, which revealed that between 44 percent and 50 percent of patients suffered withdrawal symptoms, including 10 percent to 17 percent whose side effects were rated severe. The ISMP reported that even the most mild-sounding side effects were potentially disabling—dizziness, for instance, sometimes meant vertigo so severe that patients were bedridden. Neither Lilly nor the FDA has followed up with the trials’ patients after withdrawal to determine how long the symptoms last.
“A major lapse has occurred in the FDA-approved information for patients about the risks of stopping duloxetine,” the ISMP said in an October 2012 QuarterWatch report. “The information for prescribing physicians is somewhat better, but still inadequate about counseling patients; instructions for an adequate taper regimen are omitted entirely. Furthermore, a major gap exists in our scientific understanding of the incidence and management of withdrawal syndrome cases that are severe and persistent.”
In addition to the side effects listed on the label, users have suffered full-body shakes, blackouts, and tunnel vision. Because Cymbalta’s half-life is only 12 hours—the second shortest half-life among antidepressants—the drug leaves users’ systems quickly, so patients can experience withdrawal after even one missed dose. They are often unable to work, and they resume taking Cymbalta to keep the side effects at bay.
The most significant side effect is what users call “brain zaps,” electrical pulses Wisner said they have likened to a “thunderstorm in the head.” It is often triggered by movement.
“There is obviously a whole list of side effects that are happening, but we’re looking at brain zaps especially because it’s [a side effect] you don’t get from something else,” said Harris Pogust of Conshohocken, Pa., who also represents some of the plaintiffs. “It’s like putting your finger in a light socket, and it zaps your brain instead of your finger. It’s very debilitating.”
Plaintiffs seeking economic redress for purchasing Cymbalta instead of safer, less expensive drugs filed a class action suit two years ago. Since then, 28 plaintiffs have filed personal injury suits, including 21 last month. In the class action, the parties have argued extensively whether the learned intermediary doctrine applies, but the plaintiff attorneys are confident they’ll prevail.
“Lilly has systematically misled both patients and prescribers,” said Wisner. “And since Lilly made these misleading representations to prescribers, they cannot then seek refuge in the learned intermediary doctrine defense. Doctors cannot be a ‘learned’ intermediary if they are not given accurate information in the first place.”
The class action plaintiffs expect a class certification ruling in the coming months.