This is Part 2 of an ongoing series on the Cymbalta withdrawal lawsuits. It includes an interview with Baum, Hedlund, Aristei & Goldman, PC, one of the law firms representing hundreds of patients who have been affected by Cymbalta’s withdrawal symptoms. Part 1 of this series addressed Cymbalta’s withdrawal symptoms, why the lawsuits were brought and helpful information for anyone planning to stop Cymbalta. Part 3 is a timeline of the lawsuits.
As always, I’ll post any news related to the lawsuits in my weekly news updates. To make things easy, I’ve created a page dedicated to the lawsuits where you’ll find all of FedUpwithFatigue’s Cymbalta posts, links to national media stories and other useful information. I’ll be covering these lawsuits as they unfold. Please consider subscribing (there are forms at the top of the page and the bottom of this post) to receive the latest updates.
Update 10/25/16: The Cymbalta lawsuits have been settled. Click here for details.
After I posted Part 1 of this series, I was shocked by the number of comments and emails that I received from people who had experienced Cymbalta’s withdrawal symptoms. Based on the feedback, it’s obvious this issue has affected thousands within the fibromyalgia community (and others since Cymbalta is used for various conditions).
More than 200 patients are currently suing Eli Lilly & Company, claiming the drugmaker didn’t fully disclose the severity of Cymbalta’s withdrawal symptoms. The plaintiffs in the cases say 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.
First, a little background …
As early as 2005, research indicated a high rate of what medical professionals call “adverse events” when patients stopped taking Cymbalta. This Eli 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 Eli Lilly trial involving 1,279 patients found that 51 percent of patients experienced withdrawal symptoms.
Given the high percentage (44 percent and 51 percent, respectively) of patients who reported withdrawal symptoms during these two trials, prescribing physicians should be aware of this issue and be more conscientious about weaning patients off very slowly to minimize withdrawal as much as possible.
Unfortunately, that hasn’t been the case, and there’s a good reason why so many physicians seem to be uninformed about Cymbalta’s withdrawal symptoms. If you pull up the physicians’ prescribing guide for Cymbalta on Eli Lilly’s website and read the section entitled “discontinuation of treatment with Cymbalta,” here’s what it says: “Following abrupt or tapered discontinuation in adult placebo-controlled clinical trials, the following symptoms occurred at 1 percent or greater and at a significantly higher rate in Cymbalta-treated patients compared to those discontinuing from placebo: dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis and fatigue.”
Did you catch that?
The Eli Lilly studies say these symptoms happen in 44-51 percent of patients, but Cymbalta’s prescribing guide says they occur in “1 percent or greater” of patients. Well, Eli Lilly is TECHNICALLY correct when it says “1 percent or greater,” but if the company was being transparent, shouldn’t it have included the 44-51 percent figures in its prescribing guide? Wouldn’t that have helped physicians to be more careful when patients were coming off of Cymbalta?
The two Eli Lilly trials and Cymbalta’s prescribing guide are the crux of the legal action now being heard in various federal courts.
And now, the interview …
Baum, Hedlund, Aristei & Goldman, PC, a personal injury and wrongful death law firm with offices in Washington, D.C., Philadelphia and Los Angeles, among others, generously agreed to answer a few questions about the pending lawsuits. My questions are in italics, and the firm’s responses are in regular text.
Can you give some background on how you came to learn about the issues with Cymbalta’s withdrawal symptoms and why you decided to move forward with a lawsuit?
We began investigating issues related to Cymbalta withdrawal because there were so many complaints by consumers on the internet. We discovered that Lilly’s own clinical trials revealed the risk of suffering from withdrawal is much higher than the label suggests. We decided to move forward with the lawsuits because of the volume of consumers complaining about withdrawal.
How many plaintiffs do you have taking part in the lawsuit at this point? What are their general complaints? Are any of them still having health issues as a result of taking Cymbalta?
There are currently 44 cases involving 249 individual plaintiffs pending in federal courts across the country. In addition, there are more than 100 cases pending in a coordinated proceeding in California state court in Los Angeles. There are thousands of cases in the pipeline for filing. For the most part, people suffering from withdrawal seem to eventually recover fully, however, some do report residual symptoms, and some have actually committed suicide while withdrawing from Cymbalta.
Eli Lilly’s physician prescribing guide indicates Cymbalta’s withdrawal symptoms occur in “1 percent or more” of patients, which is technically correct. Eli Lilly’s own research says these withdrawal effects occur in 44-51 percent of patients. Is that a sticking point in your argument? Shouldn’t Eli Lilly have been more forthcoming about the number of patients affected, since there is a big discrepancy between “1 percent or more” and “44-51 percent”?
That is our argument in these cases. 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). 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.
EL has prevailed in the cases that have gone to court so far. Were you surprised by these outcomes?
We were disappointed by the outcome of the cases, but not necessarily surprised. Each case has its own fact pattern, and some cases are more difficult than others. For instance, in some cases, the plaintiff did not seek medical assistance when withdrawing from Cymbalta, and we believe that could have played a big role in the jury’s decision. Some blame the doctor for not catching Lilly’s semantic game. Some agree with Lilly that the label is “technically correct,” so it is “adequate,” which to some means “good enough.”
I just read that 60+ plaintiffs’ cases have been moved to Indiana, Eli Lilly’s home state, but there are lots of cases that haven’t been moved yet. Do you think eventually all of the cases will be combined to make the legal process easier?
We expect additional cases may be transferred to Indiana, but that remains to be seen. An additional attempt to consolidate into an MDL [multidistrict litigation] was recently denied, so we are currently considering our options. The consolidated proceeding in California should help and will likely be where many future cases are filed.
The next trial is not scheduled until late next year. We intend to use that time to conduct further discovery and fine-tune the cases for future success.
Update 10/25/16: The Cymbalta cases have been settled, and Baum Hedlund is no longer accepting new plaintiffs. Click here for details on the settlement.
Have you been affected by Cymbalta’s withdrawal symptoms? Feel free to share your experience in the comments below.