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REUTERS: http://www.reuters.com/article/2015/08/03/us-eli-lilly-cymbalta-trial-idUSKCN0Q825220150803 Health | Mon Aug 3, 2015 4:16pm EDT Related: HEALTH Eli Lilly faces first U.S. trials over Cymbalta withdrawal NEW YORK | BY JESSICA DYE Eli Lilly & Co on Tuesday will confront the first U.S. trial over allegations it failed to warn users of its popular antidepressant Cymbalta that they could suffer severe withdrawal symptoms, including suicidal thoughts and electric shock-like sensations. Plaintiff Claudia Herrera is one of about 250 people who have sued Lilly over Cymbalta, and the company faces three more trials later this month involving similar claims, according to a lawyer for Herrera, R. Brent Wisner. These early trials will be a critical test for litigation over the drug, which had $3.9 billion in sales in 2013 before losing patent protection at the end of that year and brought in $561 million in the first half of 2015. Cymbalta, part of a class of antidepressants known as serotonin and norepinephrine reuptake inhibitors, was approved by the U.S. Food and Drug Administration in 2004 to treat major depressive disorder. Later, approval was expanded to include generalized anxiety disorder and fibromyalgia. Its label warns that 1 percent or more of users who discontinue Cymbalta may experience symptoms like nausea, irritability and insomnia, and that other symptoms such as sensory disturbances and seizures had been reported. But plaintiffs suing Lilly allege that withdrawal symptoms are far more common, pointing to a 2005 analysis from the Journal of Affective Disorders that found more than 44 percent of patients reported at least one discontinuation symptom. A Lilly spokeswoman declined to comment specifically on Herrera’s allegations and said that the company would vigorously defend that case and others. According to Herrera’s lawsuit in California federal court, she started taking Cymbalta in 2006 for anxiety. When her doctor instructed her in 2012 to ease off gradually, she said that she suffered electric-like “zaps,” anxiety, spasms and suicidal ideation, among other symptoms. Herrera accused Lilly of downplaying its warnings to make the drug more marketable. Lilly said in court filings that it gave sufficient warnings, and that her doctor was aware of the potential risks. A similar case is set for trial in California starting Aug. 11. Other Cymbalta lawsuits have been less successful. A New York judge last year granted Lilly a win in a case similar to Herrera's and twice, a federal judge in California has denied plaintiffs’ motions for class certification on consumer-protection claims related to Cymbalta marketing. The California trials, and two more scheduled to start in Virginia in late August, will be the first opportunities for juries to evaluate the underlying claims. “The success or failure of these cases will give us a good sense of how they are playing to these juries,” Wisner said. “Even if we lose, we have every intention of moving forward with the litigation.”

NOTE Also see 2009: FDA hears testimony about Cymbalta discontinuation syndrome Study finds some Cymbalta withdrawal "severe and persistant" Doctor is shocked at severe Cymbalta withdrawal symptoms Tips for tapering off Cymbalta (duloxetine) This is a press release seeking leads for lawyers http://www.digitaljournal.com/pr/1532756 To send an inquiry, see http://injury-law.freeadvice.com/injury-law/drug-toxic_chemicals/cymbalta-lawsuits.htm It is not clear what firm, if any, is pursuing these lawsuits. Patients Suffering Withdrawal Symptoms from Major Antidepressant Drug Suspect Manufacturer Hid Risk of Side Effect Consumers who have suffered from withdrawal of Eli Lilly & Company's anti-depressant Cymbalta have reason to believe the drug manufacturer was aware of the risk of side effects but failed to disclose information to the general public. SAUSALITO, CA, October 18, 2013 /24-7PressRelease/ -- Patients using the anti-depressant drug, Cymbalta, have reported a number of physical and emotional side effects suffered after attempting to stop use of the drug. The drug's manufacturer, Eli Lilly & Company, has come under fire for failing to disclose the risks of Cymbalta withdrawal and promoting use of the drug while downplaying its side effects. Free Advice has released new articles covering Cymbalta withdrawal to provide consumers with more information on what symptoms to expect and how injured patients can pursue legal action. FDA Finds Evidence of Cymbalta Side Effects The US Food and Drug Administration (FDA) has investigated Cymbalta withdrawal symptoms, and released the results of an agency study that found: - Clinical studies of abrupt discontinuation of Cymbalta show that withdrawal occurred in 44 to 50% of patients - Of patients suffering withdrawal symptoms, 10% of those were severe - Half of the patients who reported Cymbalta withdrawal had not resolved the side effects at the end of the two week study Patients in the FDA study displayed a wide array of physical and emotional side effects as a result of abrupt discontinuation of Cymbalta use, including: - Suicidal thoughts - Tremors - Nausea - Appetite changes and weight gain - Insomnia - Full body shaking - Tunnel vision The FDA's study also pointed out that there had been "a serious breakdown at both the FDA and the manufacturer, Eli Lilly and Company, in providing adequate warnings and instructions about how to manage [the side effects]," which suggests that Eli Lilly was aware of the potential side effects from Cymbalta withdrawal and provided neither the FDA nor the American public with adequate warning of the risks. .... Eli Lilly's History of Misleading Cymbalta Advertisements According to patients who have suffered Cymbalta withdrawal, Eli Lilly mislead consumers with a series of aggressive advertisements that highlighted the positive effects of Cymbalta and downplayed, or ignored, the potential risks of withdrawal side effects. As more patients come forward with complaints of withdrawal symptoms, Eli Lilly's recent history of unlawful promotion of the drug could suggest the company was aware of Cymbalta's risks and failed to disclose them to consumers. Eli Lilly was fined in 2007 and 2009 by the FDA for unlawfully promoting Cymbalta through mailings that gave false statements that overstated the effect of the drug and downplaying clinical studies that revealed risks of Cymbalta withdrawal. Further, the company has been accused of selectively publishing study results that over-exaggerate the effect of Cymbalta and hide the risks. Misleading Claims About Cymbalta Side Effects Could Lead to Lawsuits Citing the history of Eli Lilly's fines by the FDA and the suspicion that the company provided misleading study results, patients claim that the company has established a pattern of falsified advertising to press Cymbalta on patients without adequate warning of the risks. Attorneys preparing legal action against the company claim that Eli Lilly was aware of the moderate to severe side effects associated with Cymbalta withdrawal, promoted use of the drug without warning of these risks, and caused patients who used the drug unaware of the consequences significant injury. By arguing that Eli Lilly Company was aware of Cymbalta side effects and downplayed them to promote use of the drug, patients and their attorneys will look to hold the drug manufacturer liable for medical bills and pain & suffering damages. For more information, click here for Free Advice's latest article about Cymbalta lawsuits. As more patients come forward, experienced lawyers are offering consultations with people who have suffered moderate to severe side effects from Cymbalta withdrawal. Typical symptoms last for several weeks after ceasing the use of Cymbalta, or are so severe as to prevent the patient from being able to stop use of the drug. If you or a loved one has suffered from Cymbalta withdrawal, click here for a FREE case evaluation by an experienced attorney. --- Press release service and press release distribution provided by http://www.24-7pressrelease.com