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From Products Liability Law Daily, August 15, 2014

Eli Lilly faces new charges that it misled consumers about Cymbalta’s withdrawal side effects

By Pamela C. Maloney, J.D.

In recent weeks, dozens of lawsuits and one putative class action have been filed against Eli Lilly and Company, alleging that the company misled consumers about Cymbalta’s propensity to induce withdrawal side effects including electric-shock like sensations in their body and brain (also known as “brain zaps”), dizziness, nausea, vomiting, vertigo, excessive sweating, insomnia, nightmares, and diarrhea, according to Baum, Hedlund, Aristei & Goldman, LLC (August 14 press release). According to the press release, some of the firms representing the plaintiffs have also been litigating a consumer protection class action lawsuit against Lilly since 2012 which alleges the company omitted material information about the true risk of withdrawal in the product label and in marketing materials. (For sample complaints filed in the U.S. District Court for the Central District of California, see Barrett v. Eli Lilly and Co., and McDowell v. Eli Lilly and Co., August 14, 2014.)

Background. Both Peggy Bartlett and Jesse McDowell alleged that they experienced serious and life-threatening withdrawal symptoms as a result of ingesting Eli Lilly’s prescription drug Cymbalta (duloxetine), a selective serotonin norepinephrine reuptake inhibitor antidepressant, commonly called an “SNRI.” Specifically, Ms. Bartlett, who was prescribed the drug for treatment of multiple sclerosis and fibromyalgia, claims to have experienced painful electrical pulses in her head, dizziness, vomiting, shaking, headaches, muscle spasms, irritability, and anger as she attempted to discontinue taking the drug. Mr. McDowell was prescribed the drug for treatment of anxiety and depression, but when he continued to experience severe anxiety and depression, his physician advised him to taper his ingestion over a seven-month period. Upon tapering off his use of the drug, McDowell experienced extreme brain zaps that left him disoriented and confused. He also suffered from frequent suicidal thoughts, bouts of insomnia, and debilitating headaches.

General allegations. In 2004, after manufacturing issues were resolved, the drug was approved for treatment of Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD) with a liver toxicity warning included in the prescribing information. Since its approval, the drug, according to the complaints, has been aggressively marketed to the public and medical community.

The complaints allege that Lilly’s promotional campaigns have continuously overstated the efficacy of the drug and downplayed, and/or failed to state the true withdrawal side effects associated with its use. On the drug’s label, Lilly states that the chance of suffering from withdrawal when discontinuing Cymbalta in either an abrupt or tapered manner was “greater than or equal to 1%” when compared with patients discontinuing from the placebo. However, according to the complaint, the true rate according to Lilly’s own studies was at least 44 percent in one and 50 percent in another.

Despite Lilly’s knowledge of the high rate of withdrawal symptoms, which included, among others, headaches, dizziness, nausea, fatigue, diarrhea, paresthesia, vomiting, irritability, nightmares, insomnia, anxiety, hyperhidrosis, sensory disturbances, electric shock sensations, seizures, and vertigo, the complaints charge that Lilly failed to adequately and fully warn patients and physicians. The complaints further allege that in addition to its failure to warn, Lilly overplayed the efficacy of the drug through its misleading advertising campaigns.

Tort causes of action. Each of the complaints state counts for negligence and strict products liability in the design, manufacture, testing, advertising, marketing, promoting, labeling, supply, and sale of Cymbalta based, in part, on Lilly’s (1) failure to provide proper warnings to users and health care professionals; (2) misrepresentation of the efficacy of the drug; (3) design of the drug in a way that Lilly knew would cause physical dependency and withdrawal; (4) reckless and false representations and knowing omission or concealment of material facts regarding the efficacy of the drug; and (5) failure to comply with post-manufacturing warning duties. The strict liability counts include charges that the drug was defective in design or formulation in that it posed a greater likelihood of injury when compared to similar medications and was more dangerous than an ordinary consumer could reasonably foresee or anticipate.

In both the negligent misrepresentation and fraud counts, the complaints allege that Lilly misrepresented that the drug was safe for use and that the withdrawal side effects were no different than those associated with similar products on the market. The complaints further state that both the patients and their prescribing physicians relied upon Lilly’s representations regarding the efficacy of the drug. To support the fraud count, the complaints state that the misrepresentations were material and false, and that Lilly made these representations knowingly and/or with reckless disregard for their truth or falsity.

Unfair and fraudulent business practices. In addition to the tort counts, the complaints charge that Lilly violated California’s Unfair Competition Law by making numerous misrepresentations and misleading omissions to the patients, to healthcare providers, and to the general public. These misrepresentations and omissions include the company’s failure to disclose risk information. The complaints further charge that Lilly’s business practices with regard to this drug amounted to false advertising, intentional misrepresentation, and fraudulent concealment.

Relief sought. Both complainants sought general damages, medical and other special damages, loss of earnings and earnings capacity, medical monitoring, damages for loss of consortium, punitive damages, pre- and post-judgment interest, and the costs of suit. The complaints also sought injunctive relief against Lilly for its unlawful, unfair, and fraudulent business practices in violation of California law. In addition to injunctive relief, the complaint sought disgorgement of Lilly’s profits, exemplary and punitive damages, and attorneys’ fees.

The case number is 5:14-cv-01675-JGB-DTB (Barrett).

Attorneys: Michael Lin Baum (Baum Hedlund Aristei and Goldman PC) for Peggy Barrett and Jesse McDowell.

Companies: Elli Lilly and Co.

MainStory: TopStory DesignManufacturingNews WarningsNews DamagesNews DrugsNews CaliforniaNews

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