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From Products Liability Law Daily, September 2, 2015

Jury finds for Cymbalta-maker in warnings suits

By Susan Lasser, J.D.

A federal jury in Virginia determined that Eli Lilly and Company did not fail to provide an adequate warning of the risks associated with discontinuing the prescription drug, Cymbalta, to the prescribing physicians for two patients who experienced many withdrawal symptoms when they stopped taking the drug (Hagan-Brown v. Eli Lilly Co. and Ali v. Eli Lilly Co., September 1, 2015).

Background. One of the patients, Gilda Hagan-Brown, was prescribed the antidepressant drug, Cymbalta, by her physician in or around September 2012 for treatment of fibromyalgia and osteoarthritis of the cervical spine. Hagen-Brown’s complaint describes Cymbalta as belonging to a class of antidepressants known as “Serotonin and Norepinephrine Reuptake Inhibitors” (SNRIs). In addition to blocking the absorption of serotonin, SNRIs are thought to block the absorption of another neurotransmitter, norepinephrine, resulting in increased levels of both serotonin and norepinephrine in the brain. The drug is promoted as a treatment for pain as well as depression. About six months after treatment began, Hagan-Brown elected to wean off of Cymbalta because “she did not like the feeling of intoxication that the medication produced.” She discontinued the drug under the care and supervision of her doctor, but experienced “severe and dangerous withdrawal symptoms,” which included suicidal thoughts, severe depression, migraines, buzzing in her head, anxiety, mood swings, dizziness, glazed eyes, irritable bowel syndrome, dry mouth, and sweating, according to her complaint.

The patient alleged that at all times relevant, Eli Lilly knew or should have known that the drug was in a defective condition and was/is inherently dangerous and unsafe when used in the manner instructed and provided for by the drug maker. She further asserted that if the manufacturer had adequately, accurately and properly warned about the withdrawal symptoms associated with stopping use of Cymbalta, including accurately reporting their frequency, severity, and/or duration, Hagan-Brown’s physician would not have prescribed the drug to her; she would have refused the drug; and/or her physician would have been able to more adequately, accurately and properly weigh and convey the drug’s risks and benefits in a way as to avoid Hagan-Brown's injuries and damages. Her claims against Eli Lilly included strict liability design defect, failure to warn, and negligent design and negligent failure to warn.

Janine Ali, the second patient, like Hagan-Brown, filed her complaint on November 26, 2014. She also alleged in her complaint that her use Cymbalta and the resulting injuries and damages “were a direct and proximate result of [Eli] Lilly’s acts and omissions relating to its failure to provide adequate instructions for stopping Cymbalta and its failure to include adequate warnings that fully and accurately inform users and physicians of the frequency, severity, and/or duration of Cymbalta’s withdrawal symptoms.” Ali was prescribed the drug by her physician in May 2012, and the drug was meant to treat fibromyalgia. Because she did not think Cymbalta was helping her fibromyalgia, she elected to discontinue ingestion of the drug. Ali experienced “severe and dangerous withdrawal symptoms” when she stopped taking the drug, including depression, anxiety, panic attacks, insomnia, nightmares, out of body experiences and crying uncontrollably. She alleged that the manufacturer knew or should have known that Cymbalta was in a defective condition and inherently dangerous and unsafe when used as instructed by Eli Lilly.

She claimed that if Eli Lilly adequately, accurately, and properly warned about the withdrawal symptoms associated with the cessation of Cymbalta, including accurately reporting their frequency, severity, and/or duration, her doctor would not have prescribed the drug to her; she would have refused the drug; and/or her physician would have been able to more adequately, accurately and properly weigh and convey the risks and benefits of the drug so as to avoid Ali’s injuries and damages.

Jury verdict. The jury was asked, for both patients, whether the drug maker failed to provide an adequate warning concerning the risks associated with discontinuing Cymbalta to the patients’ prescribing physicians. The jury’s answer was, “no” for both patients.

The cases are Civil Action Nos. l:14-cv-1614 (AJT/JFA) and 1:14-cv-1615 (AJT/JFA).

Attorneys: Peter Andrew Miller (Miller Legal LLC) for Gilda Hagan-Brown. Peter Andrew Miller (Miller Legal LLC) for Janine Ali. Jeffrey Todd Bozman (Covington & Burling LLP) for Eli Lilly and Co.

Companies: Eli Lilly and Co.

MainStory: TopStory DamagesNews JuryVerdictsNewsStory DrugsNews VirginiaNews

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