Founded by Eli Lilly in 1876, Eli Lilly and Company is an American global pharmaceutical company which sells products in over 125 companies throughout the world. Currently located in Indianapolis, Indiana, their first products included mass produced penicillin, the Salk polio vaccine, and insulin. Currently Eli Lilly and Company is one of the worlds largest manufacturers and distributors of mental health medications including Cymbalta.
Eli Lilly is considered one of the most influential pharmaceutical corporations in the world. Its founder Eli Lilly was not only a successful and wealth businessman, but he also worked to improve the federal regulation of the pharmaceutical industry. His ideas were instrumental in creating the Food and Drug Administration (FDA) and starting the practice of requiring addictive medications to be dispensed only through prescriptions by a medically certified doctor. Eli Lilly also became an advocate for many charitable causes by creating the Lilly Endowment Foundation, which is currently one of the largest charitable groups in the world.
Eli Lilly and Company continues to focus on creating a business which is dedicated to research and development, as well as creating quality-assurance measures to ensure their medications are safe. In 2009, Eli Lilly was accused of marketing Zyprexa for uses not authorized by the FDA, including the treatment of dementia. They were required to pay a $515 million criminal penalty, which was the largest criminal fine paid by a pharmaceutical company to date.
Cymbalta, manufactured and sold by Eli Lilly and Company, has come under fire recently as lawsuits have been filed against the company. Cymbalta (duloxetine) which is an oral medication used primarily to treat depression, diabetic neuropathy, osteoarthritis, pain, and fibromyalgia is believed to cause severe withdrawal symptoms after abruptly discontinuing its use. The lawsuits allege that the company failed to fully disclose the dangerous risks of withdrawal and only provided the following warning: “Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.” Litigants claim this warning is insufficient because it does not fully document the severity and regularity of the side-effects of early withdrawal or what a patient can do to minimize their risks.
Claimants further claim that the symptoms for withdrawal can be both physical and neurological and can include dizziness, nausea, vomiting, headaches, Paresthesia (tingling), abnormal sweating, crying, anger, irritability, suicidal ideation, nightmares, hallucinations, personality changes, changes in weight, and loss of appetite. Recently Eli Lilly has lost their patent protection for Cymbalta. With the introduction of new generic drugs to the market the company has struggled to find new drugs to increase their sales, which have declined substantially.
Established more than 135 years ago by Colonel Eli Lilly, Eli Lilly and Company has grown into a global, research-based company. Colonel Eli Lilly was a pharmaceutical chemist and a veteran of the U.S. Civil War. After the war he decided to create a company using the best knowledge and skills of the day. No longer would medicine be dispensed by hucksters. He would improve pharmaceutical technologies, increase the quality of existing medications, and develop and discover new medications. One of the first breakthrough discoveries for the company occurred in 1923 with the product lletin, which was the first commercially available insulin produced for the treatment of diabetes. Next, the company embarked on research to create a liver-extract product which would combat pernicious anemia, a life-threatening blood disorder. Then the company developed a method to mass-produce penicillin, the worlds first antibiotic. In 1982, the company had another breakthrough with their drug Humulin, which was considered one of the most significant breakthroughs in diabetes treatment since the 1920s. Later they launched Prozac, a new drug to treat clinical depression. Since then, the company has introduced a variety of drugs to combat a variety of common health conditions.
Cymbalta, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) was first approved for the treatment of depression in August 2004. Later that same year the FDA approved the drug for neuropathic pain associated with diabetes, for the treatment of generalized anxiety disorder, and for the treatment of major depressive disorder. In 2008, the drug was approved for the management of symptoms associated with fibromyalgia. After two more years Cymbalta had been approved for generalized anxiety and chronic musculoskeletal pain. Unfortunately, claimants who have taken Cymbalta suggest that Cymbalta is associated with a variety of negative side-effects, including suicidal behavior, birth defects, and severe withdrawal symptoms. The risk of suicide has been known for several years. In fact, the company includes a Black Box warning label on its packaging for increased suicide risks. According to the claimants who have filed recent claims against Eli Lilly, however, the company has not done enough to warn users of the dangers of birth defects and early withdrawal symptoms.
Although cases against Eli Lilly and Company have surfaced within the last few years, researchers from Eli Lilly and Company had already conducted clinical trials prior to the approval of Cymbalta by the FDA and had found some evidence that withdrawal from the drug could produce serious side-effects. In fact, according to one study done by the Institute for Safe Medicine Practices (ISMP), when a select group of patients took the drug for eight to nine weeks and then were switched suddenly to a placebo the study found that “44-50% of patients suffered withdrawal symptoms after discontinuing Cymbalta, of which 10% were “severe” symptoms.” The manufacturer did include warnings about stopping an antidepressant medicine without first talking to your doctor and noted that “stopping an antidepressant medicine suddenly can cause other symptoms.” Critics argue, however, these warnings may not have been sufficient to protect claimants against serious side-effects. Dozens of claims have been filed against the company in the last few years, but in 2014 a federal judge refused to consolidate the lawsuits into a Multi-District Litigation (MDL) under one judge. As of now, the cases against Eli Lilly will have to proceed individually through the court.