Zyprexa Injury Lawyers - Zyprexa Lawsuits




		The Legal Issues on Zyprexa Pharmaceutical company Eli Lilly recently announced a $500 million settlement to cover 18,000 lawsuits from patients who claim to have developed diabetes or other ailments after using Zyprexa, Eli-Lilly’s medication for schizophrenia and bipolar disorder. This brings Eli Lilly’s financial settlements to over $1.2 billion (including a 2005 $700 million settlement covering 8,000 patients). There are still an estimated 1,200 lawsuits pending. The Background In 1996, the US Food and Drug Administration (FDA) approved the prescriptive use of Zyprexa for the treatment of the adverse symptoms of schizophrenia. FDA granted Zyprexa approval in 2000 for the treatment of bipolar disorder. Zyprexa has become the most prescribed anti-psychotic medication in the United States with Eli Lilly (the manufacturer) reporting annual revenues of $2.6 billion from the sale of the drug. In 2002, the Japanese Health and Welfare Ministry and the British Medicines Control Authority issued emergency warnings against Zyprexa because of reported diabetes cases in that year. A study by Duke University in the same year documented hundreds of cases of Zyprexa-medicated patients who developed diabetes – many of these suffering other life-threatening complications – and 23 deaths among these patients. In 2003, investigative journalist Robert Whittaker published a book about deaths tied to Zyprexa, titled Mad in America. His research, using FDA data not released to doctors or consumers, showed that clinical trials prior to the medication’s approval showed one death out of 145 trial participants. Pre-marketing trials also showed that 20 out of 2,500 participants died during the treatment and that around two-thirds of the participants weren’t able to complete the trial due to side effects and other complications. That same year, the FDA requested that Eli Lilly include prominent warnings of the link between diabetes and Zyprexa usage, and recommend monitoring of blood sugar abnormalities for patients who were obese or had a family history of diabetes. In 2004, a class action lawsuit on behalf of all the Zyprexa users in America was filed in New York. Legal Issues The key legal issue with Zyprexa is one of product liability – specifically that Eli Lilly (the manufacturer) allowed the product to be sold even though the company knew of the risk of diabetes developing in patients. Apparently (as Whittaker points out), Eli Lilly already knew of the risk of diabetes developing in patients taking Zyprexa in 1996, prior to its release into the medical and pharmaceutical community. There was a warning included in the product label about the diabetic complication but this was buried in the text, and no recommendations were made for monitoring of at-risk patients. Experts consulted during the class action lawsuit have also pointed out that Eli Lilly’s actions during this period were questionable, to say the least. One has publicly pointed out that while the company ‘admitted’ there was a problem, there was an effort to downplay the matter – in effect, diverting the attention of patients and medical professionals from the potentially deadly complications of taking the drug. In fact, Eli Lilly response to the charges has always been to focus on the perceived ‘benefits’ of Zyprexa in treating mental disorders like. On this point, medical experts point out that other, older antipsychotic drugs have been proven effective in dealing with mental disorders but they patients taking them did not suffer the side effects induced by Zyprexa. At the same time, evidence has been presented in various lawsuits that Eli Lilly embarked on a marketing campaign to aggressively ‘push’ the product to the medical community, again downplaying the complications and going so far as to encourage ‘off label prescriptions’ – with Eli Lilly representatives persuading primary care physicians to prescribe Zyprexa even for ailments that it was not supposed to be prescribed for. Legal experts point out that Eli Lilly’s acceptance of the FDA’s 2003 recommendation for a change in the diabetic warning, as well as the company’s communications in 2004 recommending the monitoring for diabetic risk factors in obese patients and those with a family history of diabetes constitute acceptance of a flaw in their earlier product literature and labeling. Developments In 2005, Eli Lilly had to make a bigger settlement for 8,000 cases as opposed to the 2007 settlement for 18,000 cases. Experts note that the difference in the settlement amounts are due to Eli Lilly’s compliance with the FDA request in 2003. Patients who took the medication after Eli Lilly complied with the FDA request are assumed to have been informed of the complications, in which case liability for the problem is split between the company, the patient and the latter’s physician or medical institution. There are still around 1,200 lawsuits pending, as well as continuing investigations into the alleged ‘off labeling prescription’ efforts. The resolutions of these cases are being watched by legal experts, the medical community, and interested parties worldwide.