The agreements reportedly cover approximately 10,500 claimants, including a large number of previously filed lawsuits (including the three purported class actions mentioned above), tolled claims, and other informally asserted claims. 'The agreements in principle are subject to certain conditions," the report notes, "including obtaining full releases from a specified number of claimants."
The Zyprexa claims not subject to these agreements, Lilly says, include approximately 800 lawsuits covering 4,700 claimants, and approximately 850 tolled claims. In addition, the filing says, Lilly has been served with a new lawsuit seeking class certification in which the members of the purported class are seeking refunds and medical monitoring.
In 2005, two lawsuits were filed in the Eastern District of New York purporting to be nationwide class actions on behalf of all consumers and third party payers, excluding governmental entities, which have made or will make payments for their members or
insured patients being prescribed Zyprexa.
These actions have now been consolidated into one lawsuit, filed under state consumer protection statutes, the federal civil RICO statute, and common law theories, seeking a refund of the cost of Zyprexa, treble damages, punitive damages, and attorneys' fees.
Two additional lawsuits were filed this year in the Eastern District of New York on similar grounds, the filing states.
Finally, in early 2005, Lilly was served with five lawsuits seeking class action status in Canada on behalf of patients who took Zyprexa with allegations similar to those in the US.
In the second quarter of 2005, Lilly recorded a net pre-tax charge of $1.07 billion for product liability matters. "The $1.07 billion net charge," the SEC report states, "takes into account the estimated recoveries from insurance coverage related to these matters."
During 2005, $700 million was paid out in connection with Zyprexa settlements, according to the report.
"Because of the nature of pharmaceutical products," the SEC filing states, "it is possible that we could become subject to large numbers of product liability claims for other products in the future."
Zyprexa was first only approved for the treatment of adults with schizophrenia, but four years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
Yet despite its limited indications for use, Zyprexa has become the top selling antipsychotic, with more than 17 million people worldwide having used the drug.
There is no way that Zyprexa could have rose to such prominence without Lilly's illegal promotional tactics. When it came on the market their was no good news to offer medical professionals on the drug.
Based on the results of a six-week clinical trial sponsored by Lilly, the FDA granted approval. The trial involved 2,500 people, and two-thirds of the participants didn't even complete the program.
Among those who stuck it out, 22% of the Zyprexa subjects suffered a "serious" adverse effect, compared to 18% in the group taking Haldol, according to Leonard Roy Frank, author of Zyprexa: A Prescription for Diabetes, Disease and Early Death, August 2005 Edition of Street Spirit.
That same year, FDA data obtained by investigative reporter and author, Robert Whitaker, under the Freedom of Information Act, revealed Zyprexa's adverse effects to include: cardiac abnormalities and hypotension 10% to 15%; Parkinson-like motor impairment 11.7%; unbearable restlessness (akathisia) 7.3%; and acute weight gain (50%) increasing the risk of diabetes.
The data also disclosed a participant dropout rate during 6-week clinical trials of 65%. In a one-year trial, the drop out rate rose to 83%.
The Zyprexa claims not subject to these agreements, Lilly says, include approximately 800 lawsuits covering 4,700 claimants, and approximately 850 tolled claims. In addition, the filing says, Lilly has been served with a new lawsuit seeking class certification in which the members of the purported class are seeking refunds and medical monitoring.
In 2005, two lawsuits were filed in the Eastern District of New York purporting to be nationwide class actions on behalf of all consumers and third party payers, excluding governmental entities, which have made or will make payments for their members or
insured patients being prescribed Zyprexa.
These actions have now been consolidated into one lawsuit, filed under state consumer protection statutes, the federal civil RICO statute, and common law theories, seeking a refund of the cost of Zyprexa, treble damages, punitive damages, and attorneys' fees.
Finally, in early 2005, Lilly was served with five lawsuits seeking class action status in Canada on behalf of patients who took Zyprexa with allegations similar to those in the US.
In the second quarter of 2005, Lilly recorded a net pre-tax charge of $1.07 billion for product liability matters. "The $1.07 billion net charge," the SEC report states, "takes into account the estimated recoveries from insurance coverage related to these matters."
During 2005, $700 million was paid out in connection with Zyprexa settlements, according to the report.
"Because of the nature of pharmaceutical products," the SEC filing states, "it is possible that we could become subject to large numbers of product liability claims for other products in the future."
Zyprexa was first only approved for the treatment of adults with schizophrenia, but four years later, it was approved for short-term treatment of adults with manic episodes associated with bipolar disorder.
Yet despite its limited indications for use, Zyprexa has become the top selling antipsychotic, with more than 17 million people worldwide having used the drug.
There is no way that Zyprexa could have rose to such prominence without Lilly's illegal promotional tactics. When it came on the market their was no good news to offer medical professionals on the drug.
Based on the results of a six-week clinical trial sponsored by Lilly, the FDA granted approval. The trial involved 2,500 people, and two-thirds of the participants didn't even complete the program.
Among those who stuck it out, 22% of the Zyprexa subjects suffered a "serious" adverse effect, compared to 18% in the group taking Haldol, according to Leonard Roy Frank, author of Zyprexa: A Prescription for Diabetes, Disease and Early Death, August 2005 Edition of Street Spirit.
That same year, FDA data obtained by investigative reporter and author, Robert Whitaker, under the Freedom of Information Act, revealed Zyprexa's adverse effects to include: cardiac abnormalities and hypotension 10% to 15%; Parkinson-like motor impairment 11.7%; unbearable restlessness (akathisia) 7.3%; and acute weight gain (50%) increasing the risk of diabetes.
The data also disclosed a participant dropout rate during 6-week clinical trials of 65%. In a one-year trial, the drop out rate rose to 83%.
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