WARNING: ALWAYS SPEAK TO YOUR PRESCRIBING PHYSICIAN BEFORE DISCONTINUING ANY MEDICATION
$9 Billion Jury Award – Actos Lawsuit Result
In the first federal Actos lawsuit to go to trial, in April, 2014 a jury in Lafayette, Louisiana, (where multidistrict Actos litigation is assigned) has awarded more than $9 Billion in damages on behalf of the plaintiffs against the drug manufacturer. The Louisiana docket lists 2,923 pending Actos cases. This huge victory by the plaintiffs’ lawyers who handled that case can only be seen as a “win” for Ellis Law‘s Actos clients, who could benefit from negotiations, which may ensue from this major victory over the drug manufacturers.
Background: The Food and Drug Administration (FDA) recently reviewed partial findings from a 10-year study by the manufacturer that determined Actos (pioglitazone hydrochloride), the prescription medication used to improve blood sugar level for those with type 2 diabetes, carries with it an increased risk of bladder cancer. The findings of the epidemiological study of 193,099 diabetic patients, which were released this past June, have created enough worry that Actos has already been banned in France and Germany because of its risk. The FDA is now advising doctors to warn patients of the risk when prescribing the medication. Further, the FDA noted in its June 15, 2011 Drug Safety Communication concerning risks of bladder cancer from use of pioglitazone:
“[compared] to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk”
Actos belongs to a class of drug known as thiazolidinedione (TZD), which now has two popular drugs associated with severe harmful side effects. Previously, concerns that the other drug in the class, Avandia, may increase the risk of heart attack prompted the FDA to restrict use of the drug. Actos has in some cases been prescribed instead of Avandia because of these concerns. Unfortunately, a recent study published in the American Heart Association journal, Circulation found that Actos may also increase the risk of heart disease.
Takeda Pharmaceuticals and Eli Lilly & Co., the manufacturers of Actos, are facing a class action lawsuit for a failure to warn consumers of the increased risks. In 2009, Eli Lilly & Co. pled guilty to illegally marketing Zyprexa, an antipsychotic drug. Ultimately the company paid out $1.42 Billion to settle the government claims and $1.2 Billion to settle the plaintiffs’ claims in the pharmaceutical class action. Ellis Law‘s Zyprexa clients shared in that settlement.
Takeda Pharmaceuticals has been the sole marketer of Actos since 2006, when Eli Lilly lost its rights to the drug. Actos has been one of the most prescribed drugs in the U.S., with sales in 2010 exceeding $2.6 Billion.
Always speak to your prescribing physician before discontinuing the use of any medication. If you have symptoms of bladder cancer, such as blood in the urine, pain or burning during urination or a change in bladder habits, speak to a doctor immediately.
Actos is also marketed under the names “Actoplus Met,” “Actoplus Met XR” and “Duetact.” Anyone who took or is taking Actos or another of these drugs should contact Ellis Law, P.C., to discuss potential involvement in the class action suit, which may bring significant compensation for injuries and wrongful death
Ellis Law‘s Clients Share In $4.85 Billion And $1.2 Billion Drug Settlements
Ellis Law is pleased to report that our Vioxx and Zyprexa clients have participated in two large settlements for these defective drugs. These include the $4.85 Billion settlement of claims against Merck, in which it was contended that the drug Vioxx caused heart attacks and strokes, along with the $1.2 Billion settlement by Eli Lilly and Company of claims involving the drug Zyprexa. The initial Zyprexa settlement by Eli Lilly of $690 Million was later increased to $1.2 Billion. The original press release concerning the latter settlement follows.
Ellis Law is currently accepting clients for a proposed claim involving heart attacks, strokes and/or blood clots allegedly caused by low testosterone (Low-T) therapy treatments. We are also accepting claims on behalf of women who used talcum powder or other products containing talc who developed ovarian cancer. If you feel you have been injured by Low-T, talcum powder, or any other allegedly dangerous or defective drug or other product, please submit a FREE INJURY ANSWERLINE® inquiry or call us at 1-800-LAW-7777 immediately!
Lilly and Plaintiffs’ Attorneys Enter Into an Agreement in Principle to Settle Majority of Zyprexa(R) Product Liability Litigation
06/09/05 – INDIANAPOLIS, Indiana, June 9 /PRNewswire-FirstCall/ – Eli Lilly and Company announced today that it has entered into an agreement in principle with plaintiffs’ attorneys involved in Zyprexa liability litigation to settle a majority of the claims against Lilly relating to the medication.
“While we believe the claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their doctors,” said Sidney Taurel, chairman, president and chief executive officer of Eli Lilly and Company. “We wanted to reduce significant uncertainties involved in litigating such complex cases. Our decision to resolve these claims does not change the fact that Zyprexa has and will continue to improve the lives of millions of patients around the world who are suffering from schizophrenia and bipolar disorder. This settlement will enable Lilly to focus first and foremost on addressing unmet medical needs through research, educational programs and partnerships with doctors and patients.”
When finalized, the settlement will resolve the majority of Zyprexa claims pending in the United States. This includes federal and state lawsuits that have been brought against Lilly, the filed nationwide class-action lawsuits (none of which had been certified by a judge), and the majority of approximately 5,000 claims that were the subject of “tolling agreements” that extended the deadline for potential claimants to file a lawsuit, as well as other potential claims against Lilly. The agreement will also result in the dismissal of claims against physicians and other health care professionals named as co-defendants in any cases covered by this settlement.
According to the agreement, Lilly will establish a fund not to exceed $690 Million for plaintiffs who agree to settle their claims. The settlement fund will be overseen and distributed by claims administrators appointed by the plaintiffs’ steering committee. At this time, the exact number of claimants covered by this settlement is unknown, but is estimated to be 8,000, comprising approximately 75 percent of claims identified to Lilly.
“We believe that this settlement is in the best interest of our clients, as well as patients, physicians and caregivers,” said Christopher Seeger, member of the plaintiffs’ steering committee, which had been directing the federal litigation for the claimants. “Our interest is in seeing that Zyprexa patients get the best medical care available and that doctors and patients receive accurate and meaningful information about the medications they use. We are pleased with the manner in which Lilly handled these claims. The patient population to which this drug is given has difficult medical histories. Protracted litigation was in no one’s interest.”
Most of the lawsuits claimed that before September 2003, the information in the medication label, which listed the risk of hyperglycemia and diabetes as an infrequent adverse event since 1996, was not adequately displayed. In September 2003, the FDA required label changes for all atypical antipsychotics to warn against this risk. “Given the background rate of diabetes in the population at large, and particularly in people with serious mental illness,” said Seeger, “we are pleased with the label change and the additional information being provided to physicians and their patients about both the risks and benefits of the drug.”
“The litigation stirred concern for physicians and spread fear among patients and caregivers, which has interfered with the process of physicians making treatment decisions,” added Taurel. “We want physicians to feel comfortable choosing the medication they believe best meets the treatment needs of their patients with serious mental illness.”
The agreement involves claimants who asserted that they developed diabetes-related conditions from their use of Zyprexa. Claimants who are not covered by the final settlement are those represented by attorneys who are not participating in the agreement in principle. Lilly is prepared to continue its vigorous defense of Zyprexa in the remaining cases.
Lilly advised investors that it anticipates taking at least a $700 Million pretax charge in the second quarter of 2005 to cover this settlement, as well as other product liability claims not covered by the settlement. This second-quarter charge will be excluded from Lilly’s adjusted second-quarter earnings.
Zyprexa® is indicated in the United States for the short- and long-term treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder. Since Zyprexa® was introduced in 1996, it has been prescribed to more than 17 million people worldwide.
Zyprexa is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. In addition, compared to placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Zyprexa.
Prescribing should be consistent with the need to minimize the risk of neuroleptic malignant syndrome, tardive dyskinesia, seizures and orthostatic hypotension.
The most common treatment-emergent adverse event associated with Zyprexa in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.
Full prescribing information, including boxed warning, is available at www.zyprexa.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
This press release contains forward-looking statements about Zyprexa®. These statements reflect management’s current beliefs, however, as with any commercial pharmaceutical product there are risks and uncertainties in the process of commercialization and regulatory review. In addition, there are no guarantees that the product will continue to be commercially successful. When final, this settlement is expected to resolve the majority of the pending and tolled claims as well as the potential claims of a large number of additional individuals; however, there is no guarantee that the settlement will become final. Also, the settlement does not resolve all pending cases and it is possible that the company could receive a substantial number of new claims in the future from individuals not subject to this settlement. For further discussion of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements