Lafayette, Louisiana, March 21, 2012 – – Baum, Hedlund, Aristei & Goldman filed an Actos lawsuit today against Japanese-based Takeda Pharmaceuticals and its subsidiaries and Eli Lilly and Company, on behalf of a Virginia man and his wife, asserting that Actos caused his bladder cancer. (Takeda Limited, one of the company’s subsidiaries, collaborated with Eli Lilly to promote and market Actos in North America, according to the complaint.)
The personal injury case (case no. 6:12:cv-709) joins similar federal Actos lawsuits which have been consolidated before U.S. District Judge Rebecca Doherty in the United States District Court for the Western District of Louisiana in Lafayette. It is estimated that Takeda may face thousands of similar personal injury and wrongful death Actos claims, based on the wide use of the drug.
Baum Hedlund is representing plaintiffs Timothy Plaugher and his wife Peggy Ann Plaugher for the injuries Mr. Plaugher suffered as a result of taking the diabetes medication Actos, an “unreasonably dangerous and defective drug” according to the complaint. Mr. Plaugher developed bladder cancer after using the prescription drug to treat his Type-2 diabetes. The suit is seeking compensatory damages on behalf of Mr. and Mrs. Plaugher.
According to the complaint, Takeda Pharmaceuticals knew or should have known that Actos use in humans increases the risk of developing bladder cancer. The suit alleges that for over a decade and to date, Takeda hid its knowledge that Actos was linked to a dangerous risk of bladder cancer and failed to completely disclose pre-clinical scientific studies that included animal evidence supporting this alarming connection. Takeda concealed this knowledge, the suit states, before applying for and obtaining approval for Actos. In fact, plaintiffs allege that Takeda has known since the early 2000’s that human clinical trials revealed a significant link between Actos and bladder cancer.
The lawsuit further alleges that Takeda willfully, wantonly and with malice withheld the knowledge of increased risk of cancer in Actos users and by doing so caused Mr. Plaugher to suffer severe and permanent personal injury, including; bladder cancer and related sequelae, pain and suffering, bodily impairment, mental anguish, diminished enjoyment of life as well as economic loss and other special damages.
“Takeda failed to properly warn plaintiffs of the very real and dangerous link between the use of Actos and bladder cancer,” stated the Plaughers’ attorney, Cynthia Garber, also an R.N. “The company had a responsibility to disclose this information to healthcare workers and patients. Instead of helping them, this prescription drug has led to disease and death. Takeda should be held accountable for their wrong-doing.”
Ms. Garber is also among the lawyers representing the families who recently filed three other Actos bladder cancer lawsuits in Los Angeles Superior Court (Case numbers BC476062/63/64).
Baum Hedlund is also representing the former medical reviewer for Takeda, the United States, and 22 states, in a whistleblower lawsuit (Case 1:10-cv-11043-FDS – U.S. District Court for the District of Massachusetts) alleging that Takeda failed to properly report all Actos related bladder cancer adverse events to the FDA.
Actos [pioglitazone] was approved in 1999 by the Food and Drug Administration (FDA) to treat Type 2 Diabetes Mellitus, the most common form of diabetes in the US.
On June 7, 2011, the Caisse nationale de l’assurance maladie published a paper in France which reported a statistically significant association between exposure to Actos and bladder cancer and that the risk increased with exposure longer than one year. Two days later, the European Medicine Agency suspended the use of Actos.
Soon after, Germany’s Federal Institute for Drugs and Medical Devices suspended the use of the drug. Health Canada is currently undertaking a review of pioglitazone-containing drugs.
The FDA has not yet suspended Actos in the U.S. but on June 15, 2011 the FDA issued a Public Safety Announcement informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. The agency also said that information about this risk will be added to Actos’ patient Medication Guide and to the Warnings and Precautions section of the label for pioglitazone-containing medicines. Additionally, the FDA recommended that healthcare professionals tell their diabetes patients diagnosed with bladder cancer to stop taking Actos or pioglitazone.
On July 12, 2011, Takeda issued a recall on Actos in France, but refused to issue a recall of Actos in the United States. This inaction, the lawsuit states, continues to subject American citizens to the significant risk of developing bladder cancer.
In later 2011, Bloomberg News reported that millions of patients switched from the controversial diabetes drug Avandia to Actos, after Avandia was linked to heart attacks and cardiovascular death. The sales of Actos rose from about $3 billion in 2006 to almost $5 billion last year. GlaxoSmithKline, manufacturers of Avandia, has paid more than $6 billion for legal costs tied to Avandia and other medicines.
About Baum, Hedlund, Aristei & Goldman, P.C.
Baum, Hedlund, Aristei & Goldman represents Actos bladder cancer patients across the country in cases against Takeda. The firm is also handling a former Takeda medical reviewer’s whistleblower lawsuit regarding Takeda’s failing to report adverse side events, including bladder cancer, related to Actos.
The team of lawyers working on the Actos bladder cancer cases have an in depth understanding of biomedical research, clinical trials, statistics, the pharmaceutical industry and marketing, as well as successful and effective discovery procedures and extensive work with experts on complicated scientific issues because of their years of experience related to Baum Hedlund’s past pharmaceutical litigation.
Baum, Hedlund, Aristei & Goldman has successfully represented clients harmed by medications in over 4,000 individual personal injury and wrongful death cases, in addition to representing consumers in multiple pharmaceutical class actions against major pharmaceutical companies such as Alpha Therapeutic, Armour Pharmaceutical Co., Baxter Health Care Corp, Bayer Corp., Dalkon Shield, Eli Lilly, GlaxoSmithKline, and Pfizer.
Please visit Baum Hedlund’s web site, Actosbladdercancer.com, to learn more.