Whistleblower Lawsuit Against Actos Dismissed
On December 6th, 2013, the 1st Circuit U.S. Court of Appeals dismissed a Qui Tam/Whistleblower lawsuit filed against Actos manufacturer Takeda Pharmaceuticals.
In March of this year, US District Judge F. Dennis Saylor had Dr. Helen Ge’s whistleblower case against Takeda Pharmaceuticals unsealed. The case was initially filed in 2010 against the pharmaceutical giant, claiming the company failed to properly report adverse side effects, such as bladder cancer and congestive heart failure, to the FDA. Dr. Helen Ge is a medical doctor, and former safety consultant to Takeda. She claims her contract was terminated after raising concerns over the company’s reporting process to executives.
Dr. Ge’s case comes in the midst of a fury of cases against Takeda Pharmaceuticals, which have been consolidated into Multidistrict Litigation (MDL) 2299, in the US District Court of Western Louisiana (Lafayette). The Honorable Rebecca Doherty presides over the case, and she has recently extended the case filing deadline in order to collect as much information about Takeda’s potential fraud.
Dr. Ge alleges that the company hid or changed the results of some studies. In her complaint, filed in 2010, Ge states: “These events were not properly identified or reported in the FDA’s safety database … Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”
In the Qui Tam lawsuit, Takeda Pharmaceuticals moved to dismiss the whistleblower case for failure to plead fraud with particularity, as well as failure to state a claim. The court agreed, finding that “although relator has alleged facts that would demonstrate a ‘fraud-on-the-FDA’ with respect to intentional under-reporting of adverse events, she has failed to allege the specific details of any claims that were allegedly rendered ‘false’ as a result.” They determined that Ge’s claims would not have been enough reason for the FDA to withdraw approval for Actos.
Actos Linked to Serious Personal Injury
The FDA is currently investigating the risks of taking Actos, and says their review will wrap up next year. Based on evidence from new studies, the government agency issued a warning against Actos and said Takeda had to package their drug with the strongest possible warning label. Meanwhile, both France and Germany banned the drug from sale in their countries, and most recently, India temporarily banned Actos and the generic form pioglitazone, but after confrontations with doctors, rescinded the ban pending further study. The generic form of Actos, pioglitazone, was approved for use by the FDA last August.
The Strom Law Firm Can Help with Personal Injury and Wrongful Death Cases, Including Against Actos
If you or a loved one have taken Actos to treat Type 2 diabetes, and have since suffered dangerous side effects including developing bladder cancer, heart disease, liver failure, or diabetic macular edema, you may be entitled to compensation. The attorneys at the Strom Law Firm can help with personal injury cases, including against Actos manufacturer Takeda Pharmaceuticals. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us. 803.252.4800