Last week, a federal False Claims Act whistleblower lawsuit against Takeda Pharmaceuticals involving Actos was unsealed, and so the lawsuit can be served on Takeda and can begin moving forward.
All drug manufacturers have a legal duty, under 21 CFR 314.80, to report a variety of “adverse drug experiences,” including any “serious adverse drug experience,” defined as:
Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
In the lawsuit, Helen Ge, M.D., alleges that she was hired by Takeda Pharmaceuticals as an independent contractor to help review the clinical and post-marketing adverse event data on Actos (pioglitazone), the best-selling diabetes medication manufactured by Takeda. Dr. Ge alleges that, after the competing diabetes medication Avandia was shown to increase the risk of acute myocardial infarction and cardiovascular death, Takeda tried to position Actos as a safer alternative by downplaying the cardiac risk of Actos. Specifically, Dr. Ge alleges Takeda instructed its researchers to ignore the last part of 21 CFR 314.80, and to instead only report congestive heart failure cases involving hospitalization or death. When Dr. Ge complained, her contract was terminated.
The lawsuit, like all False Claims Act lawsuits, was initially filed under seal - withheld even from the defendants - while the U.S. Attorney’s Office in Massachusetts reviewed the case. The U.S. Attorney’s Office and the Department of Justice declined to intervene, but they also did not ask the Court to dismiss the case, and so the case can now move forward into briefing and discovery.
Actos has been under increasing scrutiny following evidence suggesting Actos causes bladder cancer. If Dr. Ge’s allegations are true, then patients who suffered congestive heart failure while taking Actos may also have legal claims for compensation against Takeda.