Actos News

Federal Government and Prominent Law Firm Ask Appeals Court to Overturn Lower Court's Dismissal of Whistleblower Lawsuit Against Takeda Pharmaceuticals
August 15, 2013

The United States government and a nationally recognized law firm representing individuals suffering from bladder cancer after ingesting Actos have filed amicus briefs* that support Dr. Helen Ge’s whistleblower claims. Dr. Ge is suing drug maker Takeda Pharmaceuticals for submitting false claims related to Medicare and Medicaid reimbursement costs for its diabetes drug, Actos. Ge, a medical doctor and former safety consultant to Takeda, worked for the company reviewing adverse drug events related to Actos and other drugs, but her contract was terminated following conflicts regarding her medical assessments concerning bladder cancer and congestive heart failure.

Baum Hedlund Aristei & Goldman filed Dr. Ge’s qui tam action (a lawsuit brought by a private party on behalf of the government) in 2010 under the federal False Claims Act. The lawsuit alleges that Takeda intentionally made false statements to, and withheld facts from, the Food and Drug Administration in an effort to maximize profits from its diabetes drug, Actos. Takeda is currently facing thousands of lawsuits from individuals who claim the drug maker did not adequately inform doctors and consumers about the increased risk of bladder cancer associated with taking Actos.

Dr. Ge is appealing the ruling of a Massachusetts district court judge last November stating that her allegations were not specific enough and that she had not established that Takeda’s failure to fully inform the FDA of the possible adverse consequences of taking Actos would have led the FDA to withdraw its approval of Actos, thereby directly impacting Medicare and Medicaid payments to Takeda. The judge also suggested that Dr. Ge could have gone to the FDA directly to report the fraud. 

The amicus briefs counter the district judge’s ruling. In its brief, the government argued that, under the False Claims Act, liability exists when a defendant knowingly makes a false statement material to a fraudulent claim for payment, and a statement is material if it is capable of influencing the government’s decision to pay. [see U.S. brief, p. 18.] “[T]he key question,” they stated, “is not whether, in light of the defendant’s false statement about its compliance, the agency did or had to deny payment, but rather whether the agency was permitted to deny payment” (emphasis added).  [p. 21]

In other words, Dr. Ge was not obligated to prove that Takeda would not have received payment if it had been forthcoming with the FDA. She only had to show that a full disclosure of the Actos link to bladder cancer was “capable of influencing” the government’s decision.

U.S. attorneys also stated that the False Claims Act “provides no exemption from liability simply because there exists a parallel, agency-specific mechanism [i.e., petitioning the FDA] for uncovering or addressing fraud.” (pp. 15-16)

In its amicus brief, The Miller Firm recited a wealth of documentary evidence supporting Dr. Ge’s claim that Takeda pursued a long term policy of systematically withholding crucial findings regarding the Actos-bladder cancer link from the FDA. The firm also argued that full disclosure by Takeda would have made a “substantial and material difference in the prescribing habits and use of Actos.” [Miller brief, p. 12] The Miller Firm represented plaintiff Jack Cooper, who joined in The Miller firm’s Amicus Brief, in the first Actos lawsuit to go to trial earlier this year.

Michael Baum, one of Dr. Ge's attorneys and senior managing partner at Baum, Hedlund, Aristei & Goldman, expressed gratitude about the amicus briefs. “We very much appreciate the backup, first from the government, and now the Miller firm and their clients, the Coopers. The great thing about the Miller brief is it contains a recitation of previously undisclosed documents about Actos, its risks and Takeda’s conduct.  It was a result of the Cooper trial that these documents are now public. These documents corroborate Dr. Ge’s story.”

*Short for amicus curiae. An amicus (literally friend of the court) brief can be filed by a person or an officer of the United States with a strong interest in the subject matter of a legal action, but who is not a party to the action. The amicus brief offers support to the appellant and further educates the Court on points of law that are in doubt and raises awareness about some aspect of the case on appeal.