Former Takeda Medical Reviewer Says Company Evaded Reporting Actos Bladder Cancers & Heart Failures
We are no longer accepting Actos cases
U.S. District Judge F. Dennis Saylor issued an order on February 24, 2012 to unseal a whistleblower case (Case 1:10-cv-11043-FDS) by a former medical reviewer in Takeda's pharmacovigilance division involving the failure to report bladder cancer and Congestive Heart Failure (CHF) adverse events for the diabetes drug Actos (the only drug in the same class and competing with GlaxoSmithKline’s Avandia).
The whistleblower, also called a relator, is Dr. Helen Ge, a medical doctor and former safety consultant to Takeda Pharmaceuticals. She was hired by Takeda to work in the company’s pharmacovigilance department to review adverse events and to identify and evaluate potential safety signals for Actos (amongst other drugs).
Dr. Ge had direct knowledge of the Actos bladder cancer risk and, according to the complaint, encountered resistance from her superiors when she tried to report bladder cancer as related to Actos. Dr. Ge claims her supervisors directed her to change her “related” assessment to unrelated. According to her recollection of reviewing Takeda’s adverse event database for Actos, there were more than 100 bladder cancers reported to the company, but only 72 reported to the FDA, which she states is “a serious discrepancy.” Dr. Ge also states in her complaint that carcinogenesis from Actos was discovered during the initial Actos animal studies.”
She alleges that Takeda failed to properly report all of the Actos related Congestive Heart Failure adverse events to the FDA. Specifically, according to the complaint, “Takeda instructed its medical reviewers not to report hundreds of non-hospitalized or non-fatal Congestive Heart Failure cases as ‘serious’ adverse events and thus avoided its responsibility of accurately analyzing and reporting these hundreds of serious adverse events to the FDA.” Dr. Ge estimates that Takeda failed to report several hundred Congestive Heart Failure events as serious between late 2007 and 2010.
When Dr. Ge complained to her superiors that her medical assessments were being downgraded from “serious” to “non-serious” and that, as a result of this, the Congestive Heart Failure events were being under-reported to the FDA, her contract with Takeda was terminated.
Dr. Ge also claims that Takeda not only took advantage of Avandia’s downfall (due to cardiovascular risks) by pushing Actos as the safe alternative to Avandia, but possibly even orchestrated its downfall in order to seize the remaining market.
Baum Hedlund Aristei & Goldman filed the original qui tam lawsuit on June 18, 2010. An amended complaint was filed on September 29, 2011. In late 2011, Baum Hedlund was joined by Michael Sullivan, former U.S. Attorney for the District of Massachusetts, in representing the whistleblower.
Dr. Ge has filed this qui tam action on behalf of the United States and 23 states, including California, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Wisconsin, The Commonwealths of Massachusetts and Virginia, and The District of Columbia.
Related Posts:

-
A ranking in The U.S. News – Best Lawyers® “Best Law Firms” is widely regarded by both client and legal professionals as a significant honor. It is considered the most reliable, unbiased source of legal referrals anywhere.
-
Wisner Baum is proud to be a sponsor of The Truck Safety Coalition, a a group of caring individuals dedicated to reducing the number of deaths and injuries caused by truck-related crashes. Our support enables them to help families and save lives.
-
Law360 recognizes law firms that have a strong regional presence, working on important matters within their home state. “[Wisner Baum] possesses a David v. Goliath-sized slingshot while seeking justice for everyday citizens it believes were harmed or killed through corporate wrongdoing.”
-
NLJ and American Lawyer Media honor law firms and attorneys as Elite Trial Lawyers for their cutting-edge legal work on behalf of plaintiffs in practice areas ranging from mass torts to securities litigation.
-
Best Lawyers is the oldest and most respected peer-review publication in the legal profession. A listing in Best Lawyers is widely regarded by both clients and legal professionals as a significant honor, conferred on a lawyer by his or her peers.
-
Less than one-half of one percent of firms across the nation have achieved this ranking. A firm must have a high percentage of lawyers who have achieved the prestigious AV® Preeminent rating by Martindale-Hubbell®.
-
The National Law Journal inducted Wisner Baum into the Verdicts Hall of Fame for obtaining the $2 billion landmark verdict in the Roundup cancer case of Pilliod et al. v. Monsanto. The verdict was #1 in California and #2 in the U.S. in 2019 and is #9 in American history.
-
Super Lawyers is a rating service of outstanding lawyers from more than 70 practice areas who have attained a high-degree of peer recognition and professional achievement.
-
The National Trial Lawyers Top 100 recognized the law firms of Wisner Baum, the Miller Firm and Audet & Partners with the 2019 Trial Team of the Year award (in the Mass Torts category) for their work in the groundbreaking case of Dewayne “Lee” Johnson v. Monsanto Company.
-
An AV® rating reflects an attorney who has reached the heights of professional excellence. The rating signifies the highest legal ability, and very high adherence to professional standards of conduct, ethics, reliability, and diligence.
-
Wisner Baum is proud to have all of its lawyers listed in Avvo, a legal directory connecting people in need of legal services with lawyers and connecting lawyers to lawyers. Eight of our attorneys have earned a 10.0 perfect rating with Avvo.
-
CA and USATopVerdict.com ranks our $2 billion verdict in Pilliod et al. v. Monsanto as the biggest verdict in California and the second largest verdict in the U.S. in 2019. It is the ninth largest verdict in U.S. history.
-
Published annually, the Lawdragon 500 Leading Plaintiff Consumer Lawyers list recognizes the “best of the best” in this area of the law through nominations, research, and review by a board of their peers.
-
In 2020, Law360 honored the law firms ”behind the litigation wins and major deals that resonated throughout the legal industry.” It recognized our success in several landmark cases.
-
In 2018, our $289 million Johnson v. Monsanto verdict was the largest personal injury verdict in California. TopVerdict.com also ranked it #2 among all verdicts in California and #10 in the nation.
-
The Bar Register is the definitive guide to the most distinguished law firms in America. It includes only those select law practices that have earned the highest rating in the Martindale-Hubbell Law Directory and have been designated by their colleagues as preeminent in their field.

Firm Reviews
What Our Clients Are Saying
-
I Can’t Imagine a Better Law Firm
“Multiple lawyers recommended Wisner Baum to me and I have been consistently impressed with the quality of their work.”
- Best Law Firms Survey -
They Are About Changing the Systems...
“Wisner Baum are not only amazing attorneys but more importantly, they are activists. They are about changing the systems which got us into trouble in the first place. They understand their role in the process of making change.”
- Kim Witczak -
Top Legal Minds in the Country
“The Wisner Baum firm has some of the top legal minds in the country; they are driven, determined, trustworthy, ethical and passionate.”
- From Best Lawyers® Best Law Firms -
Diligent & Professional Representation
“Thanks to your efforts I was able to recover from a tragic experience and turn my life around for the best.”
- W.T. -
Our Best Interest Was Always Number One on Your List
“A special thank you to your Spanish-speaking staff for the extra effort put into this case. The language barrier was never a problem, and we are so very thankful to them. Your name holds much respect in our family.”
- G.C. & C.C