Actos Whistleblower Lawsuit

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:

  • Paxil Pediatric Class Action $63 Million
  • Third-Party Payer Class Action $40 Million
  • Defective Drug Class Action $28 Million
  • Celexa-Lexapro Pediatric Class Action $10 Million
  • Drug Injury $9 Million
  • Pharmaceutical Settlement $105 Million
/

“The Baum, Hedlund 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
  • Best Law Firms 2021
    Best Law Firms 2021

    The U.S. News – Best Lawyers® “Best Law Firms” rankings are based on lawyer evaluations, peer review from leading attorneys in their field, and review of additional information provided by law firms as part of the formal submission process.

  • National Trial Lawyers Top 100
    National Trial Lawyers Top 100

    The National Trial Lawyers Top 100 recognized the law firms of Baum Hedlund Aristei & Goldman, 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.

  • Elite Trial Lawyers
    Elite Trial Lawyers

    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.

  • AV Top Ranked Law Firm
    AV Top Ranked Law Firm

    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®.

  • Listed in Best Lawyers
    Listed in Best Lawyers

    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.

  • National Board of Trial Advocacy
    National Board of Trial Advocacy

    The National Board of Trial Advocacy is dedicated to bettering the quality of trial advocacy in our nation’s courtrooms and helping consumers find experienced and highly qualified trial lawyers.

  • Nation's Top 1%
    Nation's Top 1%

    The NADC is an organization dedicated to promoting the highest standards of legal excellence. Only the elite few attorneys are invited to join the NADC, less than 1% of practicing attorneys in the U.S.

  • Verdicts Hall of Fame
    Verdicts Hall of Fame

    The National Law Journal inducted Baum Hedlund 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.

  • AV Rated
    AV Rated

    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.

  • Super Lawyers
    Super Lawyers

    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.

  • Multi-Million Dollar Advocates Forum
    Multi-Million Dollar Advocates Forum

    Multi-Million Dollar Advocates Forum is one of the most prestigious groups of trial lawyers in the United States.  Membership is limited to attorneys who have won million and multi-million-dollar verdicts and settlements.

  • Bar Register of Preeminent Lawyers
    Bar Register of Preeminent Lawyers

    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
  • Top Legal Minds in the Country

    “The Baum, Hedlund 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
  • I Can’t Imagine a Better Law Firm

    “Multiple lawyers recommended Baum Hedlund to me and I have been consistently impressed with the quality of their work.”

    - Best Law Firms Survey
  • 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
  • We Have Never Met a More Wonderful Group of People

    “It is obvious that the people at Baum, Hedlund, Aristei, & Goldman believe in what they do. And that you all really care about your clients.”

    - The B. Family
/

Contact Us Today

No Fees Unless We Win
  • Please enter your first name.
  • Please enter your last name.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please enter your email address.
    This isn't a valid email address.
  • Please enter your city.
  • Please make a selection.
  • Please make a selection.
  • Please make a selection.
  • Please enter a message.