Former executive alleges Takeda illegally promoted Actos to treat patients with prediabetes in Massachusetts whistleblower lawsuit

by Jim Orr

Executives with Takeda Pharmaceutical, the manufacturer of Actos, admitted that they had paid physicians to prescribe the drug to patients with pre-diabetes, a former GlaxoSmithKline executive and whistleblower testified recently in Massachusetts federal court. Peter P. Lawton, the former director of patent life-cycle maximization at GSK, said that Takeda engaged in a kickback scheme despite the fact that the drug was not approved by the Food and Drug Administration to treat patients with prediabetes.

Lawton’s testimony came as part of a qui tam lawsuit filed by the former executive against Takeda over the alleged Actos kickback scheme. Under a federal law known as the False Claims Act, whistleblowers can file lawsuits on behalf of federal agencies involving allegations of fraud and recover a portion of the damages awarded to the government.

Testifying at a hearing in Massachusetts federal court, Lawton alleged that between 2000 and 2011, Takeda and parent company Eli Lilly paid doctors to give “educational” presentations about the use of Actos to treat prediabetes. According to Lawton, these speakers were paid between $1000 and $3000 per speech to promote Actos for prediabetes despite the fact that the drug was not approved for this purpose by the FDA. Under federal law, doctors are allowed to prescribe medications to treat conditions for which they have not been approved by the FDA; however, it is illegal for drug companies to promote their medications for “off-label” use.

Lawton says that during these presentations, doctors who promoted Actos for the treatment of prediabetes symptoms did not mention the fact that the drug had been linked to an increased risk of bladder cancer among patients taking the drug for an extended period. The FDA issued a “black box” warning about the link between Actos and bladder cancer in June 2011.

Attorneys for Takeda filed a motion to dismiss Lawton’s whistleblower lawsuit, arguing that it contained no specific allegations of wrongdoing against the company. However, Lawton testified that because top executives at the company knew about the Actos kickbacks scheme, it was unnecessary to prove individual claims in order to prove that the company was aware of the payments that were allegedly made to doctors to promote the drug. Lawton testified that Takeda executives who were aware of the kickback scheme included its U.K. general business counsel, its acting European patents head, its global patents head, and its European pharmaceuticals chief operating officer.

Between 2003 and 2011, sales of Actos increased from about $1.3 billion to $3.3 billion, making it one of the most widely prescribed diabetes drugs on the market. A significant percentage of this revenue involved claims to Medicare and Medicaid. Because some of these claims involved the Takeda’s alleged off-label promotion of the drug to treat prediabetes, Lawton’s suit alleges, they constitute false claims against the federal government.

Takeda also argued that because the case involved disclosures made in two other lawsuits involving Actos (Allen v. Takeda MDL and U.S. ex rel. Ge v. Takeda), the case was barred under the False Claims Act because it involved prior public disclosures. Lawton’s attorneys responded to Takeda’s allegations by arguing that because the two prior cases did not involve off-label marketing or were unrelated to allegations of illegal kickbacks and off-label marketing of Actos, his lawsuit should be allowed to move forward.

Lawsuits Filed Against Takeda by Patients Diagnosed With Cancer After Taking Actos

Patients who were diagnosed with bladder cancer after taking Actos may be eligible to file a lawsuit and receive compensation for their injuries and medical costs. Actos users who have been diagnosed with pancreatic cancer or prostate cancer may also qualify to file a lawsuit.

This evidence of a link between Actos and an increased risk of bladder cancer prompted thousands of patients who were diagnosed with the disease to file lawsuits against Takeda, the manufacturer of the diabetes drug. According to these lawsuits, Takeda failed to properly research the safety of Actos and failed to properly warn patients about the drug’s link to an increased risk of bladder cancer.

Because the risk of bladder cancer, prostate cancer, and pancreatic cancer increases the longer a patient has been treated with Actos—and because it may take years after a patient has been treated with the diabetes drug before the first symptoms of cancer are detectable—patients who were treated with Actos years ago may only now develop signs of cancer. The first step in taking action to file a case is to speak with an experienced team of attorneys to help guide you through the process of filing a lawsuit.

Our law firm, Heygood, Orr & Pearson, is pursuing Actos lawsuits on behalf of our clients and will be involved closely with the Actos MDL and other litigation matters regarding the diabetes drug. Our attorneys have accumulated years of training and experience in handling product liability lawsuits involving dangerous drugs or defective medical devices. Our attorneys will work diligently on your behalf to ensure that you receive the results that you deserve in your case.

For a free legal consultation from an attorney about filing a lawsuit and to learn more about whether you may qualify to file a case, contact the lawyers at Heygood, Orr & Pearson by calling toll-free at 1-877-446-9001. You can also contact us 24 hours a day by following the link to our free case evaluation form and answering a few simple questions about your history to get started.

by Jim Orr

Jim Orr is a licensed attorney and a partner at HO&P focusing on business and personal injury litigation. Jim was selected multiple times to the Super Lawyers List and has tried 70+ cases to verdict.