If you’ve tried to figure out what’s going on with Actos—and more specifically, Actos lawsuits–you’ve probably found it can get a bit confusing. This drug has more lawsuit angles now than a tetrahedron. So here’s a list of Actos lawsuit angles:
Actos Bladder Cancer Lawsuits
Actos bladder cancer lawsuits are not class action lawsuits. These are lawsuits filed by individuals who allege they now have bladder cancer because of taking Actos to treat their type 2 diabetes.
When there are many individual lawsuits claiming similar injury (i.e., Actos bladder cancer) brought on by the same defendant(s), it’s a mass tort not a class action. The reason for that is because even though all the victims have bladder cancer, each individual case will be different—for example, the extent of harm will be different from one victim to another, and any damages paid needs to reflect that. In a class action lawsuit, everyone in the class receives the same exact damages.
Typically, parts of a mass tort that are in common across all injured parties will be consolidated into what’s called ‘multi-district litigation’ (MDL). Once the common aspects of all the lawsuits have been resolved, any individual lawsuit differences can be addressed.
Actos Class Action Lawsuit
While there is not an Actos class action lawsuit for bladder cancer injury itself, there has been an Actos class action filed that alleges Takeda, the manufacturer of Actos, engaged in wrongful conduct when it designed, manufactured and marketed the drug–because the drug wound up being linked to bladder cancer and getting an FDA warning because of it.
Actos Whistleblower Lawsuit
Moving right along, a former consultant for Takeda, Dr. Helen Ge, came forward in a whistleblower lawsuit stating that Takeda knew about and yet either did not report or underreported cases of both Actos bladder cancer and Actos myocardial infarction (i.e., Actos heart attack).
According the lawsuit, Ge asserted that “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.
Actos Heart Attack Lawsuit
Like the song “One Thing Leads to Another”, the Actos whistleblower lawsuit sheds light on another potential Actos lawsuit angle: myocardial infarction. Initally, in 2007, the FDA placed a warning on Actos (and Avandia) for congenital heart failure. That warning, however, did not include mention of mycardial infarction (i.e., heart attack). Yet, there had been complaints of Actos heart attack, and those complaints more or less hung in limbo. With Dr. Ge stepping forward, however, it would appear that her allegations could spell more lawsuits for Takeda—this time from Actos heart attack victims. If, in fact, Takeda knew that there was an increased risk for myocardial infarction given their own adverse event reports but did not report that risk, the potential for additional Actos lawsuits is there.
And that could perhaps mean a whole other Actos lawsuit…in the form of an Actos class action. After all, remember how Takeda aggressively advertised that it was a “safer” alternative to Avandia once Avandia took the hit for heart side effects? Stay tuned.
Lots in legal news headlines from the past week that you might’ve missed including our weekly Asbestos News column and Week Adjourned—the weekly wrap of top class action lawsuits and settlements.
This week we heard about the Bumble Bee Tuna class action lawsuit (over false advertising claims) as well as the Vita Coco false advertising settlement. Big news with type 2 diabetes drug Actos as well–is it time for round #2 with Actos lawsuits? Find more in our Monday Minute update…
Not long ago the diabetes drug Avandia had all the media focus. Patients who were on the drug were hit with a barrage of information—sometimes confusing, sometimes scary—about Avandia’s link to heart attack. And thus began the mad dash to switch over to Actos. After all, while there were also some studies linking Actos to heart attack (along with the infamous TIDE trial), they were reported to be “inconclusive”. Not concrete enough to stop a flurry of prescriptions.
And the black box warning that Actos received (along with Avandia) back in 2007 was only regarding heart failure risk in the form of congestive heart failure—not heart attack or myocardial infarction.
But some Actos patients had already suffered heart attack. And many had submitted complaints in hopes of an Actos lawsuit v. Takeda, the drug’s manufacturer. But their complaints, for all intents and purposes, seemed to fall on deaf ears—at least where lawyers were concerned.
How could it be? As lawsuits about Actos bladder cancer were sprouting up, Actos heart attack complaints fell by the wayside. And yet, given they share a drug class, thiazolidinediones, there seemed to be such similarity between Avandia and Actos—why, it would be almost intuitive that they could perhaps have similar side effect or adverse event profiles, right? And what about some of those studies—was there anything to them?
Then, something unforeseen happened in the form of former Takeda consultant, Dr. Helen Ge—the Actos whistleblower.
And suddenly, everything—sadly—made sense for those Actos patients who had tried to file Actos heart attack complaints. Only now, was it too late? They had already tried to contact lawyers who had rejected them or not taken up their cause simply because there wasn’t much the lawyers could do with them.
Now, however, there might be.
The Actos whistleblower lawsuit (U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston)) has shone light on Dr. Ge’s assertion that Takeda knew about instances of Actos heart attack but downplayed them—for the sake of increasing their profits.
Dr. Ge claims she was let go from Takeda after she raised concerns over the company’s handling of the Actos safety data—and that officials at Takeda tried to direct medical reviewers, including Dr. Ge, to “change their professional opinion” regarding the potential dangers of Actos heart problems—specifically Actos myocardial infarction.
The whistleblower lawsuit is, in effect, a game-changer for Actos litigation. And former Actos victims might find that where there once was no direct path to an Actos lawsuit, there now might be.
Welcome to Round #2.