Actos Heart Attack Victims Back in the Ring for Round #2?

April 26th, 2012. By AbiK

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.

Tags: Actos, Actos Heart Failure, Actos Lawsuit, Actos Myocardial Infarction, Actos Whistleblower, Dr. Helen Ge

This was posted on Thursday, April 26th, 2012 at 1:24 pm and is filed under Class Action, Drugs/Medical, Emerging Issues, Whistleblower . Feel free to respond, or trackback. Read our comments policy.