Wednesday, May 23, 2012

Actos Lawsuits Part One: Failure to Warn and a Possible Cover Up

Nearly thirteen years ago a new diabetic drug, Actos, was approved for the treatment of Type 2 diabetes. Takeda, the Japanese manufacturer of Actos collaborated with Eli Lilly to release the drug in the United States at the time. At the same time Actos was approved, a close competitor, Avandia, was also approved. When Avandia fell under scrutiny in 2009-2010, Actos became the drug of choice for Type 2 diabetes and soon doctors were switching their patients from Avandia to Actos, believing they were offering a safer drug choice. Soon, however, reports began surfacing regarding the potential risks of taking Actos. The 2002 FDA list of products which were under the requirement of reporting heart failure incidences included the drug Actos, yet sales continued to soar. It is estimated that Takeda netted over three billion dollars from the sale of Actos in 2010 alone.

Takeda’s Cover Up?

While Takeda vouched for the safety of the drug, it is now believed that even at the time Actos was released in 1999 Takeda knew it caused cancer in rats. Though Takeda possessed this knowledge cancer-related risks were not specifically studied. In fact, only proactive studies which determined the heart-related risks of Actos were undertaken and it was not until 2005-2009 that results began pouring in regarding the potential risks of bladder cancer in those taking Actos. Even in the face of studies funded by their own company, it appears Takeda covered up results and wrote off the numbers. Eventually the truth came out, and it was shown that based on the dosage, the risk of bladder cancer could increase as much as 40% in those taking Actos.

Failure to Warn?

The FDA approval for Actos occurred in near-record time, with it blowing through the approval process in less than three months. The attorneys who are currently associated with the Actos cases against Takeda believe there was a failure to warn on the part of Takeda and that there will be lots of excellent cases, although there will be some bad ones as well. Any attorney who is considering taking on an Actos cases must watch out for causation and factors other than the drug itself. Bladder cancer is a relatively common cancer—much more common in those over the age of 60.

Other Factors in the Development of Bladder Cancer

While the survival rate in those with bladder cancer is good, survivors must watch out for recurrence, which occurs in as many as 40-50% of bladder cancer patients. Other factors in the development of bladder cancer include smoking or those who work in industrial fields, age and a previous incidence of bladder cancer. What this means is that a case involving a person under the age of 60 who doesn’t smoke, works in a relatively “safe” job and has no previous history of bladder cancer will be the best case against the manufacturer of Actos. On the other hand, those who have developed bladder cancer after taking Actos yet also smoke, are over the age of 60 or work in an industry known to contribute to bladder cancer will not have as strong a case.

The Case of Paul McMahan

Attorneys point to the case of Paul McMahan of Minnesota who was 57 when he was diagnosed with bladder cancer. Paul was a widower with three children to raise. Paul had been taking Actos for a little over a year then one day at work he went to the bathroom and noticed his urine resembled “cola.” He went to the doctor and was diagnosed with muscle-invasive bladder cancer. Paul underwent a battery of medical procedures, including the removal of his prostate and a colostomy. Eventually the cancer moved into his hip and Paul was given a terminal diagnosis. Paul suffered unbearable pain, ending up in the hospital with little hope of recovery. According to McMahan’s case, prior to the approval of Actos in July of 1999, defendants Eli Lilly and Company were well aware of the increased risks of cancer due to a twenty-four month animal study showing tumors in male rats who received equivalent human doses of Actos. The drug was approved in spite of this study, and Actos was launched with no bladder-cancer warnings. Attorneys believe cases such as this one will be the “best” Actos cases although each case must be individually assessed on its merits.

Actos Lawsuits

The first Actos lawsuit was filed in August of 2011 by a woman who took Actos for over a decade and will likely end up having her bladder removed as well as undergoing subsequent chemotherapy and radiation. The cases against Takeda are accusing Takeda of neglecting to conduct complete and proper testing of side effects prior to its release, asserting that clinical evidence had surfaced showing a link between Actos and bladder cancer but was willfully concealed from patients and doctors. Further allegations state that Takeda Pharmaceuticals was negligent in the marketing and sales of Actos and deliberately underplayed the seriousness of potential health risks, offering only vague and inadequate warnings.

Actos Whistleblower

The attorneys who will be representing Actos victims may be further assisted by a “whistleblower” named Helen Ge who was hired by Takeda as a medical reviewer. While Ge’s co-workers apparently understood they were there to provide cover which would allow Takeda to claim innocence of any harms resulting from Actos, Ge took her job seriously. When she tried to warn Takeda about discrepancies in adverse effects reporting related to Actos, she was fired. Ge claims that Takeda’s in-house database clearly showed 100 cases of Actos-related bladder cancer yet the company only reported 72 of those to the FDA. Ge further states that early animal and Phase III studies definitively proved Actos was carcinogenic yet Takeda changed trial enrollment criteria to hide that fact. Unfortunately, at this point, neither Actos nor Avandia has received an FDA black box warning even though they have been proven to harm and even kill. The attorneys who are gearing up for the flurry of Actos cases believe this will be an extremely powerful litigation and that there are a great number of very real Actos cases out there. Part two of this article regarding Actos lawsuits will talk about the highlights of the MDL Actos case as well as detail some of other lawsuits which may or may not work in the favor of Actos attorneys.

Author: Sullo & Sullo Attorneys

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