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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

Actos Lawsuit Discusses History of Actos and Bladder Cancer

Posted in Actos & Bladder Cancer, Drugs, Lawsuits

On September 9th of 2011, an Actos bladder cancer lawsuit was filed by an Actos lawyer in the United States District Court for the Eastern District of Louisiana.  The lawsuit was filed on behalf of a Louisiana husband and wife.  The husband developed bladder cancer after using Actos for a number of years.  The Actos lawsuit discusses some of the history of Actos and its link to bladder cancer:

On April 20, 2006, Takeda Limited announced the conclusion of its collaboration
in the United States between Takeda North America and Lilly to promote and market Actos, a partnership Takeda Limited described as “a great success” and “mutually beneficial to both companies.”

The fact that Eli Lilly helped with the development, promotion, and marketing of Actos means that they can also be held liable in an Actos lawsuit.

Actos is sold as a single ingredient product under the brand name Actos, and it is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and in combination with glimepiride (Duetact).

Most Actos lawyers (including me) will accept cases from individuals who were taking Actos or any of the drugs listed above. 

Prior to Actos being approved by the FDA, a two-year carcinogenicity study was conducted on male and female rats. Drug-induced tumors were observed in male rats receiving doses of Actos that produced blood drug levels equivalent to those resulting from a clinical dose.

This is one of several pieces of evidence that indicates men are at a higher risk of developing bladder cancer while taking Actos than women are.

In 2005, the results of the PROactive (PROspective PioglitAzone Clinical Trial In MacroVascular Events) three-year study were published. PROactive prospectively looked at the impact in total mortality and macrovascular morbidity using Actos. Dormandy J.A., et al. Secondary Prevention of Macrovascular Events in Patients with Type 2 Diabetes in the PROactive Study (PROspective PioglitAzone Clinical Trial In MacroVascular Events): a Randomised Controlled Trial, Lancet, 266:1279-1289 (2005).

The PROactive study was looking at cardiovascular events and outcomes. However, the study demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators. This information was not included in the published Dormandy paper.

One issue that I’m sure will come up in any Actos lawsuit that goes to trial is the reason why this information was excluded from the Dormandy paper.  Whenever negative information about a drug is concealed, juries tend to get angry.

A three-year liver safety study was also performed, and according to the FDA, that study also demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators.

On September 17, 2010, the FDA issued a Safety Announcement stating it was undertaking a review of the data from an ongoing, ten-year epidemiological study being conducted by Kaiser Permanente to evaluate the association between Actos and bladder cancer.  The planned five-year interim analysis demonstrated that the risk of bladder cancer increases with increasing dose and duration of Actos use, reaching statistical significance after 24 months.

Despite this finding by the FDA, Robert Spanheimer, Vice President of Medical and Scientific Affairs for Takeda, claimed to Reuters that the Kaiser Permanente study has not shown a risk to patients of bladder cancer or other cancers from Actos.

No surprise that a VP for the manufacturer of Takeda denied that there is a risk of developing bladder cancer from taking Actos.  At least one Actos lawyer will attempt to take this man’s deposition to ask him more about the risks of Actos and bladder cancer.

In early 2011, the American Diabetes Association published Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting, Piccinni, et al. Diabetes Care, 34:1369-1371 (June 2011), published ahead of print April 22, 2011. This study looked at adverse events reports made to the FDA between 2004 and 2009. The conclusion of that study was that “[i]n agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.”

By June of 2011, the evidence was mounting against Actos.  By that time there had been several credible studies of different types that all concluded there is a link between Actos and bladder cancer.

On June 9, 2011, the European Medicines Agency (“EMA”) announced that it had been informed by the French Medicines Agency (“Afssaps”) of its decision to suspend the use of pioglitazone-containing medicines (Actos, Competact) in France while awaiting the outcome of the ongoing European review.

France’s decision was based upon a retrospective cohort study in France using the French National Health Insurance Plan which demonstrated a statistically significant increase in the risk for bladder cancer in males exposed to Actos for more than a year. The French cohort included 1.5 million patients with diabetes that were followed for 4 years (2006-2009).

On June 10, 2011, Reuters published that Germany had joined France in suspending the use of Actos after Germany’s Federal Institute for Drugs and Medical Devices (“BfArM”) reviewed the results of the French study. BfArM recommended that doctors should not put new patients on pioglitazone.

It is always bad news for a drug company when one or more countries bans or suspends the sale of a drug.  I’m skeptical that Actos will be taken off the market here in the U.S., but that has more to do with my cynicism about the FDA than my opinion of the drug’s safety.  The FDA looks at drug companies as its customers, not patients.  The agency receives a substantial percentage of its funding from drug companies in the form of “user fees” and I think that causes the agency to be too cozy with manufacturers.

On June 15, 2011, the FDA issued another Safety Announcement stating that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” The FDA ordered information about this risk to be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines.

The FDA reported that the risk of bladder cancer increased with increasing dose and duration of pioglitazone use. When compared to persons never exposed to pioglitazone, exposed to pioglitazone therapy for longer than 12 months was associated with a 40% increase in risk. Based on this data, the FDA calculated that therapy with Actos for longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to those who never used pioglitazone.

June 15th is an important day because it will probably trigger the statute of limitations for Actos lawsuits.  What that means is that people who took Actos and got diagnosed with bladder cancer on or before June 15th of 2011 will lose their ability to file a lawsuit on June 15th of another year.  Whether that year is 2012, 2013, or another year depends upon the law of the state the person resides in.  If you’d like to know how long you have to file an Actos lawsuit, give me a call or e-mail me and I’ll be glad to discuss your situation with you.

If you’d like to read the entire 32-page Actos lawsuit, you may download it here.