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Takeda Pharmaceutical Co. holds the patent on pioglitazone. Takeda makes all of the medicines that contain pioglitazone. Takeda is the biggest drug company in Asia. Medicine containing pioglitazone is marketed in the United States, Canada, Germany, and the UK.by Eli Lilly Co. When it was first sold, a medicine containing pioglitazone was also available in France and India.

Those with type 2 diabetes can become less sensitive to insulin. Human bodies make insulin to break down glucose. Glucose that has been broken down is stored in the body or used for energy. When a person’s body doesn’t respond well to insulin, over time, their body stops making enough insulin. People with type 2 diabetes have high blood sugar.

Diabetes can hurt the heart muscle. This leads to heart failure. Diabetes hurts the kidneys. When the kidneys don’t work well that is called renal failure. People with diabetes can get damage to their eyes. New blood vessels that grow in the retina aren’t as good. This makes the macula swell, which leads to not seeing well or even going blind.

In the US, adults under 75 years old usually go blind if they suffered diabetic damage to the retinas. Diabetes injures the nerves. Damage to the nerves and neuropathy also makes muscles weak. Finally, diabetes damages the brain. People are not able to think as well, and have higher rates of dementia, including Alzheimer’s.

On June 15, 2011, the Federal Drug Administration (“FDA”) made a Safety Announcement. The FDA said that anyone taking pioglitazone for a year or more may have a bigger risk of getting bladder cancer. The FDA ordered Takeda to add to the medicine label the warning that taking pioglitazone increased a person’s risk of bladder cancer.

The FDA also told doctors not to prescribe medicine containing pioglitazone to people with bladder cancer. The FDA said if a patient had bladder cancer already, the doctor needed carefully weigh the benefit of controlling their blood sugar levels against the increased chance of making their bladder cancer worse.

The FDA made this order because of a study of 193,099 diabetic patients at Kaiser Permanente Northern California (“Kaiser”). The Kaiser study looked at the records of people who were treated from 1997 to 2008. These records showed a number of the patients who took pioglitazone then got bladder cancer.

The FDA had only looked at five years of records when they decided to tell Takeda to add warnings. They figured out there was a 40% greater chance of getting bladder cancer after 12 months taking pioglitazone, and an even higher chance of bladder cancer risk after 24 months on pioglitazone.

The FDA also said that in France, the French Agency for the Safety of Health Products (the French version of the FDA) took medicines containing pioglitazone off the market. This was done on June 9, 2011. In Europe, and in France, Takeda sold their medicine containing pioglitazone under the brand name Glustin.

The French FDA took pioglitazone off the market in France based on a study by the French National Health Insurance Plan. The Plan followed 1.9 million people with diabetes for four years. The study found that for men, larger doses of pioglitazone over a longer period of time gave a person a much bigger risk of getting bladder cancer. This study made adjustments for the patient’s ages, gender, if they smoked or took other diabetic medications, and other risk factors,

On June 10, 2011, the next day, the Federal Institute for Drugs and Medical Devices (the German version of the FDA) took action. The German FDA told doctors to not prescribe anything with pioglitazone to people until the increased risk of bladder cancer was better understood. Much later, in August of 2013, India banned all medicines with pioglitazone.

The video below explains some common side effects with pioglitazone.

In 2014, more than 15,500 Americans will die of bladder cancer. More men get bladder cancer than women. For men, it is the fourth most common cancer. For women, it is the ninth most common cancer. White people get bladder cancer more often than African-Americans. The American Cancer Society estimates that each year, more than 70,000 Americans find out they have bladder cancer. Spotting bladder cancer early is important in fighting and surviving this cancer.

Bladder cancer comes back after successful treatment more often than other forms of cancer. Smoking is the leading cause of bladder cancer. Bladder cancer symptoms are seeing blood or red color when you pee. Another symptom is feeling like you really need to pee. People with bladder cancer can have pain while peeing. Having a lot of bladder infections is a symptom.

Another symptom of bladder cancer is a pain in the back or lower abdomen.

Yes. People who took medicines containing pioglitazone and got bladder cancer have sued Takeda and Eli Lilly Co. Takeda holds the patent for pioglitazone and is the only company that makes it. Eli Lilly marketed all of the medicines containing pioglitazone in the United States.

In the first few lawsuits filed against Takeda and Eli Lilly, the big companies won. But as more cases have been filed, lawyers have been able to investigate more. In at least two cases, people who took these medicines and got bladder cancer won. In those cases, they showed that Takeda and Eli Lilly knew about the risks and didn’t tell people. The juries in those cases awarded millions of dollars in punitive damages.

Because there were a few hundred lawsuits from all around the United States suing the big companies who made and sold these drugs, these cases have been brought together. These cases are being tried in consolidated litigation in the U.S. District Court for the Western District of Louisiana. In April of 2014, the first case to go to trial in that litigation ended in a jury verdict in favor of a couple, where the husband took a pioglitazone medication and got bladder cancer.

A typical lawsuit by a person who has gotten bladder cancer after taking these medicines asks for money to pay them back for:

• Medical bills – This covers the cost of medical treatments, such as doctor visits, surgery, hospital bills, medications, frequent checkups after treatment and caregiver costs, as well as funeral expenses.
• Lost income – Often people being treated for bladder cancer can’t report to work and don’t get paid (and possibly lose their job).
• Pain and suffering – Many people find dealing with bladder cancer, invasive treatments, and the high possibility of re-occurrence make them very sad and stressed on top of their physical discomfort.
• Loss of consortium – The surgeries and treatments for bladder cancer are hard on the relationship between spouses.
• Punitive damages – If a court finds that the companies that made and sold these medicines knew and hid the fact that the medicine increased the risk of bladder cancer, that was a terrible thing to do.

Companies that sell risky drugs without telling patients, just to make more money, are ordered to pay millions of dollars to make clear how wrong and bad it is for a company to do that.

I’m Ed Smith, a Sacramento Drug Products Liability Lawyer. If you or a loved one has been injured due to a defective drug, please reach out to us for free, friendly advice. In Sacramento, call 916.921.6400 or 800.404.5400.

We are members of the Million Dollar Advocates Forum and the National Association of Distinguished Counsel.

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Editor’s Note: This page has been updated for accuracy and relevancy [cha 10.14.20]

Image by Steve Buissinne from Pixabay