Apotex and Sandoz Implicated in Bladder Cancer Case

TORONTO, October 28, 2013 - On October 25, 2013, the law firm of Rochon Genova LLP issued a class action on behalf of users of generic versions of diabetes drug ACTOS (pioglitazone hydrochloride) against generic manufacturers and distributors Apotex Inc., Sandoz International GmbH, and Sandoz Canada Incorporated.

Pioglitazone, under the brand name ACTOS®, was approved for sale in Canada in August, 2000 to control blood sugar levels in people with Type 2 (non insulin-dependant) diabetes. A June 2011 study reported to the FDA found a clear link between pioglitazone and increased bladder cancer risk. The risk for bladder cancer was found to be 30% higher among those whose duration of pioglitazone use was 12-24 months and 50% higher among those with greater than 24 months' exposure. Health Canada subsequently commenced a year-long review and, in April 2012, following that review, the product monographs of ACTOS and its generic versions were updated to reflect the increased risk of bladder cancer, but the drugs remain on the market.

The class action, filed with the Ontario Superior Court of Justice, alleges, among other things, that the defendants knew or ought to have known that their generic versions of ACTOS, namely APO-Pioglitazone and Sandoz® Pioglitazone, materially increase the risks of bladder cancer and failed to disclose those risks in a timely manner and have failed to recall the drug.

The proposed Representative Plaintiff for users of APO-Pioglitazone is a 77-year old retiree from Val Caron, Ontario. After more than five years taking pioglitazone, which included Apotex's version for three years, three cancerous tumours were discovered in his bladder. "I never would have taken ACTOS or any generic version of it had I known that it would increase my chances of developing bladder cancer; I would have asked my physician to treat my diabetes with some safer alternative."

The proposed Representative Plaintiff for users of Sandoz® Pioglitazone is a 52-year old resident of Lorne, New Brunswick. He was diagnosed with transitional cell carcinoma in March 2012 after using pioglitazone for several years, including Sandoz® Pioglitazone for two years. "My family and I were very upset when I was diagnosed with bladder cancer and I was shocked when I later learned that my years of taking pioglitazone to control my diabetes may have contributed to my cancer diagnosis. Given the serious risk of bladder cancer, these drugs should be taken off the market."

The allegations raised in the claim have not yet been proven in court. The plaintiffs and the prospective class members are represented by the Toronto based law firm of Rochon Genova LLP. For information please contact:

Rochon Genova LLP
121 Richmond St. W, Suite 900
Toronto, Ontario M5H 2K1
Telephone: 416-548-9874 or toll-free: 1-800-462-3864