ACTOS

The certification motions of both proceedings are currently anticipated to take place in early to mid 2017.

In the ACTOS Proceeding the following materials have been exchanged:

  • Certification Record delivered on January 14, 2013
  • Responding Certification Record delivered on May 15, 2013
  • Supplemental Certification Record delivered on November 27, 2014
  • Amended Statement of Claim served on January 7, 2014
  • Reply and Supplementary Certification Record delivered on January 8, 2014
  • Further Supplemental Certification Record delivered by the Defendants on April 12, 2016
  • Supplementary Certification Record delivered by the Plaintiffs on May 18, 2016
  • Supplementary Reply Record delivered by the Plaintiffs on October 12, 2016

In the Generics Proceeding the following materials have been exchanged:

  • Certification Record delivered on March 20, 2015
  • Responding Certification Motion Record delivered on April 19, 2016 (Apotex Inc.) and April 20, 2016 (Sandoz Canada Incorporated)
  • Reply Certification Record delivered on October 12, 2016

Update - October 28, 2013: Apotex and Sandoz Implicated in Bladder Cancer Case
http://www.rochongenova.com/Articles/Article173


Update - February 28, 2013: The first 3,000 actions relating to ACTOS goes to trial in the U.S.

Update - January 18, 2013: Certification Record Filed in Class Action Commenced Against Diabetes Drug Manufacturers and Distributors: ACTOS Users Are at Heightened Risk of Developing Bladder Cancer

Update - 31 juillet 2012: Recours collectif intente contre les fabricants et distributeurs d'un medicament contre le diabete : un Quebecois auquel ACTOS etait prescript est touche par le cancer de la vessie
http://www.rochongenova.com/Articles/Article159

Update - July 31, 2012: Quebec Class Action Commenced Against Diabetes Drug Manufacturers and Distributors: Quebec Man Prescribed ACTOS Contracts Bladder Cancer
http://www.rochongenova.com/Articles/Article158

Update - December 21, 2011: Class Action Commenced Against Diabetes Drug Manufacturers and Distributors: Toronto Woman Prescribed ACTOS Dies from Bladder Cancer
http://www.rochongenova.com/Articles/Article143

UPDATE - October 28, 2013

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

UPDATE: The first of 3,000 actions relating to ACTOS goes to trial in the U.S.

More details can be found at: http://www.bloomberg.com/news/2013-02-28/takeda-didn-t-warn-of-actos-cancer-risk-lawyer-says.html.

UPDATE - January 18, 2013

Certification Record Filed in Class Action Commenced Against Diabetes Drug Manufacturers and Distributors: ACTOS Users Are at Heightened Risk of Developing Bladder Cancer

TORONTO, Jan. 18, 2013 /CNW/ - On January 17, 2013, law firm Rochon Genova LLP filed its certification record in a proposed class action on behalf of users of a diabetes drug ACTOS (pioglitazone hydrochloride) against Takeda Pharmaceutical and Eli Lilly. The action alleges that the defendants knew or ought to have known that ACTOS materially increases the risks of bladder cancer and failed to disclose those risks in a timely manner and have failed to recall the drug in Canada.

The case is brought by the daughter of a Toronto woman who died in April 2011 after battling bladder cancer for more than two years following her use of ACTOS. Her daughter, a registered nurse, is confident in the strength of the evidence in support of the case: "I believe the expert evidence that's been filed confirms what manufacturers knew all along about the association between ACTOS and bladder cancer. They had this information and it should have been shared with doctors and patients years ago. There were much safer treatments my mother could have used to control her diabetes without putting her life at risk; she should have been given all the relevant information to make an informed choice about her treatment. That choice was taken away from her."The evidence in the record confirms the link between ACTOS and bladder cancer and includes the opinion of Dr. Bruce Trock, a Professor of Epidemiology at the Johns Hopkins University School of Medicine. Dr. Trock reviewed the relevant body of scientific literature and concluded that "...the body of evidence from epidemiologic studies of pioglitazone [ACTOS] and bladder cancer supports the conclusion that pioglitazone is a risk factor for bladder cancer".

The record also contains the report of Dr. Michael Pollak, a Professor of Oncology at McGill's Faculty of Medicine. Dr. Pollak noted the early evidence for the association between ACTOS and bladder cancer in preclinical toxicity studies. In his view, given the availability of safe alternative therapies, such as metformin, and the very significant morbidity and mortality associated with bladder cancer, all knowledge of a potential association between ACTOS and the development of bladder cancer should have been disclosed by the manufacturers in the information used by prescribing physicians.

A third report by consultants at AxSource, a Canadian regulatory consulting firm, concluded that the information about ACTOS published in the desk reference used by Canadian physicians did not accurately reflect the knowledge of the manufacturers about the drug's association with bladder cancer.

The allegations raised in the claim have not yet been proven in court. The plaintiff and class members are represented by the Toronto based law firm of Rochon Genova LLP.

Class Action Commenced Against Diabetes Drug Manufacturers and Distributors: Toronto Woman Prescribed ACTOS Dies From Bladder Cancer

TORONTO, December 21, 2011- Today, the law firm of Rochon Genova LLP issued a class action on behalf of users of a diabetes drug ACTOS (pioglitazone hydrochloride) against the manufacturers and distributors of ACTOS, Takeda Pharmaceutical Company, and its affiliates, and Eli Lilly.
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. As a result, the FDA in the U.S. issued a warning, now incorporated on the drug's label, that use of ACTOS for more than one year may be associated with an increased risk of bladder cancer. French and German drug regulators suspended sales of ACTOS entirely following the results of similar studies in those countries.

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 ACTOS materially increases 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 ACTOS is the Estate of a Toronto woman who passed away in April 2011 after an over two-year battle with bladder cancer. She had been prescribed ACTOS in 2002. Her daughter, a nurse in Toronto, is the proposed Representative Plaintiff representing the family members of those who are suffering or have died from bladder cancer attributable to ACTOS. "My mother suffered greatly and was often in excruciating pain from the time of her cancer diagnosis to her death. Given the other widely available alternatives to control Type 2 diabetes, my mother never would have taken ACTOS had she known that it would increase her risks of developing bladder cancer."

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