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. 

SOURCE: ROCHON GENOVA LLP

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