The Canadian lawsuit was filed in Ontario by Rosalba Joudry, who alleges Janssen did not conduct adequate long-term studies on Invokana’s effect on kidney health to determine how safe Invokana was, and further failed to provide adequate warnings about the risk of side effects. Specifically, the lawsuit alleges Janssen did not conduct any prospective or retrospective population studies, animal studies or trial studies on its drug; did not hire experts to examine the drug; and failed to review or take action on information about the risk of drugs in Invokana’s class (SGLT2 inhibitors).
“Even if the probability of injury is small or may only affect a small group of users, this risk must be balanced against considerations such as the nature of the drug, the necessity for taking it, the seriousness of the danger, and the magnitude of the increased danger to the consumer,” Joudry’s lawsuit argues.
Furthermore, Joudry alleges, Janssen ignored information concerning the risk of side effects and downplayed the seriousness of potential side effects, promoting Invokana as safe. The lawsuit alleges Invokana is an unreasonably dangerous drug that should not have been marketed at all.
Joudry was prescribed Invokana by her doctor in 2014 to manage her type 2 diabetes. A few months later, after learning through a television ad about the risk of kidney failure, Joudry underwent tests and was diagnosed with kidney failure. She says she would not have taken Invokana if she had known about the risks. According to CBC News (9/17/15), the lawsuit seeks more than $1 billion in damages on behalf of patients who were allegedly harmed by the use of Invokana.
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The US lawsuit is Anzo v. Janssen Research & Development, LLC, et al., Case number 2:15-at-01102, in US District Court, Eastern District of California.