Duty to warn where product distributed through learned intermediary

CLASS ACTIONS

Duty to warn where product distributed through learned intermediary

Motion for certification of breach of duty to warn claim in products liability class action alleging that representative plaintiff and other members of proposed class experienced neuropsychiatric adverse events (PAEs) including suicidal and homicidal ideation as consequence of ingesting prescription drug prescribed as treatment for tobacco addiction. Allegation was that monographs dated January 2007, December 2007 and May 2008 failed to warn of risks. May 2010 monograph contained black boxed warning which plaintiffs accepted as warning adequate to satisfy duty to warn. Order staying action as against United States defendant which did not manufacture drug in Canada as there was no basis in fact for duty to warn claim which did not. Position of shareholder, even a controlling shareholder, in a manufacturer insufficient to impose manufacturer’s duty. Motion for certification against Canadian defendant granted. Plaintiff adequately pleaded duty to warn claim in negligence where product is distributed through learned intermediary. Plaintiff’s expert not qualified to give opinion about whether drug actually caused PAEs but was as a practicing clinical psychiatrist qualified to express opinion about whether and when drug monograph would be adequate to provide treating doctor with information needed about possible adverse side effects. Expert also qualified to report and provide evidence of patients who had experienced PAEs during or after using drug. Plaintiff’s expert as member of intended audience for the publication and as professional familiar with issue of product monographs qualified to express opinion for certification motion about adequacy of monographs to satisfy duty to warn. Contemporaneous or near contemporaneous PAEs experienced by those using the drug also provides some basis in fact to claim there was failure to warn by manufacturer.
Parker v. Pfizer Canada Inc. (June 21, 2012, Ont. S.C.J., Perell J., File No. 08-CV-368950CP) 217 A.C.W.S. (3d) 22 (31 pp.).