Open Access

ARTICLE

Litigation associated with 5-alpha-reductase- inhibitor use: A Canadian legal database review

David-Dan Nguyen^1,*, Massine Fellouah^2,*, Anna-Lisa V. Nguyen³, David-Christian Kazu⁴, Isabel Baltzan⁵, Muhieddine Labban⁶, Shubha De⁷, Kevin C. Zorn⁸, Bilal Chughtai⁹, Dean S. Elterman¹, Quoc-Dien Trinh⁶, Naeem Bhojani⁸

1 Division of Urology, University of Toronto, Toronto, Ontario, Canada
2 Faculty of Medicine, Université de Montréal, Montréal, Quebec, Canada
3 Faculty of Medicine, Schulich School of Medicine and Dentistry, London, Ontario, Canada
4 Faculty of Arts, Université de Montréal, Montréal, Quebec, Canada
5 Faculty of Law, McGill University, Montréal, Quebec, Canada
6 Division of Urology and Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
7 Division of Urology, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada
8 Division of Urology, Centre hospitalier de l’Université de Montréal (CHUM), Université de Montréal, Montréal, Quebec, Canada
9 Department of Urology, Weill Cornell Medical College/New York-Presbyterian, New York, New York, USA
Address correspondence to Dr. Naeem Bhojani, Centre hospitalier de l’Université de Montréal (CHUM), 900 St. Denis, R08.474, Montreal, QC H2X 0A9 Canada

Canadian Journal of Urology 2023, 30(3), 11546-11550.

Abstract

Introduction: 5α-reductase inhibitors (5ARI) are commonly prescribed medications. There is ongoing controversy about the adverse events of these medications. The aim of this study is to characterize lawsuits in Canada involving medical complications of 5ARIs use.
Materials and methods: Legal cases were queried from CanLII. Cases were included if they involved a party taking a 5ARI who alleged an adverse event. Relevant full cases were retained, and pertinent characteristics were extracted with the help of a legal expert.
Results: Our deduplicated search yielded 67 unique legal documents from December 2013 to February 2019. Twelve of these documents met the inclusion criteria (representing 3 cases, considering each case had several hearings). The medical complaints filed by the plaintiffs were all related to medication side effects (n = 3, 100%). The plaintiffs were commonly patients themselves. Defendants were exclusively pharmaceutical companies. Persistent erectile dysfunction after stopping the medication was cited as a side effect in all complaints. The prescriptions were made for male pattern hair loss (n = 3, 100%) in all cases. All cases represent class actions brought by the plaintiffs, and they have been certified by their respective court. However, the cases are still ongoing.
Conclusion: While 5ARI use has been linked to undesired sexual side effects, there have been few litigations on this issue in Canada. Persisting sexual dysfunction after stopping the medication is the only complaint presented in legal action. To date, no judgment against a physician or pharmaceutical company was identified. Cases are still ongoing.

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