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dc.contributor.authorLow, Patrick
dc.contributor.authorLi, Kevin D
dc.contributor.authorHakam, Nizar
dc.contributor.authorBell, Alexander
dc.contributor.authorAbbasi, Behzad
dc.contributor.authorLui, Jason
dc.contributor.authorShaw, Nathan M
dc.contributor.authorBreyer, Benjamin N
dc.date.accessioned2023-04-06T13:28:47Z
dc.date.available2023-04-06T13:28:47Z
dc.date.issued2021-12-30
dc.identifier.citationLow P, Li KD, Hakam N, Bell A, Abbasi B, Lui J, Shaw NM, Breyer BN. 5-Alpha reductase inhibitor related litigation: A legal database review. Andrology. 2022 Mar;10(3):470-476. doi: 10.1111/andr.13145. Epub 2021 Dec 30. PMID: 34933409.en_US
dc.identifier.eissn2047-2927
dc.identifier.doi10.1111/andr.13145en_US
dc.identifier.pmid34933409
dc.identifier.urihttp://hdl.handle.net/20.500.14038/51920
dc.description.abstractBackground: 5α-reductase inhibitors are commonly prescribed medications with multiple side effects used in the treatment of male pattern hair loss and benign prostatic hyperplasia. These side effects including "post-finasteride syndrome" may result in lawsuits. Objectives: To characterize lawsuits involving the adverse side effects of 5α-reductase inhibitor to better understand drivers of litigation and outcomes. Methods: Legal cases were queried from Nexis Uni using the search terms "5-alpha reductase inhibitor" as well as specific agents "finasteride," "dutasteride" in combination with "malpractice," "negligence," "damage," "loss," "side effect," and "complication." Secondary review was performed with publicly available data on "In Re: Propecia." Relevant cases were reviewed and pertinent characteristics were extracted and summarized using descriptive statistics. Results: Our search yielded 156 unique legal cases in the Nexis Uni database from April 2003 to May 2021. Only 18 of these cases met the inclusion criteria. Adverse events experienced by patients included medication side effects (n = 12, 66.7%), delayed cancer diagnosis (n = 3, 16.7%), and lack of symptom improvement (n = 3, 16.7%). The identity of the plaintiffs were most commonly patients themselves (n = 15, 83.3%). Defendants include pharmaceutical companies (n = 6, 33.3%), a combination of parties (n = 5, 27.8%), and physicians (n = 5, 27.8%) alone. The allegations included sexual side effects such as erectile dysfunction (n = 6, 33.3%) and decreased libido (n = 4, 22.2%). These prescriptions were made for benign prostatic hyperplasia (n = 9, 50%), male pattern hair loss (n = 7, 38.9%), and feminizing hormone therapy (n = 2, 11.1%). Several of these cases involved the same plaintiffs in related cases. No verdicts were against physicians. We noted a largely settled lawsuit involving more than 1000 plaintiffs with limited data on harms alleged and a $4.3 million settled amount. Of the total cases that resulted in a verdict, 9/18 were within the last 3 years. Discussion: The most common complications experienced by patients in our legal review were those involving sexual dysfunction with erectile dysfunction and decreased libido. The growing number of cases in the later years of our review suggests litigation may continue to increase in the coming future. Our review did not identify any individual cases that resulted in a monetary payout beyond a $4.3 million settlement outside of court. Conclusion: 5α-reductase inhibitor was alleged to have sexual, mental, and physical side effects, resulting in legal litigation. Despite this, no judgment against a physician or pharmaceutical company was identified. We do note and discuss a large number of lawsuits settled out of court. Given the increase in the number of lawsuits resulting in verdicts over the last 3 years, we suspect that the frequency of litigation around 5α-reductase inhibitors will continue for the foreseeable future.en_US
dc.language.isoenen_US
dc.relation.ispartofAndrologyen_US
dc.relation.urlhttps://doi.org/10.1111/andr.13145en_US
dc.rights© 2021 American Society of Andrology and European Academy of Andrology.en_US
dc.subjectfinasterideen_US
dc.subjectlegal reviewen_US
dc.subjectpost finasteride syndromeen_US
dc.subjectside effectsen_US
dc.title5-Alpha reductase inhibitor related litigation: A legal database reviewen_US
dc.typeJournal Articleen_US
dc.source.journaltitleAndrology
dc.source.volume10
dc.source.issue3
dc.source.beginpage470
dc.source.endpage476
dc.source.countryEngland
dc.identifier.journalAndrology
dc.contributor.departmentT.H. Chan School of Medicineen_US
dc.contributor.departmentUrologyen_US
dc.contributor.studentJason Lui


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