1/7/2024 0 Comments Warning label expert witness![]() The most recent decisions we’ve found addressing this question are Montagnon v. So the context of the learned intermediary rule, the adequacy inquiry becomes: Since the warning must be adequate as to the physician, is it necessary for a plaintiff (since the plaintiff bears the burden of proving a warning is inadequate) to present the testimony of a physician with an opinion that the warning wasn’t good enough to alert doctors to the full extent of the risk?įrom what we can tell, most courts to consider the issue have required such expert testimony. In the law, when one is dealing with the requirements of a profession (such as medicine, but any profession, really) those requirements are typically proven through the testimony of an expert witness who is a member of that profession, and thus is competent to offer an opinion as to what those professional requirements are. The question of expert witnesses and warnings comes up because the learned intermediary rule only requires warnings to medical professionals – and not to ordinary people like plaintiffs/patients. ![]() Well, that request wasn’t the kind of thing that had any time urgency on it, so we’re only now getting around to it. Provenance and peer review Not commissioned externally peer reviewed.ĭata sharing statement All data relevant to the study are included in the article or uploaded as supplementary information.Quite some time ago (at least a month) a reader asked us to comment on how the learned intermediary rule affects the need for expert testimony to prove the adequacy of warnings pertaining to drugs and medical devices. Patient consent for publication Not required. DH and GTF have served as expert witnesses on behalf of governments in litigation involving the tobacco industry. GTF was supported by a Senior Investigator Grant from the Ontario Institute for Cancer Research and a Senior Prevention Scientist Award from the Canadian Cancer Society Research Institute.Ĭompeting interests DH has served as an expert witness in legal challenges against tobacco companies. ![]() DH is supported by a CIHR-Public Health Agency of Canada Applied Public Health Research Chair. ACG was supported by the CIHR Doctoral Award – Frederick Banting and Charles Best Canada Graduate Scholarship (CGS-D) (#118068). Additional support in preparing this paper was provided to University of Waterloo by CIHR (FDN-148477). The final version of this paper was reviewed and approved by all coauthors.įunding The International Tobacco Control Canada Project was supported by grants from the US National Cancer Institute (R01 CA100362, R01 CA090955, P50 CA111236 (Roswell Park Transdisciplinary Tobacco Use Research Center) and P01 CA138389) the Canadian Institutes of Health Research (CIHR) (MOP57897, MOP-79551 and MOP-115016) and the Canadian Tobacco Control Research Initiative (014578). GTF, PD, SMN and DH contributed to the revision of the draft. ![]() ACG and PD conducted the statistical analyses. Contributors ACG led in designing the study and writing the manuscript.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |