A Striking Lack of Expertise: Stout v Bayer Inc.

The Saskatchewan Court of Queen’s Bench has reaffirmed that judges play an important gatekeeper role in ensuring that only properly qualified experts be permitted to provide opinion evidence in respect to certification hearings.

It is an important reminder that evidence admissibility thresholds and the need for independence and impartiality should not be diluted for certification hearings.

Stout v Bayer Inc., 2017 SKQB 329 is a proposed class action concerning Essure Permanent Birth Control System (“Essure”), a type of permanent birth control for women. In the lead up to the certification hearing, the representative plaintiff sought to introduce expert evidence from two different individuals. The defendants objected on the basis that the subject matter of much of the evidence was beyond the scope of each expert’s expertise. They also objected on the basis that the experts were in breach of their duties owed to the court to be impartial and unbiased.

One of the experts generally claimed to be an expert in epidemiology and deposed that she was retained to provide an expert opinion on “pharmacoepidemiology, adverse event reporting systems, and methods for assessing general causation for medical devices and adverse events” (at para 13). Notably, her qualifications and experience related exclusively to nutritional epidemiology, focusing on relationships between diet, physical activity and obesity in respect to general fitness and health (at para 17). This individual’s qualifications and experience did not extend to pharmacoepidemiology, pharmacovigilance, drug regulation or medical device regulation, all of which her opinion was focused on. Indeed, she admitted to only learning about Essure at the time she was retained to provide an opinion. Accordingly, the Court struck much of her evidence as going beyond her scope of expertise.

The other individual was a lawyer from the United States. He was retained to provide opinions on “pharmacovigilance, pharmacoepidemiology, adverse event reporting systems, and methods for assessing general causation for medical devices and adverse events.” Many of the questions he was asked to consider asked whether there was “some basis in fact to believe” that Essure had various negative effects. In cross-examination, he admitted that in forming his opinion on various issues, he only considered evidence that was helpful to the Plaintiff.  In light of this, the Court held that the individual did not comply with his duty to the court to be impartial and unbiased and struck his evidence in its entirety.

Stout confirms the foundational principle that, before evidence can be weighed in respect to any standard of proof, the expert and the expert’s evidence must first pass the threshold requirements of admissibility.

Note: This article is of a general nature only and is not exhaustive of all possible legal rights or remedies. In addition, laws may change over time and should be interpreted only in the context of particular circumstances such that these materials are not intended to be relied upon or taken as legal advice or opinion. Readers should consult a legal professional for specific advice in any particular situation.