Association Alone Does Not Equal Causation in Product Liability Cases

by Bennett Jones LLP

Bennett Jones LLP

Class Action Case Update: Justice Perell's recent decision in Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 addressed a number of key areas of interest for the class action bar.

It seems simple enough: The plaintiff in a negligence case has the onus to prove that the defendant’s misconduct has the capacity to cause the alleged damage. However, Justice Perell’s recent decision in Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 reminds us that as simple as the onus to prove general causation may seem, without properly proving it, the plaintiff’s claim will fail. Importantly–association does not equal causation.

Factual Background

Wise was a proposed product liability class action concerning AndroGel™, a topical ointment marketed for the treatment of conditions associated with testosterone deficiency. The Wises commenced a proposed class action against Abbott Laboratories, Limited, Abbott Products Inc., Abbott Products Canada Inc., and Abbvie Products LLC (collectively, "Abbott"), claiming that AndroGel™ led to an increased risk of serious cardiovascular ("CV") events.

Among other claims, the Wises alleged that Abbott fabricated a condition known as "LowT" to refer to naturally occurring side effects of aging experienced by men, such as feeling sad or grumpy, deterioration in the ability to play sports, decreased libido and falling asleep after dinner. The Wises alleged that Abbott targeted its marketing for AndroGel™ at aging men with no genuine medical condition, putting them at an increased risk of harm, despite the product being essentially useless to them.

Abbott brought a pre-certification motion for summary judgment to dismiss the claim. The motion turned on Abbott's argument that the Wises could not prove general causation, a constituent element of their claims. Justice Perell found that the Wises failed to prove general causation and summarily dismissed the proposed class proceeding.

Association Does Not Equal Causation

Justice Perell explained the two aspects of causation in a negligence case. First, there is “general causation”, which concerns whether the defendant’s misconduct has the capacity to cause the alleged damage. Second, there is “specific causation”, which concerns whether the capacity to harm was actualized in the particular case.

In order to establish a claim in negligence, a plaintiff is required to prove general causation on a balance of probabilities–in medical negligence claims, that means demonstrating that the product has the capacity to cause a disease or medical condition. To meet the standard in this case, the Wises had to demonstrate on a balance of probabilities that Androgel™ was capable of causing serious CV events.

Though the Wises succeeded in proving an association between the product and serious CV events, namely that they occur together more often than can be explained simply by chance, Justice Perell found that they failed to establish the required causal link between Androgel™ and serious CV events. According to Justice Perell, "[t]he point is subtle, but all that the Wises proved was the possibility of a possibility."

The “but-for” Test

Justice Perell highlighted that a scientist's "philosophy about certainty and truth is … conceptually different from the law's approach to certainty and truth." The scientific method represents a "tentative truth" that may be subject to further investigation and development. Juristic truth, on the other hand, is final and certain.

He reviewed the expert evidence in great detail, but Justice Perell clarified that plaintiffs are not required to prove general causation to a scientific standard, nor are judges bound by statistical evidence. Rather, the law’s approach is to apply a “but-for” test on a balance of probabilities. In other words, the plaintiff must show on a balance of probabilities that “but for” the defendant’s negligent act, the injury would not have occurred.

The experts and the studies cited posited different results in relation to the link between the product and the alleged harm, but nowhere was it clear that the association between Androgel™ and serious CV events was causal. Notably–none of the experts were prepared to suggest a causal relationship.

Association May be Enough to Give Rise to a Duty to Warn

Justice Perell found that proof of an association between a product and a harm may give rise to a duty to warn. In this case, however, Justice Perell found that the duty to warn claim failed since a failure to warn that causes no harm could not be culpable negligence. Specifically, Justice Perell found “assuming the Wises were successful at trial or on this summary judgment motion in establishing that Abbott breached its duty to warn, the breach would be legally inconsequential because the breach would not have caused any harm.”


In the end, Justice Perell concluded on a balance of probabilities that the use of Androgel™ does not as a matter of general causation cause serious CV events. This conclusion led him to grant Abbott’s summary judgment motion and dismiss the Wises’ action. The decision provides a warning to plaintiffs in medical device and pharmaceutical product liability claims: association is not enough. Without causation, there will be no finding of negligence.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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