Product Defect Claims: The Trick is Proving Cause

At some point in our lives as consumers, we have all fallen victim to a faulty or defective product. Depending on the product, serious damage or loss can ensue. At that point, a customer may decide to pursue compensation for his or her losses. In starting such an action, causation will be one of the most significant issues to prove.

“Causation” means that the loss or damage a party has suffered is directly caused by the defective product. While a convincing level of certainty is required to show causation, this determination is not a mathematical calculation nor does a scientific standard of certainty have to be met.

However, the greater the certainty a party can prove, the better the chances of demonstrating the cause-and-effect relationship. For this, expert evidence will go a long way. For example, if a vehicle is purchased with defective brakes and an accident occurs, even if there was no issue with respect to the brakes, a party would still have to show that the defective brakes caused the accident. By no means is this always an easy task.

For instance, in the case of Wise v. Abbott Laboratories Ltd., Mr. and Mrs. Wise brought a proposed class action against Abbott Laboratories with the principal allegation that the AndroGel treatment for hypogonadism made by Abbott Laboratories caused serious cardiovascular events. Notably, the case also distinguished between a manufacturer’s failure to warn—in this case Abbott Laboratories’ failure to warn about the possible side effects—and the issue of causation.

The allegations in Wise stemmed from the fact that following the treatment Mr. Wise suffered cardiovascular events. Both parties presented expert evidence, but the onus to demonstrate the cause-and-effect relationship with the treatment remained with the Wises.
The experts recognized that there was an association between the product and the cardiovascular events. In other words, there was a possibility of a possibility that the product caused the cardiovascular events. But this was not enough. Mr. Wise’s experts needed to show that the product in fact caused the injury, not that it was merely possible to cause an injury.

A popular guideline to analyze the existence of causation in epidemiological studies (known as the Bradford Hill Factors) lists the following nine factors:

1. Biological plausibility
2. Consistency with other knowledge
3. Alternative explanations
4. Specificity of the association to a specific condition or disease
5. Temporality
6. Cessation of exposure
7. Strength of the association
8. Dose-response

Before any conclusion about association and any conclusion on causation can be reached, the outcome of the above factors must be examined to determine whether it is a result of chance.

Since none of the experts could testify that an inference of causation could be drawn, the judge refused to do so. However, the association between the two was not enough to meet the standard of general causation. The standard required Mr. Wise to demonstrate that but for the defective product, Mr. Wise would not have suffered the cardiovascular events.

There is some importance in demonstrating that the loss and defective product are associated. The Court in Wise noted that the association was enough to trigger a duty to warn. However, the failure to warn did not make Abbot Laboratories liable for damages because of the lack of causation. In short, while the association demonstrated that Abbot Laboratories had a duty to warn, there was insufficient evidence to show that the breach of that duty caused Mr. Wise harm.

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