Last time, we mentioned that one potential basis for product liability litigation in California is failure to warn consumers of the dangers of a product. There are a handful of elements that must be proven to make such a claim. First of all, a failure to warning claim can be aimed at either manufacturers or suppliers of the product.

The core of a failure to warn claim is that the product had potential risks or side effects which were known or could have been discovered given generally accepted medical and scientific knowledge at the time of manufacture or sale. Those risks must have presented a substantial danger if the product were to have been used as intended or misused in a reasonably foreseeable way, and ordinary consumers would not have been able to recognize these risks. In addition to these elements, a manufacturer or distributors failure to provide adequate warning must have been a substantial factor in causing the plaintiff’s harm. 

Product warnings, to be adequate, must be clearly understandable to consumers; any ambiguity that puts consumers at substantial risk can open a manufacturer or distributor up to liability if a consumer is harmed.

Certain rules apply to the duty to warn for certain manufacturers. For example, manufacturers of component parts may be able to avoid for harm that results from the component part’s use in another product if they provide subsequent warnings to users prior to the harm occurring, and manufacturers don’t need to provide warnings directly to consumers in some cases, such as those involving prescription drugs and medical devices.

For manufacturers of prescription drugs and medical devices, having a sound understanding of the legal obligations surrounding the duty to warn is critical to managing liabilities. In our next post, we’ll look at a recent court decision which highlights this point.