In our previous post, we began looking at some of the basic principles of manufacturers’ duty to warn consumers of risks associated with their products. As we noted, warnings must be provided for risks which are known or which reasonably could have been discovered by the manufacturer.

Another important issue with respect to the duty to warn is who is supposed to receive the warning. This issue can come up with prescription medications and medical devices. Manufacturers of these products certainly have a duty to warn, but to whom do they owe that duty? The answer can vary from state to state, as a recent out-of-state case shows.

Under the “learned intermediary” doctrine, which has been adopted in California, manufacturers of medical devices may fulfill their duty to warn consumers of the risks of their products by providing adequate information about risks to the physician. The idea is that physicians serve as learned intermediaries in conveying information about the risks of medical devices to consumers.

The duty to warn of risks applies not only to risks known at the time the product is first manufactured, but also to risks of which the manufacturer becomes aware after the product goes onto the market. Manufacturers may not necessarily have to issue a new warning, though, every time additional information about risks arise. In cases where an adequate warning was made at the time of sale, there may not be an additional duty to warn.

Another important point is that patients who are harmed as a result of a medical device manufacturer’s failure to warn may only hold the manufacturer accountable for warnings that would be required by the FDA. Federal law takes precedence over any state-based requirements.

Product liability is an important area for businesses to address, as significant costs can result from a finding of liability. Working with an experienced attorney is necessary not only to avoid liability, but also to address legal claims when they arise.