Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.

What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether punitive damages are appropriate. On the other hand, because of the complexity of FDA regulation, it is important for courts to control how this evidence is presented in order to avoid overwhelming a jury, which already must deal with a number of complicated issues. The Federal Rules of Evidence should be applied in a way that allows the jury to hear about the 510(k) process in way that is understandable and useful. The reasoning of these courts – that the FDA’s regulatory process is irrelevant, or even if it has some probative value, the probative value is substantially outweighed by other factors – deprives the jury of important information and potentially distorts the fact-finding process.