USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
the defendant, and the alteration or modifica - tions caused the injury. Unforeseeable Misuse The plaintiff is barred from recovery when they misuse the product in a manner unforeseeable to the manufacturer or seller, and the misuse causes the injury. Sophisticated User/Learned Intermediary The sophisticated user defence protects a man - ufacturer or product seller from liability for failure to warn when the end user knows or reasonably should know of the product’s risks. Under the learned intermediary doctrine, a prod - uct manufacturer may in some circumstances rely on the knowledge of “learned intermediary” who has received an appropriate warning. This doctrine is most applicable in the prescription drug and medical device context. Federal Pre-Emption Certain state law claims may be pre-empted and barred by a federal statute governing a particular product. Federal law pre-empts state law if: • it is expressly stated by Congress; • the state law conflicts with federal law; or • Congress has indicated that a certain area is not subject to state law. Product cases in which the defence is typically raised are prescription drug and motor vehicle defect cases. 2.13 The Impact of Regulatory Compliance on Product Liability Claims While compliance with regulatory standards is typically something the jury can consider in assessing the conduct of the defendant, it does not preclude a finding of negligence when rea -
sonable conduct would suggest that additional precautions were warranted. The failure of a manufacturer to comply with applicable federal standards can be evidence of a breach of duty or negligence per se. Compliance with regulatory standards is relevant to rebut a claim that the manufacturer’s conduct warrants the imposition of exemplary or punitive damages. 2.14 Rules for Payment of Costs in Product Liability Claims Under the “American Rule” , each party is typi - cally responsible for bearing its own litigation costs. There are exceptions to this rule, many of which vary by state. Many state rules allow recovery of certain litigation costs from the los - ing party. Certain state statutes may allow for recovery of attorney’s fees and litigation costs if a plaintiff prevails in a particular type of claim. For example, under the Massachusetts con - sumer protection statute (MGL c 93A), a breach of implied warranty is a per se violation of the statute entitling the plaintiff to their attorney’s fees and costs. The availability of “offers of judgment” under both the federal rules and certain state rules and statutes provides a potential avenue to recover - ing litigation expenses. Under Fed R Civ P 68, a party can make an offer of judgment to the other party at least 14 days before trial. If the opposing party rejects the offer and the final judgment is less than the offer, the opposing party must pay the litigation costs incurred by the party making the offer incurred after the date of the offer. 2.15 Available Funding in Product Liability Claims Contingency fee arrangements are the typical manner in which injured plaintiffs pursue prod -
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