USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers Graham and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
Material Alteration The plaintiff is barred from recovery under this defence when it is established that the product was not in materially the same condition at the time of the inci - dent as when it left the control of the defendant, and the alteration or modifications caused the injury. Unforeseeable Misuse The plaintiff is barred from recovery when they misuse the product in a manner unforeseeable to the manu - facturer or seller, and the misuse causes the injury. Sophisticated User/Learned Intermediary The sophisticated user defence protects a manufac - turer 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 product manufacturer may in some circumstances rely on the knowledge of a “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 typi - cally something the jury can consider in assessing the conduct of the defendant, it does not preclude a finding of negligence when reasonable conduct would suggest that additional precautions were warranted. The failure of a manufacturer to comply with applica - ble federal standards can be evidence of a breach of duty or negligence per se. Compliance with regula -
Court. The Supreme Court has discretion to grant or deny such petitions. In state court, there is typically a trial court, interme - diate appellate court and high court. The appellate procedure is governed by the individual state’s rules of appellate procedure. 2.12 Defences to Product Liability Claims Affirmative defences to product liability claims are typ - ically governed by state law and vary among jurisdic - tions. The defendant’s burden of proving an affirma - tive defence is by a preponderance of the evidence. The following are among the most common affirmative defences to product liability claims. Comparative/Contributory Negligence Most states follow comparative negligence princi - ples, which means that the damages awarded will be apportioned based on the parties’ respective percentages of fault. The most common compara - tive negligence schemes are the pure and modified approaches. Under the pure comparative negligence rule, the plaintiff’s recovery is reduced by their per - centage of fault. For example, if the plaintiff is 70% responsible for their damages, their recovery will be reduced by 70%. Under the modified comparative negligence rule, the plaintiff is barred from recovery if they are found more than 50% at fault. A small num - ber of states follow the contributory negligence rule, which means that the plaintiff cannot recover if they are found any amount at fault. Many states have rules or statutes that further define the scope of the comparative negligence defence. For example, in Massachusetts, the plaintiff’s com - parative negligence is not a defence to a breach of implied warranty claim unless the plaintiff voluntarily and unreasonably proceeded to encounter the defect. Assumption of the Risk The assumption-of-the-risk defence precludes recov - ery where a plaintiff voluntarily used a product when they were aware, or should have been aware, of a defect or other risk of harm, and nevertheless pro - ceeded despite having that knowledge.
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