Third Restatement: new prescription for makers of drugs and medical devices

In 1991, the American Law Institute began drafting what will evolve into the Restatement (Third) of Torts: Products Liability. Section 103 of the draft provides that, when a manufacturing defect was the likely cause of the malfunction, the trier of fact can infer that the manufacturing defect caused the harm. Under Section 105(b), when the plaintiff proves that a defect increased the harm, the manufacturer is liable for all the harm unless it is able to prove the extent of the enhanced harm. Subsection 103(a)(4) sets forth a standard of liability for design defects in prescription drugs and medical devices. It provides that manufacturers will be liable when the product's foreseeable risks outweigh its therapeutic benefits to the extent that a reasonable provider would not have prescribed the drug or device for any class of patients. The proposed Restatement, as it stands in Council Draft 1, is a solid document.