Punctuated Equilibrium: Why §402A Flourished and the Products Liability Restatement Languished
84 Pages Posted: 1 Nov 2007 Last revised: 15 Nov 2007
When the ALI in Section 402A enunciated its rule of strict products liability, it swept the country like a prairie fire, or, some thought, locusts. When the Products Liability Restatement was published, its principal critics said it did not restate the law and in fact cut the heart out of the law's expansionary, pro consumer, strict liability tool - Section 402A.
Despite the fears of many critics, the elevation of the reasonable alternative design test (which replaced the Prosserian consumer expectations test) did not eviscerate product liability law. Alternative safer design proved to be an effective tool even against tobacco's citadel, while consumer expectations was an unreliable tool even against gun manufacturers who spurned feasible safety devices.
Yet the lack of a robust statement of duty, the absence of a clarion call such as the Second Restatement's call for consumer protection made the Products Liability Restatement, as intended, a damper not an accelerant. This article surveys forty years of product liability law and concludes with a call for recognition of a robust common law duty of producers of medical products owed to those who use their products.
The duty of product stewardship is centered on an explicit duty of manufacturers to advance the patient's ability to make an informed choice regarding the course of medical treatment. The duty is owed to the patient, not the physician, who is merely an aide of the patient.
The approach declares that the manufacturer's duty is to exhaust all reasonable measures to enable the patient and her physician (or other medical service provider) to vindicate the patient's ability to make an informed choice. This patient-centered approach finds the learned intermediary doctrine too narrow. The duty of product stewardship recognizes that the post-market approval stage has been the poorly controlled human experiment stage of product development, as seen with Vioxx, drug-eluting coronary stents, and perhaps Avandia.
The duty of product stewardship is patient-centered. It emphasizes the ongoing experimental quality of drugs and other medical products. The experimental nature of (especially) new drugs and devices gives rise to a corresponding duty of product stewardship - a duty of ongoing active study and product development, a duty of systematic manufacturer active post-market surveillance of the actual use of their products after obtaining regulatory approval to market the product.
Keywords: products liability, torts, prescription drugs, medical devices, preemption,immunity,FDA, duty to warn,design defect,FDA approval
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