Product Defense And FDA Compliance

In the world of pharmaceutical litigation, the jury typically considers FDA approval on issues such as the manufacturer's compliance with its duty of care, product defectiveness, and state of the art.1 The Restatement (Third) of Torts, Products Liability - adopted in many jurisdictions - states that "a product's compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective." By this standard, it is a significant, but not determining, factor. The state of Arkansas makes the distinction that compliance is "evidence" of non-defectiveness.

However, in some states, FDA approval is the determining factor in a product liability case. In this article we'll study the extent to which FDA approval, clearance, or compliance with government regulations affects the availability of compensatory and punitive damages. Though each statute is unique in its specific language, they generally fall into four groups: (1) statutes containing a presumption against liability based on FDA approval; (2) statutes containing a presumption against liability based on compliance with governmental regulations; (3) statutes containing a bar to punitive damages based on FDA approval; and (4) statutes containing a bar to punitive damages based on compliance with governmental regulations.2

PRESUMPTION AGAINST LIABILITY DUE TO FDA APPROVAL

Michigan: "In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States Food and Drug Administration, and the drug and its labeling were in compliance with the United States Food and Drug Administration's approval at the time the drug left the control of the manufacturer or seller." MCL § 600.2946(5)

New Jersey: "If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the Federal Food and Drug Administration under the [FDCA] or [Public Health Service Act] a rebuttable presumption shall arise that the warning or instruction is adequate." N.J.S.A. § 2A:58C-4.

Texas: "[T]here is a rebuttable presumption that the defendant or defendants, including a health care provider, manufacturer, distributor, and prescriber, are not liable with respect to the allegations involving failure to provide adequate warnings or information if:

the warnings or information that accompanied the product in its distribution were those approved by the United States Food and Drug Administration for a product approved under the [FDCA] or [Public Health Service Act]; or the warnings provided were those stated in monographs developed by the United States Food and Drug Administration for pharmaceutical products that may be distributed without an approved new drug application." Tex. Civ. P. & Rem. § 82.007(a).

PRESUMPTION AGAINST LIABILITY DUE TO COMPLIANCE WITH GOVERNMENT REGULATIONS

Federal: Applies to vaccine warnings only, providing that "a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the [FDCA and the Vaccine Act] applicable to the...