The Texas Experiment: Products Liability
THE TEXAS EXPERIMENT: Products Liability
Section 6 of proposed H.R. 1215 reads: “A health care provider who prescribes, or who dispenses pursuant to a prescription, a medical product approved, licensed, or cleared by the Food and Drug Administration shall not be named as a party to a product liability lawsuit involving such product and shall not be liable to a claimant in a class action lawsuit against the manufacturer, distributor, or seller of such product.” A similar FDA shield has been used since 2003 in Texas.
HB 4 directed Texas courts to defer to federal agencies in many state products liability actions, strange for a state that is fiercely independent and that resists federal intervention at virtually every turn. For actions alleging inadequate warnings regarding pharmaceuticals, a rebuttable presumption is created in favor of defendants if the warnings that accompanied the product were approved by the United States Food and Drug Administration (i.e., the “FDA defense”). And in other products liability actions concerning the formulation, labeling, or design of a product, a similar rebuttable presumption (i.e., a legal conclusion that is taken as true unless proven otherwise) is created for product manufacturers or sellers who show that they complied with federal regulations.
At base, these reforms act to deprive state judges and juries of their ability to determine whether a product is unsafe, ceding this authority instead to unelected, unaccountable federal bureaucrats in agencies that have often been purposefully understaffed and underfunded, constrained in their authority, and are otherwise subject to influence by the industries that they are supposed to regulate.