Currently everything from pharmaceutical products and medical devices to the labels on prepared foods are subject to regulation at the federal level, under the FDA. But they are also effectively subject to an ad hoc regulation at the state level via litigation. A3581, which was introduced by Assemblyman Michael Carroll (R-25), would take a step towards ensuring New Jersey manufacturers are not doubly regulated via lawsuits.
From the bill summary:
This bill establishes immunity from liability for a manufacturer or seller for harm caused by a failure to warn, where a warning or instruction given in connection with a drug, device, food, or food additive has been approved or prescribed by the federal Food and Drug Administration.
Under current law, a manufacturer or seller is not liable for harm caused by a failure to warn if the product contains an adequate warning or instruction, or if the manufacturer or seller provides an adequate warning or instruction for dangers a manufacturer or seller discovers or reasonably should discover after the product leaves its control. In a case in which a warning or instruction is given in connection with a drug, device, food, or food additive that has been approved or prescribed by the federal Food and Drug Administration, there is a rebuttable presumption that the warning or instruction is adequate.
A warning or instruction is adequate if it is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to, the persons by whom the product is intended to be used, or in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician.
In the view of the sponsor, the presumption in favor of a manufacturer or seller does not adequately protect a manufacturer or seller from unnecessarily expending resources in response to a failure to warn claim.
It is the sponsor’s belief that by establishing immunity from liability, rather than a presumption, for a failure to warn claim in which a warning or instruction was approved by the federal Food and Drug Administration, fewer claims will be filed and the unnecessary expenditure of resources by a manufacturer or seller will be better prevented.
The bill would take effect immediately and would apply prospectively to product liability claims filed after the effective date of the bill.
The bill was referred to the Assembly Judiciary Committee.