Before Judges Dreier, Keefe and P.g. Levy.
The opinion of the court was delivered by: Dreier, P.j.a.d.
On appeal from the Superior Court of New Jersey, Law Division, Middlesex County, whose decision is reported at ___ N.J. Super. ___.
Various plaintiffs, designated as the "bellwether" parties in consolidated product liability actions, have appealed from a summary judgment determining that defendants had no duty to warn these consumers of possible adverse effects attendant upon the insertion, maintenance and removal of defendants' Norplant(TM) contraceptive medication. Judge Corodemus in her comprehensive decision of December 5, 1997, reported at ___ N.J. Super. ___ (Law Div. 1997), traced the history of plaintiffs' complaints, the State of New Jersey law, out-of-state authority, and how our statutory and common law learned intermediary rules bear upon a prescription drug provider's duty to warn the consumer of its products. We agree with her analysis and decision to select bellwether plaintiffs, as such practice of using bellwether cases is firmly established in the law. See In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700 (E.D. Tex. 1997), in which, incidentally, Chief Judge Schell reached the same substantive result as Judge Corodemus.
While we readily affirm the summary judgment based upon the clear and scholarly opinion of Judge Corodemus, some issues nevertheless need further elaboration.
It has been argued that the Restatement (Third) of Torts: Products Liability (1998) posits an additional basis for liability to be imposed upon a manufacturer of a prescription drug for failure to warn a patient. Section 6 of the new Restatement separates defects in prescription drugs or medical devices from those in other products. Although the rules governing manufacturing defects in prescription drugs or medical devices are the same as those governing other products under § 2(b) of the Restatement, design defects and warning defects receive separate treatment. The warning defect language, contained in § 6(d), reads:
(d) A prescription drug or medical device is not reasonably safe because of inadequate instructions or warnings if reasonable instructions or warnings regarding foreseeable risks of harm are not provided to:
(1) prescribing and other health care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings; or
(2) the patient when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings.
Subsection (d)(1) mirrors N.J.S.A. 2A:58C-4 which defines an adequate warning as 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, ... in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician.
The Restatement, however, adds subsection (d)(2), positing warnings being given directly to a patient "when the manufacturer knows or has reason to know that health care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings." The Reporters have appended Comment b, suggesting the application of this section to situations where the physician or health care provider has a "diminished role as an evaluator or decision maker." In such an instance, the manufacturer would have a duty to provide direct warnings to the patient. Exceptions are further explored in Comment e. For example, in mass inoculations where health care providers are unable to supervise the administration of the drug and individually advise patients about the risks attendant upon the drug's use, the manufacturer may have a duty to provide warnings.
Despite the Reporter's suggestion of a manufacturer's duty to warn in mass inoculations, we need not decide the outcome of such a case in New Jersey, even with the more restrictive language of N.J.S.A. 2A:58C-4. By the Legislature's use of the words "the prescribing physician," we might assume that it intended this statute to have effect only where there is such a prescribing physician (or other health care professional with the power to prescribe drugs, as is discussed infra). In instances such as mass inoculations where there may be no prescribing physician for the individual patients, some other form of warning might be necessary.
The more salient question in this case is whether the Legislature intended to define an adequate warning in the area of prescription drugs as one given to physicians only. It is true that the New Jersey statute speaks only of a prescribing "physician." Are we to take this as a word of limitation limited to one licensed to practice medicine or surgery under N.J.S.A. 45:9-6, et seq.? It is clear that drugs may be prescribed by dentists (N.J.S.A. 46:6-19.5b), optometrists (N.J.S.A. 45:12-1), podiatrists (N.J.S.A. 45:5-7), nurse practitioners (N.J.S.A. 45:11-49), home health care service firms (N.J.S.A. 45:11-49.1), physician's assistants (N.J.S.A. 45:9-27.16), or others similarly permitted to prescribe or administer drugs on a limited basis. It would be difficult to believe that the Legislature intended that warnings be geared only to those licensed to practice medicine and surgery, when the Legislature has authorized other health care professionals to provide a similar service. We thus assume that the Legislature intended to include within the term "physician" other such health care providers in the same manner as is stated in the Restatement.
In fact, in the case before us, plaintiff Perez had the Norplant(TM) inserted by a nurse, Diane Brevet. As noted in the trial Judge's opinion, "Nurse Brevet is certified in women's health by the National Association of Obstetricians and Gynecologists. She is authorized by law to prescribe and insert Norplant." It ...