Court Opinion

ID: 9859132
Source: CourtListenerOpinion
Date Created: 2023-09-24 18:48:57.524357+00
Date Added: 2024-06-11T10:06:38.110888
License: Public Domain

POLLOCK, J.,
dissenting
With disarming understatement, the majority opinion raises profound questions about the purpose of judicial opinions, the role of courts, and the separation of powers. In raising those questions, the majority rejects the Legislature’s endorsement of the learned intermediary doctrine as set forth in N.J.S.A. 2A:58C-4. The majority opinion sustains itself only by ignoring the plain language of an unambiguous statute, the New Jersey Products Liability Act, N.J.S.A. 2A:58C-1 to -7 (NJPLA), and by substituting its own policy preference for that of the Legislature. Contrary to the majority opinion, the point of this dissent is not that the Court should await legislative action. Ante at 16, 734 A.2d at 1254. Rather, the point is that the Legislature has already acted. Believing that the Court is bound by the NJPLA, I respectfully dissent.
Initially, the Law Division held that the duty of defendants Wyeth Laboratories Inc., American Home Products Corporation, Wyeth-Ayerst Laboratories Division of American Home Products Corporation, Wyeth-Ayerst International Inc., and Wyeth-Ayerst Laboratories Company (“defendants” or “Wyeth”) extended not to plaintiffs, but to their physicians or other health-care professionals. 313 N.J.Super. 646, 658, 713 A.2d 588 (1997). The Appellate Division affirmed. 313 N.J.Super. 511, 516, 713 A.2d 520 (1998).
On a related issue, the Law Division held that defendants adequately warned the bellwether plaintiffs’ physicians or other health-care professionals of the risks associated with Norplant. 313 N.J.Super. at 658, 713 A.2d 588. The Appellate Division likewise affirmed that holding. 313 N.J.Super at 518, 713 A.2d 520.
The majority reverses the judgment of the Appellate Division. I would affirm.
*34To place the issue in perspective, a brief summary of relevant principles of products liability law may be helpful. At common law, a manufacturer is strictly liable for a defective product. Feldman v. Lederle Laboratories, Inc., 97 N.J. 429, 441-42, 479 A.2d 374 (1984) (Feldman I). The manufacturer, however, is not liable if the product is “unavoidably unsafe” and is “accompanied by proper warning.” Id. at 447, 479 A.2d 374. In general, the manufacturer must communicate this warning directly to the consumer. Niemiera v. Schneider, 114 N.J. 550, 559, 555 A.2d 1112 (1989). With prescription drugs, the “manufacturer generally discharges its duty to warn the ultimate user ... by supplying physicians with information about the drug’s dangerous propensities.” Ibid. This rule, known as the learned intermediary doctrine, reflects the common law’s awareness of the unique role that physicians serve in warning their patients of the risks associated with prescription drugs. See Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir.1966). New Jersey courts consistently have recognized the vitality of the learned intermediary doctrine. See, e.g., Bacardi v. Holzman, 182 N.J.Super. 422, 442 A.2d 617 (App.Div.1981); Torsiello v. Whitehall Laboratories, 165 N.J.Super. 311, 322-23, 398 A.2d 132 (App.Div.) (“[W]hile it-is the customer who is entitled to the warning in respect of nonprescription drugs, only the prescribing physician need be warned as to the risks involved in a prescription drug.”), certif. denied, 81 N.J. 50, 404 A.2d 1150 (1979). In 1987, the Legislature codified the learned intermediary doctrine in the NJPLA. L. 1987, c. 197, § 4 (effective July 22, 1987). Thus, although the learned intermediary doctrine remains a common-law rule in most states, it is now a statutory rule in New Jersey.
Before the enactment of the NJPLA, this Court had issued numerous products liability opinions based primarily on the common law. In those opinions, we emphasized the rights of injured persons and consumers in a mass-marketing economy. New Jersey manufacturers, including pharmaceutical companies, thought we had gone too far. The Legislature agreed and enacted *35the NJPLA. As the passed bill memorandum to Governor Kean explained:
The New Jersey manufacturers that have lobbied heavily for the enactment of this bill argue that in certain areas the New Jersey Supreme Court has gone beyond the laws of other states. These groups state that this bill will “bring New Jersey back into the mainstream” of product liability law. New Jersey manufacturers argue that because certain areas of New Jersey product liability law provide more protection for the consumer than other states, injured consumers from out-of-state are likely to bring a lawsuit against the New Jersey manufacturers in New Jersey. Thus, to the extent this bill conforms the New Jersey product liability law to the law of the majority of states, New Jersey will no longer be a “favorable forum” to out-of-state injured parties.
[Passed Bill Memorandum, to Governor Thomas H. Kean on S-%805, at 3 (July 10,1987).]
Of special interest to the pharmaceutical companies and the Legislature was the learned intermediary doctrine.
Analysis of the status of the learned intermediary doctrine thus depends on the intent of the Legislature. Merin v. Maglaki, 126 N.J. 430, 435, 599 A.2d 1256 (1992). When a statute is clear, a court need not look beyond the statutory language to discover the legislative intent. State v. Kittrell, 145 N.J. 112, 123, 678 A.2d 209 (1996). The language of the NJPLA is clear.
The NJPLA states that a manufacturer has a duty to include an “adequate warning or instruction” with a product. Otherwise, the product may be considered defective. According to the statute, an “adequate warning” 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.
[N.J.S.A. 2A:58C-4 (emphasis added).]
The majority finds ambiguity in the NJPLA, stating that “[a]l-though the statute provides a physician-based standard for determining the adequacy of the warning due to a physician, the statute does not legislate the boundaries of the doctrine.” Ante at 16, 734 A.2d at 1254. According to the Senate Committee statement *36accompanying the NJPLA, however, a drug manufacturer’s duty to warn is owed to the physician, not the consumer:
[A] manufacturer or seller is not liable in a warning-defect case if an adequate warning is given when the product has left the control of the manufacturer or seller____ The subsection contains a general definition of an adequate warning and a special definition for warnings that accompany prescription drugs, since, in the case of prescription drugs, the warning is owed to the physician.
[Senate Judiciary Committee, Statement to Senate Bill No. 2805 (L. 1987, c. 197), N.J.S.A. 2A:58C-la (emphasis added).]
The NJPLA provides that “committee statements that may be adopted or included in the legislative history of this act shall be consulted in the interpretation and construction of this act.” N.J.S.A. 2A:58C-1a; Roberts v. Rich Foods Inc., 139 N.J. 365, 374, 654 A.2d 1365 (1995). Through that extraordinary mandate, the Legislature sought to preclude judicial circumvention of the plain meaning of the statute.
Today’s decision demonstrates that the Legislature’s efforts were unavailing. The majority has mischaracterized both the statute and the rationale for the learned intermediary doctrine. Contrary to the majority opinion, the statute directs that the warning is owed to the physician not “because drugs were then marketed to the physician,” ante at 16, 734 A.2d at 1254, but because the physician is in the best position to make an individualized evaluation of the risks of drugs and warn the patient of those risks. The patient, moreover, cannot obtain the drugs without a prescription written by a physician.
Underlying the majority opinion is the assumption that the Legislature in 1987 could not have anticipated the mass-marketing of prescription drugs. That assumption, however, has no basis in the record. In fact, the drug companies and the Legislature, like the Federal Food and Drug Administration (FDA), were aware of such marketing. See Direct-to-Consumer Advertising of Prescription Drugs, 50 Fed.Reg. 36,677 (1985) (commenting that “the public discussion on direct-to-eonsumer advertising of prescription drugs has provided interested individuals and organizations ample opportunity to consider and express opinions on the issue”). As *37the majority opinion states: “Aware of the potential threat to consumers when pharmaceutical companies first sought to advertise to non-health-care professionals, the FDA, in the early 1980s ‘initially imposed a [voluntary] moratorium on such advertising so that it could study the issue more carefully; but in 1985, it lifted the moratorium, content to apply its existing regulations to this new practice.’ ” Ante at 22, 734 A.2d at 1258 (quoting Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 Ga. L. Rev. 141, 142-43 (1997)).
The majority’s imposition of expanded duties on drug manufacturers contravenes the legislative history of the NJPLA. That history demonstrates that the statute was intended to strengthen the protections afforded manufacturers:
It is important to recognize that this bill not only conforms New Jersey product liability law to the law of the majority of states but, in some instances, changes New Jersey law in favor of the manufacturer in a way that is not currently recognized by the law of the majority of states. Thus, the effect of the enactment of this bill would be to shift the status of the law of New Jersey on certain issues from its current position of being more favorable to the injured consumer than the majority of states to being more favorable to the manufacturer than the majority of states.
[Passed Bill Memorandum to Governor Thomas H. Kean on S-2805, supra, at 3.]
Judges, although they may disagree with a legislative policy, are bound to respect it. In adapting the common law to society’s needs, this Court may not have favored manufacturers, including pharmaceutical companies, as enthusiastically as has the Legislature. The issue, however, is not whether the Court shares the Legislature’s enthusiasm or even whether the majority would prefer to amend the common-law learned intermediary doctrine. Because of the enactment of the NJPLA, the issue is whether the majority should respect the learned intermediary doctrine as declared by the Legislature.
As the majority recognizes, the modern law of product liability began with Justice Francis’s opinion in Henningsen v. Bloomfield Motors Inc., 32 N.J. 358, 161 A.2d 69 (1960), ante at 21, 734 A.2d *38at 1257; see Prosser & Keeton on Torts § 97 (5th ed.1984) (describing Henningsen as “the most rapid and altogether spectacular overturn of an established rule in the entire history of the law of torts”). Given the prominence of that opinion, 'written by Justice Francis while serving on this Court with Chief Justice Joseph Weintraub, Justice Francis’s eulogy at the proceedings before this Court in memory of Chief Justice Weintraub is worth recalling. Justice Francis eloquently described the distinction that the late Chief Justice drew between respecting the will of the Legislature and adapting the common law to the needs of the time. Speaking of Chief Justice Weintraub, Justice Francis stated:
Throughout his years on the Court, he remained acutely aware of the line of demarcation between the judicial and legislative branches of government, and of the duty of the judicial branch to refrain from encroaching on the area of operation of the legislative branch. So if a statutory rule or doctrine were in question before the Court, even if it appeared to be inadequate to serve the needs of the times, he would declare that the remedy was in the hands of the Legislature, and the Courts should not interfere.
[72 N.J. XIX, XXVIII-XXIX (1977) ].
That demarcation remains valid today.
Given the statutory basis for the learned intermediary doctrine in New Jersey, recourse to the Restatement (Third) of Torts: Products Liability § 6 (1998) (“Restatement ”) is gratuitous. Furthermore, the Restatement generally endorses the traditional rule that a drug manufacturer’s duty to warn is owed to the health-care provider, not the consumer. Id. § 6(d)(1). The Restatement suggests, however, that it may be appropriate to impose a duty to warn the patient directly “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.” Id. § 6(d)(2). Here, the Restatement does not apply for two reasons. First, as prestigious as any Restatement may be, it cannot supersede a governing statute. Second, the surgical implantation of Norplant requires the significant involvement of a health-care provider who must make an individualized evaluation of the risk to the patient. Such involvement stands in contrast to *39the “diminished role as an evaluator or decision maker” that is a predicate for liability under the Restatement. See id. § 6(d) comment a. That involvement also distinguishes the implantation of Norplant from the administration of mass inoculations, see ante at 10 -11, 734 A.2d at 1250 - 51, which proceed without an individualized evaluation of the risks to the patient.
Contrary to the majority opinion, the question is not “whether the absence of an independent duty to warn patients gives the manufacturer the right to misrepresent to the public the product’s safety.” Ante at 21, 734 A.2d at 1257. No defendant claims such a right. Neither does the FDA, which regulates prescription drug advertising, allow it. For example, FDA regulations require that print and broadcast advertisements promoting prescription drugs be “balanced.” 21 C.F.R. § 202.1(e)(6). Additionally, the FDA has issued a Draft Guidance that requires prescription drug broadcast advertisements to include a thorough “major statement” in “consumer-friendly” language about a drug’s major risks. 62 Fed.Reg. 43,171; see also Guidance for Industry: Consumer-Directed Broadcast Advertisements (visited July 14, 1999) < http://www.fda.gov/cder/guidance/index.htm >.
On the facts, moreover, Norplant is a poor vehicle to import so momentous a change. Unlike other drugs that concern the majority, the record reveals that Norplant cannot be purchased in a supermarket, see ante at 4, 734 A.2d at 1247, is not promoted by health maintenance organizations, see ante at 18, 734 A.2d at 1255, approved by compliant physicians to placate overbearing patients, see ante at 20, 734 A.2d at 1257, or implanted over the Internet, ante at 4, 29 n. 6, 734 A.2d at 1257, 1262 n. 6. Through the incorporation of presumed facts, the majority has created a phantom record to support the creation of its exception to the learned intermediary doctrine. That exercise has led the majority to wander from the confines of the present case.
Norplant is not an over-the-counter drug; it can be obtained only with a doctor’s prescription. To insert Norplant, a physician or other health-care professional anesthetizes an area in a pa*40tient’s upper arm, makes a one-eighth-ineh incision, and implants six capsules just below the patient’s skin. Similar surgery is required to remove the capsules.
The use of Norplant thus requires the significant involvement of the prescribing physician. Even Norman Rockwell, see ante at 18, 734 A.2d at 1255, would recognize the procedure as one performed in accordance with the traditional physician-patient relationship. Presumably, Wyeth’s mass-marketing campaign has increased the demand for Norplant and led many women to request it by name. In some contexts, the extent to which pharmaceutical companies seek to influence consumers, like the extent to which they seek to influence physicians, may be disturbing. Here, however, the mass-marketing campaign apparently was ineffectual; none of the bellwether plaintiffs saw any advertising about Norplant. The invasiveness of the Norplant procedure, moreover, would give any patient pause and a physician cause to evaluate the risks. As the Law Division stated, “a physician is not simply relegated to the role of prescribing the drug according to the woman’s wishes.” 313 N.J.Super. 646, 648, 713 A.2d 588 (Law Div.1997).
Earlier this year, the Fifth Circuit Court of Appeals held, in a case involving Norplant, that “as long as a physician-patient relationship exists, the learned intermediary doctrine applies.” In re Norplant Contraceptive Prods. Liab. Litig., 165 F.3d 374, 379 (5th Cir.1999). The court rejected the creation of an exception to the learned intermediary doctrine for mass-marketed drugs. Specifically, the court stated that “Norplant is nevertheless a prescription drug ... [and] physicians play a significant role in prescribing Norplant and in educating their patients about the benefits and disadvantages to using it.” Ibid.
The majority identifies four premises underlying the learned intermediary doctrine that it asserts are inapplicable when a manufacturer advertises the drug directly to consumers: “(1) reluctance to undermine the doctor-patient relationship; (2) absence in the era of ‘doctor knows best’ of need for the patient’s *41informed consent; (3) inability of drug manufacturer to communicate with patients; and (4) complexity of the subject.” Ante at 18, 734 A.2d at 1255. Contrary to the majority, ante at 18 -19, 734 A.2d at 1255 - 56, those four considerations remain relevant to the implantation of Norplant.
First, the Norplant System must be implanted surgically. Implicit in the performance of a surgical procedure is respect for the physician-patient relationship. “[T]he physician is in the best position to take into account the propensities of the drug and the susceptibilities of the patient, and to give a highly individualized warning to the ultimate user based on the physician’s specialized knowledge.” Spychala v. G.D. Searle & Co., 705 F.Supp. 1024, 1031-32 (D.N.J.1988). Second, the physician is the only person who can communicate with the patient to obtain the patient’s informed consent to the procedure. Third, a pharmaceutical company, such as Wyeth, cannot provide an adequate warning to each individual consumer about the potential side-effects and risks associated with the device. Each patient has individualized risks associated with surgical procedures. Lastly, the Norplant implant, far more than other birth control devices, is a complex contraceptive system that requires detailed instructions and warnings.
To soften the impact of its opinion, the majority creates a rebuttable presumption that a warning is adequate if it complies with FDA regulations. Ante at 25, 734 A.2d at 1259. Regrettably, the Court has not granted the parties the opportunity to address the creation, nature, or sufficiency of such a presumption. To the extent that such a presumption is essential to the majority’s rationale, the parties should have been given that opportunity. See Office of Employee Relations v. Communications Workers, 154 N.J. 98, 108, 711 A.2d 300 (1998); see also Canesi v. Wilson, 158 N.J. 490, 539-41, 730 A.2d 805 (1999) (Pollock, J., dissenting). Similarly, the parties should have been accorded the opportunity to address the issue of proximate cause, see ante at 25, 734 A.2d at 1260, as well as that of contribution and indemnity from physi-*42dans, see ante at 30, 734 A.2d at 1262-63. In a judicial proceeding, the test of a hypothesis through the adversary process serves as a safeguard when addressing issues of broad public concern, such as those introduced by the majority.
To conclude, when enacting the NJPLA, the Legislature chose to confíne the expansion of product liability law. The majority’s preference for a different policy does not justify ignoring the one chosen by the Legislature.
GARIBALDI, J., joins in this dissent.
For reversal and remandment — Chief Justice PORITZ and Justices HANDLER, O’HERN, STEIN and COLEMAN — 5.
For affirmance — Justices POLLOCK and GARIBALDI — 2.