Pierce v. Ortho Pharmaceutical Corp.

PASHMAN, J.,

dissenting.

I agree with the majority’s ruling that a professional employee may not be discharged for refusing to violate a clearly *77recognized legal or ethical obligation imposed on members of his profession. However, the majority’s application of this principle defies logical explanation and disregards established judicial doctrine on the propriety of summary judgment. The majority further errs by assuming that the absence of a written agreement signifies beyond dispute that plaintiff’s employment was strictly at the will of the drug manufacturer. I therefore respectfully dissent.

The majority’s analysis recognizes that the ethical goals of professional conduct are of inestimable social value. By maintaining informed standards of conduct, licensed professions bring to the problems of their public responsibilities the same expertise that marks their calling. The integrity of codes of professional conduct that result from this regulation deserves judicial protection from undue economic pressure. Employers are a potential source of this pressure, for' they can provide or withhold—until today, at their whim—job security and the means of enhancing a professional’s reputation. Thus, I completely agree with the majority’s ruling that “an employee has a cause of action for wrongful discharge when the discharge is contrary to a clear mandate of public policy” as expressed in a “professional code of ethics.” Ante at 72.

The Court pronounces this rule for the first time today. One would think that it would therefore afford plaintiff an opportunity to seek relief within the confines of this newly announced cause of action. By ordering the grant of summary judgment for defendant, however, the majority apparently believes that such an opportunity would be an exercise in futility. I fail to see how the majority reaches this conclusion. There are a number of detailed, recognized, codes of medical ethics that proscribe participation in clinical experimentation when a doctor perceives an unreasonable threat to human health. Any one of these codes could provide the “clear mandate of public policy” that the majority requires.

The “Declaration of Helsinki” of the World Medical Association established guidelines for conducting medical experimentation on humans. The declaration was adopted in 1962 and *78revised by the 18th World Medical Assembly at Helsinki, Finland, in 1964. 4 Encyclopedia of Bioethics 1769 (Reich ed. 1978). The House of Delegates of the American Medical Association gave official endorsement to the principles of this declaration at its annual convention in 1966. Id. at 1773. The 1964 declaration provides in part as follows:

In the field of clinical research a fundamental distinction must be recognized between clinical research in which the aim is essentially therapeutic for a patient, and the clinical research, the essential object of which is purely scientific and without therapeutic value to the person subjected to the research.
1. Basic Principles
3. Clinical research cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.
II. Clinical Research Combined with Professional Care
2. The doctor can combine clinical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that clinical research is justified by its therapeutic value for the patient.
III. Non-Therapeutie Clinical Research
1. In the purely scientific application of clinical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom clinical research is being carried out.
4b. * * * The investigator or the investigating team should discontinue the research if in his or their judgment, it may, if continued, be harmful to the individual. [Id. at 1770-1771] 1

The Declaration of Helsinki was revised in 1975 by the 29th World Medical Assembly in Tokyo, Japan. See id. at 1769. As amended, the declaration includes the following additional provisions:

I. Basic Principles
*797. Doctors should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors should cease any investigation if the hazards are found to outweigh the potential benefits.
II. Medical Research Combined with Professional Care (Clinical Research)
2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.
3. In any medical study, every patient—including those of a control group, if any—should be assured of the best proven diagnostic and therapeutic method.
III. Non-therapeutic Biomedical Research Involving Human Subjects (Non-clinical Biomedical Research) ■ r
1. In the purely scientific application of medical research carried out on a human being, * * * [t]he subjects should be volunteers—either healthy persons or patients for whom the experimental design is not related to the patient’s illness. [Id at 1772-1773]

The American Medical Association has also drafted and adopted its own ethical guidelines for clinical investigations. See Judicial Council, American Medical Association, Opinions and Reports of the Judicial Council 24-26 (1979); 4 Encyclopedia of Bioethics, supra, at 1773. These guidelines state in part:

(2) In conducting clinical investigation, the investigator should demonstrate the same concern and caution for the welfare, safety, and comfort of the person involved as is required of a physician who is furnishing medical care to a patient independent of any clinical investigation.
(3) In clinical investigation primarily for treatment—
A. The physician must recognize that the physician-patient relationship exists and that he is expected to exercise his professional judgment and skill in the best interest of the patient.
(4) In clinical investigation primarily for the accumulation of scientific knowledge—
A. Adequate safeguards must be provided for the welfare, safety and comfort of the subject.
C. Minors or mentally incompetent persons may be used as subjects only if:
*80i. The nature of the investigation is such that mentally competent adults would not be suitable subjects.2
[Opinion and Reports of the Judicial Council, supra, at 24-25 (emphasis in original; footnote added)]

A final source of ethical guidelines is what is now called the “Nuremberg Code,” a statement of principles included in the Nuremberg Military Tribunal’s decision in United States v. Karl Brandt. See 4 Encyclopedia of Bioethics, supra, at 1764. The Judicial Council of the American Medical Association has adopted the Nuremberg Code as one expression of ethical principles governing human experimentation. See Opinions and Reports of the Judicial Council, supra, at 33. The code states in part;

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.
[“Permissible Medical Experiments,” 2 Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10: Nuremberg October 1946-Aprii 1949 at 181-182 (n. d.) (quoted in 4 Encyclopedia of Bioethics, supra, at 1764-1765)]

Each of these four “codes of professional ethics” establish standards for the participation of doctors in clinical experimentation on humans. Both the source and the content of each set of guidelines provide persuasive evidence that each is a “clear mandate of public policy.” Each also provides the basis for denying defendant summary judgment. Plaintiff should receive the opportunity to prove at trial that she was discharged for her refusal to violate one or more of these ethical standards.

*81On defendant’s motion for summary judgment, the majority properly assumes the truth of plaintiff’s allegations that “the current controversy [regarding the carcinogenic potential of saccharin] made continued investigation an unnecessary risk.” Ante at 74. There is certainly enough evidence in the present record to create a “genuine issue as to [this] material fact,” R. 4:46-2. The majority notes that a safer alternative formulation of the new drug under investigation “might have been developed within approximately three months.” Ante at 62. The record contains no clear indication of the likelihood that the safer formula would have been developed. Since on a motion for summary judgment “[a]ll inferences of doubt are drawn against the movant in favor of the opponent of the motion,” Judson v. Peoples Bank & Trust Co. of Westfield, 17 N.J. 67, 75 (1954); see, e. g., United Rental Equip. Co. v. Aetna Life & Cas. Ins. Co., 74 N.J. 92, 99 (1977); Beadling v. Sirotta, 39 N.J. 34, 35 (1962), we must assume at the present time that the successful development of the safer alternative was imminent. The risks attending the formula proposed by defendant are more evident. As the majority notes, the project team developing the proposed drug formula “agreed that the formula was unsuitable for use in the United States,” ante at 62. Their agreement apparently persisted until defendant made what at present appears to have been a purely profit-motivated exercise in “corporate responsibility,” see ante at 76: to proceed with development notwithstanding the “unnecessary risk,” ante at 74.

Each of the previously described codes of medical ethics would prohibit plaintiff from conducting clinical experimentation where unnecessary medical risks have economic profit as their only justification. The original Declaration of Helsinki proscribes experimentation combined with professional care unless it “is justified by its therapeutic value for the patient,” supra at 78. Non-therapeutic research may not be conducted if, in the judgment of the investigator, it would be “harmful to the individual [test subject].” Id. The 1975 revision of the declaration also prohibits doctors from conducting experiments where they are not satisfied that the possible hazards are predictable, *82or where they outweigh the potential benefits. Supra at 79. Where the research program has a therapeutic purpose, the doctor may conduct experiments only where he weighs the proposal against other courses of treatment and concludes it is “the best proven * * * therapeutic method.” Id. The American Medical Association’s own guidelines also make participation in clinical experimentation contingent upon the doctor’s professional judgment regarding “the welfare, safety, and comfort of the [test subject],” and the “best interest of the patient.” Supra at 79. Finally, the Nuremberg Code similarly conditions a doctor’s participation on his “good faith, superior skill and careful judgment” that the experiment is safe. Supra at 80.

At this stage of the litigation—when all disputed factual issues must be resolved against defendant—plaintiff is entitled to claim the protection of one or more of these recognized codes of professional ethics. I therefore conclude that plaintiff should have an opportunity to prove those facts which may entitle her to relief under the majority’s newly promulgated cause of action.

This opportunity to prove a discharge in violation of public policy is not based solely on recognized codes of professional ethics. There is also a legislative prohibition of conduct by physicians that endangers life or health. To regulate the professional behavior of doctors, the Legislature has empowered the State Board of Medical Examiners to grant, suspend or revoke licenses to practice medicine within the State. See N.J.S.A. 45:9-6, -16. The statute enumerating the Board’s powers provides in part:

The [B]oard may refuse to grant or may suspend or revoke a license * * * to practice medicine * * * upon proof * * * of gross malpractice or gross neglect in the practice of medicine which has endangered the health or life of any person * * *.

[N.J.S.A. 45:9-16{h)]

This statutory prohibition of “gross malpractice or gross neglect” establishes another “clear mandate of public policy” which plaintiff should be allowed to invoke. Assuming without *83deciding that the infliction of unnecessary medical risks—the specific conduct plaintiff refused to perform—might have constituted “gross malpractice,” I find- not even the attempt by defendant to refute such a claim. If plaintiff could prove that defendant discharged her for refusing to engage in “gross malpractice,” defendant would be liable for its violation of a “clear mandate of public policy.” I would permit plaintiff to demonstrate at trial that her discharge was a response to her refusal to violate statutory policy as well as several codes of medical ethics.

The majority denies plaintiff this opportunity. I do not understand why. Nothing is more unfair than stating a novel principle of law for the first time on an appeal, but denying the plaintiff who sought relief under some new standard an opportunity to conform his proof to the specific requirements actually adopted. Yet it appears the majority has done precisely that. Although plaintiff might have prevailed at trial under the majority’s rule by invoking one or more of the standards I have described, the majority does not acknowledge this possibility. It rejects plaintiff’s claim under its new principle of law without showing any sensitivity to the parties’ earlier unawareness of the new rule.

The ostensible reason for the majority’s rejection is that plaintiff “did not rely on or allege violation of any other standards” besides the Hippocratic Oath. Ante at 74. Yet, the majority’s own opinion conclusively shows this statement to be inaccurate. As the majority notes, plaintiff asserted in her complaint that her participation in the proposed drug program would have been in violation of “ethical standards” other than the broad mandate or her Hippocratic Oath. See ante at- 63-64. Thus, the majority’s stated reason for upholding summary judgment contradicts its own description of plaintiff’s claims. It may be that the majority dismisses these claims because plaintiff did not allege them specifically. But this rationale would reject a possibly valid claim for a formal defect in pleading—a result our courts have long eschewed. See, e.g., Saia v. Bellizio, 53 N.J. 24, 27-28 (1968); Muniz v. United *84Hospitals Med. Cen. Presbyterian Hosp., 153 N.J.Super. 79 (App. Div. 1977); Swisscraft Novelty Co., Inc. v. Alad Realty Corp., 113 N.J.Super. 416, 425 (App.Div. 1971). The result becomes even more difficult to justify when one recognizes the source of the defect: the application of a new rule of law to pleadings drafted and discovery conducted in complete ignorance of that rule. Such a result is unacceptable, for at bottom it effectively denies plaintiff a meaningful day in court.

Three other points made by the majority require discussion, for they reflect the majority’s failure to follow the well-established rule that the claims of a party opposing summary judgment are to be “indulgently treated,” Judson, supra, 17 N.J. at 75. The first is the majority’s characterization of the effect of plaintiff’s ethical position. It appears to believe that Dr. Pierce had the power to determine whether defendant’s proposed development program would continue at all. See ante at 75. This is not the case, nor is plaintiff claiming the right to halt defendant’s developmental efforts. Interpreted “indulgently,” yet realistically, plaintiff claims only the right to her professional autonomy. She contends that she may not be discharged for expressing her view that the clinical program is unethical or for refusing to continue her participation in the project. She has done nothing else to impede continued development of defendant’s proposal; moreover, it is undisputed that defendant was able to continue its program by reassigning personnel. Thus, the majority’s view that granting doctors a right to be free from abusive discharges would confer on any one of them complete veto power over desirable drug development, ante at 75, is ill-conceived.

The second point concerns the role of governmental approval of the proposed experimental program. In apparent ignorance of the past failures of official regulation to safeguard against pharmaceutical horrors,3 the majority implies that the necessity *85for administrative approval for human testing eliminates the need for active, ethical professionals within the drug industry. See ante at 62, 73-75 & 75-76. But we do not know whether the United States Food and Drug Administration (FDA) would be aware of the safer alternative to the proposed drug when it would pass upon defendant’s application for the more hazardous formula. The majority professes no such knowledge. We must therefore assume the FDA would have been left in ignorance. This highlights the need for ethically autonomous professionals within the pharmaceutical industry—a need which the majority’s approach does nothing to satisfy.

The final point to which I must respond is the majority’s observation that plaintiff expressed her opposition prematurely, before the FDA had approved clinical experimentation. See ante at 73-75. Essentially, the majority holds that a professional employee may not express a refusal to engage in illegal or clearly unethical conduct until his actual participation and the resulting harm is imminent. This principle grants little protection to the ethical autonomy of professionals that the majority proclaims. Would the majority have Dr. Pierce wait until the first infant was placed before her, ready to receive the first dose of a drug containing 44 times the concentration of saccharin permitted in 12 ounces of soda?4 The majority minimizes the scope of plaintiff’s ethical obligation. The “clear mandate of public policy” was no less clear when she made known her opposition and refusal to participate. A professional’s opposition to unethical conduct should not be considered untimely when its unethical nature is apparent. By contrast, the majority’s requirement that proposed conduct be imminent *86would require, for example, an associate in a law firm to withhold his opposition to the preparation of perjured testimony or false evidence, see DR 7-102(A)(4), (5) & (6), until he is actually ordered to begin the preparation. This narrow view of an employee’s duty to obey codes of ethics does little to promote such clear mandates of public policy. It will allow unscrupulous employers to forestall discussion on proposed unethical conduct, and to evade the spirit of the majority’s new principle by carefully timing such conduct to prevent meaningful dissent. Thus, the majority’s additional requirement that proposed conduct be imminent is both unnecessary and self-defeating. I would hold that defendant has not eliminated “all genuine disputes as to any material facts” under the majority’s principle that an employee may not be discharged for opposing conduct in violation of a “clear mandate of public policy.” I would therefore affirm the denial of summary judgment on plaintiff’s tort claim.

Plaintiff asserts a contract claim as well as a cause of action sounding in tort. See ante at 64. The majority dismisses the contract claim by presuming that plaintiff was an employee at will. See ante at 61, 62 & 71-72. Although stated as an undisputed fact, the proposition is an inference based on the absence of evidence of a contrary agreement. See English v. College of Medicine and Dentistry of New Jersey, 73 N.J. 20, 23 (1977); Jorgensen v. Pennsylvania R.R. Co., 25 N.J. 541, 554 (1958); Schlenk v. Lehigh Valley R.R. Co., 1 N.J. 131, 135 (1948); see generally 53 Am. Jur.2d, Master and Servant § 43 at 117-118 (1970); 56 C.J.S. Master and Servant § 31 at p. 412—413 (1948). Yet the majority’s discussion says nothing about the presence or absence of a genuine dispute as to the existence of a contrary agreement. Such a dispute presently exists. Not only may principles of public policy—the very principles the majority espouses—be implied as part of an employment agreement as a matter of law, see Vasquez v. Glassboro Service Assoc., Inc., 83 N.J. 86, 90, 98 (1980); Nicoletta v. North Jersey Dist. Water Supply Comm’n, 77 N.J. 145, 179-180 (1978) (Pashman, J., concurring), but unexpressed terms arising from the relationship *87between the parties or the purposes of the agreement may also impliedly be a part of a particular contract, see, e.g., New Jersey Bank v. Palladino, 77 N.J. 33, 46 (1978); Palisades Properties, Inc. v. Brunetti, 44 N.J. 117, 130 (1965); Tessmar v. Grosner, 23 N.J. 193, 201 (1957). By asserting a contractual claim, plaintiff alleges that the relationship between a doctor, a trained and ethically motivated professional, and the pharmaceutical company that employs her creates implied contractual terms. According to those terms, the drug company shall not fire the doctor for the good faith exercise of her informed judgment on matters of professional ethics. Plaintiff’s claim of a contract implied in fact has not been refuted or even directly challenged by defendant or the majority.

The unexplained conclusion that plaintiff was an employee at will, see ante at 61, cannot substitute for a detailed examination of the factual basis for plaintiff’s cause of action for breach of contract. Nor does the majority’s passing observation that plaintiff “did not assert the breach of any specific contractual provision,” ante at 73, amount to such careful scrutiny. The lack of a written employment agreement makes the absence of “any specific contractual provision” unremarkable. The genuine issue not discussed by the majority is whether plaintiff enjoyed a contractual privilege to express her ethical views despite the absence of any pertinent writing. The resolution of this issue may lie outside any formal contractual term. See 3A A. Corbin, Contracts § 684 at 224 (1960). However, the majority demands a written guarantee of job security where none of the terms of her employment, save a secrecy agreement, was reduced to writing. This “unaccountable” requirement, see ante at 73, cannot serve “to exclude any reasonable doubt as to the existence of any genuine issue,” Judson, supra, 17 N.J. at 74, respecting plaintiff’s contract claim. I would affirm the denial of summary judgment for defendant as to this claim as well.

The majority states that generally it should not resolve disputes involving far-reaching issues of public policy on a motion for summary judgment. Ante at 65; see Salorio v. Glaser, 82 N.J. 482, 517 (1980), app. docketed, 49 U.S.L.W. 3005 (U.S. June 23, 1980) (No. 79-2026); Jackson v. Muhlenberg *88Hospital, 53 N.J. 138, 142 (1969); Lusardi v. Curtis Point Prop. Owners Ass’n, 138 N.J.Super. 44, 51 (App.Div. 1975); Bennett v. T & F Distributing Co., 117 N.J.Super. 439, 445—446 (App.Div. 1971), certif. den., 60 N.J. 350 (1972). Yet the majority today has ignored this sound principle of judicial administration. It compounds its error by refusing to apply meaningfully its substantive ruling to the case prompting it. Instead, the majority has prevented the plaintiff from proving at trial that her discharge was based on a refusal to engage in a clear violation of statutory policy or one of several codes of professional ethics. It also rejects plaintiff’s contractual allegations without any examination of their possible factual basis, let alone an examination that is properly “indulgent.” While I generally agree with the legal principles expressed in the majority’s decision, I cannot accept its grudging and inconsistent application of them. Plaintiff has been denied the benefit of the rule which she has sought to vindicate her professional conscience. Since I would permit her that benefit, I respectfully dissent.

For reversal and remandment —Chief Justice WILENTZ, and Justices SULLIVAN, CLIFFORD, SCHREIBER, HANDLER and POLLOCK—6.

For affirmance —Justice PASHMAN—1.

The United States Food and Drug Administration (FDA) has expressly adopted these guidelines as minimum standards for clinical studies conducted outside the United States which the FDA will consider as part of a new drug application. 21 C.F.R. § 312.20(b)(l)(iv) (1980).

This provision might have been relevant at trial. The present record is unclear as to whether plaintiff objected specifically to the use of young children in the proposed clinical testing program.

See, e.g., Sindell v. Abbott Laboratories, 26 Cal.3d 588, 607 P.2d 924, 163 Cal.Rptr. 132 (Sup.Ct. 1980); Mahr v. G. D. Searle & Co., 72 Ill.App.3d 540, 390 N.E.2d 1214, 28 Ill.Dec. 624 (App.Ct. 1979); Lyons v. Premo Pharmaceu*85tical Labs, Inc., 170 N.J.Super. 183 (App.Div. 1979), certif. den., 82 N.J. 267 (1979); see also McGarity & Shapiro, “The Trade Secret Status of Health and Safety Testing Information: Reforming Agency Disclosure Policies,” 93 Harv. L.Rev. 837, 840-844 (1980).

There is at present undisputed evidence in the record that the amount of saccharin in the proposed drug formulation is this high. These limits on saccharin in soft drinks are those imposed by the FDA at the time the parties were conducting discovery.