Martin v. Hacker

• Decision Date: 23 November 1993
• Citation: 628 N.E.2d 1308,607 N.Y.S.2d 598,83 N.Y.2d 1
• Parties: , 628 N.E.2d 1308, 62 USLW 2388, Prod.Liab.Rep. (CCH) P 13,793 Cynthia J. MARTIN, Individually and as Executrix of the Estate of Eugene J. Martin, Deceased, Appellant, v. Arthur HACKER et al., Defendants, and Chelsea Laboratories, Inc., et al., Respondents.
• Court: New York Court of Appeals Court of Appeals

Page 598

607 N.Y.S.2d 598

83 N.Y.2d 1, 628 N.E.2d 1308, 62 USLW 2388,

Prod.Liab.Rep. (CCH) P 13,793

Cynthia J. MARTIN, Individually and as Executrix of the Estate of Eugene J. Martin, Deceased, Appellant, v. Arthur HACKER et al., Defendants and Chelsea Laboratories, Inc., et al., Respondents.

Court of Appeals of New York.

Nov. 23, 1993.

DeLorenzo, Gordon, Pasquariello, Weiskopf & Harding, P.C., Schenectady (Nicholas E. Tishler, of counsel), for appellant.

Ainsworth, Sullivan, Tracy, Knauf, Warner & Ruslander, Albany (Margaret Comard Lynch, of counsel), for Rugby Laboratories, Inc., respondent.

Sullivan, Rehfuss, Cunningham & Brennan, Albany (Mary J. Mraz and Stephen J. Rehfuss, of counsel), for Chelsea Laboratories, Inc., respondent.

OPINION OF THE COURT

HANCOCK, Judge.

Plaintiff's decedent, Eugene Martin, became severely depressed after ingesting reserpine and hydrochlorothiazide (HCT), manufactured by defendant Chelsea Laboratories (Chelsea) and prescribed by defendant Dr. Hacker to treat his hypertension. The depression allegedly led to Martin's suicide. The issue here is whether the warning regarding the adverse reaction of drug-induced depression resulting in suicide is adequate as a matter of law. For the reasons stated below, we hold that there are no triable issues of fact regarding the warning provided to physicians by the package inserts accompanying these prescription drugs and that the warning is legally sufficient. Accordingly, there should be an affirmance.

I

There is evidence in the moving papers and the depositions that in November 1981, Eugene Martin came under the care of defendant Arthur Hacker, a licensed physician, who treated Martin for hypertension by prescribing HCT. In May 1982, while continuing the HCT prescription, Hacker also prescribed reserpine for Martin to help reduce his high blood pressure. Dr. Hacker advised Martin of the following side effects of reserpine: potassium deficiency, lethargy and weakness, stuffy nose, depression, loss of libido, nausea, vomiting and diarrhea. He also advised Martin that reserpine could produce depression but usually would not do so in the small dosage that he was prescribing.

In August 1982, Martin was hospitalized for pneumonia and came under the care of defendant Dr. George Jolly who prescribed HCT for Martin. Dr. Jolly knew that Martin had been taking reserpine before being hospitalized but he took no action regarding this drug; he neither prescribed it nor gave any advice concerning its continuance or its side effects. Martin became severely depressed and on February 13, 1983 he shot himself.

Chelsea's package insert for reserpine states in relevant part:

"ACTIONS:S: * * * Reserpine, like other rauwolfia compounds, is characterized by slow onset of action and sustained effects. Both cardiovascular and central nervous system effects may persist for a period of time following withdrawal of the drug.

"INDICATIONS:S: Mild essential hypertension; also useful as adjunctive therapy with other antihypertensive agents in the more severe forms of hypertension * * *

"CONTRAINDICATIONS:S: Known hypersensitivity, mental depression (especially with suicidal tendencies), active peptic ulcer, ulcerative colitis, and patients receiving electroconvulsive therapy.

"WARNINGS:S: Extreme caution should be exercised in treating patients with a history of mental depression. Discontinue the drug at first sign of despondency, early morning insomnia, loss of appetite, impotence, or self-depreciation. Drug-induced depression may persist for several months after drug withdrawal and may be severe enough to result in suicide.

"ADVERSE REACTIONS:S: Rauwolfia preparations have caused gastrointestinal reactions including hypersecretion, nausea, vomiting, anorexia, and diarrhea; cardiovascular reactions * * *; central nervous system reactions include drowsiness, depression, nervousness, paradoxical anxiety, nightmares, rare parkinsonian syndrome * * * Nasal congestion is a frequent occurrence * * * [several other reactions are reported]. These reactions are usually reversible and usually disappear after the drug is discontinued."

The relevant sections of Chelsea's package insert for HCT read:

"INDICATIONS:S: * * * For Oral Forms Only: Hydrochlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

"WARNINGS:S: * * * Hydrochlorothiazide may add to or potentiate the action of other antihypertensive drugs."

Plaintiff Cynthia Martin, decedent's widow and executrix, commenced this action against several defendants. This appeal, however, concerns only Chelsea, the manufacturer of reserpine and HCT, and Rugby Laboratories (Rugby), Chelsea's distributor of these drugs. Plaintiff alleged that as a result of Martin's ingestion of reserpine and HCT he became despondent and committed suicide; no issue is raised as to this allegation. As to these defendants, plaintiff alleged a breach of their duties to adequately warn both the medical profession and the ultimate user of the medications' adverse side effects. After serving their answers, Chelsea and Rugby moved for summary judgment, arguing that there was no triable issue of fact regarding the adequacy of the warnings in describing the adverse effects of these drugs.

Supreme Court granted Chelsea's motion to the extent of dismissing plaintiff's 15th and 16th causes of action that alleged failure to warn the ultimate user. It denied the rest of Chelsea's motion as well as Rugby's entire motion. The Appellate Division modified, ruling that "Supreme Court incorrectly found that triable issues of fact were presented concerning the issue of whether the warnings provided by defendants regarding reserpine and HCT to the medical profession were adequate" (Martin v. Hacker, 185 A.D.2d 553, 554, 586 N.Y.S.2d 407) and concluding that "defendants are entitled to summary judgment" because "the warnings were adequate as a matter of law" (id., at 555, 586 N.Y.S.2d 407). We granted leave to appeal and now affirm.

II

At issue is the nature and extent of a prescription drug manufacturer's obligation to make known the potential hazards of its products. The claims against defendants Chelsea and Rugby are framed in terms of strict products liability. ¹ Although a prescription drug is by its nature an inherently unsafe product and would in the usual case impute strict liability to its manufacturer, a defense is provided against such liability when the drug is " 'properly prepared, and accompanied by proper directions and warning' " (Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 61, 423 N.Y.S.2d 95, affd. 52 N.Y.2d 768, 436 N.Y.S.2d 614, 417 N.E.2d 1002 [quoting Restatement (Second) of Torts § 402A, comment k]; see generally, Rheingold, Products Liability--The Ethical Drug Manufacturer's Liability, 18 Rutgers L.Rev. 947 [1964]; 2 Frumer and Friedman, Products Liability § 12.14, at 12-147 to 12-149 [1993 revision & July 1993 CumSupp]. Therefore, even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is " 'not defective, nor is it unreasonably dangerous' " (Wolfgruber, supra, 72 A.D.2d at 61, 423 N.Y.S.2d 95). The comment k defense is unavailable for products negligently manufactured, negligently distributed or unaccompanied by proper warnings (see generally, 6 Speiser, Krause and Gans, American Law of Torts § 18:383, at 1110 [1st ed. & Mar. 1993 CumSupp]. The manufacturer's duty is to warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist ( see, Baker v. St. Agnes Hosp., 70 A.D.2d 400, 404, 421 N.Y.S.2d 81; Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 91 [2d Cir.1980]; see also, Davis v. Wyeth Labs., 399 F.2d 121, 130 [9th Cir.1968].

Warnings for prescription drugs are intended for the physician, whose duty it is to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects. The physician acts as an "informed intermediary" (see, Wolfgruber, supra, 72 A.D.2d at 61, 423 N.Y.S.2d 95; Lindsay, supra, at 91) between the manufacturer and the patient; and, thus, the manufacturer's duty to caution against a drug's side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient (see, Wolfgruber, supra, 72 A.D.2d at 61, 423 N.Y.S.2d 95; Glucksman v. Halsey Drug Co., 160 A.D.2d 305, 307, 163 A.D.2d 163, 553 N.Y.S.2d 724). The warning must provide sufficient information to that category of prescribing physicians who may be expected to have the least knowledge and experience with the drug (see, Lindsay, supra, at 91-92; see also, Guevara v. Dorsey Labs., 845 F.2d 364 [1st Cir.1988] [PR law].

Manufacturers apprise physicians of dangerous side effects in various ways. The most common are: (1) the inclusion in the Physicians Desk Reference, the annually updated encyclopedia of medications, of a formal description of each of a manufacturer's drugs; and (2) the manufacturer's formal warning in the package insert of a prescription drug (see, e.g., Baker, supra, 70 A.D.2d at 406-407, 421 N.Y.S.2d 81; Glucksman supra, 160 A.D.2d at 307, 163 A.D.2d 163, 553 N.Y.S.2d 724; see also, Lindsay, supra, at 92). Inserts must be written in accordance with the Food and Drug Administration's recommendation for the proper labeling of prescription drugs (see, 21 CFR 201.56, 201.57; 21 USC § 355[e], which as of April 1, 1979 specified that the package insert shall list the following kinds of information in this sequence:

DESCRIPTION

ACTIONS

INDICATIONS

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

DOSAGE & ADMINISTRATION

OVERDOSAGE (WHERE APPLICABLE)

HOW SUPPLIED ²

The Contraindications section includes the most stringent caveats against use, i.e., a statement of the...