Vitanza v. Upjohn Co.

• Decision Date: 07 August 2001
• Docket Number: (SC 16343)
• Citation: 257 Conn. 365,778 A.2d 829
• Court: Connecticut Supreme Court
• Parties: MICHELE M. VITANZA ET AL. v. THE UPJOHN COMPANY

257 Conn. 365

778 A.2d 829

MICHELE M. VITANZA ET AL. v. THE UPJOHN COMPANY

(SC 16343)

Supreme Court of Connecticut.

Argued April 17, 2001.

Officially released August 7, 2001.

SULLIVAN, C. J., and BORDEN, NORCOTT, VERTEFEUILLE and ZARELLA, JS.

Richard A. Silver, with whom were Jonathan M. Levine and Peter M. Dreyer, for the appellants (plaintiffs).

Timothy W. Donahue, with whom was Tracey M. Lane, for the appellee (defendant). Charles D. Ray and Alfred A. DiVincentis, Jr., filed a brief for the Connecticut Business and Industry Association as amicus curiae.

Jeffrey R. Bobbin, Jeremy G. Zimmermann, Naomi B. Graubard and Hugh F. Young, Jr., pro hac vice, filed a brief for the Product Liability Advisory Council, Inc., as amicus curiae.

William F. Gallagher and David McCarry filed a brief for the Connecticut Trial Lawyers Association as amicus curiae.

Opinion

BORDEN, J.

The dispositive issue in this case is whether the learned intermediary doctrine bars the present action brought by the named plaintiff, Michele M. Vitanza, whose husband had died as a result of ingesting a sample of a prescription drug given to her by her physician. The learned intermediary doctrine provides, in general terms, that adequate warnings to a prescribing physician obviate the need for a manufacturer of a prescription drug to warn ultimate consumers. Pursuant to General Statutes (Rev. to 1999) § 51-199a and Practice Book § 82-1,¹ the United States Court of Appeals for the Second Circuit certified the following question of law to this court: "On the facts of this case— where (i) a drug manufacturer distributed promotional free samples to physicians and provided appropriate warnings to the physicians, (ii) the drug sample states only that it is to be dispensed by prescription only, (iii) the drug sample is ingested by (and causes injury to) an otherwise unwarned person in the patient's household, and (iv) the drug manufacturer is sued for damages under the Connecticut Product Liability Act, [General Statutes § 52-272m et seq.]—is the drug manufacturer insulated from liability as a matter of law by the learned intermediary doctrine?" Vitanza v. Upjohn Co., 214 F.3d 73, 73-74 (2d Cir. 2000). We conclude that the learned intermediary doctrine does bar the present action as a matter of law.

The plaintiff² brought the underlying product liability complaint against the defendant, The Upjohn Company, pursuant to the Connecticut Product Liability Act (act), General Statutes § 52-572m et seq. The defendant removed the complaint to federal court on the basis of diversity jurisdiction. The defendant filed a special defense stating that, under the learned intermediary doctrine, it had no duty as a matter of law to provide a direct warning to the ultimate consumer of its product. The defendant moved for summary judgment on the basis of the learned intermediary doctrine. The plaintiff filed a cross motion for partial summary judgment seeking dismissal of the defendant's affirmative defense based on the learned intermediary doctrine. The United States District Court for the District of Connecticut granted the defendant's motion, denied the plaintiffs motion, and rendered judgment for the defendant. Vitanza v. Upjohn Co., 48 F. Sup. 2d 124, 132 (D. Conn. 1999). The plaintiff then appealed to the Court of Appeals, which thereafter certified the question of law to this court.

The record certified by the Court of Appeals provides the following facts and procedural history.³ The defendant manufactured and marketed the prescription drug Ansaid, which is an acronym for "a nonsteroidal anti-inflammatory drug." Ansaid is indicated for the acute or long-term treatment of signs and symptoms of rheumatoid arthritis and osteoarthritis, as well as for less serious conditions. The defendant was aware that Ansaid could produce fatal reactions in persons allergic to aspirin or other nonsteroidal anti-inflammatory drugs.

In early 1992, a sales representative for the defendant provided samples of Ansaid to the plaintiffs physician, Gary Besser, who is a board certified obstetrician and gynecologist. The samples were distributed in a box containing nine blister cards. Each blister card contained four tablets. The labeling on the back of each blister card provided:

"Complimentary Package Not for Sale 4 Tablets

Ansaid 100 mg. Tablets

FLURBIPROFEN

Each tablet contains flurbiprofen 100 mg. Information for use and dosage—see insert. Store at controlled room temperature 15°-30° C (59°-86° F)

Caution: Federal law prohibits dispensing without prescription."

In addition, each box of Ansaid samples contained one package insert that was eight columns long, single spaced, and contained information regarding clinical pharmacology, indications for use, contraindications, warnings, adverse reactions, precautions, drug interactions, overdosage, dosage and administration. The package insert referred to the possibility of allergic reactions to Ansaid, providing that: "`ANSAID should not be given to patients in whom ANSAID, aspirin, or other nonsteroidal anti-inflammatory drugs induce asthma, urticaria, or other allergic-type reactions. Fatal asthmatic reactions have been reported in such patients receiving this type of drug.'" Although each box of Ansaid samples contained nine blister cards, there was only one insert per box, and the blister cards themselves did not contain any warnings. Samples of Ansaid were packaged in accordance with federal and state law. The defendant also reprinted the Ansaid package insert in its entirety in the 1989 Supplement to the Physicians' Desk Reference, which is a standard pharmaceutical reference text for the medical profession, and in each subsequent annual edition of the reference book up to the date of the decedent's death.

In June, 1992, the plaintiff visited Besser for a postpartum examination after the birth of her daughter, at which time she complained of a stiff neck. Besser provided her with several sample blister cards of Ansaid. The plaintiff was not provided with the Ansaid package insert. The plaintiff took the Ansaid tablets, which alleviated her stiff neck symptoms.

In October, 1994, over two years after Besser had given the Ansaid tablets to the plaintiff, the decedent complained of a stiff neck. He found some remaining Ansaid tablets in the family medicine cabinet. The decedent had been advised by his doctors that he was allergic to aspirin and nonsteroidal anti-inflammatory drugs and that he should not take these drugs. The decedent consulted two medical reference books before taking the Ansaid: The Time Life Medical Reference Library: Prescription Drugs 1982-1983; and The New Lexicon Illustrated Medical Encyclopedia. Neither of these books contained any reference that Ansaid was a nonsteroidal anti-inflammatory drug or that persons with sensitivities to aspirin or nonsteroidal anti-inflammatory drugs should avoid Ansaid. He then ingested one Ansaid tablet.⁴

Shortly after taking the Ansaid tablet, the decedent experienced great difficulty breathing. He drove himself to the Stamford Hospital emergency room in Stamford. Within ten minutes of his arrival at the emergency room, and as a result of his reaction to the Ansaid, he suffered respiratory and cardiac arrest. The decedent died approximately one hour after his arrival at the emergency room. The cause of death was determined to be a severe anaphylactic reaction to Ansaid.

Thereafter, the plaintiff filed this action in the Superior Court for the judicial district of Stamford-Norwalk. The plaintiff alleged that her husband's death was caused by the defendant's failure to provide, on its sample packets, adequate warnings of possible adverse effects of Ansaid.⁵ After removing the case to the federal district court, the defendant filed an affirmative defense,⁶ asserting that, based on the learned intermediary doctrine, it had no duty to provide a direct warning to the ultimate consumer of its product because it had provided a proper warning to the prescribing physician. The defendant thereafter moved for summary judgment. The plaintiff filed a cross motion for partial summary judgment seeking dismissal of the defendant's seventh affirmative defense on the grounds that no Connecticut court had recognized the learned intermediary doctrine, and that, even if the District Court were to adopt the learned intermediary doctrine as a matter of Connecticut law, it should not recognize that doctrine as an absolute defense.

The District Court granted the defendant's motion for summary judgment, denied the plaintiffs cross motion, and rendered judgment for the defendant. Vitanza v. Upjohn Co., supra, 48 F. Sup. 2d 132. The plaintiff appealed from the judgment to the Court of Appeals, which certified to us the question of whether, under the facts of this case, the defendant is insulated from liability as a matter of law by the learned intermediary doctrine. Vitanza v. Upjohn Co., supra, 214 F.3d 73-74. We conclude that: (1) the learned intermediary doctrine is part of our state law; and (2) its application to the facts of this case bars the plaintiffs action.

Manufacturers in Connecticut are strictly liable for defective products under § 402A of the Restatement (Second) of Torts.⁷ See Giglio v. Connecticut Light & Power Co., 180 Conn. 230, 233, 429 A.2d 486 (1980) ("[i]n Garthwait v. Burgio, 153 Conn. 284, 216 A.2d 189 [1965], we accepted the principles adopted by the American Law Institute as contained in § 402A of the Restatement (Second), Torts, establishing strict liability in tort"). A product may be defective due to a flaw in the manufacturing process, a design defect or because of inadequate warnings or instructions. See, e.g., Hill v. Searle Laboratories, 884 F.2d 1064, 1067 (8th Cir. 1989) ("`defect' need not be a matter of errors in manufacture... a product is `defective' when it is ... not accompanied by adequate instructions and warnings of the dangers...