Vitanza v. The Upjohn Co., Docket No. 99-7539

• Decision Date: 15 December 1999
• Docket Number: Docket No. 99-7539
• Citation: 214 F.3d 73
• Parties: (2nd Cir. 2000) MICHELE M. VITANZA, INDIVIDUALLY AND AS EXECUTRIX OF THE ESTATE OF TIMOTHY F. VITANZA, Plaintiff-Appellant, v. THE UPJOHN COMPANY, Defendant-Appellee. August Term 1999 Argued:
• Court: U.S. Court of Appeals — Second Circuit

Page 73

214 F.3d 73 (2nd Cir. 2000)

MICHELE M. VITANZA, INDIVIDUALLY AND AS EXECUTRIX OF THE ESTATE OF TIMOTHY F. VITANZA, Plaintiff-Appellant, v. THE UPJOHN COMPANY, Defendant-Appellee.

Docket No. 99-7539

August Term 1999

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

Argued: December 15, 1999

Decided: May 05, 2000

Appeal from judgment of the United States District Court for the District of Connecticut, Dominic J. Squatrito, J., granting defendant's motion for summary judgment on the ground that the "learned intermediary" doctrine barred plaintiff's claim. Questions concerning the "learned intermediary" doctrine certified to the Connecticut Supreme Court.

JONATHAN M. LEVINE, Stamford, CT (Silver Golub & Teitell LLP, Richard A. Silver, Brad C. Gustafson, of Counsel), for Plaintiff-Appellant Michele Vitanza.

TIMOTHY W. DONAHUE, Wallingford, CT (Delaney, Zemetis, Donahue, Durham & Noonan, P.C., of Counsel), for Defendant-Appellee Upjohn Company.

Before: FEINBERG, JACOBS, and KATZMANN, Circuit Judges.

FEINBERG, Circuit Judge:

This is an appeal from a March 1999 judgment of the United States District Court for the District of Connecticut, Dominic J. Squatrito, J., granting defendant's motion for summary judgment on the ground that the "learned intermediary" doctrine barred plaintiff's claim. For the reasons stated below, we believe that the current status of the "learned intermediary" doctrine in Connecticut is not clear, and we conclude that we should certify the controlling question of law to the Connecticut Supreme Court.

Accordingly, it is hereby ORDERED that the Clerk of the Court transmit to the Connecticut Supreme Court a Certificate in the form attached, together with a complete set of the briefs, appendix and record filed by the parties with this court. This panel retains jurisdiction so that, after we receive a response from the Connecticut Supreme Court, we may dispose of the appeal. The parties are further ORDERED to bear equally such fees and costs, if any, as may be required by the Connecticut Supreme Court.

Certificate

Certificate to the Connecticut Supreme Court pursuant to Second Circuit Local Rule § 0.27 and Conn. Gen. Stat. § 51-199a (West 1999).

I. The question of law to be answered

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, Conn. Gen. Stat. § 52-572m et seq. (CPLA) -- is the drug manufacturer insulated from liability as a matter of law by the learned intermediary doctrine?

II. Discussion

A. Statement of facts relevant to the question certified

Michele M. Vitanza (Mrs. Vitanza, or simply Vitanza) brought this suit individually and as executrix of the estate of her husband, Timothy Vitanza (Mr. Vitanza), against The Upjohn Company (Upjohn), a Delaware corporation transacting business in the state of Connecticut. Upjohn manufactured and marketed a prescription drug under the name Ansaid. That name is an acronym for A Non-Steroidal 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.

Sometime in early 1992, an Upjohn sales representative provided samples of Ansaid to Mrs. Vitanza's obstetrician/gynecologist Dr. Gary Besser. The samples came in a box, which contained nine so-called blister cards with four Ansaid tablets per card. The labeling on the back of each blister card stated:

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.

Each box of Ansaid samples also contained an explanatory insert eight columns long, single-spaced, setting forth information on Clinical Pharmacology, Indications and Usage, Contraindications, Warnings, Precautions, Drug Interactions, Adverse Reactions, Drug Abuse and Dependence, Overdosage, Dosage and Administration. The insert referred to the possibility of allergic reactions to Ansaid, stating 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 there were nine blister cards in each package, there was only one insert per package. The blister cards did not themselves contain any warning. The information contained in the insert was also included in the 1989 Supplement to the Physicians' Desk Reference.

In June 1992, Mrs. Vitanza visited Dr. Besser for a post-partum examination. When Mrs. Vitanza complained that she felt stiffness in her neck, Dr. Besser recommended that she take Ansaid to relieve her symptoms, and gave her several sample blister cards containing Ansaid tablets. Dr. Besser did not, however, provide Mrs. Vitanza with a copy of the insert. Mrs. Vitanza took the Ansaid tablets, and they relieved her symptoms.

In October 1994, over two years after Dr. Besser had given the tablets to Mrs. Vitanza, Mr. Vitanza complained of a stiff neck. Searching through the family medicine cabinet, he found some Ansaid tablets in a blister card that Dr. Besser had given to Mrs. Vitanza but which she had not used. Mr. Vitanza had been informed by his doctors that he had a potentially lethal allergy to aspirin and nonsteroidal anti-inflammatory medications. Accordingly, he checked the back of the Ansaid blister card, quoted above, to determine whether there were any warnings. Mr. Vitanza also checked two medical reference works, the "Time Life Medical Reference Library: Prescription Drugs" and "The New Lexicon Illustrated Medical Encyclopedia." Mr. Vitanza did not find any express statement that Ansaid was a nonsteroidal anti-inflammatory drug or that persons with his sensitivities should avoid Ansaid. Mr. Vitanza took one Ansaid pill.

Shortly after taking the Ansaid pill, Mr. Vitanza experienced great difficulty breathing. He drove himself to the Stamford Hospital Emergency Room in Stamford, Connecticut. Ten minutes after his arrival, he suffered respiratory and cardiac arrest. Mr. Vitanza died between one and two hours later. The cause of death was determined to be a severe anaphylactic reaction to Ansaid. Mr. Vitanza was 34 years old at the time of his death.

Mrs. Vitanza originally filed this suit in October 1995 in the Connecticut Superior Court for the Judicial District of Stamford/Norwalk, stating a claim under the CPLA. Mrs. Vitanza alleged that Mr. Vitanza's death was caused by Upjohn's failure to provide adequate warnings of possible adverse effects on its sample packs. Upjohn subsequently removed this case to federal court, based on diversity. In July 1996, Mrs. Vitanza moved to certify the question presented in this case to the Connecticut Supreme Court. Judge Squatrito denied that motion, as well as Mrs. Vitanza's motion for reconsideration of that decision. In an opinion issued in March 1999, Judge Squatrito granted Upjohn's motion for summary judgment on the ground that the "learned intermediary" doctrine barred Mrs. Vitanza's claim. This appeal followed.

B. The nature of the controversy in which the question arose

1. The legal issues involved

The ultimate question of law on this appeal is whether, as the district court concluded, under Connecticut law the learned intermediary doctrine bars the present suit as a matter of law. This court ruled over three decades ago that under that doctrine, Connecticut law exempted a pharmaceutical company from strict liability so long as it warned prescribing physicians of the risks of prescription drugs. See Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969). Upjohn claims that the Connecticut Supreme Court adopted the logic of Basko in Tomer v. American Home Prods. Corp., 368 A.2d 35 (Conn. 1976). According to Upjohn, these decisions bar the present action. Vitanza responds that Tomer did not adopt the learned intermediary doctrine. Instead, Vitanza argues, Tomer merely agreed with Basko that a manufacturer had a duty to warn even where the drug might only affect a few hypersensitive users.

Since the decisions in Basko and Tomer, however, there have been a number of legal developments in Connecticut that potentially bear upon the application and vitality of the learned intermediary doctrine. In 1979, the state legislature passed the CPLA, which states that a warning is inadequate unless it is "devised to communicate with the person best able to take or recommend precautions against the potential harm." Conn. Gen. Stat. § 52-572q(d). Vitanza argues that under the CPLA, the learned intermediary doctrine is not an absolute defense as a matter of law, but a defense for the finder of fact to consider. Upjohn responds, relying on this court's decision in LaMontagne v. E.I. Du Pont De Nemours & Co., 41 F.3d 846, 855-56 (2d Cir. 1994), that the CPLA merely streamlined pleading requirements, and did not change the existing Connecticut common law on product liability. The LaMontagne court, however, rejected a much broader argument than the one Vitanza makes. The plaintiff in LaMontagne argued that under the CPLA, it was a jury question as to whether a manufacturer of a non-dangerous component of jaw implants had a duty to warn potential users of the end product even though the manufacturer had no knowledge of any hazards that the end product might cause. See id. at 859. The LaMontagn...