Vitanza v. Upjohn Co.

• Decision Date: 31 March 1999
• Docket Number: No. Civ.3:95CV2391 (DJS).,Civ.3:95CV2391 (DJS).
• Court: U.S. District Court — District of Connecticut
• Parties: Michele M. VITANZA, Individually & as Executrix of the Estate of Timothy F. Vitanza, Plaintiff, v. UPJOHN COMPANY, Defendant.

48 F.Supp.2d 124

Michele M. VITANZA, Individually & as Executrix of the Estate of Timothy F. Vitanza, Plaintiff, v. UPJOHN COMPANY, Defendant.

No. Civ.3:95CV2391 (DJS).

United States District Court, D. Connecticut.

March 31, 1999.

Richard A. Silver, Jennifer Cohen Goldstein, Silver, Golub & Teitell, Stamford, CT, for Michele M. Vitanza, Individually & As Executrix of the Estate of Timothy F. Vitanza, plaintiff.

Timothy W. Donahue, Delaney, Zemetis, Donahue, Durham & Noonan, Wallingford, CT, for Upjohn Co., defendant.

James Newfield, Rosenblum & Filan, Stamford, CT, for Lester Krasnoger, M.D., movant.

MEMORANDUM OF DECISION

SQUATRITO, District Judge.

The plaintiff, Michele Vitanza ("Mrs. Vitanza"), brings this product liability action seeking compensatory and punitive damages for the death of her husband, Timothy Vitanza ("Mr.Vitanza"), who allegedly suffered a fatal allergic reaction to a drug, Ansaid, manufactured and marketed by the defendant, Upjohn Co. ("Upjohn"). Now pending before the court are the parties' cross-motions for summary judgment. For the reasons stated below, the defendant's motion for summary judgment is granted; the plaintiff's motion is denied.

I. Facts

Examination of the memoranda, affidavits, and Local Rule 9 statements submitted in support of the motions for summary judgment and the responses thereto, discloses the following.

At the time relevant to the complaint, Upjohn manufactured and marketed the drug Ansaid, a nonsteroidal anti-inflammatory prescription drug which is indicated for the acute or long-term treatment of signs and symptoms of rheumatoid arthritis and osteoarthritis. Nonsteroidal anti-inflammatory drugs are also commonly employed for conditions which are less serious than arthritis. The Food and Drug Administration approved Upjohn's New Drug Application to manufacture and market Ansaid as a prescription medication on October 31, 1988. Ansaid contains flurbiprofen, a nonsteroidal anti-inflammatory agent that is available only by a licensed physician's prescription.

In 1992, Dr. Gary Besser, Mrs. Vitanza's doctor and a board certified obstetrician/gynecologist licensed to practice medicine in Connecticut, was given samples of Ansaid by an Upjohn sales representative. The samples came in a box which contained nine 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 in length, single-spaced, containing information regarding Clinical Pharmacology, Indications for Use, Contraindications, Warnings, Adverse Reactions, Precautions, Drug Interactions, Overdosage, Dosage and Administration. This insert referred to allergic or anaphylactic reactions in two sections: Contraindications and Adverse Reactions.

Upjohn was aware that Ansaid could possibly produce fatal reactions in persons allergic to aspirin or other nonsteroidal anti-inflammatory drugs, and reprinted the Ansaid package insert in its entirety in the 1989 Supplement to the Physicians' Desk Reference ("PDR"), a standard pharmaceutical reference text for the medical profession. This submission included the following contraindication: "ANSAID should not be given to patients in whom ANSAID, aspirin, or other nonsteroidal anti-inflammatory drugs induce asthma, urticaria, or other allergy-type reactions. Fatal asthmatic reactions have been reported in such patients receiving this type of drug." This warning was repeated in each subsequent annual edition of the PDR up to the date of Mr. Vitanza's death.

In June 1992, Mrs. Vitanza visited Dr. Besser for a scheduled post-partum examination after giving birth to a daughter. While there, she complained of a severe stiff neck. Dr. Besser recommended that Mrs. Vitanza take the drug Ansaid to relieve her neck pain. Instead of writing out a prescription for Ansaid, Dr. Besser gave Mrs. Vitanza several sample Ansaid tablets enclosed in the blister cards. She was not provided with the explanatory insert. Following her doctor's recommendation, Mrs. Vitanza took the Ansaid tablets, and her stiff neck symptoms were alleviated.

On October 14, 1994, Mr. Vitanza complained of an "awful" stiff neck. He went through the medicine cabinet and found the remaining sample Ansaid tablets which he knew that Dr. Besser had given to Mrs. Vitanza in 1992. Having been made aware by his doctor that he had a potentially lethal allergy to aspirin and nonsteroidal anti-inflammatories,¹ Mr. Vitanza checked the Ansaid sample packages, including the back of the blister card, for any warnings. He then consulted two medical reference books: Time Medical Reference Library: Prescription Drugs and The New Lexicon Illustrated Medical Encyclopedia. Finding nothing expressly stating that Ansaid was a nonsteroidal anti-inflammatory drug or that persons allergic to aspirin should avoid Ansaid because of the possibility of a fatal allergic reaction, Mr. Vitanza took one Ansaid pill.

Within a few minutes of taking the Ansaid pill, Mr. Vitanza experienced great difficulty breathing. He drove himself to the Stamford Hospital Emergency Room in Stamford, Connecticut. Within ten minutes of his arrival at the Emergency Room, he suffered respiratory and cardiac arrest. He was pronounced dead approximately one hour later.² The cause of death was ascertained to be a severe anaphylactic reaction to the Ansaid pill.³

II. Standard

A motion for summary judgment may not be granted unless the court determines that there is no genuine issue of material fact to be tried, and that the facts as to which there is no such issue warrant judgment for the moving party as a matter of law. See Fed.R.Civ.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Gallo v. Prudential Residential Servs., Ltd. Partnership, 22 F.3d 1219, 1223 (2d Cir.1994). The determination of what facts are material to a particular claim is made based upon the substantive law upon which that claim rests. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A dispute regarding a material fact is genuine "if the evidence is such that a reasonable [factfinder] could return a verdict for the nonmoving party." Anderson, 477 U.S. at 248, 106 S.Ct. 2505.

In determining whether there is a genuine issue as to any material fact, the court must resolve all ambiguities and draw all factual inferences in favor of the nonmoving party. See Anderson, 477 U.S. at 255, 106 S.Ct. 2505; Gallo, 22 F.3d at 1223; Ramseur v. Chase Manhattan Bank, 865 F.2d 460, 465 (2d Cir.1989); Project Release v. Prevost, 722 F.2d 960, 968 (2d Cir.1983). The burden of showing that no genuine factual dispute exists rests on the party seeking summary judgment. See Adickes v. S.H. Kress & Co., 398 U.S. 144, 157, 90 S.Ct. 1598, 26 L.Ed.2d 142 (1970).

On a motion for summary judgment, a court cannot try issues of fact; it can only determine whether there are issues to be tried. See Anderson, 477 U.S. at 255, 106 S.Ct. 2505; Donahue v. Windsor Locks Bd. of Fire Comm'rs, 834 F.2d 54, 57 (2d Cir.1987). The function of the court at this stage is not to weigh the evidence and determine what is true, but rather to "pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986).

III. Discussion

The defendant contends that it is entitled to summary judgment as a matter of law because it owed no legal duty to warn Mrs. Vitanza directly of the potential risks of the prescription drug Ansaid. Rather, the defendant argues that, under the learned intermediary doctrine, its duty to warn regarding the prescription medication at issue runs only to the medical community and Mrs. Vitanza's prescribing physician. In the alterative, the defendant argues that summary judgment is warranted because any alleged deficiency in its warnings regarding Ansaid was not the proximate cause of Mr. Vitanza's death.

The plaintiff, however, claims that the learned intermediary doctrine relied upon by the defendant is not a cognizable defense under the Connecticut Product Liability Act ("CPLA"), Conn.Gen.Stat. § 52-572m et seq., or, alternatively, the exception does not apply to the facts of this case, such that summary judgment in her favor is appropriate on this affirmative defense.⁴ The plaintiff also opposes the defendant's motion for summary judgment on the grounds that material issues of disputed fact remain concerning the appropriate recipient of the manufacturer's warning and whether the allegedly deficient warnings regarding Ansaid were the cause of Mr. Vitanza's death.

A. Learned Intermediary Doctrine

The learned intermediary doctrine states that adequate warnings to prescribing physicians obviate the need for manufacturers of prescription products to warn ultimate consumers directly. The doctrine is based on the principle that prescribing physicians act as "learned intermediaries" between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient's needs and assess risks and benefits of a particular course of treatment. This doctrine is well established in the field of prescription drugs. See Guevara v. Dorsey Laboratories, Div. Of Sandoz, Inc., 845 F.2d 364 (1st Cir.1988) (a drug manufacturer's warning should be sufficient to appraise a general practitioner of the dangerous propensities of the drug); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir.1984) ("The restriction of the duty to warn to physicians alone in ethical...