Vitanza v. Upjohn Co.

48 F. Supp. 2d 124, 1999 U.S. Dist. LEXIS 8056, 1999 WL 342415
CourtDistrict Court, D. Connecticut
DecidedMarch 31, 1999
DocketCiv.3:95CV2391 (DJS)
StatusPublished
Cited by4 cases

This text of 48 F. Supp. 2d 124 (Vitanza v. Upjohn Co.) is published on Counsel Stack Legal Research, covering District Court, D. Connecticut primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Vitanza v. Upjohn Co., 48 F. Supp. 2d 124, 1999 U.S. Dist. LEXIS 8056, 1999 WL 342415 (D. Conn. 1999).

Opinion

MEMORANDUM OF DECISION

SQUATRITO, District Judge.

The plaintiff, Michele Vitanza (“Mrs.Vi-tanza”), 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 *125 defendant’s motion for summary judgment is granted; the plaintiffs 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 flurbi-profen, 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 *126 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 An-said 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 ana-phylactic 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 nonmov-ing party. See Anderson, 477 U.S.

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48 F. Supp. 2d 124, 1999 U.S. Dist. LEXIS 8056, 1999 WL 342415, Counsel Stack Legal Research, https://law.counselstack.com/opinion/vitanza-v-upjohn-co-ctd-1999.