Christopher v. Cutter Laboratories

• Citation: 53 F.3d 1184
• Decision Date: 02 June 1995
• Docket Number: No. 93-3212,93-3212
• Parties: Steven CHRISTOPHER, Jason Christopher, Plaintiffs, Brenda Mills, as natural guardian of her minor child, Jason Christopher, Plaintiff-Appellee, v. CUTTER LABORATORIES, Defendant, Armour Pharmaceutical Company, Defendant-Appellant.
• Court: United States Courts of Appeals. United States Court of Appeals (11th Circuit)

Page 1184

53 F.3d 1184

Steven CHRISTOPHER, Jason Christopher, Plaintiffs,

Brenda Mills, as natural guardian of her minor child, Jason

Christopher, Plaintiff-Appellee, v. CUTTER LABORATORIES, Defendant, Armour Pharmaceutical Company, Defendant-Appellant.

No. 93-3212.

United States Court of Appeals, Eleventh Circuit.

June 2, 1995.

Edward W. Gerecke, Sylvia H. Walbolt, Alan C. Sundberg, Carlton, Fields, Ward, Emmanuel, Smith & Cutler, Tampa, FL, Douglas F. Fuson, Sara J. Gourley, Sidney & Austin, Chicago, IL, for appellant.

Jere Martin Fishback, Kleinfeld & Fishback, St. Petersburg, FL, for appellee.

Appeal from the United States District Court for the Middle District of Florida.

Before COX, BLACK and BARKETT, Circuit Judges.

BLACK, Circuit Judge:

This appeal arises from a wrongful death action brought by the natural mother and father of Jason Christopher. Jason suffered from classic hemophilia, a congenital blood clotting disorder. As part of his treatment, Jason used a number of different blood products, including one known generically as Factor VIII concentrate and sold by Appellant Armour Pharmaceutical (Armour) under the trade name Factorate. Jason died of complications from AIDS in February of 1992. Plaintiffs claimed that Jason was infected with the HIV virus by an infusion of Armour's concentrate in late 1983, as a result of Armour's negligent failure to warn Jason's treating physician that its product might transmit AIDS. A jury found in favor of plaintiffs and awarded them damages of $2,007,256.13.

We address whether plaintiffs' evidence established sufficient causation for the jury to find in their favor and whether the district court erroneously instructed the jury on Armour's learned intermediary defense. ¹ We affirm in part and reverse and remand in part, holding that plaintiffs' evidence established sufficient causation to render a verdict against Armour, but that the district court erred in its jury instructions on the learned intermediary rule by constructing an improper legal standard not supported by the record.

I. PROCEDURAL BACKGROUND

Jason Christopher's parents brought a wrongful death action against Armour, claiming that Armour negligently failed to warn Jason's prescribing physician that Factorate might transmit the HIV virus. Factorate is a biologic, licensed by the Federal Drug Administration (FDA), that contains Factor VIII clotting protein necessary for the treatment of hemophilia. The FDA must approve this biologic for sale. 21 C.F.R. Sec. 601.2(a) (1983). It is available only by prescription through a physician. The written prescribing information packaged with each vial of Factorate must include FDA-approved warnings with respect to potential hazards of use. 21 C.F.R. Sec. 201.57(e) (1983); see 21 C.F.R. Sec. 601.2(a) (1983). ² Armour cannot change the warnings without the express approval of the FDA. 21 C.F.R. Sec. 601.12(b) (1983).

Prior to January 1984, Armour's package labeling did not contain a warning with respect to AIDS. On September 30, 1983 Armour requested a labeling change for Factorate to include the following AIDS warning:

The possibility exists that Acquired Immune Deficiency Syndrome, (AIDS), an immunologic disorder with extremely severe consequences, may be transmitted by blood, blood products and blood derivatives, including clotting factors. However, the causative agent has neither been isolated nor identified. This information should be considered in determining patient care and treatment.

The FDA approved this proposed change on January 25, 1984.

Although plaintiffs did not contest the adequacy of this warning, they claimed that Armour was negligent in not seeking approval of the warning at an earlier time, alleging that Armour had reasonable evidence of a potential risk of transmission of HIV from their product before September 1983. They additionally claimed that Armour was negligent in failing to send an individual letter to physicians, known as a Dear Doctor letter, warning of the risk. ³

In order to carry their burden of proof on causation, plaintiffs had to show that their son was infected with HIV by an infusion of Armour's concentrate, Factorate, during a discrete period of time in which Armour negligently failed to warn the prescribing physician of the possibility of AIDS when it knew that reasonable evidence existed of that risk with its product. Armour asserted that plaintiffs did not prove causation because they did not establish with reasonable medical probability that Jason was infected by Factorate as opposed to the other blood treatments he had received. Armour also argued that Jason's prescribing physician, Dr. Jerry Barbosa, knew of the possibility that AIDS might be transmitted by concentrate when he first treated Jason with Armour's product. Given this alleged knowledge, Armour asserted, under the learned intermediary rule, that any failure to warn Dr. Barbosa of that possibility at an earlier time was not the proximate cause of Jason's infection.

The district court denied Armour's Rule 50 motion for judgment as a matter of law, finding sufficient causation to go to the jury. The court also did not give Armour's requested jury instruction on the learned intermediary defense. Initially, the court charged the jury, consistent with Armour's instruction, that Armour had to prove that Dr. Barbosa knew at the time of treatment of the "possibility" that AIDS might be transmitted by blood products, the language contained in the warning subsequently approved by the FDA and conceded as adequate by plaintiffs. The court continued, however, with the presently-challenged instruction that Armour had to prove that Dr. Barbosa knew of "reasonable evidence of an association of a serious hazard, that is, AIDS, with Factor VIII concentrate."

After the jury verdict in favor of plaintiffs, Armour filed both a motion for new trial and an alternative motion for judgment notwithstanding the verdict, alleging insufficient causation and error in the jury instructions. The district court, in two lengthy orders, denied both post-trial motions. Armour then appealed.

II. FACTUAL BACKGROUND

Jason Christopher suffered from moderate hemophilia, a disorder in which the afflicted person is subject to spontaneous bleeds that can cause severe arthritis, crippling, or death. The severity of the clotting disorder depends upon the extent to which the hemophiliac lacks a clotting protein in plasma called Factor VIII. To limit or treat bleeding, hemophiliacs must use blood products, donated by others, which contain the missing clotting factor. There are several types of blood products used to treat hemophilia--whole blood, cryoprecipitate, and Factor VIII concentrate--which contain the Factor VIII clotting protein. ⁴ Over the course of his life, Jason Christopher used all three products.

The disease known as AIDS first came to the attention of the United States medical community in 1981. ⁵ The first report of AIDS in hemophiliacs occurred in July of 1982 when the Center for Disease Control (CDC) reported that three hemophiliacs were diagnosed with AIDS. Although the cause of the new disease was unknown, the CDC report suggested that hemophilia patients might be at risk because of their treatment with blood products. Evidence of the possibility that AIDS might be transmitted through blood products continued to surface through July 1983 ⁶, at which time Armour concluded that there was reasonable evidence of an association of AIDS with blood products and decided to seek FDA approval of a revision to its package labeling. The proposed warning was submitted in September 1983 and approved in January 1984.

Armour introduced a new heat-treated concentrate in February 1984. Studies had shown that this heat-treated Factor VIII concentrate might reduce the risk of transmission of non-A, non-B Hepatitis. Although it was not known at that time, the heat-treated concentrate later was shown to protect against AIDS. The heat-treated concentrate contained the identical AIDS warning as approved for the non-heat-treated concentrate.

Jason used each type of blood product available for treatment of his hemophilia. Jason's medical records established his use of blood products as follows. In March and April of 1982, he received several units of whole blood and 64 units of cryoprecipitate at military bases in Germany. He received 33 units of cryoprecipitate in Washington, D.C., between April and June of 1982, 6 units in October 1982, and 4 more in January 1983. In total, Jason received 107 units of cryoprecipitate. On three occasions in July 1982, Jason received non-Armour Factor VIII concentrate. In August 1982, he was diagnosed with acute Hepatitis B, caused by one of his earlier treatments with blood products.

In February 1983, Jason began treatment with Dr. Barbosa, the chief pediatric hematologist at All Children's Hospital in St. Petersburg, Florida. He received his first Armour concentrate on July 15, 1983, after an injury requiring therapy. Dr. Barbosa treated Jason with two more infusions of Factorate in August and two in November--once on November 10 and once on November 30. On November 29, 1983, Jason developed a flu-like illness, with symptoms including fever, enlarged lymph nodes, and sore throat. After November 30, 1983, Jason received no further concentrate until May of 1984, when he began receiving heat-treated concentrate. Jason tested positive for HIV in late May 1985, developed AIDS in early 1990 and died in February 1992.

It was undisputed at trial that Jason could have been infected with the HIV virus by any one of the units of blood products used to treat his condition from May 1982 until May 1984, when the heat-treated concentrate was introduced. In order to prove Jason's infection was caused by Armour's concentrate, plaintiffs introduced the testimony of Dr. Barbosa, Jason's treating physician, and Dr. William Robinson, a professor of medicine with a...