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R.F. v. Abbott Laboratories

May 07, 1998


Argued March 17, 1998

Before Judges Long, Stern and Kleiner.

The opinion of the court was delivered by: Stern, J.A.D.

On appeal from the Superior Court of New Jersey, Law Division, Bergen County.

Plaintiffs appeal from a judgment based on a jury verdict in favor of defendant Abbott Laboratories ("Abbott"). We affirm the judgment.

In September 1986 plaintiff wife, R.F., received a blood transfusion incident to surgery and subsequently contracted human immunodeficiency virus ("HIV"). She and her husband brought this action against various defendants, including Abbott which manufactured the HIV test used to screen the blood that was used in the transfusion. After plaintiffs settled with the other defendants, the case was tried against Abbott.

Plaintiffs' claims were based on Abbott's failure to give adequate warnings about its HIV test and that the test was defective. Plaintiffs specifically asserted that the blood screening test manufactured and distributed by Abbott was not reasonably fit, suitable or safe, because it failed to detect antibodies to HIV in the unit of blood transfused. In addition to this alleged design defect, plaintiffs contended that the test was not accompanied by adequate warnings or instructions to defendant Bergen Community Blood Center ("BCBC") which did the testing. *fn1 Abbott argued that the test was accompanied by proper product warnings and instructions approved by the Food and Drug Administration ("FDA") and that the alleged defect was an inherent scientific limitation in the screening test. The jury found in favor of Abbott.

On this appeal, plaintiffs urge various grounds for reversal. We need not address them, however, because we agree with Abbott that the judgment must be affirmed because plaintiffs' claims are preempted by the Medical Device Amendments of 1976, 21 U.S.C.A. §§ 360c-360ee ("MDA"), to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. §§ 301-395.


In or around the spring of 1984 the virus later named HIV was identified as the cause of acquired immune deficiency syndrome, better known as AIDS. There can be no dispute that the development of blood tests to identify the HIV virus became a national health priority in light of the AIDS epidemic. Shortly thereafter, Dr. Robert Gallo developed the prototype enzyme-linked immunosorbent assay ("ELISA") test designed to detect HIV antibodies in the blood. Gallo's test detected the antibody to the virus in only about 85% of individuals infected with HIV. The FDA's Office of Biologics Research and Review ("OBRR"), *fn2 which oversees blood collection, processing, testing, and marketing, determined that Gallo's ELISA test represented the best available means to detect HIV in the blood supply. On May 3, 1984, by notice in the Federal Register, the FDA solicited private companies to develop an assay ELISA (or EIA) test, "for the detection of antibodies to the virus associated with AIDS." On May 9, 1984, Abbott applied "for authority to grow the HTLV III virus on a large scale, to develop an assay for detection of antibodies to HTLV III and for nationwide distribution of the assay kit." After months of work with Abbott and review of its research, on March 1, 1985 the FDA issued a license which "authorized Abbott to manufacture and sell in interstate and foreign commerce HTLV III in an in vitro ELISA test. Pursuant to the licensing regulations, [however,] the OBRR required Abbott to submit ongoing stability studies for review and inclusion in the product license file."

Plaintiff R.F. received a blood transfusion on September 5, 1986, during surgery at Valley Hospital in Ridgewood, New Jersey. The transfused blood had been collected and screened by defendant BCBC and tested using the Abbott HTLV-III ELISA test kit on August 26, 1986. This unit tested 0.121, slightly below the "cutoff value" for a positive reading of 0.128. Even though this unit was within .007 of the cutoff value, the instructions did not suggest or require retesting.

On November 4, 1986, the same blood donor again donated blood at BCBC. This donation, also tested with Abbott's ELISA test kit, was found to be above the 0.128 reading and, therefore, HIV positive. A review of BCBC records determined that blood from the earlier donation had been transfused into R.F.

Abbott's HIV screening test warned users that HIV-infected donors could escape detection. Its package insert advised that "[a] negative test result does not exclude the possibility of exposure to or infection with HTLV III." That warning, approved by the FDA, appeared in all commercially-licensed ELISA test kits. According to test instructions, only specimens with "absorbance values greater than or equal to the Cutoff Value ... should be retested." However, the package insert did not direct laboratory technicians to retest blood if the unit recorded a reading anywhere below the cutoff value. To the contrary, it provided that "[s]pecimens with absorbance values less than the Cutoff Value are negative by the criteria of ABBOTT HTLV III EIA." The insert did not mention borderline readings or any margin of error.

Plaintiffs contend that R.F.'s blood sample should have been retested on August 26, 1986 in light of the reading that day. They argued before the trial Judge that:

The Abbott instructions and warnings provided with the test kit do not recognize "weak reactive" test result or "borderline" test results. That is, if unit 0202 had tested .007 above the "cut off" it would have required retesting but since it was .007 below the "cut off" and numerically far greater than all other units tested but did not require retesting. The Abbott Laboratory instruction and warnings failed to advise the user of the test, for the Plaintiffs benefit, that under its criteria for interpreting the test results as strictly "reactive" or "non-reactive" that a certain number of "borderlines" would not be detected.

5. It is Plaintiffs allegation that Abbott Laboratories had knowledge at the time that it manufactured, marketed and distributed its HTLV-III test kit that under its criteria of interpreting test results as either "reactive" or "non-reactive" as opposed to recognizing occasional "borderline" or "weak reactive" test results.[] That in some cases "borderline" test results close to the cut off that were slightly below the cut off value would also be contaminated with the HIV virus. Plaintiff alleges that Abbott failed to provide proper instructions and warnings as to the limitations of this test. *fn3

In her December 10, 1993 affidavit in support of a motion for reconsideration of the denial of Abbott's original motion to dismiss, Marijane Sidote Gregg, Manager of the Regulatory Affairs Department and subsequently Director of Regulatory Affairs for Abbott's Diagnostic Division, stated:

7. From January to April, 1985, Abbott submitted drafts of Abbott's ELISA test package insert to the FDA. These drafts addressed subjects required by the applicable federal regulation. In many instances, the FDA suggested specific language that Abbott was required to include in the package insert and Abbott engaged in an ongoing dialogue with the FDA concerning the ELISA test package insert. The insert submitted by Abbott to the FDA on March 1, 1985 reflects the FDA's revisions. The package insert dated April, 1985 ... is a true and accurate copy of the package insert that accompanied Abbott's ELISA test from July 1985 to January 1986. The contents of this package insert were approved by the Food and Drug Administration prior to dissemination. This package insert, and all subsequent package inserts, address the subject of false negative results in the manner required by the FDA. The license, dated March 1, 1985, reflects the FDA's approval of Abbott's ELISA test package insert for release to the public.

8. On February 28, 1985, at a meeting for the final review of Abbott's package insert, the FDA and I discussed the method for calculation of the test's cutoff value. The decision as to how to calculate the cutoff value, as reflected in Abbott's ...

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