R.F. and R.F. v. Abbott Laboratories
New Jersey Supreme Court
745 A.2d 1174 (2000)
- Written by Alex Ruskell, JD
Facts
R.F. (plaintiff) received a blood transfusion that was infected with the human immunodeficiency virus (HIV). The blood had been screened as safe with a test created by Abbott Laboratories (defendant). The Food and Drug Administration (FDA) was heavily involved in the creation of the test. Importantly, the FDA had approved a package insert for the test that did not acknowledge an issue with tests that came close to the borderline for testing positive for HIV. The FDA gave Abbott a license to sell the tests, told Abbott that any amendments to the packaging would require FDA approval, and also sent out information to doctors regarding the tests. R.F. sued Abbott under state law, arguing the test was defective for the insert’s failure to note the issue with borderline tests. R.F. claimed that the package insert should have told blood banks to retest borderline tests. Abbott responded that state laws were preempted by the FDA’s heavy regulation of HIV blood testing and the FDA’s involvement in creating the test.
Rule of Law
Issue
Holding and Reasoning (Garibaldi, J.)
Dissent (Stein, J.)
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