Stanton v. Astra Pharmaceutical Products, Inc.

A products-liability and negligence action was filed against Astra Pharmaceutical Products, Inc, (Astra) (defendant), the manufacturer of an anesthesia drug, Xylocaine, by the mother of a child who suffered an adverse reaction in 1971 that resulted in severe and irreversible brain damage. An allegation was made against Astra that it failed to meet its obligations under the Food and Drug Administration’s (FDA) regulations to forward to the FDA any of the 202 reports it received of alleged adverse reactions to Xylocaine between May 28, 1964, and the end of 1970. Astra cited its reliance on the advice of its counsel why it did not forward the adverse-reaction reports, despite the fact that it included those reports as part of its Establishment Inspection Reports that were provided to nonmedical FDA inspectors who inspected Astra’s facilities between 1964 and 1971. Astra also contended that it relied on a 1963 agency letter from the New Drug Status Branch that advised that Xylocaine was no longer being considered a new drug, and the FDA’s 1964 announcement that it was postponing the effective date of some reporting requirements for new drugs pending review to support its argument that Xylocaine was not subject to adverse-reaction reporting requirements. Finally, Astra alleged that by 1964, Xylocaine had generally been recognized by experts as safe and effective and therefore the adverse-reaction reporting requirements for new drugs no longer applied to it. However, in 1968, the FDA, via the Federal Register, formally revoked all previous opinions given by the FDA whether a drug was not a new drug or no longer a new drug.