Lydia Basko v. Sterling Drug, Inc., and Winthrop Laboratories
416 F.2d 417, 1969 U.S. App. LEXIS 10522 (1969)
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Rule of Law:
A drug manufacturer may be strictly liable for physical harm caused by an "unavoidably unsafe" prescription drug if it fails to provide an adequate warning to the medical profession of known or reasonably foreseeable risks, even if the risk affects only a small number of idiosyncratic users. When multiple forces, including a defendant's breach of duty to warn for one drug, are each sufficient to cause harm, the "substantial factor" test applies to determine causation.
Facts:
- Lydia Basko was treated from 1953 to 1961 for lupus erythematosus with three different drugs: Aralen, Atabrine, and Triquin.
- Sterling Drug, Inc. and Winthrop Laboratories manufactured these drugs.
- Basko began experiencing blurring vision in 1956 and by 1965, her vision had deteriorated to near total blindness.
- Medical experts testified that Basko suffered from chloroquine retinopathy, a form of retinal damage caused by chloroquine-based drugs like Aralen and Triquin, but not Atabrine.
- Since initial development, the manufacturer knew of reports of temporary blurring of vision and corneal opacities associated with chloroquine use.
- In 1957, Dr. Amerigo Cambiaggi published an article on unusual ocular lesions in a patient treated with chloroquine, which some medical professionals interpreted as the first indication of chloroquine-induced retinal damage, though the author attributed it to lupus erythematosus.
- In October 1959, the "Hobbs Report" was published in a British medical journal, definitively concluding that retinal lesions were caused by chloroquine therapy.
- The manufacturer began revising its product literature in 1960 to warn of retinal vascular response and irreversible macular lesions, and subsequently sent "Dear Doctor" letters to physicians in January 1963 regarding visual impairment risks.
Procedural Posture:
- Lydia Basko sued Sterling Drug, Inc. and Winthrop Laboratories in the United States District Court for the District of Connecticut.
- The case was tried before a jury for two weeks.
- The jury returned a verdict in favor of the defendant drug manufacturers.
- Basko, as the plaintiff, appealed the judgment to the United States Court of Appeals for the Second Circuit.
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Issue:
Did the District Court err in its jury instructions regarding the application of the "substantial factor" test for multiple causation and the scope of a drug manufacturer's duty to warn of a prescription drug's idiosyncratic side effects under Section 402A of the Restatement (Second) of Torts?
Opinions:
Majority - J. Joseph Smith
Yes, the District Court erred in its jury instructions concerning multiple causation and the duty to warn. The court confirmed that under Connecticut law, which adopts Restatement (Second) of Torts § 402A, manufacturers of "unavoidably unsafe" prescription drugs are not strictly liable for physical harm from idiosyncratic side effects if they provide adequate warnings to the medical profession of known or reasonably foreseeable risks (comment k). However, the trial court's causation instruction, which merely stated a 'but for' test, was reversibly erroneous because it failed to incorporate the 'substantial factor' test for multiple causes. The jury should have been instructed that if Basko's blindness could have been caused by either Aralen or Triquin alone, and a breach of duty to warn was found for only one of these drugs (e.g., Triquin), the manufacturer could still be liable if that drug was a "substantial factor" in producing her injury. Furthermore, the court found plain error in the instruction that the duty to warn applied only if the drug affected an "appreciable number of users," clarifying that the obligation extends to even a small number of idiosyncratic or hypersensitive users. The court rejected the plaintiff's arguments for a directed verdict, finding the timeliness of warnings to be a jury question. It also dismissed contentions for separate instructions on negligence, implied warranty, express warranty, and fraud upon the Food and Drug Administration, reasoning that the strict liability framework under comment k adequately covers the duty to warn, and other claims were either subsumed or lacked evidentiary support.
Analysis:
This case significantly clarifies the parameters of a prescription drug manufacturer's duty to warn, establishing that warnings must be given for all known or reasonably foreseeable idiosyncratic side effects, regardless of the number of individuals affected. It also reinforces the critical application of the "substantial factor" test for causation in product liability cases involving multiple potential causes, preventing manufacturers from escaping liability when their breach of duty contributed to the harm alongside other potentially innocent factors. This ruling strengthens consumer protection by ensuring manufacturers cannot evade responsibility for inadequate warnings simply because a product's adverse effects are rare or because other factors might have contributed to an injury, demanding comprehensive warnings to the medical community.
