Tobin v. Astra Pharmaceutical Products, Inc.

When Kathy Tobin (plaintiff), who was pregnant with twins, was hospitalized for preterm labor, she was prescribed ritodrine to prevent further preterm labor. Tobin, who had a heart murmur, had previously been hospitalized during her pregnancy for a viral condition. While on the ritodrine, Tobin developed tachypnea, dyspnea, and a gallop heart rhythm. After giving birth, Tobin suffered congestive heart failure and required a heart transplant. Tobin sued the manufacturer of ritodrine and its United States distributor, Astra Pharmaceutical (defendant), in a products-liability suit alleging claims for design defect and failure-to-warn of the conditions that led to Tobin’s heart transplant. After finding Astra liable on both claims, a jury awarded Tobin almost $4.5 million. The district court denied Astra’s motions for judgment notwithstanding the verdict, or a new trial, and Astra appealed. Tobin argued that under Kentucky’s risk-utility analysis, the only way to decide whether a drug is defective and unreasonably dangerous is to ask whether an ordinarily prudent manufacturer, being fully aware of the risks, would put the drug on the market. To that end, Tobin further argued that ritodrine had no benefits regarding improving neonatal outcomes and weighed against the serious risks of the drug and what Tobin suffered, the risks outweigh the benefits such that no ordinary prudent manufacturer would have placed ritodrine on the market, notwithstanding Food and Drug Administration (FDA) approval that Tobin asserted was based on insufficient and invalid data. Astra first argued that allowing Tobin to litigate the drug’s efficacy in a state-law tort action “is a mockery of the scientific analysis employed by the FDA and the Advisory Committee which conclusively found that ritodrine was efficacious.” Astra also argued that because ritodrine is effective in prolonging pregnancy, it improves neonatal outcome, and the risks to maternal and fetal health are outweighed by the benefits of reducing neonatal morbidity and mortality.