Plaintiff sued manufacturers of ibuprofen after he contracted a rare skin disease from taking the drug. The jury returned special verdicts in one defendant’s favor on strict products liability based on failure to warn, but against the same defendant for negligent failure to warn. This decision holds the verdicts were fatally inconsistent. The verdict for the defendant on strict liability meant that there was no duty to warn of possible skin rashes, etc. because those conditions posed no substantial danger; while the negligent failure to warn verdict had to be based on a finding that a reasonable defendant would have warned of the same skin conditions because they were likely to be dangerous. When the strict liability/failure to warn and negligent failure to warn claims arise from the same facts, the strict liability claim necessarily encompasses the negligence claim, imposing a higher duty on the manufacturer. The special verdicts were also erroneous in failing to require the jury to resolve all controverted issues on the negligent failure to warn claim. The verdicts should also have asked the jury to decide whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger. Other special verdicts on this claim did not resolve this issue, but instead addressed causation. And a jury instruction on the subject is no substitute for a special verdict. Following Mut. Pharm., Inc. v. Bartlett (2013) 133 S.Ct. 2466, this decision holds that the FDA’s approval of the drug for over-the-counter sales preempts any strict liability in tort claim for defective design through the formulation of the drug (here, that a different isomer of the drug should have been used) because the FDA forbids a manufacturer from changing the drug’s formulation after FDA approval. Also, the decision holds that it was error to instruct the jury on the consumer expectation test for design defect in a case like this where only an expert could weigh whether the risks of a rare skin condition outweighed the benefits most patients received from the drug.
Jury verdict for defendant on strict liability/duty to warn was fatally inconsistent with verdict against defendant on negligent failure to warn, requiring retrial of suit by a plaintiff who contracted a rare skin disease from taking ibuprofen.