California and Mississippi have little in common, but they both apply the learned intermediary doctrine in prescription drug cases. Prescription drug manufacturers have a duty to provide adequate warnings in connection with their products, but only to prescribing physicians – the learned intermediaries – and not directly to patients. We write on the learned intermediary doctrine a lot because it comes up in so many of our cases, and also because it is a sound legal rule that should apply, and should apply consistently. Toward that end, the Northern District of Ohio recently gave us twin opinions applying the learned intermediary doctrine under the laws of California and Mississippi, and the district court found that the defendants in both cases were entitled to summary judgment.
In Miller v. Ortho-McNeil Pharmaceutical, Inc., 2013 U.S. Dist. LEXIS 158302 (N.D. Ohio Nov. 5, 2013), the plaintiff used a prescription contraceptive patch and experienced a pulmonary embolism, which she attributed to her contraceptive use. Every physician in the world knows that hormonal contraceptives of this type increase the risk of blood clots, and so did the nurse practitioner who first prescribed the plaintiff’s contraceptive patch. In fact, the nurse practitioner knew that the product’s warnings “included the elevated risks of blood clot[s].” Id. at *3. A second nurse practitioner who prescribed to the plaintiff likewise “was aware that [the contraceptive product] exposed patients to a higher concentration of hormones than typical birth control pills, increasing the risk of thrombotic disease and pulmonary embolism.” Id. at **3-4. Even with this knowledge, both nurse practitioners believed the benefits of prescribing the product to the plaintiff outweighed the risks. Id.
On these facts, the court had little difficulty granting summary judgment on a familiar two-prong basis. First, the product warnings were adequate under Mississippi law because “Defendants specifically warned of the risk of blood clots.” Id. at **10-11. We are sometimes surprised when courts allow failure-to-warn claims to proceed even where the package inserts warn about the exact risk that allegedly befell the plaintiff. But this court was on the ball and, in our view, came to the right conclusion on these facts. Second, the court ruled that the plaintiff could not prove causation because “she has not shown that a different warning would have changed the prescribing decision.” Id. at *12. This is another refreshingly straightforward holding, and it follows Mississippi’s learned intermediary doctrine to a tee: The manufacturer owes a duty to warn only the prescribing physician, so if an alleged inadequacy in the warnings had no impact on the prescribing decision, then proof on the essential element of warnings causation fails. In Miller, both prescribing nurse practitioners knew about the clotting risk, and they prescribed the product anyway. For her part, the plaintiff had no evidence that a different warning would have made any difference. Summary judgment granted.Continue Reading Learned Intermediary Rule Applies, with No Exception for Contraception