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.
The court came to the same result applying California law in Hanhan v. Johnson & Johnson, 2013 U.S. Dist. LEXIS 158301 (N.D. Ohio Nov. 5, 2013). In Hanhan, the plaintiff was another contraceptive patch user, and like the plaintiff in Miller, she alleged a blood clot that she blamed on the product. Id. at **2-3. This action, however, had an added twist: The plaintiff argued that California’s learned intermediary doctrine does not apply to contraception because “physicians passively allow patients to make most birth control decisions such that the physician’s medical judgment, which undergirds the learned intermediary doctrine, is not operable in contraception matters.” Id. at *8. We are not physicians, and we do not prescribe contraception. But we have heard this plaintiff’s reasoning before, and we have never understood it. For one thing, this formulation of the argument, framed in terms of the “passive prescriber,” seems particularly forward in its attempt to read medical professionals out of the treatment scenario. It would not surprise us if the argument rubbed prescribing physicians the wrong way. More to the point, hormonal contraceptives are prescription drugs, and patients cannot get them without a physician’s signature on the dotted line. Physicians remain the gatekeepers, and an exercise in “medical judgment” is necessary before a patient can use the product. The nature of pharmaceutical contraception does not change that analysis.
The court correctly rejected the plaintiff’s proposed exception to California’s learned intermediary rule, observing that such an exception simply does not exist under California law and that the court could not predict that California’s lawmakers would create one. Id. at *9. (As an aside, it always warms our hearts here at the Drug and Device Law Blog when federal courts applying state substantive law show restraint in making, or declining to make, Erie predictions.) The court also rejected an exception to the learned intermediary rule based on federal regulations requiring that manufacturers provide a separate “patient package insert” for estrogen-containing drugs. Id. at **9-10. This should come as no surprise, since the FDA has stated that its regulations should not affect civil tort liability for drug manufacturers. Id. at *10. The FDA has also said more specifically that “[t]he courts have not recognized an exception to the ‘learned intermediary’ defense in situations where FDA has required patient labeling, and the courts seem increasingly reluctant to recognize new exceptions to this defense.” Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66378, 66384 (FDA Dec. 1, 1998).
The causation inquiry thus properly turned on the impact of the prescribing information on the prescribing physician, and in Hanhan, “the record reflects that at the time of Plaintiff’s visit . . ., [the prescribing physician and a “health educator”] were both fully informed of [the product’s] risks and were familiar with [its] package insert, including the detailed patient labeling.” Id. at *2. They prescribed the drug with their eyes wide open because the benefits outweighed the risks for this patient, and the physician “still believes she made the right prescription decision.” Id. at *3. Again, summary judgment granted.
The learned intermediary doctrine and warnings causation are our bread and butter, these two orders provide clear and very useful roadmaps.