This is a quick-hit post bringing you two first-of-their-kind orders on proving causation in cases alleging inadequate drug or medical device warnings. In orders applying Georgia’s and Delaware’s versions of the learned intermediary doctrine, two different federal courts have held that a plaintiff alleging inadequate warnings cannot meet his or her burden of proving causation without testimony from the prescribing physician.
The cases are May v. Ethicon, Inc., No. 1:20-CV-322, 2020 U.S. Dist. LEXIS 23143 (N.D. Ga. Feb. 11, 2020), and Evans v. Johnson & Johnson Co., No. 14-1316-RGA, 2020 WL 616575 (D. Del. Feb. 10, 2020). But first, some context. Failure-to-warn claims are a staple of drug and medical device litigation, mostly because failure-to-warn claims are the most widely recognized flavor of product liability in the drug and medical device space. Sure, we also have design defect and manufacturing defect claims, but even in jurisdictions that cabin those claims in some way, the trade off is that manufacturers owe a duty adequately to warn regarding known and reasonably knowable risks.
But to whom do manufacturers owe the duty? Under the learned intermediary doctrine (some version of which applies in most every state), prescription drug and medical device manufacturers owe a duty to warn only the prescribing physician (or “learned intermediary”), not the patient directly. A corollary of that rule is that in order to prove causation in a failure-to-warn case, the plaintiff has to prove that a different or additional warning would actually have changed the physician’s decision to prescribe or implant the product.
We can quibble on exactly what that means, and we have written too many posts on warnings causation to count. But one thing is clear—because the plaintiff bears the burden of proof, a defendant is entitled to judgment as a matter of law on warnings-based claims when there is no admissible evidence from the prescribing physician. Maybe a different or additional warning would have convinced the physician to prescribe another product (or no product at all), or maybe it would not have. Without evidence, we don’t know, which means the defendant wins.
That is what happened recently in May v. Ethicon and Evans v. Johnson & Johnson. In May, the plaintiff alleged injuries arising from treatment with surgical mesh and that the defendant manufacturer had not provided adequate warnings. Under Georgia’s learned intermediary rule, “where a learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action even with the information the plaintiff contends should have been provided, courts typically conclude that . . . the causal link is broken and the plaintiff cannot recover.” May, U.S. Dist. LEXIS 23143, at *9 (internal citations and quotes omitted).
The problem for the plaintiff was that no one took the implanting surgeon’s deposition, leaving everyone to speculate on whether different or additional warnings would have changed the surgeon’s course of action. This lack of evidence resulted in summary judgment on the plaintiffs’ warnings claims. As the district court reasoned,
[D]espite the lack of Georgia precedent on this issue, the Court agrees with the Defendants that the Plaintiffs’ failure to warn claim cannot proceed in the absence of any testimony at all from the implanting physician. The Plaintiffs cannot establish the necessary elements of their failure to warn claim without any evidence indicating how the implanting physician—to whom the duty to warn was owed—responded to the Defendants’ warning or how he might have responded to some different, more comprehensive warning.
Id. at *11 (emphasis added). A similar failure of proof played out to the same result in Evans, where the court applied Delaware law. In Evans, the plaintiff alleged side effects from taking a prescription drug approved for treatment of schizophrenia and bipolar disorder. Evans, 2020 WL 616575, at *1. Again, the plaintiff alleged that the drug manufacturer failed adequately to warn regarding certain risks, which triggered application of Delaware’s learned intermediary rule. That included the burden of proving causation:
To maintain an action against a manufacturer when . . . a genuine factual dispute exists [on the adequacy of warnings], a plaintiff must show that an additional warning would have made a difference to the plaintiff’s treating physician. This is because, if a more complete warning would not have made a difference to the prescriber, a plaintiff is unable to prove but for causation.
Id. at *4 (internal citations omitted). The prescribing physician was identified by name in medical records, but no one took his deposition. As in May, that left the parties and the court to guess as to whether different or additional warnings would have affected the decision to prescribe. Rejecting the plaintiff’s excuses for why he purportedly failed to seek discovery, the court granted summary judgment on the warnings claims under Delaware law: “Plaintiff has no evidence that, but for the supposedly inadequate warning, he would not have been prescribed [the drug]. Hence, Defendants are shielded from liability by the learned intermediary doctrine.” Id. at *4
Both cases cover other issues, but we found this one-two punch on warnings causation to be the most noteworthy. Add Georgia and Delaware to the “no physician testimony, no causation” column.