For readers noticing the new byline, let me introduce myself.  I am Susanna Moldoveanu, and I practice with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare group.  I am excited to join the Drug & Device Law Blogging Team.  The best group of legal wonks there is.

Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co., 2023 WL 8717570 (W.D. Wash. Dec. 18, 2023).  A prior opinion in this case earned the top spot on the Blog’s Ten Best Prescription Drug/Medical Device Decisions of 2022.  This opinion is short and sweet, but a good one too.

To recap, earlier in the case, at the request of these pro se Plaintiffs, the District Court certified the question of whether there was a direct-to-consumer exception to the learned intermediary doctrine.  The Supreme Court of Washington answered with a resounding no.  Nothing about direct-to-consumer advertising alters the “central premise” of the learned intermediary doctrine—that a physician exercises independent medical judgment in prescribing medications and that patients rely on that judgment.   Dearinger v. Eli Lilly & Co., 510 P.3d 326, 332 (Wash. 2022).  A more fulsome discussion of the Washington Supreme Court’s answer is on the Blog.

In the most recent decision, the District Court addressed the defendant’s motion for summary judgment, along with a belated request to amend.  At the eleventh hour, Plaintiffs sought to amend to add a claim for a new injury, but the Court rejected that request.  Plaintiffs wanted to add a claim about a July 2017 retinal detachment allegedly caused by Cialis.  Because such a claim did not share “common core of facts” with the original alleged injury—a 2018 stroke—the claim did not relate back to the original complaint and thus was time-barred.  2023 WL 8717570, *3.

With the futile amendment out of the way, the District Court addressed the core of the case: the failure to warn claim. 

In discovery, Plaintiffs provided—at Lilly’s request—the text of a purportedly adequate warning.  Defense counsel asked the prescribing physician about that very warning in his deposition, and he testified it would not have altered his prescribing decision.  He also testified he was already aware of the risk of hemorrhagic strokes with Cialis.  There was therefore no causal connection between any alleged failure to warn and the Plaintiffs’ alleged injury. 

Plaintiffs had no evidence to rebut the treater’s clear testimony.  Instead, all they offered were attacks on the prescriber’s competence.  But that is the stuff of malpractice claims; it was “irrelevant” under the Washington Product Liability Act.  Id. at *4. The Court therefore granted summary judgment on the failure to warn claims.

The court also kicked the fraudulent concealment claim because the Washington Products Liability Act is the exclusive remedy for all products liability claims in Washington.  The court denied summary judgment on a throwaway design defect claim but only because it was not “meaningfully address[ed]” in the papers.  Id.  The court surmised that “[p]erhaps the same infirmity as to Counts 2 and 3 would apply to Count 1” so it too seems likely to die for lack of causation.  Id.

The District Court’s decision follows the Supreme Court of Washington’s answer to the certified question, appreciating the distinction between a product liability claim against the drug manufacturer and a claim against the doctor.  A plaintiff may argue that his learned intermediary is not so learned, but that has no bearing on the products liability claim against the drug manufacturer.