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For much of the sixteen and a half years of this Blog, we have been tracking the acceptance and rejection of the learned intermediary doctrine.  The first year that we compiled a worst decisions of the year list it was topped by a case that still holds the title for worst, most thinly veiled legislation by a court, outcome-driven decisions on the subject.  We maintain multiple cheat sheets and other posts that we update periodically regarding various aspects of the learned intermediary doctrine.  Discussion of the doctrine features in many other posts.  Why is this such a staple of the Blog?  Well, we do mostly represent prescription medical product manufacturers, failure to warn is the main theory of liability advanced across product liability cases, and the application of the learned intermediary doctrine is often critical to the outcome of the case/claim.  It is much easier for a plaintiff to escape summary judgment and win at trial if his own word on the warnings received and the impact of what he was allegedly not told matters.  A prescribing physician, without a proverbial dog in the fight, can testify that she knew about the relevant risks of the drug or device and still would have prescribed it to the plaintiff if additional warnings had been provided.

The first worst case, State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007), drew a fair amount of our ire.  It also touched off a few dives into the learned intermediary doctrine and where it stood across the country.  Our criticisms did not focus on the author’s ties to the plaintiff bar in old Wild and Wonderful or see into the future to her early retirement during impeachment proceedings.  Instead, we focused on the substance and the decision’s status as an outlier.  There was nothing peculiar about West Virginia law before 2007 that made it different from its five neighboring states, all of which already had decisions by their highest courts adopting the learned intermediary doctrine.  As Karl itself noted, its federal courts had already predicted West Virginia would adopt it too.  Id. at 912 n.18 & 915 (citing Ashworth v. Albers Med., Inc., 395 F. Supp. 2d 395, 407 (S.D.W. Va. 2005); Pumphrey v. C.R. Bard, Inc., 906 F. Supp. 334, 338 (N.D.W. Va. 1995); Rohrbough v. Wyeth Labs., Inc., 719 F. Supp. 470, 478 (N.D.W. Va. 1989), aff’d, 916 F.2d 970 (4th Cir. 1990)).  Since it chose to go with the distinct minority position, Karl has become even more of an outlier.  The headcount of states adopting the doctrine has grown.  Wisconsin is now primed to add to that list.  And Karl is not even controlling in West Virginia anymore, because the state legislature overturned it in 2016.

One state that has been a bit like where West Virginia was before Karl, with no state high court decision but multiple federal court decisions predicting adoption, is Rhode Island.  In prior posts, we have identified In re Zyprexa Products Liability Litigation, 277 F.R.D. 243, 250-51 (E.D.N.Y. 2011) (no causation where prescribing physician “testified that, despite the risks of [the drug], he believed that his decision to prescribe the medication to plaintiff was the correct one”), aff’d sub nom. Greaves v. Eli Lilly & Co., 503 F. Appx. 70 (2d Cir. 2012), and Hogan v. Novartis Pharmaceuticals Corp., No. 06–CV–260, 2011 WL 1533467, at *9-10 (E.D.N.Y. April 23, 2011).  (Note that we try not to do plaintiffs’ research for them and we rarely, if ever, discuss unpublished state trial court decisions.)  Those cases applied Rhode Island law, but were not federal courts in Rhode Island.  The Second Circuit carries plenty of weight, but sometimes—not in Karl—the hometown touch of an Erie prediction can matter more.

In Costa v. Johnson & Johnson, C.A. No. 17-452 WES, 2023 U.S. Dist. LEXIS 54734 (D.R.I. Mar. 28, 2023), we now have a Rhode Island federal court predicting that the Rhode Island Supreme Court would adopt the learned intermediary doctrine.  The author of the decision has been a district judge for more than twenty years, ended a stint as the chief judge of the district in 2019, and was once nominated to make the jump to the First Circuit.  In other words, this did not come from a newbie or rogue judge.  Costa is a pelvic mesh case on remand from an MDL in the Southern District of West Virginia.  The prescribing/implanting physician for the particular stress urinary incontinence device at issue was aware of all the relevant risks listed in the IFU and a bunch of others from his own training and research, as one would probably expect with a 2014 implant of a prescription-only polypropylene mesh sling.  Id. at *3.  The defendant manufacturer moved for summary judgment on all counts that plaintiff did not drop.  We will focus only on the failure to warn claim.

The defendant, of course, urged that the learned intermediary doctrine should apply.  Confronted with the Zyprexa/Greaves decision above, plaintiff did not argue that the Rhode Island Supreme Court would decline to adopt the learned intermediary doctrine.  Instead, she urged that the question should be certified to the Rhode Island Supreme Court.  The standards for certifying a question still require conducting a substantive analysis of the issue.  Existing state law was “sufficiently clear” to predict that the Rhode Island Supreme Court would adopt the learned intermediary doctrine based on three considerations.  First, the Costa court cited the Rhode Island Supreme Court’s discussion of “the proximate cause element of a failure to warn claim” in Hodges v. Brannon, 707 A.2d 1225, 1227-28 (R.I. 1998), as “implicitly referenc[ing] the doctrine.”  Id. at *9.  Hodges was a prescription drug case where the jury instruction on the failure to warn claim described the proximate cause standard as “whether or not [plaintiff’s prescriber] would have prescribed the drug [to plaintiff] in 1986 if he had been provided with an adequate warning.”  Next, consistent with the reasoning of the Hogan case noted above, the history of the Rhode Island Supreme Court citing with approval sections of the Second and Third Restatements of Torts that endorse the learned intermediary doctrine supported that it would follow the current Restatement,  Id. at *10.  Lastly, citing Greaves and Hogan, Costa “followed the lead of other federal courts” in predicting the adoption.  Id.  The entire analysis took a single paragraph.

With that prediction nailed down, the plaintiff could not carry her burden.  The implanting physician, as might be expected of a learned intermediary, was aware of the risks that plaintiff contended were inadequately described in the device’s Instructions for Use—poor wound healing in immunosuppressed patients, mesh erosion, acute and chronic pain, dyspareunia, etc.  Id. at *11-12.  As also might be expected, the implanter testified to a likelihood that he would have followed any “absolute contraindication” to doing the procedure with plaintiff.  However, he testified that plaintiff was an appropriate candidate for the procedure.  Id. at *12-13.  We have discussed before how these disconnected hypotheticals (e.g., “Would you have liked to have known about a horrible risk with the product (as to which there is no supporting scientific evidence)?”) should not be enough to carry the plaintiff’s burden on proximate cause for failure to warn and this one was not.  So, the defendant won summary judgment on the plaintiff’s failure to warn claim.

The result is good, especially for the defendant, but the real significance of Costa is the prediction on the Rhode Island Supreme Court adopting the learned intermediary doctrine.  As we noted, Karl rejected the doctrine despite contrary predictions by courts in both federal districts in West Virginia, so even a hometown prediction is not a guaranty.  When the Rhode Island Supreme Court does get a chance to weigh in directly on the learned intermediary doctrine—or another chance, given Hodges—it will be interesting to see if it sides with the (overturned) reasoning in Karl, which has not been followed by a single highest court of another state since, or with the reasoning in Costa and the controlling law in the overwhelming majority of states.