In addition to having Green Mountains, maple syrup, lake houses, an ice cream company run by summer camp buddies, a mitten wearing Senator, and a history of low COVID rates, Vermont has a history of being a legal outlier.  Some of its positions might be considered progressive or regressive.  The legislation discussed here is a (bad) example of the former.  The latter is exemplified by its position on the learned intermediary doctrine.  As we noted recently, there are very few states left where the high court has not adopted the learned intermediary doctrine or a federal court has not predicted that it would.  Until last week, Vermont was among the holdouts.  No longer.  (We will not weigh in on how Levine was impacted by this issue and how things might have been different if Vermont had been following the majority position back in 2004.)

Leavitt v. Ethicon, Inc., No. 2:20-cv-00176, 2021 WL 872696 (D. Vt. Mar. 9, 2021), bears some commonalities with some other cases we have been posting about recently.  It is a pelvic mesh case remanded from one of the MDLs after being there for more than six years.  (We cannot say whether it untimely filed, because the decision does not indicate the date for any revision surgery or the onset of alleged injuries, but the device at issue was implanted back in 2009 and the plaintiffs did plead a “count” for “discovery rule and tolling.)  When it was remanded, a motion for summary judgment had been pending for a year.  This is not a story about delaying justice, though.  This is one where it probably helped for the court deciding a Vermont state law issue to be in Vermont, even if it was a federal court and the task involved predicting what the Vermont Supreme Court would do.

The facts of the case are fairly simple and familiar.  The plaintiff received a prescription medical device as part of a surgery to repair her stress urinary incontinence.  On summary judgment, because of which claims were challenged and which were dropped, only those sounding in failure to warn were at issue.  The prescribing/implanting doctor did not rely on the IFU for the device.  The plaintiff (switching to singular to ignore the consortium plaintiff for the rest of the post) probably received a patient brochure, but she did not rely on it.  Instead, she relied on what the doctor told her (which was, in turn, not based on anything the defendant made).  This fact pattern sounds familiar enough that we have a whole survey on it.

The first step, though, was deciding if the learned intermediary doctrine should apply to the claims here.  The prediction of what the Vermont Supreme Court would do was based on three observations.  First, “where Vermont law is undeveloped, the Vermont Supreme Court frequently looks to the Restatement for guidance.”  Id. at *5 (citation omitted).  The Restatement (Third) of Torts, from way back in 1998, had adopted the learned intermediary doctrine for all prescription medical devices.  Second, citing the 2014 tally from the MDL court in the Tyree case, “forty-eight states have adopted, or a federal court has predicted the state’s highest court would adopt, the learned intermediary doctrine.”  Id at *5 & n.4.  The court predicted Vermont was likely to follow this “overwhelming majority.”  Id. at *5.  Third, “the learned intermediary doctrine reflects the realities of patient consultations and identifies the best source of information regarding the risks and benefits of a particular device or procedure for a particular patient.”  Id. at *6.  We like this one best.  Together with the others, there was more than enough to support a prediction that the Vermont Supreme Court would adopt the learned intermediary doctrine and we have updated our survey.  (Note that we were already citing a lower Vermont decision not cited in Leavitt.)

With that, plaintiff’s claims based on an alleged failure to warn her fell.  Her claims based on allegedly failing to warn her prescribing/implanting doctor were left, but they had major causation issues.  As we noted up front, though, Vermont can be a bit quirky.  It applies a heeding presumption to (non-learned intermediary) warnings claims.  Id. at *6-7.  But it does recognize, even with the presumption, there can be no proximate cause for failure to warning when there is proof that the user would have ignored any warning.  Id. at *7.  Applying those principles, and acknowledging the cases defendant cited where a physician’s failure to read the IFU negated proximate case, the court proceeded to analyze two versions of the failure to warn claims focused on the prescribing physician.

As to claims based on the IFU, summary judgment was granted because the prescriber did not read or rely on it.  Id. at *8.  Plaintiff’s reference to the sort of testimony often adduced—that the doctor relies on a “pool of information”—did not change the result because the testimony did not indicate the IFU she had not read was part of that pool.  Id.  Curiously, though, there was second theory based on the disclosure of risks in the patient brochure.  Based on testimony that the doctor “that she typically discussed the information in the brochure as well as the risks identified therein with her patients,” the court found a genuine issue on causation.  Id.  We are confused by this.  There was no evidence the doctor relied on a brochure written for patients for her understanding of the risks, let alone that she would have done something different in connection with the surgery with this patient.  It makes no sense that a doctor who did not read the IFU would rely on a patient brochure to make a decision on which device to use or surgery to do.  Even if there were some evidence that she would have engaged in a different discussion with plaintiff based on what the patient brochure said, the better thinking does not allow proximate cause for a claim based on a failure to warn the doctor to be based on speculative testimony about what the patient (now plaintiff) would have done with a somewhat different oral consent from the doctor.  Here, the jury would be asked to decide this issue based on the plaintiff’s self-serving testimony about how she would have done something different based on the possibility that different words might have been used in an oral conversation a dozen years earlier.  That would undercut much of the public policy the court found persuasive in predicting the adoption of the learned intermediary doctrine.  Because Vermont’s learned intermediary law is nascent, we will cut the court some slack.  In the future, this is the sort of record that should result in summary judgment on all warnings-based claims.