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The Closing Of The Learned Intermediary Frontier
Thursday, June 2, 2011
It was the last blank space on the legal map – the only state with no precedent whatsoever.
As we mentioned earlier in the week, Rhode Island has now fallen. There now remains no
state in the country totally without precedent concerning the learned intermediary rule.
Granted, for now it’s only an oral ruling in a transcript, but a federal judge has predicted that
Rhode Island would join the overwhelming consensus of jurisdictions and follow the learned
intermediary rule:
First of all, after the learned intermediary doctrine, that has been adopted by over two dozen
jurisdictions and, I think, Rhode Island would adopt it as well.
I see nothing in Rhode Island case law, including the Castrugnano [sic, should be Castrignano]
case, to suggest that Rhode Island would require direct patient warning in pharmaceutical drug
cases. Just because 4024 A [sic, should be 402A] of the second restatement says nothing
about the learned intermediary doctrine doesn’t bother me. There are a lot of states that
adopted both.
If Rhode Island doesn’t accept the doctrine in the way that most courts have, then it’s likely it's
going to look to the third restatement, which requires direct warnings when the manufacturer
has reason to know that the health care provider will not be in a position to reduce the risk to
the patient.
Unlike the mass inoculation vaccine scenario that the restatement mention in one of its
comments, Zometa is a very serious therapy that is commenced after consultation with
doctors. . . . As intended there Zometa is a type of drug learned intermediary doctrine
encourages a doctor-patient dialogue.
Zometa does not fall within the exception of the restatement and I, therefore, find a direct
warning to Mr. Hogan was not required.
Hogan v. Novartis Pharmaceuticals Corp., 06 CV 260, Trial Tr. (5/23/11), at 387-88
(E.D.N.Y.). The same court had discussed the learned intermediary rule with approval, but
avoided a direct ruling, in Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9
(E.D.N.Y. April 24, 2011).
Given that there is no longer any untamed legal frontier (the effort now shifts to whether
appellate courts might change existing precedent), this seems like a good time to review the
