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Learned Intermediary Doctrine In Puerto Rico

By James M. Beck and Mark Herrmann

On some days, we're writing about how Wyeth v. Levine will affect the entire pharmaceutical industry.

On other days, we're writing about a federal court predicting state law on the learned intermediary doctrine in Puerto Rico.

Welcome to day two.

In Mendez Montes de Oca v. Aventis, Civil No. 02-2608, 2008 U.S. Dist. Lexis 75892 (D.P.R. Sept. 30, 2008), Mendez's estate and family members sued Aventis pleading that Mendez developed a cancerous tumor as a result of an injection of the insulin product Lantus.

The package insert for Lantus accurately described the carcinogenicity data for the drug, as developed in animal studies. Id. at *7-*8. Plaintiff's expert "opined in his report that the 'professional product labeling of LANTUS provided to physicians fully disclosed the carcinogenicity potential of the product.'" Id. at *19. The expert opined, however, that the "'product labeling provided to patients did not disclose this important issue.'" Id.

The expert confirmed his thinking at deposition:

Q. You think that the FDA and Aventis did a good job with the end result of the labeling that went to physicians?
A. Correct.
Q. Your criticism is with respect to the information that went to patients, is that correct?
A. Correct.

Id.

That sets up a pretty clean test of the learned intermediary doctrine, doesn't it?

And the doctrine wins.

First, the learned intermediary doctrine "seems to be widely accepted," and "has been applied in Puerto Rico." Id. at *13.

Second, "[b]ecause the warning is directed at the prescribing physician, its adequacy is assessed with reference to the physician, not the patient." Id. at *15.

On this factual record, the court granted Aventis's motion for summary judgment based on the learned intermediary doctrine.

The court noted the supposed exception to the learned intermediary doctrine "in cases of direct to consumer advertisement by the drug manufacturing companies." Id. at *18. That approach, however, "has not been widely accepted." Id. Even if the Puerto Rican court recognized this exception, the Mendez "case is devoid of any evidence intimating that decedent even saw informational material regarding Lantus prior to his visit to Dr. Trabanco." Id. at *21. "At no point do any of the plaintiffs specifically indicate . . . that decedent was swayed by advertising promoted by Aventis to the general public which promotion led Mr. Mendez to request the product from his physician." Id. The direct-to-consumer advertising exception thus probably doesn't exist; even if it does, it wouldn't change the result.

Mendez may not be earth-shaking news, but it's nice to have another case come down on the good side of the ledger.

Full post as published by Drug and Device Law on October 28, 2008 (boomark / email).