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Blast From the Past - A Baycol Affirmance

By James M. Beck and Mark Herrmann

Last Friday, the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) issued a long awaited (some three years long) decision in the Baycol case, Pauley v. Bayer. We've been interested in Pauley because the trial court opinion being appealed was probably the best Pennsylvania/state court generally authority on inadmissibility of anecdotal adverse event reports. See Pauley v. Bayer Corp., 2006 WL 463866 (C.P. Phila. Co. Jan. 26, 2006).

Years ago - before blogging - Bexis represented a non-manufacturing defendant in Baycol litigation. As to that defendant, the litigation has long since resolved, but out of an abundance of caution, we'll stick strictly to the legal conclusions in Pauley for the duration of this post.

In the first place, we warn you that Pauley - in the Superior Court - is an unpublished, non-citable memorandum opinion, despite its being 27 pages long and addressing issues of first impression in the Pennsylvania appellate courts. Nevertheless, we're discussing it for three reasons: (1) there's no reason Pauley can't be cited outside Pennsylvania, (2) it contains a significant discussion of Ohio law, and (3) the Superior Court non-citation mandate may well violate the Open Courts provision of the state's constitution.

Here are the main holdings in Pauley:

(1) Both Ohio and Pennsylvania follow the learned intermediary rule. Pages 12-14.
(2) Adverse event reports ("AERs") are anecdotal and thus "generally unreliable and not scientifically verified," thus a drug manufacturer has no duty to inform physicians "comparative AERs" (that is, that AERs are purportedly more common for one drug than another) Pages 15-17.
(3) Because the drug's label had a specific contraindication of the particular co-prescription (prescribing drugs simultaneously) combination at issue in the case, the warning was adequate as a matter of law regardless of AERs involving the contraindicated combination. Pages 18-19.
(4) An expert who admitted that he was not an MD and thus not qualified to make medical diagnoses was properly precluded from testifying to the diagnoses of patients in a clinical trial. Pages 21-24.
(5) Animal toxicity studies were properly excluded "because the data was not probative of the drug?s actual effect on humans." Pages 25-27.

Better late than never - and better unpublished than not at all.

Full post as published by Drug and Device Law on June 15, 2009 (boomark / email).