Wednesday, August 4, 2010

GUEST POST: Recent Superior Court Cases Handed Down on Learned Intermediary Rule

I received permission from Attorney James Beck of the Philadelphia office of the Dechert LLP law firm to reprint the below July 30, 2010 post from his Drug and Device Law Blog, an excellent resource for continuing updates on that topic:

NEW DEFENSE LEARNED INTERMEDIARY WINS IN PENNSYLVANIA

This week the Superior Court of Pennsylvania (the intermediate appellate court) issued two new opinions on warning causation in the context of the learned intermediary rule. Cochran v. Wyeth, Inc., ___ A.2d ___, No. 2838 EDA 2008, slip op. (Pa. Super. July 27, 2010), and Owens v. Wyeth, No. 185 EDA 2009, slip op. (Pa. Super. July 26, 2010) (memorandum).

Both of these cases arise from the few remaining fen-phen cases in Philadelphia County, which involve primary pulmonary hypertension as the claimed injury. Obviously, Cochran is the more important of the two, because it will be published, and is precedential.

Cochran involved a peculiar warning claim. The plaintiff conceded that the warnings regarding primary pulmonary hypertension were adequate. Instead she claimed that the warnings about valvular heart disease (VHD) - a condition she admittedly never contracted - were inadequate, and that had the prescribing physician been warned of that risk (as opposed to PPH), he would not have prescribed the drug.

Obviously, opening up the entire warning to inadequacy attacks, regardless of the injury actually suffered, would have been a major increase in the scope of liability. Fortunately the Superior Court didn't buy the theory:

Here, [defendant] allegedly breached its duty in failing to disclose the risk of VHD, and Appellant’s injury was PPH. The risk of VHD did not develop into the actual injury of VHD. Although [the prescriber] testified in his deposition that he would not have prescribed [the drug] to Appellant had he known of the risk of VHD, this does not alter the fact that [defendant] failed to disclose the risk of VHD and Appellant suffered from PPH. In these circumstances, the relationship between the legal wrong (the failure to disclose the risk of VHD) and the injury (PPH) is not directly correlative and is too remote for proximate causation. Therefore, as a matter of law, there is no proximate, causal connection between [defendant's] failure to disclose the risk of VHD and Appellant’s specific injury.

Cochran, slip op. at 14-15.

In Owens - which as an unpublished opinion is neither precedential nor even citable in Pa. state court - the prescriber knew all about the risk of PPH. He testified he would have prescribed notwithstanding a black box (which wasn't on the drug at the time) because the risk of a fatal obesity-related disease (diabetes) was much worse. Slip op. at 8-9.

Owens also had the VHD/PPH issue, but the physician testimony didn't support but for (as opposed to the proximate causation rationale in Cochran) causation. Slip op. at 11.

Owens also affirmed dismissal of three novel claims. The first was "negligent marketing," which the Superior Court limited strictly to overpromotion:

Appellant next argues that her claim for “negligent marketing” is cognizable under Baldino v. Castagna, 478 A.2d 807 (Pa. 1984). Indeed, our Supreme Court has recognized a cause of action against a drug manufacturer when over-promotion of a drug effectively nullifies adequate warnings. See Baldino, 478 A.2d at 810. However, in her complaint, Appellant did not make any averments that [defendant] marketed [the drug] in a manner that negated its warnings concerning [the drug's] risks. Therefore, Appellant’s alleged “negligent marketing” claim does not fit within the rubric of Baldino’s over-promotion cause of action, and fails to state a claim upon which relief could be granted.Owens, slip op. at 12-13.

The second novel claim to bite the dust was “negligent failure to withdraw [the drug] from the market” - a failure to recall claim. The Superior Court joined unanimous precedent in rejecting that theory:

Appellant’s contention lacks merit. In [a prior case], this Court refused to recognize a duty to retrofit a product. Following the natural direction . . ., this Court is persuaded by the majority of modern jurisdictions that have decided not to impose a common law duty to recall on a manufacturer. We conclude, accordingly, that in Pennsylvania, a drug manufacturer does not have a duty to withdraw or recall a prescription drug from the market.Owens, slip op. at 13 (citations omitted).

The third novel claim was "negligent failure to test":

Pennsylvania law has not recognized an independent tort for negligent failure to test. In fact, this Court has held that the claim for negligent failure to test is not a viable cause of action recognized by our courts.Owens, slip op. at 14 (citation and quotation marks omitted).

--Posted By Bexis to Drug and Device Law at 7/30/2010 08:00:00 AM

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