Law

A few weeks ago, a judge for the Southern District of Ohio, applying Ohio law, granted in part the defendants' summary judgment motion in a fentanyl patch case. Importantly, the court killed the plaintiff's core failure to warn claim, as well as smacking down a "fraud on the FDA" claim in cursory fashion. Miller v. ALZA Corp., 2010 WL 5287514 (S.D. Ohio Dec. 17, 2010). The decision is strong on warning causation and Buckman preemption, and is notable for those reasons alone. It's just too bad the court let some other flimsy design defect, manufacturing defect, and fraud claims survive.

Fentanyl patches deliver narcotics to patients with severe chronic pain. Fentanyl is a really, really powerful drug, and doctors know this; it's about 80 times stronger than morphine. Miller, 2010 WL 5287514, at *1. The plaintiff brought an action under Ohio law as administrator for the estate of a fentanyl patient who died after suffering a fentanyl overdose. The evidence suggested that an excessive amount of fentanyl leaked through the patch, leading to "fentanyl intoxication."

The core failure to warn claim alleged that the defendants should have warned of the risk of overdose "by leaking or otherwise." Id. at *3. The plaintiffs proffered a couple of warnings experts – neither of them medical doctors – who opined that the label should have instructed doctors to check for leaks, and should have warned doctors that, even when used "appropriately," the patches can result in serious consequences, including death. Id. at *3-4. The decedent's prescribing physician, however, testified that even an allegedly "adequate" warning, along the lines of what the experts recommended, would not have made a difference. The court found that the prescribing physician testified "unequivocally" that he would have prescribed the patch even if specifically warned about leakage or the risk of death, and knowing everything he knows, the doctor still would prescribe the patch to the decedent. Id. at *5-6.

The plaintiff attempted to manufacture a warning causation fact issue by pointing to testimony suggesting that the prescriber "would have more closely monitored" the decedent had there been a more specific warning in the package insert relating to the risk of overdose. Id. at *6. On this point, it was refreshing to see the court's approach; rather than denying summary judgment in knee-jerk fashion, the court looked critically at the plaintiff's monitoring argument and concluded that it didn't add up, for a couple of reasons. First, the doctor testified that he was already generally "monitoring" the decedent "on a daily basis" because of the decedent's radiation treatment. Second, the doctor testified that the actual fentanyl level in the decedent's bloodstream was "irrelevant" to the doctor's treatment decision. Finally, the prescriber testified that he would have never read fentanyl level tables in the package insert. Id. at *6-7. So there you have it: sticks by the decision, wouldn't do anything different, and wouldn't even read the additional risk information – a veritable triple crown of helpful prescriber testimony, and in Ohio, worthy of summary judgment.

The opinion is also notable for its cursory smackdown of the plaintiff's "fraud on the FDA" claim, and wholehearted embrace of Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004). The plaintiff, of course, said that he was not attempting to assert a Buckman-preempted claim for "fraud on the FDA," but the Complaint told another story: "Defendants fraudulently and in violation of applicable regulations of the FDA, withheld [information] from the FDA known to be material and relevant to the harm that the claimant allegedly suffered, or misrepresented to the FDA information of that type." Id. at *13 (alteration in original). That sure does smell like Buckman­ preemption to us, and we're glad the court wasted no time seeing through the plaintiff's ruse.

Because the court allowed design defect, manufacturing defect, and fraud claims to survive, the case is more of a solid double than a home run. But those claims are teetering too. The design defect claim survived only because the defendants did not assert that fentanyl is "unavoidably unsafe" and thus entitled to the protection of Ohio's statutory equivalent of comment K (Ohio's one of those goofy places where some courts make the "unavoidably unsafe" determination on a case-by-case basis, rather than treating the whole category of prescription drugs under the comment K rubric per se). The manufacturing defect and fraud claims survived because the court found some "circumstantial" evidence propping up those claims, even though there was no direct evidence that the patch malfunctioned, and plaintiff failed to identify any misrepresentations allegedly made by the defendants. Overall, however, the good outweighed the bad in this opinion, and future Ohio defendants will certainly add Miller to their arsenal of good cases on warning causation/fraud on the FDA.

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Posted By Will to Drug and Device Law at 12/30/2010 01:27:00 PM

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