We read lots of cases. A few are flawless and a few have no redeeming features, but most have a little bad mixed with the good, or vice versa. We tend to be curmudgeonly, even though we are down a curmudgeon, and we will fuss about a flaw in a opinion that rules in favor of a drug or device maker. Aaron v. Wyeth, No. 2:07cv927, slip op. (W.D. Pa. Feb. 19, 2010), is such a case.
The facts are unfortunate: Randy Aaron was diagnosed by his psychologist as having serious psychological problems, including major depressive disorder and delusional disorder. The psychologist told Aaron’s primary care physician’s office that Aaron should be evaluated for antidepressants. For some reason, Aaron’s case ended up with another doctor who wasn’t Aaron’s regular physician, just part of the same practice group. This other doctor prescribed Effexor for Aaron without talking to the regular physician or the psychologist. Slip op. at 3. Over the next 11 days, Aaron continued to have problems, told his psychologist that he stopped and started taking his medication, and eventually committed suicide. Id.
Instead of suing the doctors (we’ve blogged before about how a lot of the cases we see are really malpractice cases in disguise) Aaron’s estate representative sued Wyeth, the maker of Effexor. The claims were mostly the usual thing – supposedly inadequate warnings about the risk of suicide in adults and that those supposedly inadequate warnings rather than serious mental illness caused Aaron’s suicide. After discovery, Wyeth moved for summary judgment, arguing that the warnings adequately told the prescriber of the risk at issue and that the failure to warn claims were preempted.
We’ll start with the good news: the court granted summary judgment and found that the warnings were adequate and non-causal despite some weaselly testimony from the prescribing doctor about whether the labeling warned about the risk of suicide in adults. The court first recited familiar principles of Pennsylvania law that the only possible claims against a prescription drug maker are manufacturing defect (not alleged) and negligent failure to warn and that the manufacturer’s only obligation under the learned intermediary doctrine was to warn the prescriber. Slip op. at 9-12. The court then looked at the labeling and found that the labeling appeared to advise the prescriber about the specific risk at issue in the case, the risk of suicide in adult patients. Id. at 12-13.
Plaintiff had tried to challenge the labeling with an expert report saying the label was inadequate. The court rejected the report because it was unsworn, and plaintiff had not made the expert available for deposition. Such unsworn testimony isn’t competent evidence on summary judgment because Rule 56(e) requires an affidavits, not unsworn documents. Slip op. at 13-14. We are cheered to see the court enforcing the express requirements of the rules, as courts too often consider unsworn stuff, especially from experts. We’re pleased – but perplexed. This is the kind of thing that’s usually easily fixable by plaintiff’s counsel. There’s something going on that didn’t make it’s way into the opinion; we suspect any fix would not have made a difference, so counsel decided not to bother.
But what cheered us even more was the court’s handling of the prescriber’s deposition testimony. For some reason, the prescriber testified that he “recalled” that the labeling’s suicide warnings applied only to pediatric and adolescent patients, not adult patients, and he persisted in this testimony even after he was shown the actual warnings at his deposition. Slip op. at 14. Basically he “recalled” something that was demonstrably false. We can only speculate why the prescriber gave this testimony. Perhaps he was trying to help the estate of his former patient because the plaintiff was pointing the finger at him (funny things happen when plaintiffs, but not defendants, can have informal chats with prescribers) for writing a script without investigating the facts. Perhaps the prescriber was not so good at reading drug labels, although we thought that would be required to get through medical school and licensing.
Now many judges would have thrown up their hands at this point, figuring that the prescriber’s mushy testimony created a factual issue, and denied summary judgment. To his great credit, the judge did not do that. He first recited several admissions by the prescriber that he was aware of the suicide risks regarding depressed patients and antidepressants. Slip op. at 14-15. The court then found that the prescriber had “read the appropriate literature regarding Effexor, and was therefore warned of the relevant risks.” Id. at 15. His demonstrably incorrect belief that the warning did not apply to adults was “of no moment.” Id. That is as it should be. Drug makers have a duty to put appropriate warnings in their labeling. They do not have a duty to ensure that a learned intermediary understands information written to be read by the medical community, and they cannot be held responsible if the prescriber falls below the reading comprehension expected of a professional.
The bad news is at once familiar, novel, and ambiguous, if that’s possible: The court rejected preemption as an alternative ground for summary judgment. That isn’t newsworthy, you might say; courts have been rejecting preemption defenses with depressing regularity since Wyeth v. Levine, including a decision in an SSRI/suicide case that we reported yesterday. A drug maker still should be able to establish a preemption defense consistent with Wyeth v. Levine if the FDA rejected the additional warning that the plaintiff claims should have been used, as we have discussed before.
Here’s the troubling part of Aaron: Wyeth tried to follow this path by arguing that the FDA repeatedly rejected different or additional warnings. Courts that reject this argument usually say that the FDA did not consider or reject the exact warnings at issue in the case. The Aaron court, however, appeared to fault Wyeth for failing to push harder for approval after the FDA had rejected proposed warnings. The court said: “Though the FDA disagreed with certain changes to the Effexor labeling proposed by Wyeth, Wyeth did not press its position, it instead acquiesced to the requests made by the FDA. . . . . Such evidence does not definitively show it was impossible for Wyeth to enhance its safety warnings in place at the time of Aaron’s suicide.” Slip op. at 9.
Whazzat you say?
This suggestion that a drug maker can refuse to “acquiesce to the requests made by the FDA” and must “press its position” even after the FDA has rejected a proposed warning strikes us as, to use a term not found in the Diagnostic and Statistical Manual of Mental Disorders, crazy. Surely a drug maker need not have a record of begging for reconsideration, appealing to higher authorities, disobeying requests from the FDA, and holding its breath until it turns blue in order to show that it was impossible to use a warning rejected by the FDA. And the FDA would not like a legal standard that requires drug makers to plead their cases again and again after rejection by the FDA in order to establish preemption. That makes unnecessary (not to mention annoying) extra work for the Agency.
Now the Aaron opinion is ambiguous about exactly what happened in Wyeth’s interactions with the FDA. Maybe FDA personnel merely made discouraging comments about proposed labeling in informal discussions, and Wyeth never asked for an agency decision on proposed labeling (but we doubt it). We don’t know, and the opinion doesn’t clearly tell us. So Wyeth has to take the good, with the bad, with the ugly.
Because the opinion is ambiguous about exactly what happened and because the court granted summary judgment on another ground, the opinion’s comments about Wyeth not pressing its position harder are (thankfully) mere dictum. We could ignore such little bits of dictum, but they are like weeds that can grow when fed the noxious fertilizer that comes from plaintiffs’ counsel. This weed should be yanked out before it spreads.