We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.
We adopted a Drug and Device Rescue Cat this week. Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago. We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted. And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.
In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case. Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.
Forest moved for summary judgment, arguing that (1) federal law preempted plaintiff’s state law claims; 2) the warning was adequate; 3) there was no evidence that a different warning would have prevented decedent’s suicide; and 4) there was no evidence to support an award of punitive damages. Muzichuck, 2015 U.S. Dist. LEXIS 5440 at *2-3.
Preemption
Faced with strong preemption arguments, plaintiff conceded in her opposition brief that she did “not claim that Forest could have added a Black Box warning to Lexapro’s label, or could have provided a Patient Medication Guide, without prior FDA approval.” Id. at *16. The Court, telegraphing its position, commented, “[I]t is hard to see how preemption continues to play any role in this case.” Id. Lexapro, however, is an SSRI, and given the FDA’s history with SSRIs and suicide, there are good preemption arguments. See, e.g., Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp. 2d 1264 (W.D. Okla. 2011), and posts here and here. Nonetheless, those “impossibility preemption” arguments got short shrift from this court. Rather than discuss Forest’s regulatory facts in any depth, the court cited a bunch of bad SSRI preemption cases, disagreed with the good ones, and concluded that “clear evidence” did not support preemption. Id at *16-22. It’s an unfortunate but common post-Levine result, demonstrating only that balanced applications of Levine remain elusive. Here, given the good stuff coming up, it was not even necessary to address preemption. Adequacy of the Warning
Plaintiff’s specific causation expert argued that Lexapro’s warning was inadequate because it failed to provide information about early warning signs of incipient suicidality, and failed to warn that suicide risk was highest in the early months of treatment or when the dose was changed. Forest contended that the Lexapro package insert in effect when plaintiff’s decedent was treated included all of this information. Id. at *23-24. Plaintiff’s general causation expert conceded that these warnings were in the package insert, but argued that the warnings were inadequate because they did not include a black box or updated medication guide. Id. at *26. Oops. Those are precisely the claims that plaintiff conceded were preempted because Forest could not have taken those steps without prior FDA approval. To avoid preemption, plaintiff effectively ejected her own expert. Hence, as the Court observed, “Without the possibility of a black box warning or an updated medication guide, [plaintiff’s general causation expert’s] opinion is reduced to a ratification of Forest’s warning that he admits was placed in Lexapro’s April 2004 label. Thus, the Court concludes that there is no material issue of fact in dispute about whether Forest’s warning regarding the risk of suicide associated with the use of Lexapro was adequate.” Id. at *27 (internal quotation marks omitted). Now we are getting somewhere. And the good stuff continues.
Adequacy of Forest’s Efforts to Warn
In West Virginia, in addition to including adequate content in its warnings, a manufacturer must “undertake adequate efforts to communicate that warning.” Id. (citations omitted). The Court pointed out that “the two alternatives proposed by [plaintiff’s regulatory expert] – a black box warning and a medication guide – have been abandoned by [plaintiff] in order to avoid Forest’s preemption defense.” Id. at *27-28. Nevertheless, plaintiff argued that Forest could have:
1) sent a “Dear Doctor” letter to decedent’s prescribers; 2) sent a communication to decedent; or 3) updated Lexapro’s suicide warning based on the FDA’s October 2004 Public Health Advisory. Id. at *28.
The Court first commented that, “[c]ritically, none of these alternatives is based on expert testimony.” Id. (citations omitted). Oops number 2. The court went on to hold that, in any event, a “Dear Doctor” letter would not have provided decedent’s prescriber with any information he had not already seen, as the prescriber testified that he “routinely read package inserts in order to stay current on antidepressant medications.” Id. (internal punctuation and citations omitted), and Forest could not have sent a warning directly to decedent because there was no evidence that Forest was aware of decedent before he filled his prescription. Finally, the FDA’s Public Health Advisory specifically advised Forest not to implement labeling changes until it received agency notification, and that notification was not provided until a month after decedent’s suicide. Id. at *29-30. The Court concluded, “. . . [Plaintiff’s] contention that . . . the question whether a manufacturer’s efforts to warn were adequate is always for the jury regardless of the state of the evidence is erroneous.” Id. at *30. Because plaintiff had not submitted relevant expert testimony, and had adduced no “evidence that her proposed alternative means of warning were viable,” there was “no material fact in dispute about whether Forests efforts to warn by way of its package insert were adequate.” Id. at *31. Heeding Presumption Here’s a final good point, on West Virginia law. There’s no learned intermediary rule, so the question becomes whether the patient was adequately warned. Here, the patient was dead and the prescriber unhelpful, so Plaintiff urged the Court to apply a “heeding presumption” to conclude that decedent would have read and heeded an adequate warning if it had been given. Id. at *32-33. The Court pointed out that West Virginia had never adopted a heeding presumption, id. at *33, and that other courts had explained that the presumption “operates to the benefit of the manufacturer where adequate warnings are in fact given.” Id. (citations omitted). Since the plaintiff’s own expert (except for the issues abandoned to avoid preemption), conceded that Lexapro’s suicide warning was adequate, and other evidence established that decedent had actually read the warnings in the package insert, the plaintiff came up short again. “Thus,” the Court held, “even if a heeding presumption were applied in this case, based on the evidence of record, it would not raise a genuine dispute of material fact.” Id. at *34.
The Court concluded, “Though [plaintiff’s] claims are not preempted, Forest has satisfied its burden of demonstrating the absence of any genuine issue of material fact regarding its alleged failure to warn.” As such, the Court demonstrated that a mass tort plaintiff with lifeless arguments and conflicting experts should not opt out, but should accept the gift of a guaranteed payday. Let’s hope the cat tool is as efficient.
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Posted By Rachel B. Weil to
Drug and Device Law at 1/29/2015 04:30:00 PM
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