Those of us who live in Philadelphia are endlessly fond of rocking on our porches and reminiscing about the halcyon baseball season of 2008, when our beloved Phillies won the World Series. These days, we are resigned to a team that is, euphemistically speaking, “rebuilding.” In reality, all the team is building is a staggering record of losses and a groundswell of local incredulity about management’s “strategy.” On a recent visit to the ballpark on a glorious late spring day, the only excitement in the half-empty stadium was generated by the nine-patty cheeseburger (the “triple triple”) now available at a concession stand and the cute puppies the players’ wives carried onto the field for “Take Your Dog to the Game Day.” Player after player slunk back to the dugout after being dispatched by the opposing pitcher.
Such was the fate of the Plaintiff in an excellent decision from the Northern District of Illinois, granting summary judgment for Defendant in Shah v. Forest Laboratories, Inc., 2015 U.S. Dist. LEXIS 67554 (N.D. Ill. May 15, 2015). In Shah, transferred back to its home court after pretrial proceedings in the Lexapro MDL, Plaintiff alleged that Defendant Forest’s anti-depressant Lexapro caused his relative’s suicide. Plaintiff’s complaint contained the usual litany of claims – warnings claims sounding in strict liability and negligence, warranty claims (express and implied), and a strict liability/design defect claim.
As an initial matter, the Court considered Forest’s argument to exclude certain testimony by Plaintiff’s “regulatory expert,” Dr. Michael Hamrell. While Hamrell’s MDL report “addressed perceived inadequacies in warnings prior to 2005, he did not make findings related to 2008,” when Plaintiff was prescribed Lexapro. Shah, 2015 U.S. Dist. LEXIS 67554 at *7. In his deposition, “Hamrell conceded that the warnings provided in the package insert and medication guide for Lexapro in 2008 . . . were adequate.” Id. After the case was transferred back to the Northern District of Illinois, Plaintiff asked Hamrell to review a 2005 Lexapro brochure that was found in the decedent’s personal effects after his suicide. Hamrell then filed a supplemental report, concluding that the warning section in the brochure was ‘inadequate and out of date in comparison to what was required by the FDA in the current approved labeling for Lexapro in 2008 . . . [and] that the inadequate warning in the brochure was a substantial cause and contributing factor in the death of [Plaintiff’s decedent].” Id. at *7-8 (internal punctuation omitted).
The Court held that Hamrell’s opinion must be excluded as untimely, submitted without leave after MDL Daubert briefing was complete. We agree -- MDL proceedings would mean nothing if losing plaintiffs could get “do-overs” after remand.
Moreover, even if the report weren’t untimely, the Court found, “Hamrell’s conclusion reaches far beyond any supporting facts and offers nothing more than speculation as to whether Shah had even read the brochure. Thus, Hamrell fail[ed] to build a logical bridge of reasoning as to how he could opine with such certainty that the Brochure caused Shah’s suicide.” Id. at *9-10. The Court concluded, “Simply because Hamrell seeks to testify as an expert does not mean that he is free to offer his speculation and legal opinions to the jury on any subject.” Id. at *11. We love this. And we say it every time we file a Daubert brief.
Warmup completed, the Court moved on to Plaintiff’s strict liability claims. First, the Court gave the back of its hand to Plaintiff’s design defect claims, noting that Plaintiff had “failed to provide arguments or point to sufficient evidence showing that Lexapro is inherently dangerous based on its design.” Id. at *17. Then, in an alternative holding that made our hearts sing, the Court commented, “Defendants also correctly point out that, even if Plaintiff were to pursue such a theory, the claims would be preempted by federal law.” Id. What did the defendants argue? The opinion didn’t say, so we got our hands on the brief. Short and sweet:
Plaintiff includes conclusory allegations that Lexapro was defective in design, but does not allege how the design is defective. Notwithstanding, that claim fails for the simple reason that the United States Supreme Court has held that design defect claims involving pharmaceutical products are preempted. See Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013).
Defendant’s brief, Shah, at 5 n.1 (available here). As we exulted here, it is thrilling – and it is time – that courts are finally realizing that Bartlett preemption of design defect claims should apply to branded as well as generic drugs.
Next, the Court considered Forest’s argument that the learned intermediary doctrine barred Plaintiff’s warnings claims under Illinois law. In this case, the prescribing physician, who had done compensated work for Forest, testified “that she was informed of the newly discovered risks that were associated with Lexapro “ad nauseum” . . . and that representatives of Defendants would have met with her to discuss the necessary warnings with her.” Id. at *18. The Court concluded, “Plaintiff has failed to point to evidence showing that were defendants were in any way deficient in their efforts to inform [Plaintiff’s physician] regarding the risks associated with Lexapro and provide [her] with updated warnings.” Id. Thus, the Court concluded, “the undisputed facts show that Defendants did all that was required to adequately inform the physician . . . regarding the risks associated with taking Lexapro, and Defendants are entitled to protection under the learned intermediary doctrine.” Id.
In so holding, the Court rejected Plaintiff’s argument that the Court should hold that “the learned intermediary doctrine does not apply where pharmaceutical companies directly advertise their products to consumer or where a physician is compensated by a drug manufacturer.” Id. at *19. The Court, commenting that Illinois law did not recognize the “direct to consumer” exception, “decline[d] to alter the Illinois common law in such a manner that could effectively allow the exceptions to swallow the rule,” especially where there was “no evidence presented by Plaintiff that [his decedent] observed any Lexapro advertising.” Id. at *20-21. Moreover, the Court held that there was no evidence that the physician “was in any way biased or her judgment was questionable based on any compensation she received from a pharmaceutical company.” Id. at *21. Thus, “the Court decline[d] to make such sweeping changes to the learned intermediary doctrine as proposed by Plaintiff,” id.,holding, “The undisputed facts show that Defendants met their obligations in every regard when dealing with [the physician] . . . and are entitled to summary judgment in this case.” Id.
Though it did not need to, the Court next considered Forest’s argument that, “even if the learned intermediary doctrine did not apply, the package insert and medication guide that [Plaintiff’s decedent] received . . . was adequate as a matter of law to warn [him] of the risk of harm.” Id. at *22. The Court agreed, noting that it was undisputed that, in 2008, Lexapro’s labeling included a boxed warning and lengthy additional warnings about the risk of suicidality and concluding, “Plaintiff cites to no expert testimony, other evidence or law showing that the warnings that were included in the package inserts and medication guides for Lexapro in 2008 were inadequate at that time. Plaintiff has thus failed to satisfy his burden of proof on this point.” Id. at *28. Finally, the Court rejected Plaintiff’s argument that the 2005 Lexapro brochure found in his decedent’s possession was “inadequate to warn [the decedent] of the risks he faced when taking Lexapro.” Id. at *30. With some impatience, the Court agreed with Defendants that there was “absolutely no evidence that [the decedent] ever read the brochure,” concluding, “Plaintiff cannot, in the absence of any evidence proceed to trial and ask the trier of fact to speculate that the decedent read the brochure.” Id. Moreover, “even if Plaintiff had presented evidence tying the brochure to Defendant’s duty to warn and to show that [the decedent] had read the brochure, . . . [a]ny lack of warning in the brochure related to suicidality . . . would have been rectified when he received the warnings with his prescription.” Id. at *32.
And so, faced with Forest’s arsenal of explicit warnings and a thorough and emphatic prescribing physician, Plaintiff struck out. We have often lamented courts’ propensities to disregard clear law when faced with “bad facts.” Refusing to do this, the ShahCourt hit all the bases. Would that some of this magic might rub off on a team of misfits in South Philadelphia.