The toughest thing about defending product liability cases is the occasional immersion in human misery. Securities and antitrust cases pose intellectual challenges but they are, in the end, pretty much about money. By contrast, the plaintiffs in our cases are claiming injuries to their bodies, not just their wallets. Sometimes those alleged injuries are phony or trivial. Mostly, though, they are real. You wouldn’t wish them on your worst enemy. Every once in a while, the alleged injury is unspeakably sad. That sadness hits us extra hard when the injury involves a child. For instance, several of the plaintiffs in SJS-TEN cases were children. Try to imagine what it would be like to be on the other side of the courtroom in such cases. And then there are cases brought after a child or adolescent committed suicide. No parents want to outlive their children. And the ending of a life so prematurely must be devastating. It must also be infuriating. It would be natural to blame the catastrophe on a drug. It might even be right to do so. Or it might not.
In Patton v. Forest Labs, Inc., 2018 U.S. Dist. LEXIS 160368 (C.D. Cal. Sept. 19, 2018), the plaintiffs alleged that their daughter committed suicide after taking the antidepressant Lexapro. After some dismissals and amendments, the Second Amended Complaint (SAC) was teed up for another motion to dismiss. There were claims for relief based on negligence, violation of California’s Unfair Competition Law (UCL), and wrongful death. The claims were based on allegations that the anti-depressant was marketed in such a way as to mislead the FDA, doctors, pharmacists, and the public about suicide-related risks. In considering the motion to dismiss the SAC, the court “again extends its condolences.” But the court still dismissed the SAC without leave to amend.
The central obstacle for the Patton SAC was that the suicide warning was quite clear. The Highlights section of the Lexapro label contained a boxed warning about the “[i]ncreased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.” The plaintiffs argue that the warning should have been stronger. One can always conceive of ways to enhance a warning, but the possibility of such enhancements does not mean that the original warning was not adequate. The label warned in plain and explicit terms of the specific risk that caused the alleged injury. The plaintiffs’ pleading as to why the failure to say more in the warning constituted negligence was, to say the least, confusing and amorphous. The plaintiffs pointed to nondisclosure or understatement of risks, and also inserted allegations of other misconduct, including purported violations of a Corporate Integrity Agreement. None of it mattered, because the Patton court held that the warning at the relevant time was adequate as a matter of law.
The Patton court also held, after reciting the holdings in Levine, Mensing, and Bartlett, that the warning claims were preempted because the plaintiffs could not point to any newly acquired evidence to support a label change. (This same issue was central to the case we discussed yesterday.) Moreover, there was another reason why the usual resort to the Changes Being Effected provision would not work: the change to the suicide warning would need to appear in the Highlights section, and changes to the Highlights section cannot be done without prior FDA approval. (The inability to make unilateral changes to the Highlights section might ride in to the rescue of many defendants.) The Patton plaintiffs argued that preemption did not reach claims for breach of warranty and fraud, but there was no claim for breach of warranty, and the fraud claim (part of the UCL) did not come close to satisfying the heightened pleading requirements for fraud claims, because it involved statements allegedly made to “unspecified audiences at unspecified times.”
The Patton plaintiffs’ fundamental contention was that the defendants were required change the drug label based on new information (even if we do not know exactly what the new information was). The Patton court’s rejection of this argument is worth quoting: “While it is obvious that the FDA, in approving the relevant Lexapro initial labeling and not yet requiring Defendants to change their label, disagreed with Plaintiffs, even if the FDA were wrong, only the government (i.e., not Plaintiffs) may bring a lawsuit to enforce the FDCA and the FDA’s regulations requiring Defendants to change their label.” The Patton court then cited Buckman, completing the quartet of essential drug and device preemption SCOTUS cases.
Because this was the Second Amended Complaint, and because futility had been demonstrated to a fare thee well, the Patton court dismissed the SAC with prejudice. Thus was a sad tale brought to its conclusion.