The Middle District of Florida in Gallant v. Ortho-McNeil-Jannsen Pharmaceuticals, Inc., 2014 U.S. Dist. LEXIS 131769 (M.D. Fla. Sept. 29, 2014), recently addressed a plaintiff’s negligence per se and fraud claims in the Risperdal litigation. It dismissed the negligence per se claim, a claim that is a bit unusual for a drug case. While device plaintiffs often use such claims to try to avoid preemption, plaintiffs in drug cases ordinarily don’t have that concern. But, ordinary or not, the claim remains improper.
Negligence per se claims generally seek to treat statutory requirements as standards of care that, if violated, create a private cause of action for someone injured thereby. But that can’t and shouldn’t work when FDA regulations are involved. Section 337(a) of the FDCA reserves to only the government the authority to bring an action for violations of the FDCA and FDA regulations. And the Supreme Court in Buckman clarified that only the FDA is authorized to police violations of its own regulations.
Against this background, it’s clear why violations of FDA regulations (including those that may or may not address off-label promotion) cannot support a state-law negligence per se claim. To allow such a claim would be to allow an improper circumvention of Section 337(a) and Buckman. And so Florida courts do not recognize such claims:
Gallant argues that Defendant’s failure to abide by the FDCA demonstrates a deviation from the standard of care owed to Gallant and, therefore, demonstrates that Defendants were per se negligent or reckless. However, district courts in this Circuit have consistently held that negligence per se claims premised on violations of the FDCA and/or FDA regulations are barred because Florida does not recognize such causes of action.
Id. at *4-5 (citing Small v. Amgen, Inc., No. 12-CV-476, 2014 U.S. Dist. LEXIS 28904, 2014 WL 897033, at *6 (M.D. Fla. Mar. 6, 2014); Kaiser v. Depuy Spine, Inc., 944 F. Supp. 2d 1187, 1192 (M.D. Fla. 2013); Cook v. MillerCoors, LLC, 872 F. Supp. 2d 1346, 1351 (M.D. Fla. 2012)).
And so this particular foray into negligence per se claims in drug cases ended quickly, with a dismissal, as it should have.
The Court also dismissed plaintiff’s fraud claims. Plaintiff, as plaintiffs often do, provided a laundry list of alleged misrepresentations and omissions:
[T]he Complaint alleges a series of misrepresentations and omissions committed by Defendants, including “[f]ailing to publish or report negative studies about Risperdal;” “[p]resenting false and misleading studies and reports concerning Risperdal;” “[f]ailing to file accurate and timely reports of post marketing adverse events;” and “[d]istributing promotional materials . . . which were false, misleading and/or lacking in fair balance.” The Complaint also alleges that Defendants sent healthcare professionals a false and misleading letter that minimized Risperdal’s risks and that Defendants “knew or should have known about articles written by independent researches . . . that demonstrated an association between atypical antipsychotics, including Risperdal, and serious and life threatening adverse effects . . . .”
But these are fraud claims, and that means that plaintiff must satisfy FRCP 9(b)’s particularity pleading requirements. And plaintiff’s broad allegations didn’t even identify the misstatements:
[O]ther than the conclusory allegations set out above, Gallant does not identify with particularity any allegedly false statements. As such, the Complaint lacks any facts concerning the substance and details of Defendants’ allegedly fraudulent conduct and, accordingly, Defendants have not been alerted to the precise misconduct with which they are charged.
Id. at *6-7. And so these claims were also dismissed.
Now, plaintiff did bring failure to warn and warranty claims, which we are more accustomed to seeing in drug cases, And, for now, those are essentially the only claims that the plaintiff has left.