In Burgos v. Satiety, Inc., 2010 U.S. Dist. Lexis 125924 (E.D.N.Y. Nov. 30, 2010), the court held earlier in the week that all claims (negligence, strict liability, warranty) were preempted where plaintiff received the device in question (some sort of gastric stapling system) as part of an investigational device clinical trial. The entire discussion of IDE preemption is short, pithy, and sweet:
IDE devices remain under the supervision of the FDA during and after the trial process, and the FDA imposes strict requirements regarding design, manufacture, and safety, which preempt states from passing laws, whether court or legislature initiated, affecting such requirements. Because IDE devices are subject to a level of FDA oversight and control that is, for the purpose of a preemption analysis, identical to that governing PMA devices, the body of preemption law governing PMA devices applies equally to the IDE device at issue in this case.
Burgos, 2010 U.S. Dist. Lexis 125924, at *5-6 (citations and quotation marks omitted) (emphasis added). Proponents of IDE preemption might want to add this nicely turned phrase to their arsenal.
The plaintiff didn’t really plead any parallel violation claims – except in “blunderbuss” fashion, id. at *10, that is an “opaque reference . . . to ‘statutes, codes, laws, ordinances, rules [or] regulations,'” which the court held “is no substitute for a concise allegation of the statute or regulation upon which a parallel claim is based.” Id. at *11. Plaintiff was granted leave to amend.