Everybody defending PMA medical device defendants should read Parker v. Stryker Corp., 2008 U.S. Dist. Lexis 84938 (D. Colo. Oct. 22, 2008), granting a preemption-based Rule 12(b)(6) motion to dismiss.
Parker contains a number of useful holdings:
(1) Under Twombly a plaintiff can’t state a claim simply by alleging that the defendant “violated FDA regulations” without alleging some facts to back up the claim. Id. at *8.
(2) A “parallel” violation claim is not stated by “by reference to provisions of the FDCA that govern the sale of adulterated and misbranded devices because there is no private right of action under the FDCA.” Id. at *9. For more on the tension between “parallel” violation claims and the lack of a private FDCA right of action see our post here.
(3) Alleging warning letters is not sufficient to state a claim without some facts tying the letters to the plaintiff’s case. Id. at *10-11.
(4) Express warranty claims based on statements made in FDA-approved product labeling are preempted. Id. at *12-15.