We recommend the recent decision in White v. Stryker Corp., 2011 U.S. Dist. Lexis 32568 (W.D. Ky. March 25, 2011), as a thoughtful discussion of "parallel" violation claims and pleading in the wake of the first wave of appellate predecent on the subject. White is a Trident Hip case, and those almost always focus on the acetabular cup component of this PMA approved device. Trouble was, the plaintiff's complaint wasn't very good, and that doesn't cut it anymore. The court's description of the original complaint:

"Paragraphs 7 through 14 of the original complaint make general allegations concerning the defectiveness and dangerousness of the design, manufacture, assembly, inspection, testing and marketing of the Trident System. No where does the original complaint make mention of federal regulations.

White, 2011 U.S. Dist. Lexis 32568, at *3. One would have thought that, with Riegel over two years old, now, the other side would have gotten the message that parallel claims are essential. The court allowed plaintiff an amendment, but the second time around wasn't much of an improvement:

"Paragraph 2 states that "defendants failed to manufacture [the Trident System] according to FDA approved standards and procedures for medical devices." Subsequent paragraphs assert the original causes of action and then add the same generic allegations concerning FDA standards and procedures. . . . The Amended Complaint neither cites any particular federal standard or procedure, nor does it generally state how the alleged defect deviated from a federal standard or procedure.

Id. That's a pretty weak effort. As the court points out, id. at *22, it's not as if this device has never been litigated before. If the facts could support a viable violation claim, the information's available to plead it.

Anyway, the court in White goes through the usual Riegel preemption analysis, which can be summed up as PMA = preemption - parallel claim. 2011 U.S. Dist. Lexis 32568, at *4-10. We note the court's liberal use of the FDA's "Summary of Safety & Effectiveness Data" for the device, which is posted on the FDA's website. The court doesn't address the issue of judicial notice, but we assume that's what it is doing.

So then we get to the critical issue, whether there's enough "there" there to conclude that a plausible parallel violation claim has been stated. Quite appropriately, the court commented that this issue "has generated more debate and less consensus than one might have hoped. 2011 U.S. Dist. Lexis 32568, at *10. What makes White noteworthy, is its thorough discussion of that "debate." The court marches through the five relevant appellate decisions (Howard, Sprint Fidelis, Bausch, Funk, and Wolicki-Gables) and "comment[s] on each." 2011 U.S. Dist. Lexis 32568, at *13.

Howard "suggests that alleging a violation of a sufficiently specific GMP amounts to alleging a parallel claim that escapes MDA preemption," but is unpublished and non-precedential. 2011 U.S. Dist. Lexis 32568, at *14-15.

Sprint Fidelis held "that the more general GMPs were not specific enough to constitute a federal standard and thus establish a parallel claim" but "specific" GMPs may be different. 2011 U.S. Dist. Lexis 32568, at *16.

Bausch "require[s] the least amount of pleading specificity," but that plaintiff had "included several key facts" - an FDA warning letter about the same device asserting nonconfirmity with GMPs, and that the plaintiff's device was recalled - that made out a "plausible on its face" violation claim. 2011 U.S. Dist. Lexis 32568, at *17.

Funk was another Trident case with a "generic and conclusory" complaint that "did not say how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process." Dicta suggested that an amended complaint (never appealed) might have been sufficient, and the White court even went to the trouble to dig up that complaint, which "cited the less specific GMPs, not device-specific PMA standards." 2011 U.S. Dist. Lexis 32568, at *18-19.

Wolicki-Gables "requir[es] the greatest level of pleading specificity," that a plaintiff must "allege a specific PMA-specific regulation or standard violation." 2011 U.S. Dist. Lexis 32568, at *19.

White then held that none of these "disagreements" were "consequential" because plaintiff, after being given a chance to amend, "has not alleged any specific manufacturing failure, has not alleged the violation of any specific federal standard. Id. at *20. The allegation of the purported violation fell far short of the mark:

"It does not assert either a PMA-specific standard or a GMP regulation, the violation of which might form the basis for a state law action. . . . In the face of the narrow pleading window required to avoid preemption, Plaintiff has done virtually nothing.  

Id. at *21. That killed the plaintiff under Sprint Fidelis, Funk, and Wolicki-Gables. But it didn't even pass muster under Bausch. First, there was no need for discovery, since "[a]n abundance of cases and information describe the Trident System and its PMA approval process." 2011 U.S. Dist. Lexis 32568, at *22. Second, unlike Bausch, there was no allegation that the violation pertained to the device implanted in the plaintiff. "Plaintiff does not allege that the recall pertains to the particular device that was implanted in him." 2011 U.S. Dist. Lexis 32568, at *23. Thus, the plaintiff in White was dismissed with prejudice, which we think was a correct result based upon scholarly analysis.