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 precedent 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.

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.Continue Reading Thoughtful PMA Preemption/Pleading Decision