These parallel violation claims, they seem to vex some courts, and then frustrate us.  We think it should be fairly simple to apply preemption when the medical device in question in the litigation was approved under the FDA’s PMA process.  TwIqbal pleading principles should make it even easier.  If a plaintiff’s state-law claims have requirements different from or in addition to federal requirements, they’re preempted.  If they don’t have enough detail for the court to make that analysis, they should be dismissed under TwIqbal.  If they seek to enforce the FDCA or FDA regulations, they should be dismissed because there’s no private right of action under the FDCA.  Yet, still, some courts seem to miss these basic principles when considering Riegel’s “parallel” violation exception to preemption.

Take Hawkins v. Medtronic, Inc., 2012 WL 4364171 (S.D. Oh. Sep. 24, 2012).  Please.

There, the plaintiff used a device cleared under the FDA’s PMA process.  OK, so Riegel preemption is in play.  The plaintiff made typical claims – design and manufacturing defect, failure to warn, express and implied warranty, and negligent and intentional misrepresentation.  He also made a couple of more unusual claims called negligent handling and failure to report.  He plead few facts on the device’s regulatory history and fewer on how the device or the defendant deviated from FDA regulations.  What plaintiff did instead was recite in his complaint the language from the Ohio Revised Code that authorized claims for manufacturing and design defect and failure to warn, lay out the common-law elements to his warranty claims, and provide a string of very general provisions from the FDCA and CFR about medical devices.

For the court, this was enough.

Looking at all this general language, the court held that the defect, warranty and failure to warn claims could survive a motion to dismiss because they were “premised on the theory that Defendant violated federal law.”  Id. at *6, *7, *8.  But, as we’ve said on this blog many times, private plaintiffs aren’t authorized to enforce the FDCA or FDA regulations.  Only the United States can do that.  (Note: the misrepresentation, failure to report and negligent handling claims, for unsatisfactory reasons, were dismissed.)

Continue Reading Parallel Violation Claims – Why So Hard?