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.)
Now, Riegel does provide a limited exception to preemption if there is state law with requirements parallel to – or that enforces – requirements that the FDA has imposed. But the court didn’t delve into whether Ohio had actually authorized such a claim by private plaintiffs.
In fact, the court conceded that the complaint did not allow it to compare the state and federal requirements at issue. Id. at *5, *6, *7, *8. Well, that’s a defective complaint under TwIqbal. Plaintiffs can’t do an end-run around TwIqbal with a complaint that does no more than invoke statutory and common law language unconnected to the particulars of their claims and place it next to general, non-device-specific language from the FDCA and FDA regulations. That’s conclusory language that could be used in any products complaint, regardless of the facts or plausibility of the claim. TwIqbal doesn’t allow it.
Thankfully, a few days later, something better came out of the Middle District of Florida. See McClelland v. Medtronic, Inc. (M.D. Fla. Sep. 27, 2012) (Slip. Op.). There, a patient’s estate brought negligence per se and failure to warn claims arising from the implantation of a pacemaker. As in Hawkins, the plaintiff made state-law claims premised on alleged violations of federal regulations. As in Hawkins, the plaintiff’s complaint set out those state law claims and general federal regulations. Unlike in Hawkins, however, the court took a good look at the claims and regulations to determine whether there was actually a viable claim. There wasn’t.
First, the court recognized the well-established principle that the FDCA does not authorize a private right of action to enforce the terms of the FDCA or underlying FDA regulations. (Slip. Op. at 7-8). The court also checked into whether state law authorized such a cause of action, and found that it didn’t:
[U]nder Florida law, the violation of a statute can only give rise to civil liability if the statute indicates an intention to create a private cause of action. The FDCA expressly provides that all actions to enforce the Act “shall be by and in the name of the United States.” This language evidences legislative intent to prohibit a private right of action for a violation of the FDCA. Therefore, Plaintiff cannot assert a negligence per se claim based on violation of the FDCA or the FDA’s implementing regulation.
(Id. at 8). The court dismissed the negligence per se claim. Plaintiff just couldn’t state such a claim. The court also dismissed the failure to warn claim. It was no more than a recasting of the negligence per se claim that didn’t exist.
But the court also went on to discuss preemption, looking into the particulars of what plaintiff was claiming and whether it fit with the FDA’s regulation of the device. Plaintiff pointed to the FDA’s general regulations on adverse event reporting, arguing that defendant’s failure to report certain adverse events gave rise to negligence per se and failure to warn claims.
But reporting adverse events to the FDA is different from providing warnings to doctors or prospective patients. And, with preemption, being different is fatal:
Even if Defendant breached a state law duty to warn the decedent or her physician, Plaintiff has not directed the Court to any FDA regulation that requires a device manufacturer to unilaterally contact doctors or patients regarding a potential device defect without FDA involvement. Under Plaintiff’s theory of liability, Defendant would be required to provide information to physicians and patients beyond those on the device’s labeling. Accordingly, the state and federal requirements are not “genuinely equivalent” because Defendant could be held liable under the state law without having violated the federal law. In other words, Plaintiff’s claims are preempted . . . .
(Id. at 11).
Now, that’s more like it. The analysis of parallel violation claims isn’t that complex. And, when done properly, it should show how very limited the exception actually is.