It’s Hip To Be Preempted, Again

We are celebrating an anniversary today:  We wrote our first blogpost on July 26, 2013.  Eleven years and hundreds of posts later, we have two observations.  First, we seriously need to update our blog profile photo.  Or maybe we will just ride out our blogging years promoting the fiction that we are younger and fitter than we actually are.  Second, the topic of our first blogpost was express federal preemption, because what would the blog be without a discussion of preemption? 

Express preemption did not prevail in that case eleven years ago, but what goes around comes around.  A federal court in Maryland ruled just the other day that the Medical Device Amendments to the FDCA preempted all state-law claims involving a metal-on-metal prosthetic hip replacement.  Moreover, the court’s order is noteworthy because this plaintiff tried most every avenue to get around express preemption, and the court shut down each route one by one. 

The plaintiff in Chiapello v. Corin USA Ltd., No. SAG-23-3149, 2024 U.S. Dist. LEXIS 129332 (D. Md. July 23, 2024), attributed a whole host of physical and mental issues to his FDA-approved metal-on-metal hip replacement, and his lawsuit alleged claims for design defect, failure to warn, and breach of implied warranty.  The problem for this plaintiff, however, was that his hip implant was a Class III medical device that the FDA approved under its rigorous pre-market approval process.  Id. at *2-*3.  We know from the Supreme Court’s landmark opinion in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that PMA devices are subject to express preemption.  The district court explained it as follows, in an eminently quotable passage: 

The FDCA’s statutory scheme contains two preemption provisions relevant to this case.  Congress specified that any action “for the enforcement, or to restrain violations” of the FDCA must be brought “by and in the name of the United States.”  21 U.S.C. § 337(a).  And the MDA provides that no state may impose “any requirement” regarding the safety or effectiveness of a medical device “different from, or in addition to, any [federal] requirement . . . .”  21 U.S.C. § 360k(a).  Together those two statutory provisions preempt “nearly all types of claims concerning FDA-approved medical devices.” 

Id. at *8-*9 (emphasis added) (quoting In re Medtronic, Inc., Sprint Fidelis Leads, 592 F. Supp. 2d 1147, 1161 (D. Minn. 2009)).  We like this quote for a couple of reasons.  First, it echoes the essential statutory language, which prohibits state requirements “different from or in addition to” federal requirements.  Second, the court here is giving full credit to section 337(a), which grants the United States the exclusive power to enforce the FDCA.  Courts do not acknowledge often enough that there is no private right of action, but this court got it.  As we’ve discussed elsewhere, considering section 337(a) as an express preemption provision means that the benighted “presumption against preemption” does not apply.

Federal law therefore expressly preempted the plaintiff’s claims in Chiapello unless the plaintiff could plead a so-called “parallel claim”—a valid state-law claim that is parallel to federal requirements and therefore is not “different from or in addition to” federal requirements.  It is difficult to square the “parallel claim” exception with the lack of any private right to enforce the FDCA.  In addition, because so many federal requirements deal with submissions to the FDA, it is also difficult to square the “parallel claim” exception with Buckman, which holds that claims for “fraud on the FDA” are preempted, too. 

These issues led this district court to apply a two-prong test:

Essentially, then, to state a claim, a plaintiff [must] meet both prongs of a two-prong test: (1) the plaintiff must allege that the manufacturer failed to comply with a specific federal requirement applicable to the device, and (2) the plaintiff must explain how that violation . . . also violate a provision of state law, since the FDCA forbids a plaintiff from advancing a private claim. . . .

Chiapello, at *9-*10.  We like to focus on the second prong—a violation of state law.  Although it seems obvious, courts sometimes give this prong short shrift.  The most notorious example is the Ninth Circuit’s wrongly decided opinion in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013), which held that the plaintiff had stated a “parallel claim” under Arizona law that the defendant failed to warn the FDA about adverse events—a claim that does not exist under Arizona law.  (The Ninth Circuit also applied the “presumption against preemption,” which as mentioned, is now defunct in express preemption cases.  But don’t get Bexis started on that.) 

Having framed the issue this way, the district court in Chiapello rejected all seven of the plaintiff’s attempts to state parallel claims.  First, the plaintiff alleged deficiencies in the defendants’ design process, but that claim was preempted because it imposed additional design requirements more stringent that those imposed by the FDA.  Second, the plaintiff faulted the defendant for failing to conduct “adequate bio-compatibility studies.”  The plaintiff did not, however, cite any specific federal provision requiring bio-compatibility studies, so this too would have imposed additional requirements.  Third, the plaintiff pressed “component discrepancy allegations.”  The court did not understand these allegations, and the plaintiff alleged no facts to support them in any event.  Chiapello, at *14-*15. 

Fourth, parroting Stengel, the plaintiff alleged that the defendant violated FDA reporting requirements.  But, unlike the Ninth Circuit, this court did not fall for it:  “Several of these reporting duties are owed only to the FDA . . . .  To the extent these requirements would establish some duty owed to Plaintiff, Plaintiff has neither identified the duty existing under state law nor alleged any facts to substantiate a violation of any such duty.”  Id. at *15.  Amen.

Fifth, federal law preempted the plaintiff’s claim that the defendant failed to recall or stop marketing the devices because federal requirements permitted marketing.  Sixth, the plaintiff alleged a failure to address “non-conformance” and other quality control issues, but he did not identify a federal statute or regulation requiring such actions.  A state claim would just be adding on.  Seventh, and finally, federal law preempted the plaintiff’s claims for failure to train physicians and failure to warn because the plaintiff did not allege how the training failed to comply with federal requirements, and manufacturers are not permitted to deviate from FDA-approved warnings.  Id. at *16-*17. 

This is the correct outcome on all counts, resulting from a disciplined application of express preemption.  Many thanks to Andrew Kaplan at Crowell & Moring for sending the order our way.  

#Hip #Preempted

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