This post is from the non-Reed Smith side of the blog only.

It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two.  It is a tried and true metaphor, like its modern English counterpart -- between a rock and a hard place.  But it is particularly fitting in products cases dealing with pre-market approved medical devices.  So, even though it is another favorable InFuse decision and we probably would have blogged about it anyway, the court’s clever turn of phrase was enough to reel us in:

In light of Riegel and Buckman, a plaintiff can survive a preemption challenge to a state-law tort claim concerning an allegedly defective medical device only by steering between the Scylla of express preemption under § 360k(a) and the Charybdis of the impliedBuckman preemption of claims that exist solely by virtue of the FDCA. It is a challenge to avoid one obstacle without colliding with the other, because the plaintiffs must show that a manufacturer has violated federal law if they are to defeat express preemption, but the plaintiffs must also show that their legal theories predated the federal enactment or would exist independently of federal law if they are to defeat implied preemption.

McCormick v. Medtronic, Inc., 2014 Md. App. LEXIS 117 (Md. App. Ct. Oct. 6, 2014).  Well said!  And, as has been the case in most InFuse matters – plaintiffs crashed into both obstacles leaving only small bits of their vessel (complaint) intact.

We’ve blogged about dozens of InFuse cases at this point and you can peruse those posts at your leisure here.  And, if you are defending off-label promotion claims, we recommend a less leisurely stroll – there is a lot of good stuff in these cases.  All of the InFuse plaintiffs have attempted to sail between Riegel andBuckman preemption by tethering their claims to allegations of off-label promotion – and usually not much else. Overwhelmingly, courts have seen through the gambit and the claims have either been wrecked on the rocks or swallowed by the whirlpool.  This case is really no different, but it does make some good points that we wanted to bring to your attention.

First and foremost, this is a Maryland appellate court decision explicitly rejecting an awful Maryland trial court decision in another case that held that express preemption doesn’t apply at all where off-label promotion is alleged.  That decision was more a parting of the Red Sea for plaintiffs, giving them a wide berth right through preemption.  But, the McCormick court found that the reasoning of that trial court was correctly “almost universally rejected elsewhere.”  Id. at *33 n. 13.

Maintaining that plaintiffs were still required to maneuver between both express and implied preemption, the court found all claims preempted except those premised on false off-label promotion, including breach of express warranty. Misrepresentation claims, whether sounding in fraud or negligence, parallel FDCA prohibitions on untruthful off-label promotion and therefore are not expressly preempted.  Further, because fraud and misrepresentation are “traditional state common law” claims, they exist independently of the FDCA and are not impliedly preempted.  Id. at *34-37.  Importantly, the court is adamant that the non-preempted claims are only those involving allegations of misstatements or misrepresentations:

The claims are also impliedly preempted to the extent that they may concern the act of off-label promotion itself, divorced from any misrepresentations that Medtronic may have made in the course of off-label promotion. Such a claim exists solely by virtue of the federal statutes and regulations that concern misbranding, and the claim has no independent existence in Maryland law.

Id. at *40.  We would expand that last part to include any state law, but we see where that would be overreaching by the court.

Traditional failure to warn claims were also preempted:

These claims are preempted insofar as they attack the accuracy or adequacy of the statements that Medtronic made in the FDA-mandated and FDA-approved labeling.   To fault Medtronic for making the statements that the FDA required it to make, or to impose liability on Medtronic for not making statements that the FDA required it not to make, would be to impose state-law requirements that are "different from, or in addition to," those imposed by the FDCA.  

Id. at *34-35; *41 (preempted negligent failure to warn as well).

Finally, plaintiffs’ strict liability claim was vague at best, alleging only that “off-label use of the product . . . was defective, unsafe, and ineffective.”  Id. at *42 (emphasis in original).  In so far as plaintiff framed his claim around use, he sailed right into both express and implied preemption:

To the extent that the complaint would impose liability on the basis of the risk-utility or consumer-expectation tests, it is expressly preempted under § 360k(a). The FDA has approved the Infuse product, and the agency neither has prohibited nor can prohibit its off-label use by members of the medical profession. Because Maryland cannot impose different or additional requirements, the risk-utility and consumer-expectation allegations fail to state a claim.

The complaint also fails to state a claim insofar as it attempts to premise a products liability claim on off-label use: products liability law concerns products, not the uses of products. In any event, to the extent that the [plaintiff’s] products liability claim is a stand-in for a complaint about the off-label use of the Infuse product, it is impliedly preempted under Buckman, because the concept of illegal off-label use or promotion of a medical device would not exist but for the FDCA.

Id. at *43.  And while the court concluded that plaintiff wasn’t alleging a design defect claim, the opinion notes that such a claim would have been expressly preempted because “FDA has carried out the only permissible risk-benefit analysis as to the appropriate product design.”  Id. at *44 n. 17.     

As has also been the situation in many of the InFuse cases – while fraud and misrepresentation claims aren’t preempted, they also aren’t pleaded sufficiently.  In this case, the complaint lacked specificity as to when and how the alleged false statements were made.  Vague references aren’t enough to meet the heightened standard of particularity for fraud and therefore the claims were dismissed, but plaintiff is being afforded a chance to correct the defects.

The InFuse litigation continues to offer defendants calm seas and smooth sailing.  We’ll take that every time.