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

It was the best of decisions (Scovil v. Medtronic, Inc., __ F. Supp.2d __, 2014 WL 502923 (D. Ariz. Feb. 7, 2014), it was the worst of decisions (Coleman v. Medtronic, Inc., No. B243609, slip op. (Cal. App. Jan. 27, 2014).  Scovil may not be truly the “best” of decisions and Coleman isn’t all bad either.  So what?  We have a little artistic license to make our point – that being the several inconsistencies between the most recent decisions to come out of the InFuse litigation. In fact, our point may be better made by the second clause of the opening to Dickens’ classic tale:  “It was the age of wisdom, it was the age of foolishness.”  We’ll begin with wisdom.

We’ve been reporting on the notable success Medtronic has had in the InFuse cases across the country (see here, here, here, and here).  And, to be fair we acknowledged the couple of cases that went the other way.  The worst of which is Ramirez v. Medtronic, Inc., __ F.Supp.2d __, 2013 WL 4446913 (D. Ariz. Aug. 21, 2013).  But Ramirez just had its wings clipped − being significantly limited by the ruling in Scovil.  Like in all of the other InFuse cases, plaintiff here alleged that the device was used in an off-label manner and that as a result he suffered injury. Plaintiff brought ten causes of action: manufacturing defect, failure to warn, design defect, negligence, fraud, intentional misrepresentation, violation of the Arizona Unfair Competition Law, breach of express and implied warranties, negligence per se, and strict liability.  Scovil, 2014 WL 502923 at *2.  For reasons that will be apparent when we get to the foolishness portion of this post, we note that the plaintiff here conceded that his negligence per se action is preempted.  Id. at *13 n.3.

The Scovil court spent ten pages discussing FDA preemption generally, including the poor Ninth Circuit Stengel decision and the equally unpleasant Ramirez decision.  It doesn’t appear that plaintiff pleaded a Stengel-claim (failure to warn the FDA) here and fortunately the court opted not to follow Ramirez. First the court held plaintiff’s manufacturing and design defect claims were preempted finding that in approving the manufacturing and design for the InFuse device, off-label uses were “necessarily a consideration in the risk-benefit analysis the FDA undertakes during the PMA process.”  Scovil, at *9.  Thus, a “finding that the [manufacturing] process was unsafe would necessarily undermine the FDA’s finding that the benefits of its manufacturing process for on-label uses outweighed the risks presented by off-label uses.”  Id.  The court applied the same reasoning to the design defect claim, id., to plaintiff’s negligence claim to the extent it was based on negligence in researching, manufacturing, selling, labeling, testing, distributing and analyzing, id. at *10, and to plaintiff’s strict liability claim.  Id.  at *12.

The court similarly dismissed plaintiff’s failure to warn claim “because it would create an additional duty to disclose information to patients and doctors that the FDA does not require to be disclosed.”  Id. at *10.   The Scovil court was unpersuaded that off-label use required a different conclusion, rejecting almost entirely the reasoning of Ramirez.

Marketing and promotion claims, however, were carved out as not preempted. The court equated negligent marketing with off-label promotion in violation of federal law.  Id.  But, because plaintiff’s claim was grounded in negligence, the court found it fit within the “narrow gap” of non-preempted claims.  The court also found plaintiff’s fraud and misrepresentation claims to be parallel violation claims.   The claims are based on allegedly false statements which are prohibited by both state and federal law.  Id. 

While Scovil wasn’t a complete victory, it significantly pared down plaintiff’s claims but more importantly it opened up a split in authority in Arizona – watering down Ramirez in that jurisdiction and limiting plaintiffs’ ability to effectively use it elsewhere.

So, if Scovil was our “season of light,” Coleman is our “season of darkness.”  It is another InFuse decision in which allegations of off-label use and promotion take center stage.  Plaintiff Coleman based his claims on allegations of manufacturing defect, failure to warn and off-label promotion.  Coleman, slip op. at 2. Plaintiff apparently opted not to appeal the dismissal of his fraud, misrepresentation and unfair competition claims.  Id. at 5 n.2.  The Coleman decision also contains a lengthy discussion of preemption law, but with cites to Stengel, Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Bausch v. Stryker Corp., 630 F.33d 546 (7th Cir. 2010) it’s not a version we support. Toss in misplaced reliance on In re Farm Raised Salmon Cases, 42 Cal.4th 1077 (2008) and we had generally lost any hope for a happy ending.

Like we mentioned at the start, not all of Coleman is bad.  The first thing the court did was separate plaintiff’s failure to warn claim into three different theories and dismissed two of them.  Failure to warn based on a claim that Medtronic should have given warnings different than those approved by the FDA is preempted.  Coleman, slip op. at 13.  Also preempted is any failure to warn claim premised on off-label promotion.  The court found that federal “adulteration” and “misbranding” regulations are not “genuinely equivalent” to the requirements imposed by state common law in the failure to warn context.  Id. at 16.  On this point, the Coleman court directly rejects the reasoning and conclusion of Ramirez. Id. at 17-18.  But that’s where the good news ends.

Plaintiff’s third failure to warn theory is a Stengel claim – failure to provide adverse event information to the FDA after FDA approval.  California state courts aren’t bound by Stengel, but this one “elected” to follow it.  Id. at 14.  Disappointing, but not unbelievable.  You all know what we think of Stengel; we won’t re-hash.  Similarly, you know what we think of Bausch.  So, you won’t be surprised that we weren’t happy with Coleman’s reliance on it to allow plaintiff’s manufacturing defect claim.  Coleman accepts the legal proposition that a plaintiff can state a claim for a manufacturing defect premised on non-specific allegations of failure to comply with Current Good Manufacturing Practices (CGMPs).  Id. at 22-24.  In other words, plaintiff doesn’t have to plead how the defendant violated federal regulations – a “general allegation” is enough.  At least the court acknowledged that the claim might be preempted, but was willing to defer that ruling until after some discovery.  Id. at 24.

While the Stengel and Bausch claims aren’t to our liking, our real problem with Coleman is that it allows negligence per se to escape preemption.   Remember what we mentioned above?  The plaintiff in Scovil conceded that his negligence per se claim was preempted.  Even Ramirez, for all its flaws, found negligence per se preempted:

[A] claim for negligence that is premised solely on a manufacturer’s violation of a federal standard—here the FDCA and MDA—is impliedly preempted. . . .The responsibility for enforcing the FDCA and MDA lies exclusively with the federal government. 21 U.S.C. § 337(a); Buckman, 531 U.S. at 352, 121 S.Ct. 1012.

Accordingly, federal regulations cannot be hijacked by private plaintiffs. As a practical matter, manufacturers that have to comply with the FDA’s detailed regulatory requirements knowing that they have to answer to the FDA for any violations would also face the knowledge that any of the 50 states could also be policing the manufacturer’s compliance with those laws under the guise of negligence actions. Id. at 350–51, 121 S.Ct. 1012. That regime might produce a situation where “disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.” Id. at 351, 121 S.Ct. 1012. That was the problem in Buckman. Negligence claims where the duty and breach are imported from the FDCA and MDA produce those very same concerns.

[Plaintiff]’s negligence per se claim is premised wholly on violations of the FDCA and MDA. That is the entirety of this claim, and like the fraud claim premised solely on the violations of the FDCA in Buckman, is impliedly preempted.

Ramirez, __ F.Supp.2d __, 2013 WL 4446913 at *18-19. The critical point is that the FDCA gives exclusive enforcement authority to the federal government. “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. §337(a). That means that nobody – not even a plaintiff – is supposed to be able to come into court claiming that somebody else violated the FDCA or any FDA regulation.

So, how did Coleman get it so wrong? Here comes the misplaced reliance on Farm Raised Salmon’s “it’s not federal, it’s state law” rationale.  Coleman, slip op. at 22.  Farm Raised Salmon was a food case and as such, the California Supreme Court based its decision on a food-specific amendment to §337(a).  That section, part of the 1990 Nutrition Labeling Act, provides that “no State. . .may directly or indirectly establish under any authority or continue in effect as to any food. . .any requirement for the labeling of food. . .that is not identical to the [federal] requirement.” 21 U.S.C. §343-1(a).  As we discussed at considerable length, the ruling against preemption in Farm Raised Salmon is entirely and exclusively based on the “negative implication” of §343-1(a) – that states may enforce “identical” requirements” with respect to “food” pursuant to the Nutrition Act amendments to the FDCA.  Indeed, when we first commented on Farm Raised Salmon, we noted that the court’s extensive reliance upon §343-1(a) was a silver-lining for prescription drug and device cases.  To this day Congress has not enacted anything that detracts from or contradicts its original decision to prohibit private enforcement with respect to drugs and devices.  But Coleman ignores this critical difference.

Ignoring that distinction means that there’s nothing to prevent the craziness of California food litigation from now spilling over into prescription drug and medical device litigation.  Look at the result here.  The court found failure to warn based on off-label promotion to be expressly preempted because FDA adulteration and misbranding regulations are not parallel to state law failure to warn.  But, a negligence per se claim

based on the theory of off-label promotion is neither expressly nor impliedly preempted, because if parallels the federal requirements prohibiting misbranding and adulteration. . . In pursuit of a state negligence claim, Coleman is arguing that Medtronic violated its duty of reasonable care, which would parallel the federal duty to comply with the regulations prohibiting misbranding and adulteration.

Id. at 20-21.  The court is allowing plaintiff to use negligence per se as a state-law end run around §337(a)’s prohibition against private enforcement, on the basis of a food case that turned on an exception to §337(a) that only applies to food cases. That’s simply wrong.

And it’s worse than just wrong.  At least manufacturers of PMA devices like InFuse have the Riegel preemption defense, but drug companies and 510k device manufacturers don’t even have that.  The potential is that they could wind up in a worse position than even food manufacturers, who also at least have partial preemption defenses.  Coleman leaves us very concerned that in California we could be on the brink of a “winter of despair.”