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

Since September we’ve been bringing you news from the Infuse litigation on about a monthly basis.  The overwhelming majority of that news has been positive.  And, when you’ve got a good thing going, you want to keep it going.  You also don’t want to bore your audience, so here are a bunch of links if you are interested in what’s transpired so far (here, here, here, and here).

In a nutshell, plaintiffs largely have been ineffective in getting courts to overlook preemption simply because the PMA medical device at issue was used off-label by plaintiffs’ surgeons.  That really is the crux of their argument – that off-label use should take the case outside the realm of Riegel express preemption and Buckman implied preemption because the use was not one reviewed and approved by the FDA.  But, the FDA approves devices for indications and in so doing, “contemplates that approved [devices] will be used in off-label ways.”  United States v. Caronia, 703 F.3d 149, 166 (2d Cir. 2012).  “[O]ff-label usage of medical devices . . . is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”  Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).  With that, most of the courts that have considered the Infuse cases start their analysis from the same place they would start in any PMA medical device case – acknowledging that very few causes of action survive the “narrow gap” between Riegel preemption and Buckman preemption.

Today’s cases are no different.  They are Schouest v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 38123 (S.D. Tex. Mar. 24, 2014) and Blankenship v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 39063 (E.D. Mo. Mar. 25, 2014).  In both cases, plaintiffs tether their claims to allegations of off-label promotion and failure to warn of risks associated with off-label uses.  As the Schouest court put it, plaintiffs essentially bring two claims:  “on the one hand, that Medtronic did not do enough [failure to warn], and on the other, that Medtronic did too much [off-label promotion].”  Schouest, 2014 U.S. Dist. LEXIS 38123 at *16.  Both theories present problems for plaintiffs.

Failure to warn is probably the easiest claim for court’s to dismiss.

The FDA proscribed the precise labeling that the device was required to carry. Medtronic cannot deviate from that labeling without the FDA’s permission. Under Riegel, a . . . jury finding that labeling inadequate would be tantamount to a requirement that Medtronic do something “different from, or in addition to,” what the FDA already approved.

Id. at *22.  See Blankenship, 2014 U.S. Dist. LEXIS 39063 at *17-18 (“Plaintiff’s failure to warn claim would establish labeling and warning requirements different from, or in addition to, federal requirements for the Infuse Device.”).

Both courts likewise dismissed plaintiff’s design and manufacturing defect claims as expressly preempted “because [they] would require the Infuse device to be designed or manufactured differently that the FDA authorized.”  Schouest, at *33-34.  The Blankenship court directly addressed and rejected the notion that off-label use somehow changes the analysis:

Plaintiff’s claim is that the manufacturing process became defective as a result of Medtronic’s promoting the Infuse device for off-label uses. This argument purports to impose liability on the manufacturer despite the manufacturer’s compliance with the applicable FDA design and manufacturing specification[s], as approved by the FDA during the pre-market approval process[.]  Thus, plaintiff is attempting to impose responsibilities on Medtronic that are different from, or in addition to, the federal requirements.

Blankenship, at *16-17 (citations omitted); see id at *18-20 (dismissing design defect
claim as preempted finding that “plaintiff does not allege the design of Infuse
was anything other than the design approved by the FDA”).

In both cases, plaintiffs also brought negligence and negligence per se claims.  In Blankenship, the court described plaintiff’s claims as singularly based on improper off-label promotion.  Id. at *20-21.  And therefore, found them impliedly preempted because off-label promotion is not “conduct that would give rise to a recovery under state law [ ] in the absence of the FDCA.”  Id. at *23 (citation omitted) (off-label promotion doesn’t exist except by virtue of the FDCA).  The Schouest court parsed out plaintiff’s negligence claims to apply what it determined was a critical distinction between truthful off-label promotion and negligent misrepresentations. The former is expressly preempted because truthful off-label promotion may not violate federal law, see discussion at Schouest, *16-21, and therefore a jury finding may or may not impose requirements different from or in addition to FDA requirements.  Id. at *29.

With respect to misrepresentations (negligent and fraudulent in Schouest and fraudulent in Blankenship), however, both courts found that such claims can survive preemption:

[M]aking false or misleading statements about medical devices is prohibited by federal law. This means that Schouest’s state law fraud claims based on false off-label promotion would, if proven, also amount to a violation of federal law, and thus such claims could survive preemption.

Schouest at *24-25; Blankenship at *28-29 (finding fraud and misrepresentation claims are parallel violation claims).  This is a fairly common result in these cases.  Both courts also found that Rule 9(b)’s pleading with particularity requirement applied to these claims.  In Blankenship, the court found the requirement was not met and dismissed the claims without prejudice.  Id. at *30.  Also a common result.  While the Schouest court chose not to undertake the analysis since plaintiff was going to be given an opportunity to amend her complaint anyway.  Schouest at *43-44.

One other quick note on both cases.  In each, it appears plaintiff premised a claim on allegations of failure to submit adverse event reports to the FDA.  Blankenship, governed by Eighth Circuit law (In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1205-06 (8th Cir. 2010)), found such a claim impliedly preempted as “an attempt by private parties to enforce the MDA.”  Blankenship at *18.  While Schouest, governed by Fifth Circuit law (Hughes v. Boston Scientific Corp., 631 F.3d 762, 775 (5th Cir. 2011)), was required to allow such a claim.  Schouest at *31-32.  We say was required, because the Schouest court acknowledged that the claim sure sounded like a preempted fraud-on-the-FDA claim to them, but that they were stuck with it anyway.  The Schouest court also seems to be requiring more detailed pleading of this claim, directing plaintiff in her amended complaint to “point to a state law duty to report adverse events, and, critically, what FDA reporting regulations Medtronic allegedly violated.”  Id. at *31.  That’s about as good as we could hope for in the Fifth Circuit.

While that’s it for Blankenship, Schouest also alleged express and implied warranty claims.   And again, the dividing line for the court was between a claim alleging that the defendant should have done more (implied warranty) and a claim that defendant made affirmative misrepresentations (express warranty).  A breach of implied warranty claim, therefore, was more like failure to warn — preempted because “federal law governs all statements that Medtronic is obligated to make.”  Id. at *35.  Whereas plaintiff’s

express warranty claim can survive to the extent she seeks to recover based on false warranties that Medtronic voluntarily and falsely made beyond the federally approved warning because [f]ederal law already requires [Medtronic] to ensure that any warranty statements it voluntarily makes are truthful, accurate, not misleading, and consistent with applicable federal and state law.

Id.  But this too is only theoretical because plaintiff’s complaint fails to include a description of the specific warranties allegedly made to her or her surgeon. Plaintiff is being given a chance to fix this in her amended complaint.

Both courts came at their decisions from different directions, but with the exception of where their hands were tied by circuit law, reached the same result.  Plaintiffs are getting a second bite at the apple, but it’s a much smaller apple.