We are no strangers to odd facts leading to odd results. The law develops in response to situations. When new or different situations arise, courts have to interpret the existing law and then apply it to the new circumstances. Usually the changes evolve over time – a twist here, a turn there. Legal precedent is hardly ever a straight line. There are even a few right angle turns and the occasional u-turn. Sure, there are a few straightaways as well – concepts so deeply rooted as to withstand almost any challenge. But more often than not, when there is a true dispute, it’s about those twists and turns. The places where authority is split or where the precise issue has yet to be dealt with. And when you have both unique facts and split authority – you get decisions like Raab v. Smith & Nephew, Inc., — F.Supp.3d –, 2015 WL 9026631 (S.D.W.Va. Dec. 15, 2015).
Plaintiff underwent a hip resurfacing surgery in which defendant’s PMA, Class III medical device was implanted. Due to a fracture of the device, a revision surgery was needed during which some of the PMA device components were replaced with Class II, §510k cleared components. Plaintiff suffered complications after that surgery as well and eventually underwent a third surgery where all of the defendant’s devices were removed. Id. at *1.
Recognizing that she would be facing a preemption challenge to any allegations concerning the PMA device, plaintiff broke her complaint into three sections. Section I focused exclusively on the first surgery and purported to allege parallel violation claims premised on the FDCA’s Current Good Manufacturing Practices (CGMPs). Section II focused on the revision surgery and off-label use/promotion allegations. Id. at *2. Section III was directed only at the Class II device that was inserted during the second surgery and alleged strict products liability, breach of implied and express warranties, and failure to warn. Id. at *3.
The Raab decision is long and thorough. It devotes pages to discussing the FDCA, pre-market approval and 510k clearance. It also contains a detailed discussion of the core preemption decisions – albeit slightly skewed in our opinion. It is in the application of that precedent where things get a little wonky.
As to the PMA device, plaintiff’s only allegations were that defendant failed to comply with the CGMPs – general, open-ended, non-device specific regulations that state that the defendant should adopt some sort of process for doing X, Y, or Z. Plaintiff did not cite to a single PMA, device-specific regulation that defendant allegedly violated. Id. at *12. You don’t have to look too far on this blog to uncover what we think of CGMP claims – they are “intentionally vague and flexible standards” that “lack the specificity necessary to support a parallel claim.” Id. The Raab court acknowledges but discounts the courts to have so ruled. Instead, Raab questions why the “generality” of the federal regulation should make a difference in determining whether plaintiff has stated a parallel claim. We don’t need to go back to Riegel to answer that question. The Supreme Court addressed it this year in Armstrong v. Exceptional Child Center, Inc.,___ U.S. ___, 2015 WL 1419423 (U.S. Mar. 31, 2015):
Explicitly conferring enforcement of this judgment-laden standard upon the Secretary alone establishes, we think, that Congress wanted to make the agency remedy that it provided exclusive, thereby achieving the expertise, uniformity, widespread consultation, and resulting administrative guidance that can accompany agency decisionmaking, and avoiding the comparative risk of inconsistent interpretations and misincentives that can arise out of an occasional inappropriate application of the statute in a private action.
Armstrong, 2015 WL 14194231, at *5. The Supreme Court has spoken — vague statutory provisions coupled with an express administrative remedy, precludes private enforcement in the courts.
The discussion of these CGMP claims gets even more muddled when the court adds to the equation (a) a malfunction theory (because the device failed it must be defective); (b) negligence per se (pushing aside Buckman implied preemption), Raab, 2015 WL 9026631 at *13; and (c) a disregard for TwIqbal. As to TwIqbal, the court’s reasoning seems to mirror it’s feelings on the CGMPs – general and non-specific is fine to withstand a motion to dismiss and allow the plaintiff to get to discovery. But this ignores that the TwIqbal plausibility standard is a factual sufficiency standard and that the Supreme Court has said that Rule 8 “does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.” Ashcroft v. Iqbal, 129 S. Ct. 1937, 1950 (2009).
The ultimate holding of Raab on preemption as to the PMA device is that a claim that the FDA-approved design was defective is preempted but plaintiff is given leeway on the claims that the defendant failed to comply with the CGMPs. Id. at *15. See id. at *20n.1 (“This Court determines that the plaintiffs’ first two claims for relief are not preempted only to the extent they allege noncompliance with federal regulations and the FDA approval process.”).
Section II of plaintiff’s complaint focused on plaintiff’s doctor’s decision to revise her surgery using some Class II medical device components – in other words, off-label use. Plaintiff’s first claim was that defendant failed to file a PMA supplement seeking approval for the way the device was utilized by her surgeon. Here the court got it right – the FDA does not regulate the practice of medicine. Id. “Accordingly, to the extent the plaintiffs seek to impose liability on the defendant based on [her doctor’s] off-label use of the BHR system, they seek to impose a requirement that is in addition to any provision of federal law and are expressly preempted from doing so.” Id.
The allegations then switch from off-label use to off-label promotion. Here the court recognizes that a claim based on the device’s labeling would be preempted but that as to other promotion, the decisions are split and the split centers on whether the FDCA prohibits off-label promotion across the board or whether that off-label promotion also must be false and misleading. Id. at *16. The court concluded it did not have to weigh in on that debate, finding that for these claims, plaintiff did not meet the TwIqbal standard:
The claim for relief neither identifies a specific federal standard applicable to any device manufactured by the defendant nor describes how such violation supports a negligence claim under West Virginia law. As such, the fourth claim for relief does not sufficiently plead a valid parallel claim
Id. But even more interesting about this portion of the decision is that the court seems to be saying that the “misbranding” regulations relied on by plaintiffs are non-specific enough to support her parallel violation claim:
What all of these these asserted violations have in common is an allegation that the defendant was negligent because it failed—in
unspecified ways—to market its product in accordance with statutory provisions that merely empower the FDA to impose regulations of its choosing on devices it chooses to define as “restricted.” Critically though, Plaintiffs do not allege that any of the devices at issue were actually classified as restricted devices under § 360j(e), nor do they specify any regulation or restriction enacted by the FDA under any of the cited statutory provisions and made applicable to any device manufactured by the defendant.
Id. at *17 (plaintiff’s off-label promotion claim “fails to create an inference that any federal law was violated because it does not identify any substantive federal requirement made applicable to any device at issue). This is what we mean when we say odd facts make for odd law. Here it seems to have led to a split in authority within the decision. We won’t quibble with the second ruling.
That brings us finally to Section III – straight state law claims against the Class II devices used in the revision surgery. As to strict liability design defect, the court once again relied on the malfunction theory to allow plaintiff’s claim to proceed beyond the pleadings stage. Id. at *18. The court likewise and not surprisingly allowed the failure to warn claim to stand as well. Id. On her breach of warranty claims, the court ruled that an implied warranty of merchantability claim is co-extensive with the design defect claim and therefore allowed for the same reasons. Plaintiff’s claim for breach of implied warranty of fitness for a particular purpose was dismissed because plaintiff failed to allege a particular purpose that differed from the device’s ordinary purpose. Id. The court also dismissed the express warranty claim because plaintiff failed to allege any representations as to quality made to her or on which she relied. Id.
So, if you tally everything up – plaintiff can take some discovery on the alleged CGMP violations but she can’t use them to sustain a challenge to the FDA-approved design of the PMA device and her design defect and failure to warn claims regarding the 510k cleared device remain. While there’s quite a bit of reasoning and language in this decision we could live without, the overall holding isn’t horrendous. And that’s about as far as we’ll go on this one.