Tuesday, April 17, 2012

Excellent New Pain Pump Preemption Decision – The Details

            We were so enthused by this new decision, we gave you the link to it yesterday.  Stengel v. Medtronic, Inc., No. 10-17755, slip op.  (9th Cir. April 16, 2012).  Nothing lifts our spirits quite like a dismissal based on both explicit and implied preemption.  But, if like us, you had a busy Monday, and haven’t had a chance to read it yet – here are the highlights.

            First, the product -- a Class III pain pump that received initial PMA in 1988 (modifications received PMA about a decade later).  Slip op. at 4089.  Next, the claims – state law tort claims for “strict liability, negligence, and breaches of express and implied warranties.”  Id.  Huh?  Someone is still filing these cases?  The Ninth Circuit didn’t even blink when it dismissed these claims pursuant to Reigel v. Medtronic, Inc., 552 U.S. 312 (2008):

The Stengels’ claims, as they appear in the initial complaint, are expressly preempted under section 360k and Riegel.  The claims generally challenged the safety and effectiveness of Medtronic’s pump without any hint of an allegation that Medtronic’s conduct violated FDA regulations.  To be successful, the claims would have required the trier of fact, as a matter of state tort law, to conclude that the device should have either been designed differently from what the FDA required through premarket approval, or labeled with warnings different from what the FDA required. Therefore, the district court correctly dismissed the Stengels’ initial complaint.

Stengel, slip op. at 4092. 
So the plaintiff, having belatedly become familiar with Riegel, attempted to amend his complaint to allege the same four causes of action, but this time tried to beef up his failure to warn claim with a “newly-proffered theory” that plaintiff’s injury was caused by defendant’s failure “to report information to the FDA, as was required by FDA regulations.”  Id. at 4089.  In short, the plaintiff tried to put forward a parallel violation claim.  But, plaintiff should have kept studying, because in his attempt to dodge Riegel and express preemption, he ran head first into our old friend Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) and implied preemption.

While the Ninth Circuit acknowledged that Riegel left open the possibility (as not expressly preempted) for a state law claim for alleged violations of federal regulations (a parallel violation claim), it also found that for such a claim to survive, it had to pass the test for implied preemption.  Stengel, slip op. at 4092-93.  In this case, that means Buckman.  Briefly, in Buckman the Supreme Court held that:  (1) implied preemption operates independently in the absence of express preemption, 531 U.S. at 352, and (2) claims for fraud-on-the-FDA were implied preempted because they interfere with the operation of the FDA’s enforcement and oversight responsibilities.  Id. at 348.  Similarly, in Stengel, “although the defendant had allegedly violated federal requirements, allowing the plaintiffs to bring a state cause of action to remedy the injuries caused by the violations would interfere with the congressional scheme.”  Slip op. at 4093. 

The Supreme Court reasoned that where a claim – such as fraud-on-the-FDA – is not based on a state law cause of action, but rather “exist[s] solely by virtue of the FDCA disclosure requirements,” Buckman, 531 U.S. at 352-53, it is preempted.  Relying on 21 U.S.C. § 337(a) (no private right of action to enforce FDCA), the Court found “it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Id. at 349 n.4. 

And, that’s where plaintiff Stengel’s parallel violation claims failed – they were nothing more than statutorily prohibited attempts to raise private claims that the defendant violated the FDCA.  Functionally, the failure-to-report claim was indistinguishable from the fraud on the FDA claim in Buckman.  The defendant’s purported lack of disclosure merely being “tacit” rather than “overt”:

There is no meaningful distinction between [plaintiff’s] failure-to-warn claims and the “fraud-on-the-FDA” claims held to be preempted in Buckman. . . .  The only difference is that, in Buckman, the defendant allegedly misinformed the FDA overtly by providing false information, whereas here the defendant allegedly misinformed the FDA tacitly by failing to report information that it had a duty to report. The policing of such conduct in both instances is committed exclusively to the federal government, and recognizing a state cause of action based on such conduct would conflict with the statutory scheme established by Congress. 

Stengel, slip op. at 4095.  The speculative nature of the claim was also the same – that is, like Buckman, Stengel also invited a jury to speculate that the FDA would have done something different (required a label change) had it received different information than it actually did from the defendant manufacturer.  Id. at 4094 (“[plaintiff’s] theory is that if Medtronic had acted with reasonable care in complying with the regulations . . . the FDA would have required Medtronic to warn physicians about the danger of inflammation connected to its pump”).

The plaintiff’s claims were also, as in Buckman, naked allegations of regulatory violations, not resembling any traditional tort claim.  The Stengel decision recognized that failure to report claims were creatures of federal, rather than state, law:

The federal regulations that Medtronic is alleged to have violated, which require investigation and disclosure to the FDA in a particular manner so that the FDA can make a decision whether notification of consumers is necessary, are not tied to this general duty to warn consumers under Arizona law. Thus, the Stengels’ failure-to-warn claims, to the extent they survive express preemption, exist solely by virtue of the FDCA disclosure requirements and are, therefore, impliedly preempted.
. . .

We offer no opinion as to whether a particular state claim that is tied directly to compliance with federal law would be preempted under Buckman. In this case, the duty of manufacturers under federal law to report to the FDA information regarding their devices is not tied directly to the duty of manufacturers under state law to warn consumers of a device’s dangerous condition. On the contrary, the enforcement of the duty to report is an element of the federal scheme that is committed solely to the federal government.

Stengel, slip op. at 4096 and 4097.   
            So, plaintiff tried another dodge – arguing that his case was distinguishable from Buckman because here, unlike in Buckman, the FDA had sent the defendant a warning letter, “show[ing] that the FDA had already determined that [defendant] violated its federal disclosure obligations.”  Id. at 4097.  Plaintiff, therefore, contended that he could prove his claims “without second-guessing the FDA’s decision making.”  Id.  But, the Ninth Circuit made short work of this argument because it was based on the concurrence in Buckman (see 531 U.S. at 354 (Stevens, J., concurring in the judgment)).  A concurrence “which disagreed with the majority specifically because the majority did not take the position now advocated by the Stengels.”  Stengel, slip op. at 4097.  Hence, it is not the law.

            The remainder of the Ninth Circuit’s discussion on preemption is about the circuit split on the very issue of whether state failure to warn claims based on a defendant’s alleged failure to provide the FDA with information are preempted by Buckman.  The Ninth Circuit joined the Eighth Circuit in finding the claims preempted, see In re Medtronic Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1205-06 (8th Cir. 2010), and rejected the reasoning – which we also criticized – of the Fifth Circuit in Hughes v. Boston Scientific Corp., 631 F.3d 762, 775-76 (5th Cir. 2011) which reached an opposite conclusion.  See Stengel, slip op. at 4098-99.   Since Hughes also earned our #2 worst decision ranking for last year , we think you can figure out who we think got it right.

            And finally, the cherry on top:  Stengel (like practically every recent decision) approves of taking judicial notice of FDA approval documentation to establish the PMA nature of the defendant’s device.  Slip op. at 4099-4100. That means plaintiffs can’t resort to strategic omissions in their complaints to avoid Rule 12 dismissal.

            Today’s lesson:  what Riegel giveth (parallel violation claim), Buckman taketh away – at least when the allegation is based solely on FDA disclosure requirements (and except in the Fifth Circuit).

1 comment:

Chip said...

"What _____ giveth, Buckman taketh away" was rejected on Tuesday by Judge Kramer in the California Reglan JCCP. In this case, the ____ is Wyeth v. Levine and decades of traditional state common law, and neither Mensing nor Buckman preclude bringing non-failure-to-warn torts against generic manufacturers. (Bexis - an add for your useful Mensing scorecard)

From the plaintiffs' perspective, it was so refreshing to hear a judge actually read quotes from Buckman into the record that demonstrate how Buckman doesn't do what y'all on the defense side want the courts to believe it did.