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Because we hail from San Francisco, we sometimes feel a certain hometown pride in the Ninth Circuit, whose San Francisco home is one of the most beautiful public buildings in the United States. Opened in 1905, the James R. Browning United States Courthouse underwent a spectacular renovation in the late 1990s and has survived two catastrophic earthquakes — the big one in 1906 and the one in 1989 that knocked down elevated highways and famously disrupted the World Series at now-decrepit Candlestick Park. We also frequently praise the Ninth Circuit here on the DDL blog for its sense of justice and learned contributions to drug and device law. But not today. The Ninth Circuit swung mightily and missed with McClellan v. I-Flow Corp., No. 11–35109, 2015 WL 294292 (9th Cir. Jan. 23, 2015), where the court allowed the plaintiff to proceed on a negligence per se theory based on alleged violations of the FDCA.  We have another name for claims like that—private enforcement of the FDCA, and the Supreme Court ruled that federal law impliedly preempts such claims more than ten years ago in Buckman.  In fact, this negligence per se scenario is where it seems most transparent that the plaintiff is purporting to enforce the FDCA and where Buckman should apply most strongly. Yet the Ninth Circuit somehow gave the plaintiff a green light.

How can this be?  The plaintiff underwent shoulder surgery and was prescribed continuous infusion of pain medicine through a pump, appropriately named the PainBuster.  Id. at *1.  After a second surgery, and further treatment with the infusion pump, the plaintiff experienced cartilage loss resulting in fusion of bones in her shoulder and severely restricted mobility.  Id.  Her lawsuit against the pump’s manufacturer went to trial on strict liability and negligent failure-to-warn claims, and the jury returned a defense verdict.  Id.

The plaintiff’s main beef was that the district judge refused to instruct the jury on negligence per se, and this is where the Ninth Circuit’s opinion starts to raise red flags.  You see, the court seems reluctant to inform the reader that the plaintiff’s proposed instructions sought to enforce the FDCA.  We are told the district court refused to give “jury instructions regarding negligence and federal standards” and declined “nine special instructions related to federal law.”  Id. at *2.  But in reversing the district court’s judgment, the Ninth Circuit never actually describes the contested instructions and is strangely imprecise in its discussion.  A quick review of the plaintiff’s motion for new trial confirms that the proposed instructions did, in fact, set forth legal standards from the FDCA and related regulations.  And worse yet, the plaintiff intended to argue that the defendant violated the FDCA through “expert” Suzanne Parisian, whom the district court excluded.  You won’t find any of this in the Ninth Circuit’s opinion, yet it seems directly relevant to implied preemption.
From there it is all downhill.  To begin with, the Ninth Circuit faulted the district court for failing to apply the “presumption against preemption.”  Id. at *3.  We can think of two reasons why the district court was absolutely correct to reject the “presumption against preemption”:  The Supremacy Clause of the United States Constitution and Section 337(a) of the FDCA, which says that “all such proceedings for the enforcement, or to restrain violations [of the FDCA] shall be by and in the name of the United States.”  21 U.S.C. § 337(a).  There is no room here for a “presumption,” but the Ninth Circuit spoke of it as though it were a default rule that the district court had to justify departing from.  As we have said before, that is the wrong analysis, and Buckman itself rejects it.
Next, the Ninth Circuit proceeded “with that presumption in mind” to find that Buckman did not apply because Buckman was a “fraud on
the FDA” case where federal statutes were “a critical element” of the plaintiff’s case.  Id. at *4.  The same, however, can be said for a negligence per se claim that is predicated on the FDCA, so that distinction really doesn’t work.  After all, what in negligence per se?
It’s the substitution of a governmental standard, here that of the FDA, for the “reasonable man” standard of negligence.  The federal standard in McClellan and any other FDCA-related negligence per se claim is beyond “critical” – it’s essential.  Without it, there is no such thing as “negligence per se.”
The Ninth Circuit further reasoned that Buckman “left the door open to state-law claims ‘parallel’ to federal requirements.”  Id.  But that does not make Buckman go away either because the concept of “parallel” claims is unique to express preemption.  Where a statute, such as the Medical Device Amendments, expressly provides that no state may establish requirements “different from or in addition to” federal requirements, courts have reasoned that “parallel” claims are outside express preemption because they are neither different from nor in addition to federal requirements.  That has nothing to do with Buckman, which involved implied conflict preemption.  Under that flavor of preemption, the relevant questions are whether it is impossible to comply with both state and federal law or whether compliance with state law would interfere with the purposes and objectives of federal law.  “Parallel claims” are not part of the analysis, and the Ninth Circuit was wrong to imply that they are.
The Ninth Circuit even managed to cite and rely on the Seventh Circuit’s poorly reasoned and wrongly decided opinion in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), which we called “execrable” just the other day and which stands as the “babbling zenith of parallel claim doofus-prudence.”  We outdid ourselves with that description, but you can tell that Bausch has gone down in our book as one of the worst cases of all time.
After setting forth legal reasoning that does not hold up, the Ninth Circuit concluded as follows:

In this case, we perceive nothing about McClellan’s requested instructions that conflicts with the congressional intent behind the MDA.  McClellan’s claims were not fraud-on-the-FDA claims. The failure-to-warn claims McClellan alleged did not arise solely by virtue of the MDA.  Further, there is no suggestion that Congress intended to displace traditional tort law by making all policing of medical labels and warnings the exclusive province of the FDA.

McClellan, at *4.  Let’s unpack that statement, because there are so many things wrong with it.  For one thing, the requested instructions do conflict with the congressional intent behind the FDCA (which the Ninth Circuit refers to as the MDA, although section 337 was enacted long before the MDA came about in 1976) because Congress prohibited private enforcement, which is what the instructions would have asked the jury to do.  Moreover, it does not make a meaningful difference in our minds that the plaintiff’s clams were not “fraud on the FDA” claims because they sought to enforce the FDCA regardless.  If anything, that is more offensive to the statute.

Still further, in emphasizing that the plaintiff’s claims did not arise solely out of the MDA and that the MDA did not “displace” traditional tort law, the Ninth Circuit has missed the point.  This plaintiff was allowed to present her failure-to-warn claims to a jury and was allowed to present evidence and argue that the manufacturer’s warnings were defective under state law and were beneath the state law standard of care.  In that regard, no one ever asserted in the district court that the plaintiff’s claims arose “solely” out of federal law, and the district court obviously did not allow federal law to “displace” state tort law.  In fact, we expect that the district court instructed the jury completely and thoroughly on the applicable state law, and the plaintiff had every opportunity to enforce that law at a jury trial, like plaintiffs do in medical device failure-to-warn claims every day.
The only thing the district court did not allow was a negligence per se claim bootstrapped onto federal statutes that cannot be enforced by private parties.  That was the correct decision, and the Ninth Circuit should have affirmed it.  It is still early, but we have it on good authority that this case is an early contender for our 2015 list of worst cases.  Stay with us until December to find out.