Anyway, Bausch went south on not just one, but two, major issues: pre-market approved (“PMA”) medical device preemption and Twombly/Iqbal pleading. With respect to preemption, Bausch created a circuit split – explicitly backing the partial dissent in Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010) (we previously discussed Bryant here). Bausch, 2010 WL 5186062, at *6. That has the advantage of creating a direct circuit split over the extent of PMA preemption, and direct circuit splits are one thing upon which successful United States Supreme Court appeals are based.
But on TwIqbal, what Bausch is conceptually worse than just disagreeing with a decision we like. Rather, the court essentially rebelled against the spirit and letter of Twombly and Iqbal – two controlling decisions of the Supreme Court that it was bound by the fundamental workings of our court system to follow. Bausch’s rationale, as we will see, retreats to the “let discovery solve everything” mindset that TwIqbal overturned. In a sense, that’s not terribly surprising, since Judge David Hamilton had previously taken the same track (if less explicitly) in his previous opinion while still on a district court judge in Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009). As we’ve previously pointed out, Hofts had been widely rejected as contrary to TwIqbal. If you keycite Hofts on Westlaw, you’ll see that the decision has accumulated an impressive 10 adverse citations (only two of which are mere “distinguisheds”) in less than two years. But to become the first post-TwIqbal appellate court to raise the red flag of outright rebellion, Judge Hamilton seems to have acquired some new, and somewhat disturbing, allies.
Preemption first. In one sense Bausch is fairly narrow. It affirmed, or else plaintiffs didn’t appeal, the dismissal of everything in a product liability suite involving a PMA device other than so-called “parallel” violation claims. So even with Bausch there’s not a whole lot left to the suit. Real violation claims aren’t particularly easy to plead, but they’re even harder to prove, so this is just the beginning. The easy stuff to take to a jury – warning related claims, particularly – are out of the case.
But in another sense Bausch is shockingly broad. The opinion doesn’t exhibit any inclination at all to police what plaintiffs claim as purported violations. To explain properly what’s going on, we first ought to briefly (for us, anyway) recapitulate how this concept of “parallel” violation claims came to be.
It starts with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) – which certainly would have qualified for our “worst case” designation had we been blogging in 1996, as opposed to being in the throes of Bone Screw. Lohr was a pre-TwIqbal case on the pleadings, and as a consequence involved only extremely vague allegations of supposed FDCA violations. “[T]he precise contours of their theory of recovery have not yet been defined” but “it is clear that the Lohrs’ allegations may include claims that Medtronic has, to the extent that they exist, violated FDA regulations.” 518 U.S. at 495. Lohr responded that “[n]othing in §360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.” Id. The mere addition of a damages remedy did not render such duplicative state-law claims “different from” federal requirements. Id.
Next, in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), an implied preemption case, the court considered whether there was something in the FDCA – other than the §360k(a) preemption clause – that preempted the fraud on the FDA claims the plaintiffs claimed fell within Lohr’s “parallel” violation rationale. There was. The Court unanimously held that not every “violation of the FDCA will support a state-law claim.” Id. at 353. The unpreempted violation claims in Lohr “arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.” Id. Violation claims that “exist solely by virtue of the FDCA disclosure requirements,” id., were impliedly preempted because the FDCA “leaves no doubt that 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 (citing 21 U.S.C. §337(a)). Absent any independent state-law basis, private FDA fraud claims conflicted with and were preempted by the FDCA’s exclusive grant of federal prosecutorial authority. Id. at 353-54.
That brings us to Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), a non-FDCA case involving violation claims under a different statute. The Court found the particular claims unpreempted, but emphasized the importance of making sure that such claims actually were equivalent with the relevant federal requirements. Id. at 454. To “survive preemption” the state law claim, while it “need not be phrased in the identical language,” must be “genuinely equivalent.” Id. “[A] manufacturer should not be held liable under a state [parallel] requirement . . . unless the manufacturer is also liable” under federal law “as defined by [the agency].” Id.
In Riegel, however – unlike Lohr, Buckman, and Bates – “parallel” violation claims were not really at issue. Rather, the Court “decline[d] to address” such claims “in the first instance” because they had been waived. 552 U.S. at 330. In explaining itself, the Court stated:
State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law. Thus, [the Act] does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.Id. (quoting 21 U.S.C. §360k(a)(1)). We sometimes wonder whether the plaintiffs in Riegel did that deliberately. We can’t think of another occasion where any side benefitted so greatly from their own waiver. That’s because since Riegel, courts have unanimously considered this bit of pure dictum as establishing an exemption from PMA preemption for “parallel” violation claims. There's not much we can do about it, but that doesn't make this observation any less true.
Bausch is one of a number of cases involving a recalled PMA device, a total hip replacement system called “Trident.” A lot of the Trident cases we’ve seen involved causation issues, such as the alleged FDCA violations at a different location, or pertaining to a different device, or occurring at an impossible time (that is, after the plaintiff’s surgery), from the device the plaintiff got. E.g., Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668 (W.D. La. 2010); Gelber v. Stryker Corp., 2010 WL 4740432 (S.D.N.Y. Sept. 14, 2010); Bass v. Stryker Corp., 2010 WL 3431637 (N.D. Tex. Aug. 31, 2010); Anthony v. Stryker Corp., 2010 WL 1387790 (N.D. Ohio March 31, 2010); Covert v. Stryker Corp., 2009 WL 2424559 (M.D.N.C. Aug. 5, 2009). If that kind of funny business went on in in Bausch, the Seventh Circuit simply ignored it. We will, too.
Rather, the plaintiff alleged in Bausch that six days before a Trident was implanted in her, the FDA “informed the defendants that a component . . . was ‘adulterated’ and that [defendant’s] manufacturing processes failed to comply with federal standards.” Bausch, 2010 WL 5186062, at *1. Later, after plaintiff’s device had failed and another device had to be implanted, the defendant allegedly “recalled a component of the [device] bearing the same catalogue number as the one that had been implanted in” plaintiff. Id.
The district court found preemption and interpreted the “parallel” violation as applying solely to “an action that is premised on a state regulatory enactment that provides damages remedies for violations of FDA regulations.” Bausch v. Stryker Corp., 2008 WL 5157940, at *5 (N.D. Ill. Dec. 9, 2008), rev’d, ___ F.3d ___, 2010 WL 5186062 (7th Cir. Dec. 23, 2010). No such claim existed in Illinois, the relevant jurisdiction.
That’s even narrower than we’ve advocated here. We’ve always left open the possibility that a violation of an FDA manufacturing regulation that resulted in the production of a device that did not meet the manufacturer’s standards could state a “parallel” violation claim for manufacturing defect if that nonconforming aspect of the device was also responsible for the plaintiff’s injuries. If Bausch had just said that, we wouldn’t have been that bothered. But that’s not what Bausch did.
Rather, from the decision’s initial heading – entitled the “limited scope of §360k,” we knew we were in for a Hofts-like hatchet job on preemption. 2010 WL 5186062, at *2. Bausch discussed Lohr and Riegel and stated that they “expressly left the door open for state law claims based on violations of federal law.” Id. Expressly? Was there any mention of the plaintiff’s outright waiver of the violation in Riegel? No, that unpleasant fact was whitewashed away. Instead, Bausch opined:
The Supreme Court [in Riegel] has made clear that section 360k protects a medical device manufacturer from liability to the extent that it has complied with federal law, but it does not extend protection from liability where the claim is based on a violation of federal law. In other words, where state law is parallel to federal law, section 360k does not preempt the claim.2010 WL 5186062, at *4 (emphasis original). That’s a helluva way to characterize the Supreme Court’s disposition of a waived point.
Even though the Supreme Court in Lohr never used the term, Bausch equated the vaguely pleaded Lohr claims with negligence per se. 2010 WL 5186062, at *5. We know that because Bausch cited six Illinois negligence per se cases. These are: Kalata v. Anheuser-Busch Companies, Inc., 581 N.E.2d 656, 661 (Ill. 1991) (handrail ordinance); Batteast v. Wyeth Laboratories, Inc., 560 N.E.2d 315, 323 (Ill. 1990) (FDCA drug marketing regulations); Barthel v. Illinois Central Gulf Railroad Co., 384 N.E.2d 323, 326 (Ill. 1978) (railroad crossing safety regulations), First National Bank v. City of Aurora, 71 Ill.2d 1, 15 Ill.Dec. 642, 373 N.E.2d 1326, 1329-30 (Ill.1978) (sidewalk safety ordinance); Davis v. Marathon Oil Co., 356 N.E.2d 93, 97-98 (Ill.1976) (tank truck regulations); Hartje v. Moxley, 85 N.E. 216, 217 (Ill. 1908) (speed limit).
Five of these six cases obviously have nothing to do with the effect of an FDCA violation on state-law liability in Illinois, since they have nothing to do with the FDCA. The only one that does, Batteast, probably shouldn’t have been cited at all, since the Illinois Supreme Court held that the FDCA violations at issue there did not even constitute admissible evidence, let alone inference, of negligence. 560 N.E.2d at 323 (admission of claimed FDCA violations reversible error because (1) the regulation was not safety related, and (2) “the injuries were not of the type that the regulations were designed to prevent”).
So there’s really nothing in any of the Illinois cases cited to support Bausch’s statement that an FDCA may constitute negligence per se “just as” a “speeding violation” could. 2010 WL 5186062, at *5. But it’s worse than that, because as we pointed out in our first Bausch post the Illinois Supreme Court has actually considered whether FDCA-related negligence per se case lies in Illinois – and held, rather specifically, that it doesn’t:
- “[T]o determine whether a cause of action for a violation of [an FDA regulation] exists, we examine whether such a cause of action has been recognized by the Federal courts or whether recognizing such a cause of action comports with Federal legislative intent.” Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 355 (Ill. 1996) (citation omitted).
- “This inquiry forecloses plaintiff’s cause of action. Federal courts have uniformly refused to imply a private cause of action under the [FDCA], under which [this] Federal regulation . . . was promulgated.” Id. at 355-56 (citations omitted).
- “While plaintiffs concede that Federal courts have held that no private cause of action exists under the FDCA, they suggest that these decisions are irrelevant since plaintiffs rely on the regulation to establish defendant’s duty, and do not attempt to bring an action directly under the FDCA or its accompanying regulations. . . . [Lanham Act precedent] is of no avail to plaintiffs. The FDA regulation . . . was relevant to the issue of whether defendant violated the Lanham Act – an act which, by its express provisions, provided an independent statutory basis for plaintiff’s private cause of action against defendant. In contrast, the instant plaintiffs cannot provide any independent basis for their cause of action.” Id. at 356.
This wild misstatement of Illinois law in Bausch piqued our curiosity. We went and looked at the defendant’s brief in Bausch (2010 WL 4621580) to see whether we could say that this error was deliberate. We wanted to find out if Martin was cited to the court.
In fact there wasn’t a single argument made anywhere that the plaintiff’s “parallel” claims failed under Illinois law. We’ve argued on this blog for years – see here and here for a couple of examples, or see our “negligence per se” topic generally – that defendants faced with “parallel” claims need to argue, in addition to preemption, that such claims don’t fly under state law. You can’t fight these kind of claims with one arm voluntarily tied behind your back. Now, given everything else going on in Bausch, a proper argument that Illinois didn’t recognize this sort of claim (and therefore there was nothing for it to be “parallel” to) may well not have changed the ultimate result, but at least it could have prevented (perhaps) the court from going off and saying something about Illinois law that’s not only wrong, but will complicate life on remand (and for the rest of us).
Come on defense counsel out there. Pay attention. “Parallel” necessarily means “two lines.” We learned that in fifth grade geometry. Look at both threads when moving against parallel claims. Don’t get blinded by preemption and forget about state law grounds, or you might get blindsided by a court, as in Bausch. Not only that – if you win, even if it’s on preemption, an independent state-law alternative ground almost surely keeps your win out of the Supreme Court.
But back to Bausch bashing. Rejecting a “broad view” of preemption, Bausch “essentially agree[d] with Judge Melloy’s dissent” in Bryant. 2010 WL 5186062, at *6. It doesn’t matter how vague the regulation is, this panel was going to let it go as negligence per se. 2010 WL 5186062, at *6 (rejecting argument that a “parallel” claim requires the “violation of a concrete, device-specific federal regulation”). FDA’s Good Manufacturing Practices, even if only “general requirements,” may be the basis of an unpreempted “parallel” violation claim – as §360k(a)(1) refers to “any requirement”:
[The GMPs] are legally binding requirements “under this chapter.” “The failure to comply with any applicable provision in this part [of the regulations] renders a device adulterated. . . . Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.”
Bausch, 2010 WL 5186062, at *7 (quoting 21 C.F.R. §§820.1, 820.1(c)). Well, that pretty well throws Bausch’s “just like a speeding ticket” escuse right out the window. The kind of mush in the GMPs is about as far from a specific speed limit as it’s possible to get. The whole idea behind negligence per se is that the legislature has provided something more definite than the usual “reasonable man” standard that the common-law can adopt. This GMP “do something about X” requirement is no better than a reasonable man standard.
Maybe Bausch would have benefitted from considering the holding in Bates, supra, that unpreempted “parallel” violation claims must, in fact, be “genuinely equivalent” to agency regulatory interpretations to escape preemption. Unfortunately, we didn’t see Bates cited in the defendant’s brief either. It could have been useful, since the court was “not persuaded” by “the possibility . . . that a jury deciding a common law claim might apply those requirements more stringently than the FDA intended.” 2010 WL 5186062, at *8. Well, that’s precisely what Bates’ “genuinely equivalent” standard is getting at. A lot of this stuff – especially the vague GMPs – can be read by paid litigation experts in a far different fashion than the FDA in fact reads it. The court gave four reasons for rejecting preemption despite a regulation being subject to differing interpretations – some not followed by the FDA:
- Interpretations of FDA regulations are “questions of law” for courts to decide and not a “question of fact for a jury to decide.” Id.
- As questions of federal law, interpretations of federal regulations are “subject to the usual processes for reconciling conflicting views.” Id.
- A distinction between “general” and “specific” FDA requirements is “more slippery and less workable than its proponents acknowledge." Id.
- The distinction is contrary to the “purpose” of preemption, which the court construes as “to provide preemption for medical device manufacturers to the extent they actually comply.” Id.
Also, while no distinction is perfect, a general/specific distinction is exactly what many states use to decide whether negligence per se applies as a matter of state common law. We discussed that vagueness issue here and here, among other places. So it’s hardly as slippery or unusual as Bausch makes it out to be.
Finally, as to the “purpose” of preemption – unless you have specific, concrete evidence of a violation, then plaintiffs are going to claim non-compliance where in fact the FDA doesn’t think so, and then you’re right back into the heart of “different from”/“in addition to” land.
Having expanded the (supposed) “parallel” violation exception to express preemption under §360k(a)(1) to reach any claimed violation of any FDA regulation involving manufacturing, Bausch goes on to make a similar hash of implied preemption under Buckman. The court concluded that implied preemption did not apply to traditional “tort law claims based on manufacturing defects.” Bausch, 2010 WL 5186062, at *9. Therefore, unlike Buckman, Bausch applied a presumption against preemption. Focused solely on “conflict with the federal regulations,” Bausch found none. Id.
Actually, it’s a worse hash, since you aren't going to find what you're not looking for. As we discussed above, Buckman specifically states that there’s preemption because a claim based solely on federal law violates the prohibition against private FDCA enforcement in 21 U.S.C. §337(a). But we look in vain in Bausch for any discussion at all of §337(a). Tain’t there. It’s as if the court can’t deal with it, so it hides it under a rock and hopes nobody notices.
Instead, Bausch managed to dispatch Buckman without ever coming to terms with it. Bausch pretty much holds that any claim characterized as concerning “manufacturing” escapes implied preemption as “parallel” to a common-law manufacturing defect claim:
The plaintiffs in Buckman . . . claimed that the manufacturer had defrauded the federal agency did not have an implied right of action under federal law, and they were not claiming the breach of a recognized state-law duty for their benefit. Here . . ., the plaintiff claims breach of a well-recognized duty owed to her under state law – the duty of a manufacturer to use due care in manufacturing a medical device.
Bausch, 2010 WL 5186062, at *9. The court thus rejected the position taken by the Eighth Circuit in Bryant that implied preemption based upon the FDCA’s prohibition of private enforcement could “narrow” the scope of a “parallel” violation claim – at least in the context of manufacturing related claims. Id.
That might be true of some manufacturing-based claims in some places. We admit that manufacturing-related claims can hypothetically meet both of the “parallel” lines’ requirements. But there’s no “well-recognized” duty in Bausch. Why? Because of the Martin case we've already discussed that both Bausch and the defendants fail to cite as controlling Illinois law. Illinois is one of those states that doesn’t allow negligence per se based upon the violation of a statute that the legislature says can’t be privately enforced. But you’d have to mention §337(a) to get there, and Bausch inexplicably fails to do that.
That’s preemption, and its pretty bad, but the pleading half of Bausch is worse. Although this part of the opinion started by stating that “[t]here are no special pleading requirements for . . . Class III medical device claims," in the very next paragraph Bausch created just such a special standard for medical device claims:
In applying that standard to claims for defective manufacture of a medical device in violation of federal law, moreover, district courts must keep in mind that much of the product-specific information about manufacturing needed to investigate such a claim fully is kept confidential by federal law. Formal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for her claim.
Bausch, 2010 WL 5186062, at *10 (emphasis added).
Formal discovery? That’s precisely what TwIqbal say is the problem, not the solution. Last time we looked, the Courts of Appeals were still bound by Supreme Court precedent. So we go back to TwIqbal. Both of those cases expressly rejected need for discovery as a ground for leniency in pleading. “[B]efore proceeding to discovery, a complaint must allege facts suggestive of illegal conduct.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 563 n.8 (2007). “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).
We decline respondent’s invitation to relax the pleading requirements on the ground that the Court of Appeals promises petitioners minimally intrusive discovery. . . . Because respondent’s complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise.Iqbal, 129 S. Ct. at 1953-54.
It is no answer to say that a claim just shy of a plausible entitlement to relief can, if groundless, be weeded out early in the discovery process through careful case management. . . . And it is self-evident that the problem of discovery abuse cannot be solved by careful scrutiny of evidence at the summary judgment stage,” much less lucid instructions to juries; the threat of discovery expense will push cost-conscious defendants to settle even anemic cases before reaching those proceedings. Probably, then, it is only by taking care to require allegations that reach the level suggesting conspiracy that we can hope to avoid the potentially enormous expense of discovery.
Twombly, 550 U.S. at 559 (quotation marks omitted).
Thus, Bausch uses “discovery” as an excuse to justify vague and indeterminate pleading of regulatory violations. Bausch, 2010 WL 5186062, at *11 (TwIqbal does not require a plaintiff to “specify . . . the specific federal regulatory requirements that were allegedly violated”). There’s simply no way to square the Bausch view of discovery with the Supreme Court’s rejection of the same arguments in TwIqbal. The court has thus raised the rebel flag. That alone would be good reason for the Supreme Court to take the case.
And this is where things get really bizarre. Twombly had this to say about discovery expense as a reason to maintain meaningful pleading standards:
It is no answer to say that a claim just shy of a plausible entitlement to relief can, if groundless, be weeded out early in the discovery process through “careful case management,” post at 1975, given the common lament that the success of judicial supervision in checking discovery abuse has been on the modest side. See, e.g., Easterbrook, Discovery as Abuse, 69 B.U.L. Rev. 635, 638 (1989) (“Judges can do little about impositional discovery when parties control the legal claims to be presented and conduct the discovery themselves”).
550 U.S. at 559.
Given the system that we have, the hope of effective judicial supervision is slim: “The timing is all wrong. The plaintiff files a sketchy complaint (the Rules of Civil Procedure discourage fulsome documents), and discovery is launched. A judicial officer does not know the details of the case the parties will present and in theory cannot know the details. Discovery is used to find the details. The judicial officer always knows less than the parties, and the parties themselves may not know very well where they are going or what they expect to find. A magistrate supervising discovery does not – cannot-know the expected productivity of a given request, because the nature of the requester's claim and the contents of the files (or head) of the adverse party are unknown. Judicial officers cannot measure the costs and benefits to the requester and so cannot isolate impositional requests. Requesters have no reason to disclose their own estimates because they gain from imposing costs on rivals (and may lose from an improvement in accuracy). The portions of the Rules of Civil Procedure calling on judges to trim back excessive demands, therefore, have been, and are doomed to be, hollow. We cannot prevent what we cannot detect; we cannot detect what we cannot define; we cannot define ‘abusive’ discovery except in theory, because in practice we lack essential information.” Easterbrook, Discovery as Abuse, 69 B.U.L. Rev. 635, 638-639 (1989).
550 U.S. at 560 n.6.
What’s so strange about that? Well the same Judge Easterbrook who wrote the law review article that the Supreme Court quoted from extensively in Twombly on why discovery was such a problem was on the panel in Bausch – and didn’t lift a finger. We would have thought that the court's lets solve everything with discovery approach would have brought him out swinging, but it didn’t. He joined the Bausch opinion in toto. We have no idea why.