We’ve decided to blog on a less depressing preemption subject than Wyeth v. Levine today. We’ve seen a couple of recent medical device preemption cases that just about bookend the field. In Hofts v. Howmedica Osteonics Corp., 2009 WL 331470 (S.D. Ind. Jan. 12, 2009), the court found just about as little preemption (and probably less) as there could possibly be under Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). On the other hand, the court in Horowitz v. Stryker Corp., 2009 WL 436406 (E.D.N.Y. Feb. 20, 2009), found just about as much preemption (express, anyway) as any court since Riegel.

No matter what the Supreme Court does, courts continue to view tort preemption questions through the lenses of their own particular philosophies.

Since legal bloggers are necessarily masochists, we’ll do the icky one first. In Hofts the defendant, which made a premarket approved (“PMA”) hip implant, moved to dismiss a plaintiff’s complaint that alleged most of the usual claims – strict liability and negligent manufacture, breach of express and implied warranties (both merchantability and fitness for a particular purpose), and (since when did this become usual?) consumer fraud. 2009 WL 331470, at *1.

Memo to selves – Defense counsel takes a big risk raising preemption on a motion to dismiss. Unless we know how a judge leans, it’s best to build a record – especially where the plaintiff is seriously arguing “parallel claim” in opposition to preemption.

Somewhat amazingly in light of Riegel, Hofts managed to hold that every one of these claims escaped preemption – at least on motion to dismiss. It didn’t take long to figure out that this decision was coming from the gut:

Even so, some medical device manufacturers. . .have tried recently to stretch Riegel beyond recognition by transforming its protection for FDA-approved devices that comply with federal law into a grant of civil immunity for FDA-approved devices that violate federal law.

2009 WL 331470, at *1.

Pretty stong stuff – especially since Riegel didn’t even decide any question about violation claims, since the Supreme Court held that such allegations had been waived. Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1011 (2008) (“Although [plaintiffs] now argue that their lawsuit raises parallel claims, they made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari.”). In the Supreme Court’s determination that violation claims in Riegel were waived, Hofts nevertheless found “clear instructions” that such claims survive preemption. 2009 WL 331470, at *3.

Wham! You know what they say about when you’ve got a hammer, the whole world looks like a nail. Well, every claim in Hofts hid a violation claim somehow. And the defendant in Hofts got nailed.

Manufacturing Defect – Plaintiff alleged that the defendant was “not in compliance with Current Good Manufacturing Practice requirements approved by the FDA and [the product] had an impurity, imperfection, and/or another product defect” which defect “was a deviation from design and quality manufacturing standards. . .approved by the FDA. Id. at *4 (quoting complaint). Not only that, incorporated by reference was negligence language that the defendant “failed to exercise reasonable care and/or was reckless in the testing, manufacture, quality assurance, and sale of the [device].” Id. That appears (from the opinion anyway) to be it.

Boilerplate alert! Not a fact in sight.

We’ve known for over a year now that under Bell Atlantic Corp. v. Twombly, 127 S. Ct. 1955 (2007), the plaintiff has to plead at least a couple of real, live facts to make such allegations plausible. Like what? How about that such a violation exists somewhere other than in the imagination of plaintiff’s counsel. Something the FDA said about the particular device comes to mind. Its warning letters are all online, after all. Heck, even an opinion by the plaintiff’s own paid expert (how hard could that be?) might be enough, if based on an actual fact or two.

The response in Hofts? Forget pleading facts; gotta have discovery:

[The plaintiff] has brought claims premised on [defendant’s] alleged failure to manufacture the [device] in accordance with the PMA issued by the FDA. . . . With discovery, he may or may not be able to prove those claims, but his claims are premised on requirements that are parallel to the federal requirements. His claims are not preempted at the pleading stage.

2009 WL 331470, at *7.

But that’s not Twombly – something Hofts more or less admits when it protests against “an unusually stringent application of Twombly.” 2009 WL 331470, at *6 (discussing In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009)).

What’s Twombly then? This is Twombly:

  • “Asking for plausible grounds. . .does not impose a probability requirement at the pleading stage; it simply calls for enough fact to raise a reasonable expectation that discovery will reveal evidence of illegal agreement.” 127 S. Ct. at 1965.
  • A “formulaic recitation of the elements of a cause of action will not do.” Id. at 1965.
  • “[I]t is one thing to be cautious before dismissing [a] complaint in advance of discovery, but quite another to forget that proceeding to antitrust discovery can be expensive . . . . 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.” Id. at 1967.
  • “[I]t 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.” Id.
  • “[B]efore proceeding to discovery, a complaint must allege facts suggestive of illegal conduct.” Id. at 1969 n.8.

Thus we’d say (we’re defense counsel, right?) that Hofts put the discovery cart before the pleading horse when it credited a boilerplate violation that could be slapped without changing a word into any complaint about any device.

Hofts also points out that the plaintiff’s “claims and theories are more specific than those that survived dismissal in Lohr.” 2009 WL 331470, at *7. That may well be true. The Supreme Court in Lohr certainly couldn’t tell what the plaintiffs meant. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (“the precise contours of their theory of recovery have not yet been defined”). But last time we looked 1996 was before 2007 – which means that Lohr was decided before Twombly. So Hofts’ reliance on Lohr for a specificity-of-pleading point is just another way of ignoring the Supreme Court’s more recent opinion in Twombly.

Hofts then goes on the kind of rant that would be worthy of us on one of our more hacked off days – like just about every day:

The ability to bring civil claims based on violations of federal requirements is not a “back door” that was inadvertently left open by the MDA and Riegel, but a familiar part of the common law: an alleged tortfeasor’s violation of the law (a speed limit, a building code requirement, or a PMA requirement) serves as evidence that the defendant breached a duty owed to the plaintiff. If the law were otherwise-if it were as [defendant] argues – then Riegel and the MDA would be turned upside down and Lohr would be overruled. . . . But if the MDA were construed as [defendant] argues here, the legislation would be transformed into a grant of immunity from civil liability for manufacturers who violate those same federal requirements. That result was rejected by the Court in Lohr, and neither the MDA nor Riegel supports it.

2009 WL 331470, at *7 (citations and non-rant portions omitted).

The problem is we don’t know if the premise of the rant is true or not, because plaintiff failed to plead anything other than “I got hurt, therefore defendant must have violated the FDCA” – which is even more of a stretch than “I got hurt, therefore defendant must be liable.” The latter isn’t enough to state a claim under Indiana (or any other) law. See Smith v. Michigan Beverage Co., 495 F.2d 754, 757 (7th Cir. 1974) (“Just as it is the general rule that the mere fact of injury will not create an inference of negligence, the mere fact of the accident cannot create an inference of a defect in a products case”) (applying Indiana law); Gaskin v. Sharp Electronics Corp., 2007 WL 2819660, *5 (N.D. Ind. Sept. 26, 2007) (“the mere fact that an accident occurred does not create an inference of a defect in a products liability case”; just so nobody thinks this is some outdated principle).

We also need facts to evaluate what Hofts said about Lohr because, just as Lohr isn’t the Supreme Court’s last word about pleading (assuming Lohr had anything to say about pleading at all), it’s not the last word about so-called “parallel” claims either. The Court in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), elaborated upon the brief discussion in Lohr:

We must also reject respondent’s attempt to characterize both the claims at issue in [Lohr] and the fraud claims here as “claims arising from violations of FDCA requirements”. . . . [I]t is clear that the [Lohr] claims 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. In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim.

Id. at 352-53. Because Hofts let the plaintiffs get away with pleading nothing about the nature of the purported violation, it’s impossible to tell whether the unspecified violation has any equivalent in Indiana common law.

We do know that, for a statute to constitute negligence per se under Indiana law, it must have a “construction consistent with the legislative purpose of both Indiana and federal” law. Walling v. Appel Service Co., 641 N.E.2d 647, 652 (Ind. App. 1994). We also know, because Congress told us in the statute itself, that violations of the Food, Drug and Cosmetic Act (“FDCA”) are only enforceable by the federal government, and not state tort litigants. 21 U.S.C. §337(a) (“all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States”). The Supreme Court held precisely this in Buckman. 531 U.S. at 349 n.4 (“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”) (citing §337(a)).

Thus the rant in Hofts about defense preemption arguments somehow overruling Lohr or turning Riegel upside down appears to us to be unencumbered by either facts (which aren’t pleaded) or law (which would seem to be otherwise). But we can tell you from experience, that kind of rant often makes the ranter feel better.

But we digress.

Express Warranty – That’s not preempted either. Plaintiff “claims that the [device] did not live up to the FDA-approved promises contained in its label and that he was harmed as a result.” 2009 WL 331470, at *7. Riegel didn’t hold express warranty claims are preempted, and neither has the Seventh Circuit. Id. That’s true enough, and we’ve noted in our device preemption scorecard the split of authority on this point. But then Hofts goes on to “find[] that [plaintiff’s] breach of express warranty claim is also a parallel claim and is not preempted.” Id.

Hold on, then. We’re willing to concede that there’s a split of authority post-Riegel (like there was pre-Riegel) on express warranty claims. But how did they turn into “parallel” violation claims? Since when did a breach of express warranty become an FDCA violation? Hofts cites Mitchell v. Collagen Corp., 126 F.3d 902, 915 (7th Cir. 1997), for this proposition, so we took a look:

As we noted in our earlier opinion, such warranties arise from the representations of the parties and are made as the basis of the bargain between them. A state judgment based on the breach of an express representation by one of the parties does not necessarily interfere with the operation of the PMA, and therefore we cannot say that such a cause of action is preempted.

Id. In other words, Mitchell held just the opposite – that express warranty claims escaped preemption because they had nothing at all to do with FDA oversight. See also the “earlier opinion” Mitchell v. Collagen Corp., 67 F.3d 1268, 1285 (7th Cir. 1995) (express warranty claims “seek[] recovery solely for the [defendant’s] alleged breach of its own, self-imposed undertakings”). So we have to say, while there’s an argument that express warranty claims aren’t preempted, it’s not because they’re somehow “parallel” claims as Hofts held.

Implied Warranty – Mitchell (which is binding on Indiana federal courts) held, in the paragraph immediately before the express warranty discussion we just got done quoting, “[i]f the [plaintiffs] meant to allege an implied warranty, it is preempted.” 126 F.3d at 915. But Hofts doesn’t quite see it that way:

The FDA’s own regulations explicitly restrict the reach of the MDA’s preemption clause from state law claims brought under regulations of general applicability, including the Uniform Commercial Code. The regulations specifically note that breach of implied warranty claims are not preempted . . . . See 21 C.F.R. §808.1(d)(1).

2009 WL 331470, at *8. Because the defendant “failed to demonstrate at the pleading stage” that the implied warranty claims “rest on allegations about standards other than those permitted by the FDA,” they aren’t preempted “in light of the FDA’s regulation specifically permitting breach of implied warranty claims.” Id.

So there.

But let’s see. Hmmmm…. Section 808.1(d)(1)…. Haven’t we seen that somewhere before? What’s the name of that case? Yeah, something called Riegel, we think. The Supreme Court explicitly found that same regulation to be a hash:

All in all, we think that §808.1(d)(1) can add nothing to our analysis but confusion. Neither accepting nor rejecting the proposition that this regulation can properly be consulted to determine the statute’s meaning; and neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally; the regulation fails to alter our interpretation of the text insofar as the outcome of this case is concerned.

128 S. Ct. at 1011. And to think that Hofts stated elsewhere that under the defendant’s argument “Riegel and the MDA would be turned upside down.” 2009 WL 331470, at *7. Suffice it to say, that we have a pretty hard time squaring Hofts’ reliance upon §808.1(d)(1) with the Supreme Court’s holding that the very same section – with respect to the very same implied warranty claims – “add nothing. . .but confusion.” Maybe we’re just confused. Being upside down gets disorienting.

Consumer Fraud – These aren’t preempted for the exact same reason that implied warranty claims aren’t, because §808.1(d)(1) “specifically permits” them. 2009 WL 331470, at *8. Any other reason? Nope. There’s just a reprise of the same statement as before – that the defendant “failed to demonstrate at the pleading stage” that the (substitute consumer fraud for implied warranty) “rest on allegations about standards other than those permitted by the FDA,” they aren’t preempted “light of the FDA’s regulation specifically permitting” them. Id. We’re not going to repeat ourselves on what Riegel held about that regulation. The dead horse has been thoroughly beaten.

That’s Hofts. As we’ve described, it’s reasoning provides a roadmap for plaintiffs trying to avoid preemption of product liability claims involving PMA medical devices after Riegel: Ignore Twombly, rant, ignore state law, ignore Buckman, ignore Riegel, turn controlling circuit court precedent on its head, and finally, ignore Riegel some more. Very persuasive. So persuasive that we highly recommend it to our opponents.

That’s one bookend.

Horowitz v. Stryker Corp., 2009 WL 436406 (E.D.N.Y. Feb. 20, 2009), is the other. Like Hofts, Horowitz decided a motion to dismiss. Like Hofts, Horowitz involved claims concerning a PMA hip implant. Id. at *1. Actually it involves the very same hip implant (Stryker and Howmedica are affiliated – we’re not going to bother explaining how). So did Horowitz reach the very same result on preemption?

Hardly. Or is that not hardly?

This complaint (at least as far as we can tell) was pleaded far more specifically than the complaint in Hofts – there being allegations in Horowitz about device recalls and FDA warning letters. 2009 WL 436406, at *2-3.

Even so, Horowitz took a much harder line on the alleged “parallel requirements” claims. In between Twombly cites, Horowitz held:

[G]eneralized allegations cannot withstand preemption because they fail to establish the necessary link between defendants’ federal violations and her alleged causes of action. . . . In an effort to satisfy the pleading standard and bring forth facts demonstrating the parallel nature of her claims, [plaintiff] points to two warning letters issued by the FDA. However, such letters do not provide the necessary connection to the specific [device] at issue in this case.

2009 WL 436406, at *6-7. The plaintiff’s bare recitation of warning letters and device recall didn’t establish any connection to the plaintiff’s injury. “[S]imply alleging that the defendants violated federal regulations did not necessarily mean that the plaintiff’s strict liability claim was premised on those violations.” Id. at *7. That looks a lot like Buckman’s “solely by virtue” language to us.

Neither the warning letters nor the recall cut the mustard because they didn’t involve the product at issue. Id. at *8. What a shocking proposition. You mean, because a 1960 Corvair was “unsafe at any speed,” that doesn’t mean that the 1957 Belair is defective? That logic didn’t pass muster in Horowitz:

In the present action plaintiff lacks such a tie to the device in question. Although plaintiff cites to recalls instituted by defendants, such recalls did not include the [device in question] or any of its components. Plaintiff introduces FDA warning letters mentioning defendants’ violations of federal regulations, but she never alleges that her particular product was included in the devices which were the subject of those letters nor does she provide a necessary link between the federal violations and her specific injury. Finally, plaintiff never alleges that any enforcement action was brought against defendants concerning the allegedly defective hip implant.

Id.; cf. Wyeth v. Levine, 2009 WL 529172, at *8 (U.S. March 4, 2009) (“the FDA’s belief that a drug is misbranded is not conclusive”).

Horowitz then evaluated many of the very same claims that cleared the preemption hurdle in Hofts.

Manufacturing defect – Pleading the FDA warning letters wasn’t enough. There was no explanation how the claimed violations in those 2006 and 2007 letters had anything to do with plaintiff’s device implanted in 2005. There’s no allegation that the letters involved the same production facility where plaintiff’s device was made. 2009 WL 436406, at *8. So just because a defendant once received an FDA warning letter about something doesn’t mean that every product it ever made violated the FDCA. “Plaintiff cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.” Id.

But isn’t it asking too much under Twombly to require the plaintiff to plead that the alleged violation involved the product that allegedly caused injury? After all, that wasn’t a requirement in Hofts. The Hofts argument drew a footnote in Horowitz:

Requiring the plaintiff to plead his claims with more specificity, according to the Hofts court, would amount to an unusually stringent application of Twombly. On the contrary, requiring amplification as to how the defendants’ alleged federal violations relate to the plaintiff’s claims is exactly what Twombly contemplates, especially where such a connection is implausible.

Horowitz, 2009 WL 436406, at *9 n.5. Because the plaintiff hadn’t shown that the alleged violation had anything to do with the device that was implanted, “for plaintiff to be successful in her negligence/recklessness claim a jury would have to find that the FDA requirements themselves were deficient.” Id. at *9. Such claims were necessarily preempted by Riegel. Id.

Express Warranty – “Plaintiff’s breach of express warranty claim is preempted to the extent that it is premised on FDA approved representations made by the manufacturer.” 2009 WL 436406, at *10. Some express warranty claims might escape preemption, but not those based upon statements that were contained in the labeling submitted to, and approved by, the FDA:

In order to avoid preemption, the plaintiff’s breach of express warranty claim must identify specific representations of the manufacturer which exceed the scope of the FDA approved statements, thereby establishing a contractual obligation voluntarily entered into by the manufacturer. Any claim for breach of express warranty premised on the [device’s] FDA-approved label, however, must be preempted.

Id. at *11. Horowitz didn’t even bother to address Hofts on this point. Perhaps plaintiff’s counsel, knowing the right argument to make, didn’t bother raising Hofts, since Hofts got the main argument against preemption of such claims precisely backwards.

Implied WarrantyHorowitz viewed the implied warranty claims as directly precluded by Riegel, since in Riegel the Supreme Court had analyzed such claims and held them preempted. 2009 WL 436406, at *10 (“a jury would have to find that defendants breached the implied warranty of merchantability by manufacturing a medical device that was unsafe in its federally approved design or manufacture”). The Hofts analysis of implied warranty was again dealt with in a footnote:

In Hofts[], in addressing the plaintiff’s breach of implied warranty claims, the district court found that “[t]he FDA’s own regulations explicitly restrict the reach of the MDA’s preemption clause from state law claims brought under regulations of general applicability including the Uniform Commercial Code.” The Hofts court ignores, however, that Riegel explicitly rejected that the regulation alters the outcome of the case, reasoning that such an interpretation would effectively swallow the preemption

2009 WL 436406, at *10 n.6. Yup, we thought there was a slight Riegel problem with the Hofts analysis of that claim.

Consumer Fraud – The plaintiff’s pleading in Horowitz was even worse with the consumer fraud claim than generally. “[P]laintiff makes no reference to the specific “acts, representations and/or omissions” that she claims are deceptive nor does she allege why these acts were deceptive.” Id. at *12. The FDCA violation allegations again failed because they had no connection to the plaintiff and the plaintiff’s device, and because they called FDA-approved labeling into question:

Even if the deceptive or misleading conduct [plaintiff] refers to has something to do with the FDA’s findings described in the warning letters and defendants’ failure to reveal such information to plaintiff, [plaintiff] provides no connection between the defendants’ deceptive conduct and a specific injury that she suffered as a result of that activity. . . . Similar to plaintiff’s breach of express warranty claim, plaintiff never specifies what false representations defendants made nor does she allege that she ever relied on any representations made by defendants. Moreover, using the [consumer fraud act] to attack the [device’s] FDA-approved label would run afoul of the MDA’s preemption provision.

2009 WL 436406, at *12.

Warning and Design Defect – In addition to the claims at issue in Hofts, Horowitz addressed, and held preempted, the same sorts of warning and design defect claims that were before the Supreme Court in Riegel. A “defective design claim, which challenges the FDA’s findings concerning the safety of the [device’s] design, necessarily imposes requirements that are different from, or in addition to, federal regulations.” Horowitz, 2009 WL 436406, at *10. A warning claim “would permit a jury to find that defendants were required to provide warnings above and beyond those on the [device’s] product label-a label that was specifically approved by the FDA as part of the PMA process.” Id. at *12. Nor was there even a pretense of a “parallel requirements” claim, because the FDA warning letters did not concern the product’s label. Id.

Just as Hofts was the plaintiff’s roadmap, so too is Horowitz a roadmap for the defense. We recommend it to our colleagues. What’s the difference between the two? More than anything else, we’d have to say their application of Twombly. If it’s enough to allege only that a defendant is “not in compliance” with some general type of FDA regulations and that a device “had an impurity, imperfection, and/or another product defect” which “was a deviation from” an unspecified something that was “approved by the FDA,” Hofts, 2009 WL 331470 at *4, then some of what Hofts holds about manufacturing defect, express warranty and consumer fraud (but not implied warranty) is understandable. But if Twombly means what it appears to say – and we tend to take the Supreme Court at its word – then the only result that makes sense is Horowitz.