As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee. Anybody representing PMA medical device clients will want to read (and cite) Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012). Ali involved a “lap band” − a PMA device that restricts the ability of the stomach to expand, used as a last-ditch weight control measure in cases of morbid obesity.
Ali involves several preemption issues, and is also good on TwIqbal and the Virginia Consumer Protection Act. On preemption, as usual the battleground was the so-called “parallel claim” exception. 2012 WL 3692396, at *7. Plaintiffs offered only “a series of conclusory allegations that that [defendant] violated federal law.” Id. Not surprisingly, that didn’t cut it. Thus, everything having to do with warnings was dismissed (albeit without prejudice). Id.
Plaintiffs contended that they based their negligence and implied warranty claims in a manufacturing defect. Again they faced TwIqbal. “[T]the plaintiff must allege sufficient facts to support both the inference that the defendant manufactured the device in a way that violated federal regulations and the inference that this violation resulted in the defect that caused the plaintiff's injuries.” Id. at *8. The manufacturing defect claim required: (1) that “the plaintiff identif[y] what went wrong in the manufacturing process and cite the relevant FDA manufacturing standards that were allegedly violated,” id., and (2) “sufficient facts to support the inference that the defendant's federal violations resulted in the defect that caused the plaintiff's injuries.” Id. at *9 (citations and quotation marks omitted). The Ali complaint didn’t come close, containing only “information and belief” allegations as to violations and nothing at all about causation. Id. at *10. As to what was violated, alleging “any regulations promulgated pursuant to the Act” somehow didn’t impress the court. Id. Nor do allegations that are nothing more than “simple recitations of regulatory language” enough. Id. at *11. Plaintiff can’t get away with copying sections of the Code of Federal Regulations. That the plaintiff was injured does not mean that an FDCA violation occurred:
[T]he allegation that the [product] eroded does not, by itself, suggest that [defendant] violated federal requirements in manufacturing this device. At the time the [product] obtained PMA, the FDA was aware of [a] risk of erosion and [that it] could cause serious complications. . . . Ultimately, the FDA determined that [this risk] was a rare occurrence and that serious complication resulting from [it] was an even rarer occurrence, and approved the device despite these risks.
2012 WL 3692396, at *11 (citations omitted).
The plaintiff threw in allegations that the defendant’s first try at PMA had been unsuccessful. The court essentially held “so what?” Even if PMA had at first failed, the defendant “obtained PMA more than eight years before it was first implanted in [plaintiff’s] body. Id. at *12. That there had been various recalls of similar models didn’t matter since none of them had involved the device in question or the risk in question. Id.
To get around TwIqbal, the plaintiffs in Ali trotted out Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009), the case we love to hate. The judge in Ali hated Hofts almost as much as we do:
This Court respectfully disagrees with the Hofts court’s application of the Rule 8 pleading standard. . . . This Court finds the Hofts court unusually lax in its application of the standard. In assessing the sufficiency of pleadings, district courts should not take conclusory allegations as true but must require factual support for any legal conclusions offered in pleadings. Requiring such factual enhancement does not constitute a heightened pleading standard; it is the basic pleading standard established in Rule 8 as interpreted in [TwIqbal]. Without factual allegations supporting inferences of the defendant’s liability and the plaintiff’s right to relief, pleadings fail to provide adequate notice of the grounds upon which the plaintiff's claim rests. In Hofts, the district court relaxed the facial plausibility standard out of existence with respect to the plaintiff's allegations that the defendant violated federal requirements. This Court declines to adopt that approach in the context of this case.
This Court also respectfully disagrees with the Hofts court’s approach to the breach of implied warranty claim, where the court placed the burden on the defendant to show that the claim imposed standards different from applicable federal requirements. Rule 8 places the burden of pleading a plausible claim for relief and the grounds for this claim on the claimant. . . . This Court agrees with the majority of federal courts in holding, post-Riegel, that the facial plausibility standard applies to the pleading of a federal violation in this context and requires facts indicating noncompliance with federal requirements on the manufacture of the device.
2012 WL 3692396, at *13
The plaintiffs in Ali made a premature demand for discovery before meeting their Rule 8 pleading requirements. The court had none of it, finding that request to be “precisely the sort of fishing expedition the Supreme Court [in TwIqbal] sought to avoid in requiring the plaintiff to plead facts demonstrating their entitlement to relief and the defendant's liability.” Id. at *14.
Ali also followed the majority rule on preemption of express warranty claims. If they impose duties on the purported warrantor that differ from or add to federal requirements, if they challenge the safety and effectiveness of the PMA device, or if they challenge the manufacturer’s FDA-approved labeling, express warranty claims are preempted. Id. at *15. The only way am express warranty claim survives is when there are allegations “based on representations made by the manufacturer about the device that was not approved by the FDA.” Id. at *16. The plaintiff didn’t plead anything of the sort, so the express warranty claims were also dismissed. Id.
We’ve also collected cases holding that consumer fraud claims involving drugs and medical devices fail under “regulated activity” safe harbor provisions in the relevant state statutes. Ali is another such case:
By its own terms, however, the VCPA does not apply to “[a]ny aspect of a consumer transaction which aspect is authorized under laws or regulations of this Commonwealth or the United States, or the formal advisory opinions of any regulatory body or official of this Commonwealth or the United States.” Va. Code Ann. §59.1-199(A).2012 WL 3692396, at *19. Gotta love it. Ali is the greatest.
Plaintiffs’ VCPA claim fails because it challenges conduct that is expressly excluded from the scope of the VCPA. Plaintiffs base their VCPA cause of action on representations made by [defendant] . . . in advertisements and other marketing materials concerning the safety and effectiveness of the device. Representations about the [PMA-approved device] in marketing materials for the device are authorized and regulated by the FDA under federal law. The VCPA, therefore, does not apply to it and therefore no action challenging [defendant’s] marketing practices . . . may be brought under the VCPA.
We’re somewhat less enamored with Romero v. Wyeth, C.A. No. 1:03-cv-13467, slip op. (E.D. Tex. Aug. 31, 2012), sent to us by Janelle Davis of Thompson & Knight, although we must admit Romero does have its moments.
Romero evaluates a variety of claims purportedly arising under Texas law, in the wake of the big win in Centocor, Inc. v. Hamilton, ___ S.W.3d ___, 2012 WL 2052783 (Tex. June 8, 2012). On the good side of the ledger, the court throws out all of the usual bread & butter claims in prescription drug product liability litigation − those involving failure to warn (specifically misrepresentation, fraud, negligence, misrepresentation, gross negligence, and consumer fraud). The Texas statutory presumption of adequacy of FDA-approved warnings controlled, no matter what form the defendant’s information took:
“[I]f a claim is based upon a product’s labeling, its omissions, or inaccuracies, it falls under this purview of the [statutory presumption]. . . . [Plaintiff] seeks to distinguish failure to warn claims based upon a drug manufacturer’s statements in a warning label from those premised on other representations contained, for example, in promotional and marketing materials. . . . Because [plaintiff] cites no other authority [besides the lower court decision reversed in Centocor] for the proposition that [the statute’s] provisions should be so strictly applied, the court declines to make such a determination here. Accordingly, whether [plaintiff’s] failure to warn claims are based on statements made in [defendant’s] labeling or promotional materials, they fall within the purview of [the statutory presumption of adequacy].
Romero, slip op. at 5.
That’s the good part of Romero. The parts responsible for our “you can’t get there from here” comment then follow. For one thing the court allows a naked failure to test claim to continue. Abundant precedent, including controlling precedent under Texas law, holds that “failure to test” isn’t a free-standing cause of action. The Texas Supreme Court dealt with such a claim in American Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420 (Tex. 1997), twice holding “failure to test” to be “inextricably intertwined” with failure to warn, and rising or falling with it:
The [plaintiffs’] negligent testing claim is predicated on [defendant’s] duty to test and ascertain the dangers inherent in its products about which it must warn consumers. Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.
Id. at 437.
The [plaintiffs’] negligent testing claim is also preempted. . . . [Their] negligent testing claim is inextricably intertwined with advertising and promotional materials because the [plaintiffs] allege only that [defendant] should have tested its products to determine the dangerous characteristics about which [defendant] should have warned consumers.
Id. at 439. Then there’s the Fifth Circuit. In Dow Agrosciences LLC v. Bates, 332 F.3d 323, (5th Cir. 2003), reversed on other grounds, 544 U.S. 431 (2005) (preemption), the court held that, “a negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.” Id. at 333. And again, in Skotak v. Tenneco Resins, Inc., 953 F.2d 909 (5th Cir. 1992):
[N]egligence claims, such as the alleged failure to adequately test [the product], are subsumed within this two-part standard. . . . [Plaintiffs] were required to prove that an inadequate warning was given and that the inadequate warning was the cause of the injury. [Plaintiffs] do not argue otherwise, nor do they assert here an independent, or separate, negligence claim.
Id. at 912 n.5 (affirming summary judgment).
Oh well, so much for appellate precedent. Citing general “reasonable care” negligence cases and an old asbestos case involving failure to warn, Romero concocts some sort of “independent negligence cause of action based upon [defendant’s] failure to test” that no Texas court has ever allowed. Slip op. at 7-8. It may be our favorite legal proposition, and it sure applies here - a federal court sitting in diversity is not supposed to invent new, expansive state-law causes of action.
“[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it. The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action. Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (applying Texas law). We’re sure there’s plenty more where that comes from.
Romero also allows a design defect claim, holding that Restatement (Second) of Torts §402A, comment k should be applied on a case by case basis. Slip op. at 11-12. It gets to that result by characterizing comment k as an “affirmative defense” even though no Texas law says so (we reiterate the Erie federalism point) and in Centocor the Texas Supreme Court unanimously and emphatically rejected a similar argument about the learned intermediary rule:
The learned-intermediary doctrine is not an affirmative defense. . . . While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof. Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case - that the product warning was inadequate.
___ S.W.3d ___, 2012 WL 2052783, at *20. With comment k, the analysis is the same, only it involves design rather than warning claims. Several federal courts under Texas law cases have applied comment k to all prescription medical products, not requiring the individualized sort of product by product analysis demanded in Romero. Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (vaccine); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (applying Texas law). Tellingly, Romero does not cite a single Texas prescription medical product case for its contrary proposition.
There’s more we could discuss but for now, suffice it to say that with respect to the non-warning claims, we don’t think Romero can get there from here under what Texas law really is rather than what plaintiffs might want it to be.
Finally, from our home turf here in Pennsylvania, we offer the decision in Boeynaems v. LA Fitness International, LLC, ___ F. Supp.2d ___, 2012 WL 3536306 (E.D. Pa. Aug. 16, 2012), which we received internally today. This is not a drug case, but it is a class action in which the plaintiffs were harassing the defendants with massive pre-certification discovery requests. The defendant asked the judge to require the plaintiffs to pay for that discovery themselves, and the court agreed, holding:
[T]he Court mandates cost allocation as fair and appropriate. The Court concludes that where (1) class certification is pending, and (2) the plaintiffs have asked for very extensive discovery, compliance with which will be very expensive, that absent compelling equitable circumstances to the contrary, the plaintiffs should pay for the discovery they seek.
Id. at *11. The court essentially told the plaintiffs that they had to put up or shut up − no more one-way discovery, at least pre-certification in class actions:
If the plaintiffs have confidence in their contention that the Court should certify the class, then the plaintiffs should have no objection to making an investment. Where the burden of discovery expense is almost entirely on the defendant, principally because the plaintiffs seek class certification, then the plaintiffs should share the costs.
We think that’s just about right. If the class isn’t certified because the claims are bogus, the defendant isn’t going to be able to recoup this sort of massive expense from the class plaintiffs, and the attorneys will try to walk away from the case. If the case is good, then the common fund doctrine will plaintiffs’ counsel recoup their expense. So as Ron Weasley might say, “put your Galleons where your gob is.”