FDA Regulatory Muscles: Ripped and Oiled

Here's a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for being a "Mathlete." Take that in for a moment. That's right, we were on the Math team. The true jocks snickered. But it was not entirely funny to them. They thought we pencil-necked geeks were devaluing their football and track letters. They were probably right. They were also - let's be honest about this - thoroughly repulsed by the more academic types.




Let's say two things about that (now that we have the big megaphone of the blog and now that those mesomorphs can no longer menace us at our locker):



(1) Who has the last laugh now? When she was in high school, we used to tell the Drug and Device Law Daughter that she should befriend the wonks because some day they might flower into a Bill Gates or Marc Zuckerberg. Did she listen? She did not. And what do you suppose will happen to the hockey player and Goth who captured her young heart? The closest they will come to Microsoft or Facebook will be inputting customer data at a bad retail job or posting a bong as their profile picture. Now she is in college and dating an engineering student. Maybe there's hope. Maybe some day money will flow toward us, not away from us. Maybe we won't have to eat cat food in our dotage. Maybe we should veer away from this digression.



(2) That repulsion went both ways. The wrestlers went around on match days incessantly spitting into a cup (kind of like a Texas plaintiff lawyer during a deposition). One guy in our class got into bodybuilding quite early. The movie Pumping Iron came out around this time. It was Arnold Schwarzenegger's break-through. Schwarzenegger was remarkable for more than his trolley-car sized biceps.  He was also inordinately clever at getting into his competitors' heads. He would give them "the wrong advices" (a preview of Schwarzenegger's charming battles with the English language) whilst crushing their egos. Our classmate emulated Schwarzenegger by carrying a can of protein powder around and occasionally disrobing in class to display his "guns" and "pythons". He is now a self-help maven on the Internet and claims he can uncover your past lives and make them "work for you". Perhaps he takes control over those past lives the same way he took control over things back in 1977: with threats and headlocks.



One might have thought that after four years of a fine liberal arts education and then three years of that hazing ritual known as law school, that we would cease to have very much to do with the bodybuilding cult. One would be wrong. We spent a year on a case defending a nutraceutical company accused of making a bad product and phony claims. These folks operate on a wholly different level from companies that manufacture prescription drugs or class III devices. The word "aggressive" does not begin to do them justice. One of our key company witnesses was a champion body-builder who had some sort of Ph.D. We can not remember what the Ph.D was for, but this guy clearly knew a few things. He had taken a hearty dislike of the plaintiff's lawyer. The night before he was to be deposed, he downed a concoction of herbs and other goodies that would render his breath toxic and his gastrointestinal system explosive. It worked. The deposition was extremely unpleasant for the plaintiff lawyer. (As it was for everyone there except, perhaps, the witness.) The deposition did not last very long.



As we said, nutraceuticals are different from pharmaceuticals. But they are both regulated by the FDA. And therein lies the tale of today's case, Cytosport, Inc. v. Vital Pharmaceuticals, Inc., 2012 U.S. Dist. LEXIS 126976 (E.D. Cal. Sept. 6, 2012). Cytosport makes Muscle Milk, a ready-to-drink protein shake in an octagonal bottle. Vital Pharmaceuticals makes Muscle Power, a ready-to-drink protein shake in an octagonal bottle. Cytosport sued Vital under the Lanham Act, claiming that the Muscle Power product infringed on its trademark and trade dress for Muscle Milk. Vital counterclaimed, arguing that the Muscle Milk trademark was invalid and deceptive because Muscle Milk contains not a drop of milk. Thus, this is a case concerning intellectual property. Linger on the richness of that. Much of the back-and-forth in the case involves competing surveys, with competing experts opining as to whether consumers were confused. You don't want our opinion on that, do you?



Anyway, you ask, what does any of this have to do with drug and device law? First, we don't like your tone of  impatience one little bit. This sort of 'roid rage does not become you. Frankly, you're scaring us.  Second, relax. The Cytosport case is fun. No heavy lifting required. Vital's counterclaim cited a warning letter sent from the FDA to Cytosport taking issue with the use of the word "Milk." According to Vital, the FDA warning letter should prompt the court to find the "Muscle Milk" trademark to be deceptive and, hence, invalid under 15 U.S.C. section 1125(a). If all this sounds vaguely reminiscent of Pom Wonderful, LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), it should. The Cytosport court leaned heavily on the Pom Wonderful case, which it characterized as follows: "When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to 'usurp, preempt, or undermine FDA authority.'" Cytosport, 2012 U.S. Dist., LEXIS 126976 at *17, quoting Pom Wonderful, 679 F.3d at 1176. Which way does Pom Wonderful cut in this Muscle contest? The Cytosport court says that Pom is not wonderful news for the Vital counterclaim, because "the FDA regulates the use of the term 'milk' on food labels. The FDA is aware of Cytosport's labeling and has not acted." Id.



But wait a minute, what about the FDA warning latter? And here, we encounter the same point that we blogged about yesterday. A warning letter is not a final action. It does not mean anything until it culminates in some final action by the FDA. A warning letter is an invitation to dialogue and compliance. It is almost like that semi-surprising notion in first-year Contracts class about how an advertisement is not in itself an offer, but merely an invitation to the customer to make an offer. Here is how the Cytosport court dealt with the FDA warning letter: "The fact that the FDA sent a warning letter to Cytosport concerning its labeling does not require a different finding. FDA warning letters are informal and advisory, and do not amount to an FDA action." Id. Vital then offered a back-up position: "the Court should defer granting judgment until the FDA issues a final decision on Cytosport's use of 'Muscle Milk.'" Id. at *18. Nice try. The Cytosport refused to defer. The FDA's final decision might end up supporting Cytosport, supporting Vital, or falling somewhere in between. But "the Pom holding is clear that the claims are barred until the FDA issues its decision, not that they are stayed or deferred." Id.



That is the part of the case that matters to us. Once again, private causes of action cannot muscle in on the FDA's turf. That is good news for all of us high-minded defense hacks. We put the "clean" in the clean-and-jerk. (Guess who puts in the other part.) Further, an FDA warning is tentative, incomplete, and - ta da - meaningless. More good news. Where it counts, the Cytosport opinion is a strong one for us. Use it. Hold it up. Flex with it. Feel the burn.



There are other bits that do not matter as much to us or that we don't understand. For example, Vital also brought "two state law claims which reference the FDA regulations to show that Cytosport's use of the term 'Milk' is inconsistent with FDA regulations." Id. The court holds that these state law claims "are not barred by the ruling in Pom because the FDA specifically permits states to create labeling requirements that are identical to the FDA's and establish independent causes of action for those claims." Id. Sounds like more "parallel claim" Hell to our ears. Also, the court upholds Muscle Power's advertising assertion that it has "600% less sugar and 187% less fat than Muscle Milk." Id. at *37. We agree with Cytosport that there is something mathematically nonsensical about saying that something has "600%" less of something.



Once a mathlete, always a mathlete.

One Smelly Product, Two Defendants, and Two Different Results

Out of Illinois comes a medical device case with odd and smelly facts.  Smith v. Phoenix Seating Sys. LLC, 2012 U.S. Dist. LEXIS 127865 (S.D. Ill. Sep. 10, 2012).  The medical device was a wheelchair armrest called the 312G.  The plaintiffs bought it (and, earlier, the wheelchair) from the defendant, Apria Healthcare Group.  Plaintiffs installed the armrest themselves.  Id. at *2-3.  But not right away.  That’s the odd and smelly part.  Plaintiffs claimed that when they first received the armrest in the mail and opened its box, it smelled.  How bad?  So bad that they put it out of the house.  First they put it in the garage for a week.  That didn’t work.  It still smelled.  So they moved it outside – to the patio – for another 3-4 days to air it out.  While the opinion doesn’t make it seem as if this worked completely, it apparently worked enough for plaintiffs to install the armrest. Id. at *3-4.   

That didn’t go so well.  Plaintiffs claimed that each of them then suffered injuries from a toxic combination created by a gel contained in the armrest and the gel’s surface material.  Id. at *6, 17-18. 

They sued two defendants.  One was Apria, whose role appeared to be that of the direct seller.  Id. at *29, 30-31.  Apria faced negligent failure to warn claims.  The other defendant was Phoenix Seating Systems, who designed the armrest (the extent of their involvement in the design seemed to be in dispute), received the armrest from the manufacturer, repackaged it, applied some identifying labeling, and then sent it to Apria.  Id. at *13-14.  Phoenix faced various strict liability claims. 

Alright, so the facts are a little odd.  But what about the summary judgment decision?  Not odd at all. 

Phoenix wanted out because it wasn’t a manufacturer, because there couldn’t be a failure to warn plaintiffs who had such idiosyncratic reactions, and because medical device preemption applied.  The court rejected all these arguments.  Illinois product liability actions, according to the court, apply to “all persons in the distributive chain . . . including suppliers, distributors, wholesalers[,] and retailers.” Id. at *10 (quoting Hammond v. North Am. Asbestos Corp., 97 Ill. 2d 195 (Ill. 1983).  So it didn’t matter that Phoenix wasn’t a manufacturer.  The court also found a fact dispute as to whether the plaintiffs’ reactions were idiosyncratic.  So that argument didn’t work.  As to preemption – and take heed here -- the 312G armrest was cleared under §510(k).  But current law is that preemption only applies to devices approved under the PMA process, not those cleared under §510(k).  While we’ve argued here that it’s time for the Supreme Court to reconsider this, it hasn’t done so yet. 

So no preemption, and Phoenix stays in the case. 

The court saw Apria differently.  There was insufficient evidence in the record to establish that Apria was involved in the manufacture or design of the armrest, or that Apria had reason to know of any problem that needed to be warned about:

Apria alleges it did not manufacture the 312G, take any part in its design, have knowledge concerning the specific materials contained in the 312G, or have knowledge of complaints similar to plaintiffs’ instant grievances. . . .

As plaintiffs’ response does not address Apria’s argument concerning its lack of knowledge, plaintiffs do not dispute such allegations. Moreover, plaintiffs’ complaint does not allege Apria had any role in the 312G’s design or manufacture, or knowledge of the 312G’s alleged defective design or manufacture. Similarly, plaintiffs have not instantly offered evidence demonstrating Apria was involved in the 312G’s manufacture or design, or that other complaints or reactions to the 312G have ever been reported.

Id. at *29, *30-31 (record citations omitted). 

Plaintiffs had only negligent failure to warn claims against Apria, and those claims couldn’t survive summary judgment – not on this record.  Now, just like Phoenix, Apria had a hiccup.  It claimed to be exempt from liability under a “seller’s exception” to product liability claims, but the statute that contained that exception had been declared unconstitutional years earlier by the Illinois Supreme Court.  Id. at *24-45.  So that argument didn’t work.  Fortunately for Apria, its other arguments did.  No duty, no claim – regardless of how bad the armrest smelled.  So Atria gets out of the case. 

Sometimes odd facts make for ordinary law.

More Punitive Damages Preemption, Sixth Circuit Reaffirms Garcia

The following is a guest post by Laura Mastrangelo at Reed Smith, who gets all the credit, and takes all the blame, for its contents.  Take it away Laura....

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There was a fair amount of preemption action on punitive damage statutes last week, at least with respect to those states that limit punitive damages for FDA approved drugs and devices.  John Sullivan provided excellent coverage of Zimmerman v. Novartis Pharmaceutical Corp., ___ F. Supp. 2d ___, 2012 WL 3848545 (D. Md. Sept. 5, 2012), yesterday here, so I won’t belabor that discussion further.  Flying more under the radar, though, the Sixth Circuit issued an opinion in Marsh v. Genentech, Inc., ___ F.3d ___, 2012 WL 3854780 (6th Cir. Sept. 6, 2012), which dovetails nicely with the District of Maryland’s analysis in Zimmerman.  In Marsh, the Sixth Circuit affirmed its previous holding in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), that the fraud exception to Michigan’s bar on products liability suits against drug manufacturers is preempted, even where Plaintiffs haven’t alleged fraud-on-the-FDA in the classical sense.

Plaintiffs brought consolidated products-liability actions against drug manufacturers Genentech, Inc. and Xoma (U.S.) LLC (collectively, “Genentech”) to recover for injuries allegedly sustained from use of the psoriasis medication Raptiva, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud.  Id. at *1.  The action consolidated four different plaintiffs, but apart from their dates of use and alleged injuries, the allegations for the four were identical.  Id., n.2.

Plaintiffs claimed that, both prior to and after FDA approval, Genentech knew of dangerous side effects that it concealed from the public and did not include in the drug’s label.  Id. at *1.  Specific to the arguments at issue here, Plaintiffs further alleged that Genentech “intentionally and negligently failed to update statement of contraindications, warnings, precautions, and adverse reactions that Defendant affirmatively knew about” and “intentionally and negligently failed to comply with various [FDA disclosure regulations].”  Id.

Genentech moved to dismiss, and won.  The district court held that Genentech was entitled to immunity under the Michigan Products Liability Act (the Act) and that Plaintiffs’ claim that immunity did not apply was preempted by federal law.  Id. at *2.  Citing Garcia, the district court explained that federal law preempts tort claims premised on the Act’s exceptions absent a finding by the FDA itself that the manufacturer had committed fraud or bribery.  Id.  The district court concluded that, because Plaintiffs had not alleged that the FDA had found that Genentech committed fraud, their claims were preempted.  Id.

It’s not news that Michigan law is very favorable to drug manufacturers, providing that a drug manufacturer or seller is not liable for injuries caused by the use of its products “if the drug was approved for safety and efficacy by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller.”  Mich. Comp. Laws §600.2946(5).

Statutory immunity does not apply, however, if the manufacturer or seller:  (a) Intentionally withholds from or misrepresents to the FDA information concerning the drug that is required to be submitted under the FDCA, and the drug would not have been approved, or the FDA United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted, or (b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.  2012 WL 3854780, at *2-3.  The Michigan Supreme Court has described the Act’s immunity provision as “an absolute defense to a products liability claim” premised on the determination that “compliance with federal governmental standards (established by the FDA) is conclusive on the issue of due care for drugs.”  Taylor v. Smith-Kline Beecham Corp., 658 N.W.2d 127, 130-31 (Mich. 2003).

Following Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Sixth Circuit previously held in Garcia that suits against drug manufacturers under Michigan law in which the Plaintiffs seeks to defeat immunity by invoking the Act’s fraud exceptions are equivalent to fraud-on-the-FDA claims and are thus preempted.  2012 WL 3854780, at *4.  Even though, under Michigan law, fraud on the FDA is an exception to a grant of immunity to the manufacturer rather than a stand-alone cause of action, it nonetheless ultimately “requir[es] proof of fraud committed against the FDA” to succeed, and is therefore preempted.  Id.  “Garcia thus essentially requires treating a plaintiff's fraud arguments against manufacturer immunity as a threshold “claim” that can be preempted.”  Id.

Here, Plaintiffs attempted to argue that Garcia did not apply because their claims − in what was basically a pleading trick − did not invoke the Act’s fraud exception.  Id.  Though Plaintiffs’ theory was somewhat unclear, the Court interpreted the argument to be that immunity should not apply because of Genentech’s alleged non-compliance with the terms of the FDA’s approval of Raptiva, in that Genentech failed to comply with the FDA’s post-marketing reporting requirements.  Id.  However, the purported “non-compliance” was precisely the same fraud on the FDA allegations that the same court had ruled preempted in Garcia.

The court noted that Plaintiff’s allegations of non-compliance “do not fit comfortably within the statutory language requiring compliance for immunity to apply,” because the complaint alleged that Genentech did not comply with the terms of the FDA approval by failing to update its application or submit safety reports, not that “the drug and its labeling” did not comply.”  Id. at *5.  Further, the complaint also did not allege that the dose of Raptiva she received was adulterated or that its label varied from the label that the FDA approved.  Id.

Thus, the Court considered the allegation of failure to submit reports to the FDA that the FDA requires “to be a species of fraud on the agency under the state Act.”  Id.  “Indeed, the Michigan Act’s fraud exception specifically encompasses at least some of the misconduct Marsh alleges − a manufacturer “[i]ntentionally withhold[ing] from ... the [FDA] information concerning the drug that is required to be submitted under the [FDCA] ‘when the FDA “would have withdrawn approval for the drug if the information were accurately submitted.’”  Id.

Further, even if Plaintiffs’ allegations did constitute “non-compliance” (as opposed to fraud on the FDA) within the meaning of the Act, the claim “that immunity does not apply triggers the same concerns that animated Buckman and Garcia[,]” and is therefore preempted.  Id.  In short, Plaintiffs could not plead around preemption.

Plaintiffs claimed  that “Genentech failed to submit updated safety information to the FDA as required of all applicants by FDA Form 356h and generally applicable FDA regulations,” and thus they rely on “federal enactments [a]s a critical element in [their] case.”  Quoting Buckman, 531 U.S. at 353.  Moreover, this alleged wrong was perpetrated upon the agency, and thus implicates the “inherently federal” relationship described in Buckman.  Id. at 347.  Finally, Plaintiffs’ suit would require a court to rule on the adequacy of Genentech’s post-marketing disclosures to the FDA, which is the kind of “inter-branch[ ]meddling” that concerned the Court in Buckman.  See Garcia, 385 F.3d at 966.  Having a court determine whether any non-disclosed information “ ‘may reasonably affect the statement of contraindications, warnings, precautions or adverse reactions in the draft labeling,’ “would both usurp the agency's role and go beyond the court's institutional expertise.”  Marsh, 2012 WL 3854780, at *5.

The Court did not take a position, however, as to whether an allegation of “substantive non-compliance that is unique to the terms of approval of a particular drug or that more directly involves a consumer, such as a chemical variance or an inaccurate label, would be preempted under Garcia,” as the allegations there did not implicate such a holding.  Id., n. 9.

As a final note, the Court dismissed Plaintiffs’ other arguments, concluding first that the fact that Plaintiffs’ substantive claims sound in negligence and strict products liability would not enable her to avoid preemption, because so did the claims in Garcia.  Id. at *6.  Moreover, Wyeth v. Levine did not change the analysis either, because “[a]lthough preemption principles do not foreclose state-law failure-to-warn claims once the FDA has approved a drug, Michigan law does so.”  Id.  Finally, the Court rejected Plaintiffs’ argument that as an affirmative defense, Defendants bore the burden of establishing compliance with its FDA approval, because the complaint “makes clear that Marsh could not defeat Genentech's arguments for immunity.”  Id. at *6-7.

A Better Look at Preemption in New Jersey

Those of us who practice New Jersey products liability law know McDarby v. Merck, 401 N.J. Super. 10 (App. Div. 2008).  It addressed a provision of New Jersey’s Product Liability Act that both granted manufacturers immunity from punitive damages if their product was approved by the FDA and tried to take that immunity away if the manufacturer made knowing misrepresentations to the FDA. Here’s the language of the statute:

Punitive damages shall not be awarded if a drug or device . . . which caused the claimant's harm was subject to premarket approval . . . by the federal Food and Drug Administration . . . and was approved . . . . However, where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency's regulations, which information was material and relevant to the harm in question, punitive damages may be awarded.

N.J.S.A. 2A:58C-5c (emphasis added).  We know what you’re thinking: “Wouldn’t that be preempted under Buckman?”  Yup.  And that’s what McDarby held. 

And, since this decision in 2008, courts applying New Jersey law on this topic generally cite McDarby and apply its holding.  But, last week, the court in Zimmerman v. Novartis Pharm. Corp., 2012 U.S. Dist. LEXIS 126002 (D. Md. Sep. 5, 2012), did something better.  It offered a well-reasoned, thoughtful explanation of the law on preemption and Buckman, along with an effective criticism of decisions that (we believe) get Buckman wrong.  It’s good stuff, and it provides good quotes for future briefing.  In fact, you might want to consider citing McDarby but quoting Zimmerman. 

Now, Buckman, even read narrowly, held that tort claims based on a manufacturer withholding information from or misleading the FDA are impliedly preempted because the FDCA grants the power to enforce its provisions to the United States, not private citizens.  When a federal law such as this creates an inherently federal relationship and exclusive enforcement mechanism, the presumption against implied preemption that ordinarily attaches goes away.  As the Zimmerman court wrote: 

[I]n Buckman, the Court held that there is no presumption against preemption where a jury is asked to decide whether there has been a material fraud on the FDA during the regulatory process.  This is because federal law dictated the Defendant’s interactions with and representations to the FDA. Thus, unlike circumstances that implicate “federalism concerns and the historic primacy of state regulation of matters of health and safety,” the relationship between a regulated entity and the FDA is “inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”

Id. at *37 (citations omitted).

The Zimmerman court rejected the reasoning of courts that upheld other state statutes that allowed failure to warn claims to go forward if there was a showing of fraud on the FDA.  One such court reasoned that such statutes “cannot reasonably be characterized as a state’s attempt to police fraud on the FDA” but rather they are a state’s attempt to limit tort claims.  Id. at *38 (quoting Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94 (2d Cir. 2006)).  But the Zimmerman court didn’t lose track of the most important point – it’s different when a state tort claim requires determinations about fraud on the FDA:

Although this Court agrees that the presumption against preemption applies to state tort claims implicating health and safety generally, the Court concludes that such a presumption does not apply to that part of Plaintiff’s claim, which by virtue of New Jersey law, conditions any recovery of punitive damages on a showing that a defendant-drug manufacturer “knowingly withheld or misrepresented information required to be submitted under the [FDA’s] regulations, which information was material and relevant to the harm in question.” [Quoting the N.J. statute]. This conclusion is confirmed by the Court’s analysis in Buckman. There, the Court found that the presumption against preemption did not apply to a specific type of tort claim--a fraud on the FDA claim--even though the presumption against preemption applies to traditional tort claims implicating health and safety matters.

Id. at *39-40 (citation omitted).

This is because the key question is not whether the state tort claim seeks to “police” fraud-on-the-FDA, but whether it is an obstacle to FDA regulation.  Id. at *42.  A state statute that hinges compensatory or, more so, punitive damages on a jury’s – more likely, multiple juries’ – determinations of whether the FDA was defrauded raises obstacle after obstacle.  Companies concerned that juries will see fraud where the FDA doesn’t will understandably respond by providing the FDA with the kitchen sink, causing nothing but greater delay and inefficiency. 

The Zimmerman court went further, holding that even if a presumption against preemption applied, it is rebutted because the statute requires a jury determine something exclusively left to the FDA.  Id. at *41-52.  The court rejected (what we believe is wrong-headed) reasoning by some courts that Buckman preemption applies only to pure fraud-on-the-FDA claims, not claims in which such fraud is an element of, or gateway to, a broader claim:

This distinction is meaningless because it is simply not entirely accurate. In Buckman, the plaintiffs not only had to prove the device maker’s non-compliance with FDCA disclosure requirements, which served as the predicate false representation in a common law fraudulent misrepresentation action, but also other common law elements of a fraudulent misrepresentation action such as injury and proximate cause.  Put another way, the preemption analysis does not change simply because, under New Jersey law, this Plaintiff must prove something in addition to non-compliance with a FDCA disclosure requirement to recover punitive damages.

Id. at *54 (citations omitted). 

The Zimmerman  court was not moved by the argument that the New Jersey statute does not create a fraud-on-the-FDA claim, like in Buckman, but rather only gives plaintiffs the opportunity to rebut a presumption and thereby bring a tort claim under New Jersey common law:

Once New Jersey passed the statutory immunity provision for punitive damages, the traditional cause of action is no more rooted in common law doctrine than the stand-alone claim in Buckman. This is because, in the post-statutory immunity world, a plaintiff’s punitive damages claim hinges on whether the defendant-drug maker made adequate disclosures to the agency and whether, in the face of these inadequate disclosures, the agency would have approved the drug. In this way, New Jersey’s statutory immunity provision makes fraud on the FDA a “critical element” of every punitive damages claim.

Id. at *55-56 (citation omitted).

It really is a simple analysis.  The statute authorizes juries to dig into the details of regulations and New Drug Applications and make independent determinations of what the FDA should have done or would have done, but didn’t do.  In other words, precisely what juries can’t do under federal law:

Simply put, Plaintiff’s claim for punitive damages requires a state fact finder to determine what was required to be submitted to the FDA, whether it was submitted to the FDA and, whether the FDA would have made a different approval decision had it been provided with the correct or missing information. Plaintiff’s claim thus requires a fact finder to make these types of determinations as a matter of state law even though federal law makes such determinations the exclusive province of the FDA. Accordingly, Plaintiff’s claim for punitive damages poses an obstacle to the objectives and purpose of the FDCA, and is therefore preempted by the FDCA.

Id. at *51-52.

It doesn’t, and shouldn’t, matter whether this improper determination is an element of a claim, a gateway to a broader claim, or the entirety of the claim.  Jury after jury deciding what the FDA should have gotten and done about it gets in the way of the FDA doing its job.  The Zimmerman court gave a good quotation for this too:

Allowing state fact finders to second-guess the very decisions that federal law leaves entirely to the agency presents “the same inter-branch-meddling concerns that animated Buckman.” As in Buckman, allowing punitive damages liability here would require applicants to submit a “deluge” of unnecessary information during the approval process, which in turn, delays the approval of new drugs.  In seeking to comply with various statutory immunity provisions, drug manufacturers would “exert an extraneous pull on the scheme established by Congress.”

Id. at *57. 

We told you that the court's discussion was much better than just, "see McDarby."  Keep it handy for future briefs. 

More New Stuff

Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.

Medical Device Preemption − The Greatest

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).

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.

2012 WL 3692396, at *19.  Gotta love it.  Ali is the greatest.

Prescription Drugs in Texas − You Can’t Get There from Here

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.

We Think That’s About Right

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.

Id.

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.”

What Is Buckman?

We’re rather tired of the other side, abetted by the flawed reasoning in Desiano v. Warner Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), attempting to distinguish Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), into oblivion as relating to nothing more than a “separate, freestanding” claim for “fraud on the FDA.”  We’ve argued until we’re blue in the face that Buckman (which was unanimous, but with a concurrence) was so much more than that; specifically an implied preemption case with broad implications.  Most courts get it, but enough don’t that we thought we’d investigate a little further.  So we’ve asked ourselves the question, What has the Supreme Court itself had to say about Buckman in the decade-plus since it’s been decided?


We ran a quick search and found that the Supreme Court has cited its Buckman decision seven times.  We’ll look at the drug/device cases first.  In PLIVA v. Mensing, 131 S. Ct. 2567 (2011), the Court cited Buckman as a “cf.” (that’s an abbreviation of the Latin “confer” meaning to compare/consult) to the plaintiffs’ “take steps” argument (which the Court rejected) that the manufacturer should have asked the FDA for help.  Id. at 2578.  Did the Mensing majority limit Buckman to a freestanding count for fraud on the FDA?  Hardly.  Instead, it described Buckman just the way we do, as “holding that federal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA.”  Id.  That’s how Buckman should be read − that any state-law claims purporting to intrude on a defendant’s communications with the FDA are preempted.  The quality of a regulated entity’s communications with a federal agency is simply none of state law’s business.

That’s one.

Then there’s Wyeth v. Levine, 555 U.S. 555 (2009), the case we most love to hate.  Levine also discussed Buckman, albeit in dueling footnotes, this time in the context of the “presumption against preemption.” Id. at 565 n.3.  Buckman was not, the majority noted, apt precedent for rejecting that presumption entirely in implied preemption cases, because it “involved state-law fraud-on-the-agency claims, and the Court distinguished state regulation of health and safety as matters to which the presumption does apply.”  Id.  Even in this worst case (which is what Levine is) scenario, the discussion is confined to the scope of a presumption (which later couldn’t muster a majority in Mensing) rather than addressing preemption directly.  Levine certainly is not limited to anything about freestanding claims.

The Levine dissent, of course, gave Buckman an even broader application:

Petitioner’s dealings with the FDA were prompted by federal law, and the very subject matter of petitioner's statements to the FDA were dictated by federal law.  Accordingly − and in contrast to situations implicating federalism concerns and the historic primacy of state regulation of matters of health and safety − no presumption against pre-emption obtains.

Id. at 624 & n.14 (citation and quotation marks omitted).  While we obviously prefer the Levine dissent, there doesn’t seem to be any support − in the Levine majority or dissent − for not applying Buckman’s rationale to any situation implicating the information submitted by a regulated entity to its regulating authority.

That’s two − actually call it 2½, since Buckman was string-cited (with no separate discussion) for basically the same presumption-related proposition by the dissent in Altria Group, Inc. v. Good, 555 U.S. 70, 99 (2008) (the majority in Good not mentioning it at all).

The Court’s most recent invocations of Buckman are in Arizona v. United States, 132 S.Ct. 2492 (2012), and Chamber of Commerce v. Whiting, 131 S.Ct. 1968 (2011), both involving immigration.  In Arizona all but one of the provisions of a state statute were held preempted by federal law.  The mere fact that both the majority and the dissent considered Buckman relevant indicates that it can’t be cabined in the manner plaintiffs so often attempt.  The majority cited Buckman as authority (albeit “cf.” authority) for the proposition that “[p]ermitting the State to impose its own penalties for the federal offenses here would conflict with the careful framework Congress adopted.”  Id. at 2502-03 (describing Buckman holding as “States may not impose their own punishment for fraud on the Food and Drug Administration”). That’s all federal offenses, folks, not just the FDCA.  The dissent in Arizona essentially agreed:

In some areas of uniquely federal concern − e.g., fraud in a federal administrative process . . . this Court has held that a State has no legitimate interest in enforcing a federal scheme.

Id. at 2518.  The dissent in Arizona just didn’t think that “federal alien registration” was as uniquely federal as litigation involving the sanctity of federal administrative proceedings.  Id.  Again − nothing in either opinion supporting a limitation based upon how a plaintiff chooses to plead such “fraud.”

In Whiting, a plurality (this case is split in more ways than are worth describing) distinguished Buckman on grounds similar to the dissent in Arizona.  Buckman involved a “uniquely federal area[] of regulation,” specifically “state actions that directly interfered with the operation of a federal program.” 131 S.Ct. at 1983.  Buckman was:

[a] determin[ation] that allowing a state tort action would cause applicants before a federal agency to submit a deluge of information that the agency neither wants nor needs, resulting in additional burdens on the agency’s evaluation of an application, and harmful delays in the agency process.

Id. (citation and quotation marks omitted).  Thus, whenever such “interference” − which impacted upon the quality and quantiy of information submitted to a federal agency (notably the Court substituted “agency” for “FDA”) − was present, preemption would exist.  Id.  The dissent agreed, relying on Buckman’s holding that the “relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”  Id. at 2006.  Thus we find in Whiting (in more than one of its multiple opinions) additional support for a broad reading of Buckman as applicable to all communications with all federal agencies.

Finally, Buckman has also been cited solely in dissents and concurrences.  In Thompson v. Western States Medical Center, 535 U.S. 357 (2002), Justice Thomas’ dissent cited (“cf.” again) Buckman for an extremely broad proposition − that “flexibility” is “necessary if FDA is to pursue difficult (and often competing) objectives.”  Id. at 389.  It’s only one justice, but again Buckman is recognized as standing for a proposition much more extensive than what to do with a peculiar type of claim.  In Sorrell v. IMS Health Inc., 131 S.Ct. 2653, 2678 (2011), Buckman was also cited by the dissent (once again as a “cf.”), this time for its discussion of off-label use.  That’s a more limited issue, but still one that’s not limited by any particular claim.

What we make of all this is that, on several occasions − in Mensing, Whiting, and Arizona for sure, and to a lesser extent in Levine − the Supreme Court has had occasion to comment upon what its holding in Buckman was all about.  In those cases, Buckman has been described as relating to state-law-based evaluation of the communication between a regulated person (including but not limited to drug/device manufacturers) and its federal regulating authority (including but not limited to the FDA).  In no case has the Supreme Court held, described, or suggested that Buckman is somehow limited to how a plaintiff denominates such a claim in his/her pleadings.  In sum, there’s no support in any Supreme Court case for the rationale followed by the Second Circuit in the Desiano case, and only Justice Roberts’ unfortunate recusal prevented the Supreme Court from tossing it then and there.

Off-label Promotion in California – Same Facts, Same Law, Different Results

            This post is solely on behalf of the Dechert half of the Blog.  The Reed Smith half is involved in these cases and they ain’t saying a word (not out loud, anyway).

            As litigators, we are all too familiar with the adage “you win some, you lose some.”  Unless and until an issue is decided by the Supreme Court (and all too often not even then), the law is subject to interpretation by judges, who after all are just people with their own outlooks and biases.  Hence, we often report on cases with very similar facts but very different results –often leaving us scratching our heads.  And that’s what happened in two recent California cases involving the same spinal fusion product.  Both plaintiffs alleged unlawful off-label promotion.  One court found the claims preempted, the other did not.  Go ahead, scratch away – we can’t figure out the difference either – other than one court got it wrong.

            You can guess which we think that was.

            First, we’ve said it before and we’ll say it again:  Off-label promotion is not a tort.  Courts have so held repeatedly, here’s just a sampler.  So while in some instances off-label promotion is not permitted by the FDA, “[t]he 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.”  Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 349 n.4 (2001).  This statute (21 U.S.C. §337(a)) is “clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.”  Id. at 352.  The California exemptions from §337(a) − see 21 C.F.R. §808.55 − have nothing to do with these cases or this device. 

            That brings us to the court that got it right:  Coleman v. Medtronic, 2012 WL 2335532 (Cal. Super. Jun. 13, 2012).  Under Riegel, that court had previously tossed plaintiff’s claims but  allowed plaintiff to continue to try and state a non-preempted claim by allowing leave to amend on two occasions. Plaintiff there focused on a “warning” claim alleging off-label promotion.  On motion to dismiss #2, the court took a second look at permitting the warning/off-label claim based mostly on dicta from a case in Minnesota.  Moving away from the dicta and looking at the totality of implied preemption law, the Coleman court concluded, properly, that plaintiff’s off-label promotion claims were “impliedly preempted because they would involve imposing a state requirement that is different from or in addition to the federal requirement and therefore preempted.”  Coleman, 2012 WL 2335532. 

The next court, in Cabana v. Stryker Biotech, LLC, slip op., (Cal. Super. Aug. 20, 2012), didn’t agree.  Before tackling the unfortunate preemption ruling, we should point out how little’s left of that case.  In response to defendant’s motion for summary judgment, plaintiff gave up strict liability manufacturing, design defect and failure to warn claims and her implied warranty claims.  Slip op. at 4.  That's 90%+ of most product liability cases.  All that’s left is general negligence, express warranty (which invariably vanishes the moment a plaintiff has to put up or shut up about what the warranty actually was) and fraud.  Plaintiff definitely has only a small playing field left. 

As to preemption – hey wait, we thought this was summary judgment − where are the actual facts?  For some reason, the court focused almost exclusively on mere allegations in the complaint, slip op. at 2-4, and not on whether plaintiff had any evidence to support those allegations, particularly as they concern off-label promotion.  Summary judgment, however, is supposed to pierce the pleadings; bare allegations are not sufficient:

Plaintiffs cannot simply incant the magic words that Defendants violated FDA regulations in order to avoid preemption.  Moreover, the nonmovant may not defeat a properly focused motion for summary judgment by relying on mere allegations without introducing definite and competent evidence.

Carrelo v. Advanced Neuromodulation Systems, 777 F. Supp.2d 303, 313 (D.P.R. 2011), citing, Maldonado-Denis v. Castillo-Rodriguez, 23 F.3d 576, 581 (1st Cir. 1994); Horowitz v. Stryker Corp., 613 F.Supp.2d 271, 282 (E.D.N.Y. 2009); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F.Supp.2d 1147, 1158 (D. Minn. 2009), aff’d 623 F.3d 1200 (8th Cir. 2010).  We could cite a lot more, but we think the point’s been made.

Too bad for the defense in Cabana, though; that plaintiff skated.

Reading Cabana as a whole, the court seems to hold that all a plaintiff needs to do is allege a violation of federal law – in this case off-label promotion – and that’s enough to create a triable issue of fact.  We call this a “magic words” approach.  Even though we don’t like all of the recent Cornett case (see last week’s post here), the New Jersey Supreme Court at least required facts to go forward.  Off-label promotion cases must not:

• be nothing more than a private action to enforce FDA statutes and regulations;
• be nothing more than a challenge to the approval of the device or label;
• require proof of fraud on the FDA; or
• involve off-label promotional activities that are legal under FDA guidelines.

Cornett v. Johnson & Johnson, ___ N.J. ___, ___ A.3d ___, 2012 WL 3210943, at *14 (N.J. Aug. 9, 2012).  The Cornett court sent the plaintiff back with an admonition to come up with the right evidence, otherwise “defendants may move for summary judgment, and the trial court should not hesitate to grant such relief.”  Id.

Not so in Cabana.  That court didn’t care what the state law cause of action was – if the complaint alleged the magic words -- “violation of federal law” – preemption simply disappears.  Ignoring the state-law side of “parallel” was the only way the court distinguished a wealth of cases strongly in favor of preemption.  For instance, as to Riegel v. Medtronic, 552 U.S. 312 (2008), which established express preemption, the court said:

Here . . . plaintiff’s claim is not based on allegations that Medtronic’s device violated state tort law notwithstanding compliance with the relevant federal requirements.  In contrast, plaintiff here is alleging that Medtronic promoted the use of its device in violation of federal requirements.  Accordingly, Riegel is not authority that plaintiff’s claims against Medtronic are preempted here. 

Cabana, slip op. at 4-5 (citations omitted).  That’s almost a textbook definition of a purely federal cause of action barred under Buckman and §337(a).  Heck, even Riegel involved off-label use.  552 U.S. at 320 (physician use was contraindicated by the labeling).  Likewise, the court dismissed California appellate law, McGuan v. Endovascular Technologies, Inc., 182 Cal.App.4^th 974 (Cal. App. 2010), as inapplicable, because in McGuan the plaintiff’s state law claims focused on “defects in the design, testing, and manufacture of the . . . [d]evice, the failure to warn . . ., and the fraudulent concealment of the dangers and defects of the product.”  Slip op at 5.  Oh really?  That looks no different than plaintiff’s failure to warn and fraud claims in Cabana.   If the point was to distinguish Cabana from McGuan by saying that plaintiff Cabana is bringing a claim for violation of a federal regulation, not a state law tort claim -- well, we direct your attention back to square one:  the United States, not private litigants, enforces the FDCA and FDA regulations.  Hmmm….  What should we use to make the point this time?  How about something recent?

Even if a plaintiff does properly plead facts demonstrating the defendant’s failure to satisfy federal regulations, there is no private cause of action against a device manufacturer under the FDCA.  Only the federal government may file suits against manufacturers that do not comply with federal regulations.  Although the Supreme Court acknowledged in Riegel that parallel claims based on violations of federal regulations would escape express preemption under §360k, §337(a) has been held to impliedly preempt private claims against device manufacturers for failure to comply with federal regulations.  As a result, Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption.

Gross v. Stryker Corp., ___ F. Supp.2d ___, 2012 WL 876719, at *19 (W.D. Pa. March 14, 2012).

The Cabana court was also unpersuaded by defendant’s argument that this was not a parallel violation claim because plaintiff has no evidence that any of the off-label promotion she alleges in her complaint actually violated a federal regulation. A “parallel” claim can’t be “parallel” to nothing.  We discussed this issue last week in our post on Cornett.  While Cabana cites to Cornett, at least Cornett (1) recognized the safe harbor provisions adopted by the FDA regarding off-label promotion, and (2) demanded real evidence of the purported promotion (Cornett was a legitimate pleadings-based case).  Now Cornett didn’t get it exactly either (as we alluded above), because it overlooks the fact that just because off-label promotion may fall outside the safe harbor doesn’t mean it’s tortious off-label promotion.  It’s only potentially “illegal,” and that’s up to the FDA, and the FDA only, to determine.  Cabana misses this point too.

Finally, we are left wondering how plaintiff’s off-label promotion allegations in Cabana support a failure to warn claim.  In the end, if plaintiff is basing her claim solely on allegations that defendant promoted its device for off-label purposes – then we’re in Buckman-land.  Rather, plaintiff must base her cause of action on some other recognized legal claim.  But promotion and warnings are two different things.  By definition, a failure to warn claim requires two things: a warning and causation.

As to the warning, either the risk of an off-label use is the same as that of the labeled use or it isn’t.  If it is, then the label already warns about it, and if it doesn’t, well the plaintiff is asking for something “different from or in addition to” the FDA-approved labeling.  That’s preempted.  If the risk of the off-label use isn’t shared with the labeled use, then … well, it’s the same result, isn’t it − only worse.  This sort of claim creates the potential of a finding that state law would require the defendant to add a warning uniquely related to off-label promotion.  That’s way “different from or in addition to” the approved label. 

Then there’s causation − that whatever the “known” risk (California is a state-of-the-art state) the defendant allegedly failed to warn about  was unknown to the physician using the product, that the physician actually received and relied on the allegedly inadequate information, etc….  There’s none of that in Cabana.  These additional tort requirements (required under Buckman) have nothing to do with if or how the product was supposedly promoted for off-label use.  Promotion allegations, in the end, can’t save a failure to warn claim, negligent or otherwise.  Only the FDA can require a warning about an off-label use.

All in all, we are once again wondering how two courts in the same state, governed by the same law could come to two so disparate conclusions.  While the plaintiff skirted preemption in Cabana, she still hasn’t provided the slightest indication that she actually has facts that could prove her claims – those few that remain.  On that note, we are also very familiar with the adage:  lose the battle, but win the war.   We understand from other reports on this case, there is more discovery to be done and another opportunity to have the judge in Cabana to get it right.  Here’s hoping we can report on a favorable overall outcome in Cabana in the months to come.

A Truddle, not a Muddle, through Mensing and Buckman

The scope of Mensing is one of the hotter issues in drug and device law these days. (The Bartlett appeal is one example.) To our defense-hack eyes, Mensing seems perfectly straightforward: a claim is preempted to the extent it alleges that the risks of a generic drug were not adequately disclosed. But the doctrinal landscape has quickly grown messy and treacherous. There is already a lot of legal kudzu out there, courtesy of plaintiff-lawyer ingenuity or judicial discontent with Mensing. Some attorneys and judges do not like preemption at all. Some do not smile upon the differential treatment between brandeds and generics. Accordingly, we get clever arguments and brittle analyses that limp along the page, proudly indifferent to the manner in which they manage to muck things up. It reminds us of what must surely be one of the most cynical observations of all time, when Thomas Hobbes wrote that "Reason scouts and spies for the passions." Nice (in the sense of being foolish) distinctions are drawn to preserve bogus claims.




Still, every once in a while Reason seems to stand up quite well for itself. That is the case with Truddle v. Wyeth, LLC et al., 2012 WL 338715 (N.D. Miss. Aug. 14, 2012), where the court dealt with Mensing in as clean and fair and straightforward a fashion as could be expected. The case is sad. A nineteen year old man was treated for gastritis. The doctor prescribed metoclapramide. The young man began suffering from hallucinations, extreme restlessness (akathisia), and suicidal impulses. He eventually took his own life. His parents filed suit against both brand-name and generic manufacturers, alleging negligence, strict liability, breach of warranties, misrepresentation, fraud, and negligence per se, all grounded upon an alleged failure to warn of the risks of side effects. The plaintiffs' counsel withdrew from the case (the opinion does not tell us why, prompting us to engage in all sorts of pointless speculation), the case was removed to federal court, and the generic defendants filed a motion to dismiss the case because of Mensing preemption.



The generic defendants argued exactly what we would expect them to argue -- that Mensing governed the entire case because all of claims, no matter what the styling, were predicated on an alleged failure to warn, and the generic defendants lacked any power to add warnings. The generic defendants "anticipate[d] that the Plaintiffs would argue that the Generic Defendants should have used an additional means of communicating warnings to physicians, such as letters to health care providers, and suspended sales of the drug until the brandeds were changed." Truddle, 2012 WL 3338715 at *3. The defendants also anticipated that the plaintiffs might try to assert "design defect or other legal theories to escape the preemptive reach of Mensing." That's certainly a lot of anticipation, especially against a pro se plaintiff. Maybe it is smart to trot out, and then knock down, the other side's arguments, rather than wait for the court to endeavor to help out the pro se plaintiffs. In any event, the battle-lines are pretty well drawn in Mensing cases. The potential avenues for circumventing Mensing no longer arrive as a surprise.





The Truddle court granted the generic defendants' motion and dismissed all claims on the grounds of Mensing preemption. Even though the plaintiffs asserted various theories of recovery, "all theories stem from the Generic Defendants' alleged failure to warn of the side effects of the drug." Truddle, 2012 WL 3338715 at *4. Even when the plaintiff complained of activities that might at first blush seem different from disclosing risks on the label, such as failure to investigate or test, any knowledge that would have been acquired from such investigation or testing "would have been helpful" only insofar as it would have been "communicated through labeling - which would not have made any difference as long as the Generic Defendants were following the FDA's labeling regulations." Id. The generic defendants could not have unilaterally improved the labeling even if they wanted to -- that is the point of Mensing. The Truddle judge offers a healthy dose of clear-thinking, and we wouldn't mind seeing that spread to other courts, including a couple we can walk to in ten minutes.



That ends that. Or at least, it could. But the plaintiffs' fraud and misrepresentation claims attacked the defendants for fraud on the FDA, and the Truddle court seized the opportunity to bring some additional clarity on that issue. There was a need for clarity, because a couple of Fifth Circuit cases introduced some unnecessary puzzlement into the Buckman issue. In the first case, which we would like to call the "Bad case," but which the official reporter calls Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the Fifth Circuit held that a state tort claim for negligence "that attempted to prove breach of a state law duty by asserting a violation of FDA regulations was not a fraud-on-the-FDA claim that would be preempted by Buckman." Truddle, 2012 WL 3338715 at *6. The negligence claim in Hughes was predicated on the manufacturer's failure to comply with the applicable federal statutes and regulations. Well, if there is no private right of action under the federal laws (and there isn't) what exactly are we talking about in Hughes? The negligence claim, pled under Mississippi law, charged, inter alia, that the defendant manufactured and distributed the product inconsistently with its FDA PMA approval by failing to report serious injuries and malfunctions of the device as required by MDR regulations. The Hughes court said that this theory was different from a fraud-on-the-FDA theory that would be preempted under Buckman. Maybe - but that does not make it a valid action under state law. Hughes looks like sheer nonsense, but it is Fifth Circuit nonsense, so the Truddle court had to navigate around it.



The Truddle court did so by holding fast to another case, which we like to call the "Good case," but which you will want to cite as Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012). In Lofton, the Fifth Circuit applied Buckman preemption, in contrast to the Hughes court's unconvincing effort to dodge it. The plaintiff in Lofton alleged that the manufacturer of Motrin had not warned consumers of the risk of autoimmune reactions to the drug. The failure to warn claim was brought under Texas law, which establishes a rebuttable presumption that a drug manufacturer is not liable for failure to warn if the FDA approved the warnings in question. Texas law is specific that such a presumption can be rebutted if the defendant withheld information from the FDA. The issue is whether that fraud-on-the-FDA exception was preempted by Buckman. Sound familiar? We've written about this issue before, discussing another pair of cases, with the good one being Garcia v. Wyeth-Ayerst Labs., 585 F.3d 361 (6th Cir. 2004), and the bad one (wretched, awful, horrible, etc - we're tempted to unload the thesaurus on this one) is Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff'd by an equally divided court sub nom. Warner-Lambert Co. LLC v. Kent, 552 U.S. 440 (2008). Desiano seems nutty in calling off Buckman preemption when fraud-on-the-FDA is part of an exception instead of the cause of action itself, and we would hate to see other courts latch onto the Desiano rationale. Mercifully, the Lofton court did not do so. In Lofton, the Fifth Circuit applied Buckman preemption because the relationship between the manufacturer and the federal regulator was central to the matter at issue.



The Truddle court, after being confronted with the sloppiness of Hughes and the sanity of Lofton, divined a unifying Buckman principle that it believed compelled preemption in the Truddle case: "It is likely that the Plaintiffs' fraud-on-the-FDA theory would be preempted under Buckman, as the theory concerns the 'inherently federal' relationship between the FDA and the Generic Defendants, which are entities regulated by the FDA." Truddle, 2012 WL 3338715 at *7. Now it may be that the Truddle court simply (and rightly)  preferred the interpretation of Buckman in Lofton, but it didn't have to go there because Mensing answered the question.  Lofton versus Hughes made no difference since, in either case (or in neither case) where a generic product is involved the statutory "sameness" rationale of Mensing controls (neither Hughes nor Lofton involved generics).  Clearly, the Truddle court did not merely use reason to scout and spy for a preordained result. It returned to first principles. Those first principles result in more vigorous applications of Mensing and Buckman.

Preemption in the Garden State

As we flagged for you on Friday, the New Jersey Supreme Court recently issued an opinion addressing preemption and the statute of limitations in a medical device claim.  Cornett v. Johnson & Johnson, 2012 N.J. LEXIS 831 (Aug. 9, 2012).  To say the least, it had interesting rulings and raised a number of issues to discuss. 

The case involved a drug-eluting stent that was implanted in the plaintiff for an off-label indication, and the plaintiff later suffered a thrombosis and died.  Id. at *9-11.  The plaintiff’s estate made a number of state law claims alleging improper warnings, manufacturing and design defects, improper off-label promotion and the like.  Id.  The statute of limitations and preemption issues eventually made their way to the New Jersey Supreme Court. 

Statute of Limitations

On the statute of limitations defense, the Court held that the plaintiff’s claims were barred by Kentucky’s one-year statute of limitations.  The opinion has a detailed choice of law analysis (between Kentucky and New Jersey law) that we won’t address here.  What was more interesting to us was the Court’s ruling that a plaintiff exercising due diligence should have known by December 2006 that the stent may have caused Mr. Cornett’s thrombosis.  December 2006 is when an Advisory Committee assembled by the FDA made findings related to plaintiffs’ claims, including that thrombosis from drug-eluting stents (like the defendants’) was a problem, the problem was greater when the stent was used off-label (as with the plaintiff), and drug therapy after the device is implanted should last for an extended period of time.  Id. at *28. 

With this ruling, the New Jersey Supreme Court has placed significant importance on Advisory Committee findings when considering when the statute of limitations starts to run in a product liability case.  Often the devices and drugs involved in product liability litigation have been the subject of FDA Advisory Committee meetings, and often those meetings address issues related to plaintiffs’ claims.  Now, in New Jersey, their findings may be a significant tool for weeding out time-barred claims. 

Preemption

The Cornett complaint was a consolidated complaint with over 40 other plaintiffs whose claims were not time barred.  So the Court was able to go beyond the statute of limitations to address preemption under the Medical Device Act (“MDA”) amendments to the FDCA. 

First, some general propositions about medical device preemption: Section 360k(a) of the MDA states that it preempts state law claims that address the safety and efficacy of a device and impose requirements that are “different from or in addition to” FDA regulation.  In Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the US Supreme Court held that §360k(a) preemption does not apply if the FDA cleared the device under §510k.  (You may recall that we just recommended some light summer reading that reexamines whether Lohr’s reasoning should still apply.)  In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Court held that §360k(a) preemption does apply if the device was approved under the FDA’s more rigorous Premarket Approval (PMA) process.  Finally, in Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001), the Court held that – in situations in which §360k(a) express preemption doesn’t apply, such as with a device cleared under §510k – FDA regulations nonetheless implicitly preempt state law claims, in particular fraud-on-the-FDA claims, that improperly impact the balance struck by the FDA’s regulatory scheme. 

As for the Cornett case, it does not involve a device cleared under §510k.  The drug-eluting stent was approved under the PMA process.  This implicates §360k(a)’s express preemption under Riegel.  Lohr is irrelevant, as likely is Buckman and its implied preemption given that express preemption is already in play.

In its preemption analysis, the Cornett Court considered two claims, failure to warn and breach of an express warranty.  While the Court found significant portions of each of these claims preempted, it allowed limited parts to go forward. 

Plaintiffs’ Failure to Warn Claim

On the failure to warn claim, the Court held as preempted plaintiffs’ claim that the label lacked necessary information on the fact that comparative studies were not conducted on the stent and that drug therapy should be used for an extended period of time after the stent is implanted.  This was an easy one.  The claim goes to the heart of the FDA’s approval process and the Court saw through it:

This claim is nothing more than a challenge to the adequacy of the information required by the FDA during the PMA process and the label approved by the agency.  This failure to warn claim falls within the PLA rebuttable presumption [we’ll get back to this] and the Riegel express preemption rule.  We affirm its dismissal.

Id. at *45. 

The Court also properly dismissed plaintiffs’ failure to warn claim based on an allegation that “defendants obtained FDA approval for the device only after submitting fraudulent representations to or withholding material information from the FDA,” citing Buckman.  We agree that this claim is properly preempted.  But we also note that this isn’t a 510k case in which §360k(a) express preemption doesn’t apply.  It’s a PMA case, and §360k(a) express preemption does apply under Riegel.  That is likely all that’s necessary, not implied preemption under Buckman. 

Our real concern, though, is the Court’s decision not to preempt plaintiffs’ claim that the defendants (1) withheld from doctors and the public the fact that the label’s instructions for post-implementation drug therapy were not part of the PMA process and (2) made misrepresentations to doctors and the public that the stent was not pro-thrombotic.  Id. at *47-48.  The Court reasoned that this claim was not preempted because it “overcomes the PLA’s rebuttable presumption of adequacy.”  Id. at *48.  In other words, the complaint’s allegations, for pleading purposes, were enough to overcome the NJ Product Liability Act’s presumption that an FDA-approved label was adequate. 

But that doesn’t seem to be the issue.  Before the PLA’s presumption should be considered, the determination first should be made as to whether PLA can even be applied – that is, whether it is preempted.  And a claim of failure to warn doctors and the public is preempted under Riegel.  While the PLA and its presumption might eventually be relevant in a prescription drug case where there generally is no express preemption, this is a medical device case – one that involves the PMA process and Riegel’s express preemption.  What is and is not involved in the PMA process, what is said about that to doctors and the public, and what is said about post-implementation drug therapy or the dangers and safety of the product (here, it allegedly being pro-thrombotic) are all in the wheelhouse of the FDA’s regulatory scheme. 

For instance, the FDA-approved label, according to the Court, already addressed post-implementation drug therapy.  Id. at *12.  Requiring further disclosure to doctors and the public about what the FDA considered or didn’t in granting that approval is something for the FDA to determine.  The fact that is has not done so does not act to allow the plaintiffs’ claim.  It only underscores that plaintiffs’ claim is preempted as imposing requirements different from or in addition to what the FDA required.

The Court next addressed plaintiffs’ failure to warn “concerning off-label uses . . . based on a failure to warn the medical community and the general public of adverse information gathered about the device and that instructions for post-implantation therapy were not part of the PMA process.”  Id. at *48.  The Court held that, “[t]o the extent [this] claim is founded on promotion by defendants of off-label uses of the device beyond the [FDA’s] safe harbor [for off-label promotion], the claim is not preempted.”  In other words, if the defendant’s off-label statements do not fall under a safe-harbor created by the FDA for off-label statements, then it is not preempted.

We also question this decision.  The FDA has had a lot to say about off-label promotion.  The Cornett decision cites some of it.  FDA regulations require manufacturers to warn about off-label uses in certain circumstances.  Id. at *35.  There is a safe-harbor for off-label promotion that was previously codified in the United States Code and has since been adopted by the FDA in a guidance document.  It  says that the Secretary of HHS won’t consider a manufacturer’s dissemination of information on unapproved uses to be off-label promotion if certain conditions are met.  Id. at *33-35.  And, as described above, the FDA convened an Advisory Committee to address off-label use and post-implementation drug therapy for the very stent at issue in this litigation.  There is no doubt that the FDA regulates off-label promotion and was actively doing so for this device.  Even the Riegel case, which established express preemption, involved off-label use.  552 U.S. at 320.

And we don’t see how the plaintiffs alleging off-label promotion “beyond the safe harbor” somehow exempts plaintiffs’ failure to warn claim from §360k(a)’s express preemption.  Falling within the safe harbor simply means that the FDA itself will not consider the statements to be evidence of off-label promotion.  It doesn’t mean that statements outside the safe harbor are off-label promotion.  It just means that the FDA considers them evidence of off-label promotion.  The ultimate determination is for the FDA, not private litigants.  And the United States, not private litigants, enforce the FDCA and FDA regulations.  (Setting that aside, it’s not clear how, in Cornett, falling outside the safe harbor matches up with a failure to warn claim.) 

Now, plaintiffs may argue that by invoking the safe harbor they are making a parallel violation claim, which is arguably permissible under Riegel.  But that doesn’t seem to work either.  The FDA hasn’t determined that the alleged off-label promotion in Cornett violated any FDA requirements.  And, failure to satisfy the safe harbor doesn’t create a violation either.  So plaintiffs aren’t really seeking to enforce an FDA requirement.  They can’t be making a parallel violation claim.  In short, they are seeking to enforce a requirement “different from or in addition to” FDA requirements. 

Plaintiffs’ Breach of Express Warranty Claim

Plaintiffs alleged that the defendants breached express warranties that were created by the labeling and packaging.  The Court quickly dismissed this claim as preempted under Riegel:

Plaintiffs contend that the MDA does not preempt an express warranty claim based on the information contained in FDA approved product labels and packaging inserts.  We disagree. . . . [I]n order to succeed on the breach of express warranty claim, plaintiffs must show that the label provides inaccurate or insufficient information in spite of FDA approval following the rigorous PMA process. Success on this state law claim would inevitably impose greater requirements than those already established by the MDA.  This claim is, therefore, preempted.

Id. at *51-53. 

The Court, however, also held that an express warranty claim based on statements voluntarily made to third parties and that “deviated from the labeling and instructions” are not preempted.  Id. at *53.  This seems, if we understand it correctly, to be an attempt to again make a parallel violation claim.  But it doesn’t seem to be a fit, at least not based on the information in the opinion.  A manufacturer can make statements that are not in the labeling.  Now, it may be that some of those would violate FDA regulations.  But that doesn’t mean that any deviation from the labeling is a violation.  And without any particulars, it’s not clear that plaintiffs properly stated a parallel violation claim for breach of express warranty. 

                              *                   *                 *                 *                             

All this said, there is still hope for preemption of the claims that remain after the Court’s decision.  The Court more than once qualified its decision by saying that it was being indulgent to plaintiffs’ allegations on a motion to dismiss [in state court, by the way, where TwIqbal doesn’t apply].  Discovery may reveal further information establishing that plaintiffs’ remaining claims are, as we discussed above, preempted.  Id. at *49-50, 53.  We think that, come summary judgment time, Defendants will have a good chance of establishing that the remaining claims are in fact preempted too.