Today’s guest post is by frequent contributor Dick Dean of the Tucker Ellis firm.  This time, Dick is sharing some insights on Wyeth v. Levine, 555 U.S. 555 (2009), which we consider the single worst prescription medical product decision since we started blogging.  Not surprisingly, Dick shares our views of Levine.  We agree with him.  Further, if Levine had been decided the way Dick advocates, all of the subsequent preemption focus on “independent”action, “major” changes and “newly acquired” information could have been avoided, and a more rational system turning on the substance of the conflict would have ensued.

As always, our guest bloggers are 100% responsible for the contents of their posts, deserving of all the credit (and any blame) for what they have written.

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Cases involving the “purposes and objectives” obstacle part of the implied preemption doctrine are rare.  The recent decision in Fontana v. Apple, Inc., ___ F. Supp. 3d ___, No. 2:18-cv-00019, 2018 WL 3689044 (M.D. Tenn. August 3, 2018), is a reminder of the efficacy of this powerful, but little used, defense.  Plaintiff brought a personal injury action claiming he developed cancer from the use of a cell phone.  In the 1990s these claims were addressed by extensive Daubert practice.  But this claim was dismissed at the pleadings stage because it interfered with the FCC’s ability to carry out its mission of setting radio frequency emission levels established by the Telecommunications Act of 1996.  It was specifically based on “purposes and objectives” obstacle preemption.  That is good for the cell phone industry but does it “speak” to us in the pharmaceutical defense world?  Indeed it does.  Fontana relied heavily on Farina v. Nokia Inc. 625 F.3d 97 (3rd Cir. 2010) [ed. note: blogged about here], finding a similar claim obstacle preempted, and Robbins v. New Cingular Wireless PCS, LLC, 854 F.3d 315 (6th Cir.2017) (barring an attempt to prohibit the building of a cell tower based on health reasons finding obstacle preemption).  The rationale of Fontana, Farina and Robbins is straightforward:

The reason why state law conflicts with federal law in these balancing situations is plain.  When Congress charges an agency with balancing competing objectives, it intends the agency to use its reasoned judgment to weigh the relevant considerations and determine how best to prioritize between these objectives.  Allowing state law to impose a different standard permits a re-balancing of those considerations.  A state-law standard that is more protective of one objective may result in a standard that is less protective of others.

Farina, 625 F.3d at 123 quoted by Fontana, 2018 WL3689044 at *2.

Allowing juries to impose liability on cell phone companies for claims like [plaintiff’s] would conflict with the FCC’s regulations.  A jury determination that cell phones in compliance with the FCC’s SAR guidelines were still unreasonably dangerous would, in essence, permit a jury to second guess the FCC’s conclusion on how to balance its objectives.

Farina, at 125-6 quoted by Fontana at *3.

Of course, the parallel to FDA determinations about efficacy and safety of drugs and the sufficiency of labels is striking.  The FDA engages in a classic weighing process as to whether a drug can come on the market and what its label should say.  Its processes are far more detailed than those of the FCC which played out in these three cases.  But jury second guessing of pharmaceutical labels is permitted by the Supreme Court in Wyeth v Levine, 555 U.S. 555 (2009), where the Court rejected preemption because of the manufacturer’s ability to submit a change in the label.  But that leaves the second issue in Wyeth—who should decide adequacy.  The three-Justice dissent (Alito, Roberts and Scalia) fully adopted the “purposes and objectives” argument—that the FDA should make these decisions and not be second-guessed by juries as to labeling decisions.

It should first be noted that even given Wyeth, there are areas within the pharmaceutical area where “purposes and objectives” preemption has been applied.  That is exactly what happened in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 353 (2001) (finding state law fraud on the FDA claims to be impliedly preempted).  It also happened in Zogenix v. Patrick, No. 14-11689, 2014 WL 1454696 (D. Mass. Apr. 15, 2014) [ed. note: blogged about here], where Massachusetts state rules made it impossible to market an opioid approved by the FDA.  These rules were struck down since they interfered with the FDA’s ability to carry out its mission of regulating drugs.  Specific reliance was placed on the purposes and objectives portion of implied preemption.

The power of the reasoning in Fontana, Farina and Robbins merits a review the of Wyeth analysis of “purposes and objectives” preemption.  The Wyeth majority’s rejection of the “purposes and objectives” claim is thin and wanting.  It is an afterthought to an opinion that deals primarily with impossibility preemption given the provisions of the “changes being effected” provision.  It is at odds with prior Supreme Court precedent on “purposes and objectives” in Geier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000) (finding obstacle preemption based on a general rule of the Department of Transportation favoring a “mix of seat restraints), and with subsequent precedent in Arizona v. United States, 567 U.S. 387 (2012) (an immigration case).  In Wyeth, the Court first noted that Congress had long recognized a role for state law causes of action under the FDCA.  Id. at 574–75.  But the fact that some state actions may be “complementary” does not mean that others may not be at cross purposes. Second, the court coupled the “complementary” argument with the fact that there was no express preemption provision in the FDCA.  Id.  But the Supreme Court itself has consistently held that the lack of finding of express preemption does not bar implied preemption.  See Geier, 529 U.S. at 869; Buckman, 531 U.S. at 352.  Third, it refused to consider the “new” FDA legal position on preemption.  An agency position is certainly not conclusive to whether there is “purposes and objectives” preemption, since the position of the United States on this issue is a changing one dependent on the politics of the administration in power. Moreover, implied preemption is not dependent on the FDA advancing that position.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (where implied preemption was found over agency objection).  But the major failure was that the Wyeth majority did not compare the entire federal regulatory scheme to the state jury system on the issue of who should decide adequacy; it demanded a specific regulation at odds with the jury system.  Wyeth, 555 U.S. at 580.  It distinguished Geier finding there was a “specific rule” in conflict with state tort lawsuits, but that rule was only that the Department of Transportation allowed a “mix” of restraint systems.  The generality of that “rule” does not begin to compare with the detailed federal regulations on drug approval and labeling decisions.  Simply put, the majority in Wyeth used an incorrect legal test to determine whether there was “purposes and objectives” preemption.

Wyeth, however impaired, is still the law.  But precedents do get changed.  And the Supreme Court’s treatment of this issue after Wyeth helps to demonstrate that Wyeth was wrong in its “purposes and objectives” analysis.   In Arizona v. United States the Supreme Court confronted a preemption challenge to a number of Arizona statutes involving immigration.  One such statute, section 6 of Arizona S.B. 1070, provided that a state officer could arrest someone if the officer had probable cause to believe that a person was “removable” from the country.  The United States argued that this statute was an obstacle to the “removal” system created by federal statutes and regulations.  Section 5 of the state legislation made it a misdemeanor for an unauthorized alien to apply for work in Arizona.  The government argued that was at odds with federal legislation making a specific choice not to impose criminal liability for this conduct.  The Supreme Court agreed that these statutes did create an obstacle to the full “purposes and objectives” of Congress.  567 U.S. at 406–07, 410.  It looked at what was provided for by each regulatory scheme and determined whether there was a conflict between them.

Presuming that Judge Gorsuch would follow the Scalia position in Wyeth—that has three Justices supporting that position.  Justice Thomas does not generally agree with “purposes and objectives” preemption.  But U.S. v. Arizona may be viewed by new Justices as a basis to reevaluate the Wyeth position of “purposes and objectives” preemption.  Justice counting aside, the reasoning of this part of Wyeth makes no sense.

That said, a note of caution is in order.  Cases where this defense is advanced in the pharmaceutical area should be carefully chosen with careful consideration given to the facts and the judges involved.  Enough bad law has already been made in this area.  In the short term, fact patterns like Zogenix where the state tries to intrude into the regulatory area cry out for this defense.  Using it now in a typical failure to warn claim is not likely to succeed.  But Wyeth’s reasoning is subject to challenge.  As other industries get the “cell phone” treatment on “purposes and objectives” preemption, this disparity will increase the focus on that reasoning.

We confess – when we first considered the spate of eye drop class actions a few years ago, we had trouble taking them seriously.  It was tough to get excited about penny-ante allegations that the size of eye drops warranted the attention of federal courts, or warranted class action status.  We were not alone in that assessment.  See Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017) (discussed here).

But the judicial skepticism engendered by pathetically weak and blatantly lawyer-driven litigation can produce collateral benefits – like favorable preemption decisions.  We hailed the first of those, Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. 2014), in our “Mensing – It’s Not Just About Generics Anymore” post over four years ago.  Thompson held that the plaintiffs’ attacks on the size of the eye drops was a challenge to the FDA-approved dose of that product.  Dosage alterations, however, were “major changes” that required FDA pre-approval.  The need for such pre-approval, however, barred the claim under the impossibility preemption rationale of Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).

We also considered Thompson as proof that we hadn’t been “baying at the moon” in our 2013 “‘Major’ Drug Labeling Changes That Require FDA Prior Approval” post, where we listed a bunch of drug-related changes that the FDA considered “major” and argued that they should all be preemptive under the Mensing/Bartlett rationale.

Thompson didn’t go any further, but a Massachusetts district court reached essentially the same result in Gustavsen v. Alcon Laboratories, Inc., 272 F. Supp.3d 241 (D. Mass. 2017):

FDA regulations, as interpreted by the FDA, now prevent defendants from changing the “size and/or shape of a container for a sterile drug product” unless and until the FDA determines that its benefits outweigh any harms.  The decision whether such a change should be made is, therefore, reserved for FDA, and the Supremacy Clause prohibits judges and juries from displacing or second-guessing the FDA based on the laws of Massachusetts or other states.

Id. at 255-56 (citation to same FDA guidance cited in our 2013 post omitted).  Oddly, Thompson was not cited in Gustavsen.  We blogged about that decision here.

A few days ago, the First Circuit affirmed, in Gustavsen v. Alcon Laboratories, Inc., ___ F.3d ___, No. 17-2066, 2018 WL 4057381 (1st Cir. Aug. 27, 2018), and that decision is a preemption home run.  Gustavsen decided a “single question” – “Can manufacturers of prescription eye drops change the medication’s bottle so as to alter the amount of medication dispensed into the eye without first getting the FDA’s approval?”  The answer to that question being “no,” “state law claims challenging the manufacturers’ refusal to make this change are preempted.”  Id. at *1.

The major dispute in Gustavsen wasn’t the law.  Even plaintiffs appeared to concede that preemption flowed from a “prior agency approval” requirement under Mensing/Bartlett:

The principles of federal preemption that control our disposal of this appeal are not in dispute.  If a private party (such as the manufacturers here) cannot comply with state law without first obtaining the approval of a federal regulatory agency, then the application of that law to that private party is preempted.  Conversely, a private party’s ability to do without prior agency approval that which state law requires defeats a preemption defense even if the federal regulatory agency retains authority to reject the changes, unless the defendant establishes by clear evidence that the agency would, in fact, reject the changes.

Id. (citations and quotation marks omitted).

The disputed question was whether a tort-required change to the dispenser of a drug (here, eye drops) that had the effect of reducing the size of the drop – and thus the dosage of the drug in that drop – required FDA prior approval.  The pertinent FDA regulation, 21 C.F.R. §314.70 (another part of which, (c)(6)(iii), is Levine’s notorious  “CBE regulation”),

divid[es] changes into three categories: major, moderate, and minor changes.  The classification of the manufacturer’s anticipated alteration into one of these three categories dictates the manufacturer’s ability to unilaterally implement its change.  Major changes require approval from the FDA prior to implementation, while moderate and minor changes do not.

Gustavsen, 2018 WL 4057381, at *5 (emphasis added).

Controlling case law is clear − and plaintiffs here concede − that if the change they contend state law requires qualifies as “major,” then federal law preempts plaintiffs’ cause of action because defendants cannot lawfully make such a change without prior FDA approval.

Id.  That’s the key.  Gustavsen’s main takeaway is its holding that “if the change [plaintiffs] contend state law requires qualifies as “major,” then federal law preempts plaintiffs’ cause of action.”  Id. (emphasis added).  That’s precisely what we first argued back in 2013:  that where certain “changes are considered sufficiently ‘major’ that they require FDA prior approval . . . those sorts . . . [of] changes should be preempted” by Mensing/Bartlett.

Much of the remaining preemption discussion in Gustavsen was to reject plaintiff-side pettifoggery.  The First Circuit ruled that §314.70(b) was properly read to include subsection (b)(1)’s “broad category of qualifying changes” as “major” – including “sections (b)(2)(i) through (viii).”  2018 WL 4057381, at *6.  Rejecting plaintiffs’ attempt to parse the regulation in a cramped fashion, Gustavsen “conclude[d] that, if a change fits under any of the categories listed in section (b)(2), that change necessarily constitutes a ‘major’ change requiring FDA pre-approval.”   Id. (emphasis added).  One of those categories, §314.70(b)(2)(vi), was a “comfortable” fit for the plaintiffs’ dosage claims, thus mandating preemption.  Gustavsen, 2018 WL 4057381, at *7.  Like the district court, the First Circuit in Gustavsen relied upon, inter alia, the same FDA guidance that we did back in 2013.  Id. at *8.

Finally, the First Circuit rejected each of the plaintiffs’ three “retorts.”  First, “[w]e do not share plaintiffs’ reading of the preamble” to the Federal Register notice that finalized §314.70, id., and “[i]n any event, it is well-established that a regulatory preamble is incapable of altering regulatory text’s plain meaning.”  Id. (citation omitted).  Second, the dosage was not “one drop” of any size.  Id. at *9.  Third, allegations that the FDA had, in practice, not always enforced the pre-approval requirement as to eye drops did not trump the regulation itself, since “the regulatory actions to which plaintiffs point” were “made by mid-level FDA scientists, or even a single ‘reviewer,’” and thus did not “reflect” the FDA’s “fair and considered judgment.”  Id.

We think Gustavsen is a big deal, since its logic extends far beyond the rather trivial allegations ginned up by the class action lawyers who have pursued the eye drop litigation.  There are a lot of potential drug-related changes that the FDA considers “major” under the regulation and guidance documents relied upon in Gustavsen.  These include “changes in the qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved NDA.”  §314.70(b)(2)(i) (emphasis added).  In other words, as we concluded when we first discussed Thompson, “We hasten to add that the same argument preempts all design defect claims against FDA-approved products since all design changes require pre-approval.”  Plaintiffs also frequently assail defendants for not more thoroughly testing their products.  Well, “major” changes also include “[c]hanges requiring completion of studies” and “[c]hanges to a drug product under an NDA that is subject to a validity assessment because of significant questions regarding the integrity of the data.”  Id. §(b)(2)(ii) and (viii).  A number of label changes, including to “highlights” and to “medication guides” are also “major.”  Id. §(b)(v)(B-C).

The Gustavsen rationale – “major” change = FDA pre-approval = preemption − should also apply to medical devices, since modifications to devices follow a similar regulatory framework:

(a) . . . [E]ach person who is required to register his establishment . . . must submit a premarket notification submission to the Food and Drug Administration . . . days before he proposes to begin the introduction or delivery . . . of a device intended for human use which meets any of the following criteria:

*          *          *          *

(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use.  The following constitute significant changes or modifications that require a premarket notification:

(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

(ii) A major change or modification in the intended use of the device.

21 C.F.R. §807.81(a) (emphasis added).

Finally, the Gustavsen rationale – being a basis for implied preemption – is not necessarily limited to the FDCA.  To the extent that other products are subject to federal pre-approval, they, too, may have a preemption defense available.  We don’t claim to be experts in such products, but one example that comes to mind is aviation, where FDCA “conflict preemption principles” have already been applied in at least one case.  See Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 702-03 (3d Cir. 2016).

Sometimes bad litigation can make very good law.

We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can’t help ourselves.  Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is an ever-present possibility.  To be sure, there is no shortage of litigation alleging that drug and device companies have violated state law duties, so we don’t want to overstate matters.  Regardless, federal preemption remains the bright shiny object from which we cannot avert our gaze.

Federal preemption demands our attention also because it is so often misunderstood and/or misapplied. We have said at times that some judges are hostile to preemption, and that might be true for some of the obviously result-oriented opinions that we review.  It is more likely that courts confront the many branches of preemption and the spider web of cases applying preemption in its various flavors, and they just get it wrong.  God only knows that the authorities are not always clear.

This is a long lead-in to a recent case that got preemption wrong on so many levels that we’re not completely sure what to make of it. In Tryan v. Ulthera, Inc., No. 2:17-cv-02036, 2018 U.S. Dist. LEXIS 140111 (E.D. Cal. Aug. 17, 2018), the plaintiffs sued the manufacturer of a medical device that uses ultrasound to tighten skin and reduce wrinkles on the face, neck, and chest.  The FDA cleared the device for marketing through the 510(k) premarket notification process, which is different from the more rigorous premarket approval (or “PMA”) process that some other devices go through.  The plaintiffs’ beef was that the manufacturer represented that the device was “FDA approved” (as opposed to “FDA cleared”) in violation of FDA regulations. Id. at **2-4.

The case seems fairly straightforward. Plaintiffs based their claims on an alleged violation of the Food Drug & Cosmetic Act (“FDCA”) and its regulations.  Moreover, the plaintiffs did not allege any complication with their procedures, or even that the device did not work exactly as it was supposed to.  Instead, they alleged that had they known the device was not FDA approved, and that it was merely FDA cleared, they would have paid less for the therapy or considered alternative treatments. Id. at *4.

Whatever you think of those allegations and the likelihood that any consumer would draw any distinction between “FDA cleared” and “FDA approved,” these plaintiffs were suing because of a violation of the FDCA, which runs directly into implied preemption under Buckman and 28 U.S.C. § 337(a).  Whether the device was FDA “approved,” “cleared,” or whatever, without the FDCA, there would be no FDA action at all. Buckman is the Supreme Court case that held that state-law claims conflicting with the FDCA are impliedly preempted, and Section 337 mandates that only the federal government can enforce the FDCA.  Whenever a purported state-law cause of action includes as a “critical” element some sort of FDCA violation, it runs afoul of § 337(a) and is therefore impliedly preempted under Buckman. Buckman involved a 510(k) device, so device categories do not affect implied preemption.

The manufacturer therefore justifiable moved to dismiss on implied preemption, and in denying the motion, the district court got off on the wrong foot, and it got worse from there. The district court began its discussion with the express preemption clause of the Medical Device Amendments, which expressly preempts any state law requirement which is “different from or in addition to” federal requirements. Id. at *10.  This is a valid legal principle as far as it goes, but it is completely irrelevant to this case:  The defendant did not assert that federal law expressly preempted the plaintiffs’ claims.  The defendant asserted implied preemption, under which federal law preempts state law where the state law conflicts with federal law or stands as an obstacle.

You might ask what difference that would make? Well, it makes a big difference, because in its next breath, the district court invoked the questionable and often-misunderstood “parallel claim” exception to preemption.  As the “exception” goes, because the MDA’s express preemption clause preempts state-law requirements that are “different from or in addition to” federal requirements, claims based on state-law duties that “parallel” federal requirements are not preempted.

We can debate whether the “parallel claim” exception is a good idea or whether federal authorities actually support its existence. One thing, however, is certain:

There is no parallel claim exception to implied preemption.

The district court’s introduction of express preemption at the outset of its opinion was therefore no harmless error. It started the opinion down a legal path from which the opinion would never recover, as the court forced the plaintiffs’ allegations into an “exception” that does not exist.  For example, the district court noted with approval that the plaintiffs alleged that California law “incorporates and mirrors the FDCA.” Id. at *11.  In the context of implied preemption, that observation alone should have been the death knell of this case because it acknowledged in plain terms that the plaintiffs were suing to enforce the FDCA.  We know from Buckman and section 337(a) that such actions are not allowed.  The “mirroring” of California law matters only in food cases, to which a statutory exception to section 337(a) applies.  That exception does not apply to medical devices (or drugs), which we detailed here.

Unfortunately, the district court misapprehended this point again and again. It noted the “linkage” between state and federal law and cited the plaintiffs’ use of federal “regulatory and statutory violations” as the predicates for their state-law claims. Id. The court noted that California statutes adopt federal regulations as state-law standards. Id. The court observed that California law prohibits false and misleading advertising.  And why is it misleading to say a Class II medical device cleared through the premarket notification process is “FDA approved”?  Because such a statement allegedly violates federal regulations.  All paths lead back to the plaintiffs suing to enforce the FDCA, which is the epitome of implied preemption.

The district court also wrongly cited federal law in support of its opinion. It relied on Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), to describe the FDA’s 510(k) process. Id. at **5-6.  The court certainly is not alone in citing Lohr on this point, but as we have explained here and here, Lohr understates and marginalizes the 510(k) process’ focus on safety and efficacy and was outdated even before it was published.  The district court also stated that “FDCA regulations appear to directly preclude preemption,” but once again the cited regulation defines the scope of the Medical Device Amendment’s express preemption provision.  That provision did not apply, nor did the defendants argue that it should. Id. at *13.

Finally, the court observed that 510(k) clearance does not preempt “state statutes of general application.” Id. at **13-14.  Of course the mere fact of 510(k) clearance does not create a blanket of preemption over “statutes of general application,” and we highly doubt the defendant argued that it did.  However, when the plaintiffs is claiming that a medical device manufacturer violation a state statute of any kind because its conduct violated the FDCA, that’s implied preemption, and that is exactly what the plaintiffs alleged here.

In the end, we have a class action alleging that “FDA approved” and “FDA cleared” are different enough to consumers that the law should require awarding damages to patients who allege no injury and for whom the device may have worked exactly as advertised. We are not so sure, nor are we sure that this order will survive an appeal.

Being that it was the Sixth Circuit that allowed a failure-to-update claim to proceed against a generic manufacturer, when we got the recent decision in McDaniel v. Upsher-Smith Labs, 2018 U.S. App. LEXIS 17884 (6th Cir. June 29, 2018), knowing it was about whether a claim for failure to distribute a medication guide was preempted, we flipped straight to the end looking for “affirmed” or “reversed.” We wanted to get into the proper frame of mind for reading the opinion. Were we going to be disheartened like we were by Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013). Or pleased by the court’s distancing itself from its prior ruling. Fortunately, it’s the latter.

While failure to distribute medication guide claims have been previously ruled on by district courts, it was a matter of first impression on appeal. The Eleventh Circuit had the issue before it just a couple of months ago, but decided the case on learned intermediary rather than preemption grounds. See our post on that case here. And while we’re at it, here is where you can find our discussion of Fulgenzi. The Sixth Circuit took just the opposite approach deciding not to reach the learned intermediary question but instead to focus all of its attentions squarely on preemption.

At issue was plaintiff’s husband’s use of a generic form of amiodarone. Plaintiff alleged that her husband did not receive the Medication Guide for the drug when he filled his prescriptions because the manufacturer failed to make sure they were available. McDaniel, at *3. This failure to provide the Medication Guide was the sole basis for plaintiff’s strict liability and negligence failure to warn claims.

So, to be clear, nowhere in plaintiff’s complaint does she allege that the warning that was provided with the drug (in its accompanying labeling) was insufficient or inadequate. Her only allegation is that the Medication Guide, the substance of which she also does not take issue with, was not provided to her husband as required by the FDCA. Which the Sixth Circuit determined was the pleading of a federal duty without any Tennessee state court parallel duty. “Said differently, the claims would not exist in the absence of the FDCA.” Id. at *4. And, that’s Buckman implied preemption territory.

The court starts by directly citing Buckman for the ruling that there is no private cause of action for enforcing the FDCA. Id. at *5. The court then quotes quite heavily from plaintiff’s complaint to demonstrate that she has not pleaded a traditional state law failure to warn to claim – indeed neither plaintiff’s complaint nor briefing even mentions the Tennessee Products Liability Act. Id. at *8-9. Instead, her allegations talk about the defendant’s failure to provide the guide “as required by the FDA.Id. at *6-7 (emphasis added). As if that wasn’t enough, in her briefing, plaintiff explicitly disclaimed any inadequate content basis for her failure to warn claims:

The allegation is not one of adequacy or “content” failure to warn, (i.e., the verbiage or even the format fails), but an actual and physical negligent failure of [defendant] to fulfill its federally mandated responsibility to ensure Medication Guides are available for distribution directly to patients with each prescription.

Id. at *8 (quoting plaintiff’s brief). So, we think the basis for the claim is quite clear. Failure to distribute the Medication Guide as required by the FDCA. Nothing more.

The court next moves to the decisions by various district courts finding failure to distribute claims preempted. See id. at *10-11. To which plaintiff responded by relying on Fulgenzi. Like we mentioned above, Fulgenzi was a failure to update case. Plaintiff alleged that the generic manufacturer defendant failed to update its labeling to include new warnings added by the brand manufacturer thereby violating both the federal duty of sameness required of generic labeling and Ohio state law requiring adequate warnings. The Fulgenzi court found that because it was the adequacy of the warning that was at issue – a traditional state law claim – rather than the failure to update, the claim wasn’t preempted. In other words, the allegation of the violation of the federal duty of sameness was not a “critical element” of the claim in Fulgenzi. It was pleaded by plaintiff to demonstrate that her state law failure to warn claim was not preempted because it paralleled a federal requirement. Plaintiff in McDaniel, tried to argue that she too only pleaded the federal-law violation to avoid impossibility preemption. In fact, the only element of her failure to warn claim was failure to comply with a federal duty. Id. at *11-12. The court was not willing to “ignore the language of [plaintiff’s] allegations simply so that [it could] shoehorn her claims into Fulgenzi’s realm.´ Id. at *14.

While we disagree with where Fulgenzi came out, we agree that even if you found Fulgenzi’s reasoning sound, it doesn’t apply to McDaniel. In this case, the court correctly concluded that the FDA requirements regarding distribution of Medication Guides was a “critical element” – actually only element — of plaintiff’s case, and therefore the claim was impliedly preempted.

Note that there is a dissenting opinion that argues the McDaniel case does fit within the Fulgenzi framework by finding that Plaintiff McDaniel also pleaded a failure to warn claim alleging inadequacy of the warning. We certainly think the language cited by the majority demonstrates that’s not the case, but we aren’t going to spend time quibbling over it because we don’t think adequacy should be outcome determinative. As we said back when we posted on Fulgenzi, there is no question that the duty at issue (to update or to distribute) is federal. Only the federal government may enforce it. Whether the updated warning and/or Medication Guide is, or is not, also “adequate” under state law amounts to nothing more than coincidence. At least that’s how we saw it then and still see it now.

Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today’s case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.  We were fresh off of a long flight home from Europe and were hesitant to take on a couple hundred miles of driving at each end of the day, so we investigated our options.  In the morning, direct flights from PHL to BDL abound.  But after 6 p.m., when our deposition was scheduled to end, there are no direct flights home. Nor are there Amtrak trains leaving Hartford after that hour.  So we threw up our hands and reserved a connecting flight home, reasoning that sleeping, reading, and eating Biscoff cookies would be more relaxing than driving.  This even though, to get from Hartford to Philadelphia, we had a totally illogical connection at Dulles, many miles out of the way.

Our originating flight landed at Dulles early.  And our 9:30 pm connection was showing “on time” on the board.  At 9:15 pm, the following announcement came over the loudspeaker: “We are very sorry, but your first officer is coming in on a flight that is delayed, so we need to delay your 9:30 pm flight until 11:30 pm.”  We were not pleased, but the new schedule would still get us home, crucial because we were leaving at noon on Saturday for an overnight trip.  At 11:20, the gate agent announced, “Your first officer’s flight has landed.  Give us a few minutes and we’ll get you boarded.”  At 11:30, we heard the following, dripping with contrition: “We are SO SORRY, but we are unable to put together a crew for your flight tonight, so we are delaying this flight until NOON TOMORROW.” [Emphasis added.]  Turns out that the long-awaited first officer had now exceeded his maximum hours for the day.

We did not react politely to this. We asked, “You mean to tell us that nothing in your computer could have told you this before we sat here for two hours and lost all other options??”  We did not receive a satisfactory response.  Ultimately, we took a 45-minute cab ride to Union Station (cavernous, pitch-black, and empty) and caught a 3:10 a.m. (!!) Amtrak train to Philadelphia.  When all was said and done, that was all that was left.

“Not much left” also describes (we warned you) today’s case, an excellent PMA and Buckman preemption decision out of the Northern District of Illinois.  In Gravitt v. Mentor Worldwide, 2018 WL 2933609 (N.D. Ill. June 12, 2008), the plaintiff alleged that she was injured by the defendant’s silicone breast implant.  Her complaint asserted claims under Illinois law, alleging design and manufacturing defects, failure to warn, and the defendant’s alleged failure to comply with the FDA’s pre-market approval (“PMA”) process for Class III medical devices, including numerous allegations of deficiencies in the defendant’s design and execution of post-PMA studies ordered by the FDA.

In earlier motion practice, the court dismissed most of the plaintiff’s claims without prejudice.  (We published a guest post on the first dismissals here.)  The plaintiff filed an amended complaint, which the court commented “strongly resemble[d] the original complaint.” Gravitt, 2018 WL 2933609 at *1.  The defendant again moved to dismiss, arguing that the plaintiff’s claims were expressly preempted under the Medical Device Amendments (“MDA”) to the FDCA or impliedly preempted under Buckman.

Express Preemption

The defendant argued that the plaintiff’s claims were expressly preempted to the extent that they were based on alleged methodological defects in the defendant’s post-PMA studies. The Court explained that under SCOTUS’s Lohr decision, as construed by the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as SCOTUS’s Riegel decision, state law tort claims related to Class III medical devices granted PMA are allowed to proceed if they: 1) allege violations of common-law duties that parallel federal requirements; or 2) claim violations of federal law.  Conversely, state law claims that “would impose on [the defendant] a requirement that is in addition to federal requirements” – in other words, claims that the defendant “violated state tort law notwithstanding compliance with the relevant federal requirements” – are preempted. Gravitt, 2018 WL 2933609 at *4 (internal punctuation and citations omitted).

The court held that, while the complaint alleged numerous deficiencies in the defendant’s post-PMA studies and alleged that each deficiency amounted to an “independent failure to comply with the FDA’s post-approval requirements” and thus a ground for withdrawal of PMA, the plaintiffs “simply assume[d], without legal or other support, that those deficiencies amount[ed] to violations of the FDA’s conditions for PMA.” Id. at *6 (citations omitted).   The court concluded that “such an assumption may not ground a viable claim,” id., and held that certain categories of the plaintiff’s allegations were expressly preempted.

Implied Preemption

But the court held that other categories of the plaintiff’s allegations were not expressly preempted. Specifically, the court held that “the complaint plausibly alleged that [the defendant] violated federal law” by failing to satisfy several categories of requirements related to, inter alia, follow-up of study participants, collecting and reporting of data at required intervals and related updates to labeling, warning of newly-discovered risks of the device, and failing to comply with requirements for manufacturing facilities.  Because the plaintiff “plausibly alleged” that these “shortcomings in [the defendant]’s post-PMA testing and manufacturing processes violated federal law,” section 360(a) of the MDA did not preempt those claims. Id. But the court emphasized, “Plaintiffs may proceed with those claims, however, only if they pass through a second legal filter” – the “filter” of implied Buckman preemption of “fraud on the FDA claims.” Id. at *7.

The court explained that, under Buckman, “federal law preempts claims to the extent they seek to deploy state law in the service of policing fraud against federal agencies based on statements that federal  law required the defendant to make to the agency, id. (internal punctuation and citation omitted), but doesn’t preempt traditional tort law claims involving breach of a duty to the plaintiff.  The court held:

Here, several of the claims that survive express preemption – for example, claims that the defendant reported results of the core study for fewer than the required number of years and recruited fewer than the required number of patients for a large post-approval study – are impliedly preempted under Buckman because those shortcomings breached no . . .  [tort duty to the plaintiff].  Rather, as in Buckman, those claims are unconnected to any traditional state tort duty, meaning that the existence of the relevant federal enactments is a critical element of those claims.

Id. (internal punctuation and citation omitted).  The court noted that the plaintiff attempted to tie the defendant’s alleged misconduct to her state tort claims, alleging that, if the defendant had more fully complied with the PMA process, its “disclosures would have led to much wider knowledge of the risks associated with its product.” Id. (internal punctuation and citations omitted).  But, it emphasized, “the Buckman analysis centers on the nature of the asserted claim and the source of the violation, not on the violation’s effects . . . . A claim arising entirely out of a violation of [the defendant’s] compliance with the FDA’s requirements in granting PMA is . . . . preempted under Buckman. Id.

Two categories of claims remained. The court dismissed the plaintiff’s claims alleging that the defendant’s manufacturing facilities failed to comply with applicable law and regulations, holding that the complaint had not adequately alleged a true manufacturing defect claim.  In addition, the plaintiff had failed to respond to the defendant’s arguments against these claims.  The last claim alleged that the defendant learned, but did not disclose, that its device had a higher likelihood of rupture than had been reported.  The court acknowledged that these claims were not fully developed in the complaint, but held that Rule 9(b)’s particularity requirement did not apply to the claims.  Holding that the plaintiff’s pleading “cross[ed] the line from conceivable to plausible,” satisfying Twiqbal, the court allowed the claims to proceed.

But that was all that was left.  The claims that were preempted – expressly and impliedly – were dismissed with prejudice, in an infrequent and laudable turn of events.   We would wax on at greater length, but today’s flight is boarding in a few minutes.  At least that’s what the board says.  We’ll keep you posted.

We immediately called for the further appeal and reversal of the hideous decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  However, we’re just bloggers.  Thus, we were greatly pleased when the United States Supreme Court, on December 8, 2017, requested the views of the Solicitor General on whether to grant certiorari in the Fosamax appeal, now known as Merck, Sharp & Dohme Corp. v. Albrecht, No. 14-1900 (U.S.).

We’re even more pleased, now that we have read the Solicitor General’s responsive brief, which we have just received.  Getting right to the point – the bottom line:

In the view of the United States, the petition for a writ of certiorari should be granted.

United States Amicus br. at 1.  Even though “[n]o circuit conflict yet exists,” the issue in its MDL context is sufficiently “significant” to grant certiorari now.  Id. at 12.

Although the question is close, . . . this Court should grant certiorari.  The underlying issue in this preemption case is a significant one:  whether the meaning and effect of an FDA labeling decision is a question of law for courts to resolve or a question of fact for lay juries to determine.  The petition cleanly presents that issue in an MDL context in which hundreds of separate cases . . . turn on its proper resolution.

Id. at 22-23.

First, the Solicitor General believes that preemption is a legal issue, not one for the jury, as the Third Circuit held in its unprecedented ruling:

The court of appeals erred in holding that a jury must determine whether FDA’s . . . decision − which declined to approve petitioner’s proposal to revise [the drug’s] Warnings and Precautions section . . . − preempted respondents’ state-law failure-to-warn claims arising from that same type of injury.  Where, as here, FDA renders a decision declining to approve a drug-labeling change, the interpretation of that administrative decision and its significance for a failure-to-warn claim are legal questions for a court to resolve, not factual questions for a jury.

Id. at 12.  “The meaning and effect of such agency action is a legal question within the exclusive province of a court.”  Id. at 13.  “Judges, rather than lay juries, are best suited to evaluate the scope of an agency’s legal determination in light of the relevant statutory and regulatory context.”  Id. at 14.

Second, the Solicitor General believes that the FDA’s rejection of the defendant’s request for a label change was “clear evidence” supporting preemption:

[B]ecause FDA’s decision here prevented petitioner from modifying the relevant labeling before late 2010, the court of appeals erred in rejecting petitioner’s impossibility-preemption defense.

Id. at 12.  “Nothing is ‘hypothetical’ about FDA’s actual 2009 decision in this case.”  Id. at 16.

[Levine] did not resolve how to determine the meaning and effect of an actual FDA labeling-supplement decision. . . .  [T]he court of appeals erred in transplanting [Levine’s] discussion about a hypothetical regulatory scenario to support a requirement for “clear evidence” about the scope and effect of the actual agency labeling decision in this case.

Id. at 16-17 (emphasis added).  The FDA was not quibbling about language when it rejected the label change at issue, but instead the “FDA’s decision thus was based on the lack of adequate data to support a warning.”  Id. at 21.  “Indeed, nearly a year later, FDA announced − after reviewing further data − that it had yet to find any ‘clear connection’” between the drug and the alleged risk.  Id. at 22.

Third, “clear evidence” was used in Levine “not in its ‘strict evidentiary sense’ but merely as a ‘useful reminder’ that a general presumption concerning a legal interpretation should control if substantial doubt exists.”  Id. at 18.  Thus, the Third Circuit’s “clear and convincing” evidentiary gloss in Fosamax was also error.  Rather, “to establish impossibility preemption, a name-brand drug manufacturer cannot rely on speculation or merely plausible interpretations of ambiguous features of FDA’s regulatory framework and practices.  Id. at 18-19.

Now we wait. If the Court grants review, Albrecht will likely be the most significant preemption decision since Levine itself.

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while taking a drug, but sometimes there is no fault even if there is a significant injury related to the use of the drug. If the drug’s manufacturer warned about the risk of plaintiff’s ultimate injury consistent with the available evidence, which it examined and shared with FDA appropriately in connection with approval and after approval, and the prescribing physician(s) gave due consideration to the risk in treating the patient, then the manufacturer did what it was supposed to do and the patient might suppress the urge to sue someone. Often, of course, such patients become plaintiffs and courts are faced with deciding summary judgment in cases with a real injury, related in some way to the use of the drug, but no real claim against the manufacturer. In those situations, the courts often get it wrong and allow some claim to get past summary judgment. Nelson v. Biogen Idec, No. 12-7317 (JMV) (MF), 2018 WL 1960441 (D.N.J. Apr. 25, 2018), got it right. Joe Blute and Yalonda Howze of Mintz Levin, who defended the case and told us about it, deserve some credit for that.

The facts of Nelson do not exactly scream failure to warn, even with the severity of the injury claimed by the plaintiff, who received Tysabri, a prescription medication for his multiple sclerosis. He claimed to have developed progressive multifocal leukoencephalopathy (“PML”), a condition about which the drug’s labeling contained black box warning, multiple other warnings in physician labeling, and warnings in a medication guide that the drug’s Risk Evaluation and Management Strategy (“REMS”) program required the patient acknowledge when receiving the drug through infusion provided by a healthcare provider. With such extensive warnings also comes the expected developed record of interacting with FDA about PML, which we will attempt to summarize. The medication was approved in 2004, but withdrawn because of PML cases the next year. PML results from exposure to the JC virus, which is prevalent in humans but only causes PML in vulnerable patients. Before seeking to bring the drug back to market, the manufacturer conducted FDA-requested research on testing for the JC virus. After taking an advisory committee recommendation, FDA re-approved the drug in 2006 with a slew of robust warnings on PML and a REMS program that essentially documented understanding and/or acceptance of the PML risk at each step of the prescribing chain every time the patient received the drug. The label was updated in August 2008, November 2009, and July 2010 to provide more information on the PML risk. Meanwhile, the manufacturer worked to develop a better assay to detect exposure to the JC virus. After years of research and interaction with FDA, in 2012, a new assay was approved and the label was amended to reference it.

Meanwhile, plaintiff was prescribed the drug for his MS in April 2008 after being advised of the PML risk. Plaintiff moved and continued on the drug when prescribed by two other physicians, each of whom also warned him of the risk of PML. Plaintiff was negative for the JC virus in 2009, but started demonstrating signs of PML in 2010, which was confirmed later that year by brain biopsy. Plaintiff sued and was on the fifth version of his complaint when the court considered summary judgment on plaintiff’s remaining claim for failure to warn under the New Jersey Product Liability Act (along with a Daubert motion that was denied as moot).

The court started its analysis with a discussion of three prior decisions on similar claims with the same drug. We will skip that, partly because we have discussed these cases before.  Because this was under the NJPLA, the first issue was whether the “super-presumption” of the adequacy of the PML warnings would apply given plaintiff’s argument about post-approval compliance. The presumption did not look to be dispositive, as the court noted that the substance of the warnings to both the prescribing physicians and the patient were clear, strong, and effective. Yet, the court found that there was no evidence of “manipulation of the post-market regulatory process,” the basis of the so-called “McDarby exception,” noting the interaction between the manufacturer and FDA on an assay that could be used to detect the JC virus in connection with the use of the drug. (The court also assumed without deciding that the McDarby exception could apply.) In the face of this presumption, plaintiff relied on proposed expert testimony that only indirectly addressed the adequacy of warnings. His expert claimed a better assay could have been developed and approved in time to affect the various physicians’ decision to prescribe the drug to plaintiff. Even if his testimony were admissible and if he took the next step of connecting a new assay to the content of the drug’s label—which he did not and could not as a non-physician—there were still obvious issues with relying on this testimony to establish an inadequate label and proximate cause for failure to warn, including that the prescribing physicians were aware of the PML risk and discussed it with the plaintiff on multiple occasions. Put it all together and there was no evidence to carry a failure to warn claim, with or without a presumption of adequacy

As a bit of overkill, the court went ahead and considered the manufacturer’s preemption defense, which argued that the proposed changes to the drug’s label would have been impossible to make during the relevant time. The prior decisions that we elided above also found impossibility preemption, but they were not decided in the Third Circuit after the Fosamax decision tried to make the application of Levine’s once-novel “clear evidence” standard just a question for juries. Even acknowledging the high standard and the decision in Fosamax (albeit with a recurring, and surely unintentional, misspelling), the court still found “There is clear evidence that FDA would not have approved an earlier change to the Tysabri label or have approved the JC Virus assay.” FDA specifically rejected similar proposals twice in 2010, before approving the assay and corresponding labeling change in 2012 after additional research had been committed. That was pretty clear evidence of impossibility back when plaintiff was taking the drug.

So, the manufacturer won summary judgment thrice over. The co-developer also won because it had no ability to change the label, a useful nugget as innovator liability and other theories to impose liability on other defendants continue to get raised when the logical defendant is not liable. In Nelson, no defendant was liable to an injury that, while unfortunate and serious, was warned of about as thoroughly as is possible with a prescription drug. We would prefer such a case never to have been brought or to have been dismissed for failure to state a claim, but summary judgment is still the right result.

 

This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to survive. And so far, plaintiff has been ping-ponging off the sides but hasn’t made it through the gap.

The case is Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. Apr. 4, 2018). Plaintiff had LAP-BAND surgery to aid with weight loss. The LAP-BAND is a PMA device. After seven years, plaintiff started to experience difficulty swallowing and frequent vomiting and upon investigation it was discovered that the LAP-BAND had eroded into plaintiff’s stomach and had to be removed. Id. at *2. Plaintiff conceded several of her claims. Those that remained for ruling by the court were negligence, failure to warn, and negligent or fraudulent misrepresentation. Id. at *3. Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion, studies revealed a higher complication rate. Id. at *2.

Because the LAP-BAND went through the PMA process, plaintiff’s claims are preempted unless they satisfy the “parallel claim doctrine.” That means plaintiff has to show that the state law duties she alleges defendant violated and for which she seeks damages are “genuinely equivalent” to the federal requirements imposed on the device. Id. at *5. Only when the state and federal duties are parallel will plaintiff’s claim not run afoul of the provision of the Medical Device Amendments (“MDA”) that a state not impose requirements that are “different from or in addition to” federal requirements. Id.

Plaintiff’s first negligence claim was for negligent design and manufacture. However, while she made several allegations about the device having significant risks, nowhere did plaintiff allege how the manufacturer’s duty of care under state law “parallels the federal requirement that the [device] be manufactured according to the approved specifications for the medical device.” Id. at *6. If the device was designed and manufactured according to its PMA specifications, then allowing a jury to find it was negligently designed or manufactured would be imposing a different or additional requirement on the manufacturer. Therefore, claim preempted.

Next up was plaintiff’s negligent failure to warn claim. The court actually broke the claim down into 5 theories on which failure to warn was premised: negligent marketing, negligent labeling, negligent failure to update labeling, negligent reporting, and negligent surveillance. Id. It’s worth noting here that the court applies all the same reasoning in concluding that plaintiff’s strict liability failure to warn claim is similarly preempted. Id. at *8.

Here plaintiff did cite federal regulations but still missed the mark. For instance, plaintiff cited 21 C.F.R. §99.101 which provides:

[a] manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling…provided that the manufacturer complies with all other relevant requirements under this part.

Plaintiff alleges that the defendant violated this federal regulation by failing to provide additional risk information about the device. But all this section does is provide a guideline should a manufacturer choose to disseminate additional information. Choosing not to do so doesn’t violate the provision. Id. at *6.

Plaintiff also cites to the Changes Being Effected (“CBE”) provisions arguing that the defendant violated those provisions by failing to implement a CBE warning. However, a CBE labeling-change is permission to change a label “while a manufacturer awaits a written FDA order approving the PMA supplement.” Id. at *7. But plaintiff did not allege that the defendant was awaiting an FDA order on a PMA supplement, so it is unknown if the provision even applies.

Plaintiff also tried to base her failure to warn claim on an alleged violation of defendant’s federal duties to report adverse events to the FDA and to conduct post-market surveillance. Id. But the court considered both of those claims impliedly preempted on the grounds that they were unlawful attempts to privately enforce the FDCA. The court said failure to report sounds like it could be failure to warn, but the requirement is to report to the FDA, not to plaintiff. And there simply is no state law cause of action for post-market surveillance. Id.

Finally, the court had to dismiss plaintiff’s misrepresentation claim based on plaintiff’s vague pleadings. If what plaintiff was alleging is that defendant should have disclosed additional information and such a disclosure requirement exceeded FDA’s requirements, the claim would be preempted as not parallel. If, on the other hand, plaintiff was alleging that the defendant “held its product out as meeting a higher standard than that required by the FDA,” such a claim would not be preempted. Id. Since the former is more likely, it appears that a properly pleaded claim is likely preempted.

Yesterday happened to be the deadline for plaintiff to file an amended complaint, which she did. A quick skim of the amended complaint leads us to believe it contains most of the same allegations and therefore deficiencies the court has already addressed. And, plaintiff re-pleaded the claims she conceded as insufficiently pleaded the first time around. We suspect another round of preemption briefing in this case’s future.

 

This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA, but from attempts to get around express preemption by basing claims on violations of the FDCA and running smack into implied preemption under Buckman. We have talked about the narrow gap a claim needs to squeeze through to not be subject to either version of preemption. We have, when we were feeling mythological, likened this to traversing the Strait of Messina between Scylla and Charybdis. Without overdoing the analogy, each state law claim must neither 1) impose a requirement that is “different from or in addition to” the PMA approval requirements, nor 2) have federal requirements as a “critical element,” or it will be smashed or swallowed into preemption oblivion. A good analysis of these issues starts with looking at what plaintiffs have alleged and how that fits within the cognizable causes of action under applicable state law.

In In re Smith & Nephew BHR & R3 Hip Implant Prods. Liab. Litig., No. CCB-172775, 2018 U.S. Dist. LEXIS 49021 (D. Md. Mar. 26, 2018), more than two hundred plaintiffs purported to assert fairly standard state law product liability causes of action against the manufacturer of a PMA hip implant. The actual allegations of what the manufacturer did wrong and what was bad about the device were not so standard. They were very heavy on alleged non-compliance with a range of FDA requirements. The defendant moved to dismiss under express and implied preemption and TwIqbal. We will focus on the preemption part and will resist griping about how the TwIqbal analysis should have come before the preemption analysis. We cannot, however, avoid commenting on the decision to address whether state law claims—under the law of forty-two states—are preempted without looking at state law. While the defendant may have liked the court’s willingness to address preemption on a motion to dismiss—something the plaintiffs resisted—the limited analysis helped to predict the result. The court said that “there is little need to analyze the elements of underlying state laws” and that it was “merely deciding which claims, and which arguments within those claims, would run afoul of state requirements that differ from and add to federal regulations,” but states do not impose requirements unless there is some statutory or common law claim that fits what plaintiff is complaining about in the case. Id. at **61-62.

The court started its preemption analysis by citing some cases we like, such as Mensing and the Bexis favorite Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016), on no presumption against preemption. It then cited some cases we do not like, such as Mink and Bausch on parallel claims. Id. at *66. When it said this, we knew where things were headed:

So, if a plaintiff may succeed on her state law claim by proving conduct that violates federal requirements, then that claim parallels federal requirements. The state law reliance on a federal regulation need not be explicit. Rather the elements of traditional state laws need only be satisfied by conduct leading to a violation of a federal regulation.

Id. Not only is that bit of bad logic eerily reminiscent of another case following Bausch that we lambasted, but you might want to look at the “elements of traditional state laws” before you declare them parallel to federal requirements. And there is that whole Scylla/Buckman part of the preemption analysis that cannot be defined away. With this background, the court’s analysis actually started out pretty well with strict liability design defect claims getting sucked down into the sea. “[P]remarket approval is FDA recognition of a particular medial device’s fitness for the market. Having received that approval, the BHR system cannot be labeled unreasonably dangerous by state law without imposing requirements on medical devices different from or in addition to federal regulations.” Id. at **67-68 (citing Reigel). Not bad.

The rest was. Claims for undifferentiated negligence, negligence per se—with no separate analysis—failure to warn, negligent misrepresentation, express warranty, and manufacturing defect were all considered parallel claims because they were based on the manufacturer’s “alleged failure to comply with duties already required by the FDA.” Id. at **69-70. Even if were not for Buckman, this is not what makes a state law claim parallel to a federal requirement. There needs to be a state law requirement that exists independent of FDA requirements and then it has to be parallel to the federal requirements. If state law required truthful communications about the risks and benefits of all products sold in the state and FDA required specific formats for communications about an approved device, but generally that communications about its risks and benefits be truthful, then that could be parallel. Those state law requirements probably apply equally to mushrooms as they do to implanted prescription medical devices.

By contrast, the purported state law requirement to train surgeons would be different than and in addition to federal requirements, because there is neither a federal requirement that surgeons be trained—states regulate the practice of medicine—nor a state law requirement that a manufacturer train surgeons before they can use its products. The court is correct that this claim is not impliedly preempted—it is not based on a federal requirement—but there needs to be a cognizable state law duty requiring training in the first place. Id. at *69 n.11. Similarly, the court held that a “failure to warn” claim based on reporting adverse events to FDA would not be expressly preempted, without considering whether state law imposes any duty to report—it does not. Id. at * 71. A claim for failure to warn “the general public or the medical community is, however, expressly preempted because there is no such parallel federal requirement”—but there is similarly no actual state law duty. Id. For negligent misrepresentation and express warranty, there are state law duties independent of any federal obligations and, here, we are not critical of the analysis. False marketing claims that a product is safer than it is or safer than a competing device can give rise to liability regardless of FDA requirements. So, we are fine with the court’s statement that “any state law claim that imposes liability for making false statements regarding the device’s relative safety parallels federal requirements,” even if we do not think the cases cited for that proposition are all good law. Id. at **72-73. We also agree that misrepresentation and warranty claims cannot be based on the alleged falsity of FDA-required statements about the device. Id. at *73. On manufacturing defect, the court reverted to an incomplete analysis, assuming that deviations from “the FDA’s approved design of the BHR device” could give rise to non-preempted state law claims, ignoring state law claims require manufacturing defects to render a product dangerous. Id. at *73.

Having found all these claims based on purported violations of FDA requirements to escape express preemption, without considering whether any state law authorized them, the court gave short shrift to implied preemption

All of the plaintiffs’ claims in the MACC fall within the states’ traditional power to regulate matters of health and safety. Not one cause of action tries to enforce a legal right held by a federal agency or relies on the statutory scheme for its existence—they all long predated modern medical devices.

Id. at **75-76. This is neither an accurate recap of what Buckman means, nor consistent with how the court had characterized plaintiffs’ causes of action as not seeking to impose liability based on violating requirements that were different from or in addition to FDA requirements. Rather than belabor the problems with this court’s analysis, we will end with pretty obvious gaffe. In returning to the purported state law claim for “failure to warn” by failing to report adverse events to FDA, the court concluded that “plaintiff’s failure to warn claims do not attempt to enforce the FDA’s right to be warned of information concerning the safety of approved medical devices” because plaintiffs claimed failing to report adverse events to FDA “violated a legal right owed to them.” Id. at *77. Presumably, that would be a right that the law of a state—or, rather, the law of 42 separate states—bestowed on private citizens based solely on federal law. To put it mildly, this is the kind of mess than can happen when preemption analyses skip steps and make unwarranted assumptions.

 

It took a while for courts to catch on that implied preemption in drug cases depends on whether the plaintiffs can present “newly acquired evidence” of a relevant risk, but the argument seems to be gaining some traction. The first case to recognize the “newly acquired evidence” argument was the First Circuit’s Marcus v. Forest Pharmaceuticals opinion in 2015, which we covered here.  Since then, we have covered the topic at some length in connection with orders coming out of the Eliquis MDL in New York, which you can revisit here, here, here, and here.  These posts report on a series of orders in which the district judge dismissed multiple cases because federal law impliedly preempted the plaintiffs’ claims.

A district judge has now issued a similar dismissal ruling in a prescription drug case in the Northern District of Alabama, McGee v. Boehringer Ingelheim Pharm., Inc., No. 4:15-cv-2082, 2018 WL 1399237 (N.D. Ala. Mar. 20, 2018).  Here is the gist of it.  We all understand that Wyeth v. Levine opened the anti-preemption door by recognizing that an innovator drug manufacturer could sometimes change its label without the FDA’s pre-approval through the Changed Being Effected (or “CBE”) process.  Because that allowed the manufacturer, under some circumstances, to change its label to accommodate state law without running afoul of federal law, implied preemption did not necessarily apply.  Then came PLIVA v. Mensing, which held that federal law impliedly preempted state-law failure-to-warn claims against generic drug manufactures because generic manufacturers cannot use the CBE process, and therefore cannot change their labels without pre-approval.  Because generic manufacturers cannot change their labeling to comply with state law without violating federal law, state law claims must give way.

In McGee, the district court joined others in recognizing that even an innovator manufacturer cannot use the CBE process unless there is “newly acquired evidence” of a causal association between a risk and the drug.  In that event, the innovators cannot change their drug labeling without the FDA’s pre-approval and implied preemption applies.  Id. at **3-4.  “So, if a plaintiff can allege the existence of newly-acquired information that supports a labeling change under the CBE regulation, and if the manufacturer subsequently fails to show by ‘clear evidence’ that the FDA would not have approved a change to the label, then a failure-to-warn claim will survive the manufacturer’s preemption defense.” Id. at *4.

In other words, before we even get to Wyeth v. Levine’s “clear evidence standard,” the plaintiff has to plead facts establishing that the manufacturer had newly acquired information and that the new information provides reasonable evidence of a causal association between the alleged risk and the drug.

The plaintiff in McGee failed.  He alleged that the product manufacturer failed to warn adequately regarding the risk of diabetic ketoacidosis, or “DKA.” McGee, 2018 WL 1399237, at *1.  But the complaint was ambiguous on what the manufacturer knew about that condition and when the manufacturer knew it. Id. It all came down to timing.  The plaintiff alleged that there were reports of DKA before the FDA approved the defendant’s drug, but reports that pre-date drug approval obviously are not “newly acquired” information.  In addition, any allegation that the manufacturer should have alerted the FDA about the DKA risk before approval is a fraud-on-the-FDA claim preempted under Buckman. Id. at *4.

The plaintiff also alleged that the FDA issued a warning with reference to adverse events after the plaintiff allegedly experienced DKA, but “common sense dictates that any information [the manufacturer] obtained after January 17, 2015, when Mr. McGee suffered DKA, is irrelevant to Mr. McGee’s claims because [the manufacturer] could not have used that information to change its label and prevent Mr. McGee’s injury.” Id.

In theory, the plaintiff could have stated a claim with reference to information newly acquired after approval but before he used the product.  “But Mr. McGee lumps together claims and facts from before, during, and after this brief time period” and “[w]ithout clarification, the court cannot tell when Mr. McGee alleges [the manufacturer] had what information.” Id.  Alas, the court granted leave to amend.  But the district court in the Eliquis cases gave the plaintiffs additional chances to plead too, and they were unable to come up with the facts.

The plaintiff in McGee may have similar difficulty.  We know from Eliquis that dumbing down the complaint and making the allegations more vague will not work, and the district court in McGee has already faulted this plaintiff for his imprecise pleadings in any event.  The court had particular distaste for allegations that were “nothing but a useless set of legal conclusions.” Id. at *5.  The court continued:

Worse, the complaint spews these legal conclusion with few supporting facts that would assist [the defendant] in understanding what the company did wrong. This type of “shotgun” pleading fails to plead a cognizable cause of action.  If Mr. McGee chooses to file an amended complaint, he must eliminate the unnecessary and unhelpful “shotgun” assertions and claims.

Id. (citations omitted). These are pretty strong words, but nothing beyond what any court should expect under Rule 8 and TwIqbal.  The takeaway is that the “newly acquired evidence” argument is well-grounded in the law and supported now by substantial precedent.  Moreover, plaintiffs will not always have the facts to get around it.