Today we have another guest post by long-time friend of the blog, Dick Dean, and his colleague at Tucker, Ellis, Mike Ruttinger.  Regular readers will recall, that right after Sikkelee v. Precision Airmotive Corp., ___ F.3d ___, 2018 WL 5289702 (3d. Cir. Oct. 25, 2018), was decided, we blogged about the aspect of that decision that we thought was most directly relevant to drug/device litigation – the court’s rejection of tort claims based on failure to make reports to government agencies.  We briefly mentioned the remainder of the Third Circuit’s decision (which was actually by far the lengthier discussion), but didn’t spend much time on it.  In this post, Dick and Mike rectify that oversight.  As always, our guest bloggers deserve 100% of the credit (and any blame) for their discussion.

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The Third Circuit is having a bad year on preemption.  Its decision in In re Fosamax Products Liab. Lit., 852 F.3d 268 (3rd Cir. 2017), in which it held that it is for juries and not judges to determine whether there is “clear evidence” sufficient to meet the Wyeth v. Levine, 555 U.S. 555 (2009), standard for preemption in a failure-to-warn case, was accepted for review by the Supreme Court and is widely expected to be reversed.  [Editorial note – Fosamax ended up tied for the worst decision of 2017.  We hope to be rid of it in 2018.]  And now the Circuit has injected needless confusion into the test for impossibility preemption set forth in Levine’s follow-up case, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  Mensing is familiar to many as the case that clarified the rule for determining when an impossible-to-resolve conflict between federal and state law preempts plaintiffs’ claims.  If the change the plaintiff seeks is one that requires prior approval or federal permission, then the claim is preempted.  Id. at 620 (“The question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”) (emphasis added).  [Editorial note:  We call that the “independence principle.”]

The recent Third Circuit decision, Sikkelee v. Precision Airmotive Corp., No. 17-3006, 2018 WL 5289702, at *8 (3rd Cir. Oct. 25, 2018), is a wrongful-death case that originated from a 2005 airplane crash.  As the date suggests, it has been around for quite a while; this is the litigants’ second trip to the Third Circuit after a 2016 appeal [blogged about here] culminated in denial of a petition for certiorari and a remand for the Middle District of Pennsylvania to consider conflict preemption issues.  Specifically, the focus of Sikkelee became the design of the airplane carburetor.  The district court initially found the plaintiff’s defect claim to be barred by field preemption under the Federal Aviation Act because federal regulation of aviation is so extensive as to preempt the entire field of airplane design-related tort law.  Sikkelee v. Precision Airmotive Corp., 45 F. Supp. 3d 431 (M.D. Pa. 2014).  But the Third Circuit reversed that decision, suggesting that while field preemption does not apply, “the case law of the Supreme Court and our sister Circuits supports the application of traditional conflict preemption principles.”  Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 699 (3rd Cir. 2016).  Accordingly, the Third Circuit remanded with an opinion directing that the district court should consider the conflict preemption principles set forth in Mensing.

Given the Third Circuit’s lengthy discussion of Mensing in its 2016 opinion, what came next was quite a surprise.  The panel that issued the 2016 decision acknowledged the role that Mensing, as well as a subsequent decision, Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), play in the conflict preemption analysis at length.  The court even honed in on the FAA’s “preapproval process for aircraft component part designs” as a key factor for the district court to consider in any conflict preemption analysis because the FAA would need to preapprove the alternate design that the plaintiff alleged as the basis for her lawsuit.  Sikkelee, 822 F.3d at 708 (“Thus, the reasoning of the Bartlett majority, 133 S. Ct. at 2473, 2480, and the consideration we must give to the FAA’s views under separation of powers principles, see Wyeth, 555 U.S. at 576-77, 129 S. Ct. 1187, lead us to conclude that the FAA’s preapproval process for aircraft component part designs must be accorded due weight under a conflict preemption analysis.”).  On remand, the district court followed the Third Circuit’s suggestion and found that the design-defect claim regarding the carburetor was indeed preempted because federal regulations required prior approval of the suggested design change.  Sikkelee v. AVCO Corporation, 268 F. Supp. 3d 660 (M.D. Pa. 2017).  But on October 25, that decision was reversed on appeal by a completely different panel of Third Circuit judges.  The new panel found no conflict preemption, applying the “clear evidence” test from Wyeth v. Levine rather than the Mensing prior approval test.  Specifically, the panel reasoned that “the nature of FAA regulations and Lycoming’s interactions with the FAA—including the changes it has made to its type certificate—demonstrate that Lycoming could have—indeed it had—adjusted its design.”  Sikkelee, 2018 WL 5289702 at *8.  For the defendant “to be entitled to an impossibility-preemption defense,” the court reasoned, “it must present ‘clear evidence that the [FAA] would not have approved a change.’”  Id.  Because it found evidence that the FAA would have permitted the change, the court held conflict preemption inapplicable.

The contrast between the Third Circuit’s two Sikkelee decisions is made only starker by the dissenting opinion filed by Judge Roth.  From the outset, Judge Roth notes that the majority erred by taking “a piecemeal approach to the Supreme Court’s impossibility preemption precedents.”  Id. at *13.  Put simply, Wyeth v. Levine cannot be read in a vacuum; for the Supreme Court’s trilogy of conflict preemption cases—Levine, Mensing, and Bartlett—to make sense, they must be read together.  This is not a novel position, but one spelled out by a wide variety of courts over the last five years.  Among the many to do so are Yates v. Ortho-McNeil-Janssen Pharmaceutical, Inc., 808 F.3d 281 (6th Cir. 2015), In re Celexa and Lexapro Marketing and Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015) (reading Wyeth and Mensing in combination), Utts v. Bristol-Myers Squibb Co., 226 F. Supp. 3d 166, 178-83 (S.D.N.Y. 2016), and—yes—the Third Circuit’s first Sikkelee decision, Sikkelee, 822 F.3d at 702-03 (reading Levine, Mensing, and Bartlett together to spell out different preemption rules for claims based on different regulatory scenarios).  The point, Judge Roth explained after reviewing the three decisions, is that:

When a manufacturer operating in a federally regulated industry has a means of altering its product independently and without prior agency approval . . . state-law claims against the manufacturer alleging a tortious failure to make those alterations ordinarily are not preempted; but, when federal regulations prohibit a manufacturer from altering its product without prior agency approval, state-law claims imposing a duty to make a different, safer product are preempted.

Sikkelee, 2018 WL 5289702 at *13.

Put another way, the fact that a defendant may have made changes in the past which were approved does not negate the fact that it still had to ask a federal agency for permission to make a change.  The fact that a party has to ask is dispositive, as the Supreme Court clarified in Mensing when it held that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it.”  564 U.S. at 620.  Levine was simply the wrong framework because in Levine, it was undisputed that the brand drug-manufacturer could unilaterally do what the plaintiff alleged state law required.

In contrast with Levine, on which the majority relied, it was undisputed in Sikkelee that the design change would require prior approval.  The first Third Circuit panel expressly held that “the type certification process results in the FAA’s preapproval of particular specifications from which a manufacturer may not normally deviate without violating federal law.”  Sikkelee, 822 F.3d at 702.  The majority ignored that conclusion entirely.  Indeed, though parsing several of the applicable FAA regulations, the majority never addressed whether those regulations require prior approval of the requested change.  Instead, it short-circuited the inquiry by merely concluding that since the changes had been made subsequent to the accident, the prior approval element was meaningless.  Judge Roth, in dissent, was the only member of the panel to address the prior-approval issue and came to the same conclusion as the first Sikkelee panel—that prior approval was a necessary predicate to the design change.  And since prior approval was required, the case was more like Mensing than Levine, leaving no need to apply the clear-evidence standard.

The trilogy of Levine, Mensing, and Bartlett lay out a clear rule for conflict preemption—the same one summarized by Judge Roth.  If en banc review does not cure the Sikkelee opinion, the Third Circuit may find that Fosamax is not the last preemption decision it sends to the Supreme Court for review.

 

Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive held, we called it a one-two punch. We cannot say that we coined the term as used here, but we repeated it more than a few times. It has since become fairly standard for most claims against generic manufacturers to be held preempted by the frightful duo of Mensing and Bartlett. Save abominations like the T.H. case, the concept of innovator liability has largely been put to bed like a kid crashing after a sugar high. Still, plaintiffs sometimes try to impose liability on both the generic manufacturer whose drug they took and the branded manufacturer whose drug they did not.

When they do and a court rules, we pull the one-two punch from the back of our metaphor closet and see how it lands. In Preston v. Janssen Pharms., Inc., No. 158570/17, 2018 WL 5017045 (N.Y. Sup. Ct. Oct. 12, 2018), the plaintiff claimed vision loss from her off-label use of the generic version of Topiramate, a well-established anti-convulsive. For more than a decade before she began her three year course, the label for the branded version contained warnings and precautions about ocular conditions that could result in permanent vision loss if untreated. After waiting more than two years to sue, she sued both the branded and generic manufacturers, claiming the records were unclear as to which drug she took for three years.

The branded manufacturer moved to dismiss, contending the complaint only asserted claims based on the generic drug that it did not make. It is not clear that the plaintiff tried to assert innovator liability in addition to claiming that the branded dug might have been used, but the court looked at the evidence and ruled on the merits. Because the evidence was clear that only the generic drug had been used, the next step to first punch was whether New York recognizes innovator liability. Citing the same cases we have before, the Preston court held that “named-brand drug manufacturers . . . cannot be held liable to the user of the generic form of that drug, since the manufacturer of the brand named drug owes no duty to the user of the drug’s generic form.” Id. at *3.

That takes us to the motion to dismiss of the generic manufacturer, the potential second punch. Plaintiff conceded, and the court accepted, that design claims are preempted because the generic manufacturer cannot change the drug’s design. Id. at *6. The plaintiff disputed that the warnings claim was preempted based on an alleged failure to update the generic label to match the branded drug’s label. For about eight months after the plaintiff started the generic drug, its label allegedly did not match. When the plaintiff alleged suffered her injuries, it did. A few years later, it allegedly did not match again. Plaintiff claimed that the later mismatch knocked out preemption for any warnings claim, but the court parried that argument. Following Mensing, the court held preempted claims based on any period when the warning of the generic drug matched, but allowed at the pleadings stage any claim based on the pre-injury period when there was an alleged failure to update. Id. at *5. So, the second punch did not quite land flush. It may be difficult for the plaintiff to sustain a claim about the warning when the plaintiff was first prescribed the drug when she kept receiving it when the warning was updated and her injuries allegedly developed during this later period. We suppose the warning claim might get kicked at the summary judgment stage. Preston also addressed the adequacy of pleading of various other claims that tend to be thrown into a product liability complaint, but she will have a chance to try to correct what was inadequately pled. Nothing too decisive or interesting about that, at least to us and at this stage.

Failure to warn claims premised on a failure to report incidents to a federal governing agency are preempted in the Third Circuit. Sikkelee v. Precision Airmotive Corporation, — F.3d –, 2018 WL 5289702 (3d. Cir. Oct. 25, 2018). And this would be a DDL Blog drop the mic moment if the ruling had come in a prescription drug case instead of in an opinion involving airplanes. However, throughout the decision, the court analogizes to drug preemption decisions making us feel safe to say that Sikkelee’s Buckman-based rationale applies to all governmental agencies – FDA included. This isn’t the first time we’ve blogged about Sikkelee (see here and here). It’s bounced back and forth from the Middle District of Pennsylvania to the Third Circuit a couple of times with preemption at the forefront.

And, in the unanimous portion of the decision, the Third Circuit upheld the district court’s decision to grant defendant’s summary judgement motion dismissing plaintiff’s failure-to-notify-the-FAA claim. Id. at *11. FAA regulations require manufacturers to “report any failure, malfunction, or defect in any product . . . that it determines has results in any of the [listed] occurrences.” Id. Plaintiff argued that the alleged defect at issue was the type required to be reported, that defendant failed to report, and if it had reported, the FAA would have taken action. Id. Sound familiar? Replace “defect” with “adverse event” and “FAA” with “FDA” and you’ve got a Stengel claim. But unlike the Ninth Circuit, the Third Circuit found that what plaintiff was doing was trying “to use a federal duty and standard of care as the basis for this state-law negligence claim.” Id. Right. We say that all the time in pharmaceutical cases. Federal law does not require warnings to plaintiffs or their doctors. State law does not require warnings to the FDA. In the absence of a state-law duty to make reports to a government agency, a failure to report claim is an improper private attempt to enforce the FDCA (or FAA as the case may be). The Third Circuit based its decision primarily on Buckman as analogous to a fraud-on-the-FDA claim and rendering it impliedly preempted.

After Sikkelee, we also feel it’s safe to say that the horrendous decision a few months ago in Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. Jul. 12, 2018) (recognizing failure-to-report-to-FDA claim), is now just bull. (Decision discussed here).

We can’t completely ignore that the Third Circuit also overturned, in a 2-1 decision, the district court’s decision finding plaintiff’s other claims were conflict preempted. The majority found the regulatory framework to be more like Wyeth v. Levine, 555 U.S. 555 (2009) – finding FAA regulations would have allowed defendant to make a change without prior FAA approval and therefore concluding that the claim was not preempted absent “clear evidence” that FAA would have rejected the change. Whereas the Middle District and dissenting Third Circuit opinions found PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013) controlled interpreting FAA regulations as not allowing independent design changes. Since this discussion really turns on distinguishable FAA-based regulatory facts, we don’t think it has much impact on our drug and device world except the continued recognition of Mensing and Bartlett outside the generic drug arena. Also, the clear evidence aspects of the decision likely will be affected by the Supreme Court’s decision in the pending Fosamax appeal.

Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a “murder mystery dinner theatre” in the “conservatory” of a local cemetery.   (We didn’t know cemeteries had “conservatories.”) It is a Halloween-themed event, with costumes encouraged, and we may or may not wear our eerily-lifelike Standard Poodle mask/hood. In any event, the premise of the event is that actors are scattered among the paying audience “guests.” At some point during the cocktail hour, one of the actors will “die.” During the ensuing dinner hour, clues are revealed and everyone tries to solve the “murder” in time for dessert. We think this sounds like fun, and we like the idea of not knowing what to expect and not being able to predict the result.

But sometimes a predictable result (to the extent that preemption jurisprudence is ever predictable) is just fine. In In re Bard IVC Filters Prods Liab. Litig. (Hyde v. C. R. Bard, Inc.), 2018 WL 4356638 (D. Ariz. Sept. 12, 2018), the plaintiff was implanted with the defendant’s inferior vena cava (“IVC”) filter. Three years later, the plaintiff learned that the filter had perforated the IVC wall and had fractured. The filter was removed shortly thereafter. The plaintiff filed suit, asserting the usual panoply of product liability claims. After the court granted summary judgment for the defendant on several claims, the plaintiff’s claims for strict liability design defect and negligent design remained pending, along with a claim for negligence per se.

Under Wisconsin law, which governed the plaintiff’s substantive claims, a claim for negligence per se arises from violation of a statute, where the plaintiff can show that “(1) the harm inflicted was the type the statute was designed to prevent; (2) the person injured was within the class of persons sought to be protected; and (3) there is some expression of legislative intent that the statute become a basis for imposition of civil liability.” Hyde, 2018 WL 4356638 at *2. In her negligence per se claim, the plaintiff asserted that the defendants violated provisions of the Federal Food, Drug, and Cosmetic Act. As the court commented, “Far from containing an expression that FDA regulations are intended to form the basis of civil liability, . . . [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.” Id. (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001)) (internal punctuation and additional citations omitted).   “Thus,” the court continued, a private litigant cannot bring a state-law claim [that] is in substance . . . a claim for violating the FDCA – that is, when the state claim would not exist if the FDCA did not exist,” because, under Buckman, such claims are impliedly preempted by the FDCA.  Id. (citations omitted). All correct, even if it conflates Buckman preemption with the plaintiff’s simple failure to state a negligence per se claim under the requirements of Wisconsin state law.

The court held that, as in Buckman, the plaintiff’s negligence per se claim was more accurately characterized as a “negligence claim based solely on violations of FDA regulations,” id., and was therefore impliedly preempted. As the court emphasized, “. . .where the plaintiff was not suing under state law for conduct that happen[ed] to violate the FDCA, but instead [was] suing solely because the conduct violate[d] the FDCA,” the claim was preempted by federal law. Id. (emphasis in original, internal punctuation and citation omitted). The court contrasted such claims to traditional tort claims like plaintiff’s negligent design claim, which arose from a duty owed under state law and which was not subject to Buckman preemption.

We like this correct, methodical, predictable decision.   We’ll let you know how the mystery thing goes.

The toughest thing about defending product liability cases is the occasional immersion in human misery.  Securities and antitrust cases pose intellectual challenges but they are, in the end, pretty much about money.  By contrast, the plaintiffs in our cases are claiming injuries to their bodies, not just their wallets.  Sometimes those alleged injuries are phony or trivial.  Mostly, though, they are real.  You wouldn’t wish them on your worst enemy.  Every once in a while, the alleged injury is unspeakably sad.  That sadness hits us extra hard when the injury involves a child.  For instance, several of the plaintiffs in SJS-TEN cases were children.  Try to imagine what it would be like to be on the other side of the courtroom in such cases.  And then there are cases brought after a child or adolescent committed suicide.  No parents want to outlive their children.  And the ending of a life so prematurely must be devastating.  It must also be infuriating.  It would be natural to blame the catastrophe on a drug.  It might even be right to do so.  Or it might not.

 

In Patton v. Forest Labs, Inc., 2018 U.S. Dist. LEXIS 160368 (C.D. Cal. Sept. 19, 2018), the plaintiffs alleged that their daughter committed suicide after taking the antidepressant Lexapro.  After some dismissals and amendments, the Second Amended Complaint (SAC) was teed up for another motion to dismiss. There were claims for relief based on negligence, violation of California’s Unfair Competition Law (UCL), and wrongful death.  The claims were based on allegations that the anti-depressant was marketed in such a way as to mislead the FDA, doctors, pharmacists, and the public about suicide-related risks. In considering the motion to dismiss the SAC, the court “again extends its condolences.”  But the court still dismissed the SAC without leave to amend.

 

The central obstacle for the Patton SAC was that the suicide warning was quite clear.  The Highlights section of the Lexapro label contained a boxed warning about the “[i]ncreased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder and other psychiatric disorders.”  The plaintiffs argue that the warning should have been stronger.  One can always conceive of ways to enhance a warning, but the possibility of such enhancements does not mean that the original warning was not adequate.  The label warned in plain and explicit terms of the specific risk that caused the alleged injury.  The plaintiffs’ pleading as to why the failure to say more in the warning constituted negligence was, to say the least, confusing and amorphous.  The plaintiffs pointed to nondisclosure or understatement of risks, and also inserted allegations of other misconduct, including purported violations of a Corporate Integrity Agreement.  None of it mattered, because the Patton court held that the warning at the relevant time was adequate as a matter of law.

 

The Patton court also held, after reciting the holdings in Levine, Mensing, and Bartlett,  that the warning claims were preempted because the plaintiffs could not point to any newly acquired evidence to support a label change. (This same issue was central to the case we discussed yesterday.)  Moreover, there was another reason why the usual resort to the Changes Being Effected provision would not work: the change to the suicide warning would need to appear in the Highlights section, and changes to the Highlights section cannot be done without prior FDA approval.  (The inability to make unilateral changes to the Highlights section might ride in to the rescue of many defendants.)  The Patton plaintiffs argued that preemption did not reach claims for breach of warranty and fraud, but there was no claim for breach of warranty, and the fraud claim (part of the UCL) did not come close to satisfying the heightened pleading requirements for fraud claims, because it involved statements allegedly made to “unspecified audiences at unspecified times.”

 

The Patton plaintiffs’ fundamental contention was that the defendants were required change the drug label based on new information (even if we do not know exactly what the new information was).  The Patton court’s rejection of this argument is worth quoting:  “While it is obvious that the FDA, in approving the relevant Lexapro initial labeling and not yet requiring Defendants to change their label, disagreed with Plaintiffs, even if the FDA were wrong, only the government (i.e., not Plaintiffs) may bring a lawsuit to enforce the FDCA and the FDA’s regulations requiring Defendants to change their label.”  The Patton court then cited Buckman, completing the quartet of essential drug and device preemption SCOTUS cases.

 

Because this was the Second Amended Complaint, and because futility had been demonstrated to a fare thee well, the Patton court dismissed the SAC with prejudice.  Thus was a sad tale brought to its conclusion.

 

 

 

Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a mother/daughter vacation.   Her longtime companion no longer enjoys travel, and few of her friends share her sense of adventure. So we set about finding a suitable trip for next spring. Threshold categorical decisions proved troublesome. Our normal instinct, given the pace of our everyday life, is to sit still on vacation. We are fond of cruises, and we don’t care to where because we don’t get off of the boat.   The EYDDM prefers an eight-cities-in-seven-days pace. If we have to move, we prefer to rent a car and explore – we are not fond of printed itineraries. And we lean toward countries with national languages other than English. So, in the spirit of compromise, we booked eight days on a bus in Ireland over Memorial Day. Yeah, we know. But you should have seen the EYDDM’s smile. Sometimes, the answer is simple.

As it was in today’s case.   In Romer v. Corin Group, PLC, et al., 2018 WL 4281470 (M.D. Fla. Sept. 7, 2018), the plaintiff alleged that he was injured by when the defendant’s artificial hip implant released metallic contaminants into his body, causing pain and malfunction of the device and ultimately requiring another surgery. He sued in state court on the usual product liability theories, and the defendants removed the case on diversity grounds. After removal, the defendants moved to dismiss the negligence, negligence per se, and strict liability claims.

Listing seven alleged manufacturing defects in the hip implant, the negligence per se claim alleged that the defendants failed to comply with the manufacturing standards the FDA approved as “conditions of FDA’s approval [as well as] the general regulations applicable to Class III medical devices.” Romer, 2018 WL 4281470 at *3. A second negligence per se count alleged that the defendants’ simulator testing of the device was inadequate and violated federal regulations related to the compliance with Approved Design Standards. Id.   The defendants argued that both counts failed as a matter of law because Florida does not recognize a claim for negligence per se based on alleged violations of the federal FDCA or its implementing regulations. The court agreed, holding that, “[u]nder Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence of a legislative intent to create a private cause of action.”   Id. at *4 (citations omitted). Because the FDCA and its implanting regulations do not “expressly create civil liability for non-compliance, strongly suggesting a legislative intent not to create a private cause of action,” id., the plaintiffs could not base negligence per se claims on the violations they alleged.

The defendants argued that the design defect claims sounding in both strict liability and negligence were preempted under Riegel because the hip implant device was a Class III medical device subject to pre-market approval (“PMA”) by the FDA. While the plaintiffs argued that the design defect claims escaped preemption because the claims were “based on defendants’ alleged failure to comply with federal laws after the FDA already approved the design of the device,” id. at *5, they made no allegation that the defendants had altered the design approved by the FDA during the PMA process.   The court concluded, “To the extent plaintiffs are asserting parallel claims, . . . . a valid parallel claim cannot challenge the rigorous PMA process itself or the requirements imposed by the FDA pursuant to that process. However, plaintiffs’ design defect claim does just that,” id at *6, and it was therefore expressly preempted.

Similarly, the defendants argued that the plaintiff’s negligence claims, based on the defendants’ alleged failure to warn of defects in the hip implant device or to report adverse events to the FDA, were expressly preempted because they sought “to second-guess the FDA’s determination that the warning language [was] adequate and [to] force [the defendant] to meet an additional standard beyond what the FDA requires.” Id. The defendants also argued that the reporting violations claims were impliedly preempted.

The court held that the warnings claims “imposed requirements that [were] different from, or in addition to, the federal requirements under the MDA,” and were thus expressly preempted. To the extent that the plaintiffs claimed that the defendants failed to comply with FDA reporting requirements, the claim was “simply an attempt to recast a claim for violation of the FDCA as a state law negligence claim.” Id. at *7. As such, it was “premised upon an FDA-reporting requirement that [was] not paralleled by a Florida law duty,” and was impliedly preempted under Buckman, which permits such claims to survive only to the extent that they “do not seek to privately enforce a duty owed to the FDA.” Id.

And so the court dismissed the plaintiffs’ design defect, failure to warn, and “failure to report” claims, leaving manufacturing defect claims pending. The dismissal was without prejudice, and the plaintiffs were given fourteen days to file an amended complaint. We’ll keep you posted

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.