We just returned from our annual “girl trip” to a lovely spa in the mountains of Pennsylvania. And we stared our decrepitude full in the face. For the first time, we set off enthusiastically on a bike ride (cool “fat tire” bikes we’d never seen before) and found ourselves falling behind on hills and struggling to catch up with the 25-year-olds who composed the rest of the group. Don’t get us wrong – we rowed the hell out of the rowing machines and acquitted ourselves nicely in boxing class. But we were forced to admit that the legs and knees, challenged by tough terrain and compared to those belonging to others with much fresher faces, just didn’t work the way they were supposed to anymore.

So we are heartened to present a case in which implied conflict preemption—“warnings preemption” under Wyeth v. Levine—worked just the way it was supposed to. In Maze v. Bayer Health Care Pharm., Inc., 2019 WL 1062387 (E.D. Tenn. Mar. 6, 2019), the plaintiff alleged that the defendant’s contraceptive pill caused her to suffer a stroke. She asserted the usual warnings claims, alleging that the defendant’s warnings of the risk of thromboembolism were inadequate, though admitting in the same breath that the defendant “devoted substantial space to warning of the risk of venous thromboembolism.”   Maze, 2019 WL 1062387 at *1. The defendant moved to dismiss, arguing that all of the plaintiff’s claims were preempted.

The court explained that, under Levine, state law can still hold a manufacturer liable for failing to update a prescription drug label with “newly acquired [risk] information or even a new analysis of previously submitted data.” Id. (citation to Levine omitted). But changes “not based on new information—and thus necessarily based on the same information already considered by the FDA—require prior FDA approval.” Id. (citation omitted). That is what initial FDA approval is all about. So federal law preempts any claim that the manufacturer should unilaterally have changed a label based on information the FDA had at the time it approved the label. As the court explained, this “lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing states to reach contrary conclusions when new information not considered by the FDA develops.” Id., quoting In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.2d 34, 41 (1st Cir. 2015).

Under that reasoning, the court continued, “[i]t follows . . . that any claim asserted by [the plaintiff] and based on information known to the FDA as of April 2012—when the label at issue here was approved—is plainly preempted by federal law.” In her complaint, the plaintiff alleged that the defendant was aware, at the time the label at issue was created, that the medication increased users’ stroke risk by 500% (the defendant disputed this fact), and did not set forth “any newly acquired information or even new analyses of previously submitted data,” id. at *3 (internal punctuation and citation omitted). She argued, in her motion, that such information existed, but, the court held, her “blanket statements [were] merely conclusory allegations and [did] not count as a sufficient showing that the plaintiff is entitled to relief.” Id. (internal punctuation and citation omitted).

The court continued,

Finally, and what seals the deal here, is that the label in effect during the entire relevant time repeatedly warned about the risk of stroke. Thus, even assuming the science marshaled by [the plaintiff] is newly acquired and says anything at all about the risk of stroke (as stated above, it is not and does not), nothing indicates that the risk is any higher than what is reflected in the . . . label that the FDA approved in 2012.

Id. In Levine, in contrast, the “main question [was] whether a nonexistent warning should be included in the label at all,” not whether “an FDA-approved, repeated stroke warning that the . . . label has included all along” is adequate. Id. “The former,” the court stated, “is heads-or-tails, the latter involves matter-of-degree questioning with respect to something that was clearly known and considered by the FDA in 2012.” The court concluded, “Without some indication that the science available now is somehow different, the Court will not second guess the adequacy of [the] warning label with state tort law.” Id.   And because the manufacturer could not unilaterally change the label’s stroke warnings, any claim the plaintiff might have had under state law was preempted by federal law.   Case dismissed.

This is how preemption is supposed to work, in the hands of the still-too-rare judge who is not afraid to dismiss a tort suit on preemption grounds. We like this decision, and we will continue to keep you posted on the good, the bad, and the very bad in the world of preemption jurisprudence.

If we were to recap briefly our reactions to the Levine decision and ten years of decisions attempting to apply it, then we might say something like this. The Court’s creation of a clear evidence standard for conflict preemption in the context of warnings claims for branded drugs was both novel and misguided. The Court gave more credence to the CBE mechanism as a way to change the label, at least temporarily, without FDA approval than FDA ever had. Over time, courts took baby steps to recognizing that some warnings claims—even the fundamental claims underlying a litigation—should not proceed where the label plaintiffs wanted would not have passed muster with FDA at the time. Facts like FDA’s rejection of the same proposed label, FDA’s statements about the lack of an association with the risk at issue, the lack of new evidence to justify submitting a CBE, and FDA’s pronouncements that a CBE could not be used for a certain type of labeling change allowed courts to find that the high standard had been met. The endorsement of complimentary conflict preemption principles in some Supreme Court cases and rejection of the presumption against preemption in others helped emboldened courts to find warnings claims preempted. This trend might have peaked in a series of Fosamax decisions out of the District of New Jersey, which we touted not too subtly. Then the Third Circuit reversed, essentially holding that summary judgment cannot be granted for defendants under a Levine analysis because juries have to decide whether the clear evidence bar was met. We sharpened our proverbial pens to decry the reasoning of that decision, its impact on litigation, and its invitation for juries to second-guess FDA.

We have, of course, tracked the appeal of Fosamax to the Supreme Court, including the amicus brief of the Solicitor General and the oral argument. The Solicitor’s brief advocated that judges should decide preemption under Levine when interpreting the scope of an agency decision is required for the decision. Drawing on the Administrative Procedures Act, the brief argued that “[n]o sound reason exists for treating the meaning and effect of an FDA administrative determination differently” than other federal agency decisions, which are questions of law. Drawing on Supreme Court authority in the patent context, the brief reasoned that “[t]o the extent extrinsic evidence may sometimes be relevant in litigation between private parties to determine the meaning and effect of FDA’s agency action, the court’s evaluation of such subsidiary facts does not alter the ultimate legal character of the inquiry or the court’s exclusive authority to resolve it.” Cases are not exactly on hold while the Supreme Court mulls over what to do with the Fosamax appeal, so we were intrigued by the question certified on appeal in Rinder v. Merck Sharpe & Dohme Corp., — N.E. 3d –, 2019 IL App. (1st) 171969 (Ill. App. Jan. 23, 2019):

Under [Levine] federal law preempts state-law failure to warn claims related to the use of a prescription drug if there is “clear evidence” that the FDA would not permit the manufacturer to include the plaintiff’s requested warning in the drug’s labeling. Is the question whether the defendant has presented the necessary “clear evidence” one for resolution by the court or jury?

We will skip over the underlying facts of the case, but we can say there are multiple FDA decisions to be interpreted, it was pretty to clear to us that FDA would have rejected the label plaintiff wanted when they wanted it, and the plaintiff’s arguments seemed to hinge on after-the-fact evidence of causation. But here is where we come back to Fosamax. Although most published decisions involved the court deciding whether there was the clear evidence in the record required by Levine, the court identified Fosamax as the only relevant federal circuit decision and proceeded to follow it in rejected each of defendant’s arguments for why the court should decide the issue and find it was impossible to the defendant to have the label that plaintiff wanted. In essence, the Rinder court ruled that “the issue presented by the [Levine] inquiry is simply a particular application of the task juries regularly perform in tort cases, determining what the evidence shows probably would have happened if the allegedly wrongful conduct had not occurred.” Therefore, substantive Illinois law would require a jury to consider the defense of conflict preemption and summary judgment would be impossible in cases where plaintiff could come up with some arguments against defendant’s urged interpretation of the FDA’s decisions. Until Fosamax is reversed or at least rejected by other circuit courts, this is the sort of facile decision we will keep seeing.

 

This post comes from the Cozen O’Connor side of the blog.

 

Michigan’s product liability statute says that a drug is neither defective nor unreasonably dangerous, and the manufacturer and seller cannot be liable in a product liability suit, if the FDA approved it and the drug and its labeling were in compliance with that FDA approval:

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.

MCL 600.2946(5). There are two exceptions (which, as discussed below, present their own problems): withholding or misrepresenting information that would have resulted in FDA non-approval, and bribing the FDA:

This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:

(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the [FDCA] and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.

(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.

MCL 600.2946(5) (a) & (b).

In the consolidated litigation concerning Lipitor, Michigan recently faced an effort by plaintiffs to expand these exceptions. There, plaintiffs alleged that the Pfizer failed to conduct post-marketing surveillance that would have changed Lipitor’s labeling regarding diabetes, arguing that this too triggered an exception to immunity under the statute. Trees v. Pfizer, Inc., 2018 Mich. App. LEXIS 3757, at *11 (Mich. Ct. App. 2018). After plaintiffs lost at summary judgment, the issued was teed up for the Court of Appeals of Michigan. The result was a per curiam affirmance.

In short, the Court of Appeals didn’t bite. It confirmed that statutory immunity attaches if the FDA approved the drug and the drug and its labeling complied with that approval:

MCL 600.2946(5) specifically provides that . . . the manufacturer or seller is not liable, if two conditions are met: (1) the drug was approved for safety and efficacy by the FDA and, (2) the drug and its labeling were in compliance with the FDA’s approval at the time the drug left the control of the manufacturer or seller.

Id.

Adopting the Sixth Circuit’s decision in Marsh v Genentech, Inc., 693 F3d 546 (6th Cir. 2012), the Court of Appeals held that immunity under Michigan’s product liability statute is based on “substantive compliance with FDA approval,” something that Pfizer did by marketing Lipitor under the FDA approved label. Plaintiffs’ allegations, on the other hand, suggested only “procedural non-compliance” with general FDA regulations on post-marketing safety information that apply to all manufacturers. That was insufficient to set aside the immunity granted by the statute, id. at *10-11, something that the Michigan Supreme Court has described as “an absolute defense to a products liability claim.” Taylor v. Smith-Kline Beecham Corp., 658 N.W.2d 127, 130-31 (Mich. 2003).

The statute meant what it said: “unless the fraud exception in subsection a or the bribery exception contained in subsection b applies (plaintiffs make no such claim here), a manufacturer or seller of a drug that has been approved by the FDA has an absolute defense to a product liability claim if the drug and its labeling were in compliance with the FDA’s approval at the time the drug left the control of the manufacturer or seller.” Id. at *12-13.

There is meaningful subtext to this decision. By arguing non-compliance with general FDA regulations on post-marketing surveillance, plaintiffs were trying to set aside the manufacturer’s statutory immunity while side-stepping implied Buckman preemption that would have almost certainly preempted a claim that the manufacturer withheld required information from the FDA. The Marsh court, relied on by the Court of appeals, took this issue head-on, as we discussed over six years ago here. So now, as it turns out, in Michigan, no matter how a plaintiff massages its allegations concerning post-marketing surveillance, the result will be the same. The manufacturer has immunity.

 

You’ll find plenty of decisions from the amiodarone litigation discussed on the blog.  Not surprisingly, because it is a generic drug, they almost exclusively focus on Mensing preemption – or we should say on plaintiffs’ attempts to bypass Mensing.  But there are cases involving exposure to the branded product as well.  And earlier this month, the brand name manufacturer got about the best ruling it could hope to get – defendant’s warnings were adequate as a matter of law.  Generic defendant also got dismissed after plaintiff tried to argue around Mensing by claiming the generic manufacturer was also a distributor.

Plaintiff in Marroquin v. Pfizer, Inc., 2019 WL 636845, *1 (E.D. Cal. Feb. 14, 2019), brought claims for strict liability, negligence, breach of warranty, and various fraud/misrepresentation claims.  Plaintiff’s wife suffered from fatal pulmonary disease caused by the administration of amiodarone.  Id. at *2.  While the complaint does not state why plaintiff’s wife was prescribed the drug, the decision walks through the Indications and Usage and Warnings section of the drug’s label, of which it took judicial notice.  The labeling states that the drug is to be used only to treat two very serious heart conditions and only when other treatments have failed “because of the life-threatening side effects and the substantial difficulties associated with its use.”  Id. at *5.  The label further states that the drug has “several potentially fatal toxicities, the most important of which is pulmonary toxicity,” which is fatal about 10% of the time.  Id.  The court noted that label discussed pulmonary toxicity at least 15 times.  Id. at *2.

While plaintiff argued that the adequacy of a warning is “generally” a jury question, generally doesn’t mean alwaysId. at *6.  In this case, the warnings were clear, conspicuous, and warned of the exact risk plaintiff’s wife suffered – they were adequate.  Id.  Moreover, plaintiff’s complaint contained no allegations that explain why the warning provided was inadequate.  Certainly a difficult task given the breadth and depth of the warning provided, but an essential element that can’t be overlooked.  Nor could the court overlook plaintiff’s lack of allegations that the alleged inadequate warning was a substantial factor in plaintiff’s wife’s death.  Id. at *5.  Plaintiff also tried to argue that the risks as set forth in the label would not have been understood by the “ordinary consumer.”  But that’s not the standard.  The manufacturer’s duty to warn runs to the physician, not the patient.  Id.  Whether the warning was sufficient to inform plaintiff’s wife’s physician is the appropriate question.  One the court answered in the affirmative.

Finally, on failure to warn, plaintiff tried to argue that the physician may not have read the label defendant relied on.  But failure to read does not equal failure to warn.  “The Court is unaware of any authority that holds a warning is inadequate simply because a person or physician failed to read the warning.”  Id. at *6.  Aside from the implication that physicians aren’t people, we agree with this statement completely.

On his breach of warranty claim, the court again had to remind plaintiff that the learned intermediary doctrine applied.  A core element of breach of warranty of fitness for a particular purpose is the buyer’s reliance on the skill or judgment of the seller.

[I]n a context of prescription drugs, a patient’s expectations regarding the effects of a prescription drug are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug’s properties.  For breach of warranty claims, ordinarily it is the prescribing doctor who in reality stands in the shoes of the ordinary consumer.  [B]reach of express or implied warranty claims … may not be maintained against a manufacturer of prescription drugs who has properly prepared the product and marketed it with warnings of known or knowable dangers.

Id. at *7 (citations omitted).  In this case, plaintiff did not allege what information his wife’s physician considered when deciding to prescribe the drug.  What the evidence does show is that risk of pulmonary toxicity was adequately warned about.  Id.  And, the only inference that the court could draw was that plaintiff’s wife was relying on the skill and judgment of her physician, not defendant.  Id. at *8.

That left only plaintiff’s fraud and misrepresentation claims which were all based on representations that the drug was “safe, fit, and effective for human use.”  Id. at *9.  Plaintiff conceded that he failed to plead his intentional misrepresentation claim with sufficient particularity to satisfy Rule 9(b).  Id.  Which the court informed him applied equally to negligent misrepresentation and concealment.  The defendants were lumped together and the complaint lacked any allegations of who, where, when, and how the alleged misrepresentations were made.  Id.  As to the “what” was misrepresented – safety and effectiveness – the court expressed “serious concerns over the plausibility of this allegation,” given the FDA approval of the drug as a drug of last resort for two serious heart conditions and the fact that it has been used to treat these conditions for over 30 years.  Id.  And, plaintiff’s lack of reliance on defendant, as opposed to her physician, is another obstacle to the fraud/misrepresentation claims.  Id. at *10.

The generic defendant had all of the brand warning and reliance arguments but of course also had a Mensing preemption argument.  Because plaintiff had no allegation that the generic defendant’s label differed from the brand label, plaintiff instead tried to argue that Mensing preemption does not extend to distributors which the generic defendant also was.  However, the cases plaintiff relied on to draw the distinction between distributors and manufacturers were in the context of motions to remand based on fraudulent joinder.  In those cases, where all doubts are to be resolved in favor of remand and no binding authority had extended Mensing to distributors, the courts were required to find proper joinder and remand the cases to state court.  Id. at *11.  “However, context is key.”  Id.  Outside the removal/remand situation, courts have applied Mensing to distributors.  “[A] mere distributor sits in the same shoes as a generic manufacturer, neither has the ability to alter or change an approved FDA warning label.”  Id. at *12.  The Supreme Court’s concern about misleading or confusion caused by competing, different labels applies equally, and perhaps even more so, to distributors.  Id.  Mensing requires dismissal of all of plaintiff’s claims against the generic manufacturer that are based on some duty to convey information about the drug – failure to warn, breach of warranty, fraud/misrepresentation.  It would not apply to a manufacturing defect claim if plaintiff was bringing one.  Id.

Despite the court’s “serious concerns” with the plausibility of plaintiff’s claims, it did grant leave to amend based on the allegations being so conclusory that it could not definitively decide that amendment would be futile.  But the court certainly has made it clear that plaintiff has substantial work to do if the amendment is going to overcome the vast shortcomings of plaintiff’s case.

We’ve always hated the Ninth Circuit’s decision in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (applying Arizona law), holding that allegations of failure to provide adverse event reports (“AERs”) to the FDA created a viable, and unpreempted, state law claim.  Now our #2 worst case of 2013 is effectively gone.  Kaput.

Today the Arizona Supreme Court in Conklin v. Medtronic, Inc., No CV-17-0322-PR, slip op. (Ariz. Dec. 18, 2018), expressly – and unanimously − disagreed with Stengel’s misinterpretation of Arizona product liability warning law, and since the Arizona Supreme Court is “supreme” on state-law issues, Stengel is invalid.  We’ll get directly to the good stuff:

We disagree with Stengel. . . .  In Stengel, the Ninth Circuit held that the [Medical Device Amendments] did not expressly or impliedly preempt the plaintiffs’ Arizona common law failure-to-warn claim based on Medtronic’s alleged failure to submit adverse event reports to the FDA.  That holding, however, was based on the unsupported premises that “Arizona law contemplates a warning to a third party such as the FDA” and that, “[u]nder Arizona law, a warning to a third party satisfies a manufacturer’s duty if . . . there is ‘reasonable assurance that the information will reach those whose safety depends on their having it.’”  Neither premise comports with Arizona law. . . .  [E]stablished law does not recognize a claim merely for failing to provide something like adverse event reports (which may not qualify as “warnings” under Arizona law) to a government agency that has no obligation to relay the information to the patient.

Because Stengel incorrectly recited and applied Arizona law, we decline to follow it. . . .  [O]ur case law contemplates that a medical device manufacturer may satisfy its duty to warn consumers by properly warning a third party, such as a learned intermediary.  But the FDA is not a learned intermediary or other relevant third party in that analysis.  And we are not aware of any case that supports the proposition that a manufacturer is independently required under Arizona law to warn a governmental regulatory body.

Slip op. at 10 ¶¶30-31 (citations omitted) (emphasis added, except for final emphasis, which is original).  Put the red flag on Stengel.

So how did the Conklin court reach this exemplary conclusion?  The path begins with an excellent preemption ruling in the trial court, Conklin v. Banner Health, 2015 WL 10688305 (Ariz. Super. Oct. 30, 2015), in a case involving a pre-market approved infusion pump.  That decision held all negligence per se claims (including the failure to report claim at issue here), preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  The intermediate Arizona appellate court reversed preemption of the failure to report claim, following Stengel.  See Conklin v. Medtronic, Inc., 418 P.3d 912, 919 (Ariz. App. 2017).  A further appeal produced today’s opinion.

The Arizona Supreme Court first recognized that, contrary to Stengel, there is no presumption against preemption in express PMA preemption cases.  “[A]lthough federal laws are presumed not to preempt state laws, courts do not invoke that presumption when the federal statute contains an express preemption clause.”  Slip op. at 3 ¶8 (citations and quotation marks omitted).  Interestingly, though, Conklin ultimately based its decision mostly on implied, not express, preemption, id. at 7 ¶21 (finding duty-to-report claim impliedly preempted and not reaching express preemption), so the presumption against preemption didn’t really figure in the result.

Conklin also utilized the “narrow gap” metaphor to describe the interaction of express preemption and implied preemption in PMA device cases:

Read together, these two types of preemption, operating in tandem, have created a “narrow gap” for pleadings.  To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violates that federal requirement (avoiding implied preemption).

Slip op. at 6 ¶18 (citations and quotation marks omitted).

The one aspect of the plaintiff’s duty-to-report claim that Conklin held to be expressly preempted was the assertion that the FDA was obligated to make AERs widely available to the public.  Federal law did not require that, so:

[T]o the extent [plaintiff] argues that the FDA either has or assumed a duty to convey information from adverse event reports to treating physicians, patients, or more broadly public consumers . . ., [that] claim is expressly preempted because it likewise would impose under state law a requirement that is “different from, or in addition to,” any applicable federal requirement.

Id. at 6 ¶20 (regulatory citations omitted).

The broader implied preemption ruling was based, as indicated above, on the absence of any reporting duty owed under state law.  Conklin “assume[d] without deciding” that AERs could be “warnings” under state law, but several “but cf.” citations indicated its disinclination to so rule.  Slip op. at 7 ¶22. The learned intermediary rule, which the court previously adopted in Watts v. Medicis Pharm. Corp., 365 P.3d 944 (Ariz. 2016) (we discussed Watts here and here), proved to be key.  Under Arizona law, prescription medical product warnings need only go to learned intermediaries, and the FDA didn’t qualify as a “learned intermediary.” Arizona’s learned intermediary rule “only extends . . . to prescribing and other health-care providers.”  Slip op. at 8 ¶26. There was never any state-law obligation to warn the FDA:

The FDA is not a health care provider and does not prescribe anything for patients. . . .  Accordingly, even if we assume that adverse event reports may constitute relevant warnings, Arizona law does not permit a manufacturer to satisfy its duty to warn end-user consumers by submitting adverse event reports to the FDA.  And conversely, a manufacturer does not breach its duty to warn end users under Arizona law by failing to submit adverse event reports to the FDA.  [Plaintiff] cites no authority, and we are aware of none, for the proposition that Arizona law requires a manufacturer to warn a federal agency.

Id. at 8 ¶¶26-27 (citations omitted).  The duty to warn in Arizona “has not been extended to require a manufacturer to submit warnings to a governmental regulatory body.”  Id. at 8 ¶28.  Submitting AERs to the FDA does not provide “reasonable assurance” that such information “will reach end users (or end users’ health care providers) because the FDA is not required to publicly release such reports.”  Id. at 9 ¶28 (citations omitted).

Thus, the lack of any Arizona state-law duty to report was fatal to plaintiff’s reporting-based claims.  While Conklin held that such claims don’t exist from the outset, the case was litigated and appealed on preemption grounds.  Thus followed the preemption ruling that plaintiff’s purported reporting claims were purely FDCA-related, and thus preempted under Buckman:

Because only federal law, not state law, imposes a duty on [defendant] to submit adverse event reports to the FDA, [plaintiff’s] failure-to-warn claim is impliedly preempted under 21 U.S.C. § 337(a).  Absent an independent state law duty to submit adverse event reports to the FDA, [plaintiff’s] failure-to-warn claim, at bottom, is an attempt to enforce a federal law requirement.  That claim is impliedly preempted under the MDA.

Slip op. at 9 ¶29 (Buckman citations omitted).

Then came the slicing, dicing, and pureeing of Stengel that we quoted at the outset.  Conklin closed by dispatching the other cases plaintiff relied on, thus performing the additional service of highlighting the questionable validity of Fiore v. Collagen Corp., 930 P.2d 477 (Ariz. App. 1996).  See Id. at 11 ¶33 (Fiore “adopted a minority view . . ., and in any event likely does not survive Riegel”).

On this blog, we have declared, until we are blue in the face, that it is a usurpation of state court power for a federal court sitting in diversity to make up new theories of liability under state law.  That’s what Stengel did, and thankfully, in Conklin, the state high court thereby bypassed by the Ninth Circuit’s novel ruling had both the opportunity and inclination to call out the trespassing federal court.  Once again:

We disagree with Stengel. . . . Stengel incorrectly recited and applied Arizona law.

Slip op. at 10 ¶¶31-32.

Mic drop.

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.

**********

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.