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1. Preemption In Pharmaceutical Cases: 2017 In Review

   Mar 8, 2018 | Law360

   By Connor Sheehan
   
   
   2017 was a busy year in the evolving landscape of preemption in pharmaceutical cases. Below are a few of the preemption opinions that caught our attention.

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1. Preemption In Pharmaceutical Cases: 2017 In Review

   Mar 8, 2018 | Law360

   By Connor Sheehan

   2017 was a busy year in the evolving landscape of preemption in pharmaceutical cases. Below are a few of the preemption opinions that caught our attention.
   
   Preemption of Warnings Claims
   
   In Wyeth v. Levine,[1] the U.S. Supreme Court issued its landmark opinion on the preemptive scope of failure-to-warn claims in brand drug cases. The court held that absent “clear evidence” that the U.S. Food and Drug Administration would have rejected a manufacturer’s label change, failure-to-warn claims against brand-name drug makers are not preempted.[2] What constitutes “clear evidence” that the FDA would have rejected a label change remains the subject of considerable debate and a case-by-case inquiry.
   
   In May 2017, the Tenth Circuit issued its opinion in Cerveny v. Aventis Inc., 855 F3d 1091 (10th Cir. 2017). In Cerveny, the court considered an appeal from a district court’s ruling that a brand drug manufacturer was not liable for failing to warn about birth defect risks associated with prepregnancy use of Clomid where the FDA had previously rejected a 2009 citizen petition calling for similar warnings.
   
   Specifically, the district court held that “impossibility preemption” barred the plaintiffs’ claims because it would have been impossible for Aventis to comply with both FDA regulations and state law. Noting that Clomid’s regulatory history alone did not constitute clear evidence, the Tenth Circuit held that the FDA’s rejection of the warnings sought through the citizen petition satisfied the “clear evidence” standard set forth in Levine.
   
   In affirming the district court’s preemption ruling,[3] the Tenth Circuit (i) disagreed with the plaintiffs’ contention that the FDA weighs proposed label changes presented by manufacturers more heavily than those presented by consumers in citizen petitions and (ii) declined to issue a bright line rule that the denial of a citizen petition cannot constitute “clear evidence” that the FDA would have rejected a proposed label change.[4]
   
   The Third Circuit also issued a noteworthy preemption opinion last year in In re Fosamax Prods. Liab. Litig., 852 F.3d 268 (3d. Cir. 2017). The case involved the brand-name osteoporosis drug Fosamax and allegations that the label inadequately warned with respect to an increased risk of femur fractures.[5] The New Jersey district court determined that the plaintiffs’ claims were preempted as a result of its interpretation of a 2009 FDA denial of the manufacturer’s attempt to add language regarding the risk of femur fractures to the warnings and precautions section of the drug’s label.
   
   While several courts have determined that the clear evidence analysis is a question of law, the Third Circuit reversed the district court’s preemption ruling, holding that the determination of what the FDA would have done had the plaintiffs’ requested warnings been presented was a question of fact for a jury.[6] The defendants have petitioned the Supreme Court for a writ of certiorari.
   
   Plaintiffs often contend there is a significant difference between a drug maker requesting the change to its product’s label and a third party requesting the change, but defendants frequently counter that it is irrelevant who requests the change as long as the proposed warning is shown to have been considered and rejected by the FDA. Cerveny adds another defense-favorable marker to the significant debate over the weight courts assign to unsuccessful efforts by third parties in effecting a label change through citizen petitions.
   
   In contrast to Cervany, In re Fosamax will be relied upon by plaintiffs to establish not only the exacting evidentiary standard a defendant must satisfy in the Third Circuit to prevail on a preemption-based dispositive motion but also for its holding that “[a] state-law failure-to-warn claim will only be preempted if a jury concludes it is highly probable that the FDA would not have approved a label change.”[7]
   
   Preemption of Design Defect Claims
   
   In the years after Levine, the Supreme Court established a preemptive backdrop for generic drugs with regard to design defect claims through its opinions in Mensing[8] and Bartlett[9]. Although the Supreme Court has not issued similar guidance with respect to brand drug design defect claims, manufacturers of brand-name drugs have argued that, like generic manufacturers, brand manufacturers are barred from unilaterally altering the chemical composition of their drug without prior FDA approval, and thus brand drug design defect claims should be preempted.
   
   In response, plaintiffs have alleged that design defect claims are not preempted because a manufacturer’s duty to design a safe product can and should be assessed prior to FDA approval rather than post-approval. In certain jurisdictions, plaintiffs also allege that an analysis of design defect claims requires an analysis of the drug’s warnings, and that preemption is inappropriate where the warnings can be unilaterally improved by the manufacturer.
   
   Last year, these competing design defect arguments were analyzed in several cases. In one such case, Trejo v. Johnson & Johnson, 13 Cal. App. 5th 110 (2017), the court analyzed a design defect claim in the over-the-counter drug context in a state court appeal from a $48 million Stevens-Johnson syndrome jury verdict.
   
   In support of his design defect claim, the plaintiff argued that the manufacturer should have withdrawn Motrin from the market and changed its chemical compound to include a different and allegedly less dangerous active ingredient. The jury agreed and found the defendant liable for strict liability design defect on a consumer expectation theory.
   
   The court of appeals reversed the design defect portion of the judgment and remanded the case to the trial court, based on the Supreme Court’s rationale in Bartlett and citing the Sixth Circuit’s related holding in Yates v. Ortho-McNeil-Janssen Pharm. Inc.[10] that a plaintiff’s design defect claim is preempted where it seeks design changes that significantly alter the chemical composition of the drug and would have required preapproval by the FDA.[11] The California Supreme Court denied the plaintiff’s petition for review and the Trejo opinion is now final.
   
   The court in In re Xarelto Prods. Liab. Litig., 2017 WL 1395312 (E.D. La. April 12, 2017), reached a different result. In that case, the plaintiffs alleged they suffered severe bleeding events and other injuries from the anticoagulant Xarelto.[12] In support of their design defect claims, the plaintiffs argued the manufacturer should have designed an assay that would have permitted doctors to monitor the drug’s effects and designed an antidote to neutralize bleeding events before presenting Xarelto to the FDA for approval.
   
   In the alternative, the plaintiffs contended that the defendants should have warned regarding the existence of tests to measure anticoagulation.[13] The defendants responded that the plaintiffs’ design defect claims were preempted under Bartlett.[14]
   
   The court found that the plaintiffs’ design defect claims were not preempted because (i) Louisiana law imposes a duty on all manufacturers to consider feasible, alternative designs and reasonably weigh the risks and utility of the final product before it leaves the manufacturer’s control; and (ii) federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval.[15] The court also held the design defect claims were not preempted because the defendant could have strengthened the label post-approval.[16]
   
   Despite the holdings of Bartlett and Yates, certain courts remain receptive to plaintiffs’ contentions that design defect claims are not preempted where a manufacturer can change the design of their drug prior to FDA approval, thereby providing a pathway for the continued viability of design defect liability theories in some jurisdictions.[17]
   
   Buckman Preemption
   
   Over 15 years ago, in Buckman Co. v. Plaintiffs’ Legal Committee,[18] the Supreme Court held that claims that a defendant committed “fraud on the FDA” are impliedly preempted because such claims “inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives.”[19]
   
   Buckman has an extensive history, which the Ninth Circuit added to in In re Incretin-Based Therapies Prods. Liab. Litig., 2017 WL 6030735 (9th Cir. Dec. 6, 2017). In that case, the plaintiffs contended that the defendants did not adequately warn of the risk of pancreatic cancer from Type 2 diabetes drugs. The district court granted summary judgment in favor of the defendants on preemption grounds, holding that (i) the defendants presented “clear evidence” that the FDA would not have permitted the defendants to change their labels to warn of the risk, and (ii) the plaintiffs were relying on “fraud-on-the-FDA-type allegations” that are preempted under Buckman.
   
   Without reaching the district’s court’s “clear evidence” ruling, the Ninth Circuit vacated the summary judgment and remanded the case on the basis that the district court misapplied Buckman to “impermissibly circumscribe discovery” sought by the plaintiffs in furtherance of their efforts to gather documents “relevant to whether any causal connection existed between incretin use and pancreatic cancer”[20] in a prior discovery order and, separately, erred in relying on Buckman to deem the plaintiffs’ “new safety information” to be “irrelevant” to its summary judgment decision even though the district court noted uncertainty as to how the FDA would react to the information.[21]
   
   Determining that “[e]ither of these errors would independently warrant reversal,” the Ninth Circuit vacated the judgment and remanded the case to the district court for further proceedings.[22]
   
   In re Incretin is significant not only for the limitations it applied to the scope of Buckman, but also for its holding that, in certain circumstances, plaintiffs are entitled to receive discovery of critical liability evidence before the preemption inquiry is ripe for determination.
   
   The interplay and potential collision between state law duties and federal regulatory requirements raised in the cases decided last year will continue to evolve in 2018. Litigants in pharmaceutical cases should anticipate further developments in the near term and be prepared to address the issues identified in the opinions above as they shape preemption law this year.
    

   
   Connor Sheehan is a partner at Dunn Sheehan LLP in Dallas. He handles a variety of plaintiff-side product liability cases, including serving as lead counsel in cases against pharmaceutical companies.
   
   The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.
   
   [1] 555 U.S. 555 (2009).
   
   [2] Id. at 570.
   
   [3] The Tenth Circuit reversed and remanded several of the plaintiffs’ state law claims as well as the plaintiffs’ claim that the warning was inadequate with regard to the risk of injury stemming from ingestion of Clomid during pregnancy.
   
   [4] Id. at 1101. See Rheinfrank v. Abbott Laboratories Inc., 680 Fed. Appx. 369 (6th Cir. 2017) (involving the antiepileptic brand-name drug Depakote, and holding the district court properly determined that the plaintiffs’ claims regarding an alleged failure to warn of birth defects were preempted based on an analysis of the FDA’s response to Abbott’s attempt to add similar warnings to the label); Utts v. Bristol-Myers Squibb, 251 F.Supp.3d 644 (S.D.N.Y. 2017) (holding the plaintiffs’ warnings claims preempted for a lack of “newly acquired information” necessary to trigger the CBE process in prescription blood thinner [Eliquis] case). But see In re Testosterone Replacement Therapy Prods. Litig., 2017 WL 1836435 (N.D. Il. May 8, 2017) (distinguishing Cerveny and holding that the denial of a citizen petition did not constitute “clear evidence” warranting preemption where the FDA indicated uncertainty regarding whether the warnings proposed by the plaintiffs could be added to the label).
   
   [5] Id. at 271.
   
   [6] Id. at 293 (“We therefore conclude that the question of whether the FDA would have approved a plaintiff’s proposed warning is a question of fact for the jury.”).
   
   [7] Id.
   
   [8] In PLIVA Inc. v. Mensing, 131 S. Ct. 2567 (2011), the Supreme Court held that federal law impliedly preempted failure to warn claims against generic drug manufacturers because they cannot change their labels without preapproval from the FDA. Id. at 2576.
   
   [9] In Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), the Supreme Court held that federal law impliedly preempted state law design defect claims against generic drug makers because the manufacturer cannot change a drug’s design without preapproval from the FDA. Id at 2475 (a generic drug to be approved must be chemically equivalent to the approved brand-name drug: It must have the same active ingredients, route of administration, dosage form and strength as its brand-name counterpart) (quoting 21 U.S.C. § 355(j)).
   
   [10] 808 F.3d 281 (6th Cir. 2015).
   
   [11] Id. at 156.
   
   [12] Id. at *1.
   
   [13] Id. at *3.
   
   [14] Id.
   
   [15] Id.
   
   [16] Id at *4. See Young v. Bristol-Myers Squibb Co., 2017 WL 706320 (N.D. Miss. Feb. 22, 2017) (holding design defect claim was not preempted in Farxiga case where the plaintiff alleged brand drug manufacturer should have designed the drug differently preapproval and strengthened the label post-approval).
   
   [17] See In re Xarelto Prods. Liab. Litig., 2017 WL 1395312.
   
   [18] 531 S. Ct. 341 (2001).
   
   [19] Id. at 350.
   
   [20] Id. at *2.
   
   [21] Id. at *3.
   
   [22] Id. at *1.
   

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