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Utts v. Bristol-Myers Squibb Co.

United States District Court, S.D. New York

May 8, 2017


          For Charlie Utts and Ciara Utts: Hunter J. Shkolnik Nicholas Farnolo Napoli Shkolnik PLLC

          For Bristol-Myers Squibb Company and Pfizer Inc.: Loren H. Brown Cara D. Edwards Lucas P. Przymusinski DLA Piper LLP (U.S.)


          DENISE COTE, United States District Judge

         Plaintiffs Charlie and Ciara Utts bring this product liability lawsuit against defendants Bristol-Myers Squibb Company (“BMS”) and Pfizer Inc. (“Pfizer”), alleging that Mr. Utts suffered severe gastrointestinal bleeding from taking Eliquis, a prescription drug manufactured, marketed, and distributed by the defendants. They assert that the label did not adequately warn of the risk of excessive bleeding.

         The defendants have moved to dismiss the Second Amended Complaint (“SAC”) pursuant to Federal Rules of Civil Procedure 12(b)(6) and 9(b). The primary issues in this motion to dismiss are whether the plaintiffs' state law failure to warn claims are preempted by federal law and whether the label is adequate as a matter of law. For the following reasons, the defendants' motion is granted in its entirety.

         Before describing each of the SAC's claims and addressing the legal challenges to them brought through this motion to dismiss, it is useful to provide an overview of the analysis that follows. Although the focus of the SAC is on an alleged failure by the defendants to warn that use of Eliquis, which belongs to a new class of blood thinners, runs the risk of causing excessive bleeding and has no known antidote, those allegations are largely abandoned in opposition to the motion to dismiss. The reason for this choice is not hard to discern. The risk of excessive bleeding from this blood thinner and the lack of an antidote were clearly disclosed to the Food & Drug Administration (“FDA”) when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug.

         In opposition to this motion, therefore, the plaintiffs emphasize two other, albeit related, issues with the drug. The plaintiffs emphasize in their brief that, despite the fact that there is a risk of excessive bleeding and no known antidote for the drug, the dosage recommendations for the drug are not individually tailored and the defendants do not recommend constant monitoring of patients using the drug. These claims fare no better.

         When the SAC's allegations about dosage and monitoring are examined, those allegations fail as well. For instance, the SAC does not identify any specific warnings or guidance that should have been included on the label regarding either dosage or monitoring but were not. The plaintiffs have not identified any research or other clinical work that recommends another dosage strategy than that currently described on the label, or explains what specialized monitoring of a patient would accomplish. These two complaints concern features of the design of the drug that were well known to the FDA when it approved the drug.[1]

         Faced with the fact that, as of today, there is no research or clinical experience to suggest that any changes to the Eliquis label's disclosures related to a risk of excessive bleeding are warranted, the plaintiffs argue vehemently that the motion to dismiss should be denied and that they should be permitted to conduct discovery to try to locate evidence in the defendants' files that might support their failure to warn claims. They emphasize that there is substantial ongoing litigation over the earlier drugs in the class of drugs to which Eliquis belongs. But, the ability of other plaintiffs in other litigation over other drugs to survive a motion to dismiss does not relieve the plaintiffs of the requirements imposed by Rule 12(b). Accordingly, the claims in the SAC, which reduced to their essence are attacks on the design of this drug, will be dismissed.


         The facts are construed in favor of the plaintiffs. See Keiler v. Harlequin Enters. Ltd., 751 F.3d 64, 68 (2d Cir. 2014). Plaintiffs Charlie and Ciara Utts are both residents of California. Mr. Utts was diagnosed with atrial fibrillation[2] and prescribed Eliquis by his doctor. After taking Eliquis, Mr. Utts suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for approximately three weeks to undergo blood transfusions and several rounds of dialysis.

         Eliquis -- the brand name of the prescription medicine apixaban[3] -- is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, [4] NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.

         I. FDA Approval of Eliquis

         The FDA approved Eliquis for sale and marketing in the United States in 2012.[5] Pursuant to federal law, all applications for FDA approval of new drugs must include a description of the clinical investigations of the drug, including an analysis of each clinical pharmacology study of the drug and each controlled clinical study pertinent to a proposed use of the drug. See 21 C.F.R. § 314.50(d)(5). In accordance with this requirement, the defendants submitted the results of the international clinical trials known as ARISTOTLE. The plaintiffs allege that the defendants' agents “committed fraud in their conduct of the ARISTOTLE study, ” by, amongst other things, “concealing side effects which occurred in test users of Eliquis.”[6]

         While the defendants' application was pending before the FDA, Dr. Thomas Marcinak, an FDA employee appointed to review the Eliquis application, recommended that the proposed Eliquis label discuss the quality control problems associated with the ARISTOTLE study. In response to concerns about the rigor of the ARISTOTLE study, the defendants stated that they were submitting additional data to the FDA for its consideration.

         II. The Eliquis Label

         At the time Mr. Utts was prescribed Eliquis, the label[7]contained several warnings about the risk of bleeding and the lack of an effective antidote. The label also offered specific dosing recommendations and discussed the results of the controversial ARISTOTLE study. The warnings that are pertinent to the present motion to dismiss are described here.[8]

         A. Warnings about Bleeding Risks

         The Eliquis label warns about the risk of serious bleeding no less than five times. First, in the “Highlights of Prescribing Information” section, under the “Warnings and Precautions” heading, the label states that “ELIQUIS can cause serious, potentially fatal bleeding.” In the “Full Prescribing Information” section of the label, there is a heading entitled “Warnings and Precautions” with a subheading entitled “Bleeding.” This subheading provides: “ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding.” Under the “Adverse Reactions” heading, the label states: “The most serious adverse reactions reported with ELIQUIS were related to bleeding.” Also under the “Adverse Reactions” heading, the “Clinical Trials Experience” subheading explains that the “most common reason for treatment discontinuation in both [clinical] studies was for bleeding-related adverse reactions.” Under the “Overdosage” heading, the label states that “[o]verdose of ELIQUIS increases the risk of bleeding.” Finally, under the “Patient Counseling Information” heading, the label advises physicians to inform their patients that “it might take longer than usual for bleeding to stop, and they may bruise or bleed more easily when treated with ELIQUIS.” It also instructs physicians to “[a]dvise patients about how to recognize bleeding or symptoms of hypovolemia and of the urgent need to report any unusual bleeding to their physician.”

         B. Warnings about Concomitant Therapy

         In addition to warning generally about the risk of bleeding, the Eliquis label also specifically warns about the risk of bleeding when Eliquis is used in conjunction with antiplatelet agents, such as aspirin. The “Bleeding” subheading provides that:

Concomitant use of drugs affecting hemostasis increases the risk of bleeding. These include aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitor, and nonsteroidal anti-inflammatory drugs (NSAIDs).

         Furthermore, the “Anticoagulants and Antiplatelet Agents” subheading asserts that “[c]oadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding, ” and that in the ARISTOTLE study, for example, “concomitant use of aspirin increased the bleeding risk on ELIQUIS from 1.8% per year to 3.4% per year.”

         C. Warnings about the Lack of an Effective Antidote

         The Eliquis label twice warns about the fact that there is no specific antidote to Eliquis. First, under the “Bleeding” subheading, the label unambiguously states: “A specific antidote for ELIQUIS is not available, ” and “[t]here is no established way to reverse the anticoagulant effect of apixaban, which can be expected to persist for about 24 hours after the last dose . . . .” Second, under the “Overdosage” heading, the label states: “There is no antidote to ELIQUIS.” In addition to warning about the lack of a specific antidote, the label also discusses potential reversal strategies and to what extent these strategies are supported by clinical research:

Because of high plasma protein binding, apixaban is not expected to be dialyzable . . . . Protamine sulfate and vitamin K would not be expected to affect the anticoagulant activity of apixaban. There is no experience with antifibrinolytic agents (tranexamic acid, aminocaproic acid) in individuals receiving apixaban. There is neither scientific rationale for reversal nor experience with systemic hemostatics (desmopressin and aprotinin) in individuals receiving apixaban. Use of procoagulant reversal agents such as prothrombin complex concentrate, activated prothrombin complex concentrate, or recombinant factor VIIa may be considered but has not been evaluated in clinical studies. Activated oral charcoal reduces absorption of apixaban, thereby lowering apixaban plasma concentration . . . .

         D. Dosing Recommendations

         Under the heading “Dosage and Administration, ” the Eliquis label recommends dosing adjustments for older and higher risk patients. While the recommended dose for most patients is 5 mg taken orally twice daily, a twice daily dose of 2.5 mg is recommended for patients with any two of the following characteristics: (1) 80 years or older; (2) 60 kg or less; (3) serum creatinine levels of 1.5 mg/dL or more. The label further advises that when Eliquis is coadministered with drugs that are strong dual inhibitors of “CYP3A4” and “P-gp, ” the recommended dose is 2.5 mg twice daily.

         E. No Way to Measure or Monitor the Anticoagulation Effect of Eliquis

         The “Pharmacodynamics” heading of the label ad (aPTT), ” and that “[c]hanges observed in these clotting tests at the expected therapeutic dose, however, are small, subject to a high degree of variability, and not useful in monitoring the anticoagulation effect of apixaban.” The label further advises that the Rotachrom Heparin chromogenic assay “is not recommended for assessing the anticoagulant effect of apixaban.” vises that “apixaban prolongs clotting tests such as prothrombin time (PT, INR, and activated partial thromboplastin time

         F. The ARISTOTLE Study

         The Eliquis label discusses the ARISTOTLE study at length. Some of the reported findings from the ARISTOTLE trial include that:

ELIQUIS was superior to warfarin for the primary endpoint of reducing the risk of stroke and systemic embolism . . . . Superiority to warfarin was primarily attributable to a reduction in hemorrhagic stroke and ischemic strokes with hemorrhagic conversion compared to warfarin. Purely ischemic strokes occurred with similar rates on both drugs.

         The label also reports that in the ARISTOTLE trial, Eliquis showed “significantly fewer major bleeds than warfarin.”

         III. Procedural History

         The plaintiffs filed their complaint on July 15, 2016. On October 5, the defendants filed a motion to dismiss the initial complaint pursuant to Rules 12(b)(6) and 9(b). On October 13, the defendants moved the Judicial Panel on Multidistrict Litigation (“JPML”) to transfer and coordinate what were then 34 actions pending in 13 different districts -- including the instant action --pursuant to 28 U.S.C. § 1407. On October 21, the parties in the instant action filed a letter requesting that the Honorable Lewis A. Kaplan stay all proceedings pending resolution of the JPML petition. The request to enter a stay was denied on October 28.

         On November 21, the case was reassigned to this Court as related to sixteen other product liability cases filed in this district concerning the medication Eliquis. That same day, this Court issued an Order instructing the parties in this case and all related actions to confer and identify one or two actions to proceed with early motion practice.[9] The November 21 Order also explained that the initiation of discovery in all actions would turn on whether or not the Court denies the selected motions to dismiss. On December 2, the parties agreed to proceed with a motion to dismiss in the Utts action.

         On December 23, the Court issued its Opinion in Utts, granting in part the October 5 motion to dismiss and giving the plaintiffs leave to amend all claims except for the design defect claim, which was entirely preempted. Utts v. Bristol-Myers Squibb Co. & Pfizer Inc., 16cv5668 (DLC), 2016 WL 7429449, at *11-12 (S.D.N.Y. Dec. 23, 2016) (“Utts”). An amended complaint was filed on January 20, 2017.

         On February 3, the defendants filed a renewed motion to dismiss the amended complaint pursuant to Rules 12(b)(6) and 9(b). On February 6, the Court issued an Order granting the plaintiffs leave to file a second amended complaint by February 24, noting that it would be unlikely that the plaintiffs would have a further opportunity to amend. On February 7, the multidistrict litigation panel issued an order transferring In re: Eliquis Products Liability Litigation, 17md2754, to this Court.

         The SAC was filed on February 24. The SAC asserts ten causes of action against the defendants: (1) manufacturing defect; (2) failure to warn; (3) strict liability; (4) negligence and gross negligence; (5) breach of express warranty; (6) breach of implied warranty; (7) fraud/fraudulent concealment; (8) negligent misrepresentation; (9) violation of consumer protection laws; and (10) loss of consortium. In pleading these claims, the plaintiffs rely on nine articles or documents to assert what they contend is a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. The plaintiffs have since withdrawn their manufacturing defect cause of action. In addition to compensatory damages, the plaintiffs seek punitive damages.

         On March 10, the defendants filed a renewed motion to dismiss the SAC. They urge that the plaintiffs' claims are preempted. Analyzing each of the documents on which the plaintiffs have relied to state a claim, the defendants contend that the information in those documents does not constitute newly acquired information and therefore, the federal law of preemption bars the plaintiffs' state law claims. In addition, even if the plaintiffs' claims were not preempted, the defendants argue that they must be dismissed because the warnings given on the Eliquis label were, as a matter of law, sufficient to warn of the risks associated with excessive bleeding on which the plaintiffs' claims are premised. Finally, the defendants argue that the SAC fails to meet the relevant pleading standards. The March 10 motion to dismiss became fully submitted on April 18.


         The discussion of this motion begins by describing the federal pleading standards and identifying which state's law governs the Utts' claims in the SAC. The Opinion then turns to the issue of preemption. As background to the preemption discussion, the Opinion outlines the FDA's regulatory regime for brand name pharmaceutical drugs. It then applies the law of preemption to the SAC's state law claims, and also analyzes whether it pleads plausible claims for relief under federal pleading standards.

         When deciding a motion to dismiss, a court must “accept all allegations in the complaint as true and draw all inferences in the non-moving party's favor.” LaFaro v. N.Y. Cardiothoracic Grp., PLLC, 570 F.3d 471, 475 (2d Cir. 2009) (citation omitted). “To survive a motion to dismiss under Rule 12(b)(6), a complaint must allege sufficient facts which, taken as true, state a plausible claim for relief.” Keiler, 751 F.3d at 68. See also Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (“[A] complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.” (citation omitted)). A claim has facial plausibility when “the factual content” of the complaint “allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Tongue v. Sanofi, 816 F.3d 199, 209 (2d Cir. 2016) (citation omitted).

         The plausibility standard is not a “probability requirement”; “[i]t simply calls for enough fact to raise a reasonable expectation that discovery will reveal evidence supporting a plaintiff's claim for relief.” Pension Benefit Guar. Corp. ex rel. St. Vincent Catholic Med. Ctrs. Retirement Plan v. Morgan Stanley Inv. Mgmt. Inc., 712 F.3d 705, 729 (2d Cir. 2013) (citation omitted). Nevertheless, “[w]here a complaint pleads facts that are merely consistent with a defendant's liability, it stops short of the line between possibility and plausibility of entitlement to relief.” Iqbal, 556 U.S. at 678 (citation omitted). In sum, “a plaintiff's obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citation omitted).

         To satisfy the requirements of Rule 9(b), which applies to any pleading of fraud, the complaint must: (1) detail the events giving rise to the fraud, such as the statement/omission that is alleged to be fraudulent, the identity of the speaker, the location of the fraud, and the reason the statement is fraudulent; and (2) allege facts “that give rise to a strong inference of fraudulent intent.” Loreley Fin. (Jersey) No. 3 Ltd. v. Wells Fargo Sec., LLC, 797 F.3d 160, 171 (2d Cir. 2015) (citation omitted).

         In deciding a motion to dismiss, the court considers “any written instrument attached to the complaint as an exhibit or any statements or documents incorporated in it by reference.” Stratte-McClure v. Morgan Stanley, 776 F.3d 94, 100 (2d Cir. 2015) (citation omitted). The court may also consider “documents upon which the complaint relies and which are integral to the complaint.” Subaru Distribs. Corp. v. Subaru of Am., Inc., 425 F.3d 119, 122 (2d Cir. 2005). The Eliquis labeling is integral to the SAC.

         I. Choice of Law

         Mr. Utts is a resident of California and asserts violations of California consumer protection laws. Moreover, both parties rely on California law in their briefing. Accordingly, there is no dispute that the SAC's claims arise from California statutory and common law.

         II. FDA Approval Process

         The Food, Drug, and Cosmetic Act of 1938 (“FDCA”) is a federal law that regulates the manufacture, use, or sale of drugs. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 196 (2005). To obtain authorization to market a new drug, a drugmaker must submit a new drug application (“NDA”). Such applications must include “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.” 21 U.S.C. § 355(b)(1)(A). The manufacturer's NDA must demonstrate that the drug is “safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling.” Id. § 355(d). The manufacturer's NDA must also prove the drug's effectiveness by “substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling.” Id.

         Drug manufacturers must also submit proposed labeling, with annotations, to be used with the drug. Id. § 355(b)(1)(F); 21 C.F.R. § 314.50(c)(2)(i). The FDA's premarket approval of an NDA includes the approval of the exact text in the proposed label. See 21 U.S.C. § 355; 21 C.F.R. § 314.105(b). In making a detailed review of proposed labeling, the FDA seeks to allow “only information for which there is a scientific basis to be included.” Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49603, 49604 (Aug. 22, 2008) (hereinafter, “Labeling Changes”).

         The labeling must include certain categories of information organized into predetermined headings and subheadings. See 21 C.F.R. §§ 201.56, 201.57, and 201.80. For example, the “Warnings and Precautions” section of a label must describe

clinically significant adverse reactions (including any that are potentially fatal, are serious even if infrequent, or can be prevented or mitigated through appropriate use of the drug), other potential safety hazards (including those that are expected for the pharmacological class or those resulting from drug/drug interactions), limitations in use imposed by them (e.g., avoiding certain concomitant therapy), and steps that should be taken if they occur (e.g., dosage modification).

Id. § 201.57(c)(6)(i).

         The “Adverse Reactions” section requires a description of “the overall adverse reaction profile of the drug based on the entire safety database.” Id. § 201.57(c)(7). An “adverse reaction” is defined as an “undesirable effect, reasonably associated with use of a drug.” Id. “This definition does not include all adverse events observed during use of a drug, ” but rather “only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.” Id. In addition, “any claim comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies . . . .” Id. § 201.57(c)(7)(iii).

         After approval, manufacturers are required to maintain records and disclose to the FDA any adverse health consequences reported during the prescription drug's use. 21 U.S.C. § 355(k)(1); 21 C.F.R. §§ 314.80(c), 314.81. If, on the basis of these disclosures, the FDA learns of new safety information which it believes should be included in the labeling of the drug, it retains the authority to require amendments to the drug's label. 21 U.S.C. § 355(o)(4); Wyeth v. Levine, 555 U.S. 555, 567 (2009) (observing that the 2007 FDCA amendments for the first time “granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug's initial approval.”). Alternatively, if the FDA finds that the drug is not “safe” when used in accordance with its labeling, or if, on the basis of new information, the FDA finds that the labeling of such drug is “false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of, ” the agency “shall” withdraw its approval of the drug. 21 U.S.C. § 355(e). In addition, the FDA “shall” deem a drug “misbranded” if “it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.” Id. § 352(j).

         Notwithstanding the FDA's post-approval oversight and regulation, “manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.” Wyeth, 555 U.S. at 579; see also 21 U.S.C. § 355(o)(4)(I) (providing a rule of construction clarifying that the 2007 amendments to the FDCA “shall not be construed to affect the responsibility of the responsible person or the holder of the approved application . . . to maintain its label in accordance with existing requirements”). Thus, the manufacturer is charged “both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.” Wyeth, 555 U.S. at 571.

         There are two ways for a manufacturer to fulfill its post-FDA approval labeling duties. Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application. See 21 C.F.R. § 314.70(b). A manufacturer may, however, make certain changes to its label without prior agency approval through the “changes being effected” (“CBE”) regulation. The CBE regulation allows a manufacturer to change its label unilaterally to “add or strengthen a contraindication, warning, precaution, or adverse reaction, ” Id. § 314.70(c)(6)(iii)(A), as soon as there is “reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established, ” Id. § 201.57(c)(6)(i). A manufacturer may also, pursuant to the CBE regulation, “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product, ” Id. § 314.70(c)(6)(iii)(C), or “delete false, misleading, or unsupported indications for use or claims for effectiveness, ” Id. § 314.70(c)(6)(iii)(D).

         Labeling changes pursuant to the CBE regulation may only be made on the basis of “newly acquired information.” Id. § 314.70(c)(6)(iii). “Newly acquired information” is defined as:

[D]ata, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

Id. § 314.3(b). Information previously known to the manufacturer, but not submitted to the FDA, may constitute “newly acquired information, ” provided that the information meets the other CBE requirements. Labeling Changes, 73 Fed. Reg. at 49606.

         The FDA has recognized that “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it.” Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2851 (Jan. 16, 2008). Indeed, “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.” Id. For this reason, the CBE regulation requires that there be sufficient evidence of a causal association between the drug and the information sought to be added. Id.; see also 21 C.F.R. § 201.57(c)(6)(i). Moreover, the FDA retains the authority to reject labeling changes made pursuant to the CBE regulations. Wyeth, 555 U.S. at 571. By expressly requiring that a CBE supplement only reflect newly acquired information and “be based on sufficient evidence of a causal association, ” the FDA ensures “that scientifically accurate information appears in the approved labeling.” Labeling Changes, 73 Fed. Reg. at 49604.

         III. Federal Preemption of Pharmaceutical Claims

         The Supremacy Clause establishes that federal law “shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const., art. VI, cl.2. “A fundamental principle of the Constitution is that Congress has the power to preempt state law.” Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372 (2000). State law is preempted by federal law when Congress intends federal law to “occupy the field, ” or where state law conflicts with a federal statute. Id. (citation omitted).

         Conflict preemption exists “where it is impossible for a private party to comply with both state and federal law and where, under the circumstances of a particular case, the challenged state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Id. (citation omitted). “Impossibility pre-emption is a demanding defense.” Wyeth, 555 U.S. at 573. Courts must “start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id. at 565 (citation omitted). “[T]he historic police powers of the State include the regulation of matters of health and safety.” De Buono v. NYSA-ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814 (1997). As the Supreme Court has explained,

[t]hroughout our history the several States have exercised their police powers to protect the health and safety of their citizens. Because these are primarily, and historically, matters of local concern, the States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons.

Medtronic, Inc. v. Lohr, 518 U.S. 470, 475 (1996) (citation omitted).

         In a recent trilogy of opinions, the Supreme Court addressed the issue of conflict preemption in the context of state product liability claims against drug manufacturers. As described in more detail in Utts, the Supreme Court's decisions in Wyeth, 555 U.S. 555, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466 (2013), read holistically, indicate that federal law preempts all pre-FDA approval failure to warn and design defect claims for branded prescription medication. See Utts, 2016 WL 7429449, at *6. As Utts explains, brand name drug manufacturers lack the authority to alter a drug's design or a label's warnings at the time the NDA approval process concludes. Id. at *9; see Labeling Changes, 73 Fed. Reg. at 49606 (“State law claims that challenge labeling that FDA approved after being informed of the relevant risk are preempted.” (citation omitted)). Thereafter, however, depending on the significance of the change to the drug's design or the type of change in a label, federal regulations permit -- and indeed, require --manufacturers to unilaterally alter the design and label. Thus, there may be no preemption of state product liability law where the plaintiffs' claims are based on newly acquired information that, pursuant to the CBE regulation, the defendants could unilaterally make without FDA approval. Utts, 2016 WL 7429449, at *9.

         Post-FDA approval preemption analysis proceeds in two stages. First, the plaintiff must show that there existed “newly acquired information” such that the defendants could unilaterally change the label pursuant to the CBE regulation without FDA approval. But, the mere availability of a CBE label amendment does not necessarily defeat a manufacturer's preemption defense. Because the FDA “retains the authority to reject labeling changes, ” a manufacturer may still -- even after the plaintiff has identified “newly acquired information” --establish an impossibility preemption defense through “clear evidence that the FDA would not have approved a change” to the label. Wyeth, 555 U.S. at 571; see also In re: Fosamax (Alendronate Sodium) Prods. Liab. Litig., 852 F.3d 268, 283-84 (3d Cir. 2017). In sum, if the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.

         IV. California Product Liability: Failure to Warn

         California recognizes three theories of product liability: failure to warn, design defect, and manufacturing defect. The SAC asserts only a failure to warn theory of product liability.[10] Its failure to warn claim is at the heart of the SAC and the principal focus of the parties' briefing on the motion to dismiss.

         Failure to warn arises when a manufacturer has issued no warnings or has failed to adequately warn of dangers posed by its product. See Anderson v. Owens-Corning Fiberglas Corp., 53 Cal.3d 987, 996 (1991). Under California law, a prescription drug manufacturer is strictly liable if it failed to “adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.” Carlin v. Superior Court, 13 Cal.4th 1104, 1112 (1996) (emphasis added). Failure to warn based on a negligence theory “requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about.” Anderson, 53 Cal.3d at 1002.

         Under California law, application of the failure to warn theory to pharmaceuticals requires the court to determine:

whether available evidence established a causal link between an alleged side effect and a prescription drug, whether any warning should have been given, and, if so, whether the warning was adequate. These are issues of fact involving, inter alia, questions concerning the state of the art, i.e., what was known or reasonably knowable by the application of scientific and medical knowledge available at the time of manufacture and distribution of the prescription drug. They also necessarily involve questions concerning whether the risk, in light of accepted scientific norms, was more than merely speculative or conjectural, or so remote and insignificant as to be negligible.

Carlin, 13 Cal.4th at 1116.

         As the California Supreme Court has acknowledged, in the failure-to-warn context, strict liability is, to some extent, “a hybrid of traditional strict liability and negligence doctrine” since “the knowledge or knowability requirement for failure to warn infuses some negligence concepts into strict liability cases.” Id. at 1111-12. The knowledge or knowability requirement holds a drug manufacturer to the standard of “knowledge and skill of an expert in the field, ” and further obligates the manufacturer “to keep abreast of any scientific discoveries” and to “know the results of all such advances.” Id. at 1113 n.3. The manufacturer's knowledge “must exist at the time of distribution.” Id. “[S]ubsequently developed scientific data [is not] controlling.” Id. In sum, the primary difference between a failure to warn action premised on strict liability and a failure to warn action sounding in negligence is that strict liability “is not concerned with the standard of due care or the reasonableness of a manufacturer's conduct.” Id. at 1112.

         Even where a risk is “known” or “knowable” at the time of distribution, under California law, a manufacturer “may not be held liable for failing to give a warning it has been expressly precluded by the FDA from giving.” Id. at 1115 n.4. Thus, if the manufacturer disclosed to the FDA “state-of-the-art scientific data concerning the alleged risk” and the FDA determined, after its review, “that the pharmaceutical manufacturer was not permitted to warn -- e.g., because the data was inconclusive or the risk was too speculative to justify a warning, ” then the manufacturer could not ...

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