United States District Court, D. Nebraska
JAN VALLEJO, Individually and as Personal Representative of Steve Vallejo, Plaintiff,
AMGEN, INC., WYETH, INC., and PFIZER, INC., Defendants.
MEMORANDUM AND ORDER
LAURIE SMITH CAMP, Chief District Judge.
This matter is before the Court on the Motion to Dismiss (Filing No. 10) submitted by Defendants Amgen, Inc., Wyeth, Inc., and Pfizer, Inc. (collectively "Defendants"). For the reasons that follow, the motion will be granted in part and Plaintiff will be given leave to amend.
For purposes of the pending motion, all well-pled facts in the Plaintiff's Complaint (Filing No. 1) are accepted as true, though the Court need not accept Plaintiff's conclusions of law. The following is a summary of the factual allegations.
This is a diversity case arising out of the use of Enbrel® ("Enbrel") by Steve Vallejo ("Decedent") to treat his rheumatoid arthritis. Jan Vallejo, individually and as personal representative of Decedent's estate ("Plaintiff"), alleges that Decedent died as a result of his use of Enbrel. Decedent began using the medication in or about 2004, and later experienced complications from myelodysplastic syndrome, leading to his death on May 21, 2011.
Enbrel was approved by the U.S. Food and Drug Administration ("FDA") in May 1999 as a biopharmaceutical treatment for autoimmune diseases. It also was used in the treatment rheumatoid arthritis. At all relevant times, Defendants were engaged in the business of testing, developing, manufacturing, labeling, marketing, distributing, promoting and/or selling Enbrel in interstate commerce, either directly or indirectly, through third parties or related entities.
Decedent and his prescribing health care providers were unaware of the full nature and degree of increased risks associated with the use of Enbrel. If the health care providers had been aware of such risks, they would have prescribed other treatments for Decedent's rheumatoid arthritis and/or taken other steps to manage the risks associated with his use of Enbrel. Since at least 2004, Enbrel's labels mentioned the risk of "hematological events." Before Decedent suffered his Enbrel-related injuries, however, doctors and patients were not warned that Enbrel could cause myelodysplastic syndrome.
As a direct and proximate result of Decedent's use of Enbrel, he and his estate suffered noneconomic and economic damages, and Plaintiff in her individual capacity as Decedent's surviving spouse also suffered damages.
STANDARD OF REVIEW
A complaint must contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed.R.Civ.P. 8(a)(2). "[A]lthough a complaint need not include detailed factual allegations, 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.'" C.N. v. Willmar Pub. Sch., Indep. Sch. Dist. No. 347, 591 F.3d 624, 629-30 (8th Cir. 2010) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007)). "Instead, the complaint must set forth enough facts to state a claim to relief that is plausible on its face.'" Id. at 630 (citing Twombly, 550 U.S. at 570).
"A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Ritchie v. St. Louis Jewish Light, 630 F.3d 713, 716 (8th Cir. 2011) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)) (internal quotation marks omitted). "Courts must accept... specific factual allegations as true but are not required to accept... legal conclusions." Outdoor Cent., Inc. v. GreatLodge.com, Inc., 643 F.3d 1115, 1120 (8th Cir. 2011) (quoting Brown v. Medtronic, Inc., 628 F.3d 451, 459 (8th Cir. 2010)) (internal quotation marks omitted). "A pleading that merely pleads labels and conclusions, ' or a formulaic recitation' of the elements of a cause of action, or naked assertions' devoid of factual enhancement will not suffice." Hamilton v. Palm, 621 F.3d 816, 817-18 (8th Cir. 2010) (quoting Iqbal, 556 U.S. at 678). The complaint's factual allegations must be "sufficient to raise a right to relief above the speculative level.'" Williams v. Hobbs, 658 F.3d 842, 848 (8th Cir. 2011) (quoting Parkhurst v. Tabor, 569 F.3d 861, 865 (8th Cir. 2009)).
When ruling on a defendant's motion to dismiss, a judge must rule "on the assumption that all the allegations in the complaint are true, " and "a well-pleaded complaint may proceed even if it strikes a savvy judge that actual proof of those facts is improbable, and that a recovery is very remote and unlikely.'" Twombly, 550 U.S. at 555 & 556 (quoting Scheuer v. Rhodes, 416 U.S. 232, 236 (1974)). The complaint, however, must still "include sufficient factual allegations to provide the grounds on which the claim rests." Drobnak v. Andersen Corp., 561 F.3d 778, 783 (8th Cir. 2009).
"Two working principles underlie... Twombly. First, the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice." Iqbal, 556 U.S. at 678 (citing Twombly, 550 U.S. at 555). "Second, only a complaint that states a plausible claim for relief survives a motion to dismiss." Id. at 679 (citing Twombly, 550 U.S. at 556). "Determining whether a complaint states a plausible claim for relief will... be a contextspecific task that requires the reviewing court to draw on its judicial experience and common sense." Id.
I. Plaintiffs' Claims based on Strict Liability Failure to Warn and Negligent Failure to Warn
Defendants argue that Plaintiff's claims based on strict liability failure to warn and negligent failure to warn (Counts II and IV) should be dismissed because they are barred by the learned intermediary doctrine. Defendants also argue that these claims are preempted by federal law to the extent that they allege fraud on the FDA, and that the negligence claim should be dismissed to the extent it is based on a post-sale duty to warn.
A. Learned Intermediary Doctrine
In Nebraska,  "[a] manufacturer or other seller is subject to liability for failing either to warn or adequately to warn about a risk or hazard inherent in the way a product is designed that is related to the intended uses as well as the reasonably foreseeable uses that may be made of the products it sells." Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 841 (Neb. 2000) (quoting Rahmig v. Mosley Mach. Co., 412 N.W.2d 56, 72 (Neb. 1987)) (internal marks omitted). Ordinarily, a manufacturer's duty to warn runs directly to consumers. Id. at 841. Because a patient's prescribing or treating physician is usually in the best position to determine whether a patient should use a pharmaceutical product, however, such products are generally treated differently with regard to the duty to warn. Id. at 841-42. In such cases, Nebraska courts generally apply the learned intermediary doctrine. Id. at 842. When the learned intermediary doctrine applies, a defendant's duty to warn is discharged if the defendant provided adequate warnings to a patient's prescribing health-care provider. Id. Where the doctrine applies, a plaintiff's claims are only barred under the doctrine if the Court finds, as a matter of law, that adequate warnings were given to the plaintiff's health care provider. See, e.g., Wendell v. Johnson & Johnson, C 09-04124 CW, 2010 WL 271423 (N.D. Cal. Jan. 20, 2010). ("A claim is not barred by the learned intermediary doctrine when the adequacy of the manufacturer's warning to physicians is at issue.").
Here, the parties disagree about whether the warnings provided to Decedent's physicians were adequate as a matter of law and whether any exceptions to the learned intermediary doctrine apply.
The Nebraska Supreme Court has not addressed the adequacy of specific warnings in the context of pharmaceutical products. For this reason, the Court looks to the law of other jurisdictions on the subject,  recognizing that the test is one of "reasonableness." See Freeman, 618 N.W.2d at 841; Johnson v. Am. Cyanamid Co., 718 P.2d 1318, 1324 (Kan. 1986) aff'd, 758 P.2d 206 (Kan. 1988) overruled on other grounds by Bd. of Cnty. Comm'rs of Sedgwick Cnty. v. City of Park City, 260 P.3d 387 (Kan. 2011) ("In determining warning issues, the test is reasonableness.") In other jurisdictions, "[t]o find a warning adequate as a matter of law, the label must accurately and unambiguously convey the scope and nature of the risk, with sufficient specificity given the particular... risk at issue.'" Rowland v. Novartis Pharm. Corp., 2:12-CV-01474, 2014 WL 3735622, at *12 (W.D. Pa. July 28, 2014) (quoting In re Avandia Mktg., Sales Practices & Products Liab. Litig., 817 F.Supp.2d 535, 546 (E.D. Pa. 2011); see also Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 105 (Fla. 1989) ("While in many instances the adequacy of warnings concerning drugs is a question of fact, ... it can become a question of law where the warning is accurate, clear, and unambiguous.") "In the prescription drug arena, expert medical testimony is generally required to determine whether the drug manufacturer's warning to the medical community is adequate because prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect.'" Rowland, 2014 WL 3735622, at *12 (quoting Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1154 (Pa.Super. 1996).) "Facially accurate statements of fact regarding a particular risk are not adequate as a matter of law where there are disputes over whether the warning was sufficiently explicit and detailed." Id.; see also Small v. Amgen, Inc., 2:12-cv-476, 2014 WL 897033, at *5 (M.D.Fla. March 6, 2014) (declining to grant motion to dismiss where the warning label for Enbrel contained a general warning of infection and warnings regarding specific types of infections, but did not provide a specific warning of the type of infection the plaintiff suffered).
It is undisputed that since at least 2004 the labeling for Enbrel provided a warning of the risk of hematological events. Plaintiff does not dispute that myelodysplastic syndrome is a hematological event. Defendants admit that the labeling for Enbrel did not specifically mention myelodysplastic syndrome. At this stage of the proceedings, the Court cannot determine whether a broad warning of hematological events is adequate as a matter of law to warn of myelodysplastic syndrome. Accordingly, the Court cannot conclude as a matter of law that the learned intermediary doctrine applies to bar Plaintiff's claim, and so the Court will not address the question of whether exceptions to the doctrine may be applicable.
B. Federal Preemption
Defendants argue that Plaintiff's claims based on strict liability and negligent failure to warn are impliedly preempted insofar as the claims allege fraud on the FDA. Plaintiff asserts that she is not alleging fraud on the FDA. She contends that the Defendants failed to provide information to the FDA, and such is evidence of their negligence. Because Plaintiff represents that she is not alleging that the Defendants ...