Stube v. Pfizer Inc., Case No. 6:19-cv-6087

• Decision Date: 13 March 2020
• Docket Number: Case No. 6:19-cv-6087
• Citation: 446 F.Supp.3d 424
• Parties: Marilyn STUBE and Thomas Stube, Plaintiffs v. PFIZER INC., Defendant
• Court: U.S. District Court — Western District of Arkansas

446 F.Supp.3d 424

Marilyn STUBE and Thomas Stube, Plaintiffs

v.PFIZER INC., Defendant

Case No. 6:19-cv-6087

United States District Court, W.D. Arkansas, Hot Springs Division.

Signed March 13, 2020

Filed March 16, 2020

Connor G. Sheehan, Patrick Kelly Sheehan, Dunn Sheehan LLP, Dallas, TX, Shawn B. Daniels, Daniels Law Firm, PLLC, Fayetteville, AR, for Plaintiffs.

Lyn Peeples Pruitt, Scott D. Provencher, Graham C. Talley, Mitchell William Selig Gates Woodyard PLLC, Little Rock, AR, Matthew A. Holian, DLA Piper LLP, Boston, MA, Melissa Jean Whitney, DLA Piper LLP, Washington, DC, for Defendant.

ORDER

Susan O. Hickey, Chief United States District Judge

Before the Court is Defendant Pfizer Inc.'s Motion to Dismiss. (ECF No. 18). Plaintiffs Marilyn Stube and Thomas Stube filed a response. (ECF No. 22). Defendant filed a reply. (ECF No. 25). The Court finds the matter ripe for consideration.

I. BACKGROUND

This is a personal injury and products liability case allegedly arising from Plaintiff Marilyn Stube's ("Mrs. Stube") alleged ingestion of Defendant's prescription drug, Xeljanz (tofacitinib).¹ In December 2011, Defendant applied for the United States Food and Drug Administration's ("FDA") approval of Xeljanz for use by adult patients with moderate to severe active rheumatoid arthritis

. On November 6, 2012, the FDA approved the Xeljanz application.

On March 14, 2013, Mrs. Stube was prescribed Xeljanz and she ingested it until the time of her injuries. On March 24, 2017, Mrs. Stube presented at the CHI St. Vincent Hospital in Hot Springs, Arkansas, complaining of shoulder pain after moving a kayak. She was discharged with an arm sling

and, four days later, returned to the hospital with complaints of chronic pain, fever, nausea, vomiting, and shortness of breath. After admitting her, hospital staff instructed her to stop taking Xeljanz. The next day, she experienced septic shock due to Streptococcus Group A infection and ultimately experienced multi-organ failure, gangrene, and amputation of all four of her limbs.

On July 18, 2019, Plaintiffs brought this lawsuit, asserting that Mrs. Stube's injuries were the direct result of her having taken Xeljanz and Defendant's failure to adequately warn of the risks thereof. Plaintiffs assert six state law causes of action: (1) strict products liability/failure to warn; (2) fraud and fraudulent inducement; (3) breach of implied warranty; (4) negligence; (5) negligent misrepresentation; and (6) gross negligence. Plaintiffs seek various forms of relief, including punitive damages.

On September 9, 2019, Defendant filed the instant motion to dismiss, contending that Plaintiffs' claims should be dismissed on various grounds pursuant to Federal Rules of Civil Procedure 8(a)(2), 9(b), and 12(b)(6). Plaintiffs oppose the motion.

II. STANDARD

A party may move to dismiss for failure to state a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). To survive a motion to dismiss under Rule 12(b)(6), a pleading must provide "a short and plain statement of the claim that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). The purpose of this requirement is to "give the defendant fair notice of what the ... claim is and the grounds upon which it rests." Erickson v. Pardus , 551 U.S. 89, 93, 127 S.Ct. 2197, 167 L.Ed.2d 1081 (2007) (quoting Bell Atl. Corp. v. Twombly , 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). The factual allegations of a complaint are assumed true and all reasonable inferences are drawn in the plaintiff's favor, "even if it strikes a savvy judge that actual proof of those facts is improbable." Twombly , 550 U.S. at 555-56, 127 S.Ct. 1955. A court, however, need not "blindly accept the legal conclusions drawn by the pleader from the facts." Westcott v. City of Omaha , 901 F.2d 1486, 1488 (8th Cir. 1990).

The complaint "must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ " Ashcroft v. Iqbal , 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Twombly , 550 U.S. at 570, 127 S.Ct. 1955 ). "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." Id. "A pleading that offers ‘labels and conclusions’ or ‘a formulaic recitation of the elements of a cause of action will not do.’ Nor does a complaint suffice if it tenders ‘naked assertions’ devoid of ‘further factual enhancement.’ " Id. (internal citations and alterations omitted) (quoting Twombly , 550 U.S. at 555, 557, 127 S.Ct. 1955 ). In other words, "the pleading standard Rule 8 announces does not require ‘detailed factual allegations,’ but it demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation." Id. (quoting Twombly , 550 U.S. at 555, 127 S.Ct. 1955 ).

Additionally, claims sounding in fraud must comply with the heightened pleading requirements of Federal Rule of Civil Procedure 9(b) by pleading with particularity the circumstances surrounding the fraud. United States ex rel. Costner v. United States , 317 F.3d 883, 888 (8th Cir. 2003). This pleading standard "demands a higher degree of notice than that required for other claims. The claim must identify who, what, where, when, and how." Id.

III. DISCUSSION

Defendant argues that Plaintiffs' claims should be dismissed pursuant to Rules 8(a)(2), 9(b), and 12(b)(6). Defendant argues that Plaintiffs' claims should all be dismissed for two reasons: (1) the Xeljanz label adequately warned of the injury Mrs. Stube suffered and (2) federal law preempts Plaintiffs' claims. Failing that, Defendant argues that Plaintiffs' claims should be partially dismissed because: (1) they are barred by the learned intermediary doctrine to the extent that they are based on Defendant's alleged failure to warn Mrs. Stube rather than her prescribing physician; (2) Plaintiffs fail to state a claim upon which relief may be granted for fraud, negligent misrepresentation, and gross negligence; and (3) the complaint's allegations do not support an award of punitive damages.

The Court must begin by first addressing the exhibits offered by the parties in their briefing of the instant motion. After that, the Court will address Defendant's arguments for complete dismissal and, if necessary, will then take up the arguments for dismissal of certain claims.

A. The Parties' Exhibits

Defendant's motion is accompanied by 5 exhibits, totaling 359 pages.² Plaintiffs' response brief is accompanied by 9 exhibits, totaling 225 pages. The Court must decide whether to consider these exhibits before turning to the substance of Defendant's motion.

The purpose of a Rule 12(b)(6) motion is to test the legal sufficiency of the complaint, so the Court's inquiry is limited to whether the challenged pleading sets forth sufficient allegations to make out the elements of a right to relief. Peck v. Hoff , 660 F.2d 371, 374 (8th Cir. 1981). To decide this, the Court must ordinarily confine its analysis to the four corners of the complaint and ignore all materials outside the pleadings. Porous Media Corp. v. Pall Corp. , 186 F.3d 1077, 1079 (8th Cir. 1999). However, the Court may consider "some materials that are part of the public record or do not contradict the complaint ... as well as materials that are necessarily embraced by the pleadings." Id. (internal quotation marks omitted).

Defendant suggests that the Court may consider its exhibits because they are available on the FDA's website and, thus, the Court may take judicial notice of them, presumably because the exhibits are part of the public record.³

Plaintiffs do not argue that their exhibits fall within any of the limited exceptions of extrinsic evidence that may be considered on a Rule 12(b)(6) motion.

"Most courts ... view ‘matters outside the pleading[s]’ as including any written or oral evidence in support of or in opposition to the pleading that provides some substantiation for and does not merely reiterate what is said in the pleadings." Gibb v. Scott , 958 F.2d 814, 816 (8th Cir. 1992). This "broad interpretation" is "appropriate in light of [the Eighth Circuit's] prior decisions indicating a Rule 12(b)(6) motion will succeed or fail based upon the allegations contained in the face of the complaint." Id.

It is certainly arguable that at least some of the parties' exhibits are "matters outside the pleadings" that cannot be considered in a Rule 12(b)(6) analysis. The parties offer exhibits in support of their respective positions, providing some substantiation for or against the complaint. Thus, the Court's reading of Gibb would suggest that the parties' exhibits cannot be considered at this stage. Id.

However, the Court does not need to answer that question because, assuming without deciding that the parties' exhibits can all be considered on a Rule 12(b)(6) motion, the Court declines to do so. The Court enjoys "complete discretion to determine whether or not to accept any material beyond the pleadings that is offered in conjunction with a Rule 12(b)(6) motion." Stahl v. U.S. Dept. of Agric. , 327 F.3d 697, 701 (8th Cir. 2003) ; Skyberg v. United Food & Commercial Workers Int'l Union , 5 F.3d 297, 302 n.2 (8th Cir. 1993). Thus, even if extrinsic evidence falls within one of the limited exceptions of evidence that may be considered on a Rule 12(b)(6) motion, the Court may choose to not consider it. Navarro v. Am. Nat'l Skyline Inc. of Mo. , No. 4:12-cv-801 HEA, 2013 WL 1342999, at *2 (E.D. Mo. Apr. 3, 2013).

As stated above, the purpose of a Rule 12(b)(6) motion is to test the sufficiency of the complaint. The Court does this by deciding whether the complaint sets forth sufficient allegations to make out the elements of a right to relief. Peck , 660 F.2d at 374. To the extent that Defendant's Rule 12(b)(6) arguments require the Court to look beyond the four corners of the complaint and consider approximately 584 pages of...