Murthy v. Abbott Labs.

• Decision Date: 02 May 2012
• Docket Number: Civil Action No. 4:11–cv–105.
• Parties: Gayathri MURTHY, Plaintiff, v. ABBOTT LABORATORIES, Defendant.
• Court: U.S. District Court — Southern District of Texas

847 F.Supp.2d 958

Gayathri MURTHY, Plaintiff,

v.ABBOTT LABORATORIES, Defendant.

Civil Action No. 4:11–cv–105.

United States District Court,

S.D. Texas,

Houston Division.

March 6, 2012.

Order Denying Reconsideration May 2, 2012.

Preempted

V.T.C.A., Civil Practice & Remedies Code § 82.007(b)Arnold Anderson (Andy) Vickery, Perdue Kidd & Vickery, Houston, TX, for Plaintiff.

Andrew P. Bautista, John Donley, Michael P. Foradas, Renee D. Smith, Traci L. Shafroth, Kirkland Ellis LLP, Chicago, IL, John Robert Henderson, Wilson Elser et al., Dallas, TX, for Defendant.

MEMORANDUM AND ORDER

KEITH P. ELLISON, District Judge.

THE COURT'S PRIOR MEMORANDUM AND ORDER, ISSUED ON NOVEMBER 8, 2011, IS WITHDRAWN. THIS MEMORANDUM AND ORDER IS ISSUED IN ITS PLACE.

Pending before the Court is Defendant Abbott Laboratories' (“Defendant” or “Abbott”) Motion to Dismiss Complaint for Failure to State a Claim. (Doc. No. 16.) After considering the parties' filings, all responses and replies thereto, and the applicable law, the Court concludes that Abbott's motion should be GRANTED in part and DENIED in part.

I. BACKGROUND¹

This products liability case arises out of Gayathri Murthy's (“Plaintiff” or “Murthy”)participation in an Abbott clinical trial through which she received infusions of Abbott's drug Adalimumab (“Humira”) to treat her rheumatoid arthritis.²Humira, a member of a class of drugs known as TNF-a blockers, first received approval from the United States Food and Drug Administration (“FDA”) for the treatment of moderately to severely active rheumatoid arthritis (“RA”) in 2002. Murthy was first diagnosed with RA in late 2004 after her primary care physician referred her to rheumatologist Dr. Jovan M. Popovich. Dr. Popovich initially prescribed Murthy Methotrexate to treat her RA. Later, however, Dr. Popovich approached Murthy about the possibility of her participation in a clinical trial involving Abbott's drug, Humira. In addition to being Murthy's rheumatologist, Dr. Popovich was a “Principal Investigator” for a clinical trial entitled “ Humira Efficacy Response Optimization Study in Subjects with Active Rheumatoid Arthritis” (“HERO study”). Abbott initiated and paid for the HERO study. In exchange for their participation, Abbott provided participating RA patients with a free supply of Humira throughout the study's duration. Abbott also compensated the physicians involved in the study, including Dr. Popovich.

In January 2005, before participating in the HERO study, Murthy signed a document entitled “Consent to Participate.” The document was also signed by Dr. Popovich as the “Person Explaining Authorization.” The “Risks of Adalimumab (HUMIRA®)” are discussed on page five of the agreement. With regard to lymphoma or other cancers, it states the following: “Occasionally (about 2%), various types of cancer including lymphoma (cancer of lymph node) are observed in subjects taking adalimumab. The relationship of adalimumab with these cancers is currently unknown.” Murthy alleges that, at the time she signed the document, Abbott was aware that Humira could causecancer, a fact not reflected in the “Consent to Participate” agreement.

Murthy claims that the FDA-approved full package insert in effect during the relevant period was incomplete and misleading. For example, in the “Warnings” section, Murthy alleges that it stated, in part, that in controlled portions of the clinical trials of all TNF-blockers, “more lymphoma cases were observed in patients receiving the TNF-blockers” and that “2 lymphomas were observed among 1380 Humira-treated patients with moderate to severe rheumatoid arthritis versus 0 among 690 control patients.” Murthy alleges that the increased risk of lymphoma was statistically significant. According to Murthy, the labeling further informed the consumer that, “in the controlled and open-label portions of the clinical trials, 10 lymphomas were observed in 2,468 patients” and warned that this incidence “is approximately 5–fold higher than expected in the general population.” Murthy alleges that this “is presumptively causal.”

At or about the time that she began participating in the HERO study, Murthy was shown a 14 minute, 50 second videotape, produced and provided by Abbott to Dr. Popovich. Murthy claims that the video was designed for patients who might potentially participate in the HERO study. According to Murthy, the video, which was not approved by the FDA, “paints a rosy picture of therapy with Humira, and does little if anything to alert the patient to the very real risk of life-threatening Humira-induced cancer.”

Murthy began participating in the HERO study in February 2005 and received Humira through the study for approximately two months. Following the study's completion, she continued to receive Humura injections until approximately January 2006. In February 2006, Murthy felt swelling and pain in the right side of her neck and went to her doctor. She was subsequently diagnosed with Stage III large B-cell lymphoma for which she underwent chemotherapy treatment. The rheumatologist who diagnosed Murthy with lymphoma instructed her to immediately cease taking Humira and she complied with these instructions.

Murthy alleges that the direct and actual cause of her lymphoma was her infusion with Humira. In addition to suffering personal physical injury, Murthy alleges that, as a result of her diagnosis of lymphoma, she incurred medical bills and suffered lost wages and other economic injury for which Abbott is liable. Murthy brings claims against Abbott for breach of the Consent to Participate agreement, breach of warranty, strict products liability, and negligence. Abbott has moved to dismiss all of Murthy's claims under Federal Rule of Procedure 12(b)(6).

II. LEGAL STANDARDA. Rule 12(b)(6)

“To survive a Rule 12(b)(6) motion to dismiss, a complaint ‘does not need detailed factual allegations,’ but must provide the plaintiff's grounds for entitlement to relief—including factual allegations that when assumed to be true ‘raise a right to relief above the speculative level.’ ” Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir.2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). That is, “a 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, 129 S.Ct. 1937, 1949, 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. (citing Twombly, 550 U.S. at 556, 127 S.Ct. 1955). The plausibility standard is not akin to a “probability requirement,” but asks for more than a sheer possibility that a defendant has acted unlawfully. Id. A pleading need not contain detailed factual allegations, but must set forth more than “labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555, 127 S.Ct. 1955 (citation omitted).

Ultimately, the question for the court to decide is whether the complaint states a valid claim when viewed in the light most favorable to the plaintiff. The court must accept well-pleaded facts as true, but legal conclusions are not entitled to the same assumption of truth. Iqbal, 129 S.Ct. at 1950 (citation omitted). The court should not “ ‘strain to find inferences favorable to the plaintiffs' ” or “accept ‘conclusory allegations, unwarranted deductions, or legal conclusions.’ ” R2 Investments LDC v. Phillips, 401 F.3d 638, 642 (5th Cir.2005) (quoting Southland Sec. Corp. v. INSpire Ins. Solutions, Inc., 365 F.3d 353, 362 (5th Cir.2004)).

Importantly, the court should not evaluate the merits of the allegation, but must satisfy itself only that the plaintiff has adequately pled a legally cognizable claim. United States ex rel. Riley v. St. Luke's Episcopal Hosp., 355 F.3d 370, 376 (5th Cir.2004). “Motions to dismiss under Rule 12(b)(6) are viewed with disfavor and are rarely granted.” Lormand v. U.S. Unwired, Inc., 565 F.3d 228, 231 (5th Cir.2009) (internal citation omitted).B. Choice–of–Law

As a threshold matter, this Court must determine which state's law applies to Murthy's claims. District courts sitting in diversity apply the choice-of-law rules of the state in which they sit. Klaxon v. Stentor Elec. Mfg., Inc., 313 U.S. 487, 496, 61 S.Ct. 1020, 85 L.Ed. 1477 (1941); Mayo v. Hartford Life Ins. Co., 354 F.3d 400, 403 (5th Cir.2004); Smith v. EMC Corp., 393 F.3d 590, 597 (5th Cir.2004). Texas courts determine the appropriate choice of law by determining which state, with respect to the issues, has the most significant relationship to the occurrence and the parties. In doing so, they apply the “most significant relationship” test provided by Sections 145 and 6 of the Restatement (Second) of Conflict of Laws.³Torrington Co. v. Stutzman, 46 S.W.3d 829, 848 (Tex.2000); Gutierrez v. Collins, 583 S.W.2d 312, 318 (Tex.1979). For tort cases, the Restatement instructs courts to consider the following contacts in determining which state possesses the most significant relationship:

(a) the place where the injury occurred,

(b) the place where the conduct causing the injury occurred,

(c) the domicile, residence, nationality, place of incorporation and place of business of the parties, and,

(d) the place where the relationship, if any, between the parties is centered.

Restatement (Second) of Conflict of Laws § 145 (1971). These contacts are to be evaluated according to their relative importance with respect to the particular issue before the court. Spence v. Glock, Ges.m.b.H, 227 F.3d 308, 312 (5th Cir.2000). The number of contacts is less important than the qualitative nature of those contacts as affected by the policy factors of Section 6 of the Restatement. See Gutierrez, 583 S.W.2d at...