Delano v. Abbott Labs.

• Citation: 908 F.Supp.2d 888
• Decision Date: 06 December 2012
• Docket Number: Civil Action Case No. 2:11–cv–02475–WGY.
• Parties: Frederick DELANO and Frances Delano, Plaintiffs, v. ABBOTT LABORATORIES, Defendant.
• Court: U.S. District Court — Western District of Tennessee

908 F.Supp.2d 888

Frederick DELANO and Frances Delano, Plaintiffs,

v.ABBOTT LABORATORIES, Defendant.

Civil Action Case No. 2:11–cv–02475–WGY.

United States District Court,

W.D. Tennessee,

Western Division.

Dec. 6, 2012.

Arnold Anderson Vickery, Perdue Kidd & Vickery, Houston, TX, Edmund J. Schmidt, III, Law Office of Eddie Schmidt, Nashville, TN, for Plaintiffs.

Andrew P. Bautista, David M. Tressler, Michael P. Foradas, Renee D. Smith, Kirkland & Ellis, LLP, Chicago, IL, Jill M. Steinberg, Emily Turner Landry, Nolan M. Johnson, Shannon Wiley, Baker Donelson Bearman Caldwell & Berkowitz, Memphis, TN, for Defendant.

MEMORANDUM

WILLIAM G. YOUNG, District Judge.

I. INTRODUCTION

Frederick and Frances Delano (collectively, the “Delanos”) initiated a product liability action against Abbott Laboratories (“Abbott”). The Delanos allege that Frederick Delano (“Delano”) was injured by Abbott's failure to warn about the increased risk of acquiring histoplasmosis, a fungal infection, when Abbott's drug Humira is administered with a complimentary drug in the Mississippi valley, a region with high exposure to the histoplasma fungus. Abbott has moved for summary judgment, arguing that the Delanos' product liability claims are time-barred, while the Delanos claim that Abbott waived the limitations period on their claims.

A. Procedural Posture

The Delanos brought suit against Abbott on June 12, 2011, alleging strict liability, negligence, and breach of warranty claims. Compl. ¶¶ 81–86, ECF No. 1. On September 6, 2011, Abbott moved for summary judgment. Def. Abbott Labs.' Notice Mot. Summ. J. (“Abbott Mot. Summ. J.”), ECF No. 9. At the same time, Abbott filed an unopposed motion for extension of time to file an answer in light of its motion for summary judgment. Def. Abbott Labs.' Unopposed Mot. Extension Time File Responsive Pleading, ECF No. 12. The Court granted the extension. Order Granting Def. Abbott Labs.' Unopposed Mot. Extension Time File Responsive Pleading, ECF No. 16. The parties then fully briefed the motion for summary judgment. Abbott Mot. Summ. J., Attach. 1, Mem. Supp. Def.'s Mot. Summ. J. (“Abbott Mem.”), ECF No. 9–1; Pls.' Resp. Opp'n Abbott's Mot. Summ. J., Attach 2, Pls.' Mem. Supp. Resp. Opp'n Abbott's Mot. Summ. J. (“Pls.' Mem.”), ECF No. 24–2; Reply Br. Supp. Def.'s Mot. Summ. J. (“Reply”), ECF No. 32. Abbott submitted a statement of undisputed facts, Abbott's Mot. Summ. J., Attach. 2, Statement Undisputed Facts Supp. Def.'s Mot. Summ. J. (“Def.'s Facts”), ECF No. 9–2, to which the Delanos responded, Pls.' Resp. Abbott's Statement Ostensibly Undisputed Facts & Statement Add'l Undisputed Facts (“Pls.' Facts”), ECF No. 25, and Abbott filed a response to the Delanos' facts, Reply, Attach. 1, Def. Abbott Labs.' Resp. Pls.' Statement Add'l Undisputed Facts, ECF No. 32–1.

On January 19, 2012, the Delanos filed a motion to dismiss without prejudice, requesting that they be permitted to proceed with the case in a parallel suit in an Illinois state court. Pls.' Mot. Dismiss Without Prejudice, ECF No. 37. The Delanos filed an amended motion to dismiss on June 7, 2012, noting that their action could be consolidated with seventeen other Humira-related cases against Abbott in Illinois. Pls.' Am. Mot. Dismiss Without Prejudice 1, ECF No. 43.

This Court allowed the Delanos to amend their motion to dismiss and denied the original motion as moot. See Order, Aug. 29, 2012, ECF No. 47. On September 28, 2012, this Court heard oral argument on Abbott's motion for summary judgment and the Delanos' amended motion to dismiss. Clerk's Notes, Sept. 28, 2012, ECF No. 50. After hearing oral argument, this Court denied Abbott's motion for summary judgment and granted the Delanos' motion to dismiss. Order, Sept. 28, 2012, ECF No. 51.

This opinion further explains the Court's rationale for denying Abbott's summary judgment motion. SeeFed.R.Civ.P. 56(a) (“The court should state on the record the reasons for ... denying the motion.”). When denying in its entirety a motion for summary judgment, I usually ignore this exhortation, as writing takes time and causes delay—the bane of the federal judicial system. I prefer instead the admonition of my great colleague, Judge Joseph Tauro: “What part of the word ‘denied’ don't you understand?” See also D. Brock Hornby, Summary Judgment Without Illusions, 13 Green Bag 2d 273, 288 (2010) (“[W]hen in doubt on facts or their inferences, judges should ‘just say no.’ ”). As will be seen, however, in this case an opinion is warranted.

B. Undisputed Facts

Abbott's drug Humira is in a class of biologic drugs known as “TNF-alpha blockers” or TNF-inhibitors, Def.'s Facts ¶¶ 4, 19, and the FDA approved Humira for the treatment of psoriatic arthritis in January 2008, id. ¶ 5. In October 2008, Delano's physicians prescribed Humira to treat his psoriatic arthritis, and he received Humira treatment approximately every two weeks for two and a half months. Id. ¶ 6. Delano took Humira along with another drug called methotrexate.¹ Compl. ¶ 30. In December 2008, Delano began experiencing flu-like symptoms and stopped using Humira. Def.'s Facts ¶ 7. “In early February 2009, [he] was admitted to the VA [Veterans Affairs] hospital, underwent tests, and later was admitted to St. Francis Hospital.” Id. ¶ 8.

At St. Francis, Delano was diagnosed with “disseminated histoplasmosis,” a fungal infection that had spread throughout the body. Id. ¶¶ 8, 9. The histoplasma fungus is prevalent in the Mississippi Valley region, where eighty to ninety percent of the public is exposed to the fungus. Id. ¶ 10. The Delanos allege that Abbott had not warned Delano's physicians about the “very high risk of histoplasmosis, particularly in the Mississippi River Valley” or the additional risk of histoplasmosis posed by taking Humira with methotrexate. Id. ¶ 11.

When Delano was prescribed Humira, Humira bore a label which had been approved by the Food and Drug Administration (“FDA”) on February 21, 2008. Id. ¶ 14. The label included a “black box” warning that warned of the risk of serious invasive fungal infections, and the “Warnings and Precautions” section of the label mentioned histoplasmosis as a possible infection. Id. ¶¶ 15–16. This section also noted that “serious infections have occurred in patients on concomitant immunosuppressive therapy.” Id. ¶ 16. The patient insert of the February 21, 2008, label also mentioned the risk of histoplasmosis and severe fungal infection as among “the most important information [that a patient] should know about HUMIRA.” Id. ¶ 18. In early September 2008, before Delano's February 2009 histoplasmosis diagnosis, the FDA had issued a press release regarding the risk of histoplasmosis associated with TNF-inhibitors, noting that it was requiring safety-related label changes for those drugs, including Humira. Id. ¶¶ 19, 20; Compl., Ex. B., FDA News Release, ECF No. 1–2.

In a September 4, 2008, letter, the FDA notified Abbott “of new safety information [it] believe[d] should be included in the labeling for Humira ... and which pertains to the risk of histoplasmosis with the use of the class of TNF-inhibitors.” Def.'s Facts ¶ 22 (first and second alterations in original) (quoting Abbott Mot. Summ. J., Ex. 2, Letter from Bob A. Rappaport, Dir., Div. Of Anesthesia, Analgesia, and Rheumatology Prods., FDA, to Bryan Peterson, Assoc. Dir., Global Pharm. Regulatory Affairs, Abbott (“FDA Letter”) 1, ECF No. 9–5) (internal quotation marks omitted). Abbott claims that the Humira label was revised in December 2008 in response to the FDA's request, id. ¶ 21, but the Delanos dispute whether the revised label was distributed or made available to doctors and patients, Pls.' Facts ¶ 21.

On February 2, 2009, a nurse's phone record notes that Delano “[s]topped his humira recently as he thought it wasn't working and possibly making him worse.” Def.'s Facts ¶ 26 (alteration in original) (quoting Abbott Mot. Summ. J., Ex. 3, Veteran Affairs Medical Records (“Medical Records”) FD10001013) (internal quotation marks omitted). Delano's medical record from February 2, 2009, indicates that he said he “ha[d] been feeling dizzy and unsure of himself .... [was] having difficulty sleeping, diarrhea, headaches and nausea and poor appetite .... [and] thinks (sic) is reaction to his medication Humira.” Id. ¶ 27 (quoting Medical Records FD0001001) (internal quotation marks omitted). Discharge instructions on February 8, 2009, in Delano's medical records instruct, “[s]top taking the following: methotrexate and adalimumab [Humira] ...” Id. ¶ 29 (alterations in original) (quoting Medical Records FD0000914) (internal quotation marks omitted). A physician's note from February 25, 2009, states: “Pt. [Delano] here today with wife states he is to take sporonox now for next 6 months. States this illness occurred after he started taking humara (sic) for his psoriatic arthritis last fall.” Id. ¶ 30 (second alteration in original) (quoting Medical Records FD0000905–06) (internal quotation marks omitted).

The first communication between Arnold Vickery (“Vickery”), the Delanos' counsel, and Abbott's counsel about the Delanos' claims occurred in May 2010. Id. ¶ 34. Thereafter, the Delanos claim that “[p]ursuant to an agreement between the parties, the statute of limitations was tolled.” Id. ¶ 32 (alteration in original) (quoting Compl. ¶ 6) (internal quotation marks omitted). The Delanos claim that this “informal tolling agreement” was “extended several times,” including in an email written on November 15, 2010, from John Donley (“Donley”), then-lead counsel for Abbott. Pls.' Facts ¶ 53; Pls.' Facts, Ex. 3, Email from Donley, Partner, Kirkland & Ellis LLP, to Vickery, Partner, Perdue Kidd & Vickery (Nov. 15, 2010, 9:10 AM) (“Abbott Email”), ECF No. 25–2. Consequently, Vickery believed that Abbott would not assert limitations on the Delanos' claims. Pls.' Facts ¶ 53. Specifically, Vickery wrote to Donley on November 12, 2010:

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