Dibartolo v. Abbott Labs.

Decision Date21 December 2012
Docket NumberNo. 12 Civ. 900(NRB).,12 Civ. 900(NRB).
Citation914 F.Supp.2d 601
PartiesCynthia DIBARTOLO, Plaintiff, v. ABBOTT LABORATORIES, Defendant.
CourtU.S. District Court — Southern District of New York

OPINION TEXT STARTS HERE

Arnold A. Vickery, Esq., Jim M. Perdue, Jr., Esq., Fred H. Shepherd, Esq., Perdue Kidd & Vickery, Houston, TX, for Plaintiff.

Jay P. Lefkowitz, Esq., Steven J. Menashi, Esq., Kirkland & Ellis LLP, New York, NY, Andrew P. Bautista, Esq., Benjamin Rottenborn, Esq., Michael P. Foradas, Esq., Renee D. Smith, Esq., Kirkland & Ellis LLP, Chicago, IL, for Defendant.

MEMORANDUM AND ORDER

NAOMI REICE BUCHWALD, District Judge.

I. Introduction

Plaintiff Cynthia DiBartolo (“DiBartolo” or plaintiff) brings this action against defendant Abbott Laboratories (“Abbott” or defendant) to recover for injuries she alleqedly suffered as a result of her use of defendant's drug Humira to treat psoriasis. After treatment with Humira for approximately six months, Am. Compl. ¶ 56, plaintiff was diagnosed with non-melanoma skin cancer (NMSC), specifically squamous cell carcinoma of the tongue, id. ¶¶ 33, 60, and underwent two surgeries that have allegedly left her with permanent disabilities, id. ¶¶ 65–69. In her First Amended Complaint (the “amended complaint”), filed on May 8, 2012, plaintiff asserted causes of action sounding in strict liability, negligence, and breach of warranty based on theories of design defect, failure to warn, and misrepresentation. Id. ¶¶ 78–80. Defendant filed a motion to dismiss plaintiff's amended complaint on May 25, 2012. Plaintiff filed her response to defendant's motion to dismiss on June 15, 2012, and defendant filed its reply in support of its motion to dismiss plaintiff's amended complaint on June 29, 2012. For the reasons stated below, defendant's motion to dismiss is granted in part and denied in part.

II. Background
A. Plaintiff's Pre–Treatment History

According to the amended complaint, DiBartolo, aged 49 as of the date the amended complaint was filed, is an attorney residing in New York City who has struggled with psoriasis periodically throughout her life. Am. Compl. ¶¶ 54–55, 69. Prior to her use of Humira, DiBartolo underwent various treatment regimes for her psoriasis, notably including PUVA therapy. 1Id. ¶ 55.

In late 2008, DiBartolo's psoriasis symptoms worsened, possibly related to an increase in stress, and on or about November 5, 2008, DiBartolo sought treatment for the first time from Dr. James Cui, a dermatologist in New York City. Id. ¶ 56. During that visit, Dr. Cui prescribed DiBartolo Humira in a dose of 40 mg every other week. Id.

B. Humira

Humira is a drug manufactured by Abbott that was initially launched in 2003 to treat rheumatoid arthritis. Am. Compl. ¶ 8; see also Letter from Jay P. Siegel, Food and Drug Admin. (“FDA”), to Jeanne Fox, Abbott Labs. (Dec. 31, 2002), available at http:// www. accessdata. fda. gov/ drugsatfda_ docs/ appletter/ 2002/ adalabbl 23102 L. htm (approving Humira, whose generic name is “Adalimumab,” for treatment only of rheumatoid arthritis). As explained in the amended complaint, Humira belongs to a class of drugs known as “TNF-alpha blockers.” Am. Compl. ¶ 5. These drugs operate by blocking the negative effects of Tumor Necrosis Factor (TNF), a protein that is naturally produced as part of the body's immune system but which reaches excess levels in persons with certain diseases, including plague psoriasis. SeeHumira Medication Guide, attached toHumira Label, Feb. 2008, at 34, available at http:// www. accessdata. fda. gov/ drugsatfda_ docs/ label/ 2008/ 125057 sll 4 lbl. pdf [hereinafter Humira Label]. Humira is administered by subcutaneous injection, performed either by medical professionals or by patients themselves. Humira Label, at 1, 4–5.

Subsequent to Humira's 2003 launch, Abbott obtained the FDA's approval of several other indications for the drug. See Am. Compl. ¶ 8. In January 2008, the FDA approved Abbott's application for a Humira indication for “the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.” Letter from Susan J. Walker, FDA, to Meg Drew, Abbott Labs. (Jan. 18, 2008), available at http:// www. accessdata. fda. gov/ drugsatfda_ docs/ appletter/ 2008/ 125057 s 01101 tr. pdf [hereinafter Letter from FDA to Abbott (Jan. 18, 2008) ]; see also Am. Compl. ¶ 26; Humira Label, Jan. 2008, available at http:// www. accessdata. fda. gov/ drugsatfda_ docs/ label/ 2008/ 125057 s 0110 lbl. pdf. This is the indication under which Dr. Cui prescribed Humira to DiBartolo. See Am. Compl. ¶¶ 55–56.

As it would be required to do for any prescription drug, Abbott prepared a detailed label for Humira, which was approved by the FDA and which Abbott distributed to physicians to inform them about how Humira should be used and what risks were associated with its use.2Humira Label, Jan. 2008, available at http:// www. accessdata. fda. gov/ drugsatfda_ docs/ label/ 2008/ 125057 s 0110 lbl. pdf; 21 C.F.R. pt. 201 (2012). According to the Humira label in place throughout the course of DiBartolo's Humira treatment, patients taking Humira are at risk for a number of serious side effects. In particular, the label warned on the first page that [m]alignancies [ ] are seen more often than in controls.” Humira Label, at 1. In the “Warnings and Precautions” section for “Malignancies,” the label elaborated:

In the controlled portions of clinical trials of some TNF-blocking agents, including HUMIRA, more cases of malignancies have been observed among patients receiving those TNF blockers compared to control patients.... During the controlled portions of HUMIRArheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and plaque psoriasis trials, the rate (95% confidence interval) of non-melanoma (basal cell and squamous cell) skin cancers was 0.9 (0.57, 1.35)/100 patient-years among HUMIRA-treated patients and 0.3 (0.08, 0.80)/100 patient-years among control patients. The potential role of TNF blocking therapy in the development of malignancies is not known.

Id. at 6–7. In the “Warnings and Precautions” section for “Immunosuppression,” the label warned:

The possibility exists for TNF blocking agents, including HUMIRA, to affect host defenses against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.... The impact of treatment with HUMIRA on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood ....

Id. at 9. In the “Adverse Reactions” section, the label warned that [t]he most serious adverse reactions” were serious infections, neurologic reactions, and malignancies. Id. With regard to malignancies, the label explained: “More cases of malignancy have been observed in HUMIRA-treated patients compared to control-treated patients in clinical trials ....” Id. at 10. With regard to [o]ther [a]dverse [r]eactions,” the label warned: “Other infrequent serious adverse reactions occurring at an incidence of less than 5% in rheumatoid arthritis patients treated with HUMIRA were: ... Neoplasia: Adenoma, carcinomas such as breast, gastrointestinal, skin, urogenital, and others; lymphoma and melanoma.” Id. at 12–13. Given these significant risks associated with Humira, the label stated in the “Indications and Usage” section that “HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.” Id. at 3–4.

When the FDA approved Humira for treatment of plaque psoriasis in January 2008, it determined that the “serious and significant public health concern relating to increased risk for serious infections” posed by Humira justified a requirement, under 21 CFR § 208, that Abbott publish a Medication Guide to inform patients directly of Humira's risks. Letter from FDA to Abbott (Jan. 18, 2008), at 4. The Medication Guide distributed while DiBartolo used Humira warned patients that [s]erious side effects, which sometimes lead to death, have happened in patients taking HUMIRA,” including [s]erious infections” and [c]ertain types of [c]ancer.” Humira Medication Guide, attached toHumira Label, at 36. In particular, the Medication Guide warned:

There have been cases of certain kinds of cancer, in patients taking HUMIRA or other TNF blockers. Some patients receiving HUMIRA have developed types of cancer called nonmelanoma skin cancer (basal cell cancer and squamous cell cancer of the skin), which are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn't heal.

Id. The Medication Guide also warned that Humira patients were at risk of nervous system problems, the signs and symptoms of which could include “numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.” Id. at 37. The Medication Guide was reprinted at the end of the Humira label, so any warnings contained in the Medication Guide were transmitted to both patients and physicians. SeeHumira Label, at 33–43; see also21 CFR § 201.57(c)(18).

C. Plaintiff's Treatment and Alleged Harm

After being prescribed Humira on November 5, 2008, DiBartolo took injections every two weeks for approximately six months. Am. Compl. ¶ 56. According to the amended complaint, DiBartolo was never screened for NMSC by Dr. Cui, was never warned that she was at a higher risk of developing NMSC because of her history of PUVA treatment, and was not monitored for the development of NMSC during the time she took Humira. Id. Indeed, DiBartolo never saw Dr. Cui after the initial visit in which he prescribed her Humira. Id. ¶ 28 n. 12.

On April 16, 2009, DiBartolo visited her dentist, Dr. John Purpura, with regard to a bonded tooth. Id. ¶ 58. During his examination of DiBartolo, Dr. Purpura “noticed a raised, velvety, irregular white mass on the left side of [DiBarto...

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