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Ohuche v. Merck & Co., Inc.

United States District Court, S.D. New York

October 12, 2012

Elizabeth OHUCHE, Plaintiff,
v.
MERCK & COMPANY, INC., Defendant.

Page 144

Elizabeth Ohuche, New York, NY, pro se.

Page 145

David S. Gray, Esq., Venable LLP, Baltimore, MD, Heather L. Maly, Esq., Venable LLP, New York, NY, for Defendant.

OPINIONS AND ORDER

SHIRA A. SCHEINDLIN, District Judge.

Pro se plaintiff Elizabeth Ohuche (" Ohuche" or " plaintiff" ) brings this action against Merck Sharp & Dohme Corp. (formerly known as Merck & Co., Inc.) (" Merck" or " defendant" ), alleging injuries sustained after being injected with ZOSTAVAX® . ZOSTAVAX® is a live attenuated virus vaccine manufactured by Merck and approved by the Food and Drug Administration (" FDA" ) to help prevent shingles (herpes zoster).[1] Merck now moves for summary judgment seeking to dismiss plaintiff's Complaint in its entirety. For the following reasons, defendant's motion is granted.

I. BACKGROUND

A. Plaintiff's Allegations

Plaintiff alleges that her former primary care physician, Dr. Ina Itzkovitz, injected her against her will with ZOSTAVAX® on March 12, 2009.[2] A few days later, plaintiff " developed severe headache, fever and high temperature." [3] Plaintiff's " condition escalated daily with excruciating pains followed by mumps, boils and eruptions all over her face." [4] Plaintiff's condition was " accompanied with wicked clustered and painful rashes which are very difficult to treat." [5] The eruptions on plaintiff's skin came and went " with more pains, headaches, fever, tingling and discomfort." [6] Plaintiff's eyesight was also affected as she " lost partial sight at her right eye when the eruption occurred at her eyelid." [7] Plaintiff claims that ZOSTAVAX® caused all of these adverse reactions.[8] Plaintiff further claims that her condition has gotten worse over the past two years and that she is " very ill and confined in bed." [9] Plaintiff demands that Merck provide " a cure for her condition" and " compensate her for pains and suffering." [10]

B. ZOSTAVAX® Literature[11]

In January 2009, Dr. Itzkovitz, who is board-certified in internal medicine, ordered the ZOSTAVAX® vaccine for plaintiff.[12] Ohuche received the ZOSTAVAX® vaccine approximately two months later,

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on March 12, 2009, pursuant to Dr. Itzkovitz's recommendation.[13] The FDA-approved labeling accompanying ZOSTAVAX® provides information to healthcare providers about the vaccine's efficacy and safety.[14] Information about the possible side effects of the ZOSTAVAX® vaccine appeared in the March 2009 FDA-approved labeling and in the 2009 edition of the Physician's Desk Reference (" PDR" ).[15]

The FDA-approved labeling consists of a Product Circular [16] and a Patient Product Information Pamphlet.[17] The Product Circular for ZOSTAVAX® states that " [t]ransmission of vaccine virus may occur rarely between vaccinees and susceptible contacts." [18] The Product Circular lists the following adverse events associated with the ZOSTAVAX® vaccine: erythema, pain/tenderness, swelling, hematoma, pruritus, warmth and headache.[19] The Product Circular also states that " [w]ithin the 42-day post vaccination reporting period in the SPS, non-injection-site zoster-like rashes were reported by 53 subjects (17 for ZOSTAVAX and 36 for placebo)." [20] The Product Circular lists the following additional adverse reactions identified during post-marketing use of ZOSTAVAX: pyrexia (fever), hypersensitivity reactions and rash.[21] The Patient Product Information Pamphlet lists the following side effects of ZOSTAVAX: redness, pain, itching, swelling, allergic reactions, fever and rash.[22] Substantially similar information is available from the 2009 PDR.[23]

Dr. Itzkovitz had not reviewed the Product Circular or the Patient Product Information Pamphlet for ZOSTAVAX® prior to vaccinating Ohuche. [24] Nor had Dr. Itzkovitz reviewed the section on ZOSTAVAX® contained in the 2009 edition of the PDR.[25] However, at the time Ohuche received the vaccine, Dr. Itzkovitz was aware of the nature of the vaccine and its possible

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side effects despite not having reviewed the FDA-approved labeling, the 2009 PDR excerpt on ZOSTAVAX®, or any publications about ZOSTAVAX® from the FDA, Centers for Disease Control, or the New England Journal of Medicine.[26]

At her deposition, Dr. Itzkovitz testified that she knew about the efficacy of ZOSTAVAX® because it had been discussed in board review courses that she previously attended.[27] Dr. Itzkovitz could not recall what she told Ohuche about the efficacy of ZOSTAVAX® before Ohuche was given the vaccine. [28] Dr. Itzkovitz did mention a two-page Handout that was given to patients who requested more information about the ...


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