Ohuche v. Merck & Co.

903 F. Supp. 2d 143, 2012 WL 4853038, 2012 U.S. Dist. LEXIS 147483
CourtDistrict Court, S.D. New York
DecidedOctober 12, 2012
DocketNo. 11 Civ. 2385(SAS)
StatusPublished
Cited by6 cases

This text of 903 F. Supp. 2d 143 (Ohuche v. Merck & Co.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ohuche v. Merck & Co., 903 F. Supp. 2d 143, 2012 WL 4853038, 2012 U.S. Dist. LEXIS 147483 (S.D.N.Y. 2012).

Opinion

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 plaintiffs Complaint in its entirety. For the following reasons, defendant’s motion is granted.

I. BACKGROUND

A. Plaintiffs 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 Plaintiffs “condition escalated daily with excruciating pains followed by mumps, boils and eruptions all over her face.” 4 Plaintiffs condition was “accompanied with wicked clustered and painful rashes which are very difficult to treat.”5 The eruptions on plaintiffs skin came and went “with more pains, headaches, fever, tingling and discomfort.”6 Plaintiffs 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® Literature11

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, [146]*146on 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 Circular16 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 possi[147]*147ble 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 vaccine.29 The Handout, entitled “Shingles Vaccine What You Need To Know,” contains the following language:

4 What are the risks from shingles vaccine?
A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions. However, the risk of a vaccine causing serious harm, or death, is extremely small.
No serious problems have been identified with shingles vaccine.
Mild Problems
Redness, soreness, swelling or itching at the site of the injection (about 1 person in 3).
Headache (about 1 person in 70).
Like all vaccines, shingles vaccine is being closely monitored for unusual or severe problems.

Dr. Itzkovitz could not recall if Ohuche was given a copy of the Handout before she received the vaccine.30 Dr. Itzkovitz did recall that she generally told patients that ZOSTAVAX® was “very safe.”31

C. Plaintiffs Medical Records

Several medical records for Ohuche include notations inconsistent with her allegation that she developed shingles-like symptoms shortly after receiving the ZOSTAVAX® vaccine. For example, notes from a consultation with Dr. Robert Simon, dated March 24, 2009, state that Ohuche is “Negative for rash.”32 The medical records for another consultation on June 19, 2009, by Dr. Joseph Voll, indicate that Ohuche was “Negative for pruritus and rash.”33 When Ohuche visited St. Luke’s Hospital on August 11, 2009, Dr. Kamal Medlej noted • that she was “Negative for rash and pruritis.”34

It is not until November 12, 2010, that Ohuche’s medical records begin to document a rash.35 During an office visit that day, Dr. Itzkovitz reported that the reason for Ohuche’s visit was “Rash around mouth. Itchy and dry. Going on for months. Just using face cream.”36 In another office visit on March 11, 2011, Dr. Itzkovitz indicated that Ohuche “[h]ad bad facial rash and though[t] it was due to [148]*148zostavax but unlikely since zostavax was given on 3/09.”37 Dr.

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Bluebook (online)
903 F. Supp. 2d 143, 2012 WL 4853038, 2012 U.S. Dist. LEXIS 147483, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ohuche-v-merck-co-nysd-2012.