Ohuche v. Merck & Co.
Ohuche v. Merck & Co.
Opinion of the Court
OPINIONS AND ORDER
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).
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.
B. ZOSTAVAX® Literature
In January 2009, Dr. Itzkovitz, who is board-certified in internal medicine, ordered the ZOSTAVAX® vaccine for plaintiff.
The FDA-approved labeling consists of a Product Circular
Dr. Itzkovitz had not reviewed the Product Circular or the Patient Product Information Pamphlet for ZOSTAVAX® prior to vaccinating Ohuche.
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.
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.
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.”
It is not until November 12, 2010, that Ohuche’s medical records begin to document a rash.
Allergies:
SHE IS C/O RASH ON AND OFF SINCE 2009; FEELS IT STARTED AFTER SHE HAD A VACCINE FOR VARICELLA; THIS WAS FOLLOWED 3 DAYS LATER BY RASH, FEVER AND HEADACHES. WAS SEEN BY DERMMATOLOGIST [SIC] AND SEVERAL MD’S WHO FELT RASH NOT DUE TO VACCINE. HAS HAD OUTBREAKS SINCE WHICH APPEARS AS INDIVIDUAL PUSTULES ON FACE AND EXTREMITIES.39
Dr. Mitchell also noted that Ohuche had a “FEW MACULES ON CHEEKS” but that the “ETIOLOGY OF THE LESIONS ARE UNCLEAR.”
In Plaintiffs Opposition to Defendant’s Second Motion to Dismiss Plaintiffs Case (“Pl. Opp.”), Ohuche has included several photographs of herself which distinctly show some sort of rash on her face.
II. LEGAL STANDARDS
A. Summary Judgment
Summary judgment is appropriate “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”
In deciding a motion for summary judgment, a court must “ ‘construe the facts in the light most favorable to the non-moving party and must resolve all ambiguities and draw all reasonable inferences against the movant.’ ”
B. New York’s Product Liability Law
New York law provides for product liability claims “under theories of negligence, strict liability, or breach of express or implied warranty.”
In bringing suit against a drug manufacturer based upon a failure to warn, “a plaintiff must demonstrate that the warning was inadequate and that the failure to adequately warn of the dangers of the drug was a proximate cause of his or her injuries.” The plaintiff has the burden of proving that a defect exists and that this defect is the proximate cause of the plaintiffs injury. A treating physician’s decision not to inform a patient of a side effect acts as an intervening cause which shields the drug manufacturer from any possible liability under a failure to warn theory.55
III. DISCUSSION
Because plaintiffs Complaint does not state any particular causes of action, it must be construed to raise the strongest arguments possible.
A. Causation in Fact
Under New York law, direct causation, or causation in fact, is a requisite element in a products liability action regardless of whether a claim is for negligence, breach of warranty, or strict liability.
B. Proximate Cause
“ ‘A plaintiff proceeding under a failure-to-warn theory in New York must demonstrate that the failure to warn adequately of the dangers of a product was a proximate cause of his or her injuries.’ ”
Under the “learned intermediary rule” the manufacturer of a prescription drug [or vaccine] does not have a duty to warn the patient of the dangers involved of the product, but rather the duty is owed to the patient’s doctor. The basis for this rule is that “[t]he doctor acts as an ‘informed intermediary’ between the manufacturer and the patient, evaluating the patient’s needs, assessing the risks and benefits of available drugs, and prescribing and supervising their use.”67
Here, the learned intermediary was Dr. Itzkovitz who testified at deposition that she was aware of the adverse reactions associated with ZOSTAVAX® despite not reading the available medical literature. And it was Dr. Itzkovitz who should have read the available medical literature surrounding ZOSTAVAX® before she began vaccinating patients with it. Merck, on the other hand, completely ful
IV. CONCLUSION
For the foregoing reasons, defendant’s motion for summary judgment is granted. The Clerk of the Court is directed to close this motion (Document # 23) and this case.
SO ORDERED:
. Shingles is a viral infection which often causes a painful rash that turns into clusters of blisters. Shingles occurs when a previously dormant chickenpox virus is reactivated in a person’s body. Shingles is most common in older adults and people who have weakened immune systems. There is no cure for shingles. See WebMD, http://www.webmd.com/ skin-problems-and-treatments/shingles/ shingles-topic-overview.
. See Complaint ¶¶ 2-4.
. Id. ¶ 5.
. Id.
. Id.
. Id.
. Id.
. See id. ¶¶ 6-7.
. Id. ¶ 13.
. Id. ¶ 16.
. The facts in this section are taken from defendant’s Statement of Material Facts Pursuant to Local Civil Rule 56.1 and in Support of Merck Sharp & Dohme Corp.’s Motion for Summary Judgment ("Def. 56.1”). Because plaintiff did not controvert any of the separately numbered paragraphs in Def. 56.1, they are deemed admitted for purposes of this motion. See Local Civil Rule 56.1(c).
. See Def. 56.1 ¶¶ 12-13.
. See id. ¶ 14.
. See id. ¶ 10.
. See id. ¶ 27.
. See Exs. G & H to the 7/6/12 Declaration of David S. Gray, defendant's attorney (“Gray Decl.''). Exhibit G is the Product Circular distributed on March 1, 2009, while Exhibit H is the Product Circular immediately preceding the March 1, 2009 Version. The two exhibits appear to be virtually identical. For the sake of convenience, future references will be to Exhibit G which, unless otherwise noted, contains the same language as Exhibit H.
. See id. Exs. I & J. Exhibit I is the Patient Product Information Pamphlet distributed on March 1, 2009, while Exhibit J is the Patient Product Information Pamphlet immediately preceding the March 1, 2009 Version. The two exhibits appear to be virtually identical. Thus, for the sake of convenience, further references will be to Exhibit I which, unless otherwise noted, contains the same language as Exhibit J.
. Ex. G§ 5.1
. See id. § 6.1.1, Table 2, Injection-Site and Systemic Adverse Experiences Reported by Vaccine Report Card in > 1% of Adults Who Received ZOSTAVAX or Placebo (0-42 Days Postvaccination) in the AE [Adverse Events] Substudy of the Shingles Prevention Study ("SPS”).
. Id. § 6.1.2. "In clinical trials in support of the initial licensure of the frozen formulation of ZOSTAVAX, ... [t]he Oka/Merck strain was identified by PCR [Polymerase Chain Reaction] analysis from the lesion specimens of two subjects who reported varicella-like rashes (onset on Day 8 and 17).” Id.
. See id. §6.2.
. See Ex. I at 2 (“What are the possible side effects of ZOSTAVAX? ”).
. See, e.g., id. Ex. K, Excerpt From the 2009 PDR §§ 5.1, 6.1.1 and 17.2.
. See Def. 56.1 ¶ 23.
. See id. ¶ 24.
. See id. ¶ 25.
. See 5/30/12 Deposition of Dr. Ina Itzkovitz, Ex. E to the Gray Decl. ("Itzkovitz Dep.”), at 43.
. See id.
. See id. The Handout was obtained after the instant motion was fully briefed at the request of the Court.
. See id. at 45.
. Id.
. Def. 56.1 ¶ 33 and Ex. L to the Gray Deck at ITZKOV 000084.
. Id. and Ex. L at ITZKOV 00080.
. Id. ¶ 34 and Ex. M to the Gray Deck at 1.
. See Def. 56.1 ¶ 32.
. Ex. L to the Gray Decl. at ITZKOV 000071.
. Id. at ITZKOV 000069.
. Id. at ITZKOV 000073.
. Ex. N to the Gray Decl. at 1.
. Id.
. See Pl. Opp. Exs. 1-7.
. See id. Ex. 1.
. Merck claims that it was not provided with an adequate opportunity, during fact discovery, to investigate the circumstances surrounding these photographs. See Response to Plaintiff's Proposed Facts in Her Opposition to Merck Sharp & Dohme Corp.’s "Second Motion to Dismiss Plaintiff’s Case” at 3. According to Merck,
Ms. Ohuche did not provide copies of those photographs to counsel for Merck until the June 14, 2012 pre-trial conference — after the close of fact discovery. Aside from viewing one image that may have been taken on April 2, 2012 during Ms. Ohuche’s April 20, 2102 deposition, counsel for Merck did not receive information concerning ... the dates on which those photographs were purportedly taken until the requested information was enclosed as part of Ms. Ohuche’s Opposition.
Id. at 4.
. Fed.R.Civ.P. 56(a).
. Fincher v. Depository Trust & Clearing Corp., 604 F.3d 712, 720 (2d Cir. 2010) (quoting Roe v. City of Waterbury, 542 F.3d 31, 35 (2d Cir. 2008)).
. Zalaski v. City of Bridgeport Police Dep’t, 613 F.3d 336, 340 (2d Cir. 2010).
. Cordiano v. Metacon Gun Club, Inc., 575 F.3d 199, 204 (2d Cir. 2009).
. Brown v. Eli Lilly & Co., 654 F.3d 347, 358 (2d Cir. 2011) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586-87, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986)).
. Id. (quoting Federal Deposit Ins. Corp. v. Great Am. Ins. Co., 607 F.3d 288, 292 (2d Cir. 2010)).
. Brod v. Omya, Inc., 653 F.3d 156, 164 (2d Cir. 2011) (quoting Williams v. R.H. Donnelley, Corp., 368 F.3d 123, 126 (2d Cir. 2004)).
. Kaytor v. Electric Boat Corp., 609 F.3d 537, 545 (2d Cir. 2010) (quoting Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000)) (emphasis removed).
. Brod, 653 F.3d at 164 (quoting Wilson v. Northwestern Mut. Ins. Co., 625 F.3d 54, 60 (2d Cir. 2010)).
. Lewis v. Abbott Labs., No. 08 Civ. 7480, 2009 WL 2231701, at *4 (S.D.N.Y. July 24, 2009).
. Colon v. BIC USA, Inc., 199 F.Supp.2d 53, 82-83 (S.D.N.Y. 2001).
. Krasnopolsky v. Warner-Lambert Co., 799 F.Supp. 1342, 1346 (E.D.N.Y. 1992) (quoting Glucksman v. Halsey Drug Co., Inc., 160 A.D.2d 305, 553 N.Y.S.2d 724, 726 (1st Dep't 1990) (other citations omitted)). Accord Plummer v. Lederle Labs. Div. of Am. Cyanamid Co., 819 F.2d 349, 356 (2d Cir. 1987) (“Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a 'learned intermediary’ between manufacturer and consumer.”) (quotation marks and citation omitted).
. Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 90 (2d Cir. 1980) (quoting Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95, 97 (1979) (alteration in original)).
. See Pabon v. Wright, 459 F.3d 241, 248 (2d Cir. 2006) (citing Burgos v. Hopkins, 14 F.3d 787, 790 (2d Cir. 1994)).
. Plaintiffs Complaint is bereft of any allegations that would support a design or manufacturing defect claim. Furthermore, in opposing the instant motion, plaintiff has not offered any evidence to rebut the fact that she is unaware of any design or manufacturing defect in the ZOSTAVAX® vaccine. Compare Def. 56.1 ¶¶ 49-52 with Pl. Opp. at 6 (“Defendants [sic] are saying that Plaintiff has not identified any manufacturing defect in the vaccine that she received or any defect in the design of ZOSTAVAX or a reasonable alternative design for the vaccine. This is ridiculous. If the doctor who ordered the vaccine and the Health Center that carried the vaccine do not know the information, how does one expect the Plaintiff, a lay person in the field of science and medicinef] to know the answer?").
. See Pl. Opp. at 7 (“Had the information been available to Dr. Itkovitz [sic] before she prescribed or ordered the ZOSTAVAX for Plaintiff, Dr. Itkovitz would have advised Plaintiff."). See also id. at 15 ("They supplied their product, ZOSTAVAX, ... to Dr. Ina Itkovitz without any explanation, literature or training regarding ZOSTAVAX.... Defendants [sic] failed to give adequate instruction to Dr. Itkovitz so that she could pass such information to her patient (Plaintiff).”).
. See Saari v. Merck & Co., Inc., 961 F.Supp. 387, 392 (N.D.N.Y. 1997).
. See Lindsay, 637 F.2d at 90-91 ("A plaintiff who seeks recovery for an injurious side effect from a properly manufactured prescription drug must prove that the drug caused her injury....”).
. Saari, 961 F.Supp. at 392. Accord Krasnopolsky, 799 F.Supp. at 1348 ("Notably, the [plaintiffs] have failed to submit any type of expert proof, in an affidavit or otherwise, which would establish any causation between [plaintiff’s] injury and the alleged negligence of [defendant].”).
. See Fane v. Zimmer, Inc., 927 124, 131 (2d Cir. 1991) (stating that the jury could have found direct causation from the charac
. 961 F.Supp. at 396 (emphasis omitted) (citing, inter alia, Rohrbough v. Wyeth Labs., Inc., 916 F.2d 970, 974 (4th Cir. 1990) (stating that the doctor's testimony merely established "that a temporal link existed in other cases between the vaccine and a reaction like that displayed by [plaintiff].'' The doctor "did not testify that the literature supported a causal link between the vaccine and the reaction in other cases, much less that the vaccine caused the reaction in this particular case.”)).
. During a March 11, 2011 office visit to Dr. Itzkovitz, Ohuche reported that she broke out with a rash five times over the past two years. See supra Part I.C. Given the intermittent nature of her rash, it is conceivable that Ohuche first got the rash some time after March 24, 2009, when she visited Dr. Simon, and that the rash cleared up by June 19, 2009, when she visited Dr. Voll. In any event, Ohuche submitted a photograph dated March 26, 2009, which clearly shows pustules on her cheek. See Pl. Opp. Ex. 1. Whether this photograph is accurately dated involves an issue of credibility that this Court cannot decide on summary judgment.
. Davids v. Novartis Pharm. Corp., 857 F.Supp.2d 267, 286 (E.D.N.Y.20I2) (quoting Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 75 (2d Cir. 1993)).
. Id. (quoting Glucksman, 553 N.Y.S.2d at 726) (other citations omitted).
Reference
- Full Case Name
- Elizabeth OHUCHE v. MERCK & COMPANY, INC.
- Cited By
- 6 cases
- Status
- Published