Opinion
No. 03 Cv. 8394 (SWK).
February 18, 2005
OPINION ORDER
Defendant Clairol, Inc. ("Clairol"), pursuant to Federal Rule of Civil Procedure 56(c), moves for summary judgment. The motion is granted.
FACTUAL BACKGROUND
Plaintiff alleges that in or about June 2000, he suffered a "severe anaphylactic reaction" after using Clairol Men's Choice hair color ("Men's Choice," or the "Product"). Plaintiff's Affidavit ¶ 1. According to plaintiff and his physician, Dr. Valentine Burroughs, within hours of applying the Product to his hair, plaintiff developed severe swelling and angioedema of the scalp and face, accompanied by vision loss (from facial swelling), dizziness, faintness, and burning and oozing of the scalp, Jacquemot Decl. Ex. D at 52-53, 58, 64-65, 73-74; Ex. E at 19, 22, 31, all of which required plaintiff to be taken to the emergency room and hospitalized for approximately 4-5 days. Jacquemot Decl. Ex. D at 59-60; Ex. E at 4; Ex. C at 2.
According to the Merck Manual of Medical Information-Second Home Edition (2003), "anaphylactic reactions" are "sudden, widespread, potentially severe and life-threatening allergic reactions" that are "most commonly caused by drugs (such as penicillin), insect stings, certain foods, and allergy injections (allergen immunotherapy)." Memorandum of Law In Support of Defendant's Motion For Summary Judgment ("Def. Memo") at 3.
As described by Dr. Burroughs, angioedema is "part of a spectrum of major anaphylactic reactions," Declaration of Susan Jacquemot ("Jacquemot Decl.") Ex. E at 32, involving "swelling in various areas that can lead to a very severe respiratory compromise if not treated acutely." Id. at 22. The Merck Manual defines the condition as a "swelling of larger areas of tissue under the skin, sometimes affecting the face and throat."
Plaintiff alleges that the Product was defective and unsafe and was "packaged and labeled negligently and carelessly . . . in that there was no warning of the possibility of severe allergic or other reaction to the product." Complaint ¶ 5. It is undisputed, however, that the exterior of the box containing the Product, in accordance with the federal Food, Drug and Cosmetic Act, 21 U.S.C. § 361(a) (2004); 21 U.S.C. § 331 (a) (2003), contained what is commonly referred to as a preliminary allergy test warning, or "patch" test warning. In pertinent part, that warning follows:
CAUTION — This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made.
Jacquemot Decl. Ex. F. Inside the package, under the heading "Before You Color," the insert provides directions for performing an allergy test and instructs the user to "take the allergy test" 48 hours in advance of using the Product. Jacquemot Decl. Ex. G at 1. Critically, plaintiff concedes that he did not read the cautionary language on the label or in the package insert, nor did he perform the patch test prior to using the Product. Deposition of Norman Smallwood ("Smallwood Dep.") at 32-33.
Since Clairol Men's Choice was introduced in 1994, Clairol has not received a single report of a suspected anaphylactic reaction associated with the use of the Product (other than the instant case). Declaration of Vally Jonsdottir ("Jonsdottir Decl.") ¶¶ 2-3. Additionally, Clairol did not encounter any instances of anaphylactic reaction during its own clinical safety studies. Id. ¶ 4.
APPLICABLE LAW
I. Summary Judgment
Under Fed.R.Civ.P. 56(c), summary judgment should be granted where "there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." Product liability actions, including failure to warn cases, are no exception and thus "the court can decide as a matter of law that there is no duty to warn." Gonzalez v. Morflo Indus., Inc., 931 F. Supp. 159, 168 (E.D.N.Y. 1996). In addition, summary judgment is appropriate where the plaintiff cannot possibly demonstrate that the defendant's alleged failure to warn was the proximate cause of plaintiff's injuries — a critical element of plaintiff's claim. Gonzalez, 931 F. Supp. at 168.
II. Duty to Warn
In New York, it is axiomatic that a manufacturer has a duty to warn only of "those dangers that are known or reasonably foreseeable at the time of marketing." Daley v. McNeil Consumer Prods. Co., 164 F. Supp. 2d 367, 373 (S.D.N.Y. 2001) (citing Rastelli v. Goodyear Tire Rubber Co., 79 N.Y.2d 289, 297 (1992). In the case of allergic reactions, a manufacturer is required to warn only of those reactions that are "`common to [a] substantial number of possible users.'" Id. (quoting Kaempfe v. Lehn Fink Prods. Corp., 21 A.D.2d 197, 201 (1st Dep't 1964). Thus, for there to be a duty to warn, a plaintiff must show: "(1) that [he] was one of a substantial number or an identifiable class of persons who were allergic to the defendant's product, and (2) that defendant knew, or with reasonable diligence should have known, of the existence of such number or class of persons." Kaempfe, 21 A.D.2d at 201.
DISCUSSION
I. Clairol Had No Duty To Warn
This is not a hard case. Plaintiff presents no evidence that any other user of Clairol Men's Choice hair color, let alone an appreciable number of users, has ever experienced an anaphylactic reaction to the Product. Instead, plaintiff bases his failure to warn claim on three propositions: (1) Clairol had a duty to warn because France, Germany and Sweden, at one time or another allegedly banned the use of PPD, a primary coloring agent in most hair dyes, which may or may not have caused plaintiff's anaphylactic reaction; (2) Clairol had a duty to warn because a "simple search of the web" reveals "an enormous body of literature . . . establishing PPD's toxicity;" and (3) Clairol had a duty to warn because L'Oreal, a non-party to this case whose hair products plaintiff has apparently never used, "appears to be aware of the health risks posed by PPD and therefore places clear warnings on its packages." Plaintiff's Memorandum Of Law In Opposition To Defendant's Motion For Summary Judgment ("Pl. Opp.") at 4-5.
In fact, during the year 2000 — the year Mr. Smallwood used the Product — Clairol shipped approximately 1.47 million units of the Product and received only 12 reports of adverse reactions. None of those reports involved anaphylactic symptoms. Jonsdottir Decl. ¶ 4. Indeed, despite having shipped approximately 7.7 million units since January 2000, Clairol has never received a single report of suspected anaphylactic reaction associated with the use of the Product (other than this case).Id. ¶ 2.
Not one of plaintiff's contentions is sustainable. First, there is no evidence that PPD even caused plaintiff's reaction; further, even if PPD were the cause of the reaction, plaintiff's contention that three countries in Europe banned the use of PPD, and thus Clairol had a duty to warn, is simply not credible. Second, even if the unauthenticated, uncorroborated hearsay materials found on plaintiff's "simple search of the web" were illuminative, which they are not, they cannot be considered on a motion for summary judgment. Opals on Ice Lingerie v. Body Lines Inc., 320 F.3d 362, 371 (2d Cir. 2003). Finally, plaintiff's reliance on a warning on a different product with a different formula made by a different manufacturer, in light of the fact that he did not read the warning on the product that he actually used in this case made by this manufacturer, is hard to take seriously.
Conspicuously absent from plaintiff's pleadings are a doctor's report, an expert report linking the Product or PPD to plaintiff's alleged injuries in this case, and/or depositions of any sort.
The claims that Clairol is "clueless" and chose "sales above safety" notwithstanding, plaintiff fails to establish that Clairol knew or should have known about anaphylactic reactions associated with use of the Product. Accordingly, as a matter of law, Clairol had no duty to warn. Summary judgment is hereby granted.
Standing alone, the lack of a duty to warn compels summary judgment; however, even if Clairol had a duty to warn, plaintiff's inability to establish proximate cause fatally undermines his case. Under New York law, plaintiff has the burden to establish "that [he] would have read and heeded a [different] warning had one been given." Sosna, 298 A.D.2d at 158. Accordingly, where the undisputed facts show that the plaintiff did not bother to read the manufacturer's existing warnings prior to using the product, plaintiff cannot establish the critical element of proximate cause and summary judgment should be granted. See id.; see also Carbone v. Alagna, 239 A.D.2d 454, 456 (2d Dep't 1997). Here, it is quite clear that Mr. Smallwood did not read the cautionary language on the label of the Product, nor did he perform the patch test as directed by Clairol. Smallwood Dep. at 32-33. As such, he has not, and cannot, establish proximate cause.
SO ORDERED.