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JOHNSON & JOHNSON VISION CARE v. CIBA VISION CORP.

December 10, 2004.

JOHNSON & JOHNSON VISION CARE, INC., Plaintiff,
v.
CIBA VISION CORPORATION, Defendant.



The opinion of the court was delivered by: LAURA TAYLOR SWAIN, District Judge

OPINION AND ORDER

Plaintiff Johnson & Johnson Vision Care, Inc. ("Plaintiff" or "JJVC") has brought the instant false advertising action pursuant to Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), Sections 349 and 350 of the New York General Business Law, and the common law of unfair competition, to challenge promotional materials disseminated by Defendant CIBA Vision Corporation ("Defendant" or "CIBA") in connection with CIBA's launch of its O2OPTIX contact lenses. Plaintiff JJVC, a Florida corporation with its principal place of business in Florida, manufactures, markets and sells contact lenses, including ACUVUE ADVANCE and ACUVUE 2. Defendant CIBA, a Delaware corporation with its principal place of business in Georgia, and a competitor of JJVC in the contact lens market, develops, manufactures, markets and sells optical and ophthalmic products and services, including the O2OPTIX lens.

  Plaintiff filed the complaint in the instant action on September 15, 2004, and moved on September 20, 2004, by application for an Order to Show Cause, for a preliminary injunction and an order permitting expedited discovery. At a conference held on September 22, 2004, the Court issued an order granting Plaintiff's request for expedited discovery and directing that the hearing on JJVC's motion for a preliminary injunction be consolidated with a trial on the merits of the action insofar as injunctive relief is sought.*fn1 The trial took place on October 18-21, 2004. The parties thereafter filed written closing arguments and proposed findings of fact and conclusions of law.

  The Court has jurisdiction of Plaintiff's federal claims pursuant to 15 U.S.C. § 1121 and 28 U.S.C. §§ 1331 and 1338, and of Plaintiff's New York state law claims under 28 U.S.C. §§ 1332, 1338(b), and 1367. Plaintiff principally challenges three items of advertising material that were issued by CIBA in connection with the launch of the O2OPTIX product: a two-page "sales aid" that was distributed to eye care professionals by CIBA's sales representatives (PX 2); a one-page "letter to Eye Care Professionals" that was included in packages of sample "fitting sets" of O2OPTIX lenses (PX 3); and a one-page advertisement that was placed in professional journals (PX 4). These three items were introduced into evidence at trial. Following the trial, the parties proffered additional advertising materials. The Court declines to reopen the record. Accordingly, this decision addresses the matters that were raised at the trial.

  The Court has considered thoroughly all of the parties' submissions and arguments; Plaintiff's application for a permanent injunction is hereby granted in part and denied in part, and Defendant's motion for judgment on partial findings is granted in part, for the reasons set forth below. This Opinion constitutes the Court's findings of fact and conclusions of law in accordance with Rule 52 of the Federal Rules of Civil Procedure.

  FACTS

  The Contact Lens Market

  Contact lenses are medical devices designed to be worn on the eyes to correct vision problems. (Trial Tr. at 132.) Contact lenses, which are regulated by the FDA and cannot be acquired without a prescription from an eye care professional ("ECP"), are worn by approximately 35 million Americans. (Id.)

  There are two major categories of contact lenses: rigid lenses, which are relatively firm pieces of plastic worn on the front of the eye that require precise fitting, and soft lenses, or hydrogels, which are essentially gels combined with water. Soft lenses are by far the more widely used lenses in the marketplace today. (Id. at 133.)

  Soft lenses were introduced in the United States in the early 1970's and represented a significant technological advance over rigid lenses, offering increased benefits in terms of oxygen permeability and comfort. Soft lenses are also easier to fit than rigid lenses. (Id. at 137.) Soft lenses can be worn on either a daily wear or extended wear basis. Daily wear lenses are not designed to be worn during sleep, and therefore are intended to be removed each night. They are also intended to be cleaned and disinfected between scheduled replacements. (Id. at 43, 133.) Extended wear lenses can be worn overnight, and can be left in place for a continuous period of time ranging from one to thirty days, depending on the particular product. (Id. at 133.)

  Oxygen supply to the cornea is an important factor bearing on ocular health. Hypoxia is "a relative lack of oxygen compared to that which would normally exist." (Id. at 41.) The cornea does not receive oxygen through blood vessels and thus relies almost entirely on oxygen received through the atmosphere (during sleep, the cornea relies mostly on oxygen received through the eyelid). Therefore, when wearing a contact lens, the eye only receives oxygen through the lens itself and, to a relatively small degree, through lens movement associated with blinking. Contact lenses are thus capable of interfering with the oxygen supply to the cornea, the degree of interference depending on the oxygen transmissibility level of the particular lens. When the cornea does not receive sufficient oxygen, it becomes acidified and therefore has to do more work, thereby increasing its need for oxygen. (Id. at 488-89, 525.)

  Oxygen transmissibility, as relevant to the instant dispute, is a measurement of the amount of oxygen that would pass through a particular contact lens (id. at 44), and is expressed as a number representing the ratio of a lens' permeability ("Dk") to its thickness ("t" or "L") ("Dk/t" or, less commonly, "Dk/L"). (Id. at 46-47.)

  In 1999, JJVC introduced ACUVUE 2, which is a traditional hyrdogel lens that has been approved for both daily and extended wear, although it is marketed only for daily wear. It is still on the market today and has a Dk/t of 26. (Id. at 139-41.)

  In recent years, it has become possible for polymer chemists to increase the oxygen permeability of soft lenses by adding silicone-bearing polymers. Both JJVC's ACUVUE ADVANCE with Hydraclear ("ACUVUE ADVANCE") and CIBA's O2OPTIX are examples of silicone hydrogels. (Id. at 42-43.) ACUVUE ADVANCE, which is approved for daily wear, was launched nationally in 2004 and has a Dk/t of 86. O2OPTIX, which was launched in September 2004, as a daily wear lens but has more recently been approved for extended wear use, has a Dk/t of 138.

  The Challenged Promotional Materials

  Around the time of the launch of its O2OPTIX lens, CIBA began distributing the challenged promotional materials to sales representatives for use in marketing the O2OPTIX lens primarily to ECPs. The promotional materials consisted of a sales aid, a marketing letter, and a launch advertisement. (Trial Tr. at 231, 288-93; PX 2; PX 3; PX 4.)

  The Sales Aid

  At the top of page one of CIBA's two-page sales aid are the words "Introducing new O2OPTIX." Directly below that is a statement that "A healthy cornea requires oxygen. Lots of it." Below the statement are several bullet points indicating that "[s]oft contact lenses create a barrier to the natural flow of oxygen to the cornea," that "[l]ack of sufficient oxygen can create a cumulative hypoxic stress on the cornea," and that "[t]his can be described as corneal oxygen deficiency." Under the bullet points is a bar graph depicting percentages of patients reporting various symptoms related to corneal oxygen deficiency, such as redness, blurriness/haziness of vision, eye irritation when wearing contacts, eye discomfort at the end of the day and dry eyes. To the right of the graph are several more bullet points under the heading "Clinical Signs of Corneal Oxygen Deficiency May Include." Signs mentioned are conjunctival and limbal injection, neovascularization, endothelial polymegethism, pleomorphism, and decreased cell density, refractive error, corneal staining and corneal edema. (PX 2.)

  In the middle of page one of the sales aid are the words "New O2OPTIX — the healthy choice for daily wear." Directly below that are the words "[o]xygen transmissiblity (Dk/t) is a critical success factor for healthy contact lens wear." The sales aid further asserts that "[a] revolutionary silicone hydrogel technology gives O2OPTIX," inter alia, "[a] Dk/t of 138@-3.00D, far exceeding the critical minimum threshold of 90 Dk/t to avoid severe hypoxic stress with daily wear." A footnote at the end of the statement regarding Dk/t levels cites a 1996 article by Ostrem, Fink and Hill entitled "A hypoxic response line model for the human cornea," (the "Hill Article"). Near the bottom of page one of the sales aid are the words "O2OPTIX provides 62% greater oxygen transmissibility than ACUVUE ADVANCE — and more than 5 times the oxygen of ACUVUE 2." Below that statement, at the very bottom of page one of the sales aid, is a bar graph, labeled "Critical Oxygen Transmissibility," that compares the oxygen transmissibility, or Dk/t, of four lenses — CIBA's Night & Day (Dk/t of 175), CIBA's O2OPTIX (Dk/t of 125), JJVC's ACUVUE ADVANCE (Dk/t of 86), and JJVC's ACUVUE 2 (Dk/t of 26). The graph includes two horizontal dotted lines. The first dotted line, set at 125 Dk/t, is labeled "critical minimum for no stromal anoxia during overnight wear," and is footnoted to a 1996 article by Harvitt and Bonanno entitled "Reevaluation of the oxygen diffusion model for predicting minimum contact lens Dk/t values needed to avoid corneal anoxia." The second dotted line, set at 90 Dk/t, is labeled "critical minimum to avoid severe hypoxic stress with daily wear." (Id.)*fn2 CIBA's Night & Day and O2OPTIX lenses thus are both depicted as having Dk/t's above both "critical minimums," while JJVC's ACUVUE ADVANCE and ACUVUE 2 lenses are both depicted as having Dk/t's that are below both "critical minimums."

  Page two of the sales aid begins with the legend "[t]he oxygen your patients need and the comfort they want." The following text appears immediately below the legend:
75% of lens wearers preferred O2OPTIX to ACUVUE ADVANCE.* The #1 reason was comfort.4
* In a double-masked, randomized clinical study where all patients wore both lenses.

  Footnote four of the text is found in a block at the bottom of the page, and reads: "CIBA ...


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