NEW YORK—Contact lens manufacturers Johnson & Johnson Vision Care (NYSE: JNJ) and Ocular Insight recently settled a lawsuit that J&J had filed charging Ocular Insight with false advertising concerning its Clear58 contact lens. In its complaint filed July 29 in the U.S. District Court, Southern District of New York, J&J Vision Care alleged that Ocular Insight had distributed promotional materials that falsely claimed not only that the FDA had “approved” the Clear58 lens, but that the Clear58 lens was “the first Food and Drug Administration-approved generic equivalent contact lens to replace [J&J’s] Acuvue 2" contact lens, and that the Clear58 lens was an “exact duplicate” of the Acuvue 2. In addition to seeking a permanent injunction requiring Ocular Insight to stop making such claims, J&J’s complaint sought actual damages from Ocular Insight’s sales of the Clear58 lens, treble (punitive) damages, and attorneys’ fees.

The Order on Consent issued on Aug. 15 by Judge Denny Chin permanently enjoins Ocular Insight from claiming that (i) the Clear58 lens was approved by the FDA in the first place, (ii) the FDA approved the Clear58 lens as a generic equivalent of the Acuvue 2, (iii) the Clear58 is a generic equivalent of the Acuvue 2, and (iv) the Clear58 CL is "an exact duplicate of or equivalent to the Acuvue 2.” The consent order also provides that if Ocular Insight refers to the Acuvue 2 in advertising or promotions, it must include a disclaimer saying, “The FDA did not make a determination that the Clear58 performs the same as any other Etafilcon lens, including Acuvue 2.” In addition, it requires Ocular Insight to notify all recipients of the promotional materials at issue explaining that the FDA has only “cleared,” not “approved” the Clear58 lens. J&J agreed to dismissal of its claims with prejudice and without recovering its attorneys’ fees, but it reserved the right to seek enforcement for any alleged violation of the consent order.

In a statement about the case, Naomi Kelman, president, Americas, of J&J Vision Care’s Vistakon division, stated, “Doctors write prescriptions for the particular contact lens brand that best fits the overall comfort, eye health and vision needs of the patient. Eyecare professionals who relied on Ocular Insight’s now-banned claims may not have been able to make appropriate prescribing decisions. As a result, they may have prescribed Clear58 lenses to patients for whom the Acuvue lenses may be more comfortable and efficacious.”

On behalf of Ocular Insight, Mark Levin, the company’s president, stated, “Experience has led us to allow eyecare practitioners to determine if a contact lens made of the same material, same water content, same base curve, same diameter and same method of manufacturing is a viable product to substitute for a branded product they currently dispense.”