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Perotti v. Johnson & Johnson Vision Care

12/30/2004

ell Dow Pharmaceuticals, Inc. (1991), 58 Ohio St.3d 147, 149-150, 569 N.E.2d 875. As noted by the Supreme Court of New York:


doctrine has evolved in the field of prescription drugs and requires such a manufacturer to warn of all potential dangers of which it knows or should know are associated with its product and, further, to take such steps as reasonably necessary to bring that knowledge to the attention of the medical community. The manufacturer discharges its duty in this regard by providing adequate warnings to the prescribing physician, who then acts as an informed intermediary between the manufacturer and the patient, "assessing the risks and benefits of the drug and advising the patient of its possible risks and side effects."


Bukowski v. CooperVision, Inc. (1993), 185 A.D.2d 31, 34, 592 N.Y.S.2d 807 citing Martin v. Hacker, 185 A.D.2d 553, 554.


{ } In the case at bar, defendants established that their ACUVUE contact lenses came with a package insert intended for the physician's use and reference. The insert further establishes that the prescribing physician is responsible for providing the patient with the appropriate warnings about product use or misuse. It is undisputed that this insert repeatedly warns of the risk of corneal ulcers with improper contact lens use.


{ } Further, each contact lens patient is provided with an "ACUVUE Patient Instruction Guide," which repeatedly warns the patient about corneal ulcers and how to avoid getting them by proper use and cleaning.


{ } Moreover, both the ACUVUE physician insert and the Patient Instruction Guide warn that " hen daily wear users wear their lenses overnight (outside the approved indication), the risk of ulcerative keratitis is 9 times greater than among whose who do not wear them overnight."


{ } Under "The Learned Intermediary Rule," defendants' physician insert and patient information guide sufficiently warn prescribed users about the risks associated with their ACUVUE lenses. And since the "Learned Intermediary Rule" applies only to prescribed product users, plaintiff in this case cannot challenge the adequacy of defendants' warnings under the rule because he was not a prescribed user of his wife's ACUVUE lenses.


{ } On the record before this court, we conclude that defendants did not owe plaintiff a duty in the first instance and, even if they did, plaintiff has not shown that wearing his wife's prescription ACUVUE contact lenses was the proximate cause of his injury . Moreover, defendants discharged their duty to warn under the "Learned Intermediary Rule."


{ } Accordingly, the trial court did not err in granting defendants' motion for summary judgment. Plaintiff's sole assignment of error is overruled.


Judgment affirmed.


It is ordered that appellees recover of appellant its costs herein taxed.


The court finds there were reasonable grounds for this appeal. It is ordered that a special mandate issue out of this court directing the Common Pleas Court to carry this judgment into execution.


A certified copy of this entry shall constitute the mandate pursuant to Rule 27 of the Rules of Appellate Procedure.


PATRICIA A. BLACKMON, P.J., AND ANTHONY O. CALABRESE, JR., J., CONCUR.


DIANE KARPINSKI JUDGE






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