Opinion
No. 75-284
Decided December 16, 1976. Opinion modified and as modified petition for rehearing denied February 3, 1977.
Ophthalmologists brought action to enjoin optometrists from prescribing certain type of contact lenses and from holding themselves out as being able to diagnose glaucoma. Finding lens to be a device rather than a drug, trial court denied injunction as to contact lenses but enjoined optometrists from diagnosing disease. Ophthalmologists appealed.
Affirmed
1. PHYSICIANS AND SURGEONS — Soft Contact Lens — Not a Drug — State Statute — Applicable — Permits — Prescription By Optometrists. Regardless of FDA definitions and classifications of a soft contact lens as a "drug," such term is one of art and is not to be given its normal medical meaning, and the fact that federal law allows state law to determine the "practitioner" who may dispense drugs leaves to the state the determination of who is encompassed by that term; consequently, since the state statute provides that the practice of optometry includes "the prescription of contact lenses, or the fitting or adaptation of contact lenses to the human eye," optometrists may prescribe contact lenses.
Appeal from the District Court of the City and County of Denver, Honorable Robert T. Kingsley, Judge.
Hobbs Waldbaum, P.C., Larry F. Hobbs, Leonard N. Waldbaum, for plaintiffs-appellants.
Rovira, DeMuth Eiberger, Carl F. Eiberger, Russell P. Rowe, for defendant-appellee C. E. Johnson.
Peterson Fonda, P.C., Thomas T. Farley, for defendant-appellee Dr. James F. Georgis.
Williams, Turner Holmes, Anthony W. Williams, for defendants-appellees Hurst F. Otto, H. J. Kendrick, and Terry H. Musgrave.
Lutz Gilbert, Harold D. Lutz, for intervenor Colorado Vision Services, Inc.
No appearance for Intervenor State Board of Optometric Examiners.
Plaintiffs, who are physicians and surgeons licensed to practice medicine specializing in ophthalmology, brought this action for injunctive and declaratory relief against the defendants, who are optometrists. The ophthalmologists contend that the optometrists engaged in two practices solely within the purview of the practice of medicine: (1) Holding themselves out as being able to diagnose the disease glaucoma; and (2) dispensing a soft contact lens, "Soflens," which the ophthalmologists argue is a drug. Colorado Vision Services, Inc., an insurer of optometric service costs, and the State Board of Optometric Examiners, the licensing agency for optometrists, intervened on the side of the optometrists.
Following trial to the court an order was entered enjoining optometrists, inter alia, from diagnosing disease, but specifically holding that optometrists may prescribe "Soflens" for visual acuity. The ophthalmologists appeal, and we affirm the judgment.
The question in this case is whether "Soflens" is a drug under Colorado law and thus properly prescribed only by physicians. The ophthalmologists contend that since "Soflens" was defined as a drug by the Food and Drug Administration (FDA), such definition is binding upon the state.
After the trial of the case, "Soflens" was reclassified as a device. Medical Device Amendments of 1976, Pub.L. No. 94-295, § 2 (May 28, 1976).
Therefore, they argue that since Colorado law does not permit optometrists to dispense drugs, optometrists may not prescribe "Soflens." The optometrists, on the other hand, contest the assertion that the FDA classified "Soflens" as a drug, and urge further that the apparent classification employing the term "drug," uses it as a term of art not intending to convey its normal and customary medical meaning. In any event, the optometrists argue that the federal definition is not binding upon the state, and that optometrists are at least as well qualified by training and education as ophthalmologists to dispense "Soflens."
"Soflens" is the brand name of a soft contact lens manufactured by Bausch Lomb. Since 1971, it has been marketed extensively in Colorado through optometrists. It was classified initially by the United States FDA as a "new drug," and later was defined as a therapeutic drug. Evidence revealed that "Soflens" has some properties which act on the eye as a pain reliever, as well as a lens.
[1] Regardless of the FDA definitions and classifications of "Soflens" as a drug, we agree with the optometrists that such term is one of art and is not to be given its normal medical meaning. In this regard we deem it significant that federal law allows state law to determine the "practitioner" who may dispense what is defined by federal law to be a "drug," 21 U.S.C. § 353(b)(1). This, in our view, leaves to state law the determination of who is encompassed by that term. In Colorado's statute defining the practice of optometry, § 12-40-102, C.R.S. 1973, it is stated that the practice of optometry includes "the prescribing of contact lenses, or the fitting or adaptation of contact lenses to the human eye." Thus, optometrists may prescribe contact lenses solely for the purposes of visual acuity.
We have considered the other contentions of error and find them to be without merit.
Judgment affirmed.
CHIEF JUDGE SILVERSTEIN and JUDGE RULAND concur.