Patient Harm from Illegal Dispensing of Contact Lenses

November 03, 2010

NORTH CAROLINA STATE BOARD OF EXAMINERS IN OPTOMETRY

November 3, 2010

Steve Garrett, O.D., President

North Carolina State Optometric Society

1000 Madison, Suite 3

Roxboro, NC 27573

Dear Dr. Garrett:

I am in receipt of your letter (undated, but received the week before last) relative to the dispensing (selling) of contact lenses by vendors such as beauty supply stores, convenient stores, flea markets, etc. who have no legal authority to do so, in which you allege patient harm is being done. The Board is well aware of the situation and found the most effective way to deal with the situation is to have the patient who has suffered harm as a result of such practices threaten to bring suit for damages against the seller. The problem has been that we have yet to have a single case in which there is either a willingness on the part of the patient to follow this recommendation, or there is a lack of sustainable evidence that patient harm exists based upon statements from the patient and the treating optometrist.

Nearly ten years ago I spent the better part of two days in Raleigh being deposed in connection with the FTC’s rulemaking process implementing the “Fairness to Contact Lens Consumer’s Act”, federal legislation initiated in large measure in the offices of our own North Carolina Senator, Richard Burr. 1-800-Contact representatives were present, as was the North Carolina Attorney General’s office. In the end it was the position of our Attorney General that the Commerce Clause of the United States Constitution pre-empted North Carolina law which otherwise prohibited the sale and dispensing of contact lenses in North Carolina by anyone other than a licensed optometrist, ophthalmologist or optician on prescription of an optometrist or ophthalmologist. During the period preceding the enactment of this legislation and while the FTC was in the process of issuing its “Final Rule” in the matter, both the AOA and our State Society made concerted efforts to identify patients who had been harmed due to the improper dispensing (principally by the internet sellers) of contact lenses. Of particular interest and targeted in this nationwide search were patients who allegedly had suffered “blindness” that could be attributed to such practices. Depending on one’s point of view, the results were disappointing. No such patient seemed to exist. Of the injuries reported, almost all was anecdotal and not supported by “fact”.

When the Board first set up its website a link was established where a licensee could report the unauthorized (illegal) dispensing of contact lenses by an internet seller to the Federal Trade Commission. Under “Policies” on the home page one can access the FTC report link by clicking on the dropdown on “Spectacle/CL Rx Release”.

Upon receipt of your letter I contacted Mr. Johnny Loper, the Board’s attorney, to consult with him as to the best approach the Board might take at the present time in response to your letter and to better protect the public from potential harm when using contact lenses purchased from a seller who is not legally authorized to sell or dispense contact lenses under either state or federal law. Enclosed with this letter are copies of two forms that will be presented to the Board for their approval at their upcoming meeting in Asheville. Once approved, the forms will be available on the Board’s website. In completing the patient, form the patient will be making a “sworn statement”, thus the requirement that it be notarized. The other form is for the doctor. Once completed by both parties these forms are to be submitted to the Board where they will be turned over to a “Probable Cause Committee” that will undertake an investigation and report its findings to the Board. Action by the Board will depend upon a number of factors, including, but not limited to, the recommendations of the Probable Cause Committee.

On receipt of this letter, should you or any Member of the Society’s Executive Council have questions or feel the need for further information please do not hesitate to contact me at the address and/or telephone numbers below. In the meantime, the Board will have read your letter, this letter and the forms prior to our upcoming meeting where the matter will be discussed; therefore, I should be able to report their actions in response to your request at your next meeting on Thursday evening, November 11, 2010 in Asheville.

For the Board, I am

Sincerely,

John D. Robinson, OD, Executive Director

Enclosures

cc: Board, Members of the NC Optometric Society’s Executive Council

Ms. Sue Gardner, Exec. Dir., NC Optometric Society