[T]he [laser] medical device will be purchased by or on the
order of a licensed practitioner, and used only by either a licensed physician
or a licensed practitioner as defined by applicable state law. The regulations
defining who can own and use a medical device vary from state to state and are
subject to change. It is the buyer’s responsibility to ensure that all
applicable state laws are followed.
Dr. Mesbahi later signed a sales contract and initialed the
page of the contract which contained the following provision:
Seller may provide educational sessions on the system . . .
provided, however, that the Buyer is solely responsible for the use and
operation of the device in accordance with all applicable law and regulations,
and for confirmation of all user qualifications. Buyer acknowledges improper use
of the product carries a risk of injury to patients. Buyer represents and
warrants that he, she, or it is in compliance with any and all applicable
Federal, state, and local laws and regulations.
Both of Dr. Mesbahi’s sisters worked in her Rockville
office, Mina Nazemzadeh (“Ms. Nazemzdeh”) as the business manager and Aghdas
Rahmati (“Ms. Rahmati”) as the office receptionist. Neither sister was licensed
as a physician, nurse practitioner, or physician’s assistant. However, in 2002,
both sisters were trained by the laser machine manufacturer’s representative and
certified competent to perform laser hair removal procedures. Between early 2003
and August of 2005, Ms. Nazemzadeh performed approximately four to eight laser
hair removal procedures a day, and Ms. Rahmati performed one to two laser hair
removal procedures per day during the summer of 2004 and August of 2005.
Dr. Mesbahi and her sisters received notice of charges
filed against them by the Maryland Board of Physicians (“The Board”). Among
other things, the Board alleged that Dr. Mesbahi aided unauthorized persons
in the practice of medicine by inappropriately and unlawfully delegating
laser hair removal procedures. The Board alleged that Ms. Nazemzadeh and Ms.
Rahmati practiced medicine without a license by performing laser hair
removal services. The Board relied upon Declaratory Ruling 00-1 (“DR 00-1”)
in concluding that laser hair removal is a surgical act constituting the
practice of medicine.
DR 00-1 was issued by the Board on October 30, 2002, in
response to a petition from the Board of Electrologists, to address whether
physicians may delegate laser hair removal to nonphysicians. In DR 00-1, the
Board ruled that “[t]he use of lasers for hair removal is a surgical act.
Only physicians, certified nurse practitioners, registered nurses pursuant
to Board of Nursing Declaratory Ruling 97-1, and physician assistants may
use lasers for hair removal.”
The Board concluded that Dr. Mesbahi and her sisters
were guilty of the charges against them. The Circuit Court for Montgomery
County affirmed the Board’s ruling, in part, and remanded the case as to
penalties. On appeal, the Court of Special Appeals was asked to decide
whether the Board erroneously relied on Declaratory Ruling 00-1 in
concluding that laser hair removal is a surgical act constituting the
practice of medicine.
Initially, the court held that the Board was bound by
DR 00-1. According to the court, DR 00-1 clearly holds that laser hair
removal constitutes the practice of medicine, and the Board was not free to
ignore DR 00-1. Additionally, the court held that the Board’s reliance on DR
00-1 did not give it the force of a regulation. Rather, the Board properly
treated DR 00-1 as binding precedent, not a regulation. Further, the court
rejected the contention that DR 00-1 was void because the Board failed to
follow its own regulations in issuing the ruling; though, only because the
issue was not preserved for appellate review. Finally, in addressing the
argument that the Board’s decision that laser hair removal constitutes the
practice of medicine was erroneous, the court avoided ruling on the matter
and decided the issue on procedural grounds – namely, the time for appealing
DR 00-1 has long since expired.
In DR 00-1, the Board adopted the Board of Nursing’s
definition of an “ablative surgical procedure” as “a surgical procedure
designed to destroy or excise by use of a laser.” Regarding laser hair
removal, the Board concluded that “since the goal of the procedure is
designed to destroy or damage the hair follicle . . . it is clear that the
use of lasers for hair removal is an ablative procedure.” Based upon this,
the court held that it was reasonable for the Board to find that laser hair
removal was a surgical act, encompassed in the statutory definition of the
practice of medicine. Moreover, Dr. Mesbahi and her sisters were unable to
cite any authority supporting the proposition that Maryland law permits a
layman, unlicensed in any health profession, to perform laser hair removal
without any supervision. The court, therefore, agreed with the Board’s legal
conclusions.
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