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Advertising can be
downfall in refractive surgery, even without outrageous claims The FTC is
actively looking into claims made by refractive surgeons that go beyond what
can be expected by patients.
NEW ORLEANS — Government regulatory agencies are warning the refractive eye
care market that surgeons and surgery centers need to rein in their
advertising policies. During a symposium here at the American Academy of
Ophthalmology meeting, Walter Stark, MD, chaired a session that featured
presentations from the Food and Drug Administration, the Federal Trade
Commission and an Academy representative.
During the sparsely attended symposium, the presenters warned surgeons and
surgery centers that refractive surgery lawsuits are on the rise and that
the ways surgeons and companies advertise their services can play a large
role in the outcomes of these cases.
FDA director of ophthalmic devices, A. Ralph Rosenthal, MD, warned that any
claims made in advertising or promotional material produced by surgeons or
surgery centers must be included in the refractive surgery device’s
labeling.
“A doctor may use a device off-label; however, if it’s not stated in the
labeling, a company or doctor cannot promote it,” he said. He also pointed
out that laser epithelial keratomileusis (LASEK) is currently an off-label
use of an excimer laser.
A procedure can, however, be promoted off-label if the advertising is being
used to obtain subjects for a clinical trial. Dr. Rosenthal also warned that
in any advertising the surgeon or center must disclose any complication,
contraindications or other relevant labeling.
“Draft your claims carefully” perhaps the strongest warnings came from the
FTC. Matthew Daynard from the FTC’s Division of Advertising Practices warned
that the FTC is actively looking into improper and inaccurate advertising
that is brought to the agency’s attention or found in their own
investigations.
Mr. Daynard said the FTC’s first mode of attack is prevention. He noted that
the FTC and the AAO collaborated several years ago to draft advertising
guidelines for refractive surgery. However, in his estimation more and more
surgeons and surgery centers have chosen to ignore these advertising
policies that were created for their and their patient’s protection.
If a surgeon or surgery center chooses to ignore the FTC’s guidelines and
his FTC division finds out about it, Mr. Daynard said the doctors could
expect an advisory letter, indicating that their advertising may be false or
misleading. The letter will suggest that they should change their
advertising and the letter will tell doctors that if they have questions on
how to change their advertising, they should contact the FTC.
However, when the FTC runs across grossly exaggerated efficacy claims or
business practices, Mr. Maynard warned that those could require law
enforcement actions that could result in public “consent” orders.
He advised doctors that their best bet was to work with the FTC, the AAO and
local medical boards to develop accurate and effective advertising and to
follow the established guidelines closely.
Be forthright “Tell the truth, tell all the truth and make sure it is the
truth,” Mr. Daynard said. “Anecdotal evidence is never adequate for
advertising. The use of customer testimonials can be deceptive if the
underlying efficacy claim is not substantiated. And physician endorsements
must disclose any personal or financial connection to the marketer that
consumers would consider important.”
Some claims are questionable on their face, he explained. These include such
claims as, “Throw away your glasses,” or “eliminate the need for eyewear.”
He said this claim in particular is troubling because it is an unqualified
claim that is likely false, because many complications associated with night
driving have not been eliminated and presbyopia will eventually affect most
men and women.
Mr. Daynard also spoke about a recent article in The Washington Post that
discussed up-selling or “car salesman” tactics.
“Up-selling is a questionable practice. If you advertise ‘20/20 for $499 per
eye’ and most of your 20/20 results are paying $759 per eye, that is a cause
for concern by the FTC. Fine print disclaimers may not fix the problem.
Patient counselors paid on commission to stimulate higher prices may be a
questionable practice in this context,” Mr. Daynard said.
He also pointed out that “lifetime commitment” claims could be a dangerous
promise.
“Things seem to be taking a downturn. It seems like more ads are appearing
that make spurious claims. You can’t have a disclosure that contradicts a
headline. If the majority of patients are not receiving the low-price and
vision claim, it may be a violation of state laws. If you have a question,
send your ads to your state attorney general, state MD/ophthalmology board
or the FTC,” he said.
And in protecting U.S. interests, Mr. Daynard promised that when deceptive
claims are made by Canadian or Mexican refractive centers that advertise in
the United States, the FTC will ask their Canadian or Mexican counterparts
to intervene.
Lawyers learning refractive litigation Richard L. Abbott, MD, told the
physicians and industry people in the audience that advertising is a fickle
form, especially when it is involved in lawsuits. He said that trial lawyers
are now learning how to litigate refractive surgery suits for patients.
“Safe and effective claims are the most fruitful form of attack for
litigators. Malpractice rates are going up, as are settlements and awards,”
he said.
He noted that there have been 83 lawsuits filed from 1997 to 2001. Even more
were still in the litigation pipeline, with more being filed every day.
California has had the most refractive surgery trials with 30, followed by
Colorado with seven and Florida with five.
To make matters worse for refractive surgeons, Dr. Abbott said the press is
now pointing out misleading ads, which causes damage to the industry as a
whole.
He suggested that surgeons “should have a risk manager or lawyer look over
your ads. Or just use common sense. Patient expectations are high, but are
they realistic? It’s the surgeon’s job to make that determination.”
For Your Information:
Walter J. Stark, MD, can be reached at 600 N. Wolfe St. Maumenee,
Baltimore, MD 21287; (410) 955-5490; fax: (410) 955-0867.
A. Ralph Rosenthal, MD, can be reached at Division of Ophthalmic Devices,
9200 Corporate Blvd., Room 250C, Rockville, MD 20850;
(301) 827-4601; fax: (301) 827-4601.
Matthew Daynard can be reached at Federal Trade Commission, CRC-240,
Washington, DC 20580; (202) 326-3291; fax: (202) 326-3259;
e-mail: mdaynard@ftc.gov.
Richard L. Abbott, MD, can be reached at UCSF Beckman Vision Center,
10 Kirkham St., K-301, San Francisco, CA 94143; (415) 502-6265;
fax: (415) 502-7418; e-mail:
rabbott@itsa.ucsf.edu.
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