Cmp - MID-SOUTH PCM GROUP, P.C.

9623279

UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION

In the Matter of

MID-SOUTH PCM GROUP, P.C., EYE AND VISION CLINIC, P.C., and INTERNATIONAL COMPUTERIZED ORTHOKERATOLOGY SOCIETY, INC., corporations, and J. MASON HURT, O.D., individually and as an officer of the corporations.

DOCKET NO. C-3773

COMPLAINT

The Federal Trade Commission, having reason to believe that Mid-South PCM Group, P.C., Eye and Vision Clinic, P.C., and International Computerized Orthokeratology Society, Inc., corporations, and J. Mason Hurt, O.D., individually and as an officer of the corporations ("respondents"), have violated the provisions of the Federal Trade Commission Act, and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest, alleges:

1. Respondent Mid-South PCM Group, P.C. (“Mid-South”) is a corporation formed under the laws of the state of Tennessee, with its principal office or place of business located at 2865 Summer Oaks Drive, Bartlett, TN 38134.

2. Respondent Eye and Vision Clinic, P.C. (“Vision Clinic”) is a corporation formed under the laws of the state of Tennessee, with its principal office or place of business located at 2865 Summer Oaks Drive, Bartlett, TN 38134.

3. Respondent International Computerized Orthokeratology Society, Inc. (“ICOKS”) is a corporation formed under the laws of the state of Tennessee, with its principal office or place of business located at 2865 Summer Oaks Drive, Bartlett, TN 38134.

4. Respondent J. Mason Hurt, O.D., is the sole owner and President of the corporate respondents. He formulates, directs, and controls the acts and practices of the corporate respondents, including the acts and practices alleged in this complaint. His principal office or place of business is the same as that of the corporate respondents.

5. Respondents are engaged, and have been engaged, in the promotion, offering for sale, sale, and distribution to the public of ophthalmic services, including orthokeratology (“ortho-k”) or “Precise Corneal Molding” (“PCM”) services, which involve the use of a series of contact lenses purportedly to reshape the cornea gradually for the treatment of myopia (or "nearsightedness"), hyperopia (or "farsightedness"), and astigmatism. The contact lenses used in these PCM ortho-k services are “devices,” within the meaning of Sections 12 and 15 of the Federal Trade Commission Act.

6. The acts and practices of respondents alleged in this complaint have been in or affecting commerce, as "commerce" is defined in Section 4 of the Federal Trade Commission Act.

7. In the course and conduct of their business, respondents have disseminated or have caused to be disseminated advertisements or promotional materials for the purpose of promoting the sale of PCM ortho-k services. Respondents advertise and promote their services through the use of print advertisements, radio and television advertisements, internet advertisements, free consultations, videos, brochures, and pamphlets, which are provided to patients and prospective patients, and some of which are provided to other optometrists for distribution under their own name to patients and prospective patients. Respondents' advertisements and promotional materials include, but are not necessarily limited to, attached Exhibits A through H.

8. The advertisements and promotional materials referred to above, including but not necessarily limited to attached Exhibits A-H, contain the following statements:

A. "21st Century Eyecare"

“Saturday 10 a.m. - 12 p.m. ET

It sounds too good to be true -- a safe, non-surgical alternative to restore clear vision safely, gently, and permanently.

In a modest departure from ordinary talk radio, Talk America will air a new program featuring an emerging national network of eye doctors who are performing a new, non-evasive (sic), non-surgical corrective vision procedure that reshapes the cornea, much lie (sic) braces straighten teeth. It’s called 21st Century Eyecare....

Dr. J. Mason Hurt, a Memphis-based optometrist, has developed a revolutionary new corrective eye procedure called Precise Corneal Molding (PCM for short), that will soon render glasses and contact lens (sic) obsolete....

Precise Corneal Molding is the result of merging technology and physiology. PCM evolved from a procedure called ?orthokeratology,’ clinically practiced for over thirty years. Orthokeratology involves reshaping the cornea by fitting patients with a series of special hard contact lenses, each having a slightly different curve.

Orthokeratology was limited by the older technology of the lenses and the difficulty in precisely monitoring and controlling the reshaping process.

Send Email Directly to Dr. Hurt and Sam Cooper.”

(Exhibit A) (Internet Ad)

B. "Precise Corneal Molding (PCM): Your Clearest Choice, Your Greatest Freedom"

“....In many cases, just a matter of days to weeks frees the majority of the patients from their dependence upon eyeglasses or contacts during daytime hours.

....By slight modification in the shape of the cornea, clear functional vision may be restored to the individual.

Recently several surgical procedures have been developed to attempt to accomplish the same purpose. However, their limited success has been due to the effects off (sic) scarring, irregular healing and most importantly, its temporary effect....In addition, the surgical scars cause surface irregularities on the cornea, resulting in permanent blurring that even glasses or contacts cannot eliminate. Molding avoids those complications since there is not injury to any eye tissue. The soft cornea simply reshapes itself to fill the mold. The mold is similar to a contact lens in its appearance and sensations upon wearing. The mold is worn while sleeping and/or while awake. The procedure takes just hours in mild cases to a few months in very difficult cases to reach good functional vision. The mold is worn regularly until the best vision is achieved and the cornea is allowed to stiffen in its new shape. At that point the mold wearing is gradually reduced until a minimal wear time is established that maintains that shape and good functional vision. This guarantees continued clarity without the gradual blurring that usually accompanies the surgery. Therefore, the cornea can easily be fine tuned the rest of ones (sic) life by minor modification in the retainer mold.

....PCM opens new horizons to everyone regardless of age, occupation, or ability to wear contact lenses in the past.

PCM is safe, reliable and inexpensive. PCM gives you a cure, not a maintenance of your visual handicap....”

(Exhibit B) (Patient Handout)

C. "Precise Corneal Molding"

“....'I shifted from soft contact lenses to PCM and I can see 20/20 when I take them off!' -- T.K

'I have been through the program and I am very happy with the results. I’m taking my daughter in for Precise Corneal Molding, too!' -- A.S.....

COMPARE

PCM is a safe, gentle, affordable, non-surgical alternative for wearers of glasses.

Surgery PCM

Age as a limiting factorYes No

Reversibility No Yes

Loss of work time Yes No

Worsening of night visionYes No

FAA and military approval No Yes

What is PCM?

Imagine being able to easily read an alarm clock without your glasses, see street signs clearly, or participate in sports without lenses of any kind....

...Because the procedure is non-invasive, PCM has provided thousands of patients with better vision without the risks or complications of surgery.
...PCM utilizes a series of prescription eye molds to reshape the cornea much like orthodontists use braces to straighten teeth....
...The benefits are realized in weeks or months, depending on the severity of vision problems. Retainer molds will be used on a limited basis to maintain the new shape of the cornea.

Since 1962, PCM and its predecessor, Orthokeratology, have been used to help pilots, athletes and others requiring unaided vision. Now, new research

developments such as computerized corneal topography and new mold designs and materials have established PCM as the eye care trend of the future.

The Safest Option

In contrast to Radial Keratotomy and laser surgery, PCM does not require injury to the eye, resulting in glare-inducing scars. There is also no disruption of vision as eyesight improves.

PCM for Children

One of the most exciting uses for PCM is controlling nearsightedness in children....PCM prevents deteriorating vision and even reverses it.

Proven Safe Results

PCM is highly effective in correcting nearsightedness, farsightedness and astigmatism....University research studies have shown corneal molding to be safe and effective. These studies include The University of Houston College of Optometry (5 years), University of California at San Diego Medical School (7 years), University of California at Berkeley College of Optometry (3 years), and Pacific University College of Optometry (5 years).”

(Exhibit C) (Patient Handout)

D. “Precise Corneal Molding”

JIM LINDSEY speaks as the words scroll down the screen: “Over 190 million men, women and children in America are lifetime victims of poor vision. Millions of Americans are chained to the use of glasses and contact lenses.... There is a solution today. If you are one of the 190 million Americans, this show is for you. Precise Corneal Molding, three words that will change the way you see the world, without glasses or contact lenses.

In the next 30 minutes, you will be introduced to a gentle, non-surgical, affordable procedure that will make glasses and contact lenses a thing of the past in your life....From 8 to 80, Precise Corneal Molding clearly is the medical eye care breakthrough of the century.

The gift of sight, a sense given to all human beings [spoken while the following is printed on screen: a gift given to nearly every human being at birth], yet more than 75 percent of Americans have vision disorders that require prescription glasses or contact lenses to correct. They do bring improved vision, but with every prescription change, the vision grows weaker and weaker, not stronger.

To eliminate vision disorders, surgical procedures have been developed and introduced but with limited results. In the 1960's, before the popularity of soft contact lenses, an ortho-keratology procedure was developed that could actually reshape the cornea of the eye and caused improved vision for a limited time.

The procedure was accepted by the FAA, a department of the Federal Government that regulates the airline industry....

In 1992, Dr. J. Mason Hurt, an optometrist, perfected a process called Precise Corneal Molding or PCM. With PCM, patients who had previously worn glasses or contact lenses were able to see without the use of either and without surgery. Here is why.”

DR. J. MASON HURT, O.D. (perfected P.C.M. process): “Corneal molding is very safe and effective, and I would like to show you why (standing in front of diagram of the eye). The cornea or the clear window that we see through is very soft and is subject to change. It changes its shape on a very regular basis....

The cornea wants to change shape. Now we just guide it to the shape we would like for it to have, and we do that by building a mold which will rest (draws on diagram) in the zone where we are having our shape problems, and we can reshape this cornea in a fashion very similar to wearing of contact lenses in a safe, nonsurgical, noninvasive technique that we call Precise Corneal Molding.”

STEVEN FENSLER, Computer Programmer: “....And for the past two years, I had been wearing reading glasses along with my contacts so that I could read pages, and then I was getting very tired. Been on molds for seven months, and I don’t use my reading glasses anymore at all, either with my contacts or without them. I can see everything at work I want to see....”

PEGGY COLLINS, College Coordinator: “You can see. It does correct your vision....There is no surgery, there is no blood....Just little contacts in your eyes, you sleep with them at night....I recommend it.”....

CONNIE BRADEN, Homemaker: “Scott [her son] had broken his glasses at school, and we came to get his eyes checked, and his eyes had gotten so bad in just a few months that I was told that he would have to have glasses changed every six months. So we started with the contacts, and within one week, he could see 20/20.”

CRAIG JARRELL, Oriental Rug Sales: “For anyone that has problems seeing, I would recommend it to all my friends that wear glasses; they need to come up here and get this done. It’s just great to be able to take contacts out and still be able to see.”....

ANN POSEY, School Teacher: “....my vision had just gotten so bad, and I couldn’t wear contacts any more, didn’t like wearing glasses, wasn’t wanting to have any type of surgery....Knowing that my vision is going to be 20/20 all the time is just really exciting....”

....JACKIE GREENE, Sales Manager: “I heard about this procedure and it really sounded too good to be true. But I am so excited about it now because I’ve probably had the procedure maybe six weeks, and already, within six weeks, I can drive my van without any corrective lenses whatsoever....”

....DR. HURT: [explains the PCM procedure to a patient by using the map of her cornea] “....As we keep it centered, all of these [pointing to various parts of the cornea] will mold away. So we are going to be able to mold away your astigmatism as well as your nearsightedness. And as we end up with this pink, what I call smiley face down here, then you will have your bifocal as well....”

....ANN POSEY, School Teacher: “Number one, it is wonderful to be able to wake up in the morning and to open my eyes and to see everything around me with no contacts in, nothing in, just to be able to open them up and to see....Number two, there is such security knowing financially that later in life I am not going to have to buy more glasses, change my prescriptions, get more prescription sun glasses. I am not going to have to lose a contact and find it or anything like that. I know that my vision, I am going to be able to see. And that is just wonderful.”....

NARRATOR: “....Now, through Precise Corneal Molding you can see clearly day or night and continue to see clearly for the rest of your life without depending on glasses or contact lenses....”

....JACKIE GREENE, Sales Manager: “I am very excited about this procedure, because it will work for children and I have four kids of my own. And for them not to have to go through what I went through in the third grade, if any of them for any reason has a vision problem and needs corrective lenses, they will definitely get this procedure.”....

ELLYN BENGAL, bookkeeper: “I have been doing this about a year now....If for some reason I need my glasses, I have to hunt for them up now....But mostly, I don’t wear, you know, anything. I use the molds at night and a little bit during the day but not much.”

....DR. HURT: “Precise Corneal Molding is becoming the procedure of choice all across the country. No longer do you have to be satisfied with just getting by or being visually handicapped. It is now the best that science has to offer....YOU can enjoy the freedom of seeing again without the use of glasses or contact lenses. No more wearing glasses, no more wearing contacts. The opportunity of seeing well all the time without being dependent upon these is now a reality and not a dream....”

(Exhibit D) (Infomercial)

E. “60 Sec Radio Commercial”

“You were not born to wear glasses or contacts. All of us were designed to have clear vision. And now, when the design needs correction, there’s Precise Corneal Molding. Precise Corneal Molding is safe, gentle, non-surgical method of correcting nearsightedness and farsightedness that works !! It can also eliminate astigmatism and restore good functional vision without the use of glasses.

The P-C-M practitioner in your area is offering a free corneal topography consultation so you can see how P-C-M can work for you! All you have to do is call 1-800-846-2-0-2-0 that’s 1-800-846-TWENTY-TWENTY!! The call is free and the improved vision without glasses is....well....priceless....”

(Exhibit E)

F. NARRATOR: “Thousands of men, women and children all over the country are experiencing the gift of improved vision without glasses or contact lenses. Precise Corneal Molding, three words that will change the way you see the world. Precise Corneal Molding is a safe, gentle, nonsurgical, affordable procedure that corrects nearsightedness and farsightedness.

PCM eliminates the need for glasses and contact lenses forever. The PCM practitioner in your area is offering you a free Precise Corneal Molding consultation. All you have to do is call 1-800-305-5030. The call is free, and the improved vision without glasses or contact lenses is well, priceless....”

(Exhibit F) (Short Video Promotion)

G. "Precise Corneal Molding Success Stories: From the offices of J. Mason Hurt, O.D.”

“'PCM is wonderful! I can see clearly now, even when Scuba Diving. Before PCM, I had Poor Vision. Yet with PCM, I went back to 20-20, without surgery. I am so excited that I tell everyone about the benefits of PCM.'

Peggy Collins, College Co-Ordinator.

'PCM is like a Miracle. It’s hard to believe I can see so well without glasses and without Surgery. I would recommend PCM to anyone who is Near-Sighted, Far- Sighted or has Astigmatism.'

Sara Ann Nichols, Systems Analyst

'Before PCM, my son Scott had to change glasses every six months. Yet after PCM, he could see 20-20 within one month.'

Connie Braden, Housewife.

'Before PCM, I could hardly see my computer monitor, and for the last two years, I wore both contacts and glasses. After PCM, I can see clearly and I am very happy.'

Steven Fensler, Computer Programmer.”

(Exhibit G)

H. “WELCOME TO THE PCM TEAM”

“....PCM is virtually problem free, and there is no risk. It is safer than contact lens wear. Unlike surgery, there is no such thing as mistakes. Nothing that may be induced by molding cannot be undone and fixed. If illness or extenuating circumstances occur, this only delays for a short time the final success of PCM....

A SAFE ALTERNATIVE TO RK SURGERY

In contrast to radial keratotomy surgery, which involves making incisions on the eye, PCM does not leave scar tissue which may cause vision glare at night or other side effects. PCM is also free of surgical complications or pain, and there is no disruption of vision as eyesight improves.

SAVING CHILDREN’S VISION

One of the most exciting uses for PCM is controlling myopia (nearsightedness) in children.

....PCM prevents this deteriorating vision in children by actually halting myopia in its tracks and even reversing it.

RESULTS

Myopia (nearsightedness): PCM is highly effective in improving myopia. Mild to moderate degrees of myopia are corrected and higher degrees of myopia can be controlled to allow functional vision without lenses as well.

Astigmatism: PCM usually either eliminates or greatly reduces astigmatism to great functional clarity.

Hyperopia (farsightedness): Mild to moderate cases may be improved as well.

NATURAL VISION IMPROVEMENT....

...The procedure, which is also known as PCM, has provided corrective eye care to thousands of patients without the risks or complications associated with surgery.

...PCM utilizes a series of molds prescribed in progressive stages to gently reshape the cornea, similar to the way braces are used to straighten teeth.

The PCM procedure involves thorough examinations, lens changes and/or lens modifications as needed until desired results are achieved. The process can take from a few weeks to a few months or longer to complete, depending on the severity of the problem. The result is dramatically improved vision with retainer molds being worn on a limited basis, sometimes only a few nights a week while you are sleeping, to maintain the new shape of the cornea.

SAFETY

Four University research studies have shown corneal molding to be safe and effective, with no harmful side effects. These studies include:

University of Houston College of Optometry (5 years)

University of California at San Diego Medical School (7 years)

University of California at Berkeley College of Optometry (3 years)

Pacific University College of Optometry (5 years).....”

(Exhibit H) (Patient Handout)

9. Through the means described in Paragraph 8, respondents have represented, expressly or by implication, that:

A. PCM ortho-k provides a cure for any refractive vision deficiency thereby permanently eliminating the need for all corrective eyewear, including eyeglasses and contact lenses.

B. All people can achieve normal vision without eyeglasses or contact lenses on a permanent basis if they wear PCM ortho-k devices occasionally or at night.

C. PCM ortho-k has been approved by the Federal Aviation Administration and all branches of the United States military for use in correcting refractive vision deficiencies.

D. Studies at the University of Houston College of Optometry (1976-77), University of California at San Diego Medical School (1980), University of California at

Berkeley College of Optometry (1982-83), and Pacific University College of Optometry (1984), prove that PCM ortho-k is safe and effective in correcting nearsightedness, farsightedness, and astigmatism.

E. Testimonials from consumers appearing in the advertisements for respondents' PCM ortho-k services reflect the typical or ordinary experience of members of the public who receive those services, which experience is that respondents' PCM patients typically achieve 20/20 vision and no longer need corrective eyewear.

10. In truth and in fact,

A. PCM ortho-k does not provide a cure for any refractive vision deficiency thereby permanently eliminating the need for all corrective eyewear, including eyeglasses and contact lenses.

B. All people cannot achieve normal vision without eyeglasses or contact lenses on a permanent basis if they wear PCM ortho-k devices occasionally or at night.

C. PCM ortho-k has not been approved by the Federal Aviation Administration and all branches of the United States military for use in correcting refractive vision deficiencies.

D. Studies at the University of Houston College of Optometry (1976-77), University of California at San Diego Medical School (1980), University of California at Berkeley College of Optometry (1982-83), and Pacific University College of Optometry (1984), do not prove that PCM ortho-k is safe and effective in correcting nearsightedness, farsightedness, and astigmatism.

E. Testimonials from consumers appearing in the advertisements for respondents' PCM ortho-k services do not reflect the typical or ordinary experience of

members of the public who receive those services, which experience is that respondents' PCM patients typically achieve 20/20 vision and no longer need corrective eyewear.

Therefore, the representations set forth in Paragraph 9 were, and are, false or misleading.

11. Through the means described in Paragraph 8, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 9 A - B, at the time the representations were made.

12. In truth and in fact, respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 9 A - B, at the time the representations were made. Therefore, the representation set forth in Paragraph 11 was, and is, false or misleading.

13. Through the means described in Paragraph 8, respondents have represented, expressly or by implication, that:

A. A significant number of people can achieve normal vision without eyeglasses or contact lenses on a permanent basis if they wear PCM ortho-k devices occasionally or at night.

B. All or most people will experience stabilized vision after only a few weeks or months of PCM ortho-k treatments.

C. PCM ortho-k prevents and reverses deteriorating nearsightedness in children.

D. PCM ortho-k is safer than contact lenswear.

E. PCM ortho-k is more effective than refractive surgical methods in eliminating nearsightedness, farsightedness, and all forms of astigmatism.

F. PCM ortho-k has helped thousands of people achieve normal vision.

14. Through the means described in Paragraph 8, respondents have represented, expressly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations set forth in Paragraph 13, at the time the representations were made.

15. In truth and in fact, respondents did not possess and rely upon a reasonable basis that substantiated the representations set forth in Paragraph 13, at the time the representations were made. Therefore, the representation set forth in Paragraph 14 was, and is, false or misleading.

16. The acts and practices of respondents as alleged in this complaint constitute unfair or deceptive acts or practices, and the making of false advertisements, in or affecting commerce in violation of Sections 5(a) and 12 of the Federal Trade Commission Act.

Therefore, the Federal Trade Commission this fifth day of November, 1997, has issued this complaint against respondents.

By the Commission.

SEAL

Donald S. Clark
Secretary