February 17, 2012
For clarification I had LASIK surgery on both eyes in March 2010, and LASIK Re-Treatment of both eyes in November 2010. The "team" responsible for my treatment in both surgeries was Tom Ballard, OD and Larry Robert Taub, MD.
I can provide evidence supporting the following:
1) On 2/9/2010 I received a written price quote for Custom LASIK. I did not receive Custom LASIK (Custom VUE), which is the procedure I consented to and paid for in March 2010. I have copies of my operative reports indicating I received standard LASIK in March 2010 and Custom LASIK in November 2010. This is fraud. Fraud is a criminal offense. Engaging in criminal acts is a violation of the Texas Medical Board rules or Medical Practices Act. Furthermore, using word combinations like "Custom LASIK" when the services provided are Custom VUE LASIK or a standard LASIK is misleading and deceptive. This is a violation of §164.3. Misleading or Deceptive Advertising of the board rules. Many of my preoperative measurements were also printed on documents with CustomVUE logos or headers.
2) I was not a good candidate for any refractive surgery procedure, including LASIK, due to my active participation in boxing. Tom Ballard, OD and Larry Robert Taub, MD were both informed of my participation in boxing prior to performing the surgeries. I would not have signed the informed consent had Dr. Ballard indicated that it would no longer be safe for me to participate in boxing. My wife was present for a similar conversation with Dr. Larry Taub prior to the first surgery. Dr. Taub assured me that continuing to participate in boxing would be safe after the surgery. The FDA website specifically states that a person is probably NOT a good candidate for refractive surgery if You actively participate in contact sports. You participate in boxing, wrestling, martial arts or other activities in which blows to the face and eyes are a normal occurrence I was not aware of the FDAs recommendations prior to the first surgery. The cornea is permanently weakened by LASIK surgery, and the corneal flap is easily lifted for many years. Both Dr. Ballard and Dr. Taub failed to inform me of this. This is a violation of §190.8. Violation Guidelines, section (G) failure to disclose reasonably foreseeable side effects of a procedure or treatment. If I had been informed that the corneal flap no longer contributed to the structural integrity of the cornea I would not have had the initial surgery! Information that has been omitted from the informed consent is just as important as information that has been disclosed.
3) I was not a good candidate for LASIK due to taking a prescription medication that causes fluctuating hormones. Fluctuating hormones is listed on the FDA website. Dr. Ballard never entered this medication into my records, even after I mentioned it to him on numerous occasions. My wife and I both discussed this medication with surgical staff prior to the first surgery and were assured it would not impact the surgery outcome. At a later date I even requested that Tom Ballard, OD pull my records up to review them with me and he would not, even though the computer was within arms length. Failure to maintain proper medical records is a violation of §165.1., section (5) Relevant risk factors should be identified.
4) Tom Ballard, OD and Larry Robert Taub, MD provide false or misleading information on their websites. This is a violation of §164.3. Misleading or Deceptive Advertising. These are also violations of Section 5 of the Federal Trade Commission Act (FTC Act). Larry Taub's website http://newmanandtaubvision.com/intralase.aspx specifically states LASIK is a cutting edge procedure for improving vision and getting rid of glasses or contacts forever. This is a false claim, and contradicts the informed consent that stated LASIK is to reduce independence on glasses or contacts. This creates an unjustified expectation about the results of a health care service or procedure. Tom Ballard, OD provided me with statistical data that directly correlated with Custom VUE results from his website http://www.firsteyecaredallas.com/lsk_customvue.html The title states "Updated CustomVue Results" in large, bold lettering, however the small print at the bottom of the chart states the data is from 2004. This data excludes my degree of required correction, and therefore does not provide any indication of what I could expect as an outcome. I required a higher degree of correction which made me more likely to experience complications. Furthermore, this data only included visual acuity. Quantifying the quality of vision post LASIK requires more that visual acuity. LASIK procedures induce higher order aberrations. Many patients have 20/20 visual acuity, but suffer from double vision, halos, starbursts, etc. that significantly reduce their vision quality. Advertising success in terms of visual acuity (20/20, 20/40, etc) is misleading and creates an unjustified expectation about the results of a health care service or procedure.
5) I was a high risk patient likely to experience night vision issues including: halos, starbursts, and multiple vision due to my high degree of correction and large pupil size. Having large pupils is also listed on the FDA website under "When is LASIK not for me?". I was not informed of this until after the first surgery as it was not disclosed to me until six months later, prior to the second surgery. This is a direct violation of §190.8 Violation Guidelines, sections B, C, D, and G. I have been seen by numerous optometrists and ophthalmologists who have stated that my vision problems are directly related to the "flattening" of my cornea due to the high degree of correction, and due to my pupil size. Some of these claims have been made by doctors that I was referred to by Tom Ballard, OD. However, these claims were expressed orally and were not documented in my medical records. I asked Tom Ballard directly if I would have any of the night vision issues listed in the informed consent because I was scared of having damaged night vision as I spend a significant amount of time in dim or dark lighting conditions. Tom Ballard, OD informed me that "They understand the science very well" and that these side effects are no longer an issue with the latest procedures, and that my night vision would be no worse than was at the time with my glasses or contact lenses. Prior to LASIK I was unaware of any vision issues in dim or dark lighting conditions. There are numerous medical studies and websites that define large pupils as >6 -7mm. My pupils measured as large as 7.9mm. Many responsible LASIK surgeons also display this information openly on their websites.
6) I was given expired prescription eye medication by Larry Robert Taub, MD and instructed to used the medication for six months before I would see an improvement. I was never previously diagnosed with a medical condition warranting the use of this medication, even though I had been seen by many optometrists and ophthalmologists prior to Dr. Larry Taub giving me this medication. I have both the medications and the dated dosage instructions as evidence. This is a direct violation of §190.8 Violation Guidelines, Section (A) failure to treat a patient according to the generally accepted standard of care. Providing expired medication to a patient probably does not meet the generally accepted standard of care. Prescribing a medication for a condition I DID NOT HAVE and telling me it would take six months to make an improvement significantly delayed me from receiving any true help to improve my vision.
7) I was given a prescription eye medication by Larry Robert Taub, MD that was not intended for use outside of Dr. Newman's (Larry Taub's partner) office. It was labeled "For Office Use" and did not have my name on the bottle or packaging. I have this medication and its packaging as evidence. The medication I was given was Pilocarpine. This medication was prescribed to reduce my pupil size, because I was experiencing vision problems due to the high degree of correction and large pupil size. This medication reduced my vision to the point that I could not see enough to function. I had to lie in bed because I could not see anything due to the drastic constriction of my pupils.
8) My vision was not stabilized at the time I receiving the second surgery. I have copies of my medical records from Tom Ballard, OD showing that my vision was still fluctuating just prior to the second surgery on each eye. This is a violation of §190.8 Violation Guidelines, sections B, C, D, and G. I had approximately 8 follow-up appointments between the first and second surgery and my visual acuity was not the same for any two sequential visits. My vision was not stable.
9) The surgery has induced a significant number of vitreous floaters in both of my eyes that were not present prior to the surgeries. The floaters are highly mobile and interfere with my vision. Research has indicated that as the degree of myopia increases, the incidence of LASIK induced floaters increases. The percentage of eyes affected was 32% in the high myoptic group ( defined as >7.00D). That makes this a relevant risk that was not disclosed to me prior to either surgery. Again, I was not properly informed. This side effect of the surgery was referred to as "The fleas of everyone's vision" by Dr. [Name Removed] when I discussed the issue with him over the phone. Floaters were not the fleas of my vision, but surgically induced damage to both of my eyes. This damage like all other damage that has been caused is permanent. This is a violation of §190.8. Violation Guidelines, section (G) failure to disclose reasonably foreseeable side effects of a procedure or treatment.
10) The surgeries were performed within in view of the lobby. There was a seating area designated for spectators. Performing the surgeries in front of spectators is irresponsible and I argue is a form of deceptive advertising, which is a violation of the Board Rules. This practice gives the false appearance that the surgery is safe and without risk. When I asked Dr. Ballard about their decision to allow spectators to view the surgeries and expressed my concern of how I felt tricked by the practice, he stated they do this so others are aware that they have the capability. I'm pretty sure the name "First Eye Care Infinity Laser Vision" implies that.
11) I was not adequately informed prior to the first surgery. I was not informed prior to the first surgery of the following items that would directly have impacted my decision to have LASIK. The items listed below were taken directly from the second informed consent that I received six months after the first surgery. These items were not disclosed to me prior to having the first surgery. I have copies of all consent forms. I was not properly informed and therefore could not have provided informed consent.
- The corneal flap can be easily lifted during the first two years, and in many cases lifted after several years. This one sentence would have immediately caused me to decline the procedure. This was disclosed to me six months after the initial surgery, in the second consent form before my re-treatment. This is information that could reasonably cause a large population of potential patients, including myself, to decline having the surgery. The corneal flap does not "heal" in the same manner as the general population defines healed. For example, a healed cut on one's arm after a surgery can not be easily reopened for years following the surgical procedure. I would not have accepted this side effect under any circumstance.
- The higher the attempted correction, the longer it takes the cornea to heal. This too would have caused me to decline the surgery. My wife and I had vacation plans shortly after my initial surgery date that I did not want the surgery to interfere with. This was not disclosed prior to my first surgery. This too is relevant information that was not disclosed to me prior to having the first surgery. An important vacation with my wife was ruined due to my poor vision shortly after having the first LASIK procedure.
I should not be required to obtain a medical degree to become properly educated about the risks involved with LASIK in order to make an informed decision and consent to the surgery. I should be able to rely on the education, experience, and honesty of my surgeon and/or optometrist for this info. By signing the informed consent I did not give Larry Robert Taub, MD carte blanche to make decisions that placed me at elevated risks without my additional consent, nor did I give consent for Larry Robert Taub, MD to perform a procedure I did not agree to, such as standard LASIK.
- Glare, a "starbursting" or halo effect around lights, or other low-light vision problems may be increased in patients with large pupils of high degrees of correction. Prior to the first surgery I was only informed that night vision issue may be problem. I was not informed that pupil size or degree of correction were factors for this, and both conditions had a direct impact on my probability of an unsuccessful surgical outcome. I was also told by Tom Ballard, OD that these issues do not occur with current procedures. High degree of correction and large pupils are relevant risk factors that must be disclosed prior to a procedure. This information should be a part of my medical record per §165.1. Medical Record, section (5), Relevant risk factors should be identified. Furthermore, using optical zones smaller that the pupil diameter significantly increases night vision issues. The fully corrected optical zone for the treatments I received were 6.0mm and 6.5mm. The blend zone diameters do not count as they are not a fully corrected zone. My pupils measured as large as 7.9mm. That means with a 6mm fully corrected optical zone, 42.3% of my cornea (the entrance pupil) was not fully treated. It could be foreseen that this would most certainly cause decreased night vision and other permanent complications. My damaged vision was not a result poor healing.
Each patient is unique and their health conditions must be individually addressed. I was sold these surgeries as if they were a haircut, and that I was at no greater risk than someone with smaller pupil sizes or lower refractive errors.
All of the risks listed in the consent form that I was concerned with were downplayed or I was told were not an issue or would not happen by either Larry Robert Taub, MD or the optometrist Tom Ballard, OD. Conditions unique to myself that placed me at a higher risk for complications were not disclosed to me until after the first surgery.
If a patient is going to be held to the consent form alone and all oral communication between the doctor and patient dismissed, then it is imperative that the doctors adhere to the informed consent and do not provide patients with information or perform actions deviating from what is formally documented. Larry Robert Taub, MD acted as a salesman, not a surgeon with my health or safety as his priority. I made my expectations very clear to Tom Ballard, OD and Larry Taub, MD. If my expectations were unrealistic, it was their responsibility as health care professionals to inform me of such. They did not.
As a result of Larry Robert Taub, MD and Tom Ballard, OD, I suffer from permanently damaged vision. Everyday I have to use the prescription eye medication Alphagan-P for an off-label use to reduce my pupil size so that I can be independent and drive in dim or dark lighting conditions. I am unable to participate in boxing, which was a sport that made me both healthy and happy. I have difficulty performing my work as a mechanical engineer. My cost for vision care has increased significantly. Prior to LASIK my contact lenses were $10/pair. In order to correct my vision now, I have received quotes as high as $3500 and $5000 to be fit with specialty lenses. I cannot afford proper vision correction. I also have the added expense of continuous mental health care due to my severe depression that is a direct result of my vision being damaged and the doctors involved giving me the run around or flat out lying to me about my condition. The non-disclosure of depression as a side effect is also a violation of §190.8., Section (G) failure to disclose reasonably foreseeable side effects of a procedure or treatment. I think just about everyone would agree that depression is foreseeable if surgery results in permanently damaged vision or decreased independence. Roger D. Davis, Ph.D. has presented a very thorough report that can be viewed in .pdf format at http://www.lasiksurgerywatch.org/teleconference_20090208/DrDavisPresentation.pdf
Dr. Davis has also presented information to the FDA. Video can be seen on the FDA website at the address below.
As a senior mechanical engineer and technical lead I am held to a very high standard. I frequently perform root cause failure analysis investigations. I work with optical systems nearly everyday, all day long, so I have a good understanding of why my vision is damaged. My primary job duty however is to ensure that the products I design or repair are safe. If I lie to or mislead a customer and someone is injured or killed as a result of my actions, my career would be over. I expect you to hold Tom Ballard, OD to the same standards. My request is that Tom Ballard, OD have his license to practice optometry permanently revoked, and that he is permanently barred from taking part in any LASIK screenings. I argue that numerous violations of the Texas Medical Board Rules or Medical Practices Act have occurred. Dr. Ballard presents a danger to potential LASIK patients if allowed to continue performing LASIK screenings and/or surgeries.
I am committed to pursuing every legal avenue I can identify in order to ensure that both Larry Robert Taub, MD and Tom Ballard, OD are held accountable for the permanent damaged they have inflicted to my eyes. My efforts will include complaints to the Texas Optometry Board, Texas Medical Board, The Federal Trade Commission, the Better Business Bureau, and the Attorney General. I will also utilize online communications such as personal websites, public message forums, and public business/service review sites. Additional communications will include contacting local news agencies with my story, and distributing printed copies of my story or protesting in front of the businesses of Larry Robert Taub, MD and Tom Ballard, OD on the days they are to perform LASIK surgeries.
I will provide any additional relevant information required to assist in a thorough investigation of Tom Ballard, OD. There are many additional events that have occurred since the first surgery in March 2010 that were not included in this letter. Please contact me with any questions.