Trial Date Set for Extreme Make-Over and CRSQA LASIK Surgeon Maloney
refractivesu...@yahoo.com
Trial Set for TV's "Extreme Makeover" LASIK Surgeon
Los Angeles, January 5, 2005 - Robert Maloney, MD, well known for his
role on ABC's successful "Extreme Makeover," will be the subject
of a jury trial set for April 6, 2005 in Los Angeles Superior Court,
Santa Monica, CA. In a civil suit, Maloney has been charged by one of
his LASIK patients with negligence, battery, and fraud. The case will
be heard in the Los Angeles Superior Court at Santa Monica.
The case stems from injuries inflicted on Judy Chang, a patient of Dr.
Maloney's, in 2000. Chang alleges that Maloney performed a non-FDA
approved LASIK procedure for vision correction without her knowledge
and consent. Not only did Chang suffer permanent vision loss but
metallic debris were embedded in her eyes as a result of the
procedure.
Chang alleges that Maloney and his staff knowingly concealed that the
LASIK procedure performed was non-FDA approved despite the fact that
she was given assurances that it was FDA approved.
A detailed cause of action can be obtained from the LA County Clerks
office.
LASIK vision correction surgery, much like the recently prescription
drugs Vioxx and Celebrex, became a bestseller on the strength of
advertising aimed directly at consumers. Similarly, the LASIK patient
"informed consent" has become a hot bed for litigation due to
omissions and bait-and-switch tactics. An extensive backgrounder on
refractive surgery, in particular, the informed consent and LASIK
surgery, can be found at
http://www.lasikfraud.com/news/archives/000011.html
Glenn - USAEyes.org
In 2000 all LASIK was not "FDA approved", but was an appropriate
off-label use of an excimer laser approved for PRK.
Off label is a term used for procedures that are legal, but are not
specifically approved for a particular device or drug. An example is
LASIK. The excimer laser is FDA approved for PRK, but not for LASIK,
which is a combination of ALK and PRK. The LASIK procedure comes
under the definition of the practice of medicine (also called scope of
practice), so the FDA does not necessarily need to approve the use of
the excimer laser specifically for LASIK. An easier example is the
scalpel. The scalpel is not specifically approved for all procedures
that may require a scalpel, but if a medical doctor determines the use
of this FDA approved tool is appropriate, then it is okay with the
FDA.
Some excimer lasers have received FDA approval specifically for LASIK,
but this is more for marketing purposes than to accommodate any legal
requirement. So now PRK is an off-lable use of some lasers.
It will be interesting to see what the court determines in this case.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
Barnard
-------------------------------------------
A LASIK quack is under attack! Circle the pimp wagons! Circle the
pimp wagons!
"Permanent vision loss" -- that's victim-speak for "I want a large cash
settlement," right Glenn? I suppose she's going to whine about loss of
productivity, pain and suffering, not being able to tell her kids apart
-- trivial stuff like that. I say she should count her blessings.
Why, a few short centuries ago, she would have been doomed to a life
begging on the streets. Thanks to the ADA, she has a promising future
selling pencils while playing the accordion.
"Metallic debris embedded in her eyes" -- That's the thanks one can
expect for a no-extra-charge iron supplement. No good deed goes
unpunished, eh Glenn?
Brent Hanson - LASIKFRAUD.COM
your "kill file". Then you respond to other people claiming they are me.
Perhaps you are just sore because someone pointed out that your CRSQA
"certified" surgeon Maloney is being sued.
Your history has been documented here:
http://www.lasikfraud.com/crsqa_surgeons_may_be_hazardous.html
"Glenn - USAEyes.org" <glenn.hage...@USAEyes.org> wrote in message
news:3tprt0lot5t6k4e4u...@4ax.com...
Sandy - LASIKdisaster.com - LASIKmemorial.com
For "Patient Advocate Hagele":
When a patient consults with a doctor for elective eye surgery, does
the patient have a right to know that the laser to be used has NOT been
approved for a specific procedure?
Yes or no will suffice.
Glenn - USAEyes.org
questions do not lend themselves to your simplistic view of the
practice of medicine.
If the standard of medical care is such that the procedure is a
recognized off-label use, informing the patient in advance is not
likely required. This is well established in medical protocol and
case law.
If a patient presents to a hospital emergency room with chest pain,
shortness of breath, and pain in the left arm, giving that patient an
aspirin is an off-label use of the medicine to treat an apparent heart
attack. I don't really think the doctor should be required to have
the patient sign an informed consent to take an aspirin.
In regard to LASIK, PRK, LASEK, and Epi-LASIK, the fact that it is an
off-label use should be included in the informed consent, not because
it is legally required, but because it is good customer service and
the doctor has plenty of time to explain to the patient what off-label
means. Lawyers and medical malpractice insurance companies often do
not require it, but that opens the doctor up to salacious accusations
that sound pretty bad to those who don't understand the situation and
can leave the patient felling betrayed.
Since the decision for refractive surgery is made at leisure,
including off-label language in the informed consent seems like an
awfully good idea and extra protection for patient and doctor. The
patient does not retroactively feel misled, is being fully informed
(even if it is a moot point), and the doctor does not have a patient
screaming to the press that s/her did an off-label surgery...which
happens to be totally appropriate.
Barnard
-------------------------------------------
That's good, Glenn, comparing a health emergency to elective surgery.
If I didn't have this unfortunate aversion to cue balls, I'd hire you
for our marketing department. Truly.
For those who can't or won't wade through our resident LIP's
doublespeak, here's his answer to Sandy's question:
"NO. SCREW 'EM!"
Sandy - LASIKdisaster.com - LASIKmemorial.com
"patient care". Now how about an off-label dose of Kaopectate for that
chronic finger diarrhea?
Glenn - USAEyes.org
into refractive surgery issues. (Sarcasm on full)
gos...@aol.com
trying to kid....
Read the press release more closely. The patient was told that the
procedure WAS FDA approved when IT WAS NOT. This neither appropriate
"informed consent" nor, and more importantly, morally correct behavior.
Your answer does not get to the heart of the matter and is a bunch of
CRSQA sponsored jibberish. The CRSQA is not a breath of fresh air, but,
rather, foul air.
WK
Glenn - USAEyes.org
statement is misleading and presenting the existence of statements
that I did not make.
I further clarified my general position on the issue of off-label use
being included in an informed consent in response to Keller's
information.
All information I provided in my post is accurate. If there is any
statement of fact that you believe is not accurate, provide
substantiation.
serebel
Why didn't you ask if the blade could jam? Huh, genius?
SErebel
gos...@aol.com
the original post, it is CRSQA jibberish.
Your post was not a response to anything. And with your clarification
of its accuracy, it validates my original contention that your post is
at the very least misleading.
Your behavior does not support your purported role as a patient
advocate. WK
serebel
SErebel
Ragnar
until someone takes the bait.
If I'm not mistaken both she and Hanson had LASIK done before it was
even FDA approved. That shows you how wise they were.
Loonie Ron didn't even have LAISIK, he had radial keratomy, and the
disability he collects money on has nothing to do with his eyes as has
been implied. His disability is a mental disorder caused by brain
damage from a beating - as he himself says.
, 07 Jan 2005 15:39:41 GMT, Glenn - USAEyes.org
Dr. Leukoma
The readers should be aware that LASIK has never been approved by the
FDA. Only the lasers are approved by the FDA. LASIK is a surgical
procedure that falls under the practice of medicine, like botox,
facelifts, and other cosmetic procedures.
DrG
Ragnar
Slick Gemoules strikes again.. what a load of splitting hairs.
Why is it that people have been waiting 2 years for the FDA to approve
the broader range of treatments on the VISX Customvue system?
Glenn - USAEyes.org
but LASIK was an appropriate off-label use under scope of medicine
rules. Being approved for use for PRK means that the clinical trials
data used by the FDA to determine if the device was approvable was
from PRK surgeries.
As the lasers were upgraded and expanded, the manufacturers decided to
have them approved for LASIK. The clinical trial data was from LASIK
surgeries. For those lasers, PRK is an appropriate off-label use
under scope of medicine rules.
IMO the off-label issue tends to be used by people who are confused,
want to confuse others, or want to make inflammatory accusations to
give them some sort of edge in a dispute.
gos...@aol.com
The laser manufacturer's (all of them) were unwilling to undertake a
clinical trial for LASIK once their lasers were on the market. The CRS
(a surgeon based organization) was formed and met with the FDA for the
purpose of gaining FDA approval for LASIK. This was a highly unusual
move as surgeon sponsored IDEs are rare.
Many surgeons were very concerned about the liability stemming from the
off-label use of lasers for LASIK as there is very limited protection
when a surgeon uses technology off-label (very much like Fen-Phen).
The FDA was very concerned about the rampant use of lasers for LASIK
and wanted to gain both insight and some regulatory control.
The CRS study went to the FDA gaining FDA approval in mid- 2000, almost
four years and two million plus LASIK procedures had been done (US).
Patients, prior to this approval, did not receive an approved or
reviewed informed consent.
The flaws of the CRS study are a matter of public record (FDA panel
transcripts). Subsequent manufacturer sponsored LASIK IDEs (for newer
lasers) underscore the flaws of the original study. Patients who had
LASIK from mid-2000 through late 2001 also received mis-information in
their informed consent since it was based on the initial flawed study.
Since PRK had been through the rigors of a manufacturer sponsored IDE,
manufacturer's were not required to do additional studies, other than
showing technical equivalence, for the newer lasers.
Lots of gobbledegook emanates from the halls of the CRSQA! But then
again, you are not a doctor...
WK
Glenn - USAEyes.org
and LASIK are accurate and are responsive to the issue at hand.
Several of your statements, WizKid, are incorrect.
Not only were the laser manufacturers willing to undertake clinical
trails for LASIK, Alcon, Bausch & Lomb, Visx, WaveLight, others, and
their predecessors already have, going back to at least October 1999.
See an FDA statement on this issue at
http://www.fda.gov/bbs/topics/ANSWERS/ANS00981.html
Guy M. Kezirian, MD, of CRS Clinical Research (who has unofficially
advised this organization on many occasions) directed the CRS study
with several IDE and non-IDE protocols involving more than 250
physicians and over 20,000 cases. In 1998, more than one year before
approving the Summit laser for LASIK, the FDA received CRS Study
information to review in the process of determining protocol for the
manufacturer sponsored clinical trials to approve their excimer lasers
for LASIK. The CRS Study was funded by physicians, which is not at all
unusual as at the time LASIK was an off-label use of the excimer laser
and therefore within the province of physicians, not manufacturers.
Studies to approve the devices for LASIK were appropriately funded by
the manufacturers.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor, but we are easily able to see what WizKid is...and
is not.
gos...@aol.com
did on another post here at alt.lasik-eyes. That is a service for those
seeking information.
Secondly, you still have it wrong on the Laser Manufacturers'
willingness to sponsor LASIK IDEs prior to the CRS study. They were not
willing to undertake the study and were perfectly willing to allow
LASIK to spread as an off-label procedure. Surgeons (Casebeer, et al)
who were using lasers led the effort to secure FDA approval. I am sure,
since you are not a doctor, that you do not remember the concern we all
had with regard to our liability related to off-label use of the laser.
Physician sponsored studies are a dramatic departure from FDA protocol.
There are some real interesting issues as the FDA is not to regulate
the practice of medicine. Off-label use falls under the practice of
medicine.
You know little of what you are talking about.
WK
Glenn - USAEyes.org
that my information is much more accurate than yours. Unless you also
contend that the study directors don't know what they are talking about
either.
In any event, the issue is if off-label use of an FDA approved device
is appropriate under scope of medicine rules. It is.
Barnard
killfile started working again.
Yeah, that must be it.
gos...@aol.com
nor were you directly involved. The study director of this particular
study was either brain dead at the time or is not being truthful. If
not truthful, it would be consistent with the study design and the
execution of the study. The CRS study was a sham, and most of us (in
deference to you, this does not include you) know it.
While the off-label use is appropriate under the scope of medicine (you
are correct), it carries with it less legal protection and greater
responsibility for informed patient consent and patient welfare. In
most cases, off-label procedures have no oversight, no IRB approval.
Since it is unapproved, the surgeon performing the procedure takes on
increased responsibility to "do no harm." Failure to do so has
significant downside outcomes...
WK
Glenn - USAEyes.org
respected ophthalmologists of their time - Guy Kezirian and Charles
Casebeer - to be "brain dead".
The oversight of any off-label use of an FDA approved medical device
is the same oversight for any medical proceedure - the medical board
of appropriate jurisdiction.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
Email to glenn dot hagele at usaeyes dot org
http://www.USAEyes.org
http://www.ComplicatedEyes.org
I am not a doctor.
gos...@aol.com
use of a laser is a secondary issue. The latter, however, opens up
pandora's box for a surgeon as he/she has none of the protections
available for an FDA approved technology/procedure. WK
rebecca...@lasermyeye.org
the patient suffered a significant loss of BSCVA, the manufacturers
notes in the file - in addition to finding no fault with the devices -
mention that the surgeon was using an off-label treatment. In one case,
that was monovision, and in another, using a 6.0mm zone on a laser
approved for 5.5mm. Both are very frequent off-label uses of the
device, and it would be hard to imagine a relationship between that
off-label use and the patient's loss of BSCVA.
In some such cases as these, everyone is protected except the patient.
The manufacturer can say hey the surgeon was using my device off label,
it's not my problem. The surgeon can find ten thousand peers who will
say it was a reasonable and customary off label use.
Glenn - USAEyes.org
be saying that they did nothing wrong. An informed patient who does
his or her due diligence before deciding to have an elective surgery
is equally "protected". Everyone doing things right does not
guarantee the desired outcome, but it most certainly will increase the
probability.
Richard
@c13g2000cwb.googlegroups.com:
Correct me if I'm wrong, but, the FDA does approve devices for specific
procedures. In particular, the lasers were originally approved by the FDA
for PRK, and surgeons started using them off label to perform LASIK.
--
Richard
Glenn - USAEyes.org
can decide where else it may be appropriately used. This is called
off-label use and it perfectly appropriate under scope of medicine
rules. By approving a device for only one procedure and it being used
for others, the FDA does not end up governing the entire practice of
medicine. Many devices (and medications) are traditionally used for
procedures for which they were not originally approved.
Excimer lasers that were originally FDA approved for PRK were used an
off-label for LASIK. Now many lasers are approved for LASIK and are
used off-label for PRK. An example of the off-label use of a medicine
is Alphagan P to decrease the size of a patient's pupils and reduce or
eliminate night vision problems. Alphagan P was originally approved
for the treatment of glaucoma.
gos...@aol.com
for technologies/procedures that have FDA PMA approval as long as the
doctor properly informs the patient and was not negligent in his
practice. This is evolving as case law. There are no protections
similar to this when a procedure is off-label. Surgeons do not have the
protections available to him/her that he/she would have had if it had a
PMA approval.
These protections do not extend to Class II, 510k approved devices.
Most of what Glenn has said, representing CRSQA, on this thread has
been jibberish. Silence would have served him and the CRSQA better.
WK
Glenn - USAEyes.org
or an off-label surgery are most certainly different, but both have
been adequate for about fifty years of case law.
A question for you WizKid. You are keen on phakic intraocular lenses.
Is Refractive Lens Exchange (RLE) generally appropriate surgery in
your opinion?
gos...@aol.com
up from. There was a very important Supreme Court ruling on protections
afforded by FDA approvals in the late 1990s...much less than 50 years.
The CRSQA needs to update its data bank.
RLE - for what indications, age group, etc?
WK
Sandy - LASIKdisaster.com - LASIKmemorial.com
an off-label procedure upon a patient who specifically requests that
one NOT be done upon herself, but is misled into believing that the
laser has been approved for such and on that basis, agrees to surgery.
Glenn - USAEyes.org
present? Is that your game?
If you have more than a room temperature IQ you know that for MORE
than 50 years the courts have upheld scope of medicine rules.
CRSQA and I must really threaten you somehow for you to be so
desperate to prove me wrong as to come up with nonsense like this.
And you still have not responded to my question about if you believe
Refractive Lens Exchange (RLE) is an appropriate surgery.
Barnard
-------------------------------------------
Glenn, since I know that even you wouldn't be dumb enough to get LASIK
to "enhance" your failing vision, I'll simply suggest you wipe the pimp
slime from your coke-bottle horn-rims and take another look at WizKid's
post. He asked you to clarify your moronically open-ended question.
And oh, yes, I'm sure WizKid is feeling threatened, but for a different
reason than you imply. "Glenn, no, don't do it, you heartless bastard!
You know I'm allergic to steaming piles of pimp bullshit! Please! If
you post again about your (breaks out in hives) "objectivity" and your
Council for (scratches furiously) Really Shitty Quality Assurance,
it'll push me right into anaphylactic shock! Don't do it Noooooooooo!"
gos...@aol.com
exposing the CRSQA for what it is not...NOT a patient advocacy group.
Your responses to most, not all, posts bubble with bias. The recent
post on your tax status was most revealing.
WK
gos...@aol.com
some in the industry!) to patients noted in the above complaint
continues to be a widespread problem in refractive surgery. In
tesitmony by Morris Waxler, a former FDA official, it appears that
there is also a disconnect between the industry and the FDA. Dr.
Waxler, in the following testimony, talks about the problem of
under-reporting.
MR. HARRIS: And if the doctors were never told by Alcon that 10.5
percent, operating above 10.5 percent retreatment rate was a problem,
they might not even know that, true?
DR. WAXLER: That's true. It's really an interesting situation where
the, both the panel and Dr. Rosenthal explicitly stated in their panel
meeting that the retreatment rate was an important part, and it was
required of all manufacturers in response to panel members questions,
and it was in the labeling, and it is in the labeling for all the
machines, not just Alcons. And the fact that neither Alcon nor
apparently the agency or apparently the docs have emphasized that
feature of the requirements doesn't mean it's not a problem. It means
that there's been some serious problem in communication about the
importance of retreatment and a lack of understanding of, of paying
attention to it. And I think the manufacturer, you know, it's their
machine. I mean, to be honest with you, I mean, the manufacturer
incurs a heavy responsibility, and I feel for them because they really,
you know, anybody can use their machine. They sell it to people. They
don't -- they can't keep track of their outcomes. It's quite true.
They depend on these docs to report to them. But they also -- those
docs depend on accurate information from the company about what was
expected in terms of, you know, what's an acceptable retreatment rate?
And I don't know from firsthand knowledge what, what Alcon communicated
to its docs about what is an acceptable retreatment rate.
gos...@aol.com
gos...@aol.com
What is the latest on this case? Rumor has it that Dr. Maloney recently
lost several motions in Appeals Court related to this case.
WK
gos...@aol.com
TheTruthAboutLASIK
We have followed the case closely.
In the last 30 to 50 days Dr. Robert Maloney´s dream team of lawyers
have lost 4 or 5 motions to try to rescind-rewind the case and make it
go away.
This lawsuit is of a very serious matter and subject. If I recall
correctly, the charges are battery and assualt, and not informing or
consenting the patient ethically and honestly.
This case will resonate through the hallways of ophthalmology and
allow others injured by LASIK to pursue action due to poor informed
consent. This case follows Dr. Machat´s Pilot (Steve Post vs. UPI
Tucson, AZ $4.3 million) and is chapter 1 in a series of many
lawsuits. Dr. Machat´s case, as we in the industry call it, is the
preface of the inaguration of an excellent book for those that have
been wronged.
So hang on for the rollercoaster ride, and hang on to your wallets,
especially the deep one.
gos...@aol.com wrote in message news:<1108863000.2...@z14g2000cwz.googlegroups.com>...
Sandy - LASIKdisaster.com - LASIKmemorial.com
attention.