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-Ex FDA
Legal Counsel, Mr. Larry Pilot, Disgusted With FDA LASIK Issues-
Feb. 11th, 2010
Dear Mr. Stossel,
(Fox News)
First, congratulations to you and FOX for providing viewers
with the opportunity to the share the benefits of your
resources. I am one of the many who have enjoyed the
diversity of your efforts during your tenure with ABC.
Second, Mr.
Kantis (Founder of www.LifeAfterLasik.com 'Hurt LASIK Patient Network) shared with me his message to
you about what I consider to be a MAJOR failure by the Food
and Drug Administration (“FDA”). Sometime around 1996-1997,
you presented an excellent evaluation of the performance of
the FDA Center for Devices and Radiological Health (“CDRH”)
as related to various medical devices for which the FDA had
become more of an impediment to progress rather than a
facilitator. I recall that the “Breast Pad”, Ambu CardioPump,
and the Laerdal Automated External Defibrilator (“AED”)were
among the topics reviewed. I had the pleasure of interacting
with Barbara Nienaltowski at the time, because Ambu and
Laerdal were clients of mine for matters relating to
compliance with laws and regulations as subject to FDA
authority. Your presentation did have an impact on Congress
and was a positive influence in support of 1997 Amendments
to the Federal Food, Drug, and Cosmetic Act (“FDCA”).
Mr. Kantis is one of thousands of patients who suffered
irreversible damage to their eyes and for which to this day
the FDA has not undertaken meaningful efforts to assure
required compliance by User Facilities, in particular
Ambulatory Surgical Facilities (“ASF”s) many of which are
located outside of Hospitals such as shopping malls. LASIK
eye surgery is a delicate procedure for which the
application to cosmetic correction of vision requires
informed consent by patients whose eyes are within a very
strict criteria for application of the procedure by
qualified ophthalmologists. Assuming that the more than 12
million people who have had this procedure performed by
skilled ophthalmologists and are qualified consenting
individuals, the rate of dissatisfaction is about 5%. At
minimum, 600,000 thousand patients may have experienced a
broad range of injuries. Some have committed suicide as a
direct result of the damage to their eyes.
In 1990, the Congress passed the Safe Medical Device Act of
1990 which required User Facilities to report to the FDA
serious injuries and death from use of devices. Moreover,
the FDA Medical Device Regulation (“MDR”) has required that
LASIK ASFs maintain and comply with written procedures. Yet,
during the period from 2000 through 2008, the FDA/CDRH did
not inspect a single ASF to determine compliance.
Consequently required reports of injury as require by law
did not get reported to the FDA, and the FDA/CDRH attitude
continues to be dismissive and blasé.
I do hope that you might take an interest in investigated
this gross misfeasance by the FDA which continues to result
in irreversible harm to a significant number of unsuspecting
human beings. As a former FDA Official responsible for the
creation and development of the FDA Medical Device program
beginning in 1970 through 1979 and in the practice of Food
and Drug Law since then, I welcome the opportunity to be of
assistance to you and your colleagues.
Cordially,
Larry R. Pilot
Attorney at Law
September 16th, 2009
Dear Mr. Kantis,
Thank you for your comments. The Safe
Medical Devices Act of 1990 explicitly directed that User
Facilities, like Manufacturers, were to provide the FDA with
device related injury/death reports. The MDR regulation, 21
C.F.R. Part 803, requires maintenance of and adherence to
documented procedures in order to implement these
requirements. ALL LASIK Ambulatory Surgical Facilities (ASFs)
must comply with these requirements, because failure to do
so is a violation of law.
I have been intimately involved since 1970
with the development and implementation of FDA’s ‘device’
regulatory authority as a FDA employee and in the practice
of law. The CDRH has been relatively aggressive in pursuit
of complaints against manufacturers who allegedly do not
comply with the MDR regulation, but nearly silent about User
Facility compliance.
CDRH failure to investigate the LASIK ASF
‘industry’ is a pitiful disgrace that deprives the CDRH of
the very ‘safety’ information that the 1990 Amendments were
designed to produce. When CDRH Director Schultz in a 2008
letter received by me acknowledged that three(3) LASIK ASFs
had been inspected since around the year 2000, he did not
mention whether any one of these LASIK ASFs had been
inspected for compliance with the MDR regulation. In spite
of requests by you, others, and me since then, it appears
that the FDA/CDRH has not yet inspected a single LASIK ASF
to determine whether documented procedures are and have been
in place as required and whether there has been compliance.
Surely,
the FDA has sufficient resources to inspect at least one
nearby LASIK ASF near one of its many offices during a
ten(10) year period of time. I do hope that Commissioner
Hamburg will seek the truth and ask the CDRH to explain what
it has done to answer whether LASIK ASFs have been and are
complying with the MDR regulation requirements.
Cordially,
Larry R. Pilot, ESQ
| Schultz:
People Angry, But LASIK Strategy Coming |
| 09/15/2008
(Source: www.fdaweb.com) |
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In
the wake of continuing patient complaints
about injuries from vision-corrective LASIK (laser-assisted in situ keratomileusis)
procedures, especially in ambulatory
surgical facilities, CDRH director Daniel Schultz told FDA
Webview 9/15 his Center is
“putting together a total strategy for LASIK, and we
are trying to get some of this stuff that we
are doing out there.”
Speaking after an appearance at the
Regulatory Affairs Professionals Society
annual meeting in Boston, Schultz
acknowledged that “there is this sort of
this vacuum of information that looks like
we had the public meeting and nothing has
happened and that is not right.”
According to an FDA Webview on-line check the same day, CDRH’s Web site
for LASIK has
not been updated since March, a month before
a 4/25 meeting of the Center’s Opthalmic
Devices Panel heard patient testimony about injuries.
Since then, the Center has “opted” to redact patient, physician, surgical facility,
manufacturer and other information from the
public comments it has received and posted
to another part of its Web site.
In a 9/15 email to FDA Webview and other interested parties on the
redaction issue, FDA Dockets Management
Branch systems administrator Karen
Kennard did not acknowledge CDRH’s
decision to “opt” for redacting but instead
cited an agency “policy” of not posting
individual consumer comments, which she said
“was established due to the high number of
individual consumer requests to remove their
names and comments from the FDA Web site. In
addition,” Kennard continued, “if there is
any personal information contained in the
comment, it is not posted. Therefore, any
comment which contains ‘individual consumer’
in the ‘Submitter Category’ or personal
information in the comment, does not get
posted to the FDA Web site. This does not
mean that [they] are not reviewed by the
scientific reviewers. Every comment is
reviewed,” Kennard emphasized, “whether it
is posted to the web or not.”
Meanwhile, as if to further muddy the
picture, FDA on 9/12 opened a formal public docket to receive
public comments on LASIK experiences which “may be
posted to the FDA’s Web site for public
viewing,” but did not say in its
announcement that personal or other
identifying information will be redacted
from such comments.
One of the recipients of Kennard’s email,
Washington attorney Larry R. Pilot (McKenna Long & Aldridge) promptly
challenged her on the “policy” she claimed
had been adopted.
“This ‘policy’ is new to me,” he said in a
reply email. “Would you provide me with a
copy of same along with related supporting
documents? In addition, please identify the
statutory reference that supports such
policy and explain how this policy is
reconciled with specific language appearing
in FDA's FOIA regulations appearing in 21
CFR Part 20.”
Back in Boston and presumably not apprised
of these new developments, Schultz
volunteered to us that “We need to figure
out how to get the information out there.
There are a lot of angry people out there,
no question, and I think we need to be
careful when we put information out, you
know, recognizing that are a lot of happy people out there.”
Asked by FDA Webview whether inspections would be part of the
plan or whether there was a resource issue
involved, Schultz answered: “No, I don’t
think it is so much a resource issue. I
think it should be part of an overall
coordinated plan. Okay?” Already delayed, he
quickly departed the dais.
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| CDRH ‘Opted’
to Redact Info from Public Comments |
| 08/28/2008
(Source: www.fdaweb.com ) |
| |
Through FDA’s Press Office, Freedom of
Information Division director Frederick J. Sadler told FDA Webview 8/27 that
patient privacy concerns caused CDRH to
“opt“ to redact information from public comments.
Sadler did not address 21 CFR 20.103
regulatory requirements on disclosure, but
did note that the comments were not
submitted to “a formal docket,” nor did he
cite statutory or regulatory authority for
the redactions, which also included
manufacturer and device names.
Sadler’s response in full follows:
“The comments were submitted to FDA’s Center
for Devices and Radiological Health (CDRH)
by members of the general public for the
Ophthalmic Devices Advisory Committee
meeting and not through a formal docket.
Most of these comments contained personal
(home) addresses, e-mail addresses, home
telephone numbers, as well as the names of
patients and their attending physicians. The
vast majority of the written comments were
from patients themselves, although in some
cases the comments related to other persons
who were known to, or related to, the
writer.
“It is apparent that the majority of these
persons were not informed that written
comments could be posted on a public Web
site. Many submitted extensive personal
information about themselves, their medical
conditions and treatment. Because CDRH
received public comments up until and
following the panel meeting, it was
impossible to seek and obtain each
correspondent’s permission to post the
comments. Therefore, CDRH opted to ensure
the protection of personal privacy
information and redacted personal, patient
and doctor information from the written
comments received. While a docket was not
available to receive comments prior to the
meeting, CDRH is in the process of opening a
docket to receive additional comments.”
As for other redactions, such as device
names and their manufacturers, a follow-up
question produced this response from the
Press Office:
“The device and manufacturer names are often
associated with a particular LASIK center.
Therefore, they were removed uniformly to
prevent association of either negative or
positive comments with a particular LASIK provider.
“We will notify you when the public docket
is open. At that time, any of the
individuals who submitted comments
previously will have the opportunity to post
their un-redacted information to the public
docket at that time with the full
understanding that it will be widely
available to the public.”
Washington device attorney Larry Pilot told FDA Webview that in his view, CDRH “has no right to
‘assume’ the intent of the writer or to act
as his/her representative without
permission. This is a public agency for
which correspondence to the FDA is public
unless otherwise stipulated. Many people
appeared personally and explained their
story with medical facts and physician
identification. The CDRH knew who these
people were in advance. So, did they advise
any of them in advance that they should not
identify themselves, wear masks, hide behind
a screen, etc.? Give us a break!”
Meanwhile, FDA’s conduct of the 4/25 panel
meetings that drew the comments continues to
be controversial among the network of
injured LASIK patients. Philadelphia-area elevator
constructor Joseph Schnell, who was initially rebuffed due to a
scheduling error when he showed up to
present, told online network member 8/27 he
considered the “the whole hearing a sham.
... I cannot think otherwise; I have spoken
and written from my heart from the beginning
of my LASIK experience and am becoming more convinced
with the passage of time of the lack of
oversight and premature approval of this
procedure as well as many other refractive
eye surgeries. The health of the patient is
ignored and the fundamentals remain the
same, that LASIK and other refractive eye surgeries are
medically unsound.”
National Institute of Environmental Health
Sciences molecular genetics core facility
director Lauranell Burch,
whose eyesight was allegedly impaired by LASIK, has petitioned FDA to ban the use of all
refractive surgery lasers for LASIK surgery
“due to substantial deception in the
labeling and an unreasonable and substantial
risk of injury.” Her petition also asks the
agency to “acknowledge and enforce remedy
for the misbranding of lasers used for LASIK (false
and misleading labeling) due to failure to
properly report adverse events and
complications.”
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| LASIK Dangers Untold, ADEs
‘Not Being Reported’ |
| 04/23/2008
(Resource: www.fdaweb.com ) |
| |
On Friday, FDA’s Ophthalmic Device Advisory Panel will be told by
two LASIK patients
that unknown thousands of serious adverse events
leading even to suicide and divorce attributable to
the procedure are not being reported to the agency’s
Center for Devices and Radiological Health (CDRH),
and that the Center has no compliance program for LASIK. It is estimated
that 7.6 million Americans have had LASIK (Laser-Assisted In Situ Keratomileusis) vision-correction
procedures, but CDRH reportedly has only 140 LASIK adverse events
in its MAUDE database.
In an apparent joint effort to head off a potential
public relations disaster from the patients’
testimony, which is expected to be heavily reported
by mass media outlets, earlier this month FDA partnered with LASIK surgeons’ organizations in a task force to
“study” the procedure’s quality-of-life impacts. One
of the partners, the American Society of Cataract
and Refractive Surgery, boasts on its Web site that “FDA Reaffirms
Safety & Effectiveness of LASIK; Sees Value in Understanding Diverse
Factors That Comprise Quality of Life.”
For its part, CDRH maintains a LASIK information page on
its Web site that provides a 10-item check list of
conditions that make people “poor candidates” for LASIK; it also has a
link to 15 FDA-approved LASIK devices since 1995. The procedure involves cutting a
flap in the cornea which in some cases never heals,
permanently damaging vision. And in another late
move, FDA announced 4/23 that it will ask Friday’s
panel meeting for input on a new FDA-developed LASIK safety reporting program, for what is
euphemistically described as “patient-reported
outcomes” and “quality of life” parameters.
Patient Dean Kantis, of Fort
Lauderdale, FL told FDA Webview 4/23 that he will tell the panel he was permanently
injured in 1999 by LASIK surgeon Nick Caro, a family friend
in Chicago, against whom over 40 lawsuits from
allegedly injured LASIK patients have been filed. Kantis, who maintains a Life
After LASIK Web
site, said his eyesight since the procedure is
“terrible,” everything he sees is double, with
streaks, although he can see “centrally.” One
lawsuit against him by Caro was dismissed in 2006.
Kantis said he was divorced last year because of
death threats and other stresses arising from his
anti- LASIK activities.
FDA seized Caro’s unapproved “custom” laser, we were
told, but “never did anything about it.”
Another patient who’ll testify, Michael
Patterson, of Atlanta, GA, told FDA Webview he will tell about
CDRH’s alleged failure to investigate a complaint he
attempted to file against a surgeon over his failed LASIK procedure, in
which the microkeratome device was allegedly reused
contrary to label. He said the Center claimed no
jurisdiction, but he asserted that end-user
reporting of adverse events is a legal requirement,
and no report was filed in his case. Indeed,
Patterson said, CDRH indicated that only 140 adverse
events had ever been reported for LASIK procedures. He
said that in his own geographic area, he knows of at
least that many LASIK adverse events. Without a CDRH compliance program
for LASIK end user
facilities, which are increasingly located in
shopping centers, most probably do not know they
have to report, Patterson said.
He has written a letter to FDA commissioner Andrew von Eschenbach in which he alleges
that not only do LASIK ambulatory surgical facilities (ASFs) not report
adverse events to FDA, but they also reuse
single-use devices not in compliance with FDA
regulations. His letter asks the commissioner
whether FDA/CDRH has inspected “any or all of the LASIK ASFs since 2000.
If yes, how many have been inspected, and how many
have been identified as deficient in their
responsibility to comply with the MDR regulation?
Have any Warning Letters relating to MDR violations
been issued to any ASFs?”
Patterson also asks von Eschenbach to consider
“using independent, unbiased researchers and/or ...
a patient or ‘consumer’ representative” on the joint LASIK task force the
agency has formed with surgeons’ organizations.
Attorney Larry R. Pilot (McKenna Long & Aldridge) told FDA
Webview that if FDA is unable to
provide satisfactory answers to Patterson’s
questions, it will speak “very poorly” for CDRH’s
MDR program, which in a much smaller area of
possible patient harm had resorted to
disproportionately heavy and unjustified civil money
penalties action against TMJ Implants.
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