UNITED STATES DISTRICT COURT
FOR
THE MIDDLE DISTRICT OF FLORIDA
ORLANDO
DIVISION
UNITED STATES OF AMERICA,
)
)
Plaintiff,
)
)
v.
) Case No. 6:06-CV-1281-Orl-18KRS
)
ENDOTEC,
INC., a corporation,
)
MICHAEL
J. PAPPAS, Ph.D.,
)
FREDERICK
F. BUECHEL, M.D., and
)
JARED
PAPPAS, individuals,
)
)
Defendants.
)
)
ANSWER
TO COMPLAINT FOR PERMANENT INJUNCTION
Defendants, ENDOTEC, INC. (Endotec), MICHAEL J. PAPPAS,
Ph.D. (Dr. Pappas), and FREDERICK F. BUECHEL, M.D.
(Dr. Buechel), by and through their undersigned counsel,
answer the Complaint for Permanent Injunction as follows:
1. While plaintiff has by its bare allegations
alleged jurisdiction for purposes of initiating a
federal statutory action purportedly involving the
regulatory affairs of the Food & Drug Administration
(FDA), defendants deny that this Court, pursuant to
28 U.S.C. §§ 1331, 1337, and 1345, and 21
U.S.C. § 332(a), has jurisdiction over this action,
as the actual specific acts or conduct complained
of, constitute the practice of medicine by Dr. Buechel,
and by named and unnamed physicians not a party to
this action, in furtherance of which Dr. Pappas and
Endotec assist. The direct control of the practice
of medicine is in the States and beyond the power
of the federal government to codify and regulate.
Linder v. U.S.,
268 U.S.
5, at 18 and 17, 45 S. Ct. 446,
at 449, 69 L.Ed. 819 (1925). The practice of medicine concept is to a degree
admitted by certain provisions of the Federal Food,
Drug & Cosmetic Act (Act) by “exemptions”
set out in and under the Act which otherwise recognize
the right of a licensed physician to order or manufacture
and prescribe medical devices for the treatment of
his or her individual patient in accordance with the
physician’s best judgment.
For
purposes of this action, defendants admit the allegations
regarding venue under 28 U.S.C. §§ 1391(b)
and (c).
2.
Paragraph no. 2 of the complaint, which alleges
the bringing of a statutory injunction proceeding
under 21 U.S.C. § 332(a), requires no response
other than the assertion by defendants that the devices
and acts complained of are exempt and/or beyond the
power of the federal government to restrain.
A. Defendants deny the allegations of paragraph
2.A. of the complaint which allege a violation of
21 U.S.C. § 331(a) regarding unnamed articles
of device, as defined by 21 U.S.C. § 321(h).
1.
Defendants deny the allegations of paragraph 2.A.1.
concerning unnamed adulterated devices under 21 U.S.C.
§ 351(f)(1)(A). As to any unnamed
device manufactured by defendants, but not offered
for commercial distribution through labeling or advertising
in the United States, the specific device or devices
are exempted from (FDA) regulation.
2.
Defendants deny the allegations of paragraph 2.A.2.
concerning adulterated devices under 21 U.S.C. §
351(f)(1)(B). As to any unnamed device
manufactured by defendants, but not offered for commercial
distribution through labeling or advertising
in the United States, the specific device or devices
are exempted from (FDA) regulation.
3.
Defendants deny the allegations of paragraph 2.A.3.
of a failure to comply with requirements under which
unnamed devices may be exempted for investigational
use. As to any unnamed device manufactured by
defendants, but not offered for commercial distribution
through
labeling or advertising in
the United States, the
specific device or devices are exempted from (FDA)
regulation.
B. Defendants deny the allegations of paragraph
2.B. of a violation with respect to unnamed misbranded
devices under 21 U.S.C. § 331(a), as defined
by 21 U.S.C. § 321(h), within the meaning of
21 U.S.C. § 352(o)—Drugs or devices from
nonregistered establishments, as required by 21 U.S.C.
§ 360(k), as the unnamed device or devices complained
of were not introduced into interstate commerce for
commercial distribution through labeling or advertising in the United States
and are exempted from FDA regulation.
C. Defendants deny the allegations of paragraph
2.C. of a 21 U.S.C. § 331(k) violation
alleging the alteration, mutilation, destruction,
obliteration, or removal of labeling, etc., after
shipment in interstate commerce causing unnamed devices
to become adulterated within the meaning of 21 U.S.C.
§§ 351(f)(1)(A), 351(f)(1)(B), and/or 351(i),
as described in paragraph no. 2.A. of the complaint,
and misbranded within the meaning of 21 U.S.C.
§ 352(o)—Drugs or devices from nonregistered
establishments, as described in paragraph no. 2.B.
of the complaint, wherein it is alleged in the complaint
that such unnamed devices are held for sale after
shipment of one or more of their components in interstate
commerce.
D. Defendants deny the allegations of paragraph
2.D. of an alleged 21 U.S.C. § 331(q)(1) violation,
of unnamed devices the subject of Investigational
Device Exemptions (IDEs) pursuant to 21 U.S.C. §
360j(g), and failure to comply with unspecified requirements
prescribed under 21 U.S.C. § 360j(g), and failure
to furnish unspecified notification or other material
or information required by or under 21 U.S.C. §
360j(g) and the implementing regulations set forth
in 21 C.F.R. Part 812.
3.
Defendant Endotec admits the allegations of paragraph
3 of the complaint, but denies that it commercially
distributes within the United States any ankle, knee
or temporal mandibular joint systems that requires
approval by the Food & Drug Administration (FDA),
and further states: Endotec is the outgrowth
of an entity known as Endomedics, a small orthopaedic
manufacturing company, founded in 1982 by Defendants,
Drs. Frederick F. Buechel, M.D. and Michael J. Pappas,
Ph.D., to manufacture implants or artificial joints,
including hips, knees, and shoulder devices, for Dr.
Buechel in treating his patients. Endotec, Inc.
was formed from Endomedics in 1989. Endotec,
Inc. has continued to make artificial joints for use
by Dr. Buechel, and other doctors, to their specifications
for their special needs and the needs of their patients.
Endotec has also manufactured an artificial
joint known as the Hoffman-Pappas Temporal Mandibular
Joint Replacement System for a Dr. Hoffman under an
IDE granted by the FDA. Endotec also manufactures
variations of a mobile bearing ankle design commonly
known as the Buechel-Pappas Total Ankle Replacement
System (B-P Ankle) on the order of and for the use
of Dr. Buechel, in treating his patients. Endotec
has also manufactured a variation of the B-P mobile
bearing design developed by a Dr. Feldman, known as
the Feldman Total Ankle for his use in treating his
patients. Endotec also manufactures this ankle
for worldwide distribution outside of the United States. This ankle employs a mobile
bearing design system, in contrast to all other ankles
approved for use by the FDA in the United
States which utilize a fixed
bearing design. It is the contention
of the Defendants, Drs. Buechel and Pappas, that a
mobile bearing design markedly minimizes the wear
associated with fixed bearing designs approved by
the FDA. While the Buechel-Pappas ankle is not
commercially distributed in the United
States, it is commercially distributed
throughout the world outside the United States by the Defendant, Endotec, Inc.,
and/or through foreign entities, such as Wright Medical
UK Ltd., Elemed Medical Equipment SA, of Greece, Endotec
Australia Pty Ltd., and Invicta Meditek Limited, of
India.
The mobile bearing design, which is not commercially
available in the United
States, is, outside the United
States the preferred and dominant
design over the fixed bearing design commercially
available in the United
States.
4.
Defendant Michael J. Pappas, Ph.D. admits the allegations
of paragraph 4 of the complaint, but denies the erroneous
allegation that he resides in Delray Beach, Florida,
and denies that he performs his duties at 2546 Hansrob
Road, Orlando, Florida, and further states:
he was born in 1932, received his Ph.D. in 1970 from
Rutgers University in Mechanical Engineering specializing
in computer-aided structural design. Dr. Pappas has
worked with the Defendant Dr. Buechel for over 30
years in the development of improved orthopaedic joint
replacements, including the LCS Knee, Self-Centering
Hip Cup and ankle designs. Dr. Pappas, in association
with Dr. Buechel, has published 39 papers and has
been issued 47 United
States patents in the area of
orthopaedic joint replacements. Drs. Buechel
and Pappas are the most prolific of the U.S.
patent holders in this field. Almost all of
these patents have equivalent patents in several foreign
countries. Additionally, Dr. Pappas has 26 published
papers and holds 8 U.S. patents in other fields. Dr. Pappas
has made hundreds of presentations on orthopaedic
joint replacements throughout the world.
5.
Defendant Frederick F. Buechel, M.D. admits the allegations
of paragraph 5 of the complaint, and further states:
he was born in 1945, received his medical degree in
1971 from the University of Medicine and Dentistry
of New Jersey (UMDNJ), and has been a clinical professor
of orthopaedics at UMDNJ for the past 10 years, where
he has established a Chair in Joint Replacement Research
at UNDNJ-N.J. Medical School at Newark, N.J.
Dr. Buechel is a licensed medical practitioner and
maintains a private orthopaedic practice in South
Orange, New Jersey. During
the past 30 years Dr. Buechel has been associated
with the creation, implantation and increased function
of human joint replacement implants, and with Dr.
Pappas has developed mobile-bearing knee, ankle and
hip replacements as well as a comprehensive shoulder
replacement system. Dr. Buechel has been utilizing
these implants for his patients for 25 years and has
routinely published his clinical results throughout
this duration. As Medical Director of Endotec,
Dr. Buechel evaluates requests from other surgeons
for specific devices needed for their patients, and
develops improvements in implants and instruments
along with Dr. Pappas. Dr. Buechel has lectured
at more than 500 lectures and presentations and performed
instructional surgery in countries throughout the
world.
6.
The first sentence of paragraph 6 of the complaint
is admitted in that Jared Pappas was previously employed
by Defendant, Endotec, Inc., but he is not currently
so employed. The second sentence of paragraph
6 regarding Jared Pappas’ responsibilities,
as to day-to-day operations is denied, as to manufacturing,
packaging, labeling, and quality assurance the same
is denied, as to review but not approval of device
history records is admitted, as to release of lots
from quarantine is denied—with the notation
that no lots have ever been quarantined, as to acceptance
of incoming components is denied, but as to complaint
investigations is admitted. The third sentence
of paragraph 6 as to processing IDE submissions is
denied, but admitted as to monitoring and controlling
Endotec’s clinical trials and monitoring the
distribution of investigational devices is admitted.
It is admitted that Jared Pappas reported directly
to Michael Pappas. It is admitted that Jared
Pappas performed his duties at Endotec’s New Jersey facility, but denied as to 2546 Hansrob Road, Orlando, Florida.
7.
Defendant Endotec admits the allegations
of paragraph 7 of the complaint, except that Endotec
has a 510(k) clearance (K012702 granted January 30,
2002) pursuant to 21 U.S.C. § 360 and therefore
this knee does not need an approved PMA or PDP pursuant
to 21 U.S.C. §§ 360e or 360e(f).
8.
Paragraph 8 is admitted.
9.
Noting that the Defendants are unaware of what other
“TMJ device” plaintiff is referring to
and that “another knee replacement device”
is not identified with any specificity in paragraph
9, the allegations of paragraph 9 are denied in their
entirety.
10.
Noting that plaintiff refers to a universe of “various
articles of devices”, which include “the
orthopedic joint implants and unapproved devices”
without identifying with any specificity what devices
it contemplates in addition to “the orthopedic
joint implants and unapproved devices”, defendants
are unable to intelligently respond to paragraph 10
and therefore deny the allegations of paragraph 10
in their entirety.
11.
In response to the allegation in paragraph 11 of the
complaint, that “Defendants’ orthopedic
joint implants and unapproved devices have been classified
as Class III devices either by regulation, see,
e.g., 21 C.F.R. §§ 872.3940, 872.3950,
888.3120, or by statute, 21 U.S.C. §360c(f),
because they are intended for human use, were not
introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28,
1976, and do not meet the exemptions set forth in
21 U.S.C. § 360c(f)(1)”, defendants deny
the allegation to the extent that the majority of
its devices are actually classified as Class II devices,
irrespective of plaintiff’s characterization
of the devices or references to the Code of Federal
Regulations and 21 U.S.C. § 360c(f)(1).
Although plaintiff could have described the devices
with some specificity and the circumstances of their
use or application with particularity, it chose not
to. Not having been given the information necessary
to differentiate any device as to whether it is Class
III or Class II, defendants deny the allegations of
paragraph 11 in their entirety.
November
2005 Inspection
12.
Defendants admit that the FDA inspected Endotec’s
Florida facility on November 7-10, 2005.
13.
To the extent that no additional meaning
is given to the wording of the allegations in paragraph
13 other than the words used in their plain meaning,
paragraph 13 is admitted.
14.
The first sentence of paragraph 14 is denied.
With respect to the second sentence contained in paragraph
14 and its subparts,
A. Defendants are unable to intelligently respond
to the plaintiff’s allegations in subparagraph
A as plaintiff fails to identify the devices or physicians
it refers to, and fails articulate what approved IDE
it refers to, and paragraph 14.A is therefore denied
in its entirety.
B. Defendants are unable to intelligently respond
to the allegations in subparagraph B as none of the
“Form FDA 483a (4/83)” reports provided
in connection with the inspection of Endotec’s
facility on November 7-10, 2005 contain any notice
or statement by the investigators who performed the
inspection that defendants had failed to prepare and
submit to FDA any complete, accurate, and timely reports,
and paragraph 14.B is therefore denied in its entirety.
2004-2005
Inspections
15.
Paragraph 15 is admitted to the extent the FDA
inspected Endotec’s New
Jersey facility on March 2, 2004 through April 20, 2004, on May 20, 2004,
16. Defendants admit that the inspections claimed
numerous deficiencies of a minor nature, which were
corrected, but deny that the inspection revealed any
violation of distribution of unapproved devices or
one or more orthopedic joint implants outside the
scope of their IDE approvals. Specifically,
A. Subparagraph A is admitted, but any violation
is denied unless the investigational devices were
so distributed, which they were not.
B. Subparagraph B is admitted, but this
is not a violation if the device was exempt.
C. Subparagraph C is denied.
D. Subparagraph D is admitted, but this is not
a violation if no change was made.
E. Defendants are unable to intelligently respond
to the allegations in subparagraph E as none of the
“Form FDA 483a (4/83)” reports provided
in connection with the inspection of Endotec’s
facility contain a notice or statement that defendants
failed to prepare and submit to FDA any complete,
accurate, and timely reports and subparagraph 16.E
is therefore denied in its entirety.
F. Subparagraph F is denied.
G. Subparagraph G is admitted, but this is not
a violation if the device was exempt.
17. Defendants admit that the majority
of Endotec’s manufacturing processes were relocated
to Orlando, Florida on or about September 2004, but
are otherwise unable to respond to paragraph 17 as
no Form FDA 483 or documentation was provided to defendants
with regard to an inspection or any violations at
the Florida facility on August 30, 2004, and defendants
accordingly and otherwise deny the allegations of
paragraph 17.
Prior
Inspections
18.
Defendants admit that the FDA inspected the New Jersey facility August 20-24, 27, 29, and September
10, 2001 resulting in a Form FDA 483 and on August
12, 13, 14, 16, 19, and 30, 2002. resulting in a Form
FDA 483. The August-September 2001 inspection
concerned itself solely with the Buechel-Pappas Ankle
and its investigational implantation into some 123
patients for which the FDA had granted an Investigational
Device Exemption (IDE) under 21 USC §360j(g).
The August 2002 Form FDA 483 concerned itself with
a modular salvage humeral shoulder device and had
nothing to do with any device the plaintiff complains
of, and accordingly defendants deny that the August
2002 inspection concerned itself with any observed
conduct the same as or similar to that described in
paragraph 16. During the August-September
2001 inspection, the FDA did observe from Endotec’s
records that, in addition to 123 patients in whom
the Buechel-Pappas Ankle was implanted by nine clinical
investigators in connection with the IDE, that the
records also showed that prior to FDA’s approval
of the IDE, that Dr. Buechel, who was observed not
to be one of the clinical investigators involved in
the IDE, had since 1994 implanted 218 Buechel-Pappas
Ankles in the United States. The report also
noted that a Dr. Feldman, who was one of the clinical
investigators in the IDE, had implanted an additional
10 ankles outside of the IDE, which he had developed
and which were a variation of the B-P ankle mobile
bearing device and otherwise known as the Feldman
Total Ankle. The FDA report further noted that
the 218 ankles implanted by Dr. Buechel and the 10
ankles implanted by Dr. Feldman were termed “Surgeons
(sic) Specials” in Endotec’s records.
The report noted, “These ankles are termed
‘Surgeons’s Specials’ and are defined
by Endotec as a device made to a surgeons (sic) specifications,
to be used only in that surgeons (sic) practice and
not for general distribution.” With
respect to the specific conduct claimed to have been
observed in paragraph 18, defendants respond as follow:
A. Defendants deny that the distribution
of the Ankle outside the scope of its approved IDE
is a violation of the Act as the ankles implanted
by Dr. Buechel and Dr. Feldman are exempt from FDA
regulatory oversight for one or more of the following
reasons:
(i) The implantation of the devices by
Defendant Dr. Buechel and Dr. Feldman constitutes
the practice of medicine by a medical practitioner,
and direct control of medical practice in the States
is beyond the power of the federal government.
Linder v. U.S.,
268 U.S.
5, at 18 and 17, 45 S. Ct. 446,
at 449, 69 L.Ed. 819 (1925).
(ii) The implantation of the devices by Defendant
Dr. Buechel are exempt from premarket notification
and all related requirements.
21 CFR §807.85—Exemption from premarket
notification, provides, “(a) A device is exempt
from the premarket notification requirements of this
subpart if the device intended for introduction into
commercial distribution is not generally available
in finished form for purchase and is not offered through
labeling or advertising by the manufacturer, importer,
or distributor thereof for commercial distribution,
and the device meets one of the following conditions:
(1) It is intended for use by a patient named in the
order of the physician … ; or (2) It is intended
solely for use by a physician … and is not generally
available to, or generally used by, other physicians
… .”
(iii) The requirements of the Food Drug &
Cosmetic Act (Act) with regard to registration of
devices, in §510 [21 U.S.C. 360], per §510(g)(2)
do not apply to—practitioners licensed by law
to prescribe or administer drugs or devices and who
manufacture, prepare, propagate, compound, or process
drugs or devices solely for use in the course of their
professional practice.
(iv) The devices implanted by Defendant Dr.
Buechel are exempt from FDA regulatory oversight as
“custom devices”. A custom device
is defined in 21 CFR § 812.3(b) as
a device that: (1) Necessarily deviates from devices
generally available or from an applicable performance
standard or premarket approval requirement in order
to comply with the order of an individual physician
or dentist; (2) Is not generally available to, or
generally used by, other physicians or dentists; (3)
Is not generally available in finished form for purchase
or for dispensing upon prescription; (4) Is not offered
for commercial distribution through labeling or advertising;
and (5) Is intended for use by an individual patient
named in the order of a physician or dentist, and
is to be made in a specific form for that patient,
or is intended to meet the special needs of the physician
or dentist in the course of professional practice.
(v) It follows
that if Dr. Buechel is exempt, then Dr. Pappas, the
biomedical engineer who assists Dr. Buechel, and Endotec,
the company used by Dr. Buechel to manufacture the
devices that he implants into his patients, are also
exempt.
B. Defendants deny that the distribution
of the Ankle to any physicians, including Dr. Buechel,
who were not approved clinical investigators, constitutes
any violation as the ankles implanted by Dr. Buechel,
or other unnamed physician(s), are exempt from FDA
regulatory oversight for the reasons set forth in
paragraph 18.A.(i)-(iv) above.
C. Defendants deny that the distribution of
the Ankle to physicians under the alleged guise of
the “custom device” exemption (21 U.S.C.
§360j(b) are a violation, as the devices are
exempt under the “custom device” exemption,
and if not under the arbitrary and irrational interpretation
of the exemption by the FDA, are nevertheless exempt
for the reasons set forth in paragraph 18.A.(i)-(iv)
above. Contrary to the assertion of the plaintiff,
the FDA has been attempting to unlawfully interfere
with the practice of medicine by a physician under
its arbitrary interpretation of the “custom
device” exemption by fabricating the false impression
that an unapproved device cannot be implanted unless
it qualifies for an FDA exemption. The dispute
between defendants and the FDA is in measure the result
of the failure of the FDA to issue “guidelines”
for the use of this exemption. Such guidelines
are normally provided to help industry apply specific
regulations. The FDA does not care for
the custom exemptions since it places such devices
outside of their control. This is an anathema
to bureaucrats. The absence of such guidelines
stems from the failure of the FDA to accept the will
of Congress on the matter of customs. Thus, since
the FDA cannot define customs both to their satisfaction
and the intent of Congress, they have failed to provide
such guidance for the industry. The FDA
attempts to impose its will on customs by means of
intimidation rather than law. Nowhere
in the complaint does the FDA state the manner by
which Endotec has failed to meet the custom device
exemption. Rather, the FDA merely alleges that
some Endotec devices are other than custom devices
without setting forth the basis for its claim.
19.
Defendants admit the allegations of paragraph 19 regarding
the 2001 inspection to the extent that the FDA investigators
issued a list of Inspectional Observations (“Form
FDA 483”) but deny that any of the observations
concerning the implantation of the ankle by Dr. Buechel,
or the additional ankles implanted by Dr. Feldman,
were presented as violations or adverse findings—rather
these observations were merely presented as observations
unattended by any allegation of any violation of the
Act. The observations that were presented as
failings consisted of documentary and record keeping
shortcomings with regard to the IDE, the investigators’
difficulty in reconciling B-P ankle usage as international
sales, customized “Surgeon Special” pieces
which used one of the components of the B-P ankle
and the shipping of the B-P ankle to Clinical Investigators
in the U.S. were kept on the same database, which
contained over four thousand entries, but defendants
responded to all of these failings with corrective
action.
20.
The allegations of paragraph 20 duplicate the allegations
of paragraph 2.A, and in response to paragraph 20,
defendants re-allege their response to paragraph 2.A.
21.
The allegations of paragraph 21 duplicate the allegations
of paragraph 2.B, and in response to paragraph 21,
defendants re-allege their response to paragraph 2.B.
22.
The allegations of paragraph 22 duplicate the allegations
of paragraph 2.C, and in response to paragraph 21,
defendants re-allege their response to paragraph 2.C.
23.
The allegations of paragraph 23 duplicate the allegations
of paragraph 2.D, and in response to paragraph 23,
defendants re-allege their response to paragraph 2.D.
Prior
Notice of Violations
24. Defendants deny the allegations of paragraph
24 and to the contrary assert that plaintiff should
be well aware that the conduct of Endotec and Drs.
Pappas and Buechel does not violate the Act.
The FDA has refused to concede that it is possible
for two mutually exclusive scenarios to exist, wherein
Dr. Buechel, or other physicians, with the assistance
of Dr. Pappas, and utilizing the resources of Endotec,
can on the one hand, without FDA regulatory approval,
manufacture implants that Dr. Buechel or other physicians
deem superior to existing devices for the benefit
of their patients, and on the other hand, for Drs.
Pappas and Buechel to own a company that is attempting
in accordance with the Act to obtain FDA regulatory
approval for the commercial distribution of the implant
in the United States. While Dr. Buechel has
necessarily subjected himself to the authority of
the FDA for the purpose of attempting to obtain FDA
regulatory approval of the Buechel-Pappas Ankle for
commercial distribution through labeling or advertising
in the United States, the FDA fails to acknowledge
that the specific acts of which plaintiff complains
of in this action actually constitute the practice
of medicine over which it does not have regulatory
authority and which is beyond its jurisdiction.
There is no law that requires that a physician abandon
his practice of medicine involving a device, upon
application to the FDA for approval of the device
for the benefit of patients other than his own.
25. Endotec admits the allegations of paragraph
25. Defendant in writing respectfully disagreed
with the FDA’s interpretation of the law.
26. Paragraph 26 is admitted and corrective
action was taken with regard to the documented observations,
none of which noted a violation with regard to the
subject matter of this action
27. The letter to which reference is made
in paragraph 27 is not identified by a specific date,
and since a copy is not attached to the complaint,
defendants are unsure of what letter the plaintiff
is referring to. Further, the conditions for emergency
use are not set forth in 21 CFR § 812.35, but
in 21 CFR § 812.36. Defendants do,
however, admit to communications with the FDA during
this time period with regard to the IDE on the Ankle,
and that the FDA suggested that Endotec utilize the
compassionate use exemption for the implantation of
the Ankle in view of the FDA’s interpretation
that the Ankle could not be considered a custom implant
as defined by 21 CFR 812.3(b). Subsequently,
supplements to the IDE were proposed for the use of
the B-P Ankle in certain patients, but the FDA invariably
disapproved the supplements, as in part evidenced
by the FDA’s letter of November 29, 2001 to
Jared Pappas and Endotec, and instead suggested the
use of an alternative treatment (fusion of the ankle
bones, which results in loss of up and down movement
of the foot, or amputation of the foot) or the use
of a legally marketed predicate device, e.g. the fixed
bearing Johnson & Johnson Depuy Agility Ankle
(irrespective of the medical practitioner’s
overall assessment and concerns or preference for
a mobile bearing device for the patient). Defendants
contend that the problem with accepting the suggestion
of the FDA is that ankle devices, even though approved
by the FDA under their ankle classification 21 C.F.R.
§ 888.3110, are well known to contain a serious
design deficiency. The plastic bearings of the fixed
bearing ankle devices, as cleared for sale by the
FDA, are clearly overloaded. The contact pressures
of such devices are on the order of double the pressures
recommended by a manufacturer of the plastic for industrial
use. The contact pressures for human use should be
lower than this recommendation, not much higher. No
competent design engineer familiar with stress analysis
would allow such pressures in devices intended for
human use. The problem arises from the need to provide
mobility, which with fixed bearing ankles can be accomplished
only with contact incongruity. This incongruity results
in these excessive contact pressures. The problem
of designing an ankle device with needed mobility,
but with acceptable contact pressures, is better resolved
by the use of a mobile bearing design. Mobile bearings
better provide both needed mobility and congruity
while allowing acceptable levels of contact pressures.
The clinical success of mobile bearing ankles is well
documented in the medical literature as is the poor
performance of the fixed bearing ankles on which FDA’s
21 C.F.R. § 888.3110 classification is based.
This documentation is well known to the FDA since
it is extensively documented in Endotec’s ankle
reclassification petition submitted to the FDA in
2001. The FDA has been resisting this petition since
that time. It is for these reasons that, outside
the United
States, mobile bearing ankles
are used almost exclusively. Only in the United States, by
virtue of the FDA’s regulation of medical devices,
is the FDA approved fixed bearing design used to any
extent. The problem is compounded by the refusal of
the FDA to approve 510(k) applications for mobile
bearing ankles, such as the Buechel-Pappas Ankle,
on the basis of irrational, unscientific, inconsistent
and erroneous reasoning. It would almost appear
that the FDA has an unwritten unreasoned policy, which
defendants contend, files in the face of FDA regulations,
that no mobile bearing device will be cleared by 510(k),
thereby denying the use of superior devices to the
American public. Other than that they have previously
been approved, the FDA has provided no reasonable
basis for their acceptance of fixed bearing devices
with a well know serious design defect, and their
inhibition of devices which tend to eliminate that
defect. The situation in the case of knee replacements
is similar. Defendants contend that the FDA has stymied
the reclassification of mobile bearing knees for several
years even though there is overwhelming proof that
such knees are safe.
28. The allegations of paragraph 28 are admitted
with the observation that the allegations have nothing
to do with the subject matter of this action and the
observation that the issuance of the Application Integrity
Policy letter by the FDA on February 14, 2002 was a draconian abuse of the policy by the FDA.
The AIP is a fraud policy announced by the FDA on
“Fraud, Untrue Statements of Material Facts,
Bribery, and Illegal Gratuities, in part resulting
from the acceptance of fraudulent data by corrupted
FDA officials. It was never intended to apply
to submissions the FDA did not consider inadequate
where no fraud was involved. Thus the
application of this policy to Endotec, where no fraud,
untrue statements of material facts, bribery, and
illegal gratuities was alleged, was a clear abuse
of this policy. Further, the AIP letter, which
had the effect of finality, was issued without prior
notice and without affording the defendants any opportunity
to present their views prior to the issuance of the
letter, contrary to the representations by the FDA
to Congress that such prior notification would be
given. Absent any due process afforded to the
defendants, the AIP letter has the status an internal
FDA document only and is of no consequence to this
action. Defendants appealed the issuance of
the letter on March
7, 2002, and after numerous requests by the defendants
to the FDA to rule on the appeal, filed a petition
to expedite the appeal. Although the appeal and petition
to expedite the appeal were never ruled on, the FDA,
by notice of November 14, 2005 conditionally lifted
or removed defendants from the provisions of the Application
Integrity Policy. Defendants would note
that while their appeal was pending that they did
take corrective action to remedy documentary shortcomings
by the submission of a Corrective Action Plan (CAP)
to the satisfaction of the FDA.
29.
Defendants admit the allegations of paragraph
29 with regard to the issuance of a Warning Letter
on March 15, 2002 and note that this Warning Letter
only concerned the Buechel-Pappas Ankle and only addressed
the defendants’ “procedures for ‘Surgeon
Specials’ and ‘Custom’ devices,
and the devices distributed to Drs. Buechel and Feldman
under those procedures.” Defendants
further admit that in response to their written correspondence
(of April 4, 2002) to the FDA respectfully expressing
disagreement with the FDA’s assertions, and
requesting clarification, that they subsequently received
a letter from the FDA dated June 28, 2002.
Defendants note that while the plaintiff refers to
the FDA letter dated June 28, 2002 as a “third
letter”, that the defendants are uncertain as
to whether a second letter, which the FDA has not
identified, was sent to defendants as the FDA letter
of June 28, 2002 begins, “This is in response
to your letter dated April 4, 2002, replying to our
Warning Letter of March 15, 2002, … .”
Defendants submit that even if the devices distributed
to Drs. Buechel and Feldman failed to satisfy the
FDA’s interpretation of a “custom device”,
and therefore exempt from premarket notification,
IDE, or premarket approval requirements, that the
devices were nevertheless so exempt for the reasons
set out in defendants’ responses to paragraph
18.A. Endotec’s letters to the FDA of
August 30, 2002 and September 6 2002 in response to the FDA
warning letter Endotec outlined its new policy on
customs to which the FDA offered no objection. Endotec’s
actions were consistent that policy and there is no
mention of illegal activity in any document Endotec
received from the FDA since.
30. Defendants deny the allegations of paragraph
30 and note that the FDA has kept its observations
secret from defendants, and that defendants have not
therefore been able to take issue with such unspecified
observations.
31. Paragraph 31 is admitted.
32. Defendants deny that an injunction or restraint
by order of this Court is necessary or appropriate
as defendants are not violating 21 U.S.C. §§
331(a), (k), and (q), and as a restraint will only
serve to chill defendants’ First Amendment right
to express their disagreement with interpretations
or positions taken by the FDA.
AFFIRMATIVE
DEFENSES
33. Defendants affirmatively claim that the
devices complained of are exempt from FDA regulatory
oversight.
DEMAND
FOR TRIAL BY JURY
34. Defendants demand pursuant to 21 U.S.C.
§ 332(b) trial by jury of all issues so triable
as a matter of right.
WHEREFORE, Defendants pray:
I.
That plaintiff’s
requests contained in its ad damnum clause be denied.
II.
That this Court
award defendants their costs and reasonable attorney’s
fees, and such other relief as the Court deems proper.
I CERTIFY
that on December , 2006, I electronically
filed the foregoing with the Clerk of the Court by
using the CM/ECF system.
Respectfully
submitted,
___/s/
Vello Veski____________________
VELLO
VESKI
Attorney
for ENDOTEC, INC.,
MICHAEL
J. PAPPAS, Ph.D., and FREDERICK F. BUECHEL, M.D.
Fla.
Bar I.D. No. 195264
3241
S. W. Island Way
Palm
City, Florida 34990
Telephone:
(772) 287-1001
Facsimile:
(772) 287-1018
E-Mail:
vveski@hotmail.com
