Duane A. Admire, Esq., State Bar No. 173699
ADMIRE & ASSOCIATES
3790 Via de la Valle, Suite 313
Del Mar, CA 92037
Tel: (858) 350-5566 Fax: (858) 350-1046
DAdmire@[EMAIL PROTECTED]
for Plaintiffs and the Class
[Additional Attorneys listed on following page]
UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF CALIFORNIA
ROBERT PEREZ, NANCY ART and BRETT HARBACH, on behalf of themselves
and
all others similarly situated,
Plaintiffs,
vs.
NIDEK CO. LTD.; NIDEK INCOR****ATED; NIDEK TECHNOLOGIES INCOR****ATED;
MANOJ V. MOTWANI, M.D., GARY M. KAWESCH, M.D., LINDA VU, M.D., JOSEPH LEE,
M.D., FARZAD YAGHOUTI, M.D., RANDA M. GARRANA, M.D., THOMAS S. TOOMA,
M.D.,
PAUL C. LEE, M.D., KEITH LIANG, M.D., ANTOINE L. GARABET, M.D., WILLIAM
ELLIS, M.D., GREGG FEINERMAN, M.D., MICHAEL ROSE, M.D., JOHN KOWNACKI,
M.D.,
STEVEN MA, M.D., Estate of GLENN A. KAWESCH, M.D., TLC VISION COR****ATION
also dba TLC LASER EYE CENTERS, INC.; CALIFORNIA CENTER FOR REFRACTIVE
SURGERY, A MEDICAL COR****ATION; LASER EYE CENTER MEDICAL OFFICE INC.;
SOUTHWEST EYE CARE CENTERS INC.; and DOES 1 through 1000, inclusive.
Defendants.
)
)
)
)
)
)
)
)
)
)
)
)
)
)
)
)
)
)
CASE NO. 3:08-CV-1261 BTM (JMA)
CLASS ACTION
SECOND AMENDED CLASS ACTION COMPLAINT FOR:
(1) VIOLATIONS OF HEALTH AND SAFETY CODE § 24176
(2) VIOLATIONS OF CIVIL CODE §1750, ET SEQ.;
(3-5) VIOLATIONS OF BUSINESS AND PROFESSIONS CODE § 17200, ET SEQ.;
AND
(6) CIVIL CONSPIRACY
James M. Lindsay, State Bar No. 164758
Gene J. Stonebarger, State Bar No. 209461
LINDSAY & STONEBARGER
A Professional Cor****ation
620 Coolidge Drive, Suite 225
Folsom, CA 95630
Tel: (916) 294-0002 Fax: (916) 294-0012
jlindsay@[EMAIL PROTECTED]
R. Patterson, State Bar No. 211102
Harry W. Harrison, State Bar No. 211141
HARRISON PATTERSON & O'CONNOR LLP
402 West Broadway, 29th Floor
San Diego, CA 92101
Tel: (619) 756-6990 Fax: (619) 756-6991
jpatterson@[EMAIL PROTECTED]
for Plaintiffs and the Class
Plaintiffs file this Class Action Complaint on behalf of themselves and
all
others similarly situated and by their attorneys allege upon information
and
belief the claims set forth herein against all defendants (collectively as
"DEFENDANT PHYSICIANS & NIDEK"), based upon do***entary evidence, the
investigation of attorneys, the investigation of the Federal Food and Drug
Administration("FDA"), and the federal Food, Drug, and Cosmetic Act ("the
Act"), interviews and deposition transcripts of potential witnesses and
persons knowledgeable of these events as follows:
I.
NATURE OF THE ACTION
1. This is a class action brought on behalf of persons who
underwent Hyperopic (farsightedness) Laser in Situ Keratomilesis ("LASIK")
and/or Hyperopic PhotoRefractive Keratectomy ("PRK") with a NIDEK EC-5000
Excimer Laser System ("the Laser") on or about February of 1996 until the
date of October 11, 2006 ("the Class Period") who did not consent to and
were not included in an approved FDA clinical trial.
2. During the Class period, the FDA had not approved the safety
and effectiveness of the Laser to perform hyperopic corrections, i.e. the
reduction or elimination of farsightedness. NIDEK had earned pre-market
approval ("PMA") for three different parameters of myopic corrections,
i.e.
the reduction or elimination of nearsightedness. Nearsighted treatments
involve simply flattening of the cornea similar to a strait blade cut
across
the cornea and thus easier to achieve (and consequently gain FDA approval
for), while hyperopic corrections involve steepening the cornea which
requires a more difficult doughnut shape cut of cornea tissue and thus was
not attempted with the initial excimer eye lasers-nor approved by the FDA
in
any of the original excimer laser approvals.
3. At various times from the lasers original myopic
(nearsightedness) approval in 1996 through its first hyperopic approval in
October 2006, the laser was being investigated with various forms of
hyperopic hardware and software under FDA approved clinical trials by both
NIDEK and independent physician groups. Eventually in October 2006, the
laser was approved for hyperopic use with improved and updated software
and
treatment parameters for hyperopic treatments, as opposed to what was used
illegally by Defendant Physicians herein.
4. From its inception into the United States market in 1996,
DEFENDANT PHYSICIANS, NIDEK, and DOES 1-1000 engaged in a nationwide
scheme
and conspiracy to alter the laser's software and hardware to enable it to
perform hyperopic corrections. Theses hyperopic corrections were not
approved by the FDA absent the physician being involved one of the
above-mentioned FDA approved hyperopic clinical trials. The Laser is
considered by the FDA to be a Class III medical device under the Act; as
such, the additional unapproved hardware and/or software (2.25 dhc
software
was never approved for commercial distribution in the United States) added
to these Lasers makes them "adulterated" under the Act unless there is a
PMA
or an investigational device exemption (IDE) in effect for such hardware
and
software.
5. The California Protection of Human Subjects in Medical
Experimentation Act provides minimum statutory protection for California
patients with regard to human experimentation and provides penalties for
those who violate such provisions. The law prohibits any person from being
subjected to any medical experiment, until the person has given fully
informed specific written consent. The law states: "Any person who is
primarily responsible for conduct of a medical experiment and who
negligently allows the experiment to be conducted without a subject's
informed consent. . . shall be liable to the subject in an amount not to
exceed ten thousand dollars($10,000), as determined by the court. The
minimum amount of damages awarded shall be five hundred dollars ($500)".
The
law continues that one who willfully fails to obtain the subject's
informed
consent . . . shall be liable to the subject in an amount not to exceed
twenty-five thousand dollars ($25,000) as determined by the court. The
minimum amount of damages awarded shall be one thousand dollars ($1,000).
6. The current penalties were increased in September 2003, the
former law made such a person who willfully failed to obtain the Subject's
informed consent liable to the subject for a maximum amount of $5,000 and
$10,000 for willful violations which "exposes a Subject to a known
substantial risk of serious injury. . . ." The Plaintiffs herein allege
that
Defendants negligently and/or willfully failed to obtain their informed
consent and did in fact subject them to a known substantial risk of
serious
injury. The law further states that "Each and every medical experiment
performed in violation of any provision of this chapter is a separate and
actionable offense". § 24176 Health & Safety.aq. Thus, if a patient
underwent hyperopic surgery on her left eye, followed by hyperopic 1 2
surgery on her right eye, without proper written consent and being
included
in a legitimate FDA clinical trial, the patient would be entitled to
collect
the statutory penalties for each surgery.
7. The conduct by DEFENDANT PHYSICIANS, NIDEK, and DOES 1-1000
is
unlawful, unfair, and fraudulent, and therefore in violation of
California's
Unfair Business Practices and Consumer Legal Remedies Act. Yet, despite
years of complaints and warnings by the FDA and the American Academy of
Ophthalmology that such use of the Laser was unlawful, DEFENDANT
PHYSICIANS
continued to conspire with NIDEK, , DOES 1-1000 and their agents to
distribute, sell, service, enable and use the Laser in domestic commerce
with parameters that allowed for hyperopic corrections, which were outside
the specifications of its PMA.
8. During the Class Period, Plaintiff s and members of the
Class
underwent Hyperopic LASIK and/or PRK with the unapproved and/or illegal
Laser and did not consent to this unauthorized use and/or were not
informed
and/or included in an FDA approved clinical trial.
9. For these and several other reasons, this Court should
declare
that conduct by DEFENDANT PHYSICIANS, NIDEK, and DOES 1-1000 and their
agents, violates the California Health and Safety Code, is fraudulent,
negligent, constitutes a civil conspiracy, battery, and is unlawful within
the meaning of the California's Unfair Business Practices and Consumer
Legal
Remedies Act. This Court should award statutory penalties according to the
California Health and Safety Code, and full restitution of all funds to
which Plaintiffs can claim an owner****p interest received by DEFENDANT
PHYSICIANS, NIDEK, and DOES 1-1000.
II.
THE PARTIES
A. PLAINTIFFS
10. Plaintiff Robert Perez is over 18 years of age and is a
resident of the State of California and the County of San Diego. On August
15th and September 12th of 2002, ROBERT PEREZ underwent hyperopic LASIK
surgery with the Nidek Laser to attempt to correct his far-sightedness.
These unapproved surgeries were performed by Defendant Manoj Motwani, M.D.
(herein referred to as "MOTWANI") in San Diego, California. ROBERT PEREZ
did
not discover an unapproved, illegal or unlawful laser had been used on him
until October, 2007. ROBERT PEREZ was not included in and did not consent
to
being included in an FDA clinical trial for the Nidek Laser. Plaintiff
PEREZ
saw an ophthalmologist on or about October, 2007, who advised him to
consider speaking to an attorney because his history revealed he had
hyperopia and had Lasik surgery performed by Defendant MOTWANI using the
Laser that was not FDA approved. Prior to PEREZ's visit with the
ophthalmologist, PEREZ had no knowledge or suspicion that an unlawful,
illegal, or unapproved laser had been used on him. Further, the
Defendant's
fraudulently concealed their conspiracy and illegal use of the Laser on
this
and all Plaintiff's herein; their purpose of such concealment was to be
able
to sell, service, use and as such increase their financial profits by
illegally using the laser on farsighted patients as oppose to its approved
and authorized use of nearsighted patients only. Plaintiffs did not and
could not have reasonably discovered this unauthorized and illegal use of
the Lasers on them prior to their discovery in 2007 as mentioned above.
11. Plaintiff NANCY ART is over 18 years of age and is a
resident
of the State of California and the County of San Diego. Plaintiff BRETT
HARBACH is the son of NANCY ART and is over 18 years of age and also a
resident of the State of California and the County of San Diego. On
September 28th of 2000, Both NANCY ART and BRETT HARBACH underwent
hyperopic
LASIK surgery with the Nidek Laser to attempt to correct their
far-sightedness. Thereafter, on May 23, 2001 BRETT HARBACH underwent a
further hyperopic surgery in his right eye. These unapproved surgeries
were
performed by Defendant GLENN A. KAWESCH, M.D. (sued herein as ESTATE OF
GLENN A. KAWESCH herein referred to as "GLENN KAWESCH") in San Diego.
NANCY
ART and BRETT HARBACH did not discover an unapproved, illegal or unlawful
laser had been used on her until approximately October, 2007. NANCY ART
and
BRETT HARBACH were not included in and did not consent to being included
in
an FDA clinical trial for the Nidek Laser. Plaintiff ART saw an
optometrist
on or about October, 2007, who advised her to consider speaking to an
attorney because her history revealed she had hyperopia and had Lasik
surgery performed by Defendant GLENN KAWESCH that was not FDA approved.
Prior to ART's visit with the optometrist, ART had no knowledge or
suspicion
that an unlawful, illegal, or unapproved laser had been used on her, or
that
clinical trials for Hyperopia on the Nidek laser were being conducted.
Plaintiff ART is the mother of Plaintiff HARBACH and was aware he had also
underwent hyperopic Lasik surgery performed by Defendant GLENN KAWESCH at
the same time she had her surgery. On or about October, 2007, Plaintiff
ART
advised Plaintiff HARBACH of what she learned from her optometrist.
Further,
the Defendant's fraudulently concealed their conspiracy and illegal use of
the Laser on this and all Plaintiff's herein; their purpose of such
concealment was to be able to sell, service, use and as such increase
their
financial profits by illegally using the laser on farsighted patients as
oppose to its approved and authorized use of nearsighted patients only.
Plaintiffs did not and could not have reasonably discovered this
unauthorized and illegal use of the Lasers on them prior to their
discovery
in 2007 as mentioned above.
B. DEFENDANTS
12. Defendant NIDEK CO., LTD. is a cor****ation organized and
existing under the laws of Japan. The cor****ate office is located in
Gamagori, Japan. Said defendant is, through its officers, agents, and
employees, manufacturers the Laser for sale, distribution, lease, and
service and is doing business in California with offices located in
Fremont,
California.
13. Defendant NIDEK INCOR****ATED is a cor****ation organized and
existing under the laws of the State of California and is a wholly owned
subsidiary of NIDEK CO., LTD. Said defendant is, through its officers,
agents, and employees, engages in, markets, sells, services, and
commercially distributes the Laser. Said defendant is the largest
ophthalmic
equipment marketer in the world with sales and service located in Fremont,
California. Said defendant sells and distributes laser systems and
diagnostic equipment developed and manufactured by defendant NIDEK CO.,
LTD., for uses in ophthalmology, optometry, general surgery, gynecology
and
cosmetic dermatological surgery.
14. Defendant NIDEK TECHNOLOGIES INCOR****ATED is/was a
cor****ation organized and existing under the laws of California and. It
is/was through its officers, agents, and employees were doing business in
California with offices located in Pasadena, California. It is/was a
wholly-owned subsidiary of NIDEK CO., LTD. (NIDEK CO., LTD., NIDEK
INCOR****ATED and NIDEK TECHNOLOGIES INCOR****ATED is herein referred to
collectively as "NIDEK".)
15. At all times herein mentioned, Defendant MANOJ V. MOTWANI,
M.D., was a practicing physician, surgeon in the County of San Diego,
State
of California, duly licensed to practice medicine under the laws of the
State of California.
16. At all times herein mentioned, Defendant GARY M. KAWESCH,
M.D., was a practicing physician, surgeon and ophthalmologist in the State
of California, duly licensed to practice medicine under the laws of the
State of California.
17. At all times herein mentioned, Defendant LINDA VU, M.D.,
was
a practicing physician, surgeon and ophthalmologist in the State of
California, duly licensed to practice medicine under the laws of the State
of California.
18. At all times herein mentioned, Defendant JOSEPH LEE, M.D .,
was a practicing physician, surgeon and ophthalmologist in the State of
California, duly licensed to practice medicine under the laws of the State
of California.
19. At all times herein mentioned, Defendant FARZAD YAGHOUTI,
M.D., was a practicing physician, surgeon and ophthalmologist in the
County
of San Diego, State of California, duly licensed to practice medicine
under
the laws of the State of California.
20. At all times herein mentioned, Defendant RANDA M. GARRANA,
M.D., was a practicing physician, surgeon and ophthalmologist in the State
of California, duly licensed to practice medicine under the laws of the
State of California.
21. At all times herein mentioned, Defendant THOMAS S. TOOMA,
M.D., was a practicing physician, surgeon and ophthalmologist in the State
of California, duly licensed to practice medicine under the laws of the
State of California.
22. At all times herein mentioned, Defendant PAUL C. LEE, M.D.,
was a practicing physician, surgeon and ophthalmologist in the State of
California, duly licensed to practice medicine under the laws of the State
of California.
23. At all times herein mentioned, Defendant KEITH LIANG, M.D.,
was a practicing physician, surgeon and ophthalmologist in the State of
California, duly licensed to practice medicine under the laws of the State
of California.
24. At all times herein mentioned, Defendant ANTOINE L.
GARABET,
M.D., was a practicing physician, surgeon and ophthalmologist in the State
of California, duly licensed to practice medicine under the laws of the
State of California.
25. At all times herein mentioned, Defendant WILLIAM ELLIS,
M.D.,
was a practicing 1 2 physician, surgeon and ophthalmologist in the State
of
California, duly licensed to practice medicine under the laws of the State
of California.
26. At all times herein mentioned, Defendant GREGG FEINERMAN,
MD., was a practicing physician, surgeon and ophthalmologist in the State
of
California, duly licensed to practice medicine under the laws of the State
of California.
27. At all times herein mentioned, Defendant MICHAEL ROSE,
M.D.,
was a practicing physician, surgeon and ophthalmologist in the State of
California, duly licensed to practice medicine under the laws of the State
of California.
28. At all times herein mentioned, Defendant JOHN KOWNACKI,
M.D.,
was a practicing physician, surgeon and ophthalmologist in the County of
San
Diego, State of California, duly licensed to practice medicine under the
laws of the State of California.
29. At all times herein mentioned, Defendant STEVEN MA, M.D.,
was
a practicing physician, surgeon and ophthalmologist in the County of Los
Angeles, State of California, duly licensed to practice medicine under the
laws of the State of California.
30. At all times herein mentioned, Defendant GLENN A. KAWESCH,
M.D., was a practicing physician, surgeon and ophthalmologist in the
County
of San Diego, State of California, duly licensed to practice medicine
under
the laws of the State of California. Defendant Glenn A. Kawesch has
subsequently died and is sued herein as ESTATE OF GLENN A. KAWESCH, M.D.)
Defendant GLENN A. KAWESCH, M.D.'s entire medical practice was
subsequently
purchased by his brother GARY M. KAWESCH, M.D., who is already a named
defendant in this action for using his Nidek Lasers illegally on
Plaintiffs
in his Northern California offices.
31. Defendant, TLC VISION COR****ATION also dba and/or formerly
dba TLC Laser Eye Centers, Inc. is a person in the course of doing
business
within the meaning of Health & Safety Code § 25249.11 and a person within
the meaning of Business & Professions Code § 17201. TLC VISION COR****ATION
also dba and/or formerly dba TLC Laser Eye Centers, Inc. also owns Nidek
lasers that were used to perform the unauthorized procedures and/or
employs
one or more Defendant physicians and/or DOES who performed the
unauthorized/illegal surgeries in California. TLC VISION COR****ATION also
dba and/or formerly dba TLC Laser Eye Centers, Inc. is a foreign
cor****ation
1 2 organized and existing under Canadian law, and maintaining its
principal
place of business in MISSISSAUGA, ONTARIO and incor****ated in the
jurisdiction of NEW BRUNSWICK, CANADA.
32. Defendant, CALIFORNIA CENTER FOR REFRACTIVE SURGERY, A
MEDICAL COR****ATION is a person in the course of doing business within the
meaning of Health & Safety Code § 25249.11 and a person within the meaning
of Business & Professions Code § 17201. CALIFORNIA CENTER FOR REFRACTIVE
SURGERY, A MEDICAL COR****ATION also owns a Nidek laser or lasers that were
used to perform the unauthorized procedures and/or employs a Defendant
physician and/or DOES who performed the unauthorized/illegal surgeries in
California. CALIFORNIA CENTER FOR REFRACTIVE SURGERY, A MEDICAL
COR****ATION
is a California cor****ation organized and existing under California law,
and
maintaining its principal place of business in California.
33. Defendant, LASER EYE CENTER MEDICAL OFFICE INC. is a person
in the course of doing business within the meaning of Health & Safety Code
§
25249.11 and a person within the meaning of Business & Professions Code §
17201. LASER EYE CENTER MEDICAL OFFICE INC. also owns a Nidek laser or
lasers that were used to perform the unauthorized procedures and/or
employs
a Defendant physician and/or DOES who performed the unauthorized/illegal
surgeries. LASER EYE CENTER MEDICAL OFFICE INC. is a California
cor****ation
organized and existing under California law, and maintaining its principal
place of business in California.
34. Defendant, SOUTHWEST EYE CARE CENTERS INC., is a person in
the course of doing business within the meaning of Health & Safety Code §
25249.11 and a person within the meaning of Business & Professions Code §
17201. SOUTHWEST EYE CARE CENTERS INC. also owned a Nidek laser that was
used to perform the unauthorized procedures and/or employed a Defendant
physician or physicians and/or DOES who performed the unauthorized/illegal
surgeries. SOUTHWEST EYE CARE CENTERS INC. is a California cor****ation
organized and existing under California law, and maintaining its principal
place of business in California.
35. The above Defendants represented and held themselves out to
the public and to plaintiffs as being skilled, careful and diligent in the
practice of the profession of medicine and surgery and are herein referred
to as "DEFENDANT PHYSICIANS."
C. DOE DEFENDANTS
36. DOES 1-200, and each of them, are officers, employers, or
agents of the defendants and/or entities owned or controlled by the
defendants and/or individuals and/or entities that owned or controlled the
laser with the illegal and/or unapproved software and/or individuals
and/or
entities that serviced, sold, enabled and/or installed the laser with the
illegal and/or unapproved software. DOES 1-200 participated in the course
of
conduct that is the subject of this action as alleged herein.
37. DOES 101-200, and each of them, are "persons" which
participated in the course of conduct that is the subject matter of this
action as alleged herein.
38. DOES 201-1000, and each of them, are practicing
"physicians,"
"surgeons," and/or "medical centers" that perform refractive surgeries and
participated in as well as conspired with other defendants in the course
of
conduct that is the subject matter of this action as alleged herein.
39. Plaintiffs and members of the Class are informed and
believe,
and thereon allege, that at all times herein mentioned, each of the
defendants was the agent, servant and employee of the remaining
co-defendants, and as such was acting within the time, place, purpose, and
scope of said employment and agency and each defendant has ratified,
authorized, and approved the acts of his agents.
40. Except as described herein, plaintiffs are ignorant of the
true names, capacities and nature and extent of participation in the
course
of conduct alleged herein of the persons sued as DOES 1-1000 inclusive,
and
therefore sue these defendants by such fictitious names. Plaintiffs will
amend this complaint to allege the true names and capacities of the DOE
defendants when ascertained.
D. CO-CONSPIRATORS
41. Various persons, individuals, partner****ps, cor****ations,
and
associations, not named as defendants in this Complaint, have also
participated as co-conspirators in the violations alleged herein and have
performed acts and made statements in furtherance thereof.
III.
CLASS ACTION ALLEGATIONS
42. Plaintiffs bring this action on behalf of themselves and as
representative parties on behalf of all members pursuant to Rule 23 of the
Federal Rules of Civil Procedure. The class that plaintiffs ROBERT PEREZ,
NANCY ART and BRETT HARBACH seek to represent is composed of and defined
as
follows: All persons who underwent Hyperopic LASIK and/or PRK with the
Nidek
Laser that were not given proper written informed consent and included in
an
approved FDA clinical trial during the Class Period.
43. This action has been brought and may be maintained as a
class
action, pursuant to the provisions of Rules23(a) and (b)(3)of the Federal
Rules of Civil Procedure because questions of law or fact common to class
members predominate over any questions affecting only individual members,
and that a class action is superior to other available methods for fairly
and efficiently adjudicating the controversy in the following ways:
A. The Class is so numerous that the individual joinder of all members
is
impracticable under the cir***stances of this case. While the exact number
of class members is unknown to the plaintiffs at this time, it based upon
the number of persons whom underwent Hyperopic LASIK and/or PRK with the
Laser that were not given proper written informed consent and included in
an
approved FDA clinical trial during the Class Period. Plaintiffs believe
the
persons in the class are so numerous, consisting of thousands of
individuals, that the disposition of their claims in a class action rather
than in individual actions will benefit the parties and the court.
B. Common questions of law and fact exist as to all members of the
Class and predominate over any questions which affect only individual
members of the class. These common questions of law and fact include,
without limitation:
(i) whether DEFENDANT PHYSICIANS, NIDEK and DOES 1-1000 violated
The
California Protection of Human Subjects in Medical Experimentation Act of
the California Health and Safety Code § 24176 against plaintiffs and
members
of the Class;
(ii) whether DEFENDANT PHYSICIANS, NIDEK and DOES 1-1000 committed
fraudulent acts and/or omissions against plaintiff and members of the
Class;
(iii) whether DEFENDANT PHYSICIANS, NIDEK and DOES 1-1000
committed
civil conspiracy against plaintiff and members of the Class;
(iv) whether DEFENDANT PHYSICIANS, NIDEK and DOES 1-1000 violated
the Unfair Business Practices §17200 et seq.;
(v) whether the amount of additional revenues and profits obtained
by DEFENDANT PHYSICIANS, NIDEK and DOES 1-1000, are attributable to their
violations of the Unfair Business Practices §17200 et seq.;
C. The claims of plaintiffs are typical of, and not antagonistic to,
the claims and interests of the members of the Class. Plaintiffs and all
members of the Class sustained statutory and restitution damages arising
out
of DEFENDANT PHYSICIANS, NIDEK and DOES 1-1000 common course of conduct in
violation of law as complained herein.
D. Plaintiffs ROBERT PEREZ, NANCY ART and BRETT HARBACH will fairly
and
adequately protect the interests of the Class. Plaintiffs paid for and
underwent hyperopic LASIK and/or PRK with the unapproved and/or illegal
Laser which was being investigated by the FDA for its safety and
effectiveness to perform hyperopic treatments and did not give written
consent to be included and were not included in an FDA clinical trial;
they
are entitled to statutory damages and damages for restitution and are
adequate representatives of the Class as they have no interests which are
adverse to the interests of absent class members. Plaintiffs ROBERT PEREZ,
NANCY ART and BRETT HARBACH have retained competent counsel who have
substantial experience and success in the prosecution of complex class
actions and intend to vigorously prosecute this action.
E. A class action is superior to other available means for the fair
and
efficient adjudication of this controversy since individual joiner of all
members of the Class is impracticable. Class action treatment will permit
a
large number of similarly situated person to prosecute their common claims
in a single form simultaneously, efficiently, and without the unnecessary
duplication of effort and expense that numerous individual actions would
engender. Furthermore, as the damages suffered by each individual member
of
the Class may be relatively small, the expenses and burden of individual
litigation would make it difficult or impossible for individual members of
the class to redress the wrongs done to them, while an im****tant public
interest will be served by addressing the matter as a class action. The
cost
to the court system of adjudication of such individual litigation would be
substantial, individualized litigation would also present the potential
for
inconsistent of contradictory judgments.
F. There is no plain, speedy, or adequate remedy other than by
maintenance of this class action since plaintiffs have been informed and
believes that the damage to each plaintiffs are relatively small in
amounts
to the regression of vision making it economically unfeasible to pursue
remedies other than a class action. Consequently, there would be a failure
of justice but for the maintenance of the present class action.
G. Plaintiffs ROBERT PEREZ, NANCY ART and BRETT HARBACH are unaware
of
any difficulties that are likely to be encountered in the management of
this
action that would preclude its maintenance as a class action.
IV.
JURISDICTION & VENUE
44. This Court has jurisdiction over the subject matter of this
action. This is a civil action for statutory penalties and full
restitution
and/or disgorgement of all revenues, earnings, profits, compensation, and
benefits obtained by DEFENDANT PHYSICIANS, NIDEK and DOES 1-1000
inclusive,
as a result of their unlawful, acts alleged herein as prohibited by The
federal Food, Drug and Cosmetic Act and thus, in violation of The
California
Protection of Human Subjects in Medical Experimentation Act and the
California Unfair Business Practices Act. This Court also has diversity
jurisdiction over this matter under the Class Action Fairness Act of 2005
in
that the aggregate amount in controversy is over $5,000,000 and primary
Defendant NIDEK CO. LTD. and Defendant TLC VISION COR****ATION also dba
and/or formerly dba TLC Laser Eye Centers are foreign cor****ations, while
the named Plaintiffs are California residents.
45. Venue is proper in this judicial district, as defendants
committed many of the acts alleged herein and named Plaintiffs and many
other class members reside in this District.
V.
FACTUAL ALLEGATIONS & BACKGROUND
46. All laser products manufactured are subject to the
requirements of the federal Food, Drug, and Cosmetic Act (the "Act").
Excimer lasers are classified under 21 U.S.C. § 360e, 360c as Class III
medical devices. The Act requires premarket approval ("PMA") as a
condition
before the manufacturer may sell or distribute the Laser into domestic
commerce.
47. On December 17, 1998, NIDEK earned its first PMA for the
Laser for PRK for myopia (emphasis added), i.e. the reduction or
elimination
of nearsightedness in the low, moderate, or high ranges (-.75D to -13.0D)
of
refractive error. The FDA granted NIDEK the PMA based upon the following
restrictions: the Laser would not be used to perform hyperopic (emphasis
added) corrections, i.e. reduction of elimination of farsightedness. The
labeling, promotion, and advertising was restricted to what the Laser was
approved. The sale, distribution, service and use of this Laser is
restricted to its approval. All promotion and advertising was to include
its
restrictions. Annual re****ts were to be submitted. Re****ts of any
instances
of tampering with the device were to be immediately submitted. Most
im****tantly, NIDEK, and its agents, were not permitted to introduce the
Laser into commerce for hyperopic corrections.
48. In its approval order, the FDA warned NIDEK, and its
agents,
that failure to comply with the above conditions would invalidate its
approval. Yet, despite these warnings, NIDEK, DEFENDANT PHYSICIANS and
DOES
1-1000, continued to sell, distribute, service, and use the Lasers to
perform unapproved hyperopic treatments and introduce the Laser into
domestic commerce with hardware and software applications different from
the
devices PMA which enabled it to perform unapproved hyperopic treatments.
Nidek had service contracts on the vast majority of the lasers they sold
in
the United States (these service contracts sold to physician owners during
the time period for between $30,000 and $70,000 per year; the contracts
included several service visits per year by Nidek technicians.) During the
Class period, Nidek was well aware that the Defendant physicians and other
DOE physicians were using the lasers to perform unauthorized hyperopic
treatments. Nidek was aware of these facts since it was Nidek service
technicians themselves that were installing, servicing and enabling the
Lasers to perform the unauthorized hyperopic treatments.
49. On September 29, 1999, NIDEK, received another PMA by the
FDA
for the Laser for PRK for the reduction or elimination of myopia with
astigmatism ranging in severity from -1.0D to -8.0D.
50. The FDA again granted NIDEK, the PMA based upon the same
restrictions as their previous PMA which were applicable to NIDEK, its
agents, as well as physicians, users, and purchasers: Most im****tantly,
NIDEK, and its agents, were not permitted to use or introduce the Laser
into
commerce for hyperopic corrections.
51. In its approval order, the FDA again warned NIDEK, that
failure to comply with the conditions would invalidate its approval;
thereby
commercial distribution of the Laser not in compliance was deemed
unlawful.
Yet, despite these warnings, as mentioned above, NIDEK, DEFENDANT
PHYSICIANS
and DOES 1-1000, continued to sell, distribute, service, and use the
Lasers
to perform unapproved hyperopic treatments. Further, the DEFENDANT
PHYSICIANS, and other DOE physicians 201-1000 failed to obtain the proper
written informed consent from Plaintiffs and members of the class relating
to the FDA clinical trials for hyperopia.
52. On April 14, 2000, NIDEK, and its agents, earned another
PMA
from the FDA for the Laser for LASIK for myopia from -1.0D to -14.0D with
or
without astigmatism less than 4.0D.
53. The FDA granted NIDEK's PMA based again upon the same
restrictions including that the Laser not be used for hyperopic
corrections.
54. DEFENDANT PHYSICIANS, and other DOE physicians 201-1000
were
using the lasers to perform unauthorized hyperopic treatments without
giving
patients proper informed written consent and/or including them in an FDA
clinical trial.
55. In order for NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
to
perform hyperopic corrections, the Laser were manipulated, tampered with,
and/or adulterated with illegal hardware and software. Prior to adding the
illegal specifications, NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000 knew
it
was illegal, conspired to manipulate, tamper, and adulterate the Laser
against FDA protocol rendering the Laser illegal and/or unapproved by the
FDA.
56. On December 20, 2000, the FDA sent defendant NIDEK a letter
addressing illegal uses of the Laser. This letter spoke of "ease by which
illegal chips may be replaced in previously distributed units, thereby
enabling these devices for indications beyond which they have been
cleared..." The FDA determined NIDEK, and its agents, and the physicians
and
their agents, were aware and/or using the Laser to perform hyperopic
corrections for several months before re****ting the situation to the FDA,
contrary to what is required for its PMA. Moreover, the FDA addressed
allegations that NIDEK employees have been providing the illegal chips to
physicians. Specifically, the warning letter stated,
"We understand you have begun to address the chip replacement issue by
visiting laser sites under service contract with NIDEK, and have
determined
that a significant number of those lasers have been tampered with and have
been enabled for unapproved applications, such as hyperopia. We also
understand you had been aware of this problem for several months before
initially re****ting it to the FDA, contrary to what is required as a
condition of approval of your PMA."
"There have been allegations that NIDEK employees have been providing
these chips, and we are aware that you have terminated at least one
employee
for providing this service..."
"FDA is growing increasingly concerned that illegal chips are too
easily
replaced in NIDEK units and replacement chips have become too widely
available."
57. Thereafter, the FDA issued two sets of Warning Letters to
physicians. On July 11, 2001, the first Warning Letter stated in part,
"During an inspection of your facility, our investigator determined
that
you are using an excimer laser system for refractive surgery, including
enhancement procedures that utilize hyperopia. Nidek CO., LTD in Japan
manufactured this laser in February 1996, prior to the approval of their
premarket approval application for the EC-5000 excimer laser."
The letter further stated,
"Medical devices used by doctors in the course of their practice to
treat patients are "marketed" and "held for sale" with the meaning of the
Federal Food, Drug, and Cosmetic Act (the Act). An excimer laser is a
class
III device under section 513(f) of the Act, and as such is adulterated
under
section 501(f)(1)(B) of the Act unless there is a PMA or an
investigational
device exemption in effect for it. Although your laser has a long working
distance arm installed by Nidek Co., Ltd, while it was in Canada, this
laser
still contains software version 2.2.5 dhc, which is a version, not
approved
for commercial distribution in the United States."
"This laser does not meet all of the specifications for approval of
Nidek's PMA for the EC-5000 Excimer laser and is not considered to be
covered by that PMA. Because an approved PMA or an approved IDE does not
cover this laser, it is adulterated within the meaning of the Act.
Therefore, you should not be using this laser to treat patients."
"It is unlawful to sell unapproved devices in domestic commerce or to
ex****t them...Continued use of your excimer lasers for which neither a PMA
nor IDE is currently in effect, is unlawful."
58. On July 26, 2001, the FDA sent a second warning letter
entitled "Revised Warning Letter" to physicians, which restated the
information in the first Warning letter dated July 11, 2001 and added,
"Your modified NIDEK lasers also need to be certified as in compliance
with the Federal laser product performance standard pursuant to 21 Code of
Federal Regulations (C.F.R.) §1040.10(I)."
"Laser product manufactured after August 1, 1976, are subject to all
of
the applicable requirements of the Federal performance standard for laser
products specified in 21 CFR §1040.10 and 1040.11 and for certifying the
products pursuant to 21 C.F.R. §1010."
"It is unlawful for manufacturers to introduce such products into
commerce if they fail to comply with the standard or fail to submit
re****ts
as required by 21 C.F.R. §1002. Our records show that no laser product
re****ts for your modified devices have been received by our office."
59. On December 3, 2001, the FDA published an Im****t Alert,
which
represented the Agency's current guidance to FDA field personnel regarding
manufacturers' products. In the re****t, the FDA addressed the following
problem,
"The software and specifications for these devices [NIDEK EC-5000
Excimer Laser] differ from the devices under the approved PMAs. The
software
and specification differences, however, are not discernable from an
outside
inspection of the device. Most of the ex****ted device also do not contain
a
counting device used to monitor the number of procedures, and the labeling
on the ex****ted devices differs from that of approved devices. These
previously ex****ted devices are considered to be adulterated under the Act
if they are sold or offered for sale in domestic commerce."
60. Despite these actions by the NIDEK, DEFENDANT PHYSICIANS
and
DOES 1-1000, inclusive, continued to sell, distribute, lease, use,
service,
and market the Lasers in the United States with the capacity to perform
hyperopic procedures. Hyperopic procedures consist of 25% of the
population,
thereby rendering a great profit motive for NIDEK, DEFENDANT PHYSICIANS
and
DOES 1-1000, inclusive, to ignored federal regulations and continue to
sell,
use, and service the Laser despite its illegal nature.
61. In early 2001, in conjunction with negotiations with the
FDA,
NIDEK obtained a PMA to modify the Laser and install a "lock out" or
"block"feature on the laser. This action essentially authorized and
enabled
Nidek representatives to remove the illegal hyperopic hardware and
software
(2.25dhc) which had been installed on the majority of the laser in the
United States and replace it with the approved myopic software 2.25e.
However, although many of the Nidek service records thereafter indicated
that such software had been removed, the truth is that Nidek continued to
install, service and enable the lasers to use the illegal software and
perform hyperopic corrections; while many NIDEK service records thereafter
indicated that the laser had been brought within the approved standards
with
approved 2.25e software, such records were falsified by Nidek and many of
the lasers thereafter continued to use the unapproved hyperopic 2.25dhc
software and hardware to treat unsuspecting patients.
VI.
FIRST CAUSE OF ACTION
Violation of Human Subjects in Medical Experimentation Act
(California Health and Safety Code §24176)
(Against All Defendants)
62. Plaintiffs and members of the Class repeat and reallege
each
of the preceding paragraphs as though fully set forth herein.
63. DEFENDANT PHYSICIANS and DOES 201-1000, engaged, as herein
alleged, violated the California Health and Safety Code §24176, against
Plaintiffs and members of the Class, while NIDEK and DOES 1-200 also
engaged
in direct violation of this law and a conspiracy to violate the
above-mentioned Code in detriment to Plaintiffs and members of the Class.
64. The California Protection of Human Subjects in Medical
Experimentation Act provides minimum statutory protection for California
patients with regard to human experimentation and provides penalties for
those who violate such provisions. The law prohibits any person from being
subjected to any medical experiment, until the person has given fully
informed specific written consent. The law states: "Any person who is
primarily responsible for conduct of a medical experiment and who
negligently allows the experiment to be conducted without a subject's
informed consent. . . shall be liable to the subject in an amount not to
exceed ten thousand dollars($10,000), as determined by the court. The
minimum amount of damages awarded shall be five hundred dollars ($500)".
The
law continues that one who willfully fails to obtain the subject's
informed
consent . . . shall be liable to the subject in an amount not to exceed
twenty-five thousand dollars ($25,000) as determined by the court. The
minimum amount of damages awarded shall be one thousand dollars ($1,000).
65. The current penalties were increased in September 2003, the
former law made such a person who willfully failed to obtain the Subject's
informed consent liable to the subject for a maximum amount of $5,000 and
$10,000 for willful violations which "exposes a Subject to a known
substantial risk of serious injury. . . ." The Plaintiffs herein allege
that
Defendants willfully failed to obtain their informed consent and did in
fact
subject them to a known substantial risk of serious injury by performing
laser eye surgery on them with these unapproved, adulterated lasers
without
their informed consent. The law further states that "Each and every
medical
experiment performed in violation of any provision of this chapter is a
separate and actionable offense". § 24176 Health & Safety. Thus, if a
patient underwent hyperopic surgery on her left eye, followed by hyperopic
surgery on her right eye, without proper written consent and being
included
in a legitimate FDA clinical trial, the patient would be entitled to
collect
the statutory penalties for each surgery.
66. The Code states that "informed consent" means the
authorization given pursuant to Section 24175 to have a medical experiment
performed after numerous conditions have been satisfied. This includes:
A. A written consent form signed and dated by the subject.
B. The subject is informed both verbally and within the written
consent
form, in nontechnical terms of facts of the proposed medical experiment,
including, but not limited to:
(i) An explanation of the procedure and medical device to be
utilized,
including the purposes of devices.
(ii) An instruction to the subject that he or she is free to
withdraw
his or her prior consent to the medical experiment and discontinue
participation in the medical experiment at any time, without prejudice to
the subject.
(iii) The name, institutional affiliation, if any, and address of
the
person or persons actually performing and primarily responsible for the
conduct of the experiment.
(iv) The name of the sponsor or funding source, if any, or
manufacturer if the experiment involves a drug or device, and the
organization, if any, under whose general aegis the experiment is being
conducted.
(v) The name, address, and phone number of an impartial third party,
not associated with the experiment, to whom the subject may address
complaints about the experiment.
(vi) The material financial stake or interest, if any, that the
investigator or research institution has in the outcome of the medical
experiment or other income, regardless of when it is earned or expected to
be earned.
(vii) Consent is voluntary and freely given by the human subject or
the conservator or 1 2 guardian, or other representative, as specified by
Section 24175, without the intervention of any element of force, fraud,
deceit, duress, coercion, or undue influence.
67. None of the above written warnings were given by
Defendant's
in this case to the Plaintiffs or any members of the class. Defendant's
negligently and/or intentionally withheld these disclosures in an effort
perform these illegal hyperopic procedures to increase their profits.
Plaintiffs believe and herein allege that Defendants willfully failed to
obtain their informed consent and did in fact subject them to a known
substantial risk of serious injury; as such, they would be entitled to the
heightened penalties under the Statute.
VI.
SECOND CAUSE OF ACTION
Unfair Or Deceptive Acts Or Practices In Violation
Of California Civil Code Section 1750 Et Seq.
68. Plaintiffs and members of the Class repeat and reallege
each
of the preceding paragraphs as though fully set forth herein.
69. By their wrongful conduct as alleged herein, Defendants
have
created, engaged in, and/or participated in unfair practices, in violation
of California Civil Code Section 1750 et seq., the Consumers Legal
Remedies
Act.
70. Defendants have engaged in unfair or deceptive acts or
practices intended to result in the sale of their goods and services in
violation of California Civil Code Section 1770, including but not limited
to:
A. Misrepresenting the source, sponsor****p, approval, or
certification
of goods or services, in violation of Section 1770(a)(2); and
B. Representing that goods or services have sponsor****p, approval,
or
characteristics which they do not have, in violation of Section
1770(a)(5).
71. Pursuant to Section 1780, Plaintiffs and the members of the Class
seek
to enjoin Defendants from engaging in their unfair practices as alleged
herein.
71. Pursuant to Section 1780, Plaintiffs and the members of the
Class seek to enjoin Defendants from engaging in their unfair practices as
alleged herein.
VII.
THIRD CAUSE OF ACTION
Violations of Unfair Competition Law
(California Business and Professions Code §17200 et seq.)
Based Upon Federal Food, Drug, and Cosmetics Act.
(Against All Defendants)
72. Plaintiffs and members of the Class repeat and reallege
each
of the preceding paragraphs as though fully set forth herein.
73. Business practices in which all defendants, NIDEK,
DEFENDANT
PHYSICIANS and DOES 1-1000, engaged, as herein alleged, constitute
unlawful,
unfair, and fraudulent business practices in violation of Business and
Professions Code §17200 et seq. A violation of any underlying federal
and/or
state law effects a violation of Business and Professions Code §17200 et
seq.
74. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000, inclusive,
profited from their unfair business practices. Defendant's failure to
comply
with federal and state regulations increased the sales of the Lasers,
thereby creating a greater profit for NIDEK, DEFENDANT PHYSICIANS and DOES
1-1000.
75. Actions filed under Business and Professions Code §17200 et
seq. may be brought by any person acting for the interest of itself, its
members, or the general public. Plaintiffs have standing to bring this
action under California Business & Professions Code §17200 because they
have
suffered injury in fact and have lost money because of the Defendant's
conduct.
76. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000 inclusive,
violated the provisions of the Act, 21 U.S.C. §331, which provides that
the
following acts and causing thereof are hereby prohibited (emphasis added)
in
part:
(a) The introduction or delivery for introduction into interstate
commerce
of any device that is adulterated or misbranded;
(b) the adulteration or misbranding of any device in interstate
commerce;(c) the receipt in interstate commerce of any device that is
adulterated or misbranded and the delivery or proffered delivery thereof
for
pay; (k) the alteration, mutilation, destruction, obliteration, or removal
of the whole or any part of the labeling of, or the doing of any other act
with respect to, a device if such act is done while such article is held
for
sale after ****pment in interstate commerce and results in such article
being
adulterated or misbranded.
77. As defined in part by the Act under 21 U.S.C.
§§351(f)(1)(B),
360c(f), 360e(a), a Class 1 2 III medical device shall be deemed to be
adulterated unless it has PMA or an investigational device exemption that
is
in effect.
78. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000, inclusive,
adulterated the Laser by intentionally and/or negligently leasing, using,
selling, distributing, and servicing the Laser and introducing it into
commerce with parameters allowing for hyperopic corrections, servicing the
Lasers to perform hyperopic corrections in violation of its PMA.
79. Because NIDEK violated the conditions of its PMA, the Laser
is not considered to be covered by that PMA. The specifications for the
Laser differ from the Lasers approved under its PMA. This violates 21
U.S.C.
§331 (a)-(c), (k), because NIDEK permitted the use, sale, lease, service,
of
an adulterated laser, and introduced such laser into commerce.
80. The Act was intended to prevent this type of damage to the
public; plaintiffs are members the Class for whose protection the statutes
were adopted.
81. Said conduct by NIDEK, DEFENDANT PHYSICIANS and DOES
1-1000,
inclusive, has resulted in statutory violations of the Act and Code as
mentioned and therefore constitutes unlawful and unfair business practices
within the meaning of the Business and Professions Code §17200. The Act
and
H & S Code placed mandatory duties on defendants.
82. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000 received funds
from Plaintiffs and members of the Class as a result of the aforementioned
acts. Plaintiff and members of the Class paid DEFENDANT PHYSICIANS, their
agents, other DOE physicians, and their agents as well as DOES 201 to 1000
to perform Lasik procedures on them. DEFENDANT PHYSICIANS, their agents,
other DOE physicians, and their agents as well as DOES 201 to 1000 in turn
used Plaintiffs and members of the Class' money to pay NIDEK and DOES
1-200
for the purchase of their lasers and for expensive ($30,000 to $70,000 per
year) service and maintenance contracts on their illegal lasers. Pursuant
to
Business and Professions Code §17203, the plaintiffs and members of the
class are entitled to restitution of the funds they have an owner****p
interest in from NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000. Pursuant to
Code of Civil Procedure §1021.5, the plaintiffs are entitled to cost,
including attorneys' fees, for prosecuting this action in the public
interest.
VIII.
FOURTH CAUSE OF ACTION
Violations of Unfair Competition Law
(California Business and Professions Code 17200 et seq.)
Based Upon Federal Food and Drug Administration
Department of Health and Human Services.
(Against All Defendants)
83. Plaintiffs and members of the Class adopt this cause of
action repeat and reallege each of the preceding paragraphs as though
fully
set forth herein. The claims asserted herein arise out of the same nucleus
of operative facts as those alleged under the preceding Count.
84. Business practices in which NIDEK, DEFENDANT PHYSICIANS and
DOES 1-1000, inclusive, engaged, as herein alleged, constitute unlawful,
unfair, and fraudulent business practices in violation of Business and
Professions Code §17200, et seq. A violation of any underlying federal or
state law effects a violation of Business and Professions Code §17200 et
seq.
85. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000, inclusive,
profited from their unfair business practices. NIDEK's failure to comply
with federal regulations increased the sales of the Lasers, thereby
creating
a greater profit for NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000. NIDEK,
DEFENDANT PHYSICIANS and DOES 1-1000, inclusive, were able to sell, use,
purvey, and profit from an increased use and sales volume of the Laser due
to the fact that NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000 sold and/or
distributed and/or serviced and/or enabled and/or introduced the Laser
into
domestic commerce with specifications different from the devices under the
approved PMA rendering the Laser unlawful. Such Lasers are illegal and
should not to be used to treat patients. Further, NIDEK, DEFENDANT
PHYSICIANS and DOES 1-1000, inclusive, failed to notify the FDA of these
acts and/or that the Laser was being used for a procedure unapproved by
the
FDA rendering the Laser illegal.
86. Actions filed under Business and Professions Code §17200 et
seq. may be brought by any person acting for the interest of itself, its
members, or the general public. Plaintiffs have standing to bring this
action under California Business & Professions Code §17200 because they
have
suffered injury in fact and have lost money because of the Defendant's
conduct.
87. Under the FDA, all Laser products must be in accordance with
21
C.F.R. §1040.10(a), §1040.10, which provides:
Manufacturers of Laser products shall provide or cause to be provided:
(I) the modification of a Laser product, previously certified under
§1010.2,
by any person engaged in the business of manufacturing, assembling, or
modifying Laser products shall be construed as manufacturing under the act
if the modification affects any aspects of the product's performance or
intended functions for which this section and §1040.11 have applicable
requirement. The manufacture who performs such modification shall
recertify
and reidentify the product in accordance with the provisions of 21 C.F.R.
§§
1010.2, 1010.3.
88. As defined by the FDA and the implementing regulations
thereto, NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000, have failed to
comply
with recertification and reidentification standards, as they have engaged
in
modifying, assembling, manufacturing, as well as the selling, use, and
distribution and service of the Laser enabling it to perform LASIK and/or
PRK refractive surgeries for corrections beyond which they have been
cleared. NIDEK failed to recertify and reidentify the Laser after its
modification in violation of 21 C.F.R. §§1040.10(a), §1040.10.
89. Said conduct by NIDEK, DEFENDANT PHYSICIANS and DOES
1-1000,
inclusive, in violation of this section proximately caused plaintiffs and
members of the Class to undergo LASIK surgery with an unapproved Laser,
and
an unlawful procedure as alleged above, and incor****ated herein in full.
90. The FDA regulations are intended to prevent this type of
damage to the public; plaintiffs and members of the Class are persons for
whose protection the statute was adopted.
91. Said conduct by NIDEK, DEFENDANT PHYSICIANS and DOES
1-1000,
inclusive, has resulted in statutory violations of the Health and Safety
Code and therefore constitutes unlawful and unfair business practices
within
the meaning of Business and Professions Code §17200. The FDA and the
Department of Health and Human Services places mandatory duties upon
defendants.
92. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000 received funds
from Plaintiffs and members of the Class as a result of the aforementioned
acts. Plaintiff and members of the Class paid DEFENDANT PHYSICIANS and
DOES
201-1000 to perform Lasik procedures on them. DEFENDANT PHYSICIANS and
DOES
201-1000 in turn used Plaintiffs and members of the Class' money to pay
NIDEK and DOES 1-200 for the purchase of their lasers and for service and
1
maintenance contracts on their illegal lasers.
93. Pursuant to Business and Professions Code §17203, the
plaintiffs and members of the class are entitled to restitution of the
funds
they have an owner****p interest in from NIDEK, DEFENDANT PHYSICIANS and
DOES
1-1000.
94. Pursuant to Code of Civil Procedure §1021.5, plaintiffs and
members of the Class are entitled to cost, including attorneys' fees, for
prosecuting this action in the public interest.
IX.
FIFTH CAUSE OF ACTION
Violations of Unfair Competition Law
(California Business and Professions Code 17200 et seq.)
Based Upon California Health and Safety Code §24176
(Against All Defendants)
95. Plaintiffs and members of the Class adopt this cause of
action repeat and reallege each of the preceding paragraphs as though
fully
set forth herein. The claims asserted herein arise out of the same nucleus
of operative facts as those alleged under the preceding Count.
96. Business practices in which NIDEK, DEFENDANT PHYSICIANS and
DOES 1-1000, inclusive, engaged, as herein alleged, constitute unlawful,
unfair, and fraudulent business practices in violation of Business and
Professions Code §17200, et seq. A violation of any underlying federal or
state law effects a violation of Business and Professions Code §17200 et
seq.
97. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000, inclusive,
profited from their unfair business practices. NIDEK's failure to comply
with State regulations increased the sales and service contracts of the
Lasers, thereby creating a greater profit for NIDEK, DEFENDANT PHYSICIANS
and DOES 1-1000. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000, inclusive,
were able to sell, use, purvey, and profit from an increased use and sales
volume of the Laser due to the fact that NIDEK, DEFENDANT PHYSICIANS and
DOES 1-1000 ignored state and federal used the illegal and untested laser
on
unsuspecting customers (patients) or in other words, the plaintiffs and
class.
98. Actions filed under Business and Professions Code §17200 et
seq. may be brought by any person acting for the interest of itself, its
members, or the general public. Plaintiffs have standing 1 2 to bring this
action under California Business & Professions Code §17200 because they
have
suffered injury in fact and have lost money because of the Defendant's
conduct.
99. As alleged in the First Cause of Action, Defendants also
violated California Health and Safety Code §24176 which provides:
"Any person who is primarily responsible for conduct of a medical
experiment and who negligently allows the experiment to be conducted
without
a subject's informed consent. . . shall be liable to the subject in an
amount not to exceed ten thousand dollars($10,000), as determined by the
court. The minimum amount of damages awarded shall be five hundred dollars
($500)". The law continues that one who willfully fails to obtain the
subject's informed consent . . . shall be liable to the subject in an
amount
not to exceed twenty-five thousand dollars ($25,000) as determined by the
court. The minimum amount of damages awarded shall be one thousand dollars
($1,000). The current penalties were increased in September 2003, the
former
law made such a person who willfully failed to obtain the Subject's
informed
consent liable to the subject for a maximum amount of $5,000 and $10,000
for
willful violations which "exposes a Subject to a known substantial risk of
serious injury. . . ."
100. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000, have failed
to
comply with the informed consent requirements outlined above.
101. Said conduct by NIDEK, DEFENDANT PHYSICIANS and DOES
1-1000,
inclusive, in violation of this section proximately caused plaintiffs and
members of the Class to undergo LASIK surgery with an unapproved Laser,
and
an unlawful procedure as alleged above, and incor****ated herein in full.
102. The State regulations are intended to prevent this type of
damage to the public; plaintiffs and members of the Class are persons for
whose protection the statute was adopted.
103. Said conduct by NIDEK, DEFENDANT PHYSICIANS and DOES
1-1000,
inclusive, has resulted in statutory violations of the Health and Safety
Code and therefore constitutes unlawful and unfair business practices
within
the meaning of Business and Professions Code §17200. The FDA and the
Department of Health and Human Services places mandatory duties upon
defendants.
104. NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000 received funds
from Plaintiffs and members of the Class as a result of the aforementioned
acts. Plaintiff and members of the Class paid DEFENDANT PHYSICIANS and
DOES
201-1000 to perform Lasik procedures on them. DEFENDANT PHYSICIANS and
DOES
201-1000 in turn used Plaintiffs and members of the Class' money to pay
NIDEK and DOES 1-200 for the purchase of their lasers and for service and
1
maintenance contracts on their illegal lasers.
105. Pursuant to Business and Professions Code §17203, the
plaintiffs and members of the class are entitled to restitution of the
funds
they have an owner****p interest in from NIDEK, DEFENDANT PHYSICIANS and
DOES
1-1000.
106. Pursuant to Code of Civil Procedure §1021.5, plaintiffs
and
members of the Class are entitled to cost, including attorneys' fees, for
prosecuting this action in the public interest.
X.
SIXTH CAUSE OF ACTION
Civil Conspiracy
(Against All Defendants)
107. Plaintiffs and members of the Class repeat and reallege
each
of the preceding paragraphs as though fully set forth herein.
108. Defendants NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
inclusive, were aware of the federal and state standards regarding the
Laser, knew that the Laser was in violation of the standards, and that the
Laser was unlawful and/or illegal to use on patients.
109. Defendants NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
inclusive, owed a duty to plaintiffs and members of the Class adopting
this
cause of action to give Plaintiffs and members of the class proper
informed
consent of the clinical trials and disclose to plaintiffs and members of
the
Class notice prior to undergoing refractive surgery that the surgery would
be performed with an unapproved and/or illegal Laser. Given the nature of
the activities in which defendants engaged, they had a heightened duty to
undertake no acts that would endanger the public at large.
110. Defendants NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
inclusive, knowingly and willfully conspired and agreed among themselves
to
withhold from governmental authorities and plaintiffs and members of the
Class their knowledge that the Laser is illegal and/or unlawful.
111. Defendants NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
inclusive, knowingly and willfully conspired and agreed among themselves
to
continue treating plaintiffs and 1 2 members of the Class with the illegal
and/or unlawful Laser and to not give them proper informed consent as
required by the Act and the Health and Safety Code.
112. Defendants NIDEK, and DOES 1-200, inclusive, knew that the
plaintiffs were exposed and treated on by an unlawful and/or illegal Laser
as a result of their and other defendants conduct.
113. Defendants NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
inclusive, knew at all relevant times that plaintiffs and the class relied
upon the Laser to be safe, effective, and approved by the FDA.
114. Defendants DEFENDANT PHYSICIANS and DOES 201-1000,
inclusive, had a duty, as described herein, to cease treating plaintiffs
and
members of the Class with the Laser knowingly that it is illegal and/or
unlawful.
115. Defendants NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
inclusive, knowingly, intentionally conspired and agreed amongst
themselves
to misrepresent the safety and efficacy of the Laser.
116. Defendants NIDEK, DEFENDANT PHYSICIANS and DOES 1-1000,
inclusive, committed the acts and/or omissions herein alleged pursuant to,
and in furtherance of, the conspiracy of above-alleged agreement.
117. All defendants' conspiracy to suppress the information
herein alleged was made with the fraudulent intent to induce plaintiffs to
act in reliance thereon, and undergo refractive surgery without knowing
the
Laser was in fact unlawful and/or illegal, and as a result, all defendants
NIDEK and DOES 1-200 were able to sell and service more Lasers to
DEFENDANT
PHYSICIANS and DOES 201-1000, of which were able to perform more
operations
and all defendants increased their profits.
118. Plaintiffs and members of the Class are informed and
believe
and thereon allege that the above-described conspiracy has existed since
1996 and that the conspiracy continued throughout the class period.
119. Pursuant to Code of Civil Procedure §1021.5, the
plaintiffs
and members of the Class are entitled to cost, including attorneys' fees,
for prosecuting this action in the public interest.
XI.
PRAYER FOR RELIEF
WHEREFORE, Plaintiffs and members of the Class pray for judgment as
follows:
AS TO ALL CAUSES OF ACTION:
(Against All Defendants)
1. That this Court determine that this action may be maintained
as a class action pursuant to Rule 23 of the Federal Rules of Civil
Procedure, on behalf of the Class, designating Plaintiff ROBERT PEREZ,
NANCY
ART and BRETT HARBACH as Lead Plaintiffs and Plaintiffs' counsel as Lead
Counsel, and certifying the Plaintiffs ROBERT PEREZ, NANCY ART and BRETT
HARBACH as proper class representatives;
2. For costs of suits herein, including reasonable attorney's
fees for prosecuting this action in the public interest;
3. That plaintiffs and the other members of the Class be
granted
other and further relief as the nature of the case may require or this
court
deems just or proper.
AS TO THE FIRST CAUSE OF ACTION:
(Against All Defendants)
1. That Defendants be found to have failed to obtain each
Plaintiff and each member of the Class's informed consent in violation of
§24176 of the California Health and Safety Code;
2. That Defendants be ordered to pay each plaintiff and each
member of the Class the maximum penalty pursuant to California Health and
Safety Code §24176;
AS TO THE SECOND CAUSE OF ACTION:
(Against All Defendants)
1. That the Court permanently enjoin Defendants from engaging
in
the illegal conduct alleged in this Complaint;
AS TO THE THIRD THROUGH FIFTH CAUSES OF ACTION:
(Against All Defendants)
1. That Defendants be found to have engaged in unlawful,
unfair,
and fraudulent competition in violation of §17200 of the California
Business
and Professions Code;
2. That the Court order Defendants to disgorge all monies
wrongfully obtained and all revenues and profits derived by Defendants as
a
result of their acts or practices as alleged in this Complaint;
3. That Defendants be ordered to make restitution to each
plaintiff and each member of the Class pursuant to California Business and
Professions Code §§17203 and 17204;
AS TO THE SIXTH CAUSE OF ACTION:
(Against All Defendants)
1. That Defendants be found to have engaged in a civil
conspiracy
to defraud Plaintiffs and the class of plaintiffs;
2. That the Court order Defendants to disgorge all monies
wrongfully obtained and all revenues and profits derived by Defendants as
a
result of their acts or practices as alleged in this Complaint;
3. That the Court order Defendants to pay restitution to
restore
to all affected persons all funds acquired by means of any act or practice
declared by this Court to be an unlawful, unfair or fraudulent act.
AS TO THE FIRST THROUGH SIXTH CAUSES OF ACTION:
(Against NIDEK and DOES 1-200)
1. Defendants NIDEK and DOES 1-200 acted with deliberate and/or
reckless disregard for the rights of the Plaintiffs and the class. These
acts were willful and/or wanton or reckless for their own self-interest.
Defendants should also be held liable for punitive damages.
2. Further, Plaintiffs will bring a motion at the appropriate
time seeking punitive damages against Defendant Physicians and DOES
201-1000
according to California Civil Code of Procedure section 425.13(a) which
provides:
In any action for damages arising out of the professional negligence
of
a health care provider, no claim for punitive damages shall be included in
a
complaint or other pleading unless the court enters an order allowing an
amended pleadings that includes a claim for punitive damages to be filed.
The court may allow the filing of an amended pleading claiming punitive
damages on a motion by the party seeking the amended pleading and on the
basis of the sup****ting and opposing affidavits presented that the
plaintiff
has established that there is a substantial probability that the plaintiff
will prevail on the claim pursuant to Section 3294 of the Civil Code.
Dated: October 7, 2008 Respectfully submitted:
By: /s Duane A. Admire
Duane A. Admire
Attorney for Plaintiffs
Robert Perez, Nancy Art & Brett Harbach
http://www.usaeyes.us/do***ents/class_action_vs_nidek_et_al.html
|
