Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 1 of 9

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STATE OF COLORADO
OFFICE OF ADMINISTRATIVE COURTS
1525 Sherman Street, 4th Floor
Denver, Colorado 80202
BEFORE THE COLORADO MEDICAL BOARD:

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GARY WEISS, M.D.
LICENSE NO. DR 25800,

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IN THE MATTER OF THE DISCIPLINARY
PROCEEDING REGARDING THE LICENSE TO
PRACTICE MEDICINE IN THE STATE OF
COLORADO OF:

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COURT USE ONLY 4

CASE NUMBER
ME 2014-

Respondent.

COMPLAINT, NOTICE OF DUTY TO ANSWER, NOTICE TO SET, NOTICE OF
HEARING AND STATEMENT REGARDING OPTION TO ENGAGE IN
ALTERJ\lATIVE DISPUTE RESOLUTION
To: GARY WEISS, M.D.
FORMAL COMPLAINT
Inquiry Panel B of the Colorado Medical Board (the "Board") makes this
Complaint against Gary Weiss, M.D. ("Respondent"), pursuant to section 12-3611 8(5 ), C.R.S.

JURISDICTION AND THE PARTIES
1. Respondent is licensed to practice medicine in Colorado and holds license

No. DR 25800.
2. The Board has jurisdiction over Respondent and the subject matter of
these proceedings pursuant to sections 12-36-101 et seq. and 24-4-101 et seq., C.R.S.

FACTUAL ALLEGTIONS
3. Patient A was an individual with multiple sclerosis ("MS") and a history
of seizures.

EXHIBIT L.t;

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Exhibit 11

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 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 2 of 9

4. Patient A's MS escalated to secondary progressive MS after a 1996
automobile accident.
5. At all relevant times, there was no approved treatment for secondary
progressive MS in the United States.
6. Between January 2009 and May 2009, Patient A was in and out of the
hospital due to multiple infections and pneumonia.
7. A hospitalist recommended that Patient A be evaluated by Respondent.
8. Respondent is a neurologist, who at all relevant times treated patients in
Gypsum, Colorado at Next Step Institute.
9. On May 7, 2009, Respondent examined Patient A and diagnosed her with
relapsing and remitting MS with possible secondary progression.
10. At all relevant times, relapsing and remitting MS could be treated with the
drug Tysabri.
11. Tysabri can prevent recurrent inflammation in patients with relapsing and
remitting MS.
12. Tysabri can also cause a life threatening disease called progressive
multifocalleukoencephalopathy ("PML").
13. Tysabri was not approved for treatment of secondary progressive MS at
the relevant time.
14. Respondent started Patient A on Tysabri in July 2009.
15. Respondent instructed Patient A to stop taking her seizure medications.
16. Respondent did not document what steps, if any, that he took to determine
whether it was safe to take Patient A off her seizure medications.

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Exhibit 11

 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 3 of 9

17. After she began Tysabri treatment, Patient A walked and swam for the
first time in nine years.

18. On June 22, 20 I 0, Patient A complained of imbalance.
19. Respondent prescribed Ampyra, the so called "walking pill" for MS.
20. Ampyra should not be prescribed for patients with a history of seizures.
21. At the relevant time, Respondent, through Weiss Medical Associates,
P.C., owned an MRI machine and interpreted his own MRI studies.
22. Respondent is not a radiologist.
23. Respondent is not board certified in neuroradiology.
24. In August 2010, Respondent ordered MRI studies of Patient A's brain.
25. Respondent interpreted Patient A's MRI studies and did not notice any
new lesions on Patient A's brain.
26. In November 2010, a family member told Respondent that Patient A was
more forgetful and acting differently.
27. By February 2011, Patient A had worsening gait, weakness in her right
hand and right leg and had become dependent on a wheelchair.
28. Patient A had classic signs ofPML.
29. Respondent failed to recognize Patient A's PML signs.
30. Respondent ordered MRI studies of Patient A's brain in February 2011.
31. Respondent interpreted Patient A's MRI studies.
32. Respondent did not see evidence ofPML on Patient A's February 2011
MRI studies at the relevant time.

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Exhibit 11

 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 4 of 9

33. At the relevant time, Respondent failed to appreciate a new brain lesion
visible on Patient A's February 2011 MRI studies.
34. Patient A's February 2011 MRI studies were not interpreted by a
radiologist.
35. Respondent continued Patient A's Tysabri treatment after the February
2011 MRI.
36. Thereafter, Respondent increased Patient A's Tysabri treatments to every

25 days.
37. By May 2011, Patient A's right sided weakness increased and she had
slurred speech.
38. Respondent ordered MRI studies of Patient A's brain in May 2011.
39. Respondent interpreted Patient A's May 2011 MRI studies.
40. Respondent did not diagnose enhancing lesions or new lesions on Patient
A's May 2011 MRI studies at the relevant time.

41. Respondent failed to appreciate a brain lesion shown on Patient A's May
2011 MRI that was more suspicious for PML.
42. Respondent continued Patient A's Tysabri treatment after the May 2011
MRI.
43. Patient A's May 2011 MRI studies were not interpreted by a radiologist.
44. By June 22, 2011, Patient A was struggling to speak and her family
reported to Respondent a definite change in her cognition.
45. Respondent ordered another brain MRI in June 2011.

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Exhibit 11

 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 5 of 9

46. Respondent interpreted the June 2011 MRI and noticed a lesion that was
characteristic ofPML.
47. Patient A's care was transferred to the University of Colorado.
48. Patient A underwent plasma exchange to remove the Tysabri from her
system.
49. Patient A was affected with right hemiplegia and aphasia.
50. Patient A died in September 2011.
51. Respondent now recognizes that there was a new lesion on Patient A's
February 2011 MRI stndies that was the start ofPML.

COUNT I
UNPROFESSIONAL CONDUCT
(Violation of Colo. Rev. Stat. §12-36-117(1 )(p) - substandard care)
52. The Board incorporates by reference the allegations contained in
Paragraphs 1-51 as if fully set forth herein.
53. Respondent failed to meet the generally accepted standard of medical
practice in his care and treatment of Patient A and, therefore committed unprofessional
conduct pursuant to Colo. Rev. Stat.§ 12-36-117(1)(p), by one or more of the following:
a. mis-diagnosing Patient A;
b. treating Patient A with Tysabri;
c. continuing to treat Patient A with Tysabri after there were signs
that it was not effective;
d. continuing to treat Patient A with Tysabri after there were signs of
PML;
e. failing to properly monitor Patient A's neurological status;

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Exhibit 11

 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 6 of 9

f.

prescribing Ampyra to Patient A;

g. misinterpreting Patient A's MR!s;
h. failing to interpret Patient A's MRis based on clinical context;
i.

failing to have Patient A's MRls read by a radiologist or neuroradiologist;

j.

failing to compare MRI studies with prior MRI studies to assess
for interval change;

k. ordering improper interval studies;

1.

failing to order an EEG before prescribing Ampyra

m. unqualified interpretation ofMRI studies;
n. prescribing Tysabri more frequently than recommended; and
o. failing to recognize brain lesions on Patient A's MRis.
COUNT II
UNPROFESSIONAL CONDUCT
(Violation of Colo. Rev. Stat. §12-36-117(I)(cc) - substandard care)

54. The Board incorporates by reference the allegations contained in
Paragraphs 1-53 as if fully set forth herein.
55. Accurately documenting the physical and mental status of a patient being
treated with Tysabri are essential entries in a patient's medical record.
56. Documenting considerations and impressions ofMRis are essential entries
in medical records
57. Respondent repeatedly failed to make essential entries in Patient A's
medical records, in violation of Colo. Rev. Stat. § 12-36-117(1 )( cc), by one or more of
the following:

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Exhibit 11

 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 7 of 9

a. Failing to provide quantitative documentation of Patient A's
mental status when there were concerns of her mental status;
b. Failing to document the steps, if any, that he took to determine
whether it was safe to take Patient A off her seizure medications;
c. Failing to document a clear picture of Patient A's MS before
prescribing Tysabri;
d. Failing to document his impression of each MRI study;
e. Failing to document whether he compared MRI studies with prior
MRI studies;
f

Failing to document a complete health history for Patient A;

g. Failing to keep a copy of all MRI images in his medical chart; and
h. The subjective assessment of Respondent's medical records on the
dates ofJune 16, 2011, March 9, 2011, April 13, 2011, May 4,
2011 and May 11, 20 11 contradict the information contained in the
Gait & Station section of the same medical reports.
58. Falsifying or repeatedly making incorrect essential entries or repeatedly
failing to make essential entries on patient records is unprofessional conduct within the
meaning of Colo. Rev. Stat.§ 12-36-117(1)(cc).
WHEREFORE, the Board respectfully requests that an administrative law judge
discipline Respondent's license to practice medicine in the State of Colorado, as provided
by law.

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Exhibit 11

 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 8 of 9

NOTICE OF DUTY TO ANSWER
YOU ARE HEREBY NOTIFIED that, pursuant to Colo. Rev. Stat.§ 24-4-104(2),
you are required to file a written answer to this Complaint, Notice of Duty to Answer,
Notice to Set, Notice of Hearing and Statement Regarding Option to Engage in
Alternative Dispute Resolution ("Complaint") with the Office of Administrative Courts,
1525 Sherman Street, 4'h Floor, Denver, CO 80203, within 30 days after the mailing of
this Complaint. You must also mail a copy of such answer to the attorney for the Panel,
Allison Ailer, Assistant Attorney General, Office of the Attorney General, Ralph Carr
Judicial Center, 1300 Broadway,

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Floor, Denver, CO 80203.

If you fail to file your written answer within 30 days, an order entering a

default decision may be issued against your Colorado medical license for the relief
requested in the Complaint or such other penalties which may be provided for by
law without further notice.

NOTICE TO SET
YOU ARE HEREBY NOTIFIED that an attorney for the Panel will appear in
person or by telephone at 11:15 a.m. on April25, 2014, in the Office of the Director for
the Office of Administrative Courts, 1525 Sherman St., 4th Floor, Denver, CO 80203, to
set a date and obtain a location for a hearing regarding the Complaint. You may be
present in person or by counsel, or you may make prior arrangements to be reached by
telephone at the time and date specified above by contacting the setting clerk prior to the
day of setting at (303) 866-5797. If you fail to appear, a date will be obtained and you
will be notified in writing of the hearing date, time and place.

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Exhibit 11

 Case 1:17-cv-00057-WYD-MEH Document 50-11 Filed 01/02/18 USDC Colorado Page 9 of 9

NOTICE OF HEARING
YOU ARE HEREBY NOTIFIED, that pursuant to Sections 12-36-118, 24-4-104
and 24-4-105, C.R.S., a hearing will be held before an authorized administrative law
judge pursuant to the Complaint for the purpose of detennining whether you engaged in
unprofessional conduct as set forth in section 12-36-117(1 )(p), C.R.S. of the Colorado
Medical Practice Act and whether your license to practice medicine in Colorado should
be disciplined pursuant to section 12-36-118(5), C.R.S.
YOU ARE FURTHER NOTIFIED that at the hearing in this matter, you shall
have the right to appear in person and/or by legal counsel, to present evidence on your
own behalf, to cross-examine any witnesses presented by the Board and to rebut any
evidence presented by the Board. You may also have subpoenas issued on your behalf
upon request to the administrative law judge.
Respectfully submitted this 19th day of March, 2014.

JOHN W. SUTHERS
Attorney General

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L SON R. AlLER, 33008*
Assistant Attorney General
Medical Board Unit
Business & Licensing Section
Attorneys for Panel A
Ralph L. Carr Colorado Judicial Center
1300 Broadway, 8th Floor
Denver, Colorado 80203
Telephone: 720-508-6392
Email: Allison.Ailer@state.co.us
*Counsel of Record

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Exhibit 11