Defendant’s Brief Regarding Bond and Conditions of Release — Mark Schena, No. 5:20-mj-70721-MAG (Dkt. 12, N.D. Cal.)

Summary

Todd Pickles of Greenberg Traurig filed this June 16, 2020 brief for Mark Schena, asking Judge Laurel Beeler to modify the special conditions of release so that Dr. Schena can perform technical work and engage in clinical operations in the laboratory at Arrayit Corp. Dr. Schena was arrested on June 9, 2020 on a criminal complaint and released on a bond in the amount of $2,000,000. The brief opposes any increase in the bond or any requirement of security, citing residence in California since 1980, a surrendered passport and no criminal history. It argues that the conditions barring COVID-19 testing that is not FDA approved or emergency use authorized, and barring billing of any health care insurance plan, could be construed to keep Dr. Schena out of the laboratory, and says Arrayit has a pending EUA application for its COVID-19 serology test.

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Case 5:20-mj-70721-MRGD Document 12 Filed 06/16/20 Page 1 of 5

1 Todd Pickles (SBN CA 215629)
GREENBERG TRAURIG, LLP
2 1201 K Street, Suite 1100
Sacramento, California 95814
3 Telephone: 916.442.1111
Facsimile: 916.448.1709
4 picklest@gtlaw.com

5
Defendant Mark Schena
6

8 UNITED STATES DISTRICT COURT
9 NORTHERN DISTRICT OF CALIFORNIA
10

11 United States of America, CASE NO. 5:20-mj-70721-MAG
12 Plaintiff, Defendant’s Brief Regarding Bond and
Conditions of Release
13 v.
14 Mark Schena, DATE: June 17, 2020
TIME: 10:30 a.m.
15 Defendant. CTRM: Courtroom B, 15th Floor
JUDGE: Honorable Laurel Beeler
16

18 Defendant Mark Schena hereby submits this brief regarding the conditions of release. Specifically,

19 Dr. Schena requests that the Court modify the special conditions of release, which presently contain vague

20 or ambiguous language, to permit him to perform technical work and engage in clinical operations in the

21 laboratory at Arrayit Corp. or, in the alternative, find that Dr. Schena’s work in the laboratory is not

22 prohibited by the special conditions of release. Dr. Schena also opposes any efforts to increase the bond

23 amount, including requiring security, or to impose additional conditions of release.

24 A. This is the First Time the Bond or Conditions of Release Have Been Reviewed by the Court
With Benefit of Defense Counsel
25

26 Dr. Schena was arrested on June 9, 2020 on a criminal complaint. Apparently due to the time it

27 took to transport and process him into federal custody, Dr. Schena was not placed onto the Court’s calendar

28 for an initial appearance and arraignment until June 10, 2020. Even then, there was apparently an error at

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Defendant’s Brief Regarding Bond and Conditions of Release
Case 5:20-mj-70721-MRGD Document 12 Filed 06/16/20 Page 2 of 5

1 Santa Rita such that Dr. Schena was not present for the court proceedings on June 10, 2020. Fortunately,

2 the Court ordered Dr. Schena released, imposing the conditions requested by the government, including a

3 bond in the amount of $2,000,000, and with the standard and special conditions of release. See ECF No.

4 7. At the time those conditions were imposed on June 10, 2020, Dr. Schena had not had the opportunity

5 to even meet with his Court-appointed counsel. Dr. Schena retained his current counsel at Greenberg

6 Traurig the following day June 11, 2020. When Dr. Schena had his arraignment and initial appearance

7 later on June 11, 2020, counsel advised the Court that he had only recently been retained and had not yet

8 had the chance to sufficiently consult with Dr. Schena or even review with him the terms already imposed.

9 The Court indicated that the bond amount, as well as the special conditions and terms of release, would be

10 reviewed in a further hearing before this Court. Dr. Schena has complied with those terms since imposed.

11 However, a review of Dr. Schena’s history and characteristics and the allegations in the affidavit filed in

12 this matter demonstrates that the conditions and terms imposed are not the “least restrictive further

13 conditions, or combination of conditions” to assure Dr. Schena’s attendance at all proceedings or to protect

14 the public.

15 B. There is No Danger of Flight or Non-Appearance

16 There is no colorable argument that Dr. Schena poses a risk of flight. He has resided in California

17 continuously since 1980 when he arrived for college at University of California, where he obtained his

18 bachelor of sciences degree. Dr. Schena has owned the same home here for twenty years with his wife

19 Rene, also a California resident. His family is located either in California or in Upstate New York. Dr.

20 Schena has not traveled abroad in almost three years, does not have any substantial overseas ties, and has

21 surrendered his passport to Pretrial Services as ordered by the Court. He has no criminal history at all.

22 Dr. Schena has a Ph.D. in Biochemistry from the University of California, San Francisco. Dr.

23 Schena has worked at Arrayit since approximately 1999. Arrayit is a commercial laboratory located in

24 Sunnyvale, California. Arrayit is certified by the California Department of Public Health and the Center

25 for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) of 1988. Dr.

26 Schena is an officer of the company and also the Laboratory Manager. Other than the fact that the

27 allegations mention COVID-19, the defense suspects that Dr. Schena would have been released on his

28 personal recognizance or otherwise under 18 U.S.C. § 3142(b). Certainly a $2 million bond dollar appears

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Defendant’s Brief Regarding Bond and Conditions of Release
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1 extreme given the history and characteristics of Dr. Schena and the absence of any risk of flight. Increasing

2 this amount, or imposing a requirement of security, would further be unreasonable. If anything, the Court

3 should reduce the amount of the bond. Nonetheless, the current bond amount, with Rene Schena as co-

4 signer if that is determined necessary by the Court, are more than sufficient to ensure Dr. Schena’s

5 appearance at all court proceedings and compliance with the other terms of release.

6 C. Special Conditions Potentially Prohibiting Dr. Schena From Working Are Unsupported

7 Two of the four special conditions of release are vaguely worded and potentially would prohibit

8 Dr. Schena from effectively working at Arrayit at all. To the extent this is how the government interprets

9 them, the conditions are not the “least restrictive,” particularly when considering the untested allegations

10 in the complaint.

11 Specifically, the conditions of release impose the following special conditions:

12 Defendant shall not engage, directly or indirectly, in any COVID-19 testing
that is not FDA approved or emergency use authorized. Defendant shall
13 not bill or cause to be billed any health care insurance plan, other than for
his own medical care. Defendant shall not liquidate, sell, trade, or
14 otherwise transfer shares or securities in Arrayit. Defendant shall not have
contact with any victim or witness in the case.
15

16 Dr. Schena does not object to the latter two conditions, with the request that the government provide to

17 him a list of those it considers to be a “victim or witness in the case.” With the first two conditions, these

18 could be construed to mean that Dr. Schena cannot work within the laboratory at Arrayit in connection

19 with performing the numerous other tests that are ordered by physicians in the community.

20 As noted above, Dr. Schena is, among other things, the Laboratory Manager at Arrayit. In that role,

21 Dr. Schena is involved in the technical and clinical operation of processing specimens. A third party is

22 responsible for making the test result available to physicians who have prescribed testing for their patients

23 for diagnostic and treatment purposes. A different third party vendor submits all claims on behalf of Arrayit

24 to the applicable third-party payor (i.e., group health plan, HMO, etc.) in connection with the tests

25 performed by Arrayit. Dr. Schena himself is not involved in payor negotiations or any billing aspect.

26 Rather, his work is in the laboratory facility as a scientist, where he is responsible for technical work and

27 management of the clinical operations. He is also responsible for quality control and compliance with

28 federal and state regulatory standards. Nonetheless, because the conditions refer to Dr. Schena engaging

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1 in conduct that may “caused to be billed,” there is uncertainty as to whether it applies to his any or all of

2 technical work. Dr. Schena should be permitted to continue his technical work, and nothing in the

3 complaint supports prohibiting such conduct.

4 The gravamen of the unexamined allegations in the complaint regarding testing and billing is that

5 Dr. Schena allegedly conspired with a particular physician for that physician to submit tests to Arrayit even

6 though the tests were unnecessary, and that the physician gave Dr. Schena his/her identification number

7 and that test were submitted without the physician’s knowledge. Putting aside the fact that (a) all that is

8 known about the physician is that he/she is cooperating with the government to obtain a reduced sentence;

9 (b) there is no discussion at all as to the source of the physician’s knowledge; and (c) much of the allegations

10 refer generally to “Arrayit” or “others” or an “executive” at Arrayit, even if these were true they would not

11 support prohibiting Dr. Schena from working in the laboratory. Presumably no tests have been submitted

12 by this physician since he began working with the government, and any alleged tests under the physician’s

13 name can be removed from the queue if they ever were there. Prohibiting Dr. Schena from working in the

14 laboratory to perform any testing is thus not the “least restrictive” condition given the limited historical

15 allegation of processing unnecessary tests submitted by a particular physician.

16 The other theory of criminal liability in the complaint is that Dr. Schena allegedly made various

17 statements to the public and others about COVID-19 testing or other aspects of Arrayit that were allegedly

18 inaccurate. Again, putting aside the fact that much of this appears to have been drawn from unattributed

19 posts on a public investor message board, or parsing particular tweets that are attributed by the government

20 to Dr. Schena, much of this conduct is from 2019 or before and, equally saliently, this does not relate to

21 Dr. Schena’s work in the laboratory. Notwithstanding the above, as noted, Dr. Schena does not object to

22 a prohibition on communications, including tweets or on other venues. Thus, the government’s concern

23 about misinformation is already adequately addressed by a different condition of release. On the other

24 hand, barring Dr. Schena from the laboratory has no connection with the allegations of inaccurate

25 statements.

26 Finally, the complaint includes allegations about the COVID-19 testing performed by Arrayit and

27 that it is somehow not in accordance with the standards by the Federal Food and Drug Administration

28 (FDA) or results in false positives. To be clear, FDA has not “approved” any COVID-19 test in the United

4
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1 States, but rather there is only FDA “authorized” COVID-19 tests under emergency use authorization

2 (EUA) which authorization is not required under FDA policy for tests developed and used in a CLIA-

3 certified high-complexity laboratory such as Arrayit. Nonetheless, Arrayit has voluntarily submitted a

4 pending EUA application with FDA that for its COVID-19 serology test because it has validated an

5 antibodies test with nearly one hundred percent specificity and sensitivity (the allegations about the

6 specificity and sensitivity of Arrayit’s test for COVID-19 in the criminal complaint is inaccurate and out

7 of date). The FDA and California regulatory bodies are the appropriate agencies to determine the efficacy

8 of the serology testing by Arrayit; especially during the current shortage of clinical laboratories able to

9 perform such testing across the country. Regardless, the present complaint and conditions of releases

10 involve only Dr. Schena. Dr. Schena should be permitted to perform the work of a Laboratory Manager at

11 Arrayit.

12 D. Conclusion

13 The Court should find that Dr. Schena’s work in the laboratory as the Laboratory Manager at Arrayit

14 is permitted under any terms and conditions of release. No further conditions should be imposed, including

15 requiring security for the bond.

16 Respectfully,

17 DATED: June 16, 2020 GREENBERG TRAURIG, LLP

20 By
Todd Pickles
21 Defendant Mark Schena
22

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Defendant’s Brief Regarding Bond and Conditions of Release

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