Defendant's brief - excerpt:
The gravamen of the unexamined allegations in the complaint regarding testing and billing is that Dr. Schena allegedly conspired with a particular physician for that physician to submit tests to Arrayit even though the tests were unnecessary, and that the physician gave Dr. Schena his/her identification number and that test were submitted without the physician’s knowledge. Putting aside the fact that (a) all that is known about the physician is that he/she is cooperating with the government to obtain a reduced sentence; (b) there is no discussion at all as to the source of the physician’s knowledge; and (c) much of the allegations refer generally to “Arrayit” or “others” or an “executive” at Arrayit, even if these were true they would not support prohibiting Dr. Schena from working in the laboratory. Presumably no tests have been submitted by this physician since he began working with the government, and any alleged tests under the physician’s name can be removed from the queue if they ever were there.
Prohibiting Dr. Schena from working in the laboratory to perform any testing is thus not the “least restrictive” condition given the limited historical allegation of processing unnecessary tests submitted by a particular physician. The other theory of criminal liability in the complaint is that Dr. Schena allegedly made various statements to the public and others about COVID-19 testing or other aspects of Arrayit that were allegedly inaccurate. Again, putting aside the fact that much of this appears to have been drawn from unattributed posts on a public investor message board, or parsing particular tweets that are attributed by the government to Dr. Schena, much of this conduct is from 2019 or before and, equally saliently, this does not relate to Dr. Schena’s work in the laboratory. Notwithstanding the above, as noted, Dr. Schena does not object to a prohibition on communications, including tweets or on other venues. Thus, the government’s concern about misinformation is already adequately addressed by a different condition of release. On the other hand, barring Dr. Schena from the laboratory has no connection with the allegations of inaccurate statements.
Finally, the complaint includes allegations about the COVID-19 testing performed by Arrayit and that it is somehow not in accordance with the standards by the Federal Food and Drug Administration (FDA) or results in false positives. To be clear, FDA has not “approved” any COVID-19 test in the United States, but rather there is only FDA “authorized” COVID-19 tests under emergency use authorization (EUA) which authorization is not required under FDA policy for tests developed and used in a CLIA certified high-complexity laboratory such as Arrayit. Nonetheless, Arrayit has voluntarily submitted a pending EUA application with FDA that for its COVID-19 serology test because it has validated an antibodies test with nearly one hundred percent specificity and sensitivity (the allegations about the specificity and sensitivity of Arrayit’s test for COVID-19 in the criminal complaint is inaccurate and out of date). The FDA and California regulatory bodies are the appropriate agencies to determine the efficacy of the serology testing by Arrayit; especially during the current shortage of clinical laboratories able to perform such testing across the country. Regardless, the present complaint and conditions of releases involve only Dr. Schena. Dr. Schena should be permitted to perform the work of a Laboratory Manager at Arrayit.
(Brief signed by Attorney Pickles regarding conditions of release.)
