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Ironically Holmes might end up getting her wish about all Lab Developed Tests (LDTs) needing to go through FDA approval in addition to CLIA certification, which cover the operation of a lab, not the design and validation of the machines in the lab.

This series of events will create a business case for the ages, one that MBA students will read right after they study the J&J Tylenol crisis of 1982 (http://www.ou.edu/deptcomm/dodjcc/groups/02C2/Johnson%20&%20...)

I am not familiar with the actual laws involved in this kind of case. If it were proven that a Theranos tests harmed a patient and that Theranos willingly obscured the accuracy data to regulars could Holmes be held criminally liable?

That would likely fall under a civil statute. But criminal fraud seems likely. I'd be willing to take a bet on even more trivial matters like falsification of evidence once things started to go south ("it's the coverup, not the crime"). Investigated properly this will probably blow up the FDA too.