Legal guys - Theranos jury deadlocked on 3 counts.

[Hank Reardon]

So the jury is deadlocked on three counts. No indication of the other eight counts. What would that suggest? It would seem to me that if they agreed on not guilty for the other 8 then there wouldn't be much reason the be hung on three other counts. There are three counts here relating to the defrauding of actual patients. Maybe those? Seems like that might be tougher to prove.

Seems to me as if she's quite a charlatan. But I'm no lawyer. Cute though.

 

[Hank Reardon]

Never mind. Guilty on 4 counts.

 

[mcmurtry66]

Never mind. Guilty on 4 counts.

The documentary on her was entertaining

 

[UncleMark]

Never mind. Guilty on 4 counts.

I'd like someone to explain to me why this medical testing device -- which would be directly responsible for diagnonses -- wasn't required to have some kind of FDA or similar agency approval before being put into actual use.

 

[Hank Reardon]

I'd like someone to explain to me why this medical testing device -- which would be directly responsible for diagnonses -- wasn't required to have some kind of FDA or similar agency approval before being put into actual use.

Apparently there are 3 classes of medical devices, and somehow Theranos was able to claim that theirs was a Class I device, which is the classification for low-risk devices and not subject to great FDA scrutiny.

How the FDA unwittingly helped Theranos dupe America

Since Elizabeth Holmes and Theranos first duped America, not much has changed in the FDA's review practices for medical tests and devices.

www.popsci.com

"The FDA assigns medical devices to one of three categories based on risk. Class I devices, such as manual stethoscopes or toothbrushes, are considered low-risk. Class III encompasses the riskiest devices, such as implantable pacemakers. The higher the class, the greater the number of requirements a company has to meet before making the device available to consumers.

The FDA concluded in 2015 that the nanocontainer was a Class II device, which requires special labels, certain performance standards, and post-market surveillance. But Theranos claimed it was Class I and for two years was shipping it without proper clearance from the FDA."