5 ms·

When they have been found guilty in a court of law ?

function_seven 11y ago
Ha. Your answer was technically correct but completely useless. Implicit in Animats' question was when that whole process happens.
- ageofwant 11y ago
  The FDA does not have the power to jail people. Determining whether the state has sufficient reason to incarnate individuals is responsibility of the justice system. People go to jail when a judge and or jury recon thats justified. The FDA will make its case when it believes it has one. Will anyone from a 10B startup go to jail ? Probably not, but we can schedule that for afternoon tea outrage.
  - function_seven 11y ago
    Again, you're spouting Civics 101 answers here. I'm familiar with how the US justice system operates. The question isn't looking for that. The FDA obviously won't have an FDA Judge send people to FDA Jail after they've been arrested by the FDA Police. Literally nobody here thinks that. But they do initiate investigations, and it is a crime to defraud or attempt to defraud the FDA. And if the FDA so chooses, they can forward their information to Justice and participate in the proceedings against the accused. They could provide the evidence of wrongdoing and increase the political pressure to act. They can do a lot to ensure that the state determines it has sufficient reason.
HarryHirsch 11y ago
But who has standing to sue? Whoever suffered a stroke because their warfarin dose was too high or too low is dead, they cannot sue any longer. Whose dose was accidentally correct or whoever was lucky enough not to suffer a stroke did not suffer harm, so they can't bring suit either. And Holmes and the board believed in good faith that their prothrombin test was accurate. No mens rea, no culpability. No prison for anyone.
- mbreese 11y ago
  The government always has standing for criminal cases (the only kind that involve jail) because the offense is against society. The families of a deceased person has standing to sue in a civil case. Any one who had a test run by the company has standing to sue as well, even if there was no harm - they did not receive the product that was advertised, namely a validated test. I doubt this will result in jail time for the principles, but they should be expecting lawsuits over this.
- alistairSH 11y ago
  The estate/heirs of the deceased have standing. And, there should be some civil remedy that costs Theranos big-time. Massive fines, one-site FDA overseers, etc. That said, I don't think I'll be sending my bloodwork to Theranos any time soon. That's some scary stuff.
  - HarryHirsch 11y ago
    Past experience with industrial accidents is that fines for safety violations resulting in death is a few ten thousand dollars. No one goes to prison ever, even if the omissions that caused the incident were grave. Here is a report on the fallout from an incident that caused four deaths and much head-shaking in the chemical engineering community: http://cenblog.org/the-safety-zone/2015/05/osha-fines-dupont-for-methyl-mercaptan-deaths/ http://cenblog.org/the-safety-zone/2015/05/osha-fines-dupont... With that background, your faith in the system is touching but unwarranted.
- ageofwant 11y ago
  The federal agency tasked with that responsibility I would naively presume, or do you prefer trial by media ? And why, exactly, would someone that acted in good faith deserve prison ?
  - brohee 11y ago
    Are you seriously asking if negligence causing an accidental death can lead to prison? Think people dying when a building in disrepair burns.

Ha. Your answer was technically correct but completely useless. Implicit in Animats' question was when that whole process happens.

ageofwant 11y ago
The FDA does not have the power to jail people. Determining whether the state has sufficient reason to incarnate individuals is responsibility of the justice system. People go to jail when a judge and or jury recon thats justified. The FDA will make its case when it believes it has one. Will anyone from a 10B startup go to jail ? Probably not, but we can schedule that for afternoon tea outrage.
- function_seven 11y ago
  Again, you're spouting Civics 101 answers here. I'm familiar with how the US justice system operates. The question isn't looking for that. The FDA obviously won't have an FDA Judge send people to FDA Jail after they've been arrested by the FDA Police. Literally nobody here thinks that. But they do initiate investigations, and it is a crime to defraud or attempt to defraud the FDA. And if the FDA so chooses, they can forward their information to Justice and participate in the proceedings against the accused. They could provide the evidence of wrongdoing and increase the political pressure to act. They can do a lot to ensure that the state determines it has sufficient reason.

HarryHirsch 11y ago

But who has standing to sue? Whoever suffered a stroke because their warfarin dose was too high or too low is dead, they cannot sue any longer. Whose dose was accidentally correct or whoever was lucky enough not to suffer a stroke did not suffer harm, so they can't bring suit either. And Holmes and the board believed in good faith that their prothrombin test was accurate. No mens rea, no culpability. No prison for anyone.

mbreese 11y ago
The government always has standing for criminal cases (the only kind that involve jail) because the offense is against society. The families of a deceased person has standing to sue in a civil case. Any one who had a test run by the company has standing to sue as well, even if there was no harm - they did not receive the product that was advertised, namely a validated test. I doubt this will result in jail time for the principles, but they should be expecting lawsuits over this.
alistairSH 11y ago
The estate/heirs of the deceased have standing. And, there should be some civil remedy that costs Theranos big-time. Massive fines, one-site FDA overseers, etc. That said, I don't think I'll be sending my bloodwork to Theranos any time soon. That's some scary stuff.
- HarryHirsch 11y ago
  Past experience with industrial accidents is that fines for safety violations resulting in death is a few ten thousand dollars. No one goes to prison ever, even if the omissions that caused the incident were grave. Here is a report on the fallout from an incident that caused four deaths and much head-shaking in the chemical engineering community: http://cenblog.org/the-safety-zone/2015/05/osha-fines-dupont-for-methyl-mercaptan-deaths/ http://cenblog.org/the-safety-zone/2015/05/osha-fines-dupont... With that background, your faith in the system is touching but unwarranted.
ageofwant 11y ago
The federal agency tasked with that responsibility I would naively presume, or do you prefer trial by media ? And why, exactly, would someone that acted in good faith deserve prison ?
- brohee 11y ago
  Are you seriously asking if negligence causing an accidental death can lead to prison? Think people dying when a building in disrepair burns.