Everyone who has had one of their tests and a health issue will sue them. How can they survive? Is their war chest that big? I can't see them getting any more money.
The real question is whether it is possible for those impacted to be able to pierce the corporate vale in anyway. IMNAL, so maybe someone familiar with these types of situations may be able to add some more color. Areas where I think there may be a case would be:
Against the executive team - Tough because they likely will not have much $$$.
Against the board - Maybe hit the directors' insurance?
Against investors who are also advisors - Probably not, but IDK?
Against the company where they had the test done if not done at Theranos? - Very likely
It's not clear in the OP, but according to the complaint, the test that the plaintiff underwent was the finger prick method:
> 76. Theranos drew blood from R.C. using its “tiny drop” finger prick method. The process was painful and was not quick as advertised. The phlebotomist struggled to secure enough blood from R.C.’s finger and had to repeat the painful process several times before collecting enough to test.
IIRC, Theranos did regular type of draws, too, as the finger prick tests weren't performing particularly well. They touted their venous draws as being more efficient and cheaper than the standard tests, though:. From their homepage:
> Our tests, including venous draws, require smaller samples than traditional labs. We also use much smaller needles. Ones designed specifically for collecting blood for children, taking the smallest sample possible. Theranos tests mean less blood, an easier process, and a clear difference in your experience.
> Our tests, including venous draws, require smaller samples than traditional labs.
This seems highly suspect, considering that their venous draws were processed on the same equipment as that used by "traditional labs", following the same procedures as those used by "traditional labs" - or so, at least, have run the company's claims, when they're arguing that only the Edison tests are invalid, and that the non-Edison tests are as reliable as those performed by "traditional labs". I don't see how both sets of claims can be true at once.
Normally nurses draw more than necessary so that the lab can do retests, or do additional tests. Once you're sticking a needle in someones vein the marginal aggravation of taking extra blood is pretty small.
So they could probably get away with taking less blood.
- Theranos' vein-stick patients, in the aggregate, got stuck more often than patients whose bloodwork was processed by other "traditional labs", because their vein stick samples didn't include the usual amount of padding; or
- Theranos' "traditional", i.e. non-Edison, results were more than ordinarily bogus, too, because they didn't have enough sample to rerun questionable results and didn't poke another hole in the patient to get more.
Obviously people are looking to cash in. The lack of details on this one is expected. What could be the starting situation in which a man is on medication for something (unstated) and his blood lipids and blood sugar come back normal when they were in reality abnormal and, further, if that abnormality had showed up the doc would have changed the meds in such a way that the heart attack wold have been prevented one month later? One one month pre heart attack you are probably pretty occluded already. Are we to assume this guy had no angina a month prior? Are we to assume that he did not but seeing a high blood sugar would have led his physician to an investigation that would have led to a cardiac study?
I do not see this as an "obvious" attempt to take advantage of Theranos' bad situation. The lawsuit claims that the patient and his doctors made medical decisions based on the test results, and those decisions likely contributed to his heart attack. That sounds like a reasonable argument to me.
Clearly you do not have a medical background and either ignored or did not comprehend what I wrote. You offer no counterargument. You are simply restating their vague argument more succinctly and asserting it is reasonable.
I agree that one month is very short to prevent an attack.
However, cardiologist De Jong for example showed that a second attack is less likely than you might expect. The severity of the situation leads to significant life changes in regularity of medicine use and healthy eating habits.
This guy did not get his wake-up call from Theranos so now he had to get it from mother nature. It must be seen if he had a right on getting the proper information or if he could expect that by using a company with experimental methods he should have taken into account that the results would not be up to par. It also has to be establish how many false negatives a company is allowed to produce.
if he could expect that by using a company with experimental methods he should have taken into account that the results would not be up to par
No!
Instruments that have not been validated are allowed to produce results, but those results have to be verified against a validated instrument. An instrument that has been validated is expected to be correct. It doesn't get excused when it's wrong. It's not like a new treatment for a disease that has no other treatment available.
Now, instruments will sometimes produce bad results. It happens; nothing's perfect. However, the instrument itself is expected to check its own results as much as it can, and alert if something might be amiss.
Also, the lab's (daily/multiple times a day) Quality Control checks will usually catch a misbehaving instrument. When QC fails and it's not the lab's fault, the lab will inform the manufacturer. It's not something they take lightly. By FDA mandate, every manufacturer of a medical device has to respond to Complaints so it will be acted upon. Quickly!
Instruments can be recalled for evidence indicating that they might produce a bad result, even if it's never actually happened.
From the http://theranos.com/test-menu only HSV1 has been cleared by the FDA. They could do this through a regulatory loophole of "laboratory developed tests". This loophole has also been used by Strand Life Sciences and Pathway Genomics and Admera Health according to a www.theverge.com article.
That's a good point. I wasn't thinking of lab developed tests. I'm aware of them, but not of the specifics that the FDA expects in terms of safety & efficacy.
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Against the board - Maybe hit the directors' insurance?
Against investors who are also advisors - Probably not, but IDK?
Against the company where they had the test done if not done at Theranos? - Very likely
I imagine that this situation goes on for years.
But to be clear, Theranos should not survive. Medicine is all about trust. Theranos appears to rightfully have nobody's trust.
> 76. Theranos drew blood from R.C. using its “tiny drop” finger prick method. The process was painful and was not quick as advertised. The phlebotomist struggled to secure enough blood from R.C.’s finger and had to repeat the painful process several times before collecting enough to test.
IIRC, Theranos did regular type of draws, too, as the finger prick tests weren't performing particularly well. They touted their venous draws as being more efficient and cheaper than the standard tests, though:. From their homepage:
> Our tests, including venous draws, require smaller samples than traditional labs. We also use much smaller needles. Ones designed specifically for collecting blood for children, taking the smallest sample possible. Theranos tests mean less blood, an easier process, and a clear difference in your experience.
This seems highly suspect, considering that their venous draws were processed on the same equipment as that used by "traditional labs", following the same procedures as those used by "traditional labs" - or so, at least, have run the company's claims, when they're arguing that only the Edison tests are invalid, and that the non-Edison tests are as reliable as those performed by "traditional labs". I don't see how both sets of claims can be true at once.
So they could probably get away with taking less blood.
- Theranos' vein-stick patients, in the aggregate, got stuck more often than patients whose bloodwork was processed by other "traditional labs", because their vein stick samples didn't include the usual amount of padding; or
- Theranos' "traditional", i.e. non-Edison, results were more than ordinarily bogus, too, because they didn't have enough sample to rerun questionable results and didn't poke another hole in the patient to get more.
Neither seems a point in favor.
However, cardiologist De Jong for example showed that a second attack is less likely than you might expect. The severity of the situation leads to significant life changes in regularity of medicine use and healthy eating habits.
This guy did not get his wake-up call from Theranos so now he had to get it from mother nature. It must be seen if he had a right on getting the proper information or if he could expect that by using a company with experimental methods he should have taken into account that the results would not be up to par. It also has to be establish how many false negatives a company is allowed to produce.
No!
Instruments that have not been validated are allowed to produce results, but those results have to be verified against a validated instrument. An instrument that has been validated is expected to be correct. It doesn't get excused when it's wrong. It's not like a new treatment for a disease that has no other treatment available.
Now, instruments will sometimes produce bad results. It happens; nothing's perfect. However, the instrument itself is expected to check its own results as much as it can, and alert if something might be amiss.
Also, the lab's (daily/multiple times a day) Quality Control checks will usually catch a misbehaving instrument. When QC fails and it's not the lab's fault, the lab will inform the manufacturer. It's not something they take lightly. By FDA mandate, every manufacturer of a medical device has to respond to Complaints so it will be acted upon. Quickly!
Instruments can be recalled for evidence indicating that they might produce a bad result, even if it's never actually happened.