ZDNet has an interesting article about whether or not med-tech companies should be held liable if their product fails, causing injury to a patient. It’s a very interesting question, and it seems as if a precident had been set in the 2008 Riegel vs. Medtronic case which barred lawsuits from ‘challenging the safety or effectiveness of a medical device,’ as long as the device is marketed in a form that received premarket approval from the FDA.”
So does this apply to pathology? Should it? If it does, how would it?
In my narrow experience, my initial impression is that it seems like really murky waters. First, you have to consider the approval portion the ruling. There is FDA approval for many laboratory test, but others, done in-house, may not be approved by the FDA. As per protocol, reports generated from these results are mandated to indicate in writing that the test is not FDA approved, and has been developed and validated in-house.
Which brings me to my next point: validation.
Each laboratory needs to validate their testing procedures. So, if an in-house validated, non-FDA approved test fails or malfunctions, does the doctor or the hospital become liable for damages? Well, I guess I’d draw a parallel to the conventional practice of medicine, sans technology. If the risk of a certain surgery is death, and this is well documented, and then the patient dies, then there is no malpractice, no deviation from the standard of practice that directly harms the patient occurred. So the same should be true of medical technology. Can one expect all hardware and software to be 100% accurate all the time? I suppose one could make the argument that machines are more consistent than humans, but you, and I both know that nothing is 100%. This is one of those murky areas – if the specificity of a test is 99.999% and there is ever a false negative should the company that developed the test be held liable? Personally, I’d have to say no, that is ridiculous.
Or take an example from our lab- for IHC, we used slides with a red-painted stripe to separate the control from the test sample. For whatever reason, recently the antibody would stain the control but not roll over to the sample. I suppose this is the fault of the lab; or is it the slide maker? Or is it the automated stainer? Or should the pathologist recognize a negative stain when the control works (assuming there’s no internal control in the sample). If the slide and automated stainer have been validated to work with each other, who is to blame; or is there no blame, no fault? I suppose I would have to put my foot down on my last supposition.
Nobody and no thing is perfect. Sometimes machines fail, and sometimes people fail; While we strive for perfection, we never will be. Without documentable negligence you have to be let off the hook, whether you are a doctor or the CEO of Medtronic.
If I am misguided, let me know. Also, please share your own opinion on the matter; perhaps I’m preaching to the choir, perhaps not…