It seems that the patients are claiming that the doctor did not inform them that 1) CCSVI is a hypothetical medical condition and 2) there is no evidence that angioplasty corrects the condition. Ergo, they could not properly give informed consent to have the procedure done to them.
My guess is that the doctor will argue that angioplasty is an approved treatment for a number of defined venous conditions, so he didn’t need to do the procedure within an approved clinical trial, even if the venous condition was still a hypothetical one (off label use?). Ergo, the patients were properly informed of all the risks and benefits.
So, if the doctor can show that the patients both signed an informed consent release form before the had angioplasty, can the patients still claim that they did not fully consent to the procedure because the doctor did not tell them that CCSVI has yet to be proven to exist and there’s no evidence that angioplasty is the proper treatment for it.
Can the doctor argue caveat emptor? And why include Stanford in the suit?
A signed consent form does not completely protect the physician. The plaintiff can still convince a jury that they did not understand what they signed, that what they were told verbally was what was in the form was not what was actually on the paper. The conversation is the informed consent; the form merely potentially corroborating evidence of said conversation but not incontrovertible proof of it.
The “article” linked seems mor like an advertisement for the law firms than an objective report.
Looking for another source I can find this and indeed another physician who has used the procedure seems to be taking the tact drkstr anticipated:
But there is no question that the doctor needed to inform the patient that there is minimally some controversy as to whether or not the procedure can help (even if he biased the pot by stating that it his belief that it does), and that there are serious potential risks associated with it including stroke and death. Signed consent or not, independent evidence that the plaintiff did not understand the consent and understood instead that the procedure was exploratory only, to be followed by discussion after before any further action was taken (as is stated to exist in the op’s link) would be very damning.
The original link is not a news story, it is press release from the law firm. It could be anything from aggressively slanted, to highly inaccurate. I strongly doubt that it is a fair and balanced summary of the facts. And, with all respect to the injured gentlemen, I do not accept the unsupported word of anyone when millions of dollars are at stake. So, I am not ready to draw and quarter the Stanford doctor, yet.
The radiologist at Synergy Health Concepts, Dr. Arata, I have my doubts about. I imagine the only thing the FDA wants a medical professional to say it (they?) has no authority over is compounding pharmacy. I don’t understand why he would not have written up - or tried to get a clinical trial to support* - a treatment that is 90% effective, even if only for symptoms such as fatigue, head-aches, and “brain fog”, which I think are primarily self-reported.
Johnson & Johnson, Abbott, Medtronic … I know they’ve all received warning letters, possibly for marketing off-labels uses …
(And, I have to tell you, I do NOT trust the name “Synergy Health Concepts”.)
Generally, clinical trials are sponsored by the medical product company. They do additional studies on approved products to get additional uses added to the label.
Respondeat Superior. An employer can be held responsible for his employees actions, if the employee did something wrong while following the employer’s instructions. In the case of a medicine, the Chief of Medicine at the institution is responsible for making sure subordinate doctors follow the institution’s rules.
Normally in a case of Respondeat Superior, the employer will attempt to show that the employee was engaged in misbehavior that was so far outside the scope of his work that the employer could not be reasonably expected to control or foresee it happening. There’s a lot of gray area there.
Also, that’s not to say that Standford IS responsible, just that the plaintiff would like to hold them liable.
This is the part that I find most disturbing:
It’s completely indefensible to do something the patient specifically told you not to do.
Is it possible that during the investigative part the doctor found a potentially life threatening situation and had little/no choice on how to proceed?
Normally, the doctor may do whatever is necessary to aid an unconscious patient, on the assumption that if they were conscious they would probably consent. This is called “implied consent” and is normally used in situations that involve life-or-death problems like car crashes or strokes.
The problem here is that the patient already told the doctor he doesn’t want the stents. The fact that the patient gave an “informed refusal” means the patient knew the risks and still told the doctor “no.” Doing the thing the patient told him not to do is impermissable.
If a doctor cuts somebody open and for one reason, and then discovers something else is wrong, they are not usually allowed to make these kinds of decisions without consulting the patient or their designated representative. For example, if your doctor was doing an appendectomy and also found some cancer on your stomach, they wouldn’t be justified in doing surgery on your stomach without consulting you about your wishes. This has already been established in court. But then again, that was not an immediate, life or death situation (I bet the stents weren’t either).
But what you’re really asking is the tricky part: What if a patient gave an informed refusal that he didn’t want X. The doctor starts cutting, and then discovers he does need X for immediate, life-saving reasons that were NOT a part of the original brief. Is a refusal really “informed” if a person didn’t know all of the facts? Can you give X to an unconscious patient under the “implied consent” doctrine, in the belief that the new and immediately necessary information might change his mind?
My interpretation is that if something totally unforseen happened, and you can no longer consider the patient’s refusal to be “informed,” then it might be okay. But that’s just me. That question is waaay beyond my EMTB manual. If anybody knows better than I do, please weigh in.
Thanks for all the informative responses so far. I thought that all Dr. Dake needed to show was that the plaintiffs had signed release forms to prove that they were fully informed of the risks. Apparently, it’s more complicated than that.
It occurred to me that another factor that might be relevant to the case is that social media (instead of research by academics or pharm/medical device companies) were largely responsible for driving the demand for this unproven treatment: http://www.scientificamerican.com/article.cfm?id=the-youtube-cure
It’s seems that the initial promise of CCSVI and angioplasty led many MS sufferers to go online, research CCSVI/angioplasty further and actively seek doctors who would perform the surgery. And MS suffers who got it done were more than happy to share information and names.
If it can be proven that the plaintiffs went to one of these discussion forums and actively sought out further information on CCSVI/angioplasty as well as doctors who were willing to do the procedure on them, can Dr. Dake then argue that the plaintiffs were well aware of the hypothetical nature of CCSVI and the experimental status of the procedure and still proceeded to seek him out?
Also, I’m wondering if the plaintiffs’ inclusion of Stanford in their lawsuit is an attempt to get Stanford to put pressure on Dr. Dake to just settle the lawsuit asap and give the plaintiffs what they want.
Shudder. This is why pharmaceutical companies did not allow posting on their sites, to the horror of “civilians”.
“How can they stop us from saying what we think?”
Because you just might be very, very ill informed, and they could be responsible for what you say.
Probably not. (See above, sp. “ill informed”)
Possibly. OTOH, people do tend to think that there is no real danger in the 21st century.* They might real believe if they were hurt, somebody must have done something wrong.
I was working a second job in a retail establishment when the smell of ketones filled the retail area. I left my station (encouraged by the waiting customers) to get to the back room; someone who had to spray paint something decided to do it inside with the windows closed because it was cold. When I informed him that he had to stop, or I was legally required to inform OSHA (okay, I lied), he said “They couldn’t sell this stuff if it was dangerous.” He was dead serious. The manager almost believed him. Nice guys, and not stupid. (Fortunately, a customer who was an organic chemist stuck his head in and said, “She right”.)
Well, you said “completely indefensible” - clearly there are defenses available - and all we have (and I have not researched further than this thread) is the claims of the plaintiff.
While I have a tendency to agree with you on principle - “I said don’t do that” - I am also willing to bet that in the waivers/etc there is language that is very clear that the decisions of the doc once the procedure starts are covered in cases like this.
Why was the plaintiff so adamant about not wanting stents?
We don’t know that the plaintiff was adamant about not wanting stents; we know that he said several times that he didn’t want them, possibly once for each time the doctor brought them up.
He apparently wanted the test, and wanted to discuss the results of the test before treatment, a very reasonable and common position.
It doesn’t matter whether the waiver contains language implying consent for the doctor to make a decision after the procedure starts; the patient has decided, and the patient’s express wishes cannot be violated even in exigent medical circumstances – implied consent is only possible when a patient hasn’t outright refused consent.
Add to this the fact that the doctor violated the standard of care; he performed an experimental technique without approval of the IRB, and he implanted a medical device not merely outside of the approved use – he might have been clear on that, with proper patient consent – but he implanted it in a part of the body for which it was not approved, and for which there are known medical reasons not to do so. Plaintiff Zahn then experienced the exact known consequence of implanting a stent in a vein: it dislodged and entered his heart, necessitating a grueling surgery.
Methinks Dr. Dake is about to see his malpractice premiums hit the ceiling, or go down to zero.
