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Roger
Roger, Attorney
Category: Legal
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Im trying to find the Law in the state of CA that protects

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I'm trying to find the Law in the state of CA that protects patients from being left with FDA ruled adulterated device in their bodies by the implanting physician.
There must be a law that says a doctor MUST inform a patient if the device he is using is a Class 3 device, on a trial, unapproved, and/or when he learns of the FDA's reason for not approving it that he MUST inform the patient of the dangers of the device the moment he is aware.

How do I find this Law? It must exist to protect patients from being left with toxic products in their bodies.

Kirk Adams : Hi - my name is XXXXX XXXXX I'm a litigation attorney. Thanks for your question.
Kirk Adams : These laws are known as "informed consent" laws.
Kirk Adams : Here's a link to the California laws that relate to a medical provider's responsibility to inform the patient of all aspects of a medical procedure in order to establish that the patient consents to treatment: http://www.canhr.org/stop-drugging/archives/191
Kirk Adams : Here's the most relevant statute:
Kirk Adams : California Code of Regulations, Title 22, Section 72527(a)(3), (4) & (5), 72527(e)(a) Patients have the rights enumerated in this section and the facility shall ensure that these rights are not violated. The facility shall establish and implement written policies and procedures which include these rights and shall make a copy of these policies available to the patient and to any representative of the patient. The policies shall be accessible to the public upon request. Patients shall have the right:(3) To be fully informed by a physician of his or her total health status and to be afforded the opportunity to participate on an immediate and ongoing basis in the total plan of care including the identification of medical, nursing and psychosocial needs and the planning of related services.(4) To consent to or to refuse any treatment or procedure or participation in experimental research.(5) To receive all information that is material to an individual patient’s decision concerning whether to accept or refuse any proposed treatment or procedure. The disclosure of material information for administration of psychotherapeutic drugs or physical restraints or the prolonged use of a device that may lead to the inability to regain use of a normal bodily function shall include the disclosure of information listed in Section 72528(b).(e) Patients’ rights policies and procedures established under this section concerning consent, informed consent and refusal of treatments or procedures shall include, but not be limited to the following:(1) How the facility will verify that informed consent was obtained or a treatment or procedure was refused pertaining to the administration of psychotherapeutic drugs or physical restraints or the prolonged use of a device that may lead to the inability of the patient to regain the use of a normal bodily function.(2) How the facility, in consultation with the patient’s physician, will identify consistent with current statutory case law, who may serve as a patient’s representative when an incapacitated patient has no conservator or attorney in fact under a valid Durable Power of Attorney for Health Care.
Kirk Adams : If you were not properly informed of the procedure, the devices being used in the procedure, etc., then you would likely have a claim against the medical provider for negligence, and for damages related to/stemming from the damage.
Customer:

Thanks Kirk, I was implanted with a device and just weeks after while still in the doctors care the device was ruled "adulterated" by the US FDA and "not safe and effective for use in the body as the long term health effects are unknown". I continued to see the doctor for a month after and contacted him several times within 18 months following my surgery and NEVER ONCE did he mention the implant was banned by the FDA.

Kirk Adams : Wow - - I'm sure this has been a VERY stressful situation given that your health is at issue.
Kirk Adams : The fact that the medical provider never followed up with you and never informed you of the issue and options to remedy the situation certainly sounds negligent.
Customer:

I lived with it in my body for 12 years, the last several I became Ill and underwent test after test to try to figure out what was wrong. Then in May of 2012 I saw a new special on ABC and they mentioned the dangers of the device I had in that report. I of course freaked, contacted the doctor who is now retired and asked him to pay for me to get them removed. He would never speak to me. Instead he hired an attorney whom I tirelessly negotiated with until 1 day before my statute of limitations expired. The doctors Insurance provider offered to pay to help me get them removed but the doctor would not approve it, have any mediation with me which I offered to happily do. Nothing. He claims that he "didn't know" the status of that device and feels it never made me ill. Like he gets to make that call? The FDA already said it was toxic. Anyway I ended up having to sue him in small claims court because of the Micra statute in CA. It makes it impossible for me to get an contingent attorney as the case is expensive to pursue.

Customer:

My case will be this month if he doesn't file for an extension. He is still retaining an attorney to advise him for court and had them contact me to request a new date so the retired doctor can go on vacation. Unbelievable.

Customer:

Thank you for the help

Kirk Adams : Sure. Glad to help. The WORST thing about MICRA is the very short statute of limitations for a medical malpractice action.
Kirk Adams : Doctors with deep pockets have been able to woo legislatures all over the country to cap damages and shorten statutes of limitaiton.
Customer:

Well in my case it's a year from my date of discovery to sue the doctor. That's what I used and I stuck to suing for 10K even though my expenses to correct it have been higher. That is not addressing ANY of the health stuff. Just the fix

Customer:

I think I have an excellent case. It's hard to believe he wouldn't allow the Ins Co. to help pay for the fix.

Kirk Adams : If the doctor is retired, he likely has very little concern about how this turns out because it's not going to impact his practice AND the insurance company is going to pay any damages - - so the doctor is likely not very concerned about this from a legal perspective.
Customer:

Well in a Small Claim he will have to pay. The ins Co. will no longer cover him.Signing off. Thank you again. Pray for my success in the court proceedings. There are so many women he has never told that my be really sick or dead today. He needs to be accountable somehow.

Kirk Adams : Glad to help. I hope that all works out for you and that the judge will award you for the damages you've suffered. Nothing can repay you or give you back what this device likely has taken from you, but it is really the only recourse you have at this juncture.
Customer:

:O) yes sir take care

Kirk Adams : Thanks, XXXXX XXXXX do the same.
Kirk Adams : Please let me know if you have any additional questions.
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