The civil lawsuit against Stemgenex here in California has been substantially narrowed by a judge and some of the judge’ t comments were surprising in suggesting limitations in just how patients may respond to stem cell clinics or various other businesses if they are unhappy enough to consider filing suit. For further on the court’ s ruling see the previous post.
I asked the California legal expert, who prefers to remain anonymous, for take on this and at the handling of patient permission in particular.
Below is their reaction.
“ The fundamental problem appears to be the definition reported by the court:
‘ As used in this particular chapter, “ medical experiment” means:
(a) The severance or penetration or damaging associated with tissues of a human subject or the use of a medication or device, as defined in Section 109920 or even 109925, electromagnetic radiation, heat or cold, or a natural substance or organism, in or upon an individual subject in the practice or research of medicine within a manner not reasonably related to maintaining or improving the healthiness of the subject or otherwise directly benefiting the subject.
(b) The investigational use of a drug or gadget as provided in Sections 111590 and 111595.
(c) Withholding medical treatment from a human issue for any purpose other than maintenance or improvement of the wellness of the subject.
(Amended by Statistics. 1996, Ch. 1023, Sec. 205. Effective September twenty nine, 1996. )’
The “ not really reasonably related to maintaining or improving the health” offer provides an “ out” for them (Stemgenex). As the court information, they represent their product as “ improving one’ s quality of life. ” My understanding is that the law and court views the representation (intent) of the claim since the trigger here. It does not matter that they do not have compelling scientific proof of benefit because the product is “ reasonably related” to standard of living improvement in the eyes of the provider.
Traditional backdoor provision that enables people to skirt the spirit from the law.
With that said, would be concerned if they do attempt to “ consent” patients for research; because… they might undermine the “ consent” “ research” paradigm.
This case underscores the need for reasonable notification associated with patients. ”