The civil lawsuit against Stemgenex here in California was substantially narrowed by a judge and some of the judge’s comments were surprising in suggesting limitations in how patients may respond to stem cell clinics or other businesses if they are unhappy enough to consider filing suit. For more on the court’s ruling see my previous post.
I asked a California legal expert, who prefers to remain anonymous, for their take on this and at the handling of patient consent in particular.
Below is their reaction.
“The fundamental problem appears to be the definition cited by the court:
‘As used in this chapter, “medical experiment” means:
(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
(b) The investigational use of a drug or device as provided in Sections 111590 and 111595.
(c) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
(Amended by Stats. 1996, Ch. 1023, Sec. 205. Effective September 29, 1996.)’
The “not reasonably related to maintaining or improving the health” clause provides an “out” for them (Stemgenex). As the court notes, they represent their product as “improving one’s quality of life.” My understanding is that the law / court views the representation (intent) of the claim as the trigger here. It does not matter that they do not have compelling scientific evidence of benefit because the product is “reasonably related” to quality of life improvement in the eyes of the provider.
Classic backdoor provision that enables people to skirt the spirit of the law.
With that said, would be concerned if they did attempt to “consent” patients for research; because…they could undermine the “consent” “research” paradigm.
This case underscores the need for reasonable notification of patients.”