A patient in Japan has reportedly filed suit against an adipose stem cell clinic and has won a judgement of 1.84 million yen in total (about $15,000 USD).
The Tokyo District Court reportedly ruled in favor of the patient and most of the award is reimbursement. Authors Ikka, et al report on the case and changes in Japanese law overseeing regenerative medicine in a new Cell Stem Cell piece.
The Mainichi reports that the female patient sought treatment from the stem cell clinic for “numbness of the body”. Mainichi also says that the clinic in question is “The Sakura Clinic” in Shibuya-ku, Tokyo. I am looking to independently confirm this. The stem cell clinic website makes many surprising claims such as gene therapy for all cancer and stem cell therapies.
The judgment included half a million yen “on the grounds of a breach of the Obligation of Explanation.” This sounds like improper informed consent.
Without referring to the clinic’s name and only “X clinic”, Ikka and colleagues (Tsunakuni Ikka, Misao Fujita, Yoshimi Yashiro, Hiroshi Ikegaya) summed it up this way:
“Although the sole point of dispute in the lawsuit was the breach of the Obligation of Explanation, the real issues in this case were, in our understanding, the propriety issues surrounding the medical care actions themselves, namely the issues involving the risks inherent in the actions performed by X clinic (the performance of allogeneic ADMSC infusion therapy for a patient who had undergone a kidney transplant, despite the unverified safety and efficacy of the therapy and the surgeon’s failure to diagnose the patient’s numbness) and X clinic’s medical care provision system (administering cells in the patient’s home).”
I expect we’ll see more such lawsuits in the US and other parts of the world.