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Regenerative Medicine Legal Challenges: US and Japan Cases

Explore notable legal cases in the regenerative medicine field, including lawsuits from the US and Japan. Covers timeline of legal proceedings, malpractice lawsuits, and implications for future legal issues.

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Regenerative Medicine Legal Challenges: US and Japan Cases

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  1. Until someone gets hurt:  the first regenerative medicine law suits from the US and Japan‘Dr Christine Beuermann

  2. Timeline of Legal Proceedings • 2010 – death 73 year old Korean man in Japan – RNL Bio • 2010 – Dr Robert Trossel (Dutch trained) struck off UK medical register • 2012 – RNL Bio/Human Biostar class action – LA patients, therapies administered overseas • 2012 – death Karen Hones – treatment for idiopathic bronchiectasis provided in USA by BioregenesisInstitute

  3. Karen Hones Case – Statement of Claim Young was at all times charged with the professional responsibility of conducting an ethical experiment where risks did not exceed benefits, of determining the universe of harm through proper preclinical animal studies, of properly conducting the informed consent process, of rendering proper care and treatment to Ms Hones, of properly and carefully designing and administering the experiment’s protocol in a careful and prudent fashion, of assuring that proper care and attention were provided during all periods of time during which she remained under his care and treatment, and of candidly and honestly advising her of the results and consequences of the experiment. Leigh Turner ‘ Medical malpractice lawsuit following death of stem cell recipient’ (November 27 2012) Health in the Global Village Blog

  4. Timeline of Legal Proceedings • 2015 – personal injury Elizabeth Nobel - treatment for macular degeneration provided by US Stem Cell Clinic • 2015 – Japan – first case to go to full trial – paralysis resulting from stem cell therapy for systemic numbness- breach of Obligation of Explanation established

  5. Future Legal Issues • Type of legal action • Causation • Nature of informed consent and/or negligent failure to disclose material risks • Damages for loss of an opportunity to pursue other therapies

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