title: Liability versus innovation: the legal case for regenerative medicine.
abstract: Medical innovation occupies a position somewhere between standard practice and clinical research, but innovation is primarily intended to benefit an individual patient where standard treatment fails. Medical innovations in the area of regenerative medicine have the potential to completely transform medical practice, but rely upon some major revision to the nature of treatments beyond drug-based therapies. There is considerable investment in scientific and clinical research, but further attention could be paid to legal barriers to medical innovation imposed by the threat of medical malpractice. We survey in this article the legal framework for making determinations of medical malpractice in general, and highlight the issues specific to innovative treatments. In essence, liability could be imposed for failing to adequately inform the patient about the innovative nature of the suggested therapy or based on the fact that the risks outweighed the benefits. As for the latter, we examine whether liability is likely to be based merely on deviating from existing practice or on an examination on the merits of the treatments' risks and benefits. The facts that some risks are unforeseeable and some benefits are external to the patient complicate negligence determinations. The first fact relates to the problem of judging adverse events in hindsight; the second, to the obligation to make decisions based on the patient's best interest and avoid conflict of interests. In addition, we evaluate the relationship between the obligations to secure the patient's informed consent and to avoid clinical negligence. We identify the need for further research to examine the significance of the putative anti-innovation bias that current liability regimen has, and to examine whether a move to strict liability might avoid such bias, while being fair to patients who contribute for the advancement of medical knowledge by participating in innovative therapies.
authors.affiliation: 1 School of Law, Keele University , Stoke-on-Trent, United Kingdom .
authors.forename: Tsachi
authors.initials: T
authors.lastname: Keren-Paz
authors.forename: Alicia J
authors.initials: AJ
authors.lastname: El Haj
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D008318:Malpractice / Q000331:legislation & jurisprudence*; D010349:Patient Compliance; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence / Q000592:standards; D018570:Risk Assessment; D059039:Standard of Care / Q000331:legislation & jurisprudence / Q000592:standards