A 56-year old woman filed a medical malpractice case against her dermatologist for injecting non-FDA approved agent. The dermatologist in question is known for a high quality and innovative work. Three years ago he had injected hyaluronic acid filler agent to treat the sun damaged the skin of a woman patient. This woman had also received the same filler injection into her nasolabial folds around 10 years ago.
For some reasons, this patient developed multiple erythematous papule and nodules at many of the injection sites, as well as at the nasolabial site. After a year of repeated injections, she filed a medical malpractice case against him for injecting non-FDA approved agent. In the majority of US court's opinion disclosure of FDA status of a medical device is only for regulatory purposes and FDA regulation status may not be required for appropriate consent. However, in the case of…
