Thursday, October 16, 2003

Update: Divided FDA Approves Silicone Breast Implants

The FDA has reapproved silicone breast implants by a 9-6 vote. Here's Gina Kolata's NYT report. The approval is contingent on education of surgeons and patients, and on continued monitoring of women who receive implants.

One is sniffing involvement by litigators in forging this grand design. If frequent complications spark new litigation, will all this "education" help insulate the manufacturer from liability? If that's the plan, it just might work -- at least if the notion of informed consent is observed in fact and not merely in form.

posted by pn at 2:06 AM  

Fed. R. Evid. 702: If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.