Monday, November 10, 2003

Fate of Breast Implant Reapproval Still in Doubt

The media gave it scant play, but this article from last Thursday's Washington Post reports that the decision on FDA reapproval of silicone breast implants may not be so final as it first seemed. Last month, an FDA advisory panel voted 9-6 to recommend reapproval. But it now transpires that the panel's chairman (who, pursuant to FDA rules, did not vote) has written a letter to FDA Commissioner Mark McClellan, urging that the advisory panel's vote was misguided and should be rejected. Among the points raised by opponents of reapproval: every plastic surgeon on the panel voted in favor of permitting the implants.
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.