Date: Dec 21, 2011
Keller and Heckman Partner Rick Stearns was quoted in a December 16, 2011 article in General Surgery News titled, "FDA Squeezes California Surgery Centers for Improper Promotion of Gastric Banding." The article reported that on December 13, the Food and Drug Administration (FDA) sent warning letters to eight surgical centers in California and one marketing firm for misleading advertisements about Lab-Band System, a gastric banding technique. Several lawsuits were filed against the companies prior to FDA issuing the warning letters.
"The existence of the lawsuits and the fact that the advertising is very blatant and directly to the public make this activity higher-profile than most...FDA's position about the lack of appropriate risk information is not unusual. The safety concerns coupled with the very public nature of the advertising certainly played a big role in FDA's decision to issue the warning letters. I'm sure this is something that FDA has been aware of for a while," Mr. Stearns said in the article.