FDA Targets Gastric Band Surgery Advertisements
In late 2011, the U.S. Food and Drug Administration (“FDA“) launched an initiative targeting marketers of gastric band surgery following the death of five patients. The FDA is concerned that gastric band advertisements glamorize the surgical procedure without communicating any of the risks. Many of these advertisements feature slender men and women claiming to have lost massive amounts of weight and gained control of their lives solely as a result of undergoing gastric band surgery.
Gastric banding is a surgical procedure intended to reduce the size of the stomach for weight loss by placing a silicone band around the upper portion of the stomach to create a small pouch. As of todays date, the FDA has approved two gastric banding devices, the Lap-Band by Allergan, Inc. and the Realize Adjustable Gastric Band by Ethicon Endo-Surgery, Inc.
Pursuant to the Federal Food, Drug and Cosmetic Act (“FDCA“), product advertising for certain medical devices, such as gastric bands, must contain relevant warnings and information regarding precautions, side effects, and contraindications. Advertisements that do not contain all of the required information are considered misleading. As a result of misleading advertisements, the medical device will be deemed to be misbranded.
On December 13, 2011, the FDA issued Warning Letters for misleading gastric band advertisements and misbranded gastric band devices to eight surgical centers and one marketing firm. On June 25, 2012, the FDA issued another Warning Letter to a doctor for Lap-Band advertisements which misbrand the device pursuant to Sections 502(q), 502(r), and 201(n) of the FDCA. The Warning Letters stated that the advertisements failed to reveal material facts, including relevant risk information regarding the use of the gastric band, age and other qualifying requirements for the procedure, and the need for ongoing modification of eating habits, as provided in the approved gastric band device labeling.
FDA Warning Letters notify the recipient and the public that the FDA believes that a particular firm has violated federal law. Thus, given the bad publicity that these letters generate, it is advantageous for firms to correct possible violations even before the FDA issues Warning Letters. The recipients of Warning Letters have 15 days to address the misbranding issues contained in the Warning Letter and to develop specific corrective actions. Failure to do so may put the recipient in jeopardy of facing product seizures or formal legal action by the FDA. Although some courts have previously ruled that Warning Letters are not immediately challengeable in federal court, the United States Supreme Courts recent ruling in Sackett v. EPA (which we discussed here) may have created a sea change in that jurisprudence. We will follow this issue closely, both for our clients and this blog.
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