The U.S. Attorney’s Office for the Southern District of Florida announced on December 9, 2016 that two Florida men were indicted on December 8, 2016 and charged with conspiring to misbrand and sell for profit expired medical devices, i.e., Gastric Banding Systems.
The two men were indicted on a single count of conspiracy to commit wire fraud in violation of Title 18, United States Code, Section 1349; three counts of wire fraud, in violation of Title 18, United States Code, Section 1343; a single count of conspiracy, in violation of Title 18, United States Code, Section 371; and, six counts of misbranding devices after shipment in interstate commerce, in violation of Title 21, United States Code, Section 331(k).
The indictment reportedly charges that between June 2014 and October 15, 2015, the two defendants, who were employees of Apollo Endosurgery, Inc., where they served as Senior Account Executives between June 2014 and August 2015, engaged in a scheme to unlawfully enrich themselves by misbranding LAP-BAND Adjustable Gastric Banding Systems, changing the serial number and expiration date in order to sell expired medical devices for profit.
The indictment alleges that one of the men would purchase expired or nearly expired LAP-BANDS through the internet and then supply the other man with these expired or nearly expired LAP-BANDs. The second man allegedly created false labels with fraudulent serial numbers and expiration dates to hide the true expiration date of the LAP-BANDs and then would provide the first man with the misbranded LAP-BANDs, the labeling of which bore false expiration dates. The first man then sold the misbranded LAP-BANDs to local physicians, according to the indictment.
What Are Gastric Bands?
Gastric bands are devices that are implanted around the upper part of the stomach to create a “pouch.” The small pouch limits the amount of food that can be eaten at one time, making the patient feel full faster and potentially lose weight.
The FDA has approved two gastric bands: Lap-Band, by Allergan Inc., and Realize Adjustable Gastric Band, by Ethicon Endo-Surgery Inc. Both bands are approved for use in adults age 18 and older who have not lost weight with non-surgical methods, such as diet, exercise or behavior modification, and have a body mass index (BMI) of at least 40 (a 5-foot-6-inch person weighing 248 pounds has a BMI of 40) or a BMI of at least 35 (217 pounds at 5-foot-6 inches) and at least one health condition linked to obesity, such as diabetes or high blood pressure.
Allergan’s Lap-Band is also approved for those with a BMI of 30 to 34 who have a health condition related to their obesity.
In 2011, the FDA warned eight surgical centers and the marketing firm 1-800-GET-THIN LLC in California about misleading advertising of the Lap-Band. The ads, placed on billboards, bus placards, newspaper advertisements, the Internet and elsewhere, featured slender, smiling men and women claiming they lost massive amounts of weight and gained control of their lives after Lap-Band surgery. The FDA’s warning letters directed the California marketing firm and surgical centers to pull their misleading ads and to notify FDA within 15 working days of action taken to correct them.
The Director of the Office of Compliance in FDA’s Center for Devices and Radiological Health stated at that time, “FDA’s concern is that these ads glamorize the Lap-Band without communicating any of the risks. Consumers, who may be influenced by misleading advertising, need to be fully aware of the risks of any surgical procedure.”
By federal law, product advertising for certain medical devices, such as the Lap-Band, must contain relevant warnings and information about precautions, side effects, and contraindications (medical reasons that make a treatment inappropriate).
If you or a loved one suffered harm due to a defective medical device, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you in a claim against a medical device manufacturer, if appropriate.
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