On April 16, 2018, the United States Attorney for the District of Maryland announced that Allergan Inc. (“Allergan”) has agreed to pay $3.5 million to resolve allegations that Allergan caused health care providers to submit false claims to Medicare and other federal healthcare programs relating to the LAP-BAND Adjustable Gastric Banding System, a device approved by the FDA for weight reduction for adult patients with obesity who have failed more conservative weight-reduction alternatives.
Allergan distributed, marketed, and sold the LAP-BAND, an inflatable silicone band that is placed around a patient’s stomach during a surgical procedure. Adding or removing saline fluid through a subcutaneous access port adjusts the LAP-BAND, which in turn constricts or expands the size of the stomach pouch.
The United States alleged that between January 2008 and November 2010, Allergan knowingly sold LAP-BANDs with defective or flawed access ports. The government alleged that in order to conceal the defect or flaw and to induce health care professionals to continue using the LAP-BAND, Allergan misrepresented facts concerning the cause of access port leaks to the public, health care professionals, and the FDA; failed to collect or maintain required data and complaint files; and offered and provided remuneration to health care professionals who reported access port leaks.
The United States further alleged that between 2008 and 2012, Allergan knowingly advertised, marketed, and distributed the LAP-BAND for use in two procedures that were not approved by the FDA. The government alleged that some of these procedures were not reasonable and necessary for the diagnosis or treatment of an illness or injury. The government further alleged that in order to market and to induce health care professionals to use the LAP-BAND for these uses, Allergan provided remuneration to health care professionals in connection with proctoring, workshops, advisory boards, and training events in which these two uses were discussed and/or demonstrated.
The Federal share of the civil settlement is $3,300,360 and the state Medicaid share of the civil settlement is $199,640. The two whistleblowers will receive approximately $594,064 from the settlement. The civil lawsuit was filed in the U.S. District Court for the District of Maryland under the whistleblower provision of the False Claims Act, which permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the government’s recovery. The federal case is captioned United States ex rel. Schwartz and Tinsley v. Allergan, CCB-10-2796.
If you have information regarding false claims having been submitted to Medicare, Medicaid, TRICARE, other federal health care programs, or to other federal agencies/programs, and the information is not publically known and no actions have been taken by the government with regard to recovering the false claims, you should promptly consult with a False Claims Act attorney (also known as qui tam attorneys) in your U.S. state who may investigate the basis of your False Claims Act allegations and who may also assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
Click here to visit our website or call us toll-free in the United States at 800-295-3959 to be connected with qui tam lawyers (False Claims Act lawyers) in your U.S. state who may assist you with a False Claims Act lawsuit.
Turn to us when you don’t know where to turn.