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Robert B. Vogel, MD, JD
Retinal Ophthalmologist at Piedmont Eye Center, Lynchburg VA;
Attorney, Overbey Hawkins & Wright, PLLS, Lynchburg, VA;
Adjunct Professor, Humanities and Bioethics, Liberty University School of Medicine, Lynchburg, VA.
Allergan Inc. will pay $3.5 million to resolve allegations brought against it under the False Claims Act (FCA). The allegations surround Allergan’s LAP-BAND device, which is used by physicians to assist obese patients with weight reduction.
The LAP-BAND is an adjustable gastric banding system made of an inflatable silicone band. The band is surgically placed around a patient’s stomach, and its tightness can be adjusted from an external port.
The federal government alleged that between January 2008 and November 2010, Allergan knowingly sold LAP-BAND devices with defective or flawed access ports.
According to the allegations, Allergan knew that the ports were prone to leakage, but misrepresented the facts to the public, physicians, and the Food and Drug Administration (FDA). The government also alleged that Allergan offered and provided remuneration to physicians who reported access leaks.
The complaint further alleged that Allergan knowingly advertised, marketed, and distributed the product for procedures not approved by the FDA.
The $3.5 million payment will be shared by federal and state Medicaid programs, as well as the whistleblowers, who will receive approximately $600,000.
The resolution does not involve admission of civil liability by Allergan. At press time, there was no statement regarding these allegations on the company’s website.