Federal prosecutors allege that Allergan knowingly sold LAP-BANDs with defective or flawed access ports and lied to the FDA about the cause of the leaks.
Drug and medical device maker Allergan Inc. will pay $3.5 million to resolve whistleblower allegations that it knowingly sold defective LAP-BAND surgical gastric bands to healthcare providers, the Department of Justice said.
"Patients have every right to expect that medical devices used during surgery are free of defects," Robert K. Hur, U.S. Attorney for Maryland, said in a media release.
"Patients also have the right to expect that procedures involving medical devices have been subject to the rigorous review and approval process of the Food and Drug Administration," Hur said. "When marketing and selling medical devices that may have defects or may be used in unapproved procedures, patients can be put at risk."
An Allergan spokesperson on Wednesday declined to comment on the settlement.
The LAP-BAND is an inflatable silicone band that is placed around a patient’s stomach during surgery. Adding or removing saline through a subcutaneous access port adjusts the LAP-BAND, which constricts or expands the size of the stomach pouch.
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Federal prosecutors allege that between 2008 and 2010 Allergan knowingly sold LAP-BANDs with defective access ports. To conceal the defect and to induce healthcare professionals to continue using the LAP-BAND, Allergan misrepresented facts concerning the cause of access port leaks to the public and the FDA.
Allergan allegedly failed to collect data and complaint files, nor did it provide remuneration to clinicians who reported access port leaks, DOJ said.
In addition, prosecutors allege that between 2008 and 2012, Allergan knowingly advertised, marketed, and distributed LAP-BAND for use in two procedures that were not approved by the FDA.
Allergan allegedly induced clinicians to use LAP-BAND for these unapproved procedures through proctoring, workshops, advisory boards, and training events in which these two uses were discussed and/or demonstrated.
The two whistleblowers who brought the suit will split $594,064, the federal government will collect $3.3 million, and state Medicaid programs will receive $200,000.
The settlement was filed with the U.S. District Court in Maryland.
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.