Allergan LAP-BAND: Payments to Clinicians Who Reported Leaks

Allergan agreed to pay $3.5 million in a LAP-BAND access port settlement over allegations that it sold defective ports, concealed their defects and promoted unapproved procedures. The government alleged that the company misrepresented why ports leaked, failed to keep required complaint records and paid clinicians who reported leaks to keep them using the device. For someone inside quality, sales or clinical training, the case connects what the company heard about its product with what it did to keep selling it.

The Justice Department announced the civil settlement on April 16, 2018. It alleged that New Jersey-based Allergan caused health care providers to submit false claims to Medicare and other federal healthcare programs. The case began with a whistleblower lawsuit under the False Claims Act.

The Access Port Controlled the Band

The LAP-BAND is an inflatable silicone band placed around a patient’s stomach during surgery. Clinicians adjust it by adding or removing saline through an access port beneath the skin. That adjustment constricts or expands the stomach pouch. Allergan distributed, marketed and sold the system.

The device’s approved purpose was weight reduction for adults with obesity who had failed more conservative alternatives. The access port was part of how the device worked after implantation: it provided the route for changing the band’s inflation. The company’s explanation for a leak mattered to clinicians deciding whether to keep using the band.

Access-Port Leaks and Missing Complaint Files

The United States alleged that Allergan knowingly sold LAP-BANDs with defective or flawed access ports between January 2008 and November 2010. According to the settlement announcement, the company misrepresented the causes of leaks to the public, health care professionals and the Food and Drug Administration to conceal the problem and encourage continued use.

The government also alleged that Allergan failed to collect or maintain required data and complaint files. A series of leak reports can show a pattern inside the business. Device reporting rules recognize that analyzing trends can alert a manufacturer to a problem needing corrective action.

The clinicians reporting access-port leaks were also clinicians to whom Allergan allegedly offered and provided financial benefits. The government described those benefits as part of the effort to conceal defects and keep clinicians using the LAP-BAND. The doctor reporting a leak was also a customer Allergan wanted to keep. Patients relied on the implanted device, while Medicare and other government programs faced claims tied to the alleged concealment and promotion.

For an insider, the useful comparison is between the report that arrived, the explanation that went back out and the complaint record left behind. We examine those alongside payments to the reporting clinician. The connection between those records can explain how a quality problem became a decision about sales.

Unapproved Procedures Promoted Through Training

The government separately alleged that, between 2008 and 2012, Allergan advertised, marketed and distributed the LAP-BAND for two procedures the FDA had not approved. It alleged that some of those procedures were not reasonable and necessary to diagnose or treat illness or injury.

Here, the alleged payments accompanied proctoring, workshops, advisory boards and training events where the uses were discussed or demonstrated. The government said Allergan provided those benefits to market the uses and induce clinicians to perform them.

For a clinical trainer or sales representative, an event calendar becomes more informative when read with the presentation and the payment record. What technique did the session demonstrate? What was the clinician paid to do? Which use was the company trying to encourage? Those are the connections we examine with someone who knows what happened inside the program.

When Training Is Tied to Future Sales

The whistleblower complaint against NuVasive alleged that the company paid training expenses for surgeons who had used its devices and expressed interest in using more.

In the Allergan case, the government identified paid events at which the unapproved uses were discussed or demonstrated.

How the Device Sale Reached a Government Claim

The payment request came from the provider using the device. The government’s account connected Allergan’s defect representations and promotion to those downstream bills.

A 2020 analysis in the Journal of Forensic and Investigative Accounting, A Forensic Accountant’s Guide to the Most Potent Federal Laws Used Against Healthcare Fraud, asks whether a false statement got the government to pay a claim it should not have paid. Applied here, that means following the explanation of a leak or the promotion of a procedure through to the provider’s bill. The complaint file explains what the company knew. The training and payment records explain what it encouraged. The claim connects those decisions to public money.

What an Insider Can Connect

Quality staff, clinical trainers and sales employees see different parts of the same sequence. Complaint files record what clinicians reported and how the company classified the problems. Training materials describe the procedure being encouraged. Proctoring and advisory-board records identify the purpose and recipient of a payment.

Our whistleblower experts work with you to connect the product problem, the people making commercial decisions and the care billed to a government program. In a case shaped like these allegations, a dated leak report and the company’s response can matter alongside an event agenda or clinician payment. Your knowledge of what those records mean inside the business helps explain why the decisions were made.

The Civil Settlement and Whistleblower Recovery

The civil settlement included money for the federal government and state Medicaid programs. The announcement also provided a share of the settlement for the whistleblowers who brought the case in the District of Maryland.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Saw the Complaint and the Commercial Response

If you know how a device company answered leak complaints or paid clinicians to promote unapproved procedures, speak to one of our Whistleblower Experts about what you saw. We build your strongest medical device whistleblower case with you, bring in medical device whistleblower lawyers who understand defect concealment and physician payments, and stay beside you through the pursuit of a recovery.