37th United States Congress

A settlement has been reached in a whistleblower class action lawsuit brought against Endoscopic Technologies Inc (Estech) who is accused of marketing its medical devices for uses other than what is approved by the U.S. Food and Drug Administration (FDA).

The whistleblower will receive $210,000 as a recovery reward.

The case was originally filed by a whistleblower.  The United States' complaint alleged Estech marketed its medical devices to treat atrial fibrillation (the most common cardiac arrhythmia or abnormal heart rhythm), a use that is not approved by the FDA). The government also alleged that Estech promoted expensive heart surgeries using the company’s devices when less invasive alternatives were appropriate, advised hospitals to up-code surgical procedures using the company’s devices to inflate Medicare reimbursements, and paid kickbacks to healthcare providers to use its devices. The United States asserted that by engaging in this conduct, Estech knowingly violated the Food, Drug and Cosmetic Act and caused the submission of false and fraudulent claims in violation of the False Claims Act.

A settlement has been reached in a whistleblower class action lawsuit brought against NuVasive Inc who is accused of causing health care providers to submit false claims to Medicare and other federal health care programs.

According to the settlement agreement, the federal share of the civil settlement is $12,583,413.84, and the state Medicaid share of the civil settlement is $916,586.16. The whistleblower will receive a $2.2 million share of federal reward.

The whistleblower case was originally filed in September 2012.  The United States complaint alleged that between 2008 and 2013, NuVasive promoted the use of the CoRoent System for surgical uses that were not approved or cleared by the FDA, including for use in treating two complex spine deformities, severe scoliosis and severe spondylolisthesis.  As a result of this conduct, the United States alleged that NuVasive caused physicians and hospitals to submit false claims to federal health care programs for certain spine surgeries that were not eligible for reimbursement.  In more detail, the government complaint asserts NuVasive knowingly offered and paid illegal remuneration to certain physicians to induce them to use the CoRoent System in spine fusion surgeries, in violation of the federal Anti-Kickback Statute.  The illegal remuneration consisted of promotional speaker fees, honoraria and expenses relating to physicians’ attendance at events sponsored by a group known as the Society of Lateral Access Surgery (SOLAS).  SOLAS was allegedly created, funded and operated solely by NuVasive, despite its outward appearance of independence.      

A settlement was reached to resolve False Claims Act allegations against Ultralife Corporation, formerly known as Ultralife Batteries Inc., who is accused of failing to provide current, accurate and complete cost and pricing data related to three contracts with the U.S. Army.

In each of the three contracts at issue, Ultralife was alleged to have knowingly provided government contracting personnel with false certifications concerning the company’s cost and pricing information, which was not current, accurate and complete as required by law. As a result of the defective price disclosures, the Army paid inflated prices for the batteries it purchased.

A settlement has been reached in a whistleblower class action lawsuit brought against Midtown Imaging LLC, a radiology clinic, and its former owners Midtown Imaging P.A. and PBC Medical Imaging. They are accused of submitting false claims to Medicare during the period 2000 through 2008.

The whistleblowers will share in $600,000 of the government's recovery.

Originally filed in November 2009, the United States alleged that the West Palm Beach clinic is alleged to have submitted false claims to Medicare during the period 2000 through 2008 by entering into certain leasing and professional services agreements with referring physicians and physician groups that violated the Anti-Kickback Statute and Stark Law.