An employee whistleblower who last year filed a civil whistleblower claim against Johnson & Johnson over business practices at Acclarent, a company that Johnson & Johnson acquired in 2010, has netted the employee $3.5 million in a whistleblower award from the federal government. Because of the information brought to the federal government by the employee whistleblower, the Department of Justice was able to establish a case against Johnson & Johnson and the company agreed to pay $18 million to settle the claims.
The Allegations Against Acclarent
In her complaint, former Accelerant employee Melayna Lokosky alleged that Accelerant illegally marketed its Relieva Stratus MicroFlow Spacer (Stratus) to doctors as a drug delivery device, despite the fact it had not been approved for that use by the FDA, causing doctors and medical servicers to submit false claims to the federal government based on the use of the Stratus.
Accelerant had received approval from the FDA in 2006 to market the Stratus to be used as a spacer to keep nasal passages open following surgery, but, according to allegations in the whistleblower lawsuit, the company marketed the Stratus to be used to deliver prescription corticosteroids, and specifically to deliver a drug called Kenalog-40.
The FDA had actually denied the company’s application to have the Stratus approved for use as a drug delivery device in 2007, but the company went ahead and marketed it to physicians for that exact purpose. Evidence indicated that the company created a video for doctors showing the Stratus being used with a substance that appeared to be Kenalog-40 and demonstrated it to doctors by using Kenalog-40. Even after adding a label saying it was not for use as a drug delivery device in 2010, the company continued to market it for that very purpose.
The Federal Government Will Reward Facts Showing Off-Label Use
In announcing the $18 million fine against Johnson & Johnson and $3.5 million reward for Melayna Lokosky, the Department of Justice made it clear that it will take allegations of off-label marketing (marketing for uses not approved by the FDA) by drug and medical device very seriously. The Special Agent in charge of the investigation stated, “It is imperative that medical device companies adhere to FDA approval requirements so that patients are not subject to questionable medical treatments at taxpayer expense…Our investigators, working closely with our law enforcement partners, will continue to pursue allegations of such misconduct to hold fraudsters accountable and deter those tempted to launch such illegal scams.”
The Department of Justice has been increasing its focus on healthcare fraud in recent years through the creation of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, and, according to the Department, “one of the most powerful tools in this effort is the False Claims Act,” the act under which Lokosky was able to obtain the $3.5 million award.
Work With a False Claims Act Attorney to Claim Your Reward
If you are aware of healthcare fraud and have information which can show violations of the False Claims Act, you too may be eligible for a large cash award. Our experienced healthcare fraud attorneys will work with you every step of the way to determine your appropriate course of action, protect you from retaliation, and collect your much-deserved reward. If you suspect that someone is committing Medicare fraud, contact us today for an evaluation of your allegations.Johnson & Johnson Whistleblower Wins $3
