J&J Subsidiary to Pay $18 Million for Marketing Device Off-Label

Johnson & Johnson subsidiary Acclarent Inc. has agreed to pay $18 million to resolve a False Claims Act case alleging that the company illegally marketed its device, the Relieva Stratus MicroFlow Spacer, for unapproved uses.  The FDA had only approved the use of the device, which holds the nasal passages open after surgery, with saline.  However, Acclarent allegedly marketed the device for delivery of prescription medication–a use the FDA had specifically rejected.  According to the government, the company continued to market these off-label uses even after it added a warning to the product label regarding such use.

The allegations were brought to light by a whistleblower, who will receive $3.5 million as an award for bringing the scheme to the government’s attention.

In addition to the civil case, both the former CEO and VP of Sales for Acclarent were convicted of misdemeanor counts of introducing adulterated and misbranded medical devices into interstate commerce.

Read the DOJ press release