When the FDA gives its stamp of approval for a medical device, it clears or approves the device for very specific uses. However, when a medical device-maker then promotes that device for a different use, the company potentially runs afoul of various laws, including the False Claims Act.
At times, it is difficult to show that the company promoted its device for a use outside of its FDA approval. However, the allegations are greatly strengthened when there is widespread evidence of company employees and representatives altering the device specifically for the unapproved use.
The government recently recovered $22.28 million in a False Claims Act qui tam settlement involving biotech company Genzyme Corporation. According to the government, the company allegedly marketed a so-called “slurry” version of its Seprafilm adhesion barrier, a thin film intended to reduce adhesions after surgery. The government alleged that while the product was FDA-approved for use in open abdominal surgery, Genzyme engaged in off-label marketing by promoting it for minimally invasive surgeries, such as laparoscopic or keyhole surgery.
To boost uses for minimally invasive surgeries, the government alleged that Genzyme sales representatives taught physicians and other staff to cut the Seprafilm sheets into small pieces, add saline and allow the pieces to dissolve until the desired consistency was reached. This “slurry,” was used by physicians in laparoscopic or “keyhole” surgeries by inserting a catheter filled with the mixture into the body and squirting it into the abdominal cavity.
According to the government, such “slurry” promotions allegedly caused hospitals and other purchasers of Seprafilm to submit false and fraudulent claims to federal health care programs for uses of Seprafilm that were not reimbursable.
More information for whistleblowers is located at the Nolan Auerbach & White website.