Atlanta Off-Label Marketing Lawyer
Medical devices and prescription drugs need Food and Drug Administration (FDA) approval before they can be sold. This approval process is grueling. Manufacturers must run tests showing the safety of their products, and the FDA ends up approving them for certain uses.
Off-label marketing consists of promoting devices or pharmaceuticals for use the FDA hasn’t yet approved. This practice not only endangers public safety, but it constitutes fraud. When government insurance programs pay for off-label use, they are bilked out of millions of dollars.
At Stacey Evans Law, our Atlanta healthcare fraud lawyer has ample experience helping whistleblowers bring off-label marketing cases to the attention of government regulators. Contact us today to learn more.
A Closer Look at Off-Label Marketing
Many patients have been prescribed prescription drugs for off-label use. And, in reality, the law allows doctors to do so when they believe it is in the patient’s best interest.
However, federal law prohibits pharmaceutical or medical device manufacturers from promoting this off-label use. Manufacturers cannot reach out to doctors encouraging them to use products for purposes that haven’t been approved by the FDA.
In some extreme cases, manufacturers might promote experimental devices or drugs that have not received any approval from the FDA, for any use. This is also an example of off-label marketing.
Sometimes, doctors participate in off-label marketing. They might allow manufacturers to quote them promoting off-label use, or they might accept payment to give lectures around the country promoting an unapproved use. Manufacturers might also offer kickbacks to medical providers to use drugs or devices “off label.” A kickback is anything of value—such as payment or discounts on products—to induce a provider to use a given product.
How to Fight Off-Label Marketing
Off-label marketing can break a host of laws. If Medicare or Medicaid are billed for these drugs or devices, then the federal False Claims Act (FCA) is implicated. It is illegal to submit a claim to a federal program fraudulently, and billing these programs for off-label products could constitute fraud.
The government relies on whistleblowers with inside information to identify fraudulent schemes, including off-label schemes. If you know of any off-label marketing taking place, or if you are aware of kickbacks being offered or received, you could file a qui tam lawsuit under the FCA today. The lawsuit seeks to claw back money paid for fraudulent claims, and the government might investigate or even take over the case. In some situations, the private plaintiff leads the litigation.
In our experience, many sales or account representatives are aware of improper off-label marketing taking place. Someone working at a doctor’s office might also be aware of kickbacks being accepted to prescribe drugs or devices off label.
Speak with an Atlanta Off-Label Marketing Lawyer Today
Stacey Evans Law has helped many workers blow the whistle on fraudulent activity which steals from the government. To learn more, please contact our law firm and schedule a free consultation. We can discuss how federal law protects whistleblowers and what monetary compensation is available.
