The False Claims Act Poses Additional Risks To Medical Device Makers
Medical device manufactures who sell defective products paid for by Medicare, Medicaid, or other government health programs may face additional penalties and liability when compared to other manufacturers.
On top of the already potent enforcement tools at the Food and Drug Administration’s disposal and the risk of consumer class actions, device manufacturers who knowingly sell defective products that are paid for by the government may incur damages of up to three times the value of goods sold to the government as well as civil penalties of $11,000 per occurrence. These additional damages and penalties are provided for under the False Claims Act (“FCA”). The FCA dates to the Civil War and was intended to prevent fraud committed by suppliers of goods to the Union Army. Today, the FCA is frequently used by private individuals and the government to recover large sums of money against healthcare providers and government contractors…
“The False Claims Act Poses Additional Risks To Medical Device Makers.” Pharmaceutical Compliance Monitor (June 21, 2013)