Novo Nordisk settles DOJ's manufacturing-related false claims allegations for $6.3M

Novo Nordisk will shell out $6.3 million to settle allegations from the Department of Justice (DOJ) that the company violated U.S. law by selling injection needles to the government that it manufactured in “non-designated” countries.

The settlement puts to rest allegations the Danish drug manufacturer violated the Trade Agreements Act. The law “restricts the procurement of goods under certain government contracts to purchases from specific designated countries," the DOJ’s U.S. Attorney’s Office of the District of New Jersey said in a statement. By selling products made in "non-designated countries” to the government, Novo Nordisk broke the law, authorities said.

The case involved claims running from July 2012 through November 2020 for Novo's NovoFine 30G 8-mm needles. It also included claims from May 2016 to November 2020 for NovoFine 32G 6-mm needles. The products were manufactured in countries that were not approved under the Trade Agreements Act, the government said.

The claims settled by the agreement were allegations only, and there has been no determination of liability.

Meanwhile, Novo Nordisk has been no stranger to litigation over recent years. In January, Novo Nordisk settled a three-year-old shareholder lawsuit that targeted the company’s public communications about its insulin business.

In settling that case, which was a Danish securities lawsuit, the company said its agreement contained “no admission of liability, wrongdoing or responsibility by Novo Nordisk” and that it wouldn’t make any payments to the plaintiffs.