An ongoing investigation is looking into Boston Scientific’s business in Vietnam following the submission of a whistleblower letter detailing alleged violations of U.S. law governing international operations, the company said this month.
The disclosure was tucked into the quarterly report (PDF) that Boston Scientific filed with the U.S. Securities and Exchange Commission (SEC) on Aug. 4, covering the company’s activities and earnings throughout the second quarter of the year.
In the filing, the devicemaker said it received the whistleblower’s letter in March. The letter claims the company violated the U.S. Foreign Corrupt Practices Act with its activities in Vietnam; Boston Sci said it “is cooperating with government agencies while investigating these allegations.” A representative told Fierce Medtech on Tuesday that the company had no further comment beyond the contents of the quarterly report.
The medtech giant didn’t provide any further details about the nature or scope of the alleged violations, or about the investigation into those claims. The Foreign Corrupt Practices Act makes it illegal for American businesses and their employees to make payments or offers of any kind to foreign government officials in exchange for obtaining or retaining their business.
The law also requires that companies reporting to the SEC meet certain accounting provisions. Specifically, according to the Department of Justice, they must “make and keep books and records that accurately and fairly reflect the transactions of the corporation” and “devise and maintain an adequate system of internal accounting controls.”
Boston Scientific is far from the first devicemaker to face an FCPA probe. In the last decade, companies like Alere, Biomet and DePuy have all been targeted by DOJ investigations into their international operations.
And in 2019, the FBI launched a far-reaching investigation into more than 20 medtech developers after Brazilian prosecutors alleged that they’d formed a “cartel” that fixed prices of medical equipment and illegally paid off government officials for decades in return for public health program contracts. That group included Johnson & Johnson, Siemens, GE and Philips, among others.
Aside from the mention of the whistleblower investigation, Boston Scientific’s second-quarter earnings report showed business as usual for the company. It took in sales of more than $3.2 billion for the period—a 5.4% leap over the same time span last year and over 7% higher than its earnings for the first quarter of 2022.
Editor's note: This article was updated to include a response from Boston Scientific.