Nicole D. Lueddeke

White-Collar Defense, Investigations

Los Angeles

In a little more than eight years at Paul Hastings, Nicole Lueddeke has moved from brand new associate to managing one of her firm's largest white-collar defense cases. Working with a team of about two dozen associates, she represents a multibillion-dollar, multinational medical technology company based in the U.S. under investigation by the SEC for having possibly violated the Foreign Corrupt Practices Act in its operations in Japan.

The Justice Department also investigated the company, but it dropped its probe after Lueddeke demonstrated to investigators that her client had violated internal controls but not the law. She continues to negotiate with SEC investigators, to whom she made a presentation late last month.

"We're about to enter into negotiations for a potential resolution," she said.

In addition, Lueddeke is managing another tricky matter for a U.S. biotech company under investigation by the Justice Department, also over possible FCPA violations. This case, however, concerns whether the company may have misrepresented cybersecurity requirements in communications about Medicare claims submitted to the FDA and other agencies.

It initially received a subpoena from the DOJ, but in the process of overseeing the company's investigation into the issue, Lueddeke discovered other potential problems related to possible off-label promotion and kickback schemes. That, she said, was "a new investigative work stream that the DOJ was potentially interested in."

The early subpoenas from the government tend to be broad and general, she said. "It's part of our job to conduct the investigation responding to the subpoena, but also kind of figure out and negotiate the scope with the DOJ," Lueddeke said.

To do that, she and her teams have to be very familiar with all the issues, including additional or ancillary issues that might crop up during an investigation "and make sure our client is ready for them and make sure that we could ... remediate them if necessary."

It also helps to know that certain prosecutors are very well versed in certain issues, such as, in this case, off-label issues. "If we see what could trigger potential off-label concerns in documents when the DOJ is looking for something else ... we know that if the DOJ sees this document, they're not going to turn a blind eye to it."

Lueddeke has represented other life science companies with other FCPA and False Claims Act problems, and in fact she obtained a certification in a healthcare compliance with a specialization on the Foreign Corrupt Practices Act.

But she also takes on other white-collar defense and investigation matters. For instance, Lueddeke represents the founder of a South Korean cryptocurrency company that collapsed in May 2022, causing a nearly $45 billion loss in market capitalization. As a result, she is now overseeing investigations by the DOJ and the SEC into alleged market manipulation and fraud. And she is working with the founder's defense counsel in Korea.

-- Don DeBenedictis