George B. Breen, Member of the Firm in the Health Care & Life Sciences and Litigation practices and Co-Chair of the firm’s National Health Care & Life Sciences Practice Steering Committee, in the firm’s Washington, DC, office, was a featured voice in the Medtech Insight forecast article “Medtech 2025: ‘Moving Forward, No Matter What,” by Natasha Barrow, Brian Bossetta, Elizabeth Orr, and Marion Webb.

Following is an excerpt:

The new year promises to bring plenty of challenges and opportunities for the medtech industry, with experts eyeing developing markets, technological advances and better reimbursement as areas of significant potential. But counterfeit devices and political chaos remain significant challenges. …

Q: What are your biggest concerns and where do you see the biggest opportunities for the new year?

A: George Breen

I am eager to see to what extent a second Trump administration presents the opportunity for a Department of Justice (DOJ) that is more “business friendly” or, perhaps better stated, “business realistic.”

The first Trump administration reflected a focus on regulatory reduction, review, and elimination. We also saw during that time the issuance of the Brand Memo by the Department of Justice directing that prosecutors not rely on sub-regulatory guidance in bringing matters against defendants in False Claims Act (FCA) cases—guidance that was subsequently rescinded by the Biden administration when Attorney General Garland took office.

I hope defendants in FCA cases will be better received when they approach DOJ and request that, when the agency is considering a case brought by a qui tam relator and declines to intervene in the case, DOJ also seeks to dismiss the case outright, thus saving subject defendants the cost and expense of a litigation that DOJ does not see the merit to litigate on its own.

I expect defendants in FCA cases to continue to challenge the constitutionality of the FCA’s qui tam provisions, following Justice Thomas’ dissent in US ex rel. Polansky v. Executive Health Resources. A recent decision from the Middle District of Florida, US ex rel. Zafirov v. Florida Medical Associates LLC, found the provisions to be unconstitutional. While this decision is an outlier among those cases where these provisions have been challenged, I do expect this will continue to be pressed by defendants in cases across the country.

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