James Boiani Quoted in “Troubled Health Start-Up Theranos Faces Washington Reckoning”


James A. Boiani, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO, in “Troubled Health Start-Up Theranos Faces Washington Reckoning,” by Darius Tahir.

Following is an excerpt:

Neither produced a favorable report. FDA cited the company for improper quality and safety controls. The Centers for Medicare and Medicaid Services, meanwhile, concluded that the lab’s “deficient practices pose immediate jeopardy to patient health” and gave Theranos ten business days to come into compliance, later extending the deadline to Friday.

Non-compliance could be crippling. The government could level a $10,000 per day civil penalty, but more importantly, regulators could “create significant problems” with Theranos’ ability to operate other labs, said James Boiani, a life sciences lawyer with Epstein, Becker & Green.