FCA Suits Over Poor Drug Quality Are Down But Not Out

Law360, New York (February 28, 2014, 5:17 PM EST) -- The Fourth Circuit's new ruling that sloppy drugmaking can't support False Claims Act cases is the latest blow to lawsuits that equate regulatory noncompliance with fraud, but experts say whistleblowers and prosecutors may still be able to successfully target manufacturers that have egregious quality-control lapses.

In its recent decision, the appeals court flatly rejected the idea that billing the government for impure medications can by itself give rise to FCA liability. All that's required for coverage by Medicare and Medicaid is approval by the U.S. Food and Drug Administration, and nothing bars those programs from paying for medicines that aren't of...

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