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Are GMP Violations The “Next Hot Thing” In False Claims Act Litigation?

Executive Summary

Former prosecutors say there are cases pending under seal, but it is uncertain whether the government will intervene. They note the difficulty in proving the allegations and say FDA’s regulatory regime may be a better route for handling GMP issues.

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DoJ and GMPs: A Prosecutor’s Take on Enforcing Product Quality

The wave of marketing promotions undertaken by the Department of Justice over the past decade may be abating, but prosecutors are looking at manufacturing violations as fertile new territory for cases. One prosecutor shares her thoughts on how companies can protect themselves.

GSK’s $750 Mil. DoJ Settlement: When GMP Violations Equal Healthcare Fraud

GlaxoSmithKline’s $750 million settlement with the Department of Justice raises a worrisome question for industry: will violations of current good manufacturing practices become a target for whistleblower suits?

Supreme Court May Find Patent Board Judges Unconstitutionally Appointed But Favor Narrow Fix

During oral argument in the Arthrex case, several justices seemed to agree with the Federal Circuit that PTAB judges should have been appointed by the president. They could opt to get around the problem by enabling the PTO director to review all panel decisions.


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