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Mintz’s Health Care Qui Tam Update

Mintz’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides a broad overview of 58 recently unsealed health care–related qui tam cases, with an in-depth look at four cases, including an off-label marketing settlement and a notable decision applying the Rule 9(b) requirements for pleading fraud to a claim for violation of the False Claims Act.

The four featured cases are:

  • United States ex rel. John Rector v. Bon Secours Richmond Health Corp., No. 3:11cv00038JRS (E.D. Va.) regarding false claims allegedly submitted through the health system defendants’ patient “concierge” program.
  • United States ex rel. Beth Gorawksi v. Berchtold Corp., No. 2:11-cv-2601-RMG (D.S.C.) regarding ongoing fraudulent conduct in sales of surgical tables and related equipment to military hospitals.
  • United States ex rel. Ryan v. Endo Pharms Inc., No. 05-cv-3450 (E.D. Pa.); United States ex rel. Weathersby v. Endo Pharms. Inc., No. 10-cv-2039 (E.D. Pa.); United States ex rel. Dhillon v. Endo Pharms., No. 11-cv-7767 (E.D. Pa.) regarding off-label marketing and false claims for the drug Lipoderm.
  • United States ex rel. Stephens v. Malik, No. 2:12-cv-00306-WCL-PRC (N. Ind.) regarding false claims arising out of referrals that violated the Stark Law and the Anti-kickback Statute and from “up-coded” claims.

The decision in the Bon Secours case is a significant development in Rule 9(b)’s gatekeeping function for FCA claims in federal courts.  Mintz has discussed the split among federal circuit courts of appeal over what Rule 9(b) requires defendants to allege when pleading FCA claims, and the Supreme Court’s decision in March to deny certiorari to resolve the issue.

In our Qui Tam Update series, we monitor recently unsealed FCA cases, identify trends in health care enforcement, and discuss noteworthy cases and developments.  To receive the Qui Tam Update by email, subscribe here.

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Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.