FCA NOW

20 Jan, 2017

Northern District of Illinois Dismisses Whistleblower’s FCA Suit for Failing to Connect Allegations of Misconduct with Submission of False Claims

In United States ex rel. Keen v. Teva Pharmaceuticals USA, Inc., relator Janice Keen sued her former employer—the pharmaceutical company Teva—for violations of the FCA. According to Ms. Keen, Teva trained its sales force to misleadingly promote and sell a medicine used to treat muscle spasms. Ms. Keen alleged that Teva’s deceptive practices caused physicians to prescribe the medicine in situations for which it was...

Fraud-in-the-Inducement / Healthcare

3 Jan, 2017

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims were futile. D’Agostino, et al. v. EV3, Inc. et al., 2016 WL 7422943 (1st Cir. Dec. 23, 2016). D’Agostino’s complaint alleges False Claims Act (“FCA”) violations related to the Onyx and Axium medical...

Enforcement / Healthcare / Kickbacks

29 Dec, 2016

OIG Creates New AKS Safe Harbors, Codifies Others

On January 6, 2017, two new safe harbors to the federal anti-kickback statute (the “AKS”) will become effective pursuant to a final rule published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) on December 7, 2016. The final rule also codifies safe harbors for certain AKS exceptions and makes a technical correction to the existing safe...

Enforcement / Procedure

27 Dec, 2016

Jury Verdict in Declined Civil FCA Action Need Not Bar Criminal Prosecution for Same Conduct

The qui tam provisions of the False Claims Act allow private citizens to file FCA claims on behalf of the government. The government may elect to intervene in the action—or it may not. The United States District Court for the Western District of Virginia held earlier this month that when the government does not intervene, it is a party in interest, but not a party to...

Procedure / Seal

7 Dec, 2016

Supreme Court Concludes that Violation of FCA Seal Provision Does Not Necessarily Mandate Dismissal of Qui Tam Suits

The Supreme Court held yesterday that a violation of the False Claims Act’s seal provision does not mandate dismissal of a relator’s complaint. Justice Kennedy authored the Court’s opinion in the unanimous 8-0 decision. State Farm was accused of defrauding the government by falsely classifying wind damage caused by Hurricane Katrina as flood damage, which would allow State Farm’s costs to be covered by the...

Seal

23 Nov, 2016

Supreme Court Hears Argument About Violation of FCA Seal Provision

This month the Supreme Court heard oral argument in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby, a case centered on allegations dating back to Hurricane Katrina. The Fifth Circuit had previously upheld a jury verdict finding State Farm liable for $758,000 in damages based on a claim that State Farm defrauded the government. Whistleblowers, including respondent Cori Rigsby, alleged that...

Enforcement / Kickbacks / Settlements

19 Oct, 2016

Omnicare Inc. Settles Kickback Allegations for $28 Million

The United States Justice Department (DOJ) announced this week that Omnicare, Inc. (Omnicare), the largest nursing home pharmacy in the United States, will pay approximately $28 million dollars to resolve charges that it received kickbacks from Abbott Laboratories (Abbott) to promote Abbott’s anti-epileptic drug, Depakote, to nursing home patients. According to the press release, Omnicare, whose consultant pharmacists review nursing home resident’s medical charts and...

Healthcare / Penalties / Settlements / Stark Law

4 Oct, 2016

Former CEO of Health System Agrees to Pay $1 million to Settle False Claims Act Case with U.S. Department of Justice

In the most recent example of its continued effort to hold individuals accountable for corporate misconduct, the U.S. Department of Justice (“DOJ”) announced on September 27, 2016, that the former CEO of Tuomey Healthcare System has agreed to pay $1 million to settle claims arising from his involvement in the hospital’s violations of the Stark Law. In addition to the $1 million civil fine, the...

False Statement / Public Disclosure / Relators

30 Sep, 2016

New Orleans Federal Court Dismisses Relators’ Improper Billing Claims against FEMA Temporary Housing Contractor Due to Insufficient Evidence

On September 14, 2016, the United States District Court for the Eastern District of Louisiana granted a government contractor’s summary judgment motion and dismissed a lawsuit brought against it by False Claims Act relators (“Relators”) because Relators failed to identify evidence supporting the existence of a genuine issue of material fact regarding their claims that the contractor had improperly billed the Federal Emergency Management Agency...

False Statement / Healthcare

29 Aug, 2016

Eighth Circuit Determines that Compliance with Reasonable Interpretation of Government Regulation Sufficient to Avoid FCA Liability (Absent a Government Warning to the Contrary)

The Centers for Medicare and Medicaid Services (“CMS”) establishes requirements for how medical procedures must be performed for a medical provider to seek payment for those procedures. Seeking payment without properly performing the procedure might expose the provider to alleged liability under the False Claims Act (“FCA”). But what if the requirements for the procedure are ambiguous? Will a provider’s reasonable interpretation of a requirement...

FCA NOW

FCA NOW

Northern District of Illinois Dismisses Whistleblower’s FCA Suit for Failing to Connect Allegations of Misconduct with Submission of False Claims

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

OIG Creates New AKS Safe Harbors, Codifies Others

Jury Verdict in Declined Civil FCA Action Need Not Bar Criminal Prosecution for Same Conduct

Supreme Court Concludes that Violation of FCA Seal Provision Does Not Necessarily Mandate Dismissal of Qui Tam Suits

Supreme Court Hears Argument About Violation of FCA Seal Provision

Omnicare Inc. Settles Kickback Allegations for $28 Million

Former CEO of Health System Agrees to Pay $1 million to Settle False Claims Act Case with U.S. Department of Justice

New Orleans Federal Court Dismisses Relators’ Improper Billing Claims against FEMA Temporary Housing Contractor Due to Insufficient Evidence

Eighth Circuit Determines that Compliance with Reasonable Interpretation of Government Regulation Sufficient to Avoid FCA Liability (Absent a Government Warning to the Contrary)

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Chair, Government Enforcement and Corporate Investigations Practice Group

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