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Third Circuit Affirms Dismissal of FCA Suit against Genentech Based on Supreme Court’s Materiality Standard

On May 1, 2017, the US Court of Appeals for the Third Circuit affirmed the dismissal of United States ex rel. Petratos, et al. v. Genentech, Inc., et al., No. 15-3801 (3d. Cir. May 1, 2017). On appeal from the US District Court for the District of New Jersey, the Third Circuit reinforced the applicability … Continue Reading

Second Circuit Deals Blow to Off-Label Marketing Claims

On May 17, the United States Court of Appeals for the Second Circuit affirmed the dismissal of a relator’s False Claims Act (FCA) claims predicated on allegations that Pfizer “improperly marketed Lipitor, a popular statin, as appropriate for patients whose risk factors and cholesterol levels fall outside the National Cholesterol Education Program (NCEP) Guidelines.”  In … Continue Reading

Decade Old Device Off-Label Marketing Case Ends with Manufacturer Win

On April 7, a Texas jury handed a victory to Abbott Laboratories in a 10-year False Claims Act litigation battle with the relator concerning the off-label use of its products by physicians.  This is the latest in several cases over the past few years that cast doubt on the viability of an off-label marketing theory … Continue Reading

FCA Claims Based on Average Wholesale Price (AWP) Theory Barred by Public Disclosure Bar

On January 20, 2016, the U.S. District Court for the Eastern District of Missouri dismissed a complaint based on allegations of Average Wholesale Price (AWP) fraud under the False Claims Act (FCA) against CSL Behring, LLC (Behring) and specialty pharmacies Accredo Health, Inc., (Accredo) and Coram LLC (Coram).  See United States ex rel. Lager v. … Continue Reading

District of Massachusetts Rejects Relators’ Attempt to Convert Products Liability Theory into FCA Claim

On February 2, 2016, U.S. District Court for the District of Massachusetts dismissed a complaint alleging sweeping allegations of purported fraud under the False Claims Act (FCA) relating to hip replacement devices, and in doing so reaffirmed the principle that where an FCA complaint fails to plead the specifics of actual false claims, it cannot … Continue Reading

FDA Settles Exparel Marketing Lawsuit, Signaling Change for Off-Label FCA Cases

Last summer, we reported on the U.S. District Court for the Southern District of New York’s significant decision in Amarin Pharma, Inc. et al. v. Food and Drug Administration, et al., holding that a drug company may engage in “truthful and non-misleading speech” about off-label uses of an approved drug without the threat of a misbranding … Continue Reading

Amarin Ruling Solidifies Off-Label Marketing Options but Raises Questions About False Claims Act Enforcement Action

The Southern District of New York recently ruled in Amarin Pharma, Inc. et al. v. Food and Drug Administration, et al. that a drug company may engage in “truthful and non-misleading speech” about off-label uses of an approved drug without the threat of a misbranding action under the Federal Food, Drug, and Cosmetic Act. No. … Continue Reading

Court Again Rejects Alleged ‘Fraud on the FDA’ Theory of Implied Certification Liability

On June 12, 2015, the U.S. District Court for the Northern District of California granted Gilead Science’s second motion to dismiss Relators’ False Claims Act (FCA) claims premised on Gilead’s alleged failure to obtain timely supplemental approval from the U.S. Food and Drug Administration (FDA) for use of a new unapproved manufacturing source. See U.S. … Continue Reading

Whistleblower Wins Reinstatement Fight, Demonstrating the Need for Detailed Personnel Files

In 2012, a jury concluded that Bayer Corporation (Bayer) unlawfully terminated a sales representative, Mike Townsend, because he reported to the Arkansas Attorney General that with the alleged knowledge of Bayer’s sales force, physicians were overbilling Medicaid for Bayer’s drugs. See Townsend v. Bayer Corp., 774 F.3d 446, 452 (8th Cir. 2014). Shortly before Townsend … Continue Reading
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