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Supreme Court Declines to Hear Omnicare False Claims Act Case
October 6, 2014By Jennifer M. Thomas –
We wanted to briefly update our readers on a case we blogged about in February of this year, United States ex rel. Barry Rostholder v. Omnicare, Inc., 745 F.3d 694 (4th Cir. 2014). To recap, in Omnicare the Fourth Circuit affirmed a lower court’s dismissal of the False Claims Act (“FCA”) for failure to state a claim – rejecting the relator’s theory that Omnicare had violated the FCA when it produced drugs in violation of FDA regulations. On October 6th, the U.S. Supreme Court denied Rostholder’s petition for certiorari in the case (Case No. 13-1411).
Omnicare is a leading case among several in which qui tam plaintiffs have tried to shoehorn an alleged FDCA violation – such as an alleged cGMP violation – into a FCA case. Many hoped that the Supreme Court would hear the Omnicare case to bring certainty to the question of whether that theory is viable. Given the Supreme Court’s refusal to hear this case, we will need to await further lower court rulings to see if the Court will take the issue up in another case.
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- New HHS Policy on Buprenorphine for the Treatment of Opioid Use Disorder – Finally, Treatment is More Accessible than Opioids…. UPDATE January 26, 2021
- HP&M’s Frank Sasinowski to Present at Kinexum’s “Wow or Yeow?! FDA Outlook for 2021 and Beyond” January 25, 2021
- Most Favored Nation Drug Pricing Rule on Hold Awaiting Changes January 22, 2021
- FDA Continues Discussion of AI/ML Software Medical Devices January 21, 2021
- Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning January 20, 2021
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized