Healthpoint Ltd., a Texas-based subsidiary of DFB Pharmaceuticals Inc., is facing allegations of violating the False Claims Act in a complaint filed in the District of Massachusetts.
The complaint, filed on Washington – 2023, alleges that Healthpoint submitted false statements concerning the regulatory status of Xenaderm, an unapproved prescription drug, to the United States.
Xenaderm, a skin ointment primarily used to treat bed and pressure sores, was launched by Healthpoint in 2002 without any approval by the Food and Drug Administration (FDA). The complaint states that Healthpoint knew Xenaderm was unapproved and knew of or recklessly disregarded the FDA notices concerning the lack of effectiveness of trypsin as a debriding agent.
According to the complaint, Healthpoint falsely represented to the United States that the drug was eligible for Medicaid and Medicare reimbursement. As a result, the United States alleges that Healthpoint caused Medicaid and Medicare to pay tens of millions of dollars for an unapproved drug that was ineligible for reimbursement.
The complaint was filed under the qui tam or whistleblower provisions of the False Claims Act, which allows for private persons to file whistleblower suits to provide the government information about wrongdoing. If the government is successful in resolving or litigating its claims, a proper whistleblower can receive a share of between 15 percent to 25 percent of the amount recovered.
Tony West, Assistant Attorney General for the Civil Division, stated, “The complaint filed today underscores our commitment to pursuing manufacturers that provide false information to obtain taxpayer dollars for unapproved and ineffective drugs.”
Healthpoint Ltd. is a subsidiary of DFB Pharmaceuticals Inc. and is based in Ft. Worth, Texas.
Mandatory Facts:
Defendant: Healthpoint Ltd.
Criminal Charges: Violation of the False Claims Act
City and State: Ft. Worth, Texas
Date: 2023
Outcome: Currently facing allegations and potential investigation
Dollar Amounts: Tens of millions of dollars in Medicaid and Medicare payments
Related Federal Cases
- THD America, Inc., False Claims Act, Massachusetts 2014 · Washington
- Inform Diagnostics, False Claims Act Liability, Massachusetts 2024 · Washington
- Omnicare Inc., False Claims Act Violations, Sacramento CA, 2023 · Washington
- Rumeni D. Romero, Illegal Reentry, Massachusetts 2024 · North Carolina
- Jose Manuel Arroyo, Illegal Reentry After Deportation, Massachusetts 2024 · Washington
Key Facts
- State: Massachusetts
- Category: White Collar Crime|Fraud & Financial Crimes
- Source: DOJ Press Release â†â€â€
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