A settlement has been reached in two whistleblower class action lawsuits brought against Schwarz Pharma Inc who is accused of causing false claims to be submitted to federal health care programs.
The federal share of the settlement is $12,243,836 and the state Medicaid share is $9,756,164. The two whistleblowers will receive a total of $1,836,575 from the federal share and additional amounts from the state share.
The United States allegations were in reference to Schwarz Pharama Inc's drugs, Deponit and Hyoscyamine Sulfate Extended Release (Hyoscyamine Sulfate ER).
Deponit is a nitroglycerin skin patch that has been used to prevent angina. Hyoscyamine Sulfate ER is an antispasmodic medication that has been used to treat various stomach, intestinal, and urinary tract disorders that involve cramps, colic, or other painful muscle contractions. While the active ingredients in Deponit and Hyoscyamine Sulfate ER had been in products on the market for many years, the Food and Drug Administration made determinations in 1997 and 1999 that resulted in the drugs being ineligible for reimbursement by government health care programs such as Medicaid.
The United States alleged that Schwarz misrepresented the regulatory status of both drugs and failed to advise CMS that these unapproved drugs did not qualify for coverage under federal health care programs. As a result, the government contends, Schwarz knowingly caused false claims to be submitted for Deponit and Hyoscyamine Sulfate ER. Ultimately, neither Deponit nor Hyoscyamine Sulfate ER ever received full regulatory approval for safety and effectiveness, and neither product is currently on the market.
