Omnicare off the hook in drug packaging case after Supreme Court passes
Long-term care pharmacy Omnicare will not face False Claims Act penalties for drug packaging practices that apparently ran afoul of safety regulations. The U.S. Supreme Court has declined to take up the case, meaning that an appeals court ruling in Omnicare's favor will stand.
A whistleblower alleged that cross-contamination occurred at a location where Omnicare was packaging both penicillin and non-penicillin drugs. Many of these medications then went to nursing homes, which presumably received funds from government health plans for them. By billing for these mispackaged drugs, the nursing homes essentially submitted false claims, and so Omnicare should be held accountable under the False Claims Act, the whistleblower argued.
A district court and federal appeals court both ruled against the whistleblower, and the Supreme Court denied review of the matter on Monday. The high court did not comment on its decision, according to the Bureau of National Affairs.
“The relevant statutes do not provide that when an already-approved drug has been produced or packaged in violation of FDA safety regulations, that particular drug may not be the proper subject of a reimbursement request under Medicare and Medicaid,” the appeals court judges wrote in their February ruling.
Other courts have ruled differently, not requiring an “express payment condition” in order to bring False Claims charges, BNA noted.
Omnicare received a warning letter in 2005 from the Food and Drug Administration about the packaging practices at the Ohio facility in question, after which the company disposed of $19 million in inventory, according to court documents.