McKesson Corp., one of the nation’s largest pharmaceutical companies, and two of its subsidiaries have had federal and state False Claims Act allegations filed against them on behalf of the federal government, 30 state governments, and the city governments of Chicago, New York City, and the District of Columbia. The complaint alleges that McKesson overfilled bottles of single-use oncology and blood cell medications and skimmed the excess for repackaging.

The filing alleges that from 2001 to 2010 McKesson took the overfill from its drug bottles, repackaged the drugs, and then distributed them to medical providers who sought government reimbursement for the drugs. The United States Pharmacopeial Convention permits the single-use vials of these medications to be slightly overfilled to allow for proper dosing. Federal Drug Administration guidelines, however, do not allow improper overfill, do not allow the overfill to be billed, and do not allow adulterated medications that are repackaged in unapproved facilities to be billed.   

The complaint alleges that McKesson knowingly harvested overfill and then pooled the oncology drugs in plastic prefilled syringes and resold the syringes to medical practices who used them for chemotherapy and other treatments for oncology patients. The filing also asserts that prefilled syringes were filled in unsterile environments. The bottles from which the overfill was harvested were marked for single use. Because the price of the prefilled syringes was lower than the single-use vials, the government claims that it overpaid for these medications.

Under the FCA, the defendants would be liable for knowingly submitting false claims to the government healthcare programs by causing a medical professional to use the adulterated product and then submit a claim for reimbursement. The complaint also alleges that by inducing medical professionals to use this product, McKesson violated the Anti-Kickback Statute (AKS). Violations of the AKS can be filed as FCA violations.

Robert B. Vogel, MD, JD
Retinal Ophthalmologist at Piedmont Eye Center, Lynchburg VA;
Attorney, Overbey Hawkins & Wright, PLLS, Lynchburg, VA;
Adjunct Professor, Humanities and Bioethics, Liberty University School of Medicine, Lynchburg, VA.