BOSTON (Legal Newsline) – Teva Pharmaceuticals says it is being punished by the federal government for trying to help those suffering from Multiple Sclerosis.
The company on Oct. 19 filed its motion to dismiss the feds’ False Claims Act lawsuit that alleges it has violated the Anti-Kickback Statute by donating funds to groups that helped patients make co-payments on the MS drug Copaxone.
When a Medicare patient purchased the drug, Teva had two foundations pay the co-pay, which resulted in hundreds of millions of dollars in kickbacks and a rise in the drug’s cost, the lawsuit says.
“The government does not, and cannot, allege that Teva had control of the charities’ use of donated funds, much less the right to require the charities to use Teva’s donations for Copaxone,” attorneys for the company wrote.
“On the contrary, the funds to which Teva donated supported a number of MS products, and the charities retained control over the use of those. That ultimate independence over how the funds were dispensed is fatal to the government’s case. It ‘severs the nexus’ of Teva’s donations under the AKS.”
Teva also says the feds fail to allege any physician was influenced to prescribe Copaxone. And they fail to identify a comparable lower-priced treatment when alleging Teva’s donations resulted in higher prices for Copaxone, the company says.
“Instead, the complaint sets forth the unfortunate but unremarkable proposition that the Medicade Part D structure shifts significant cost burdens onto seniors, many of whom cannot afford much of their medication regimen without help,” the motion says.
“That pharmaceutical companies assist in addressing this burden in a manner that can also benefit their own products does not convert charitable contributions into criminal acts.”
The lawsuit says Copaxone’s price rose at a rate more than 19 times the rate of inflation, and the Medicare program ended up paying more than it should have.
Teva paid the Chronic Disease Fund and The Assistance Fund more than $300 million to cover co-pay obligations of Medicare patients, the suit says.
Teva previously asked Boston federal judge Dennis Saylor to consolidate the case with a similar one against Regeneron Pharmaceuticals, which is alleged to have used the Chronic Disease Fund to subsidize co-pays for Eylea, a drug that treats wet age-related macular degeneration.