Johnson & Johnson Fights US Over Kickback Case
4 CommentsBy Ed Silverman // June 9th, 2010 // 9:08 am
Johnson & Johnson is denying claims in a whistleblower lawsuit, which was joined by the US government, and charges the healthcare giant with paying kickbacks - in the form of rebates and educational grants - to the Omnicare nursing home pharmacy so its Risperdal antipsychotic would be prescribed more often. The lawsuit also alleged J&J’s Janssen unit hid the payments from Medicaid to avoid reporting a ‘best price’ that would have triggered rebates to the agency (background).
In a filing this week, J&J asked a judge to dismiss the January 15 lawsuit by saying the government is arguing that allowable rebates are actually illegal under the Anti-Kickback Statute. “This case is a remarkable attempt to attack common discounting arrangements that are expressly protected under federal and state law,” the healthcare giant maintains. Meanwhile, Omnicare last fall settled civil claims that it accepted kickbacks by agreeing to pay $98 million, although the pharmacy never addmited liability (see here).
Nonetheless, J&J maintains that offering customers higher rebates based on market share or usage in hopes of winning formulary placement is not out of the ordinary. The government and the whistleblower, former Omnicare pharmacist Bernard Lisitza, “seek to penalize (J&J) for the use of standard and lawful formulary and disease management practices that the federal and state governments themselves routinely use,” J&J argues. “Today, rebates remain standard industry practice and are absolutely essential to our health care system.”
The US didn’t charge Omnicare made any factually false claims for Medicaid reimbursement or falsely certified conditions were met to participate in the program, according to J&J, which also charged the government failed to link kickback claims to improper switching of patients to Risperdal without the approval of doctors.
“Their response misses the point of the government complaint,” Michael Behn, Lisitza’s lawyer, tells Bloomberg News. This “ignores the overwhelming evidence that the point of Johnson & Johnson’s payments was to steer nursing home patients to Risperdal.” Lisitza claims he was fired after complaining about patient switching.
One exhibited contained in the lawsuit appears to raise the issue of off-label promotion (see this).
Former Big Pharma MD
Is it just me being cynical, or are all these companies simply rotten to the core? It’s no wonder that their reputation has sunk to the gutter level of the tobacco and oil companies!
Doc
If J&J wants to give market share based rebates - go for it.
However, as a taxpayer (and knowing that the U.S. Govt is J&J’s single largest payor - the Govt (us) should get whatever the best price those rebates work out to.
If we are paying for 40%+ of J&J’s products through Medicare, Medicaid, DOD, VA, Etc - we should get the top rebate.
John English
Thanks for supplying the links back to the court documents. It really let us understand what the issues are, if we chose to do so.
AND the first footnote to the J&J move to dismiss is very interesting in the current context. Thanks again, Ed, for your great work!
M. Black
Former Big,
My blogs are usually on a fair devil’s advocate level. Most in the pharma industry see things that if seen by an FDA inspector, would result in a slap on the wrist.
Ooooooooooooooooh an effing slap on the wrist.
Much is demanded by law without full consideration of what it means for a company to become compliant with it (or them, and including current regulations).
A system of open communication and harmony (for lack of a better word) needs to be established between regulators and companies so that the desired outcome is achieved.
Between the companies and the regulators.
Another reason why the frivolous banter about how many wall clocks a rep may hand out per week. Funds should be reallocated from the sales side and it’s funds be put toward this effort.
That’s my take.
~ M. Black