Off-Label Whistleblower Suits: Slower and Subtler

Author: Mary Holloway

Although the news of pharmaceutical and medical device settlements in 2010 would lead you to believe otherwise, the rate of new qui tam filings has slowed and the accusations are focused more on subtle versus blatant violations according to an article in the Rx Compliance Report. This is a good sign for an industry that has been working hard trying to revise its marketing practices and eliminate off-label promotion.

Unfortunately, the case backlog from past conduct and their resulting settlements give the impression that blatant off-label promotion is still very present today.  In reality, much of the egregious behavior occurred well in the past.  The illegal conduct alleged in new qui tam cases is more subtle.  Attorney Robert M. Thomas, Jr.  comments in Rx Compliance Report:

“We are seeing people driving 67 in the middle lane as opposed to 92 in the fast lane.”1

Sara Bloom, Assistant U.S. Attorney in the U.S. Attorney’s Office in Boston reinforced this focus and points to the future of off-label prosecutorial focus stating that comparative claims along with:

“..considerations such as dosages and promoting for the side effects of a product rather than its approved use are now considered legitimate areas of investigation.” 1

While the flood of qui tam suits may have slowed due to tightened compliance, compliance teams and sales training colleagues need to ensure that they understand how subtle off-label behavior looks and sounds.  More importantly, they need to communicate this in a clear and memorable way to their sales force. You do not want representatives guessing whether their selling statements are on or off-label.

If you need a few reasons to shore up your training, below is a look at the top 2010 pharmaceutical and medical device settlements relating to off-label marketing.

Company Settlement Amount 2010  Settlement Date Product
Allergan $600M September Botox
AstraZeneca $520M April Seroquel
Novartis $423M September Trileptal
Forest $313M September Celexa/Lexapro
J&J $258M October Risperdal
Elan $203M July Zonegran
J&J (Ortho-McNeil-Janssen) $81M April Topomax
KOS $41M December Advicor/Niaspan
Synthes $23M October Norian XR/SRS
Stryker $1.4M August OP-1 /Calstrux

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3 responses to “Off-Label Whistleblower Suits: Slower and Subtler

  1. Pingback: 7 New Insights to Preventing Off-Label Sales Promotion | Good Promotional Practices

  2. Greg,
    Thanks for your comment back. I agree about the look of astonishment, which is a good sign that the message is getting through and is being understood. With the increase in qui tams I am afraid that your are right about the backlog looking like current behavior.

  3. Thank you, Mary, for this great synopis and “alert” about the changes in whistle-blower lawsuits. Having just completed the 2nd-year training curriculum of a 5-year CIA Requirement at a vendor site, I see the look of astonishment on employees’ faces when they realize the magnitude of these settlements. Although it’s good to know that overall the violations are decreasing, it certainly won’t appear that way until the backlog subsides.

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