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Class offers big pharma tips on avoiding lawsuits

January 8, 2009 by  

Class advises to be careful about memosPharmaceutical and medical device companies who want to protect themselves against litigation can now take a course offered by a former U.S. prosecutor.

According to a report on Reuters, Nancy Singer – founder of the Medical Technology Learning Institute and Compliance-Alliance – is offering a course on how to avoid "land mines in your FDA records and emails."

Central to the course’s ethos is the idea that external and internal communications should be closely controlled to avoid raising red flags with regulators or litigators.

Singer told the news provider that the class is not intended to promote the cover-up of illegal practices or concealment of negative data.

"To survive in our litigious society, organizations need to have the right communications culture," she explained.

For example, she advises never to use words such as "illegal" or "negligent" but instead phrase sentiments more like "it could be argued that that doesn’t comply with requirements."

Singer also recommends monitoring employee emails and discouraging people from putting their concerns in writing to protect themselves, as these memos will only be used against the company in a lawsuit.

Companies including Merck have found themselves in court confronting leaked internal documents that indicate they were aware their products could cause harm.
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  • Bob Livingston

    Nancy Singer told the news provider that her class was not intended to promote the cover-up of illegal practices or concealment of negative data. Take a good look at this: Nancy, a former US prosecutor advising big pharma how to avoid litigation. What they are doing in effect is protecting the pharmaceuticals from their own negligence and potential lawsuits that they have already factored into their cost before releasing the product.

  • Phil D

    When you find yourself in a “lawsuit” it is most probably because you have been found “liable” by someones attorney for infractions of some heretofore unknown public protection law in the manufacture, distribution or content of your product. In-other-words, it has been determined somewhere along the line to cause someone harm or potential harm within acceptable limits or boundries. Otherwise you would not need tips on “Avoiding Lawsuits”…

    • Eugene Manel

      The statement I am replying to is a sweety tablecloth on the otherwise less dignified table. In reality, if you are found yourself in a lawsuit of that kind, some attorney somewhere found you not necessarily ‘liable’ but rather ‘milkable’ or ‘billkable; if you prefer. No attorney, with a few exceptions, and I love to find one or two, would go into a lawsuit project if the value of assets of the party they are going after has less than four 0s at the end of the number.
      Sorry, I am preaching trivialities, everyone with open eyes must know this reality by now.
      So, more to the point, any party potentially exposed to the claws of what I may call a ‘financial lawsuit’ DOES need practicing rules of self-defense.

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