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Question regarding Qui Tam?

Delmar, NY |

Situation: Lady works for this medical device manufacturer company. The area where the workers create the medical devices is considered a clean area. Even with that bacteria from outside still come on to the floor from the shoes of the workers.

These places are regulated by the FDA. I am not sure whether the FDA has such rules for product accidentally going on the floor. They always instructed us(workers) to trash any product that has touched the floor when being audited but when we aren't we are told and practiced to wipe the product off with alcohol and push the product through the normal process.

The medical devices are used inside of people to help with the heart and other important body parts inside the body. Bacteria isn't a good thing. If the product is to be trashed when being

audited, why not practice the same when not being audit. The lady isn't sure about all dept in the company but this is done in her dept where she works. Even the instructor of the line has no problem with this. I am sure the government money is being used for some of these products being pushed out. If the patient has medicare or medicaid and go to the hospital to get treated and treatment requires the use of this product than the cost of the product will be transfer into the bill billed to the government. Should this person speak to a lawyer who handles Qui Tam?

Attorney Answers 3


This doesn't sound to me to be a good case under New York's Falso Claim Act, as I don't exactly see from the facts provided exactly what the false claim is. Perhaps they are negligent, but the False Claims Act is really about stopping others from committing fraud. It would not hurt to talk to attorney about it, of course, but personally I don't think I would bother.

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I believe you have asked this question a number of different ways over the past couple weeks. You will need to report the inproper product handling before you are eligible for a whistle blower suit.

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There are some False Claims Act cases involving adulterated and misbranded drugs and medical devices, but the situation you describe appears to be more properly addressed to the Food and Drug Administration, or even your company's own compliance department. If the violations are widespread and condoned by management, then a call to the FDA would appear to be appropriate.

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