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    Saturday, October 29, 2005

    Flu Shots from the Wrong End of Town: The owner of a home health care business in Houston, located in the part of town " known for selling counterfeit designer handbags and perfume knockoffs", stands accused of giving fake flu shots:

    The FBI was alerted to the alleged vaccination scam after a contract nurse hired by El Hawa to help give flu shots at the Exxon Mobil plant learned that one of El Hawa's employees stayed up the night before filling syringes.

    Flu shots come from the manufacturer in pre-filled syringes or in vials that are drawn up into syringes for each patient.

    The nurse also noted that the employee seemed unfamiliar with the standard practice of recording lot numbers to track buyers and users of a vaccine in the event of a problem, according to the criminal complaint.

    Investigators said the employee also told the nurse he had pricked his fingers a few times while filling the syringes, and warned the nurse not to allow another doctor at the Exxon event to see any of the flu vaccine syringes.

    The nurse reported the information after the Exxon Mobil event and delivered two of the syringes to the FBI's Houston offices Oct. 21.

    The nurse estimated that 1,600 shots were given at the Exxon health fair, investigators said.

    But the reason it's a crime is that he gave fake shots to 14 nursing home patients - and that is Medicare fraud.

    UPDATE: According to a legal reader, there's more crime:

    There were other crimes committed (assuming that the accusations are
    true.) From the perspective of the FDA, at least:

    - Manufacturing drugs at an unlicensed, unapproved plant
    - Failure to comply with Quality System Regulations, specifically
    sterile practices,
    - Marketing a drug without FDA approval
    - Selling an adulterated drug
    - Failure to register as a drug manufacturer

    And these could reach over 25 years in jail.

    The concern I would have in prosecuting these is getting sufficient accurate and detailed evidence to pin down who committed the acts and who was a victim of the acts. I'm sure that the defenses would include claims by some that they were innocent victims, etc. I think that they have 10 years to file charges, so now that the criminals are stopped from doing further harm there is time to figure out which ones knew what and make the appropriate additional charges later.

    Do all of those FDA charges apply for a placebo, though?

    posted by Sydney on 10/29/2005 05:55:00 PM 0 comments


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