12.07.2015 Views

Third Amended Master Long Form Complaint - Dispute Resolution ...

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214. BRAND NAME DEFENDANTS knew, or in the exercise of due care to avoidcausing personal injuries to others, should have realized, that a physician’s prescribing decisionsmade in reliance on inaccurate, misleading, or otherwise false information about the therapeuticeffects or side effects of a prescription drug would be likely to place his or her patients atpotentially grave and unreasonable risk of avoidable personal injury from the effects of the drug.215. BRAND NAME DEFENDANTS also knew, or in the exercise of due care toavoid causing personal injuries to others, should have realized, that a physician’s prescribingdecisions made in reliance on inaccurate, misleading, or otherwise false information about thetherapeutic effects or side effects of a prescription drug would, under the circumstancesprevailing, place his or her patients at the same risk of suffering the same injuries, whether apharmacy dispensed, per the prescription, the name brand version or a generic version of thedrug, and that the pharmacy was likely to dispense a generic version. Defendant SchwarzPharma, through omission and failure to notify physicians and patients of the information in theirpossession about inaccurate rate of risk and significant duration of use, failed to effectivelycommunicate changes in the label. As regards any and all prescription drugs that may lawfullybe distributed in this country, and therefore would generally be distributed in this country, thosecircumstances include:a) With respect to any generic prescription drug, for which the FDAhas approved an ANDA, the drug is accepted by physicians to be, abioequivalent generic version of a prescription drug, usually a counterpartname brand drug, for which the FDA has already approved an NDA orANDA.b) A generic version of a drug that is intended to be bioequivalent to abrand name version of the drug generally is accepted by physicians to be,medically and therapeutically identical to the name brand version of thedrug and all other bioequivalent generic versions of the drug, and thereforeis expected to have, the same therapeutic effects and side effects.- 73 -Case ID: 100101997

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