Tag: Pharmaceutical
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Compliance Expert’s Testimony on the Marketability of the Olivetol Excluded
Noramco and Dishman entered into a contract (“the Supply Agreement”) under which Dishman agreed to provide Noramco with a large amount of olivetol, an ingredient used in the manufacture of pharmaceutical products. The Supply Agreement required Dishman to supply Noramco with olivetol manufactured at Dishman’s facilities in India. The Agreement represented that those facilities were “c-GMP…
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Law & Legal Expert Helps Jury Understand Medicaid’s Complex Regulatory Framework
Plaintiff State of Washington alleged that Novo Nordisk Inc. (“NNI”) caused physicians to prescribe its drug, NovoSeven®, to Washington hemophilia patients by: (1) promoting it “off-label” for prophylaxis and “high dose” use; (2) paying kickbacks to physicians; and (3) paying bribes to patients, all of which rendered claims to Medicare and Washington Medicaid false. The…
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Court refuses to exclude Pharmaceutical Expert Witness’ Opinions Regarding Breadth of Asserted Claims
A district judge in Florida refused to exclude the testimony of a pharmaceutical expert witness despite allegations of fundamental flaws in the assumptions on which her calculations are based. Defendant Aveva Drug Delivery Systems, Inc. of an Abbreviated New Drug Application (“ANDA”) No. 217221 to the U.S. Food and Drug Administration (“FDA”) sought approval to…
