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FDA takes hard stance on youth e-cigarette use, puts manufacturers, retailers on notice
The FDA believes that youth use of e-cigarettes is reaching epidemic proportions and in response has announced a series of historic enforcement actions related to the sale and marketing of e...
FDA ordered to expedite schedule for Tobacco Control Act graphic warnings rule
A district court held that the FDA unlawfully withheld or unreasonably delayed promulgating a Final rule that it has been working on for five years and claims to need another three years to complete...
Causation discovery properly limited in suit alleging Enbrel® caused MDS
A Nebraska federal court properly limited causation discovery by the deceased’s wife in a suit against Amgen contending that its drug Enbrel® caused the myelodysplastic syndrome (MDS) that...
Government presence in qui tam litigation deemed ‘independent and derivative’
In an appeal brought by United Biologics, L.L.C. (United), the Fifth Circuit affirmed the district court's grant of a motion to voluntary dismiss with prejudice a qui tam action against United...
Overpayment final rule failed to achieve actuarial equivalence
A federal district court invalidated CMS’ 2014 overpayment Final rule, finding that it violates the statutory mandate of "actuarial equivalence" between payments under the Medicare...