…civil penalties are not reason enough to avoid violating the Federal Food, Drug, and Cosmetic Act, then perhaps the possibility of an alternative sanction like that agreed to by James…

…three circumstances is dispositive in establishing an actual declaratory judgment controversy as to all the paragraph IV certified patents, whether the patentee has sued on all or only some of…

…into the U.S. Attorneys’ Manual here, has four key features: Criminal enforcement authority cannot be used to persuade a company to pay a larger settlement in a civil case, such…

…Another recent example is subsection (jj) which makes it illegal to fail to submit information on clinical trials to Clinicaltrials.gov. Congress also significantly expanded the potential criminal liability of those…

…numbers of similarly situated people and that the federal government is entitled to relitigate matters in multiple circuits, citing the principle of nonmutual offensive collateral estoppel as not applying to…

…evaluate ramifications of potential enforcement activities, including administrative, civil and criminal actions against it. Register for this webinar here. Participants will receive a copy of Chapters 11 (Devices: Medical Device…

…(No. II) – This case stems from a February 2009 challenge by the FTC and the California Attorney General concerning  Solvay Pharmaceuticals, Inc.’s ANDROGEL (testosterone gel) 1%, in which the…

…not remotely intended to open the proverbial floodgates to manipulative, exclusivity-divesting patent delistings by brand manufacturers, and thus sub silentio to abrogate the longstanding prohibition against such delistings that Ranbaxy…

…compete.  A declaratory judgment redresses this alleged injury because it eliminates the potential for the corresponding listed patent to exclude the generic drug from the market.” (Internal citations omitted.) Given…

…kratom powder and capsule products labeled as supplements, as well as bulk kratom powder and capsules. The government’s complaint alleges that there are serious concerns regarding the health impacts of…

…in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I). The MMA also added an almost identical counterclaim provision at FDC Act §505(c)(3)(D)(ii)…

…criminal and civil penalties under the CSA, including individual or personal liability for long-term care administrators for the wrongful acts of facility designees, for diverting drugs or violating recordkeeping requirements. …

…the chemicals. 77 Fed. Reg. 12,510. DEA also noted that “these products are manufactured by spiking plant material with the synthetic cannabinoids and then distributed in a way that poses…

…unapproved sodium thiopental for use by state Departments of Corrections to carry out death sentences by lethal injection.  (See our previous post here.) KV argues in its Opening Brief that…

…alternative, Defendant moved to dismiss the case under the primary jurisdiction doctrine and because of the Plaintiff’s failure to satisfy Federal Rule of Civil Procedure 9(b).  Judge Houston denied the…