Justia Drugs & Biotech Opinion Summaries

In 2008, Santiago Alirio Gomez Rivera began working with co-conspirators in Latin America to obtain and transport cocaine for importation into the United States. Rafael Segundo Castro Diaz joined the conspiracy later, helping transport 1,200 kilos of cocaine in April 2013. The United States Coast Guard intercepted the boat carrying the cocaine, and the men aboard were arrested. Years later, a federal grand jury returned three indictments against Gomez Rivera and Castro Diaz, with the second superseding indictment expanding the conspiracy period from January 2008 to September 2013.The United States District Court for the Southern District of Florida denied the defendants' motions to dismiss the second superseding indictment, which they argued was untimely and broadened the original charges. The defendants then negotiated a stipulated bench trial, preserving their right to appeal the denial of their motions to dismiss. The district court adjudicated them guilty, but there were clerical errors in Castro Diaz's judgment documentation.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that a superseding indictment can satisfy the statute of limitations if it is independently timely or relates back to a timely prior indictment. The second superseding indictment was independently timely, as it was returned within five years of the alleged conspiracy period. The court also found sufficient evidence to support the convictions, as both defendants stipulated to facts indicating their involvement in the conspiracy until September 2013. The court affirmed the convictions and sentences but remanded for the correction of clerical errors in Castro Diaz's judgment. View "USA v. Santiago Alirio Gomez Rivera" on Justia Law

Detectives with the Fort Myers Police Department observed Alphonso Lataurean James engaging in suspected drug transactions at a gas station. James was seen wearing a cross-body bag, which he later took into a vehicle. After stopping the vehicle, detectives found the bag containing a handgun and ammunition. They also discovered drugs in the car, including fentanyl and cocaine. James admitted to possessing the bag but denied knowledge of the firearm. DNA testing linked James and others to the gun. James, a convicted felon, was charged with possession of a firearm by a convicted felon.The United States District Court for the Middle District of Florida sentenced James to ninety-two months in prison, applying a four-level enhancement under U.S.S.G. § 2K2.1(b)(6)(B) for possessing a firearm in connection with another felony offense. James objected, arguing that the enhancement was improperly applied based on the Sentencing Guidelines' commentary. The district court overruled his objections, finding that the firearm was in close proximity to the drugs, thus meeting the "in connection with" requirement.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that the phrase "in connection with" in U.S.S.G. § 2K2.1(b)(6)(B) is unambiguous and does not require deference to the Sentencing Guidelines' commentary. Despite the district court's error in relying on the commentary, the appellate court found that the district court's factual findings were sufficient to support the enhancement. The court affirmed James's sentence, concluding that he possessed the firearm in connection with drug trafficking. View "USA v. James" on Justia Law

Ranbaxy, a pharmaceutical company, seeks money damages and injunctive relief for alleged misrepresentations made by FDB, a company that publishes a drug information database for use by pharmacies across the United States. Ranbaxy alleges that FDB’s database, MedKnowledge, falsely represents that Ranbaxy’s acne drug Absorica is non-unique. The district court granted summary judgment to FDB. The court affirmed the order and judgment, concluding that Ranbaxy has not raised a genuine issue of material fact with regard to falsity. The court concluded that, because FDB provides ample explanation of the information and terms in its database, no reasonable reader would conclude that Absorica was therapeutically equivalent to or substitutable for other drugs. View "Ranbaxy Labs. Inc. v. First Databank, Inc." on Justia Law

VRC filed suit against HHS and the Secretary, seeking the recoupment of payments VRC returned to Medicare after it was issued notice of an overpayment. At issue is the reimbursement rate of the intravitreal injection of Lucentis. VRC did not follow the Lucentis label’s instructions limiting dosage to one per vial. Instead, VRC treated up to three patients from a single vial. Because VRC was extracting up to three doses from a single vial, it was reimbursed for three times the average cost of the vial and three times the amount it would have received had it administered the drug according to the label. The court affirmed the denial of recoupment, concluding that VRC's charge to Medicare did not reflect its expense and was not medically reasonable; the Secretary's decision was supported by substantial evidence; and VRC is liable for the overpayment. View "Vitreo Retinal Consultants v. U.S. Dep't of Health & Human Servs." on Justia Law