Justia Drugs & Biotech Opinion Summaries

In the case before the United States Court of Appeals For the Eighth Circuit, the defendant, Kaycee Heard, appealed his 180-month sentence for involvement in a drug-trafficking conspiracy that transported oxycodone and fentanyl pills from Michigan to North Dakota for distribution. Heard pleaded guilty to conspiring to distribute and possess with intent to distribute controlled substances, and his sentence exceeded his Guidelines range of 135 to 168 months. Heard's appeal centered around three key claims: the district court miscalculated his criminal history score, wrongly applied a Guidelines enhancement for his role in the conspiracy, and issued an unreasonable sentence.The Court of Appeals rejected all three of Heard's claims. First, the court found that the district court was correct to assess a criminal history point for a two-year probation term Heard served under Michigan’s Holmes Youthful Trainee Act. Despite Heard's argument that this sentence should not have counted towards his criminal history score as no conviction was entered and the underlying charges were dismissed, the Appeals Court ruled that Heard's admission of guilt by pleading guilty meant the probation term was correctly counted as a "prior sentence".Second, the Appeals Court upheld the district court's application of a three-level enhancement for Heard's role in the conspiracy, finding that Heard had exhibited sufficient managerial or supervisory authority to warrant this enhancement. The court pointed to evidence that Heard had recruited co-conspirators, used a co-conspirator’s apartment as a stash house, directed a co-conspirator to travel to get pills for distribution, and received proceeds from the pills’ sale.Finally, the court found Heard's sentence to be both procedurally and substantively reasonable. The district court had varied up from the Guidelines range based on Heard's conduct in pretrial detention, including his participation in a prison riot and assaults on two inmates. The Appeals Court found no clear error in the district court's determination that Heard had participated in the riot, and concluded that the 180-month sentence was within the realm of reasonableness given Heard's drug trafficking and pretrial detention misconduct. The court also rejected Heard's claim that his sentence created unwarranted disparities with his co-conspirators, stating that the need to avoid unwarranted sentence disparities refers to national disparities, not differences among co-conspirators. The court therefore affirmed the district court’s judgment. View "United States v. Heard" on Justia Law

In the case before the Court of Appeal of the State of California First Appellate District Division Four, the plaintiffs, thousands of individuals who suffered adverse effects from the use of a prescription drug, TDF, made by Gilead Life Sciences, Inc., brought a claim of negligence and fraudulent concealment against Gilead. The plaintiffs alleged that while Gilead was developing TDF, it discovered a similar, but chemically distinct and safer potential drug, TAF. However, Gilead allegedly decided to defer development of TAF because it was concerned that the immediate development of TAF would reduce its financial return from TDF. Gilead sought summary judgment on the ground that in order to recover for harm caused by a manufactured product, the plaintiff must prove that the product was defective. The trial court denied Gilead's motion for summary judgment in its entirety.In reviewing this case, the appellate court held that the trial court was correct to deny Gilead's motion for summary judgment on the negligence claim. The court reasoned that a manufacturer's duty of reasonable care can extend beyond the duty not to market a defective product. The court found that the factual basis of the plaintiffs' claim was that Gilead knew TAF was safer than TDF, but decided to defer development of TAF to maximize its profits. The court held that if Gilead's decision to postpone development of TAF indeed breached its duty of reasonable care to users of TDF, then Gilead could potentially be held liable.However, the appellate court reversed the trial court's decision regarding plaintiffs' claim for fraudulent concealment. The court concluded that Gilead's duty to plaintiffs did not extend to the disclosure of information about TAF, as it was not available as an alternative treatment for HIV/AIDS at the time the alleged concealment occurred. Consequently, the court granted in part and denied in part Gilead's petition for a writ of mandate, directing the superior court to vacate its order denying Gilead's motion for summary judgment and to enter a new order denying summary adjudication of the negligence claim but granting summary adjudication of the fraudulent concealment claim. View "Gilead Tenofovir Cases" on Justia Law

The Supreme Judicial Court of Maine upheld the conviction of Ralph A. Tripp Jr., who was found guilty of several drug-trafficking offenses, possession of a firearm by a prohibited person, and criminal forfeiture of property. Tripp appealed on the grounds that he should be immune from prosecution for his drug-related offenses, that there were errors in the State's conduct during its opening statement and closing argument, and that the jury was not provided with clear instructions. The court ruled that Maine’s immunity statutes did not apply in this case, that any prosecutorial error did not affect Tripp’s substantial rights, and that the trial court sufficiently corrected any potential confusion stemming from its initial jury instructions. The court therefore affirmed the judgment. The case involved Tripp and his wife, Amanda Tripp, who resided in a rooming house in Bangor. After the Tripps moved in, residents noticed an increase in visitors, found hypodermic needles outside the building, and frequently observed the Tripps letting visitors into the building. On one occasion, Tripp called 9-1-1 to report a person unconscious in one of the shared bathrooms of the rooming house. The person was later pronounced dead, and the cause of death was determined to be acute intoxication from multiple drugs. When the police executed a search warrant for Tripp’s room, they seized a handgun, various drugs, drug paraphernalia, and cash. Tripp was subsequently charged with several offenses. View "State v. Tripp" on Justia Law

In this appeal before the United States Court of Appeals For the Eighth Circuit, the defendant, Linda Riaski, who was convicted of one count of conspiracy to distribute methamphetamine and one count of possession of a firearm in furtherance of a drug trafficking crime, appealed the denial of her request for a hearing under Franks v. Delaware. The case involves a search warrant that was issued based on an affidavit prepared by Deputy Sheriff Jerry Brisky, who relied on information provided by a confidential informant (CI). The CI claimed to have observed Riaski packaging methamphetamine for distribution and to have seen Riaski with a black 9 millimeter handgun. The search of Riaski's residence resulted in the discovery of methamphetamine and firearms.Riaski's appeal was based on the argument that the district court erred in denying her request for a Franks hearing to challenge the validity of the search warrant. She claimed that the affidavit supporting the search warrant was misleading because it omitted information about the CI’s credibility, her criminal history, her drug use, the financial arrangement between her and Deputy Brisky, and certain facts alleged in Riaski’s own affidavit.The court affirmed the district court's decision, holding that Riaski failed to make a substantial preliminary showing that Deputy Brisky intentionally or recklessly omitted facts with the intent to mislead the issuing judge, and that the affidavit, even if supplemented by the omitted information, could still support a finding of probable cause. The court reasoned that the omitted information about the CI's criminal history and drug use would not have altered the probable cause determination, as the affidavit had already provided a basis for the CI’s reliability, disclosing that she previously had provided accurate information and had made controlled purchases under Brisky’s supervision. The court also found that the omission of the details and existence of the agreement between Brisky and the CI did not render the affidavit misleading. The judgment was affirmed. View "United States v. Riaski" on Justia Law

The United States Court of Appeals for the Second Circuit upheld the life imprisonment sentence of Azibo Aquart, who was found guilty of multiple federal homicide and drug trafficking crimes. The court had previously affirmed his conviction but vacated his death sentence, remanding the case for a new penalty proceeding. On remand, the government decided not to pursue the death penalty, and Aquart was resentenced to life imprisonment. Aquart appealed, arguing that the district court erred in refusing to address new challenges to his conviction and in sentencing him for both drug-related murder and drug conspiracy, which he argued constituted double jeopardy. The Appeals Court rejected both arguments, ruling that the district court correctly applied the mandate rule and that Aquart's double jeopardy argument was without merit. View "United States v. Aquart" on Justia Law

The case involves appellant Soleiman Mobarak, who appealed the judgment of the Tenth District Court of Appeals dismissing his petition for a writ of mandamus against appellee, Franklin County Court of Common Pleas Judge Jeffrey M. Brown. Mobarak had sought to vacate his criminal convictions for lack of subject-matter jurisdiction in the trial court. The court of appeals held that the trial court had jurisdiction over Mobarak’s criminal case and that Mobarak had an adequate remedy in the ordinary course of the law.In 2012, Mobarak was indicted on charges of engaging in a pattern of corrupt activity, aggravated trafficking in drugs, and aggravated possession of drugs. The charges alleged that Mobarak had possessed and sold a controlled-substance analog commonly known as bath salts. In his petition, Mobarak asserted that the trial court lacked subject-matter jurisdiction over his criminal case on several grounds including that there was no statute prohibiting the possession or sale of bath salts at the time his offenses were alleged to have occurred, and that the controlled-substance-analogs law was unconstitutionally vague.The Supreme Court of Ohio affirmed the Tenth District Court of Appeals' judgment dismissing Mobarak’s petition. The court held that Mobarak’s petition failed to state a mandamus claim because he had an adequate remedy in the ordinary course of the law and failed to show that the trial court had patently and unambiguously lacked jurisdiction over his criminal case. The court found that by virtue of the Ohio Constitution and R.C. 2931.03, the trial court had jurisdiction over Mobarak’s criminal case. The court also noted that Mobarak’s arguments were similar to those raised and rejected in his prior appeals. The court stated that extraordinary writs may not be used as a substitute for an otherwise barred second appeal or to gain successive appellate reviews of the same issue. View "State ex rel. Mobarak v. Brown" on Justia Law

This case involves a pharmaceutical manufacturer, Gilead Life Sciences, Inc., and its development and sale of a drug, tenofovir disoproxil fumarate (TDF), to treat HIV/AIDS. The approximately 24,000 plaintiffs allege that they suffered adverse effects from TDF, including skeletal and kidney damage. Gilead developed a similar but chemically distinct drug, tenofovir alafenamide fumarate (TAF), which could potentially treat HIV/AIDS with fewer side effects. The plaintiffs claim that Gilead delayed the development of TAF to maximize profits from TDF.The plaintiffs do not claim that TDF is defective. Instead, they assert a claim for ordinary negligence, arguing that Gilead's decision to delay the development of TAF breached its duty of reasonable care to users of TDF. They also assert a claim for fraudulent concealment, arguing that Gilead had a duty to disclose information about TAF to users of TDF.The Court of Appeal of the State of California, First Appellate District, Division Four, partially granted Gilead's petition for a writ of mandate and held that the plaintiffs could proceed with their negligence claim. The court concluded that a manufacturer's legal duty of reasonable care can extend beyond the duty not to market a defective product. However, the court reversed the trial court's decision denying Gilead's motion for summary adjudication of the plaintiffs' claim for fraudulent concealment. The court held that Gilead had no duty to disclose information about TAF to users of TDF, as TAF was not available as an alternative treatment at the time. View "Gilead Tenofovir Cases" on Justia Law

The defendant, Rodriquies Evans, was convicted of four criminal offenses related to his involvement in a multistate conspiracy to transport and distribute methamphetamine and other controlled substances. The district court sentenced him to the statutory maximum of 80 years in prison. The Fourth Circuit United States Court of Appeals found that the district court had erred in calculating Evans’s Sentencing Guidelines range and vacated his sentence, remanding the case for resentencing. The court determined that the district court had incorrectly attributed nearly three kilograms of crystal methamphetamine seized from a co-conspirator to Evans. The court held that for sentencing purposes under the Sentencing Guidelines, only acts that fall within the scope of the criminal activity the defendant agreed to jointly undertake can be considered relevant conduct. The district court had attributed the drugs based on the broader standard of substantive liability under Pinkerton, which allows a defendant to be held liable for the acts of co-conspirators if they are within the scope of the overall conspiracy and reasonably foreseeable to the defendant. The court also found that the district court had erred in applying a threat enhancement in calculating Evans's Sentencing Guidelines range, as the possession of a firearm enhancement could not by itself be the basis for a threat enhancement. View "US v. Evans" on Justia Law

In the case of Wages and White Lion Investments, L.L.C., doing business as Triton Distribution; Vapetasia, L.L.C., versus the Food & Drug Administration, the court found that the FDA acted arbitrarily and capriciously in its denial of Premarket Tobacco Product Applications (PMTAs) for flavored e-cigarette products.The petitioners, Triton Distribution and Vapetasia, are manufacturers of flavored e-cigarette liquids. They filed PMTAs for their products, as required by the Family Smoking Prevention and Tobacco Control Act, which prohibits the sale of any “new tobacco product” without authorization from the FDA. The FDA, after issuing detailed guidance on the information it required for approval of e-cigarette products, subsequently denied all flavored e-cigarette applications, including those of the petitioners, on the grounds that they failed to predict new testing requirements imposed by the FDA without notice.The court found that the FDA had failed to provide the manufacturers with fair notice of the rules, had not acknowledged or explained its change in position, and had ignored the reasonable and serious reliance interests that manufacturers had in the pre-denial guidance. Furthermore, the FDA attempted to cover up its mistakes with post hoc justifications at oral argument.As a result, the court granted the petitions for review, set aside the FDA's marketing denial orders, and remanded the matters to the FDA. The court rejected FDA's argument that even if it arbitrarily and capriciously denied petitioners’ applications, that error was harmless, stating that the harmless error doctrine is narrow and does not apply to discretionary administrative decisions. The court also rejected FDA's contention that it gave manufacturers fair notice of their obligations to perform long-term scientific studies in its pre-denial guidance documents. View "Wages and White Lion Invest v. FDA" on Justia Law

The United States Court of Appeals for the Ninth Circuit upheld the drug-trafficking and money-laundering convictions of Benjamin Galecki and Charles Burton Ritchie for their distribution of "spice," a synthetic cannabinoid product. The defendants were found guilty of manufacturing and distributing spice through their company, Zencense Incenseworks, LLC. The drug-trafficking charges were based on the premise that the cannabinoid used, XLR-11, was treated as a controlled substance because it was an "analogue" of a listed substance. The court rejected the defendants' arguments that their convictions should be set aside due to Fourth Amendment violations, insufficient evidence, and vagueness of the Controlled Substance Analogue Enforcement Act of 1986. However, the court reversed their mail and wire fraud convictions due to insufficient evidence. The case was remanded for further proceedings. View "USA V. GALECKI" on Justia Law