Justia Drugs & Biotech Opinion Summaries

The case involves two defendants, Christopher Yates and Shawn Connelly, who were convicted for conspiring to distribute methamphetamine. The conspiracy operated out of Macomb, Illinois, and lasted thirteen months, from January 2019 to February 2020. Yates supplied the methamphetamine, initially purchasing the drugs from an unknown source in Joliet, Illinois, with alleged Mexican cartel connections. After the arrest of that supplier, Yates sought out a new source. Connelly was among the distributors.The United States District Court for the Central District of Illinois sentenced both defendants. Yates argued that the government failed to prove the purity of all the methamphetamine involved in the conspiracy, having only tested a small, unrepresentative amount. Connelly argued that the court should not have relied on his coconspirators’ statements to calculate the total drug weight, and that the full weight was not reasonably foreseeable to him. The district court rejected both arguments and sentenced Yates to 168 months in prison and Connelly to 188 months’ imprisonment.On appeal, the United States Court of Appeals for the Seventh Circuit vacated Yates’s sentence and remanded the case. The court found that the government did not provide reliable evidence to support the district court's finding that the conspiracy involved at least 737.1 grams of “ice” methamphetamine. Therefore, Yates was entitled to resentencing. However, the court affirmed Connelly’s sentence, finding that the district court did not err in its calculation of the total drug weight attributable to him. View "United States v. Connelly" on Justia Law

The case revolves around a dispute over a medical marijuana cultivation license issued by the Arkansas Medical Marijuana Commission to Bennett Scott “Storm” Nolan II. 2600 Holdings, LLC, an unsuccessful applicant for the same license, filed a lawsuit against the Commission and other state entities, alleging that Nolan's application did not meet the minimum merit selection criteria and that the Commission violated its own rules and the Arkansas Constitution in awarding the license to Nolan. Nolan was not initially named as a defendant or joined as a party in the lawsuit.The Pulaski County Circuit Court denied Nolan's multiple motions to join the lawsuit as an indispensable party under Rule 19(a) of the Arkansas Rules of Civil Procedure and granted summary judgment in favor of 2600 Holdings. The court ruled that the Commission had exceeded its discretion and violated the Arkansas Constitution and its own rules in awarding the license to Nolan.On appeal, the Supreme Court of Arkansas reversed the lower court's decision, finding that Nolan was indeed an indispensable party under Rule 19(a)(2). The court held that the lower court erred in not joining Nolan as an indispensable party to the litigation. As a result, the court vacated the order granting summary judgment to 2600 Holdings and remanded the case for further proceedings. The court did not address Nolan's remaining issues as they were deemed moot due to the reversal and remand. View "Nolan v. 2600 Holdings, LLC" on Justia Law

In 2019, MO CANN Do, Inc. (MCD) applied for a medical marijuana cultivation license in Missouri. However, the Department of Health and Senior Services (DHSS) rejected MCD's application as it failed to include a certificate of good standing demonstrating its authorization to operate as a business in Missouri. An administrative hearing commission upheld DHSS's decision, and MCD appealed to the circuit court, which also affirmed the decision.The Supreme Court of Missouri found that MCD's application did not meet the minimum standards for licensure, as it failed to provide a certificate of good standing from the Secretary of State, as required by DHSS's regulations. MCD argued that its certificate of incorporation satisfied the standard requiring proof of authorization to operate as a business in Missouri, but the Court disagreed, stating that the regulatory language was unambiguous and the certificate of good standing was a specific requirement.MCD further argued that DHSS waived the certificate of good standing requirement by failing to specify it in the deficiency letter sent to MCD. The Court rejected this argument, stating that DHSS never affirmatively waived the deficiencies in MCD's application.Lastly, MCD claimed that DHSS should be estopped from denying its application based on the missing certificate of good standing due to its failure to notify MCD of this specific deficiency. The Court denied this claim, stating that it is generally inappropriate to estop governmental agencies tasked with administrating licensure in highly regulated industries, which include the marijuana industry. In conclusion, the Supreme Court of Missouri affirmed the circuit court’s judgment. View "MO CANN Do, Inc. vs. Missouri Department of Health and Senior Services" on Justia Law

The Florida Supreme Court was asked to review a proposed amendment to the state constitution legalizing the recreational use of marijuana. The court evaluated the amendment for adherence to the constitution’s single-subject requirement, the clarity of the ballot summary, and whether the amendment was facially invalid under the federal constitution. The amendment, titled "Adult Personal Use of Marijuana," aimed to modify the Florida Constitution to legalize the personal use of marijuana by adults and allow licensed centers to sell and distribute marijuana for personal use.The court ruled that the amendment adhered to the single-subject requirement as it focused on a single dominant plan or scheme, which is the legalization of marijuana for personal use. The court disagreed with the argument that the amendment violated the single-subject requirement by both decriminalizing and commercializing recreational marijuana, stating that the sale and possession are logically and naturally related as part of a dominant plan or scheme.The court also ruled that the ballot summary met the statutory standard for clarity. The court disagreed with the opposition that the ballot summary was misleading because it implied that there were already other state-licensed entities ready to engage in the sale of recreational marijuana.Lastly, the court ruled that the amendment is not facially invalid under the U.S. Constitution. The court rejected the argument that the proposed amendment is preempted by the federal Controlled Substances Act and thus invalid under the Supremacy Clause.In conclusion, the court approved the proposed amendment for placement on the ballot, finding it complies with the requirements imposed by the Florida Constitution and Florida Statutes. View "Advisory Opinion to the Attorney General Re: Adult Personal Use of Marijuana" on Justia Law

This case deals with the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collectively, "Meril") into the United States for a medical conference in San Francisco. The plaintiff, Edwards Lifesciences Corporation and Edwards Lifesciences LLC (collectively, "Edwards"), a competitor medical device company, alleged that this act constituted patent infringement. Meril argued that the importation was covered by the "safe harbor" provision of 35 U.S.C. § 271(e)(1), which exempts certain activities from being considered patent infringement if they are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.The district court granted summary judgment in favor of Meril, and Edwards appealed to the United States Court of Appeals for the Federal Circuit. The Court of Appeals affirmed the decision of the district court, noting that the undisputed evidence showed that the importation of the valve systems was reasonably related to submitting information to the United States Food and Drug Administration. The court rejected Edwards' arguments that the district court had disregarded contemporaneous evidence, applied the safe harbor with an objective standard, and relied improperly on declarations from Meril employees. The court affirmed the district court's conclusion that there was no genuine dispute of material fact and that Meril was entitled to judgment as a matter of law. View "EDWARDS LIFESCIENCES CORPORATION v. MERIL LIFE SCIENCES PVT. LTD. " on Justia Law

This case was before the United States Court of Appeals for the Fourth Circuit where the City of Huntington and Cabell County Commission (plaintiffs) brought a suit against AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and McKesson Corporation (defendants), three distributors of opioids. The plaintiffs alleged that these companies perpetuated the opioid epidemic by repeatedly shipping excessive quantities of opioids to pharmacies, thus creating a public nuisance under West Virginia common law. The district court ruled in favor of the distributors, holding that West Virginia’s common law of public nuisance did not cover the plaintiffs’ claims.After a bench trial in 2021, the district court held that the common law of public nuisance in West Virginia did not extend to the sale, distribution, and manufacture of opioids. The court found that the application of public nuisance law to the sale, marketing, and distribution of products would invite litigation against any product with a known risk of harm, regardless of the benefits conferred on the public from proper use of the product. The court also rejected the plaintiffs’ proposed remedy, a 15-year “Abatement Plan” developed by an expert in opioid abatement intervention. The court held that this relief did not qualify as an abatement as it did not restrict the defendants' conduct or their distribution of opioids but generally proposed programs and services to address the harms caused by opioid abuse and addiction.The plaintiffs appealed the decision to the United States Court of Appeals for the Fourth Circuit, which certified the following question to the Supreme Court of Appeals of West Virginia: Under West Virginia’s common law, can conditions caused by the distribution of a controlled substance constitute a public nuisance and, if so, what are the elements of such a public nuisance claim? View "City of Huntington v. Amerisourcebergen Drug Corporation" on Justia Law

In this case, the United States Court of Appeals for the Tenth Circuit dealt with the appeal of Youlian Zhong, who contested her mandatory minimum sentences for crimes related to her participation in a conspiracy to manufacture and distribute large quantities of marijuana. Zhong argued that the district court erred in finding that she did not qualify for the statutory safety valve for mandatory minimum sentences.Zhong and her husband, Housheng Xian, were found guilty of conspiring to grow more than 1,500 marijuana plants in their residence, intending to process and sell the marijuana. They were convicted on three counts: conspiring to manufacture and possess with the intent to distribute 1,000 and more marijuana plants, manufacturing and possessing with intent to distribute 1,000 or more marijuana plants, and using and maintaining their house for the purpose of manufacturing and distributing marijuana.Before sentencing, Zhong and Xian requested a non-guideline sentence of time served plus five years of supervised release, arguing that they met the requirements of the safety valve provisions. However, the court found that they did not provide all necessary information to the government, particularly regarding their mens rea, or intent, for the crimes for which they were convicted.On appeal, the Tenth Circuit affirmed the lower court's decision. The appeals court held that a defendant must provide the government with information sufficient to prove the mens rea required for the crimes of conviction to meet the requirement of providing “all information and evidence” concerning the offense for the safety valve provision to apply. The court concluded that Zhong did not provide sufficient information about her intent to commit the crimes for which she was convicted, and thus, did not meet her burden to prove that she qualified for safety-valve relief. View "United States v. Zhong" on Justia Law

The United States Court of Appeals for the Second Circuit heard a case initiated by Adam Hart, who filed a qui tam action under the False Claims Act (FCA) against pharmaceutical distributor McKesson. Hart alleged that McKesson provided business management tools to its customers for free in exchange for commitments to purchase drugs, which he claimed violated the federal anti-kickback statute (AKS) and several analogous state laws. The district court dismissed Hart's FCA claim, determining he failed to allege McKesson acted "willfully" as required by the AKS.On appeal, the Second Circuit held that to act "willfully" under the AKS, a defendant must knowingly act in a way that is unlawful. The court found that Hart failed to provide sufficient facts to meet this standard. However, the court disagreed with the district court's assertion that Hart's state claims were premised solely on a violation of the federal AKS. Consequently, the Second Circuit affirmed the dismissal of Hart’s federal FCA claim, vacated the dismissal of the remaining state claims, and remanded for further proceedings. View "United States, ex rel. Hart v. McKesson Corp." on Justia Law

The case involves Andre Dubois, who was convicted on several federal firearm offenses. These offenses arose when Dubois attempted to ship a box containing firearms from Georgia to Dominica. The United States Court of Appeals for the Eleventh Circuit was asked to address five issues on appeal.Firstly, the court dismissed Dubois's argument that a recent Supreme Court case overturned the precedent upholding a ban on felons possessing firearms. The court held that the Supreme Court case did not abrogate the precedent, and therefore Dubois's argument failed.Secondly, the court affirmed that there was sufficient evidence for a reasonable jury to find that Dubois knew he was in possession of a firearm.Thirdly, the court found that Dubois's prior conviction for possession with intent to distribute marijuana under Georgia law qualified as a "controlled substance offense" under the federal Sentencing Guidelines, triggering a higher base offense level.Fourthly, the court rejected Dubois's argument that the application of a sentencing enhancement for possession of a stolen gun violated his due process rights.Finally, the court held that the district court had not erred in imposing a $25,000 fine on Dubois, as there was sufficient evidence to suggest that he could afford to pay the fine.Therefore, Dubois's convictions and sentence were affirmed. View "USA v. Dubois" on Justia Law

A group of individuals filed a lawsuit against Genzyme Corporation, a drug manufacturer, for injuries allegedly caused by the company's mishandling of a prescription drug shortage between 2009 and 2012. The lawsuit was filed several years after the events in question occurred and would typically have been considered too late under the applicable statutory limitations periods. However, the plaintiffs argued that previous class actions, a savings statute, and a tolling agreement between the parties allowed the lawsuit to proceed. The district court partially agreed and rejected Genzyme's argument that the delay in filing required dismissal of the lawsuit. However, it dismissed the claims of all but four plaintiffs for lack of standing, and dismissed the remaining claims on the merits.On appeal, the United States Court of Appeals for the First Circuit found that all plaintiffs have standing and the court has jurisdiction to proceed with the case, at least with respect to the plaintiffs' individual claims. However, it concluded that four plaintiffs waited too long before filing this lawsuit, and their claims are time-barred. For the remaining plaintiffs, the court vacated the judgment dismissing their claims and remanded the case to the district court for further proceedings. View "Wilkins v. Genzyme Corporation" on Justia Law