Justia Drugs & Biotech Opinion Summaries

Articles Posted in Constitutional Law
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The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law

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The case involves the Iowaska Church of Healing (the "Church"), an organization whose religious practices involve the consumption of Ayahuasca, a tea containing the hallucinogenic drug dimethyltryptamine (DMT), which is regulated under the Controlled Substances Act (CSA). The Church had applied for tax-exempt status under 26 U.S.C. § 501(c)(3) but was denied by the Internal Revenue Service (IRS) on the grounds that the Church's religious use of Ayahuasca was illegal. The Church challenged this decision in the District Court, arguing that the IRS's determination was based on an incorrect assumption of illegality and that the denial of tax-exempt status violated the Religious Freedom Restoration Act of 1993 (RFRA).The District Court denied the Church's motion and granted the Government's motion for summary judgment. The court held that the Church lacked standing to assert its RFRA claim and that the lack of standing also undermined its tax-exemption claim. The court found that the Church's religious use of Ayahuasca was illegal without a CSA exemption, and the IRS had no authority to assess whether the Church's proposed Ayahuasca use warranted a religious exemption from the CSA.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the District Court's judgment. The Court of Appeals held that the Church lacked standing to assert its RFRA claim because the economic injury it claimed was neither an injury-in-fact nor redressable. Without a cognizable RFRA claim, the Church's tax-exemption claim also failed. The Court of Appeals found that the Church could not proffer evidence of a CSA exemption to show it passed the organizational and operational tests for tax-exempt status. View "Iowaska Church of Healing v. Werfel" on Justia Law

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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

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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

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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

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Former executives of medical device manufacturer Acclarent, Inc., William Facteau and Patrick Fabian, were found guilty of multiple misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FDCA) for commercially distributing an adulterated and misbranded medical device. They appealed their convictions, claiming First Amendment violations, due process violations, and insufficiency of evidence. The United States Court of Appeals for the First Circuit rejected all of these claims and affirmed the convictions. The court held that the use of promotional speech as evidence of a device's intended use did not implicate the First Amendment. The court also found that the term "intended use" was not unconstitutionally vague and that Facteau and Fabian had fair warning of the conduct prohibited under the FDCA. Finally, the court found that the evidence was sufficient to support the convictions and that Fabian's fine did not violate the Eighth Amendment. View "United States v. Facteau" on Justia Law

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The United States District Court for the Northern District of Ohio certified two questions to the Georgia Supreme Court regarding whether a state entity could continue asserting claims against opioid manufacturers and distributors after the State of Georgia entered into a settlement with the pharmaceutical companies, and as part of the settlement, the General Assembly enacted OCGA § 10-13B-1, et seq. (the “Settlement Act”) in 2022, which included a litigation preemption provision that “bar[s] any and all past, present or future claims on behalf of any governmental entity seeking to recover against any business or person that is a released entity under the terms of the relevant settlement.” OCGA § 10-13B-3 (a) (the “preemption provision”). In April 2019, before Georgia entered into the state-wide settlement with the pharmaceutical companies, the Hospital Authority of Wayne County, Georgia (“HAWC”) filed suit against a number of such entities, seeking to recover unreimbursed amounts it claims to have expended in treating opioid-dependent patients. HAWC subsequently chose not to participate in the state-wide settlement and did not individually release any of its claims. At some point, HAWC’s litigation was consolidated, along with over 3,000 other cases, into a federal multidistrict litigation in the District Court. See In re Natl. Prescription Opiate Litigation, (MDL No. 2804). Seven defendants named in HAWC’s complaint filed a motion to dismiss HAWC’s claims against them (the “Motion”), contending that the suit was barred by the preemption provision. The Georgia Supreme Court concluded that the Georgia General Assembly's passage of the preemption provision took away any power HAWC otherwise might have had under OCGA § 31-7-75 to pursue claims that the preemption provision and the Settlement Act were unconstitutional, and the answer to the first question certified by the District Court was no. In light of this answer, the Supreme Court did not need to answer the second certified question. View "Hospital Authority of Wayne County v. AmeriSourceBergen Drug Corp, et al." on Justia Law

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Doctor Shakeel Kahn (Dr. Kahn) was convicted in federal district court in Wyoming, in part, for dispensing controlled substances not “as authorized,” in violation of the Controlled Substances Act (the CSA). Included in his appeal to the Tenth Circuit Court of Appeals was his contention that the jury instructions issued by the district court improperly advised the jury regarding the mens rea requirement of CSA § 841(a). The Tenth Circuit affirmed Dr. Kahn’s convictions, rejecting both his challenge to the instructions given, and his challenges to multiple searches and the evidence seized. In upholding the instructions, the Tenth Circuit relied on precedent, United States v. Nelson, 383 F.3d 1227 (10th Cir. 2004), and further reaffirmed its holding, which was guided by 21 C.F.R. § 1306.04(a). Dr. Kahn appealed to the U.S. Supreme Court, raising only his instructional challenge. The Supreme Court held that § 841(a)’s “knowingly or intentionally” mens rea applied to the “except as authorized” clause of the statute, vacated the Tenth Circuit's judgment, and remanded the case for further proceedings consistent with its opinion. The parties submitted supplemental briefing, and the matter went again before the Tenth Circuit. After review, the Tenth Circuit concluded the jury instructions issued in Dr. Kahn’s trial incorrectly stated the mens rea requirement of § 841(a) and the error was not harmless beyond a reasonable doubt. This prejudicial error infected all of Dr. Kahn’s convictions. Therefore, Dr. Kahn’s convictions were v View "United States v. Kahn" on Justia Law

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An opioid manufacturer appealed a $465 million verdict following a bench trial in a public nuisance lawsuit. The district court held the opioid manufacturer liable under Oklahoma's public nuisance statute for its prescription opioid marketing campaign. The State of Oklahoma counter-appealed. The Oklahoma Supreme Court retained the appeal and held that the opioid manufacturer's actions did not create a public nuisance. The district court erred in extending the public nuisance statute to the manufacturing, marketing, and selling of prescription opioids. View "Oklahoma ex rel. Attorney General of Oklahoma v. Johnson & Johnson" on Justia Law

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Plaintiffs, who were prescribed a metered-dose inhaler manufactured by defendant and approved by the FDA to alleviate symptoms of chronic obstructive pulmonary disease, filed suit alleging violations of state law premised on defendant's allegedly deceptive labeling or defective design and manufacture of the metered-dose inhaler.The Second Circuit affirmed the district court's dismissal of the claims as preempted by federal law. The court explained that plaintiffs' state law design and manufacturing defect claims are preempted to the extent that they would require any change listed in 21 C.F.R. 314.70(b)(2). In this case, the modifications that plaintiffs' claims would require under state law constitute "major" changes, and therefore those claims are preempted by federal law. Finally, the complaint failed to state any non-preempted claim and plaintiffs' remaining arguments are without merit. View "Ignacuinos v. Boehringer Ingelheim Pharmaceuticals Inc." on Justia Law