Justia Drugs & Biotech Opinion Summaries

NiGen, manufacturer and distributor of dietary supplements, Isodrene and The HCG Solution, appealed the dismissal of its constitutional and state law claims against the Attorney General based on state sovereign immunity. NiGen had filed suit under 42 U.S.C. 1983 after the AG sent letters to NiGen and its retailers, intimating that formal enforcement was on the horizon for both NiGen and its retailers. The retailers pulled the products from their shelves in Texas and other states, allegedly costing NiGen millions of dollars in lost revenue. The court concluded that it is at least partially correct that NiGen’s claims are not barred from federal jurisdiction on the basis of Ex parte Young; federal jurisdiction plainly exists over most of the constitutional claims pled; and NiGen has standing to sue. Accordingly, the court affirmed in part, and vacated, remanding in part for further proceedings. View "NiGen Biotech, L.L.C. v. Paxton" on Justia Law

Laura Nunez's attorneys served Lunada with a notice under the Consumer Legal Remedies Act (CLRA), Civil Code section 1750 et seq., alleging that her dietary supplement, Amberen, was being marketed falsely and misleadingly as a natural remedy for Menopausal symptom relief. Lunada subsequently filed a declaratory relief action against Nunez and her attorneys. Nunez and her attorneys moved to strike the complaint under the anti-SLAPP statute, Code of Civil Procedure section 425.16. The trial court granted the motion and Lunada appealed. The court held that the declaratory relief action seeking a declaration that Lunada had not violated the CLRA is subject to the anti-SLAPP statute because it arose out of protected activity under the statute. Consequently, the trial court properly granted the special motions to strike because Lunada's declaratory relief action had no probability of success. The court, under the reasoning of Filarsky v. Superior Court, held that a potential defendant in a CLRA damages action after receiving the statutory notice may not maintain a declaratory relief action to establish that there was no violation of the CLRA. Accordingly, the court affirmed the order striking the complaint and the award of attorney fees to Nunez and her attorneys. View "Lunada Biomedical v. Nunez" on Justia Law

Plaintiffs, non-profit organizations representing the manufacturers and distributors of pharmaceutical products, filed suit challenging the Alameda County Safe Drug Disposal Ordinance, which requires that prescription drug manufacturers, who either sell, offer for sale, or distribute "Covered Drugs" in Alameda, operate and finance a "Product Stewardship Program." The court concluded that the Ordinance, both on its face and in effect, does not discriminate because it applies to all manufacturers that make their drugs available in Alameda County - without respect to the geographic location of the manufacturer; the Ordinance does not directly regulate interstate commerce where it does not control conduct beyond the boundaries of the county; under the balancing test in Pike v. Bruce Church, Inc., the court concluded that, without any evidence that the Ordinance will affect the interstate flow of goods, the Ordinance does not substantially burden interstate commerce; and therefore, the Ordinance does not violate the dormant Commerce Clause. Accordingly, the court affirmed the district court's grant of summary judgment to defendants. View "PRMA v. County of Alameda" on Justia Law

GSK filed suit against Abbott over a dispute related to a licensing agreement and the pricing of HIV medications. The central issue on appeal was whether equal protection prohibited discrimination based on sexual orientation in jury selection. GSK contended that a new trial was warranted because Abbott unconstitutionally used a peremptory strike to exclude a juror on the basis of his sexual orientation. The court concluded that GSK had established a prima facie case of intentional discrimination where the juror at issue was the only juror to have identified himself as gay on the record and the subject of the litigation presented an issue of consequence to the gay community. The court held that classifications based on sexual orientation were subject to a heightened scrutiny under United States v. Windsor. The court also held that equal protection prohibits peremptory strikes based on sexual orientation. The history of exclusion of gays and lesbians from democratic institutions and the pervasiveness of stereotypes about the group leads the court to conclude that Batson v. Kentucky applied to peremptory strikes based on sexual orientation. The court also concluded that a Batson challenge would be cognizable only once a prospective juror's sexual orientation was established, voluntarily and on the record. The court rejected Abbott's harmless error argument. Accordingly, the court reversed and remanded. View "SmithKline Beecham Corp. v. Abbott Laboratories" on Justia Law

Plaintiffs, a group of prisoners, filed suit against the FDA for allowing state correctional departments to import sodium thiopental (thiopental), a misbranded and misapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 381(a), and the Administrative Procedure Act (APA), 5 U.S.C. 706(2)(A). The court concluded that, because there were clear statutory guidelines for the agency to follow in exercising its enforcement powers, the FDA's compliance with section 381(a) was subject to judicial review under the standards of the APA. The court also concluded that the FDA's policy of admitting foreign manufactured thiopental destined for state correctional facilities were not in accordance with law because section 381(a) required the agency to sample and examine for violations of any drug offered for import that had been prepared in an unregistered facility. The court concluded, however, that the district court erred by failing to seek the joinder of the state governments whose possession and use of the thiopental at issue the court declared illegal. Accordingly, the order of the district court pertaining to the thiopental already in the possession of the states was vacated, but the underlying judgment of the district court was affirmed. View "Cook, et al. v. FDA, et al." on Justia Law

Vermont's Prescription Confidentiality Law, Vt. Stat. Ann., Tit. 18, 4631(d), restricted the sale, disclosure, and use of pharmacy records that revealed the prescribing practices of individual doctors. Respondents, Vermont data miners and an association of brand-name drug manufacturers, sought declaratory and injunctive relief against state officials, contending that section 4631(d) violated their rights under the Free Speech Clause of the First Amendment. At issue was whether section 4631(d) must be tested by heightened judicial scrutiny and, if so, whether Vermont could justify the law. The Court held that the Vermont Statute, which imposed content-based and speaker-based burdens on protected expression, was subject to heightened judicial scrutiny. The Court also held that Vermont's justifications for section 4631(d) did not withstand such heightened scrutiny and therefore, affirmed the Second Circuit's judgment that section 4631(d) unconstitutionally burdened the speech of pharmaceutical marketers and data miners without adequate justification. View "Sorrell, et al. v. IMS Health Inc., et al." on Justia Law

Plaintiffs commenced this putative class action alleging that defendants participated in a global Internet conspiracy to sell illegal prescription drugs, in violation of the laws of the United States and Virginia. At issue on appeal was whether the district court erred in dismissing the complaint against four foreign banks for lack of personal jurisdiction. The court concluded that Rule 4(k)(2) did not justify the exercise of personal jurisdiction over the banks because exercising jurisdiction over them would not, in the circumstances here, be consistent with the United States Constitution and laws. Subjecting the banks to the coercive power of the court in the United States, in the absence of minimum contacts, would constitute a violation of the Due Process Clause. Accordingly, the court affirmed the district court's orders dismissing the complaint against the banks. View "Unspam Technologies v. Chernuk" on Justia Law

The DEA, under the authority of the Controlled Substances Act of 1970, 21 U.S.C. 812(b)(1)(B), classified marijuana as a Schedule I drug, the most restricted drug classification under the Act. Petitioners challenged the DEA's denial of its petition to initiate proceedings to reschedule marijuana as a Schedule III, IV, or V drug. The principal issue on appeal was whether the DEA's decision was arbitrary and capricious. First, the court denied the Government's jurisdictional challenge because the court found that at least one of the named petitioners had standing to challenge the agency's action. On the merits, the court held that the DEA's denial of the rescheduling petition survived review under the deferential arbitrary and capricious standard where the petition asked the DEA to reclassify marijuana, which, under the terms of the Act, required a "currently accepted medical use." A "currently accepted medical use" required, inter alia, "adequate and well-controlled studies proving efficacy." The court deferred to the agency's interpretation of these regulations and found that substantial evidence supported the agency's determination that such studies did not exist. Accordingly, the court denied the petition for review. View "Americans for Safe Access, et al v. DEA" on Justia Law

Defendant appealed from a conviction of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. 331(a) and 333(a)(1). Defendant, a pharmaceutical sales representative, promoted the drug Xyrem for "off-label use." The court agreed with defendant that he was convicted for his speech -- for promoting an FDA-approved drug for off-label use -- in violation of his right of free speech under the First Amendment. The court limited its holding to FDA-approved drugs for which off-label use was not prohibited. Accordingly, the court vacated and remanded. View "United States v. Caronia" on Justia Law

Plaintiff sought to develop a rapid, self-administered test to determine a person’s HIV status. The development process included collection of human blood and saliva samples. Plaintiff sued the United States under the Federal Tort Claims Act for the destruction of its blood and saliva specimens by the Food and Drug Administration. The specimens had been seized during a criminal investigation and the freezer in which they were stored broke down. The district court entered summary judgment that the suit arose from a law enforcement officer’s detention of property, excepting the claims from the FTCA waiver of sovereign immunity, 28 U.S.C. 2680(c). The Seventh Circuit affirmed. The government presented uncontroverted evidence that the officer detained the specimens as a law enforcement officer View "On-Site Screening, Inc. v. United States" on Justia Law