Justia Drugs & Biotech Opinion Summaries

The First Circuit affirmed the judgment of the district court dismissing Plaintiff's putative class action against McNeil Nutritionals, LLC and Johnson & Johnson Consumer, Inc. challenging certain statements on the packaging of Lactaid products, holding that the district court correctly dismissed the complaint.Plaintiff brought this action claiming that Lactaid's labels violated federal labeling requirements, leading Plaintiff to have been mislead into purchasing Lactaid products, which she claimed were more expensive than other lactase supplements. The district court granted Defendants' second motion to dismiss. The First Circuit affirmed, holding that Plaintiff's claims were impliedly preempted by the statutory enforcement authority of the Food and Drug Administration. View "DiCroce v. McNeil Nutritionals, LLC" on Justia Law

Genentech manufactures and sells Rituxan, a drug used to treat leukemia and lymphoma. Rituxan is sold in single-use vials. Williamson was diagnosed with follicular lymphoma and was treated with Rituxan. Williamson later sued Genentech, on behalf of himself and a putative class of similarly situated individuals. He claims that Genentech violates the unfair competition law by selling Rituxan (and three other medications) in excessively large single-use vials; because the appropriate dosage varies based on a patient’s body size, Genentech’s vial sizes are too large for most patients. He argues Genentech should be required to offer smaller vials to reduce the waste of expensive medicine. In addition to injunctive relief, Williamson seeks to recover the amount the class spent on wasted Rituxan (and three other medications). Williamson took only Rituxan, not the other three medications, and paid a $231.15 deductible– the rest of the payments were made by his health insurer.The court of appeal affirmed the dismissal of the case for lack of standing under California’s unfair competition law (Bus. & Prof. Code 17200). Williamson suffered no economic injury caused by the alleged unfair practices and cannot establish standing by borrowing an economic injury from his insurer. The collateral source rule, under which a tortfeasor must fully compensate a victim and cannot subtract compensation the victim may have received from their insurer or another collateral source, does not apply. View "Williamson v. Genentech, Inc." on Justia Law

The Butter! Spray is a butter-flavored vegetable oil dispensed in pump-action squirt bottles with a spray mechanism. The front label on the product states that the Butter! Spray has 0 calories and 0 grams of fat per serving. Plaintiffs are a class of consumers who brought their lawsuit against the then-manufacturer, Unilever United States, Inc., contending that the product’s label makes misrepresentations about fat and calorie content based on artificially low serving sizes. The district court found that Plaintiffs failed to plausibly allege that Butter! Spray was not a “spray type” fat or oil under Food and Drug Administration (FDA) regulations. The district court further held that the FDCA preempted plaintiffs’ serving size claims.   The Ninth Circuit affirmed the district court’s Fed. R. Civ. P. 12(b)(6) dismissal. The panel held that, as a matter of legal classification, Butter! Spray was a “spray.” In common parlance, a “spray” refers to liquid dispensed in the form of droplets, emitted from a mechanism that allows the product to be applied in that manner. In addition, the notion that Butter! Spray could be housed under the FDA’s legal classification for “butter” is implausible. The panel also rejected Plaintiffs’ argument that Butter! Spray is a “butter substitute” based on how it is marketed so it should be treated as “butter” for serving size purposes, too. The court explained that because Plaintiffs’ challenge to the Butter! Spray serving sizes would “directly or indirectly establish” a requirement for food labeling that is “not identical” to federal requirements, the FDCA preempts their serving size claims. View "KYM PARDINI, ET AL V. UNILEVER UNITED STATES, INC." on Justia Law

The Food and Drug Administration (“FDA”) approved mifepristone to be marketed with the brand name Mifeprex under Subpart H (the “2000 Approval”). In January 2023, FDA approved a modified REMS for mifepristone, lifting the in-person dispensing requirement.  Plaintiffs (physicians and physician organizations) filed a suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs challenged FDA’s 2000 Approval of the drug and also requested multiple grounds of alternative relief for FDA’s subsequent actions. Plaintiffs moved for a preliminary injunction ordering FDA to withdraw or suspend (1) FDA’s 2000 Approval and 2019 Generic Approval, (2) FDA’s 2016 Major REMS Changes, and (3) FDA’s 2021 Mail-Order Decision and its 2021 Petition Denial of the 2019 Citizen Petition. The district court entered an order staying the effective date of the 2000 Approval and each of the subsequent challenged actions.   The Fifth Circuit granted Defendants’ motions for a stay pending appeal. The court wrote that at this preliminary stage, and based on the court’s necessarily abbreviated review, it appears that the statute of limitations bars Plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. However, Plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with Plaintiffs’ alternative arguments. As to those alternative arguments, Plaintiffs’ claims are timely. Defendants have not shown that Plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, Defendants’ motions for a stay pending appeal are denied in part. View "Alliance Hippocratic Medicine v. FDA" on Justia Law

The Supreme Court affirmed in part, reversed in part and vacated in part the judgment of the circuit court holding that Bristol-Myers Squibb and Sanofi had violated Hawai'i's Unfair or Deceptive Acts or Practices law (UDAP) by misleading the public about the safety and efficacy of their anitplatelet drug, Plavix, holding that remand was required.The circuit court concluded that Defendants misled Hawai'i consumers by failing to warn them that Plavix was less effective for poor responders, granted the State's motion for partial summary judgment, and imposed an $834 million penalty. The Supreme Court (1) reversed the circuit court's deceptive acts or practices holding, holding that the summary judgment ruling circumscribed Defendants' ability to present a full defense and affected the penalty award, requiring a new trial; (2) affirmed the holding that Defendants committed unfair acts under UDAP; and (3) held that Defendants' procedural arguments failed. View "State v. Bristol-Myers Squibb Co." on Justia Law

Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.   The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law

Nexus Pharmaceuticals, Inc. (Nexus) developed the trademarked and FDA-approved drug Emerphed, ready-to-use ephedrine sulfate in a vial. Drug compounding by “outsourcing facilities” is permitted without FDA approval, but 21 U.S.C. Section  353b, a part of the Food, Drug, and Cosmetic Act, excludes from this exception compounded drugs that are “essentially a copy of one or more approved drugs.” To avoid the Act’s bar on private enforcement, Nexus alleged violation of state laws that prohibit the sale of drugs not approved by the FDA.   The Ninth Circuit affirmed the district court’s dismissal, for failure to state a claim, of state law claims brought by Nexus against Central Admixture Pharmacy Services, Inc., operator of a network of compounding pharmacies that sold the drug ephedrine sulfate pre-loaded into ready-to-use syringes without FDA approval.   The panel affirmed the district court’s conclusion that, under the implied preemption doctrine, Nexus’s state law claims were barred because they were contrary to the Food, Drug, and Cosmetic Act’s exclusive enforcement provision, which states that proceedings to enforce or restrain violations of the Act, including the compounding statute, must be by and in the name of the United States, not a private party. The panel held that all of Nexus’s claims depended on a determination of whether Central Admixture’s ephedrine sulphate was “essentially a copy” of Nexus’s Emerphed, and the plain text of the Food, Drug, and Cosmetic Act left that determination in the first instance to the FDA and its enforcement process. View "NEXUS PHARMACEUTICALS, INC. V. CAPS, ET AL" on Justia Law

Gripum manufactures and distributes flavored liquids for use in e-cigarette devices. Gripum submitted a “premarket tobacco product application” to the federal Food and Drug Administration (FDA) in 2021. The agency denied the application, reasoning that Gripum had failed to demonstrate public-health benefits as required by the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387j. The 2016 “Deeming Rule,” promulgated under the Act requires denial of an application to market a new tobacco product if the manufacturer fails to show that the product would be “appropriate for the protection of public health,” considering the risks and benefits to the population as a whole, including users and non-users, the “increased or decreased likelihood that existing users of tobacco products will stop using such products and those who do not use tobacco products will start using such products.The Seventh Circuit upheld the denial. The FDA required Gripum to show that its flavored e-cigarette products were relatively better at reducing rates of tobacco use than products already on the market. It properly applied the comparative standard mandated by the statute. Gripum failed to provide evidence specific to its products; its studies of other products did not even compare tobacco-flavored e-cigarette products to flavored products resembling Gripum’s products. View "Gripum, LLC v. United States Food and Drug Administration" on Justia Law

The First Circuit affirmed in part and vacated in part the judgment of the district court granting Edge Pharma, LLC's motion to dismiss for failure to state a claim the allegations brought by Azurity Pharmaceuticals, Inc. under both the Lanham Act and Mass. Gen. Laws ch. 93A based on statements that Edge made on its website, holding that Azurity's claims cannot survive.Azurity's suit alleged that the statements at issue falsely represented that Edge was not in violation of the Food, Drug, and Cosmetic Act (FDCA) and that the statements falsely held out Edge's vancomycin drug as being superior to Azurity's. The district court concluded that the FDCA precluded Azurity's Lanham Act claim, which meant that the Chapter 93A likewise failed "as it is premised on the same allegations" as the Lanham Act claim. The First Circuit held (1) the district court properly dismissed the Lanham Act claim on the alternative ground that Azurity did not plausibly allege that some of the statements made a misleading representation of fact and that other statements at issue were in violation of the Lanham Act; and (2) insofar as no variant of Azurity's Lanham Act claim could survive, for the same reasons this Court vacates and affirms in part the dismissal of Azurity's Chapter 93A claim. View "Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC" on Justia Law

After the district court granted summary judgment in favor of two government agencies and a pharmaceutical company in this Freedom of Information Act ("FOIA") case. Plaintiff, a science writer and journalism professor, sought records from the government agencies relating to the pharmaceutical company's successful application for accelerated approval of a drug for the treatment of a neuromuscular disease. The agencies produced over 45,000 pages of documents, some of which were redacted under Exemption 4 of FOIA. The district court granted summary judgment for the agencies and the pharmaceutical company on the basis that the redacted information fell within Exemption 4 and publication would either cause foreseeable harm to the interests protected by Exemption 4 or was prohibited by law.Plaintiff appealed and the Second Circuit affirmed the district court’s ruling. The court held that the interests protected by Exemption 4 are the submitter's commercial or financial interests in the information that is of a type held in confidence and not disclosed to any member of the public by the person to whom it belongs. Defendants' declarations show that the release of the information Plaintiff seeks would foreseeably harm the pharmaceutical company’s interests and Plaintiff does not raise a genuine dispute as to that showing. View "Seife v. FDA, et al." on Justia Law