Justia Drugs & Biotech Opinion Summaries

Articles Posted in Constitutional 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

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After Boehringer developed a drug called Pradaxa to help reduce the risk of stroke, the FDA approved the drug and its label. Betty Knight suffered complications from taking the drug and eventually died. Betty's children filed suit against Boehringer asserting a variety of state-law claims alleging Boehringer failed to adequately warn about the risks associated with taking Pradaxa. Boehringer argued that federal law preempted the claims, the district court agreed with plaintiffs, and then the jury returned a mixed verdict. Boehringer appealed, claiming that plaintiffs' fraud claim based on the physician label was preempted.The Fourth Circuit reversed the district court's order denying Boehringer's post-trial motion for judgment as a matter of law. The court held that there is no bright-line, one-size-fits-all line marking the moment when an analysis reveals new information. A careful review of the record is needed to determine whether a conclusion has been reached. Applying careful review here, the court concluded that Boehringer did not have "newly acquired information" regarding an optimal Pradaxa blood concentration level which would have warranted a unilateral change to the physician label. Therefore, the state-law fraud claim is preempted. View "Knight v. Boehringer Ingelheim Pharmaceuticals, Inc." on Justia Law

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E-cigarette manufacturers and retailers, as well as a nonprofit organization, challenged the FDA's Deeming Rule, which deemed e-cigarettes to be "tobacco products" subject to the Family Smoking Prevention and Tobacco Control Act's requirements, under the Appointments Clause and the First Amendment of the Constitution.The DC Circuit affirmed the district court's grant of summary judgment to the FDA and held that appellants' Appointments Clause challenge lacks merit and their First Amendment challenge is foreclosed. In this case, even assuming for purposes of argument, that Associate Commissioner for Policy Kux's issuance of the Deeming Rule violated the Appointments Clause and that FDA Commissioner Califf's general ratification of prior actions by the FDA as part of an agency reorganization was invalid, FDA Commissioner Gottlieb's ratification cured any Appointments Clause defect. Furthermore, appellants' challenge to the Act's preclearance pathway for modified risk tobacco products as violative of the First Amendment is foreclosed by Nicopure Labs, LLC v. FDA, 944 F.3d 267, 271 (D.C. Cir. 2019). In Nicopure Labs, the court found unpersuasive the objection that appellants make now, namely that the Deeming Rule violates the First Amendment because it places the burden on manufacturers to show that certain of their marketing claims are truthful and not misleading before they make them. View "Moose Jooce v. Food & Drug Administration" on Justia Law

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In July 2019, the Department of Justice announced a revised protocol for execution by lethal injection using a single drug, pentobarbital. Plaintiffs, federal death row inmates, sought expedited review of three of the district court's rulings, and two plaintiffs with upcoming execution dates moved for stays of execution pending appeal.The DC Circuit held that the district court did not err in granting summary judgment for the government on plaintiffs' Federal Death Penalty Act (FDPA) claim. In this case, plaintiffs had pointed to several alleged discrepancies between the 2019 Protocol and state statutes dictating different methods of execution or aspects of the execution process. The court agreed with the district court's conclusion that there was no conflict, either because the government had committed to complying with the state statutes at issue or because no plaintiff had requested to be executed in accordance with them.However, the court reversed the district court's dismissal of plaintiffs' Eighth Amendment challenge for failure to state a claim. The court held that, by pleading that the federal government's execution protocol involves a "virtual medical certainty" of severe and torturous pain that is unnecessary to the death process and could readily be avoided by administering a widely available analgesic first, plaintiffs' complaint properly and plausibly states an Eighth Amendment claim. The court denied Plaintiffs Hall and Bernard's request for a stay of execution based on the Eighth Amendment claim. The court also held that the district court should have ordered the 2019 Protocol to be set aside to the extent that it permits the use of unprescribed pentobarbital in a manner that violates the Federal Food, Drug & Cosmetic Act (FDCA). Finally, the court affirmed the district court's denial of a permanent injunction to remedy the FDCA violation. View "Roane v. Barr" on Justia Law

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After the State of Hawaii filed suit against several pharmaceutical companies in state court for allegedly deceptive drug marketing related to the medication Plavix, the companies turned to federal court, seeking an injunction against the state court litigation based on a violation of their First Amendment rights.The Ninth Circuit agreed with the district court that the state court litigation is a quasi-criminal enforcement proceeding and that Younger v. Harris, 401 U.S. 37 (1971), bars a federal court from interfering with such a proceeding. The panel explained that, even though the state proceeding is being litigated by private counsel, it is still an action brought by the State of Hawaii. The panel stated that what matters for Younger abstention is whether the state proceeding falls within the general class of quasi-criminal enforcement actions—not whether the proceeding satisfies specific factual criteria. Looking to the general class of cases of which this state proceeding is a member, the panel concluded that Younger abstention is appropriate here. In this case, the State's action has been brought under a statute that punishes those who engage in deceptive acts in commerce, and the State seeks civil penalties and punitive damages to sanction the companies for their allegedly deceptive labeling practices. Because the companies' First Amendment concerns do not bring this case within the scope of Younger's extraordinary circumstances exception, they have no bearing on the application of Younger. Accordingly, the panel affirmed the district court's dismissal of the action. View "Bristol-Myers Squibb Co. v. Connors" on Justia Law

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The Ninth Circuit reversed the district court's dismissal of a putative class action against CVS based on Federal Food, Drug, and Cosmetic Act (FDCA) preemption of California state law claims. Plaintiff alleged that the supplement he purchased, and five additional CVS glucosamine-based supplements, did not provide the advertised benefits. The FDCA distinguishes between "disease claims" and "structure/function claims" that manufacturers make about their products, applying different regulatory standards to each.The panel held that the district court erred in concluding that the FDCA preempts plaintiff's state law causes of action simply because CVS's glucosamine-based supplements present only structure/function claims. The panel explained that Dachauer v. NBTY, Inc., 913 F.3d 844 (9th Cir. 2019), was distinguishable from this case and the district court erred by applying it. Furthermore, the district court erred by greatly expanding the present state of federal preemption jurisprudence under the FDCA, contrary to public policy. The panel also held that the district court erred in dismissing the complaint without granting plaintiff leave to amend to add allegations regarding an implied disease claim. In this case, plaintiff may have been able to "bolster" his complaint with allegations of extra-label evidence showing that CVS's glucosamine-based supplements present implied disease claims. Accordingly, the panel remanded for further proceedings. View "Kroessler v. CVS Health Corp." on Justia Law

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Essure--permanent birth control for women--originally was manufactured and developed by Conceptus, a California corporation. Bayer bought Conceptus. Bayer marketed Essure as safer and more effective than other birth control. Two residents of Madison County, Illinois, filed personal injury complaints, alleging that Essure caused debilitating pain, heavy bleeding that necessitated medication, and autoimmune disorders. including 179 plaintiffs from at least 25 states. Months later, the U.S. Supreme Court issued its “Bristol-Myers” decision. Bayer argued that, following Bristol-Myers, a court cannot exercise specific personal jurisdiction over an out-of-state defendant as to the claims of out-of-state plaintiffs when the conduct giving rise to the claims did not occur in the forum state. The plaintiffs argued Illinois courts had specific personal jurisdiction over Bayer because it “created the Essure Accreditation Program and the marketing strategy for Essure in Illinois,” conducted clinical trials in Illinois, and used Illinois as a testing ground for its physician training program. The appellate court affirmed the denials of motions to dismiss: Bayer “conducted a part of its general business in Illinois, and [p]laintiffs’ claims arose out of" trials conducted, in part, in Illinois.The Illinois Supreme Court reversed. The nonresident plaintiffs identified no jurisdictionally relevant links between their claims and Illinois. The nonresidents have not explained how Illinois could be a convenient location for this litigation; they were not implanted with their devices here and have identified no other activity that would connect their specific claims to Illinois. Many nonresident plaintiffs initiated duplicate actions in California, indicating that the interests of judicial economy are not furthered by permitting their claims to proceed in Illinois. A corporation’s continuous activity of some sort within a state is not enough to render the corporation subject to suits unrelated to that activity. View "Rios v. Bayer Corp." on Justia Law

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The Eleventh Circuit vacated the district court's dismissal of plaintiffs' claims against defendants based on lack of standing. The court held that plaintiffs plausibly alleged that they suffered an economic loss when they purchased supplements that were worthless because the Federal Food, Drug, and Cosmetic Act (FDCA) prohibited sale of the supplements. The court explained that Congress, through the FDCA and the Dietary Supplement Health and Education Act (DSHEA), banned adulterated supplements to protect consumers from ingesting products that Congress judged to be insufficiently safe.In this case, the complaint's allegations establish that plaintiffs purchased adulterated dietary supplements that they would not have purchased had they known that sale of the supplements was banned. The court also held that plaintiffs sufficiently alleged sufficient facts to show that their injuries were fairly traceable to defendants. Accordingly, plaintiffs had Article III standing to pursue their claims. View "Debernardis v. IQ Formulations, LLC" on Justia Law

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Merck’s drug Fosamax treats and prevents osteoporosis in postmenopausal women. When the FDA approved Fosamax in 1995 (21 U.S.C. 355(d)), its label did not warn of the then-speculative risk of atypical femoral fractures associated with the drug. Stronger evidence connecting Fosamax to such fractures developed later. The FDA ordered Merck to add a warning to the Fosamax label in 2011. Individuals who took Fosamax and suffered atypical femoral fractures sued, claiming that state law imposed upon Merck a legal duty to warn. Merck asserted that the FDA would have rejected any attempt to change the label. The district court agreed with Merck’s pre-emption argument and granted Merck summary judgment. The Third Circuit vacated.The Supreme Court remanded. The Third Circuit incorrectly treated the pre-emption question as one of fact. A state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. “Clear evidence” shows the court that the manufacturer fully informed the FDA of the justifications for the warning and that the FDA would not approve a label change to include that warning. FDA regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” The pre-emption question can only be determined by agency actions taken pursuant to the FDA’s congressionally delegated authority. The question of agency disapproval is primarily one of law for a judge to decide. Judges, rather than juries, are better equipped to evaluate an agency’s determination and to understand and interpret agency decisions in the statutory and regulatory context. While contested facts will sometimes prove relevant, they are subsumed within a tightly-circumscribed legal analysis and do not warrant submission to a jury. View "Merck Sharp & Dohme Corp. v. Albrecht" on Justia Law