Justia Drugs & Biotech Opinion Summaries

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Kennedy worked for Novo, promoting a new diabetes drug, Victoza. FDA approval of Victoza included specific conditions concerning a possible risk of thyroid cancer. According to Kennedy, in preparation for Victoza’s commercial launch, she was directed to market the drug in ways inconsistent with those FDA limitations. Kennedy filed a False Claims Act (FCA) complaint, alleging that Novo caused people to submit millions of dollars in false claims for payment under federal health care programs. Several such cases were consolidated in the District of Columbia. The government intervened. Novo, the government, and Kennedy reached a settlement for $46.5 million.The government filed a separate complaint against Novo, under the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, alleging Victoza was an unlawfully “misbranded” drug. In the FDCA Settlement, Novo admitted that it had trained its employees to undermine the risks and agreed to pay the government $12,150,000. Kennedy was not a party to the FDCA litigation.Kennedy sought a share of the FDCA Settlement, arguing that it was an “alternate remedy” under the FCA, 31 U.S.C. 3730(c)(5). The D.C. Circuit reversed Kennedy’s award. The FCA confines qui tam plaintiffs to recoveries only for claims seeking relief based on fraud or falsehoods covered by that statute. The government’s separate FDCA enforcement action did not involve the type of claim cognizable under the FCA, nor did it allege a false or fraudulent effort to obtain money or property from the government. Kennedy received an agreed-upon FCA payment with knowledge of the separate action and is not entitled to further recovery. View "Kennedy v. Novo A/S" on Justia Law

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The First Circuit affirmed the judgment of the district court in favor of Defendants, denying Plaintiff's motion for class certification, and denying Plaintiff's motion to file a third amended complaint, holding that Defendant sufficiently warned investors about the vulnerability of its manufacturing infrastructure so that Plaintiff knew of the investment risks when he purchased his shares.Plaintiff was an investor who lost money when he bought stock in Keryx Biopharmaceuticals, Inc. and watched the value plummet soon after that purchase. Plaintiff sued Keryx and its executives, alleging that Keryx's inadequate disclosures about its manufacturing defects amounted to securities fraud. The district court allowed Defendants' motion for judgment on the pleadings. The First Circuit affirmed, holding that Plaintiff failed to state a claim under section 10(b) of the Securities Exchange Act. View "Karth v. Keryx Biopharmaceuticals, Inc." on Justia Law

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Educational Center treats patients with severe mental disabilities, some of whom suffer from severe self-injurious and aggressive behaviors that are difficult or impossible to treat using conventional behavioral and pharmacological techniques. Some patients have suffered brain trauma, broken and protruding bones, and blindness as a result of their behaviors. Before the ban, the Center treated some self-injurious and aggressive patients with an electrical stimulation device called a graduated electronic decelerator, which briefly shocks patients causing them to reduce or cease their self-injurious behaviors. The Center is the only facility in the country that uses electric shock therapy to treat individuals who severely self-injure or are aggressive. Other health care practitioners administer electrical stimulation devices to treat a wide variety of other conditions, including tobacco, alcohol, and drug addictions, as well as inappropriate sexual behaviors following traumatic brain injuries. The Center manufactures its own devices, which are regulated by the FDA, 21 U.S.C. 360c(a)(1)(B).In 2020, the FDA determined that the devices presented a substantial and unreasonable risk to self-injurious and aggressive patients and banned the devices for that purpose. The D.C. Circuit vacated the rule. Banning a medical device for a particular purpose regulates the practice of medicine in violation of 21 U.S.C. 396. View "The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration" on Justia Law

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Belcher filed suit against its competitor, Hospira, under the Lanham Act, alleging that the labels of two of Hospira's drug products falsely implied that the products and their uses were FDA-approved, and that Hospira's misrepresentations allowed it to cut into the sales of Belcher's drug. The district court granted summary judgment to Hospira.The Eleventh Circuit concluded that the Lanham Act can peacefully coexist with the Food, Drug, and Cosmetic Act for many drug-related claims, including this one. Although Belcher's Lanham Act claim was not precluded by the FDCA, the court concluded that it also was not supported by evidence of any misleading statements on Hospira's labels. The court explained that, because Belcher never showed that Hospira made representations that misled consumers about the FDA's approval of its drug products, Hospira is entitled to summary judgment. Accordingly, the court affirmed the district court's judgment. View "Belcher Pharmaceuticals, LLC v. Hospira, Inc." on Justia Law

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In the lawsuit underlying these consolidated writ proceedings, the People of the State of California, by and through the Santa Clara County Counsel, the Orange County District Attorney, the Los Angeles County Counsel, and the Oakland City Attorney, filed an action against defendants— various pharmaceutical companies involved in the manufacture, marketing, distribution, and sale of prescription opioid medications. The People alleged the defendants made false and misleading statements as part of a deceptive marketing scheme designed to minimize the risks of opioid medications and inflate their benefits. This scheme, the People alleged, caused a public health crisis in California by dramatically increasing the number of opioid prescriptions, the use and abuse of opioids, and opioid-related deaths. These proceedings pertained to a discovery dispute after several of the defendants served subpoenas on two nonparty counties, petitioners County of Los Angeles and County of Alameda, seeking records of patients in various county programs, including individual prescription data and individual patient records related to substance abuse treatment. After petitioners and the Johnson & Johnson defendants engaged in various informal and formal means to attempt to resolve the dispute, the superior court issued a discovery order granting the Johnson & Johnson defendants’ motions to compel production of the records. The Court of Appeal concluded petitioners established that the superior court’s order threatened a serious intrusion into the privacy interests of the patients whose records were at issue: the Johnson & Johnson defendants failed to demonstrate their interests in obtaining “such a vast production of medical information” outweighed the significant privacy interests that the nonparty petitioners identified. Accordingly, the Court granted petitioners’ writ petitions and directed the superior court to vacate its order compelling production of the requested documents, and to enter a new order denying Johnson & Johnson defendants’ motions to compel. View "County of Los Angeles v. Superior Ct." on Justia Law

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In these consolidated petitions in which Petitioners - Defendants in Opioid Litigation, which included more than eighty lawsuits pending before the Mass Litigation Panel - sought extraordinary relief prohibiting enforcement of two of the Panel's recent rulings, the Supreme Court granted in part one petition and denied the other, holding that Petitioners demonstrated that extraordinary relief was warranted to preserve their right to try Respondents' legal claims to a jury.The Opioid Litigation began in 2017 when various cities, counties, hospitals, and the State sued manufacturers and distributors of prescription opioid pain medication and other defendants. In these consolidated petitions, Petitioners sought to prohibit enforcement of the Panel's recent rulings that Petitioners did not have a right to a jury trial of Respondents' public nuisance claims and that those same public nuisance claims were not subject to the 2015 amendments to West Virginia's comparative fault statute. The Supreme Court held (1) the Panel did not clearly err when it found that the 2015 amendments did not apply to the public nuisance claims; but (2) the Panel clearly erred by not safeguarding Defendants' right to try issues common to Plaintiffs' public nuisance claims and their legal claims to a jury. View "State ex rel. AmerisourceBergen Drug Corp.v. Honorable Moats" on Justia Law

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The Supreme Court dismissed this interlocutory appeal brought by the State challenging a sanctions order entered by the circuit court pursuant to Ark. R. Civ. P. 37, holding that this Court lacked appellate jurisdiction over the appeal.The Arkansas Attorney General brought this action in the name of the State against several pharmaceutical companies in connection with Defendants' role in the ongoing opioid epidemic. During the proceedings, the circuit court found that the Attorney General had not provided complete and specific discovery responses, in violation of the court's discovery orders, and then entered an order sanctioning the Attorney General. The Attorney General appealed. The Supreme Court dismissed the appeal, holding that the sanctions order was not a final or otherwise appealable order under Ark. R. App. P.-Civ. 2(a)(4). View "State ex rel. Rutledge v. Purdue Pharma L.P." on Justia Law

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Oakwood hired Dr. Thanoo in 1997. As Oakwood's Senior Scientist, he signed confidentiality agreements. Thanoo designed Oakwood’s microsphere process technology. Oakwood invested more than $130 million and two decades in its Microsphere Project and developed the “Leuprolide Products,” which are bioequivalent to Lupron Depot®. Aurobindo contacted Oakwood to discuss collaboration. Some of Oakwood’s trade secret information was shared under a confidentiality agreement. Negotiations failed. Aurobindo hired Thanoo six months later and began developing microsphere-based injectable products that Oakwood alleges are “substantially similar to and competitive with Oakwood’s Microsphere Project." Oakwood asserts that the product could not have been developed within the rapid timeframe without Thanoo’s assistance and the use of Oakwood’s trade secret information.The Third Circuit vacated the dismissal of Oakwood's suit, asserting trade secret misappropriation, breach of contract, and tortious interference with contractual relations. Under the Defend Trade Secrets Act, 18 U.S.C. 1836(b), Oakwood sufficiently identified its trade secrets and sufficiently alleged that the defendants misappropriated those trade secrets. The “use” of a trade secret encompasses all the ways one can take advantage of trade secret information to obtain an economic benefit, competitive advantage, or other commercial value, or for an exploitative purpose, such as research or development. A trade secret plaintiff need not allege that its information was the only source by which a defendant might develop its product. Aurobindo's avoidance of substantial research and development costs that Oakwood has invested is recognized as "harm" in the DTSA. View "Oakwood Laboratories LLC v. Thanoo" on Justia Law

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The FDA filed suit against the Clinic, alleging that the Clinic's stem cell procedure violates the Federal Food, Drug, and Cosmetics Act. The Clinic offers a procedure, which purportedly treats all kinds of chronic conditions, in which they remove fat tissue from a patient, isolate the portion containing stem cells, and inject that portion back into the patient. The district court granted summary judgment for the FDA and enjoined the Clinic from offering its procedure until it can demonstrate to the FDA that its stem cell therapy is safe and effective.The Eleventh Circuit affirmed, concluding that the Clinic's stem cell procedure does not fall within the "same surgical procedure" exception or the "361 HCT/P" exception to regulation under the FDCA. The procedure does not fall within the same surgical procedure exception because the biological material implanted into the patient is not the same as that removed. Furthermore, the procedure does not fall within the 361 HCT/P exception because the Clinic intends the stem cells to perform functions after the procedure beyond the basic functions the stem cells performed prior to the procedure. View "United States v. US Stem Cell Clinic, LLC" on Justia Law

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The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 321(g) regulates homeopathic drugs. A 1988 FDA guidance document outlined the circumstances in which the FDA intended to exercise its discretion not to enforce the full force of the FDCA against homeopathic drugs. In 2019, the FDA withdrew the guidance document, explaining that the homeopathic drug industry had expanded significantly and it had received numerous reports of “[n]egative health effects from drug products labeled as homeopathic.” The FDA then implemented a “risk-based” enforcement approach and added six of MediNatura’s prescription injectable homeopathic products to an import alert, notifying FDA field staff that the products appeared to violate the FDCA.The D.C. Circuit affirmed the dismissal of MediNatura’s challenges. When a product is detained under an import alert, the importer is given notice and an opportunity to be heard, so the import alert was non-final agency action. The court declined to enjoin the withdrawal of the 1988 guidance, noting the public’s strong interest in the enforcement of the FDCA. Requiring the FDA to keep in place a guidance document that no longer reflects its current enforcement thinking, particularly in light of present public health concerns related to homeopathic drugs, is not in the public interest. View "MediNatura, Inc. v. Food and Drug Administration" on Justia Law