Justia Drugs & Biotech Opinion Summaries

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

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

Abbott Laboratories and Abbott Laboratories, Inc. (collectively, "Abbott"), petitioned the Alabama Supreme Court for a writ of mandamus to direct the Mobile Circuit Court to dismiss all claims asserted by the Mobile County Board of Health and the Family Oriented Primary Health Care Clinic (collectively, "Mobile Health") against Abbott on the basis that those claims are barred by the rule of repose or by the applicable statute of limitations. Mobile Health alleged that Abbott had participated in the marketing of a specific prescription drug, OxyContin. Mobile Health alleged that this marketing campaign "precipitated" an "opioid crisis" in the United States, and specifically in Alabama, because it caused an astronomical increase in the use of opioids by patients who quickly became dependent upon the drugs. Mobile Health asserted that it brought this action because of the burdens it had to bear as a result of the "opioid epidemic." The Alabama Supreme Court concluded the applicable statutes of limitations barred Mobile Health's claims against Abbott. Therefore, the Court granted Abbott's petition for a writ of mandamus, and directed the circuit court to enter an order dismissing Mobile Health's claims against Abbott. View "Ex parte Abbott Laboratories and Abbott Laboratories, Inc." on Justia Law

The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, sets forth separate and detailed regimes for the regulation of medical products classified as drugs or devices. Since 2017, the U.S. Food and Drug Administration (FDA) has exercised its claimed discretion to classify Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, notwithstanding the FDA’s recognition that the products “appear” to satisfy the statutory definition for devices. Contrast agents are used in medical imaging to improve the visualization of tissues, organs and physiological processes. The FDA claims that, if a medical product satisfies the statutory definitions of both a “drug” and a “device,” the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime. Genus challenged the FDA’s classification decision as inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. 706(2), and the FDCA.The D.C. Circuit affirmed summary judgment in favor of Genus. The FDCA unambiguously forecloses the FDA’s interpretation. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.” View "Genus Medical Technologies LLC v. United States Food and Drug Administration" on Justia Law

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 suit against 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. The People alleged this scheme caused a public health crisis in California by dramatically increasing opioid prescriptions, opioid use, opioid abuse, and opioid-related deaths. In their suit, the People allege causes of action for violations of the False Advertising Law, and the public nuisance statutes. After several years of litigation, the defendants served business record subpoenas on four nonparty state agencies: the California State Board of Registered Nursing (Nursing Board), the California State Board of Pharmacy (Pharmacy Board), the Medical Board of California (Medical Board), and the California Department of Justice (DOJ). The Pharmacy Board, the Medical Board, and the DOJ served objections to the subpoenas. The Nursing Board filed a motion for a protective order seeking relief from the production obligations of its subpoena. After further litigation, which is recounted below, the trial court ordered the state agencies to produce documents in response to the subpoenas. In consolidated proceedings, the state agencies challenged the trial court's orders compelling production of documents. After review, the Court of Appeal concluded the motions to compel against the Pharmacy Board and Medical Board were untimely, and the defendants were required to serve consumer notices on at least the doctors, nurses, pharmacists, and other health care professionals whose identities would be disclosed in the administrative records, investigatory files, and coroner’s reports. Furthermore, the Court concluded the requests for complete administrative records and investigatory files, were overbroad and not reasonably calculated to lead to the discovery of admissible evidence. "The requests for complete administrative records and investigatory files also ran afoul of the constitutional right to privacy and the statutory official information and deliberative process privileges." The trial court was directed to vacate its orders compelling production of documents, and to enter new orders denying the motions to compel and, for the Nursing Board, granting its motion for a protective order. View "Board of Registered Nursing v. Super. Ct." on Justia Law

Johnson & Johnson and other pharmaceutical defendants sought mandamus relief from an Alabama circuit court order that refused to transfer venue of the underlying lawsuit to the Jefferson County, Alabama circuit court, on grounds that venue in Conecuh County was not proper as to all plaintiffs, or alternatively, on the basis that convenience of the parties and/or the interest of justice required it. In 2019, the plaintiffs filed a complaint at the Conecuh Circuit Court against numerous defendants that, they averred, manufactured, marketed, distributed, and/or dispensed opioid medications throughout Alabama in a manner that was misleading, unsafe, and resulted in drug addiction, injury, and/or death to Alabama citizens. The complaint asserted claims of negligence, nuisance, unjust enrichment, fraud and deceit, wantonness, and civil conspiracy. The manufacturer defendants moved to transfer the case to Jefferson County, reasoning that because 8 of the 17 plaintiffs either had a place of business in Jefferson County or operated hospitals in Jefferson County or adjacent counties, logic dictated that a large percentage of the witnesses for those plaintiffs (i.e., prescribing doctors, hospital administrators, etc.) and their evidence were located in or around Jefferson County. After a review of the circuit court record, the Alabama Supreme Court determined defendants did not demonstrate a clear, legal right to transfer the underlying case from Conecuh to Jefferson County. Therefore, the petition was denied. View "Ex parte Johnson & Johnson et al." on Justia Law

In 2012, 41-year-old Karen Hubbard suffered a catastrophic stroke caused by a blood clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen’s Beyaz prescription warned of a risk of VTEs and summarized studies.The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question. The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen to be sound and appropriate. View "Hubbard v. Bayer Healthcare Pharmaceuticals Inc." on Justia Law

Pharmacy benefit managers (PBMs) reimburse pharmacies for the cost of drugs covered by prescription-drug plans by administering maximum allowable cost (MAC) lists. In 2015, Arkansas passed Act 900, which requires PBMs to reimburse Arkansas pharmacies at a price at least equal to the pharmacy’s wholesale cost, to update their MAC lists when drug wholesale prices increase, and to provide pharmacies an appeal procedure to challenge MAC reimbursement rates, Ark. Code 17–92–507(c). Arkansas pharmacies may refuse to sell a drug if the reimbursement rate is lower than its acquisition cost. PCMA, representing PBMs, sued, alleging that Act 900 is preempted by the Employee Retirement Income Security Act (ERISA), 29 U.S.C. 1144(a).Reversing the Eighth Circuit, the Supreme Court held that Act 900 is not preempted by ERISA. ERISA preempts state laws that “relate to” a covered employee benefit plan. A state law relates to an ERISA plan if it has a connection with or reference to such a plan. State rate regulations that merely increase costs or alter incentives for ERISA plans without forcing plans to adopt any particular scheme of substantive coverage are not preempted. Act 900 is a form of cost regulation that does not dictate plan choices. Act 900 does not “refer to” ERISA; it regulates PBMs whether or not the plans they service fall within ERISA’s coverage. Allowing pharmacies to decline to dispense a prescription if the PBM’s reimbursement will be less than the pharmacy’s cost of acquisition does not interfere with central matters of plan administration. The responsibility for offering the pharmacy a below-acquisition reimbursement lies first with the PBM. Any “operational inefficiencies” caused by Act 900 are insufficient to trigger ERISA preemption, even if they cause plans to limit benefits or charge higher rates. View "Rutledge v. Pharmaceutical Care Management Association" on Justia Law

The Supreme Court held that the Arizona Department of Health Services' (ADHS) interpretation of Arizona Administrative Code R9-17-303, which governs ADHS's allocation of marijuana dispensary registration certificates, violated Ariz. Rev. Stat. 36-2804(C).On June 16, 2016, ADHS announced that, because every county had at least one dispensary, it would allocate new registration certificates based on other factors set forth in R9-17-303. Saguaro Healing LLC timely applied for a certificate for its dispensary in La Paz County. During the application period, the only dispensary in La Paz County relocated out of the county. ADHS, however, did not consider the vacancy when prioritizing registration certificates and did not issue a certificate to Saguaro, leaving La Paz County without a dispensary. Saguaro filed a complaint for special action. The trial court dismissed the complaint because R9-17-303(B) "does not say when, during the process of issuing new certificates, [ADHS] must determine how certificates will be allocated." The Supreme Court reversed, holding (1) Ariz. Rev. Stat. 36-2804(C) requires ADHS to issue at least one medical marijuana dispensary registration certificate in each county with a qualified applicant; and (2) ADHS's interpretation of R9-17-303 contrary to this statutory mandate violates section 36-2804(C). View "Saguaro Healing LLC v. State" on Justia Law

Cottingham sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10, alleging that a Gardasil® vaccination received by her minor daughter, K.C., in 2012, for the prevention of HPV, caused K.C. injuries. The claim was filed immediately before the limitations period ran out.The government stated argued that a "reasonable basis for bringing the case may not be present.” Cottingham’s counsel was granted additional time but was unable to submit an expert opinion supporting her claim. The Special Master denied compensation. Cottingham sought attorneys’ fees and litigation costs ($11,468.77), 42 U.S.C. 300aa-15(e)(1). The Master found no evidence to support the "vaguely asserted claims" that the vaccination caused K.C.’s headaches, fainting, or menstrual problems." While remand was pending the Federal Circuit held (Simmons) that although a looming statute of limitations deadline may impact the question of whether good faith existed to bring a claim, that deadline does not provide a reasonable basis for asserting a claim. The Master decided that Simmons did not impact his analysis, applied a “totality of the circumstances” standard, and awarded attorneys’ fees. The Claims Court vacated and affirmed the Special Master’s third decision, finding no reasonable basis for Cottingham’s claim.The Federal Circuit vacated, noting that there is no dispute that Cottingham filed her claim in good faith. Simmons did not abrogate the “totality of the circumstances inquiry.” K.C.’s medical records paired with the Gardasil® package insert constitute circumstantial, objective evidence supporting causation. View "Cottingham v. Secretary of Health and Human Services" on Justia Law