Justia Government & Administrative Law Opinion Summaries

Connecticut Governor Ned Lamont and the state's Commissioner of the Department of Emergency Services and Public Protection James Rovella appeal from the district court's order granting a preliminary injunction ordering that the Governor repeal, in light of the COVID-19 pandemic, a provision to suspend collection of fingerprints in connection with applications for authorization to obtain firearms. The injunction also ordered that the Governor repeal that provision of the executive order and that the DESPP Commissioner resume fingerprinting services at that agency.The Second Circuit vacated the preliminary injunction and concluded that: (1) with respect to the individual plaintiffs, the preliminary injunction motion became moot in the district court; and (2) CCDL lacked organizational standing. Because the motion was moot and CCDL lacked standing, the district court had no jurisdiction to issue the preliminary injunction. View "Connecticut Citizens Defense League, Inc. v. Lamont" on Justia Law

The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act to establish a comprehensive regulatory scheme for tobacco products, defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product,” 21 U.S.C. 321(rr)(1). The 2016 FDA "Deeming Rule" deemed all products that meet the Act’s definition of “tobacco product,” including any “component” and “part” but excluding any “accessory” of those products, to be subject to the Act. Premarket review by FDA was required before the introduction into interstate commerce of any “new tobacco product.” FDA adopted “staggered compliance periods” for premarket review requirements of newly deemed products that were being marketed as of the Rule’s effective date. FDA also promulgated a separate rule addressing the assessment of user fees for manufacturers and importers of cigars and pipe tobacco.The D.C. Circuit affirmed summary judgment in favor of FDA on five Administrative Procedure Act challenges to the Deeming Rule concerning its implementation of the premarket review requirements, underlying cost-benefit analysis, and classification of a pipe as a “component or part” of a tobacco product subject to regulation, and an APA challenge to the User Fees Rule. View "Cigar Association of America v. United States Food and Drug Administration" on Justia Law

The issue this case presented for the New Jersey Supreme Court's consideration was whether, under the facts of this case, plaintiff Leah Coleman, the victim of a violent assault by social worker Sonia Martinez’s patient, could bring a negligence claim against Martinez. Martinez’s patient, T.E., suffered two violent episodes prior to her treatment with Martinez. Coleman worked for the Division of Child Protection and Permanency (DCPP) and was tasked with ensuring the welfare of T.E.’s children when the children were removed from T.E.'s care after her hospitalization following her second violent incident. In a letter to Coleman dated October 1, 2014, Martinez stated that T.E. had been compliant during her sessions and with her medication and was ready and able to begin having unsupervised visits with her children with the goal of reunification. At her deposition, Martinez acknowledged the inaccuracy of representing that T.E. did not exhibit psychotic symptoms in light of what she and the group counselor had seen. During a November 7 appointment, Martinez disclosed to T.E. Coleman’s report of T.E.’s hallucinations. T.E. “became upset” and “tearful,” denied any psychotic symptoms, and reiterated her goal of regaining custody of her children. Later that day, T.E. called DCPP and spoke with Coleman. During their conversation, T.E. referenced her session with Martinez, denied that she was experiencing auditory hallucinations, and stated she did not understand why such a claim would be fabricated. Coleman advised T.E. to seek advice from an attorney as DCPP would “maintain that she [was] not capable of parenting independently due to her mental health issues.” Six days later, T.E. made an unscheduled visit to DCPP offices, where she stabbed Coleman twenty-two times in the face, chest, arms, shoulders, and back. Coleman filed a complaint against Martinez, alleging that Martinez was negligent in identifying her to T.E. as the source of information about T.E.’s hallucinations, and that T.E.’s attack was a direct and proximate result of Martinez’s negligence. The trial court granted summary judgment in favor of Martinez, finding no legal duty owed to Coleman under the particularized foreseeability standard set forth in J.S. v. R.T.H., 155 N.J. 330 (1998). The Supreme Court disagreed, finding that Martinez had a duty to Coleman under the circumstances here. The trial court's judgment was reversed and the matter remanded for further proceedings. View "Coleman v. Martinez" on Justia Law

The Ninth Circuit reversed the district court's grant of summary judgment in favor of Agendia in an action alleging that the HHS wrongfully denied its claims for reimbursement for diagnostic tests under the Medicare health insurance program. Agendia contends that the denial was improper because the local coverage determination was issued without notice and opportunity for comment in violation of a provision of the Medicare Act—specifically, 42 U.S.C. 1395hh.The panel held that section 1395hh's notice-and-comment requirement does not apply to local coverage determinations, and that the district court erred in interpreting the statute otherwise. The panel rejected Agendia's alternative argument that the Medicare Act and its implementing regulations have unconstitutionally delegated regulatory authority to Medicare contractors by permitting them to issue local coverage determinations. The panel held that, because those contractors act subordinately to the HHS officials implementing Medicare, there is no unconstitutional delegation. View "Agendia, Inc. v. Becerra" on Justia Law

Allstate Insurance Company et al. (Allstate) filed a complaint on behalf of itself and the People of California (qui tam) against Dr. Sonny Rubin and related medical providers (Rubin). Allstate generally alleged Rubin prepared fraudulent patient medical reports and billing statements in support of insurance claims. Rubin filed an anti-SLAPP motion, arguing the preparation and submission of its medical reports and bills were protected litigation activities. The trial court denied Rubin’s motion. "Litigation is not 'under [serious] consideration' - and thereby protected activity under the anti-SLAPP statute - if the ligation is merely a 'possibility.'" The Court of Appeal found that Rubin failed to show its medical reports and bills were prepared outside of its usual course of business in anticipation of litigation that was “under [serious] consideration.” Thus, the Court affirmed the trial court’s order denying Rubin’s anti-SLAPP motion. View "California ex rel. Allstate Ins. Co. v. Rubin" on Justia Law

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

The hospital, located in Philadelphia, received a reclassification into the New York City area, which would sizably increase the hospital’s Medicare reimbursements due to that area’s higher wage index, 42 U.S.C. 1395ww(d). Although a statute makes such reclassifications effective for three fiscal years, the agency updated the geographical boundaries for the New York City area before the close of that period and reassigned the hospital to an area in New Jersey with an appreciably lower wage index. The hospital successfully sued three agency officials in the Eastern District of Pennsylvania.The Third Circuit vacated and remanded for dismissal. The Medicare Act, 42 U.S.C. 1395oo(f)(1), channels reimbursement disputes through administrative adjudication as a near-absolute prerequisite to judicial review. The hospital did not pursue its claim through administrative adjudication before suing in federal court. By not following the statutory channeling requirement, the hospital has no valid basis for subject-matter jurisdiction. View "Temple University Hospital, Inc. v. Secretary United States Department of Health & Human Services" on Justia Law

The 2010 Patient Protection and Affordable Care Act required most Americans to obtain minimum essential health insurance coverage and imposed a monetary penalty upon most individuals who failed to do so; 2017 amendments effectively nullified the penalty. Several states and two individuals sued, claiming that without the penalty, the Act’s minimum essential coverage provision, 26 U.S.C. 5000A(a), is unconstitutional and that the rest of the Act is not severable from section 5000A(a).The Supreme Court held that the plaintiffs lack standing to challenge section 5000A(a) because they have not shown a past or future injury fairly traceable to the defendants’ conduct enforcing that statutory provision. The individual plaintiffs cited past and future payments necessary to carry the minimum essential coverage; that injury is not “fairly traceable” to any “allegedly unlawful conduct” of which they complain, Without a penalty for noncompliance, section 5000A(a) is unenforceable. To find standing to attack an unenforceable statutory provision, seeking only declaratory relief, would allow a federal court to issue an impermissible advisory opinion.The states cited the indirect injury of increased costs to run state-operated medical insurance programs but failed to show how that alleged harm is traceable to the government’s actual or possible enforcement of section 5000A(a). Where a standing theory rests on speculation about the decision of an independent third party (an individual’s decision to enroll in a program like Medicaid), the plaintiff must show at the least “that third parties will likely react in predictable ways.” Nothing suggests that an unenforceable mandate will cause state residents to enroll in benefits programs that they would otherwise forgo. An alleged increase in administrative and related expenses is not imposed by section 5000A(a) but by other provisions of the Act. View "California v. Texas" 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

The Supreme Court affirmed the decisions of the circuit court in these consolidated cases, holding that the West Virginia Health Care Authority's interpretation of the State Health Plan Home Health Services Standards was not arbitrary or capricious and was entitled to judicial deference pursuant to Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. 467 U.S. 837 (1984).The Standards governed the Authority's consideration of applications from entities and individuals seeking to provide home health care services in a particular county. The Standards included a methodology for determining whether there was an unmet need for such services in the county. Petitioners argued that unmet need could not be established unless the evidence showed that at least 229 individuals in the subject county were in need of home health care services. Respondents countered that the Standards required the new applicant to demonstrate a need at or beyond the 229 average usage figure. The circuit court concluded that the Authority did not err. The Supreme Court affirmed, holding that the Authority did not exceed its constitutional or statutory authority and its decision was not arbitrary or capricious. View "Amedisys West Virginia, LLC v. Personal Touch Home Care of W. Va., Inc." on Justia Law