Justia Government & Administrative Law Opinion Summaries

Plaintiffs were injured in unspecified accidents and treated by South Carolina health care providers. Seeking to pursue personal injury lawsuits, Plaintiffs requested their medical records from the relevant providers. Those records—and accompanying invoices—were supplied by defendants Ciox Health, LLC and ScanSTAT Technologies LLC, “information management companies” that retrieve medical records from health care providers and transmit them to requesting patients or patient representatives. Claiming the invoiced fees were too high or otherwise illegal, Plaintiffs filed a putative class action against Ciox and ScanSTAT in federal district court.   The district court dismissed the complaint and the Fourth Circuit affirmed. The court explained that South Carolina law gives patients a right to obtain copies of their medical records, while capping the fees “a physician, or other owner” may bill for providing them. However, the statutory obligations at issue apply only to physicians and other owners of medical records, not medical records companies. View "Tammie Thompson v. Ciox Health, LLC" on Justia Law

The Council for Education and Research on Toxics (CERT) brought these actions under Proposition 65 (Prop. 65) against Respondents, dozens of companies that roast, distribute, or sell coffee. CERT claimed that Respondents had failed to provide required Prop. 65 warnings for their coffee products based on the presence of acrylamide. While the litigation was pending, the Office of Environmental Health Hazard Assessment (the Agency) adopted a new regulation providing that “exposures to chemicals in coffee, listed on or before March 15, 2019, as known to the state to cause cancer, that are created by and inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”   CERT moved for summary adjudication, challenging the regulation’s validity on various grounds. In opposing summary judgment, CERT also contended that regardless of the regulation, triable issues remained regarding the presence of acrylamide resulting from additives. CERT challenged the trial court’s grant of summary judgment for Respondents, its denial of its motion for fees, and its award of section 998.   The Second Appellate Court affirmed the trial court’s orders granting summary judgment and denying attorney fees. The court reversed the order denying CERT’s motion to tax costs. The court explained that Respondents’ assertion ignores claims beyond the scope of CERT’s actions that were to be released under the offers. Given that the proposed releases in section 998 offers covered this and other potential claims, the trial court could not have determined that the offers were more favorable than the judgment. Thus, the offers were invalid for purposes of section 998. View "Council for Education and Research etc. v. Starbucks Corp." 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

Kirtz obtained loans from the Pennsylvania Higher Education Assistance Agency (AES), a “public corporation” that makes, guarantees, and services student loans, and the USDA through the Rural Housing Service, which issues loans to promote the development of affordable housing in rural communities. Kirtz alleges that, as of June 2018, both of his loan accounts were closed with a balance of zero. AES and the USDA continued to report the status of Kirtz’s accounts as “120 Days Past Due Date” on his Trans Union credit file, resulting in damage to his credit score. Kirtz sent Trans Union a letter disputing the inaccurate statements. Trans Union gave AES and USDA notice of the dispute, as required by the Fair Credit Reporting Act (FCRA), 15 U.S.C. 1681. According to Kirtz, neither AES nor the USDA took any action to investigate or correct the disputed information.The district court dismissed Kirtz’s lawsuit, concluding that FCRA did not clearly waive the United States’ sovereign immunity. Courts of Appeals that have considered this issue are split. The Third Circuit reversed. FCRA’s plain text clearly and unambiguously authorizes suits for civil damages against the federal government. In reaching a contrary conclusion, the district court relied on its determination that applying the FCRA’s literal text would produce results that seem implausible. Implausibility is not ambiguity, and where Congress has clearly expressed its intent, courts may neither second-guess its choices nor decline to apply the law as written. View "Kirtz v. Trans Union LLC" on Justia Law

The Consumer Product Safety Commission (CPSC or Commission) promulgated a mandatory safety standard governing all previously unregulated infant sleep products, including ones for which there was no voluntary safety standard in effect. Finnbin, LLC sold baby boxes, an infant flat sleep product covered by the final rule. Finnbin’s boxes lack a firm stand and elevation, so Finnbin may no longer sell them as designed. Finnbin sought judicial review of the final rule.   The DC Circuit denied in part and dismissed in part Petitioner’s motion seeking judicial review of the final review. Finnbin made two arguments why, in its view, the final rule exceeds the CPSC’s statutory authority under section 104. The court held that because the extant voluntary standard here covers only inclined sleep products, the Commission could not impose a broader standard extending to previously unregulated flat sleep products.   Finnbin further contended that section 104 permits the CPSC to impose safety standards but not product bans, which it says must be done under 15 U.S.C. Section 2057. Moreover, Finnbin continues, the final rule bans products like baby boxes. The court explained that by its terms, the final rule creates performance requirements for infant sleep products not already covered by a section 104 standard. Finnbin provides no reason to think that the rule effectively bans any discrete product.   Finally, the court explained in contending the CPSC failed to provide an adequate explanation, Finnbin highlights cases faulting the Commission for relying on imprecise injury reports. But these cases involved rules promulgated under the Consumer Product Safety Act—which, unlike section 104, requires a rigorous cost-benefit analysis. View "Finnbin, LLC v. CPSC" on Justia Law

The  FDA declared that “preventing tobacco use initiation in young people is a central priority for protecting population health.” Congress has called on the FDA to regulate e-cigarette products pursuant to the Family Smoking Prevention and Tobacco Control Act.   Prohibition Juice makes flavored liquids containing nicotine derived from tobacco. Prohibition applied in September 2020 for FDA authorization to market several flavors in a range of sizes. The FDA denied those applications a year later. The FDA requires applicants to present reliable evidence of robust public health benefits exceeding known risks. Finding the manufacturers had presented insufficient evidence that their flavored products are more effective than unflavored products in helping adult cigarette smokers decrease or quit harmful tobacco uses, the FDA denied the applications. The manufacturers petitioned for a review of those denials.   The DC Circuit denied the petitions. The court explained that FDA plainly had statutory authority under the Tobacco Control Act to regulate as it did. As to the arbitrary and capricious challenges, the court held that the FDA did not change the evidentiary or substantive standard from its 2019 Guidance. The court further held that any error in the FDA’s failure to consider the marketing plans was harmless because the manufacturers failed to identify how an individualized review of the plans they submitted could have made any difference. Finally, the FDA did not otherwise fail to consider important aspects of the problem. View "Prohibition Juice Co. v. FDA" on Justia Law

Petitioners Wages and White Lion Investments, LLC, d/b/a Triton Distribution (“Triton”) and Vapetasia, LLC (“Vapetasia”) sought to market flavored nicotine-containing e-liquids for use in open-system e-cigarette devices. Petitioners needed to submit premarket tobacco product applications as required by 21 U.S.C. Section 387j—which the Food and Drug Administration (“FDA”) deemed applicable to e-cigarette tobacco products. FDA denied the requested marketing authorizations, finding that Petitioners failed to offer reliable and robust evidence (such as randomized controlled trials or longitudinal studies) to overcome the risks of youth addiction and show a benefit to adult smokers. Petitioners sought review of those marketing denial orders (“MDOs”), and prior to the consolidation of the two cases. Petitioners argued that the FDA lacks the authority to impose a comparative efficacy requirement and that FDA acted arbitrarily and capriciously by “requiring” scientific studies.   The Eleventh Circuit denied the petitions for review. The court explained that Congress passed the Family Smoking Prevention and Tobacco Control Act (“TCA”) in an active effort to protect public health. Relevant here, the Deeming Rule subjected e-cigarette manufacturers to the TCA’s prior authorization requirement—manufacturers of “new tobacco product[s]” must submit premarket tobacco product applications (“PMTAs”). The court held that the FDA’s consideration of the lack of cessation as a risk and comparing that risk between new tobacco products and old tobacco products “fall[s] squarely within the ambit of the FDA’s expertise and merit[s] deference.”  As such, the court cannot say that FDA acted arbitrarily and capriciously by disagreeing with Petitioners as to the significance of the evidence they presented. View "Wages and White Lion Investmen v. FDA" on Justia Law

Appellant used an email application on his laptop to send Freedom of Information Act ("FOIA") records requests to fourteen components of the U.S. Department of Defense (DOD). Not having received any response, he filed a complaint in district court almost seven months later seeking an order to require the DOD to conduct a search for and promptly produce the requested records. Appellant attached copies of the emails to the complaint. The DOD responded by moving for summary judgment, relying on a DOD official’s declaration that all fourteen components had searched for but had not received any request from Appellant. The district court granted the DOD’s motion, concluding that Appellant had not created a genuine dispute as to the DOD’s “receipt” of the requests under 5 U.S.C. Section 552(a)(6)(A)(i).   The DC Circuit affirmed the district court’s ruling granting summary judgment to the DOD. First, Appellant argued that it “goes well beyond any agency deference and borders on vacuous” to allow the government to prevail based solely on a declaration that it could not find a request. But, the court reasoned, Appellant’s framing—that any declaration denying receipt after a search would warrant granting summary judgment to the government—is flawed. The court affords a presumption of good faith only if we conclude that an agency’s declaration is “relatively detailed and non-conclusory, and . . . submitted in good faith.”  The court explained that Appellant, who filed suit over six months after saving the requests on his computer, has presented insufficient evidence to create a genuine dispute regarding the DOD’s “receipt” of his FOIA requests View "Patrick Eddington v. DOD" on Justia Law

In June 2019, Plaintiffs submitted a FOIA request to the IRS seeking disclosure of the terms of a third-party authentication process set forth within IRM Sec. 21.1.3.3, pertaining to the tax professional authentication process. in August 2019, the IRS denied Plaintiffs' request citing the material was properly withheld pursuant to 5 U.S.C. Sec. 552(b)(7)(E), and then plaintiffs filed an action in federal court.The district court granted the IRS’s motion for summary judgment, rejecting Plaintiffs' request for an in-camera review of the documents.The Eighth Circuit reversed, remanding for the district court to conduct an in-camera inspection of the documents. To meet its burden under 5 U.S.C. Sec. 552(b)(7)(E), the IRS must prove the withheld material was “compiled for law enforcement purposes." Here, to effectively determine whether the IRS meets the requirements of 5 U.S.C. Sec. 552(b)(7)(E), an in-camera review is necessary. Thus, the district court erred in failing to hold an in-camera review. View "T. Keith Fogg v. Internal Revenue Service" on Justia Law

Plaintiff, a North Carolina attorney, believed he uncovered fraud perpetrated by forty-five adult care homes upon the United States and the State of North Carolina. According to Plaintiff, Defendants violated a North Carolina Medicaid billing regulation, and did so knowingly, as evidenced by the clarity of the regulation and by the fact Defendants did not ask the regulators for advice. The district court granted Defendants’ motion for summary judgment, holding that Plaintiff failed to proffer evidence showing “that the bills submitted by Defendants to North Carolina Medicaid for PCS reimbursement were materially false or made with the requisite scienter.”   The Fourth Circuit affirmed the district court’s decision. The court held that no reasonable juror could find Defendants acted with the requisite scienter on Plaintiff’s evidence. The court explained that The False Claims Act (“FCA”) imposes civil liability on “any person who . . . knowingly presents, or causes to be presented” to the Federal Government “a false or fraudulent claim for payment or approval.” The Act’s scienter requirement defines “knowingly” to mean that a person “has actual knowledge of the information,” “acts in deliberate ignorance of the truth or falsity of the information,” or “acts in reckless disregard of the truth or falsity of the information.” Here, Plaintiff failed to identify any evidence that Defendants knew, or even suspected, that their interpretation of the relevant policy and the guidance from NC Medicaid was incorrect. Nor did Plaintiff identify any evidence that Defendants attempted to avoid discovering how the regulation applied to adult care homes. View "US ex rel. Stephen Gugenheim v. Meridian Senior Living, LLC" on Justia Law