Justia U.S. 4th Circuit Court of Appeals Opinion Summaries

Articles Posted in Health Law
by
Plaintiff filed suit against GBMC, seeking to recover funds to Medicare and to collect for herself under the Medicare Secondary Payer Act, 42 U.S.C. 1395y, which authorizes a private cause of action for double damages where a recalcitrant payer "fails" to reimburse Medicare. Sixteen days after plaintiff filed the federal suit, GBMC paid her $403,722.24, which represented the amended final judgment amount plus post-judgment interest. The Fourth Circuit affirmed the district court's grant of GBMC's motion for summary judgment, holding that, although plaintiff was injured when GBMC was obligated under law to pay for her medical care but did not, GBMC did not fail to reimburse plaintiff because its payment was well within plaintiff's proposed deadline. View "Netro v. Greater Baltimore Medical Center, Inc." on Justia Law

by
In 2017, Maryland enacted “An Act concerning Public Health – Essential Off-Patent or Generic Drugs – Price Gouging – Prohibition.” The Act, Md. Code, Health–General 2-802(a), prohibits manufacturers or wholesale distributors from “engag[ing] in price gouging in the sale of an essential off-patent or generic drug,” defines “price gouging” as “an unconscionable increase in the price of a prescription drug,” and “unconscionable increase” as “excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health” that results in consumers having no meaningful choice about whether to purchase the drug at an excessive price due to the drug’s importance to their health and insufficient competition. The “essential” medications are “made available for sale in [Maryland]” and either appear on the Model List of Essential Medicines most recently adopted by the World Health Organization or are “designated . . . as an essential medicine due to [their] efficacy in treating a life-threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living.” The Fourth Circuit reversed the dismissal of a “dormant commerce clause” challenge to the Act, finding that it directly regulates the price of transactions that occur outside Maryland. View "Association for Accessible Medicine v. Frosh" on Justia Law

by
Plaintiff filed a qui tam suit under the False Claims Act (FCA), 31 U.S.C. 3729-3733, and the state equivalents, alleging that Manor Care was overbilling the government for medical services. Plaintiff also alleged a separate claim of retaliation, claiming that he was terminated after he notified his employer of the alleged overbilling. Christine A. Ribik had previously filed a qui tam suit under seal in the Eastern District of Virginia on behalf of the United States against Manor Care. The court dismissed the complaint under the FCA's first-to-file rule. The court concluded that plaintiff has not managed to avoid the first-to-file bar simply by alleging additional facts relating to how Manor Care overbilled, even though some of those specific allegations were not mentioned in Ribik's complaint. The court also concluded that plaintiff's alternative argument, that his complaint should not be dismissed because the district court consolidated them with Ribik's, failed under the plain language of the FCA. Therefore, the district court properly determined that it lacked subject matter jurisdiction over plaintiff's qui tam action under the FCA. The court concluded, however, that the first-to-file rule has no relation to a claim for retaliation. Finally, the court concluded that the district court did not support its decision with any discussion or authority to establish that any of the states apply the FCA first-to-file rule, or its equivalent, to that state's statute. Therefore, the court affirmed in part, but vacated and remanded that part of the judgment concerning plaintiff's retaliation and state fraud claims. View "US ex rel. Carson v. Manor Care, Inc." on Justia Law

by
Seaside filed suit under the Federal Tort Claims Act (FTCA), 28 U.S.C. 1346(b), 2671-2680, alleging that the FDA negligently issued a contamination warning in response to an outbreak of Salmonella Saintpaul that devalued Seaside’s tomato crop by $15,036,293.95. The court affirmed the district court's holding that the FDA was exercising a discretionary function in connection with the contamination warning. The court explained that the ruling was essential to protect the FDA’s vital role in safeguarding the public food supply. Accordingly, the court affirmed the judgment. View "Seaside Farm, Inc. v. United States" on Justia Law

by
The Hospital system filed suit seeking to obtain a writ of mandamus compelling HHS to adjudicate immediately its administrative appeals on claims for Medicare reimbursement. The parties agree that, as of February 2014, the Secretary had 480,000 appeals awaiting assignment to an ALJ, and the Secretary conceded in her brief that the number had by then climbed to more than 800,000 appeals, creating a ten-year backlog. The court concluded that the Medicare Act, 42 U.S.C. 1395 et seq., does not guarantee a healthcare provider a hearing before an ALJ within 90 days, as the Hospital System claims. Rather, it provides a comprehensive administrative process that a healthcare provider must exhaust before ultimately obtaining review in a United States district court. The court further concluded that the issuance of a judicial order now, however, directing the Secretary to hear the Hospital System’s claims in the middle of the administrative process, would unduly interfere with the process and, at a larger scale, the work of the political branches. Moreover, such intervention would invite other healthcare providers suffering similar delays to likewise seek a mandamus order, thereby effectively causing the judicial process to replace and distort the agency process. Accordingly, the court affirmed the district court's dismissal of the complaint. View "Cumberland Cnty. Hosp. v. Burwell" on Justia Law

by
Concerned by Plaintiff’s “increasingly threatening” Facebook posts, two Marine veterans who had served with Plaintiff contacted the FBI. After interviewing Plaintiff, two FBI agents consulted with Michael Campbell, a local mental health evaluator, as to whether they should detain Plaintiff for a mental health evaluation. Campbell recommended that Plaintiff be detained. After interviewing Plaintiff, Campbell petitioned for and received a temporary detention order from a magistrate judge. Plaintiff was taken to a hospital, where he was involuntarily admitted for treatment for seven days. Following his release, Plaintiff filed suit under 42 U.S.C. 1983, seeking damages and injunctive relief against Campbell for violating his Fourth Amendment and First Amendment rights. The district court granted summary judgment to Campbell on the basis of qualified immunity. The Fourth Circuit affirmed, holding (1) Campbell did not violate Plaintiff’s Fourth Amendment rights based on existing precedent; (2) Plaintiff did not make out a First Amendment violation; and (3) injunctive relief was not appropriate on this record. View "Raub v. Campbell" on Justia Law

by
Plaintiffs, physicians and abortion providers, filed suit challenging a North Carolina statute that requires physicians to perform an ultrasound, display the sonogram, and describe the fetus to women seeking abortions. N.C. Gen. Stat. 90-21.85(b). The court concluded that a heightened intermediate level of scrutiny in this case is consistent with Supreme Court precedent and appropriately recognizes the intersection here of regulation of speech and regulation of the medical profession in the context of an abortion procedure. The Display of Real-Time View Requirement is unconstitutional because it interferes with the physician's right to free speech beyond the extent permitted for reasonable regulation of the medical profession, while simultaneously threatening harm to the patient's psychological health, interfering with the physician's professional judgment, and compromising the doctor-patient relationship. Accordingly, the district court did not err in concluding that section 90-21.85 violates the First Amendment and in enjoining the enforcement of that provision. The court affirmed the judgment. View "Stuart v. Camnitz" on Justia Law

by
Plaintiffs filed suit challenging the validity of an IRS final rule implementing the premium tax credit provision of the Patient Protection and Affordable Care Act (ACA), 26 U.S.C. 36B. The final rule interprets the Act as authorizing the IRS to grant tax credits to individuals who purchase health insurance on both state-run insurance "Exchanges" and federally-facilitated "Exchanges" created and operated by HHS. The court found that the applicable statutory language is ambiguous and subject to multiple interpretations. Applying deference to the IRS's determination, the court upheld the rule as a permissible exercise of the agency's discretion. Accordingly, the court affirmed the judgment of the district court. View "King v. Burwell" on Justia Law

Posted in: Health Law, Tax Law
by
Relator filed a qui tam action under the False Claims Act (FCA), 31 U.S.C. 3729-3733, against Omnicare, alleging that defendants violated a series of FDA safety regulations requiring that penicillin and non-penicillin drugs be packaged in complete isolation from one another. The court concluded that the public disclosure bar did not divest the district court of jurisdiction over relator's FCA claims. The court concluded that once a new drug has been approved by the FDA and thus qualified for reimbursement under the Medicare and Medicaid statutes, the submission of a reimbursement request for that drug could not constitute a "false" claim under the FCA on the sole basis that the drug had been adulterated as a result of having been processed in violation of FDA safety regulations. The court affirmed the district court's grant of Omnicare's motion to dismiss, holding that relator's complaint failed to allege that defendants made a false statement or that they acted with the necessary scienter. The court also concluded that the district court did not abuse its discretion in denying relator's request to file a third amended complaint. View "United States ex rel. Rostholder v. Omnicare, Inc." on Justia Law

by
Plaintiffs, out-of-state medical providers seeking to open facilities in Virginia, filed suit challenging Virginia's certificate-of-need requirement. In order to launch a medical enterprise in the state of Virginia, a firm was required to obtain a certificate of public need. Plaintiffs alleged, among other things, that Virginia's requirement violated the dormant Commerce Clause by discriminating in both purpose and effect. The district court dismissed the suit for failure to state a claim upon which relief could be granted. The court concluded that plaintiffs' Commerce Clause challenges required closer scrutiny and further proceedings before the district court. The court concluded, however, that plaintiffs' Fourteenth Amendment claims were properly dismissed. Accordingly, the court affirmed in part, reversed in part, and remanded for further proceedings. View "Colon Health Centers v. Hazel" on Justia Law