Justia Health Law Opinion Summaries

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

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

Defendant, an interventional cardiologist, appealed his conviction and sentence for health care fraud and making false statements in connection with the delivery of or payment for health care services. The convictions arose from a scheme to defraud insurers by submitting claims for medically unnecessary coronary stent procedures. The court found that, although proof of a physician's failure to meet medical standards, by itself, could not sustain a conviction for the federal offense of health care fraud, the evidence was sufficient in this case to support the jury's verdict. The court found no reversible error in defendant's remaining arguments and affirmed the judgment. View "United States v. McLean" on Justia Law

Plaintiffs, thirteenth North Carolina residents who lost access to in-home personal care services (PCS) due to a statutory change, brought suit challenging the new PCS program. The district court granted plaintiffs' motions for a preliminary injunction and class certification. Defendants appealed, raising several points of error. The court agreed with the district court's conclusion that a preliminary injunction was appropriate in this case. The court held, however, that the district court's order failed to comply with Federal Rule of Civil Procedure 65 because it lacked specificity and because the district court neglected to address the issue of security. Accordingly, the court remanded the case. View "Pashby v. Delia" on Justia Law

Plaintiffs-Appellees Wheeling Hospital and Belmont Hospital along with other medical providers, filed this putative class action in West Virginia state court against the Ohio Valley Health Services and Education Corporation, Ohio Valley Medical Center and East Ohio Regional Hospital, (collectively, the "OV Health System Parties"), and Appellant The Health Plan of the Upper Ohio Valley, Inc. The plaintiffs sued in order to collect amounts allegedly owed to them by employee benefit plans established by the OV Health System Parties, for which The Health Plan acted as administrator. After pretrial activity, The Health Plan moved to dismiss the claims brought against it by the hospital plaintiffs pursuant to an arbitration agreement between the parties. The district court denied this motion, holding that The Health Plan had defaulted on its right to arbitrate. The Health Plan appealed. Upon review, the Fourth Circuit concluded that the district court erred in its determination that The Health Plan defaulted on its right to arbitrate. The Court therefore reversed the district court’s denial of The Health Plan’s motion to dismiss. View "Wheeling Hospital, Inc. v. Health Plan of the Upper Ohio Valley, Inc. " on Justia Law

Plaintiff, the Chapter 7 trustee for the bankruptcy estate of BioniCare Medical Technologies, contested determinations of the Medicare Appeals Council (MAC) refusing to provide coverage for the BIO-1000, a device to treat osteoarthritis of the knee. Plaintiff alleged that the Secretary improperly used the adjudicative process to create a policy of denying coverage for the BIO-1000, that the MAC's decisions were not supported by substantial evidence, and that the MAC's decisions were arbitrary and capricious on account of a variety of procedural errors. The court rejected those contentions and affirmed the judgment of the district court. View "Almy v. Sebelius" on Justia Law

This appeal arose from the district court's order granting final judgment to the United States upon equitable claims of payment by mistake of fact and unjust enrichment against Tuomey arising out of alleged violations of the Social Security Act, 42 U.S.C. 1395nn, (the Stark Law), and awarding damages plus pre- and post-judgment interest. Because the court concluded that the district court's judgment violated Tuomey's Seventh Amendment right to a jury trial, the court vacated the judgment and remanded for further proceedings. Because the court was remanding the case, the court also addressed other issues raised on appeal that were likely to recur upon retrial. View "Drakeford v. Tuomey Healthcare System" on Justia Law

Plaintiff, a minor, sustained serious injuries at birth due to the negligence of medical professionals who attended her delivery. As a result of plaintiff's injuries, DHHS, through the state Medicaid program, paid more than $1.9 million in medical and health care expenses on her behalf. Plaintiff instituted a medical malpractice action in state court and eventually settled the action for a lump some of approximately $2.8 million. The settlement agreement did not allocate separate amounts for past medical expenses and other damages. DHHS subsequently asserted a statutory lien on the settlement proceedings pursuant to N.C. Gen. Stat 108A-57 and 59 (third-party liability statues), which asserted that North Carolina had a subrogation right and could assert a lien upon the lesser of its actual medical expenditures or one-third of the medicaid recipient's total recovery. Plaintiff brought the instant action seeking declaratory and injunctive relief pursuant to 42 U.S.C. 1983, seeking to forestall payment under federal Medicaid law known as the "anti-lien provision," 42 U.S.C. 1396p. The court was persuaded that the unrebuttable presumption inherent in the one-third cap on the state's recovery imposed by the North Carolina third-party liability statutes was in fatal conflict with federal law. Accordingly, the court vacated the judgment in favor of the Secretary and remanded for further proceedings. View "E.M.A v. Cansler" on Justia Law

Plaintiff brought an action alleging that his dismissal from medical school for unprofessional behavior violated the Rehabilitation Act of 1973, 29 U.S.C. 794, and the Americans with Disabilities Act (ADA), 42 U.S.C. 12182. The district court granted summary judgment in favor of the medical school and plaintiff appealed. Because the court agreed with the district court that, with or without a reasonable accommodation of plaintiff's ADHD and anxiety disorder, plaintiff was not "otherwise qualified" to participate in the medical school's program, the court affirmed the judgment. View "Halpern v. Wake Forest Univ. Health" on Justia Law

This case involved a widow's claim for survivors' benefits under the Black Lung Benefits Act (BLBA), 30 U.S.C. 901-944, as amended by the the Patient Protection and Affordable Care Act (PPACA), Pub. L. No. 111-148, Section 1556, 124 Stat. 119, 260. The PPACA amendments revived Section 422(l) of the BLBA, 30 U.S.C. 932(l), which provided that an eligible survivor of a miner who was receiving benefits at the time of his death was automatically entitled to survivors' benefits without having to establish that the miner's death was due to pneumoconiosis. Relying on an amended section 932(l), the Benefits Review Board, ruled that the miner's widow was entitled to survivors' benefits. On appeal, petitioner raised a variety of constitutional and statutory challenges to the PPACA's restoration provision. The court held that because retroactive application of amended Section 932(l) was hardly arbitrary or irrational, petitioner's substantive due process argument was unavailing. Because amended Section 932(l) merely required petitioner to pay money - and thus did not infringe a specific, identifiable property interest - the Takings Clause was not applicable. The court also held that the miner's widow was derivatively entitled to survivors' benefits pursuant to Section 932(l). Finally, because petitioner made its contention, that 30 U.S.C. 901, 921(a), and 922(a)(2) prevented the miner's widow from receiving automatic survivors' benefits, for the first time at oral argument, the court held that it was waived. Accordingly, the judgment of the Board was affirmed.