Justia Health Law Opinion Summaries

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

Plaintiffs, collection agencies, appealed the district court's dismissals with prejudice of their claims against defendants, seeking double damages against defendants under the Medicare Secondary Payer Act and alleging that actors within the Medicare Advantage system, including Medicare Advantage Organizations (MAOs) and various "downstream actors" that contracted with MAOs, had assigned their Medicare Secondary Payer Act claims to plaintiffs for collection.The Eleventh Circuit vacated the dismissals of plaintiffs' claims based on assignments from downstream actors, holding that the district court erred by narrowly construing 42 U.S.C. 1395y(b)(3)(A) to categorically exclude claims by downstream actors. The court explained that both the text and the objective of section 1395y(b)(3)(A) support allowing downstream actors to bring suit, or assign their right to bring suit, against primary payers. Therefore, the court remanded these claims for further proceedings.The court found that the district court erred insofar as it dismissed MSPRC's HFAP claims with prejudice, and ordered that the district court's dismissal be without prejudice. The court also found that the district court erred in dismissing MSPA's FHCP and IMC claims based on the purported cancellation and validity of MSPA's assignments. Finally, defendants' alternative claims are without merit. The court vacated the dismissal of plaintiffs' remaining claims in case number 18-12149. In case number 18-13049, the court affirmed the dismissal of plaintiffs' claims but modified the dismissal of these claims to be without prejudice. View "MSP Recovery Claims, Series LLC v. Ace American Insurance Co." on Justia Law

Hepatitis C (HCV) is a bloodborne virus. Only about 1% of the general population suffers from HCV; its prevalence among prison inmates is much higher. HCV primarily attacks the liver, causing scarring, or “fibrosis,” which is measured from F0 (no fibrosis) to F4 (cirrhosis). Many people “spontaneously clear” HCV without treatment. HCV patients were previously prescribed weekly injections of Interferon, which caused unpleasant side effects, and succeeded in eradicating HCV only about 30% of the time. In 2013, a new HCV treatment became available—direct-acting antiviral (DAA) pills, with few side effects and a 95% cure rate. DAAs are very expensive.Chronic-HCV inmates incarcerated in Florida prisons filed a class action under 42 U.S.C. 1983, alleging deliberate indifference to inmates’ serious medical needs. Florida then hired Dr. Dewsnup, who had developed and implemented an HCV-treatment plan for the Oregon prison system. Florida adopted Dewsnup's proposal of providing DAAs for all inmates at level F2 and above and monitoring F0- and F1-level inmates and treating them with DAAs under certain circumstances. Ultimately, the court ordered DAA treatment of all F0s and F1s within two years of their initial staging. The Eleventh Circuit reversed. The state’s plan to monitor all HCV-positive inmates, including those who have not exhibited serious symptoms, and provide DAAs to anyone with an exacerbating condition, showing signs of rapid progression, or developing even moderate fibrosis, satisfies constitutional requirements. View "Hoffer v. Secretary, Florida Department Corrections" on Justia Law

SmileDirect filed suit against the Georgia Board of Dentistry, including the Board’s members in their individual capacities, alleging inter alia, antitrust, Equal Protection, and Due Process violations related to the amendment of Ga. Bd. of Dentistry R. 150-9-.02. On appeal, the Board members challenged the denial of their motion to dismiss the complaint with respect to the alleged antitrust violations.After determining that it does have appellate jurisdiction under the collateral order doctrine, the Eleventh Circuit affirmed, holding that, based on the facts alleged in SmileDirect's complaint, the Board members are not entitled to state-action immunity under Parker v. Brown, 317 U.S. 341 (1943), at this point in the litigation, and the district court properly denied their motion to dismiss. In this case, the Board members have failed to satisfy the Midcal test by failing to meet the "active supervision" prong of the test and both prongs are necessary to satisfy the test. Furthermore, the court rejected the Board members' argument that ipso facto state-action immunity is available merely because of the Governor's power and duty, and without regard to his actual exercise thereof. The court explained that the Board members have established no more than the mere potential for active supervision on the part of the Governor, and thus they have fallen far short of establishing that the amended rule was "in reality" the action of the Governor. View "SmileDirectClub, LLC v. Battle" on Justia Law

After the Medical Center suspended plaintiff's medical privileges, plaintiff filed suit against the Medical Center, an injunction against the suspension, and a declaration that the Health Care Quality Improvement Act provided no immunity from damages to the Medical Center.The Eleventh Circuit vacated the district court's judgment and remanded with instructions to dismiss plaintiff's complaint for lack of subject matter jurisdiction. Plaintiff contends only that federal question jurisdiction exists over his suit, but a request for declaratory relief that a federal law does not entitle the opposing party to a defense ordinarily does not raise a federal question under 28 U.S.C.1331. The court explained that, because the Declaratory Judgment Act does not enlarge the court's jurisdiction, plaintiff must still assert an underlying ground for federal court jurisdiction. In this case, plaintiff's complaint does not establish that the Medical Center could file a coercive action under federal law. Furthermore, a plaintiff cannot create federal question jurisdiction by seeking a declaration that a federal defense does not protect the defendant. Therefore, plaintiff's request for declaratory judgment does not establish federal question jurisdiction. View "Patel v. Hamilton Medical Center, Inc." on Justia Law

The Eleventh Circuit affirmed the district court's dismissal based on lack of standing of this action for damages under the Medicare Secondary Payer Act and remanded with instructions for the district court to dismiss the complaint with prejudice. The court held that the Addendum (but not the Nunc Pro Tunc Assignment) is impermissible parol evidence; although the Nunc Pro Tunc Assignment could create standing on the basis of retroactive assignment of claims, plaintiffs did not receive any rights under it; and the court declined to consider whether the Recovery Agreement by itself equitably assigned plaintiffs HFHP's rights under the Act because plaintiffs did not assert this argument before the district court. View "MSP Recovery Claims, Series LLC v. QBE Holdings, Inc." on Justia Law

Plaintiff sought declaratory and injunctive relief to prevent the Florida Agency for Health Care Administration (FAHCA) from recovering beyond that portion of her settlement specifically designated by the settling parties as compensation for her past medical expenses.The Eleventh Circuit reversed the district court's grant of summary judgment in favor of plaintiff. As a preliminary matter, the court held that the parties' unilateral allocation does not bind FAHCA. On the merits, the court held that federal medicaid law does not preempt FAHCA's practice of seeking reimbursement from portions of a settlement that represent all medical expenses. The court also held that federal law does not preempt Florida's method of allocating the share of a personal injury settlement from which it is entitled to seek reimbursement: its formula of half the settlement after 25 percent attorney's fees, combined with the procedure in which a recipient may challenge that allocation in an administrative hearing by clear and convincing evidence. View "Gallardo v. Mayhew" on Justia Law

The Eleventh Circuit stayed an injunction that was issued by the district court against the County and the Director of the Miami-Dade Corrections and Rehabilitations Department (MDCR), requiring defendants to employ numerous safety measures to prevent the spread of COVID-19 and imposing extensive reporting requirements. Metro West inmates had filed a class action challenging the conditions of their confinement under 42 U.S.C. 1983 and seeking habeas relief under 28 U.S.C. 2241 for the named plaintiffs with a "medically vulnerable" subclass of inmates.The court held that defendants established that they are likely to prevail on appeal. In this case, the district court likely committed errors of law in granting the preliminary injunction when it incorrectly collapsed the subjective and objective components of the deliberate indifference inquiry. Defendants are also likely to succeed on appeal because plaintiffs offered little evidence to suggest that defendants were deliberately indifferent. Furthermore, defendants have shown that they will be irreparably injured absent a stay where defendants will lose the discretion vested in them under state law to allocate scarce resources among different county operations necessary to fight the pandemic. Finally, the balance of the harms and the public interest weigh in favor of the stay. Because defendants have satisfied all four Nken factors for a stay, the court granted the stay pending appeal and motion to expedite the appeal. View "Swain v. Junior" on Justia Law

The Eleventh Circuit denied a motion for a stay of a preliminary injunction that enjoins certain applications of a public health order issued in response to the COVID-19 pandemic in Alabama. The public health order, published on March 27, 2020, mandated the postponement of all dental, medical, or surgical procedures. Plaintiffs, abortion providers in Alabama, sought a temporary restraining order (TRO) preventing enforcement of the public health order as applied to pre-viability abortions. After the district court issued a TRO, the state filed a motion to dissolve the TRO and included clarifications. The district court subsequently adopted the state's clarifications and issued an April 3rd order, staying the TRO in part. The state later changed its interpretation again. Based on the evidence presented at the preliminary injunction hearing, the district court determined that the medical restrictions, as read pursuant to the state's earlier interpretation, violate the Fourteenth Amendment.The court held that the state has not made a strong showing that it is likely to succeed on the merits of its appeal or that it will be irreparably injured absent a stay. In this case, because of the state's shifting interpretations of the March 27th and April 3rd orders, the district court had ample authority to issue a preliminary injunction to preserve the status quo and prevent the state from reverting to its initial and more restrictive interpretations.The district court considered Jacobson v. Commonwealth of Massachusetts and Smith v. Avino, but read them together with cases holding that the Fourteenth Amendment generally protects a woman's right to terminate her pregnancy. Applying both the Jacobson framework and the Casey undue-burden test together, the district court concluded that the April 3rd order imposed a plain, palpable invasion of rights, yet had no real or substantial relation to the state's goals. The court held that the district court was permitted to reach this conclusion and to issue a status quo preliminary injunction to ensure that the state did not deviate from the Alabama State Health Officer's interpretation of the April 3rd order at the preliminary injunction hearing. View "Robinson v. Planned Parenthood Southeast Inc." on Justia Law

Four liver-transplant candidates and more than a dozen transplant hospitals challenged HHS's adoption of a new policy for allocating donated livers. The Eleventh Circuit held that plaintiffs have not shown a substantial likelihood of success on the merits of their first claim—their allegation that the Secretary failed to follow legally required procedures under 42 C.F.R. 121.4(b) during the new liver-allocation policy's development. The court held that section 121.4(b) does not require the Secretary to take two procedural steps that all agree he did not: (1) referral of the new liver allocation policy to an entity called the Advisory Committee on Organ Transplantation and (2) publication of the new policy in the Federal Register for public comment. The court remanded for the district court to consider plaintiffs' remaining Administrative Procedure Act and Fifth Amendment claims that it failed to address in the first instance. View "Callahan v. U.S. Department of Health and Human Services" on Justia Law