Justia Health Law Opinion Summaries

In a multi-district litigation involving diabetes drug saxagliptin, the plaintiffs claimed that the drug caused their heart failure. They presented a single expert to show the drug could cause heart failure. After a Daubert hearing and expert motions, the United States Court of Appeals for the Sixth Circuit found that the expert's testimony was unreliable due to methodological flaws and therefore excluded it. Subsequently, the district court granted summary judgment for the defendants, rejecting the plaintiffs' claim that other evidence created a genuine issue of material fact. The court also refused the plaintiffs' request for ninety days to find a replacement expert. On appeal, the plaintiffs challenged the district court's exclusion of their expert, its grant of summary judgment, and its refusal to give them more time to find another expert witness. The Court of Appeals affirmed the district court's decisions, stating that the plaintiffs' claims lacked merit. The court found that the expert's reliance on one study to the exclusion of all others was unreliable, that his use of animal data was unreliable due to his admitted lack of qualifications to analyze such studies, and that he did not reliably apply the Bradford Hill criteria - a scientific framework used to analyze whether an association between two variables is causal. The court also found that all jurisdictions require expert testimony to show general causation in complex medical cases such as this one. As the plaintiffs failed to identify a reliable general causation expert, the court granted summary judgment for the defendants. The court also found no good cause to grant the plaintiffs more time to find a replacement expert. View "In re Onglyza (Saxagliptin) and Kombiglyze (Saxagliptin and Metformin) Products Liability Litigation" on Justia Law

In the case before the United States Court of Appeals for the Sixth Circuit, the defendant, Thomas O’Lear, was convicted of healthcare fraud, making a false statement in connection with healthcare services, and aggravated identity theft. O’Lear ran a company that provided mobile x-ray services to residents in nursing homes. However, he used the company to defraud Medicare and Medicaid programs by billing for fictitious x-rays using the identities of nursing-home residents. When an audit revealed the fraud, O’Lear attempted to conceal it by forging staff names and duplicating x-rays in the patient files.On appeal, O’Lear raised several questions. Firstly, he questioned whether his Sixth Amendment right to an impartial jury was violated by excluding individuals who had not been vaccinated against COVID-19 from the jury pool. The court ruled that the unvaccinated do not qualify as a “distinctive group” that can trigger Sixth Amendment concerns. Secondly, O’Lear questioned whether the nursing-home residents were “victims” of his fraud under a “vulnerable victims” sentencing enhancement, even though the monetary losses were suffered by Medicare and Medicaid. The court ruled that the residents were indeed victims, as O’Lear had used their identities and health records without their permission, which constituted taking advantage of them.O’Lear also challenged his two aggravated-identity-theft convictions and objected to his 180-month sentence on various grounds, but these arguments were also dismissed by the court. Ultimately, the court affirmed O’Lear's conviction and sentence. View "United States v. O'Lear" on Justia Law

Adams, born in 1960, smoked about a pack a day starting at age 18 and worked in coal mines at times between 1979-1995, mostly underground using a “cutting machine” in the “dustiest” areas. Adams struggled to breathe after his retirement. Adams’s 1998 application under the Black Lung Benefits Act, 30 U.S.C. 901(b), was denied because he failed to prove that he had pneumoconiosis. In 2008, Adams sought benefits from Wilgar. His treating physician, Dr. Alam, identified the causes of his 2013 death as cardiopulmonary arrest, emphysema, coal worker’s pneumoconiosis, throat cancer, and aspiration pneumonia.A 2019 notice in the case stated “the Court may look to the preamble to the revised” regulations in weighing conflicting medical opinions. Wilgar unsuccessfully requested discovery concerning the preamble and the scientific studies that supported its conclusions. The ALJ awarded benefits, finding that Adams had “legal pneumoconiosis” and giving Dr. Alam’s opinion that Adam’s coal mine work had substantially aggravated his disease “controlling weight.” All things being equal, a treating physician’s opinion is “entitled to more weight,” 30 C.F.R. 718.104(d)(1). Wilgar's three experts had opined that Adams’s smoking exclusively caused his disease The ALJ gave “little weight” to these opinions, believing that they conflicted with the preamble to the 2001 regulation.The Benefits Review Board and Sixth Circuit affirmed. The preamble interpreted the then-existing scientific studies to establish that coal mine work can cause obstructive diseases, either alone or in combination with smoking. The ALJ simply found the preamble more persuasive than the experts. View "Wilgar Land Co. v. Director, Office of Workers’ Compensation Programs" on Justia Law

During the COVID-19 pandemic, Twitter broadened its definition of censorable, harmful information to include “content that goes directly against guidance from authoritative sources of global and local public health information.” Twitter began permanently suspending any user who received five or more infractions for violating its COVID-19 policy. The plaintiffs,Twitter users who used their accounts to question responses to the COVID-19 pandemic, suffered multiple temporary suspensions. They claim the Biden administration became involved, announcing that “[t]he President’s view is that the major [social-media] platforms have a responsibility ... to stop amplifying untrustworthy content, disinformation, and misinformation, especially related to COVID-19 vaccinations.” Later, the Surgeon General released an advisory statement related to COVID-19 misinformation and (according to Plaintiffs) “command[ed] technology platforms” to take several steps. President Biden stated that social media platforms are “killing people” with COVID-19 misinformation. Days later, USA Today reported that the “[t]he White House is assessing whether social media platforms are legally liable for misinformation.”Plaintiffs sued the Department of Health and Human Services (HHS), asserting claims under the First Amendment, Fourth Amendment, and Administrative Procedure Act, citing HHS’s unlawful efforts to “instrumentalize[] Twitter” to “silenc[e] opinions that diverge from the White House’s messaging on COVID-19.” The Sixth Circuit affirmed the dismissal of the complaint. The plaintiffs have not adequately pleaded that HHS compelled Twitter’s chosen course of conduct, leaving a “highly attenuated chain of possibilities” that is too speculative to establish a traceable harm View "Changizi v. Department of Health and Human Services" on Justia Law

Waters was born with homocystinuria and diagnosed with that condition at the age of six. Homocystinuria is a genetic attribute that causes metabolic issues that prevent Waters’s liver from metabolizing methionine, an amino acid, that produces L-cysteine, another amino acid. Her physician prescribed HCU coolers–a medical food containing a methionine-free protein formula. Waters ingests HCU coolers orally; she has a fully functioning gastrointestinal tract. Waters sought reimbursement for HCU coolers purchased during 2018-2019, under the prosthetic-device benefit of Medicare Part B, 42 U.S.C. 1395k(a)(2)(I); 1395x(s)(8). The National Coverage Determinations Manual explains that, as part of the prosthetic-device benefit, enteral nutrition is considered reasonable and necessary when a patient “cannot maintain weight and strength commensurate with his” “general condition” because food does not reach the digestive tract and specifies that “[e]nteral therapy may be given by nasogastric [nose], jejunostomy [small intestine], or gastrostomy [stomach] tubes.” The NCD acknowledges “[s]ome patients require supplementation of their daily protein and caloric intake,” but “[n]utritional supplementation is not covered under Medicare Part B.”The Sixth Circuit affirmed several levels of denial of Waters’s claim, acknowledging the difficult circumstances of Waters and her family. An HCU cooler is not a stand-alone prosthetic device based on the plain meaning of prosthetic “device” and because an HCU cooler is a medical food according to the FDA. View "Waters v. Becerra" on Justia Law

The district court preliminarily enjoined Kentucky’s ban on sex-transition care for minors. The court later stayed its injunction in light of a recent Sixth Circuit decision in which the court balanced the likelihood of success on the merits, irreparable harm, the balance of harms, and the public interest and held that those factors favored allowing Tennessee to enforce its law. Kentucky bans the same conduct as in that case; the plaintiffs bring the same Equal Protection and Due Process claims that the Sixth Circuit held were unlikely to succeed. The Sixth Circuit declined to lift the stay. As a sovereign state, Kentucky has an interest in creating and enforcing its own laws. The people of Kentucky enacted the ban through their legislature. View "Doe v. Thornbury" on Justia Law

Tennessee enacted the Prohibition on Medical Procedures Performed on Minors Related to Sexual Identity, citing concerns that gender dysphoria treatments “can lead to the minor becoming irreversibly sterile, having increased risk of disease and illness, or suffering adverse and sometimes fatal psychological consequences” while less risky, non-irreversible treatments remain available. Prohibited procedures include surgically removing, modifying, or entering into tissues, cavities, or organs and prescribing or dispensing any puberty blocker or hormone with exceptions for treating congenital defects, precocious puberty, disease, physical injury, and continuation of ongoing treatment. It provides for professional discipline of healthcare providers and creates a private right of action.The district court entered a preliminary injunction, finding that the challengers lacked standing to contest the surgery ban but that the ban on hormones and puberty blockers infringes the parents’ “fundamental right” to direct their children’s medical care, improperly discriminates on the basis of sex, that transgender persons constitute a quasi-suspect class, and that the state could not satisfy the necessary justifications.The Sixth Circuit stayed the injunction, finding that Tennessee is likely to succeed on appeal. The district court erred in its facial invalidation of the law, as opposed to an as-applied invalidation. “Life-tenured federal judges should be wary of removing a vexing and novel topic of medical debate from the ebbs and flows of democracy by construing a largely unamendable federal constitution to occupy the field.” A right to new medical treatments is not “deeply rooted" in history and traditions. Tennessee could rationally exercise caution before permitting irreversible medical treatments of children. View "L. W. v. Skrmetti" on Justia Law

The False Claims Act imposes civil liability for “knowingly present[ing], or caus[ing] to be presented, a false or fraudulent claim [to the government] for payment or approval,” 31 U.S.C. 3729(a)(1)(A). Individuals with knowledge of false claims may bring private qui tam lawsuits, on behalf of the government. The Act covers claims resulting from a violation of the Anti-Kickback Statute, 42 U.S.C. 1320a-7b(g), which prohibits medical providers from making referrals “in return for” “remuneration.”Oaklawn Hospital is in Marshall, Michigan, which had two ophthalmologists. Oaklawn extended one of those doctors (Martin) a tentative offer to work at the hospital after hearing that the other doctor (Hathaway) planned to move his surgeries elsewhere. Hathaway told the hospital’s CEO that he wanted to continue working with Oaklawn and that Oaklawn hiring Martin would be the “death knell” of his practice. Oaklawn’s Board ultimately did not hire Martin.Martin filed a qui tam action, alleging an illegal fraudulent scheme under the Anti-Kickback Statute and that claims for Medicare and Medicaid reimbursement resulting from the kickbacks violated the False Claims Act. The Sixth Circuit affirmed the dismissal of the suit, which essentially argued that Oaklawn’s rejection of Martin’s employment in return for Hathaway’s commitment to continue sending surgery referrals violated the Anti-Kickback Statute. The Martins have not plausibly alleged causation; the alleged scheme did not change anything. When Oaklawn decided not to establish an internal ophthalmology line, it simply left things where they were. View "Martin v. Hathaway" on Justia Law

Smucker’s is a federal contractor that supplies food items to the federal government. In 2021, by Executive Order, President Biden directed all federal contractors to “ensure that all [their] employees [were] fully vaccinated for COVID-19,” unless such employees were “legally entitled” to health or religious accommodations. The order made contractors “responsible for considering, and dispositioning, such requests for accommodations.” In September 2021, Smucker’s notified its U.S. employees that it would “ask and expect” them to “be fully vaccinated.” A month later, in the face of “deadlines in the federal order,” Smucker’s announced a formal vaccine mandate with exemptions based on “sincerely held religious beliefs.”The plaintiffs unsuccessfully sought religious exemptions, then sued Smucker's under the First Amendment's free-exercise guarantee. The Sixth Circuit affirmed the dismissal of the suit. When Smucker’s denied the exemption requests, it was not a state actor. Smucker’s does not perform a traditional, exclusive public function; it has not acted jointly with the government or entwined itself with it; and the government did not compel it to deny anyone an exemption. That Smucker’s acted in compliance with federal law and that Smucker’s served as a federal contractor, do not by themselves make the company a government actor. View "Ciraci v. J.M. Smucker Co." on Justia Law

In May 2020, Koballa died of COVID-19. Hudak, the executrix of Koballa’s estate, sued, asserting negligence and related state-law claims against Elmcroft, an assisted-living facility. Elmcroft removed the case to federal court under the general removal statute, 28 U.S.C. 1441(a), and the federal-officer removal statute, 28 U.S.C. 1442(a)(1), based on arguments it made under the Public Readiness and Emergency Preparedness Act (PREP), 42 U.S.C. 247d-6d.The district court found that the PREP Act did not provide grounds for removal under either removal statute and remanded the case to state court for lack of subject-matter jurisdiction. The Sixth Circuit affirmed. Hudak does not allege that Elmcroft engaged in willful misconduct in the administration or use of a covered COVID-19 countermeasure, so the PREP Act does not “provide[] the exclusive cause of action for the claims” and does not completely preempt Hudak’s state-law claims. Hudak’s state-law claims do not arise under federal law and could not be removed. Elmcroft is not a "federal officer"; it operated a facility that came under significant federal regulation as part of the federal government’s COVID-19 response but did not have an agreement with the federal government, did not produce a good or perform a service on behalf of the government, and has not shown that the federal government exercised control over its operations to such a degree that the government acted as Elmcroft’s superior. View "Hudak v. Elmcroft of Sagamore Hills" on Justia Law