Justia Health Law Opinion Summaries

Cottingham sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-10, alleging that a Gardasil® vaccination received by her minor daughter, K.C., in 2012, for the prevention of HPV, caused K.C. injuries. The claim was filed immediately before the limitations period ran out.The government stated argued that a "reasonable basis for bringing the case may not be present.” Cottingham’s counsel was granted additional time but was unable to submit an expert opinion supporting her claim. The Special Master denied compensation. Cottingham sought attorneys’ fees and litigation costs ($11,468.77), 42 U.S.C. 300aa-15(e)(1). The Master found no evidence to support the "vaguely asserted claims" that the vaccination caused K.C.’s headaches, fainting, or menstrual problems." While remand was pending the Federal Circuit held (Simmons) that although a looming statute of limitations deadline may impact the question of whether good faith existed to bring a claim, that deadline does not provide a reasonable basis for asserting a claim. The Master decided that Simmons did not impact his analysis, applied a “totality of the circumstances” standard, and awarded attorneys’ fees. The Claims Court vacated and affirmed the Special Master’s third decision, finding no reasonable basis for Cottingham’s claim.The Federal Circuit vacated, noting that there is no dispute that Cottingham filed her claim in good faith. Simmons did not abrogate the “totality of the circumstances inquiry.” K.C.’s medical records paired with the Gardasil® package insert constitute circumstantial, objective evidence supporting causation. View "Cottingham v. Secretary of Health and Human Services" on Justia Law

In the Patient Protection and Affordable Care Act (ACA), Congress directed each state to establish an online exchange through which insurers may sell health plans if the plans meet certain requirements. One requirement is that insurers must reduce the “cost-sharing” burdens—such as the burdens of making co-payments and meeting deductibles—of certain customers. When insurers meet that requirement, the Secretary of Health and Human Services shall reimburse them for those cost-sharing reductions, 42 U.S.C. 18071(c)(3)(A). In October 2017, the Secretary stopped making reimbursement payments, due to determinations that such payments were not within the congressional appropriation that the Secretary had, until then, invoked to pay the reimbursements. Sanford, a seller of insurance through the North Dakota, South Dakota, and Iowa exchanges, and Montana Health, a seller through the Montana and Idaho exchanges, sued.The trial courts granted the insurers summary judgment, reasoning that the ACA reimbursement provision is “money-mandating” and that the government is liable for damages for its failure to make reimbursements for the 2017 reductions. The court did not reach the contract claim in either case. The Federal Circuit affirmed, citing the Supreme Court’s 2020 “Maine Community,” addressing a different payment-obligation ACA provision. Maine Community indicates that the cost-sharing-reduction reimbursement provision imposes an unambiguous obligation on the government to pay money; that obligation is enforceable in the Claims Court under the Tucker Act, 28 U.S.C. 1491(a)(1). View "Sanford Health Plan v. United States" on Justia Law

The parents were domiciled in Nassau, the Bahamas. Mother traveled to the U.S. five times while pregnant. A.R. was born in November 2015, in Nassau, and lived in Nassau for six months. He received his first two sets of vaccinations in Nassau, with no apparent adverse consequences. During his six-month well-child visit in Nassau, A.R. received his third set of eight vaccinations that are listed in the Vaccine Injury Table and were manufactured by companies with a U.S. presence. Days later, A.R. became ill. A.R. was flown to Nicklaus Children’s Hospital in Miami, Florida, where he was diagnosed with hemophagocytic lymphohistiocytosis, an autoimmune disease of the blood. He remained in Florida as an outpatient, returning to Nassau for Christmas, and months later, was diagnosed with acute myeloid leukemia. A.R. underwent treatment, at Cincinnati Children’s Hospital and at Johns Hopkins before he died.The Federal Circuit affirmed the dismissal of the parents’ Vaccine Act claim (42 U.S.C. 300aa). The parents asserted that the condition that caused A.R.’s death was a complication resulting from the treatment he had received for his vaccine-induced condition. The Act grants standing to a person who “received [a covered] vaccine outside the” U.S. if “such person returned" to the U.S. not later than 6 months after the vaccination. A.R., while living outside of his mother’s body, was never present in the U.S. before his vaccinations such that his entrance for medical treatment could be a “return.” View "Dupuch-Carron v. Secretary of the Department of Health & Human Services" on Justia Law

In July 2010, L.M. was born at full-term and developed normally for six months. In February 2011, L.M. received childhood vaccines, including the diphtheria-tetanus-acellular pertussis vaccination. By that evening, L.M. had a fever, was lethargic, had poor muscle tone, and would not eat., Any disturbance caused L.M. to scream. L.M. began to have several seizures a day. At seven years of age, L.M. could crawl and walk with the assistance of a walker. She had a poorly coordinated grasp, suffered cortical visual impairments, and was nonverbal, though she could use a few signs to express ideas such as “yes,” and “no.” Testing revealed that L.M. had a genetic mutation.In a claim under the National Vaccine Injury Compensation Program, L.M. alleged that the vaccinations administered to L.M. in February 2011, significantly aggravated L.M.’s pre-existing condition under two alternative theories. The Special Master denied the petition, finding that L.M.’s genetic mutation was “the most compelling explanation for her predisposition to develop a seizure disorder.” The Federal Circuit affirmed the denial of an “on-table” claim, finding no support for an argument that most encephalopathies do not become acute until after vaccination. The court vacated and remanded the denial of an “off-table” claim, which requires determining whether the child’s receipt of vaccinations significantly aggravated her seizure disorder in the face of an underlying genetic mutation. View "Sharpe v. Secretary of Health and Human Services" on Justia Law

In 2011, K.G., age 48, received an influenza vaccination in advance of knee replacement surgery. Over the next several months, she experienced increasingly severe nerve pain in her hands, arms, feet, and legs; she succumbed to alcoholism, spent months in the hospital, and developed amnesia. In 2014, an Iowa state court declared K.G. incapable of caring for herself and, against K.G.’s will, appointed K.G.’s sister as her guardian. K.G. regained her mental faculties by May 2016. She then retained an attorney who filed her claim under the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-1. A Special Master held that equitable tolling was not available during the period that K.G.’s sister acted as K.G.’s guardian and dismissed K.G.’s claim as not timely filed within the three-year statute of limitations. The Federal Circuit vacated. Equitable tolling is available in Vaccine Act cases and the appointment of a legal guardian is only one factor a court should consider when deciding whether equitable tolling is appropriate in a particular case. K.G. was not required to argue the legally irrelevant question of whether she personally was diligent while she was mentally competent and she preserved her argument that her legal representative exercised reasonable diligence under the circumstances. The Special Master erred in adopting a per se rule. View "K.G. v. Secretary of Health and Human Services" on Justia Law

The Kreizenbecks sought compensation under the National Vaccine Injury Act, 42 U.S.C. 300aa-1–34, alleging that vaccinations administered to their son aggravated an underlying mitochondrial disorder and caused him to suffer immune system dysfunction and other medical problems. They submitted 1,500 pages of medical records, medical literature, Mrs. Kreizenbeck's affidavit, and reports from three medical experts. The government submitted reports from three experts. The Special Master determined that “a ruling on the papers was preferable to a hearing,” expressed “serious misgivings about the claims’ substantive validity,” and explained that if the parties proceeded to a hearing, he was unlikely to compensate the Kreizenbecks for costs. The Kreizenbecks chose to forgo a hearing but objected to a ruling on the record. The Master allowed the parties to submit final briefs, then determined that nothing in the record and expert reports suggested that the outcome would be different after a hearing. He found the government’s mitochondrial expert “reliable and persuasive,” the Kreizenbecks’ expert reports “conclusory or unsubstantiated” and Mrs. Kreizenbeck’s affidavit uncorroborated and inconsistent with the medical records. The Kreizenbecks did not dispute the substance of the claim denial but challenged the dismissal of their petition on the written record.The Claims Court affirmed, finding that the Master provided ample opportunity to support the claims with written material. The Federal Circuit affirmed, noting the Master’s broad discretion to rule on the record and rejecting a due process argument based on evaluating the credibility of the experts and Mrs. Kreizenbeck without live testimony or cross-examination. View "Kreizenbbeck v. Secretary of Health and Human Services" on Justia Law

J.B. was born four weeks prematurely but progressed normally. At his four-month well-baby visit, J.B. was healthy, with normal chest and lungs and no fever, nasal congestion, or cough; J.B. received vaccinations for diphtheria-tetanus-acellular pertussis, inactivated polio, pneumococcal conjugate, rotavirus, and Hepatitis B. That evening, J.B. reportedly had a fever. At 4:00 AM and 8 AM, J.B.’s parents gave him Advil. In the early afternoon, J.B.’s father put him down for a nap on his back in his crib. J.B.’s mother checked on him and found him unresponsive on his right side. At 2:39 PM, J.B.’s mother called 911 and attempted CPR. Responders transported J.B. to the hospital. J.B. was pronounced dead at 4:01 PM. His crib contained soft blankets and a flat soft pillow but no clutter or toys. The medical examiner concluded that the cause of death was SIDS. In a case under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1, a Special Master found that the parents were entitled to compensation. The Claims Court reversed and the Federal Circuit agreed, holding that the Special Master erred by lowering the standard of proof for causation in a case involving an injury not listed on the Vaccine Act Injury Table. The parents failed to prove by a preponderance of the evidence that vaccinations can and did cause or contribute to J.B.’s SIDS death. View "Boatmon v. Secretary of Health & Human Services" on Justia Law

A.M. received a human papillomavirus vaccine in 2007. Shortly thereafter, she developed autoimmune limbic encephalitis and an intractable seizure disorder, resulting in cognitive impairment. Her mother (McCulloch) sought compensation under the Vaccine Act, 42 U.S.C. 300aa. A special master awarded compensation for A.M.’s injury and accepted the parties' agreement on the amounts and mechanisms of compensation. Neither party sought review. Months later McCulloch sought an award of attorneys’ fees and costs under section 300aa15(e)(1). A special master awarded fees and costs and included amounts to cover the expenses, under Florida guardianship law, of maintaining the guardianship for A.M,-- a required condition for receiving the full payments under the merits judgment. The Claims Court upheld inclusion of those amounts, but cited section 300aa-15(a), the provision governing merits awards of compensation, instead of 300aa-15(e), the fees/costs provision on which the special master relied. The Federal Circuit affirmed while acknowledging that the Claims Court improperly reopened a final merits judgment by awarding money under section 300aa-15(a). Nonetheless, it was appropriate for the special master to award guardianship-maintenance expenses under that section because McCulloch incurred a continuing liability to pay such expenses as a condition of receiving, for her daughter, the compensation awarded on the merits in this proceeding. View "McCulloch v. Secretary of Health and Human Services" on Justia Law

Procopio served aboard the U.S.S. Intrepid in 1964-1967. In July 1966, the Intrepid was deployed in the waters offshore the landmass of the Republic of Vietnam, including its territorial sea. Procopio sought entitlement to service connection for diabetes mellitus in 2006 and for prostate cancer in 2007 but was denied service connection for both in 2009. The Federal Circuit reversed, holding that the unambiguous language of the Agent Orange Act, 38 U.S.C. 1116, entitles Procopio to a presumption of service connection for his prostate cancer and diabetes mellitus. The term “in the Republic of Vietnam,” unambiguously includes the territorial sea under all available international law. Congress indicated those who served in the 12 nautical mile territorial sea of the “Republic of Vietnam” are entitled to section 1116’s presumption if they meet the section’s other requirements. View "Procopio v. Wilkie" on Justia Law

In April 2009, E.O. visited a pediatrician for his six-month visit and received several vaccinations. That night, Mrs. Oliver found E.O. seizing in his bed and called 9-1-1. At the emergency room, E.O. presented with a fever, red eyes with discharge, and a runny nose. The next day, E.O.’s pediatrician diagnosed E.O. with “complex febrile seizure and conjunctivitis.” E.O. did not have any health issues or seizures for two months but had several seizures over the summer and began to experience prolonged seizures in March 2010. Each seizure resulted in an emergency room visit. A pediatric neurologist diagnosed E.O. with an SCN1A gene defect. E.O. exhibited developmental delay. A pediatric neurologist performed examinations, which demonstrated “intractable, symptomatic childhood absence and complex partial seizures of independent hemisphere origin secondary to SCN1A gene defect (borderline SMEI syndrome) and encephalopathy characterized by speech delay.” E.O.’s family sought compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-2–300aa-33, alleging that E.O. developed Dravet syndrome as a result of the vaccinations. The Claims Court and Federal Circuit affirmed the rejection of their claim. The government’s expert provided strong evidence that Dravet syndrome will develop in children with the SCN[1]A mutation, whether or not they receive vaccinations; the Olivers failed to establish that their theory has garnered widespread acceptance, as evidenced by an extensive discussion of articles with contradictory findings. View "Oliver v. Secretary of Health and Human Services" on Justia Law