Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the Federal Circuit
by
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

by
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

by
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

by
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

by
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

by
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

by
A three-year “risk corridors” program described in the Patient Protection and Affordable Care Act, 42 U.S.C. 18001, implemented by the Department of Health and Human Services (HHS), was intended to promote participation in insurance exchanges. Participating insurers, whose costs of providing coverage exceeded the premiums received (using a statutory formula) were to be paid a share of their excess costs while participating plans whose premiums exceeded their costs would pay in a share of their profits. The program “permit[ted] issuers to lower [premiums] by not adding a risk premium" for uncertainties in the 2014-2016 markets. The actual total "payments in"were less than requested "payments out" and Congress prohibited HHS from using its appropriations for the program. Prorated payments were issued. The insurer filed suit. The Federal Circuit affirmed summary judgment in favor of the government. The statute created an obligation of the government to pay exchange participants the amount indicated by the statutory formula but riders in the FY 2015 and 2016 appropriations bills repealed or suspended the obligation to make payments out in an aggregate amount exceeding payments in. Congress made the policy choice to cap payments. No statement or action by the government evinced an intention to form a contract; the risk corridors program was simply an incentive program. Because there was no contract, the insurer’s “takings” claim also failed. View "Land of Lincoln Mutual Health Insurance Co. v. United States" on Justia Law

by
A three-year “risk corridors” program described in the Patient Protection and Affordable Care Act, 42 U.S.C. 18001, implemented by the Department of Health and Human Services (HHS), was intended to promote participation in insurance exchanges. Participating insurers, whose costs of providing coverage exceeded the premiums received (using a statutory formula) were to be paid a share of their excess costs while participating plans whose premiums exceeded their costs would pay in a share of their profits. The program “permit[ted] issuers to lower [premiums] by not adding a risk premium" for uncertainties in the 2014-2016 markets. The actual total "payments in"were less than requested "payments out" and Congress prohibited HHS from using its appropriations for the program. Prorated payments were issued. Moda filed suit. The Claims Court granted Moda partial summary judgment as to liability, stipulated to be $209,830,445.79. Dozens of other insurers filed actions, with mixed results. The Federal Circuit reversed. The statute created an obligation of the government to pay exchange participants the amount indicated by the statutory formula but riders in the FY 2015 and 2016 appropriations bills repealed or suspended the obligation to make payments out in an aggregate amount exceeding payments in. Congress made the policy choice to cap payments. No statement by the government evinced an intention to form a contract; the statute, its regulations, and HHS’s conduct simply created an incentive program. View "Moda Health Plan, Inc. v. United States" on Justia Law

by
TRICARE provides current and former members of the military and their dependents' medical and dental care. Hospitals that provide TRICARE services are reimbursed under Department of Defense (DoD) guidelines. TRICARE previously did not require, DoD to use Medicare reimbursement rules. A 2001 amendment, 10 U.S.C. 1079(j)(2), required TRICARE to use those rules to the extent practicable. DoD regulations noted the complexities of the transition process and the lack of comparable cost report data and stated “it is not practicable” to “adopt Medicare OPPS for hospital outpatient services at this time.” A study, conducted after hospitals complained, determined that DoD underpaid for outpatient radiology but correctly reimbursed other outpatient services. TRICARE created a process for review of radiology payments. Each plaintiff-hospital requested a discretionary payment, which required them to release “all claims . . . known or unknown” related to TRICARE payments. Several refused to sign the release and did not receive any payments. Although it discovered calculation errors with respect to hospitals represented by counsel, TRICARE did not recalculate payments for any hospitals that did not contest their discretionary payment offer. The Claims Court dismissed the hospitals’ suit. The Federal Circuit reversed in part, finding that they may bring a claim for breach of contract but may not bring money-mandating claims under 10 U.S.C. 1079(j)(2) and 32 C.F.R. 199.7(h)(2) because the government’s interpretation of the statute was reasonable. View "Ingham Regional Medical Center v. United States" on Justia Law

by
Goodman served in the U.S. Army, 1972-1992, with service in Southwest Asia during the Persian Gulf War. During his service and at his discharge, Goodman underwent medical examinations that returned negative for rheumatoid arthritis; he denied having pain in his joints or arthritis. In 2007, Goodman sought treatment at a VA medical center for hand stiffness and knee pain, which he said had begun during service. He sought VA benefits for rheumatoid arthritis. The Board sought an independent medical advisory opinion from the Veterans Health Administration, which was conducted by a VA medical center Director of Rheumatology in 2014 and concluded that “it is less likely than not” that Goodman’s rheumatoid arthritis can be characterized as a medically unexplained chronic multi-symptom illness (MUCMI) under 38 C.F.R. 3.317, and that it “is less likely than not that his rheumatoid arthritis is related to a specific exposure event experienced … during service. The Board concluded that Goodman was not entitled to a presumptive service connection for a MUCMI; the Federal Circuit affirmed. The VA adjudicator may consider evidence of medical expert opinions and all other facts of record to make the final determination of whether a claimant has proven, based on the claimant’s unique symptoms, the existence of a MUCMI. View "Goodman v. Shulkin" on Justia Law