Justia Public Benefits Opinion Summaries

The National Childhood Vaccine Injury Act of 1986 established a no-fault compensation system to stabilize the vaccine market and expedite compensation to injured parties. Under the Act, a proceeding for compensation is “initiated” by service upon the Secretary of Health and Human Services and “the filing of a petition containing” specified documentation with the clerk of the Court of Federal Claims, who forwards the petition for assignment to a special master. 42 U. S. C. 300aa–11(a)(1). An attorney may not charge a fee for services in connection with such a petition, but a court may award attorney’s fees and costs incurred by a claimant in any proceeding on an unsuccessful petition, if that petition was brought in good faith. In 1997, shortly after receiving her third Hepatitis-B vaccine, Cloer began to experience symptoms that led to a multiple sclerosis (MS) diagnosis in 2003. In 2004, she learned of a link between MS and the Hepatitis-B vaccine, and in 2005, she filed a NCVIA claim. The special master concluded that Cloer’s claim was untimely because the Act’s 36-month limitations period began to run when she had her first MS symptoms in 1997.The Federal Circuit agreed. Cloer then sought attorney’s fees and costs. The Federal Circuit ruled in Cloer’s favor. The Supreme Court affirmed. Nothing in the attorney’s fees provision suggests that the reason for the subsequent dismissal of a petition, such as untimeliness, nullifies the initial filing. An NCVIA petition delivered to the court clerk, forwarded for processing, and adjudicated before a special master is a “petition filed under section 300aa–11.” The government’s contrary position is inconsistent with the fees provision’s purpose, which was to avoid limiting petitioners’ ability to obtain qualified assistance by making awards available for “non-prevailing, good-faith claims.” View "Sebelius v. Cloer" on Justia Law

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

At age four months, Elias received a Diptheria-Tetanus-acellular-Pertussis (DTaP) vaccine. Elias developed a seizure disorder shortly afterwards. While a petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1, was pending, Elias died as a result of his seizure disorder at the age of seven. A special master determined that the DTaP vaccine caused Elias’ epilepsy and resulting death. The Secretary of Health and Human Services and the estate agreed to a $250,000 death benefit plus $175,000 for actual pain and suffering and past unreimbursable expenses. The estate also sought future lost earnings under section 300aa-15(a)(3)(B). The special master determined that the estate was entitled to future lost earnings. Subject to the right to seek review, the Secretary proffered, and the estate accepted the sum of $659,955.61 as a measure of the lost earnings. The Claims Court affirmed the special master’s future lost earnings award. The Federal Circuit reversed, holding that an estate cannot recover lost future earnings under section 300aa-15(a)(3)(B) when the person injured by a vaccine dies before entry of a compensation judgment. View "Tembenis v. Sec'y of Health & Humans Servs." on Justia Law

Zizic is the former CEO of BioniCare, which sold the BIO-1000, a medical device designed to treat osteoarthritis of the knee. BioniCare attempted to bill Medicare for the BIO-1000, but many claims were denied as not medically necessary. Q2A contracted with the government to review such claim denials across the nation. Q2A’s denials were reached without physician review, which is required by the Medicare Act, 42 U.S.C. 1395, HHS regulations, and its contract. A former Q2A employee testified that it implemented an internal policy to deny all BIO-1000 claims, which were reviewed by a single nurse rather than a panel of physicians; later allowed non-physician subcontractors to prepare BIO-1000 appeals for review by a single physician; and finally developed a mail merge letter that automatically denied BIO-1000 claims without any review. BioniCare’s trustee in bankruptcy became aware of and disclosed these practices. Zizic filed a qui tam suit under the False Claims Act, 31 U.S.C. 3729-33. The district court dismissed, concluding that it lacked jurisdiction because the allegations against Q2A and RTS were based on prior public disclosures and because Zizic was not an original source of that information. The Third Circuit affirmed. View "Zizic v. Q2Adm'rs LLC" on Justia Law

The National Childhood Vaccine Injury Act of 1986 established a no-fault compensation system to stabilize the vaccine market and expedite compensation to injured parties. Under the Act, a proceeding for compensation is “initiated” by service upon the Secretary of Health and Human Services and “the filing of a petition containing” specified documentation with the clerk of the Court of Federal Claims, who forwards the petition for assignment to a special master. 42 U. S. C. 300aa–11(a)(1). An attorney may not charge a fee for services in connection with such a petition, but a court may award attorney’s fees and costs incurred by a claimant in any proceeding on an unsuccessful petition, if that petition was brought in good faith. In 1997, shortly after receiving her third Hepatitis-B vaccine, Cloer began to experience symptoms that led to a multiple sclerosis (MS) diagnosis in 2003. In 2004, she learned of a link between MS and the Hepatitis-B vaccine, and in 2005, she filed a NCVIA claim. The special master concluded that Cloer’s claim was untimely because the Act’s 36-month limitations period began to run when she had her first MS symptoms in 1997.The Federal Circuit agreed. Cloer then sought attorney’s fees and costs. The Federal Circuit ruled in Cloer’s favor. The Supreme Court affirmed. Nothing in the attorney’s fees provision suggests that the reason for the subsequent dismissal of a petition, such as untimeliness, nullifies the initial filing. An NCVIA petition delivered to the court clerk, forwarded for processing, and adjudicated before a special master is a “petition filed under section 300aa–11.” The government’s contrary position is inconsistent with the fees provision’s purpose, which was to avoid limiting petitioners’ ability to obtain qualified assistance by making awards available for “non-prevailing, good-faith claims.” View "Sebelius v. Cloer" on Justia Law

Figueroa received the flu vaccine in 2008. Within 20 days, he developed numbness in his face, impaired speech, and weakness. He was diagnosed with Guillain-Barré Syndrome, a sometimes fatal nervous system disorder. Because GBS is not listed on the Vaccine Injury Table, 42 U.S.C. 300aa-14(a), it requires proof of causation, although flu vaccine GBS cases have been compensated under the National Childhood Vaccine Injury Act. Figueroa had 36 months from the onset of symptoms to file a petition under the Act (until November, 2011), but, in 2010, he died of pancreatic cancer. His widow timely sought compensation for the vaccine-related neurological injuries suffered prior to his death. A special master dismissed, reasoning that because Figueroa had died of pancreatic cancer, a non-vaccine-related cause, Ms. Figueroa lacked standing to seek injury compensation. The Court of Federal Claims affirmed. The Federal Circuit reversed, interpreting a section that provides: “any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine ... may ... file a petition for compensation,” 42 U.S.C. 300aa-11(b)(1)(A) View "Figueroa v. Sec'y of Health & Human Servs." on Justia Law

Hibbard, then 41 years old and working as a teacher, received a flu vaccination in 2003. She claims that the flu vaccine caused her to develop a neurological disorder known as dysautonomia, a dysfunction of the autonomic nervous system and sought compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.300aa-1 to 300aa-34. Following a two-day hearing, a special master found that Hibbard had failed to show that her dysautonomia resulted from autonomic neuropathy caused by the vaccine she received in 2003. The Court of Federal Claims upheld the decision. The Federal Circuit affirmed, finding substantial evidence to support the denial. View "Hibbard v. Sec'y Health & Human Servs." on Justia Law

Humana sued, alleging that Glaxo was obligated to reimburse Humana for expenses Humana had incurred treating its insureds’ injuries resulting from Glaxo’s drug, Avandia. Humana runs a Medicare Advantage plan. Its complaint asserts that, pursuant to the Medicare Act, Glaxo is in this instance a “primary payer” obligated to reimburse Humana as a “secondary payer.” The district court dismissed, agreeing with Glaxo that the Medicare Act did not provide Medicare Advantage organizations with a private cause of action to seek such reimbursement. The Third Circuit reversed and remanded. The Medicare Secondary Payer Act, in 42 U.S.C. 1395y(b)(3)(A), provides Humana with a private cause of action against Glaxo. Even if the provision is ambiguous, regulations issued by the Centers for Medicare and Medicaid Services make clear that the provision extends the private cause of action to MAOs. View "Humana Med. Plan Inc. v. GlaxoSmithKline LLC" on Justia Law

Plaintiffs sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa, for injuries to their children allegedly caused by the Diptheria-Tetanus-acellular Pertussis vaccine. The children suffer a seizure disorder, known as Severe Myoclonic Epilepsy of Infancy. The same special master presided over both cases and determined that plaintiffs failed to show entitlement to compensation because evidence showed that a gene mutation present in both children was the sole cause of their injuries. The Court of Federal Claims affirmed. The Federal Circuit affirmed, noting considerable evidentiary support for the conclusion. View "Stone v. Sec'y of Health & Human Servs." on Justia Law

Olivia, born in 2000, apparently healthy, became ill after her first vaccinations. Her condition required extensive hospitalization; she still requires a ventilator and a wheelchair. Her parents filed a petition with the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa-1 to34. Olivia's injuries are not covered by a table of injuries presumed to be caused by vaccines, so the parents were required to show that one of the administered vaccines caused or significantly aggravated her condition. They submitted two reports by experts. The special master identified unanswered questions, but the parents took the position that it was unreasonable to require such detail at the pre-hearing stage. Based on failure to submit a supplemental report and failure to identify a clear theory of causation, the special master dismissed. The claims court affirmed. The Federal Circuit reversed. The special master did not appropriately review the evidence of causation under the summary judgment standard. View "Simanski v. Sec'y of Health & Human Servs." on Justia Law