Justia Health Law Opinion Summaries

Griglock, a 70-year-old retired woman, received an influenza vaccination in 2005. Weeks later, she went to her doctor, complaining of weakness, and was admitted to the hospital. Her treating neurologist determined that she suffered from Guillain-Barré Syndrome. She improved initially, but soon developed respiratory failure and was placed on a ventilator. She died about 18 months later; her death certificate lists “ventilator-dependent respiratory failure due to GBS” as the immediate cause of death. Her estate filed a petition for compensation under the Vaccine Injury Compensation Program, 42 U.S.C. 300aa-1, 300aa-10(a). The government responded that there was insufficient evidence to find that the influenza vaccine caused her GBS and death, but that it would not contest the issue and recommended an award of up to $250,000. The estate then sought unreimbursable medical expenses and compensation for pain and suffering. The Special Master determined that Griglock’s death was caused by an influenza vaccination, that her estate had standing, but that entitlement was limited to death benefits because injury benefits were barred by the statute of limitations. The Court of Federal Claims affirmed. The Federal Circuit affirmed. View "Griglock v. Sec'y of Health & Human Servs." on Justia Law

Allcare owns a patent directed to “managed health care systems” used to interconnect and integrate physicians, medical care facilities, patients, insurance companies, and financial institutions, particularly with respect to utilization review, the process of determining whether a health insurer should approve a particular treatment for a patient. In general, the patent’s claims cover a method of determining whether utilization review is necessary in a particular instance, and whether a recommended treatment is appropriate. If utilization review is required, the method prevents authorization and payment until the appropriateness of the treatment has been determined and the treatment has been approved. The district court held that the patent was not infringed by Highmark, found the case exceptional under 35 U.S.C. 285 and awarded attorneys’ fees and costs to Highmark. The Federal Circuit affirmed the finding that Allcare’s allegations of infringement of claim 102 rendered the case exceptional, but reversed a finding that other claims and actions supported an exceptional case finding. Remand was necessary to determine the amount of fees apportionable to each of the issues. View "Highmark, Inc. v. Allcare Health Mgmt. Sys. Inc." on Justia Law

Locane, born in 1983, was adopted and does not know her family medical history. She suffered her first symptoms within two weeks of being vaccinated in 1997 and was diagnosed with Crohn’s Disease. She sought compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-1 to -34, alleging that she suffered Crohn’s disease as a result of hepatitis B vaccination. A special master denied the claim, finding Locane’s disease began before her vaccination and that Locane failed to prove by a preponderance of the evidence that the vaccine caused or significantly aggravated her disease. The Federal Circuit affirmed. View "Locane v. Sec'y of Health & Human Servs." on Justia Law

Heino, a veteran, is prescribed a daily dose of 12.5 milligrams of Atenolol. The lowest strength available for the prescription is a 25 milligram tablet, so his physician instructed him to split each tablet in half. Heino paid a $7 copayment for a 30-day supply of 15 tablets, which he claimed was excessive in light of the fact that some veterans paid the same co-payment for twice the medication. The VA refused his request for adjustment. The Veterans Court affirmed, rejecting arguments that the regulation the VA uses to calculate his copayment amount, 38 C.F.R. 17.110, conflicts with 38 U.S.C. 1722A(a)(2), which prohibits the VA from charging a copayment “in excess of the cost to the Secretary for medication,” because the actual cost of his Atenolol prescription was well below $7.3, and that his copayment was excessive. The Federal Circuit affirmed. View "Heino v. Shinseki" on Justia Law

Heinzelman, born in 1971, received a flu vaccine in 2003, and within 30 days, was hospitalized for Guillain-Barre syndrome, a disorder affecting the peripheral nervous system. She was previously employed full-time as a hairstylist earning $49,888 per year. Due to her injury, Heinzelman will never be able to work again and is eligible to receive SSDI benefits of approximately $20,000 per year. In 2007, she sought compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1 to 300aa-34. A special master rejected the government’s argument that her eligibility for SSDI benefits should be considered in determining compensation under the Vaccine Act, finding that SSDI is not a "federal . . . health benefits program" within the meaning of section 300aa-15(g), and awarded $1,133,046.08, plus an annuity to cover future medical expenses. According to the government, Heinzelman's lost earnings award would have been roughly $316,000 less had the special master taken her anticipated SSDI benefits into account. The Claims Court and the Federal Circuit affirmed. View "Heinzelman v. Sec'y Health & Human Servs." on Justia Law

Baxter's patent relates to hemodialysis machines that can function in place of a human kidney to cleanse the blood of toxins using a solution called a dialysate. The patent, entitled "Method and Apparatus for Kidney Dialysis," discloses and claims a hemodialysis machine integrated with a touch screen user interface that allows an operator to monitor and control a number of parameters. To ensure that the process does not filter essential nutrients from the blood, a hemodialysis machine must facilitate the monitoring and control of a number of parameters. In parallel with litigation concerning the patent, the U.S. PTO reexamined and rejected claims in the patent as obvious, 35 U.S.C. 103. The Federal Circuit affirmed. View "In Re Baxter Int'l, Inc." on Justia Law

The FDA last approved a typical antipsychotic in 1975. Despite drawbacks, typical antipsychotics are still used to treat schizophrenia. In the early 1960s, researchers discovered clozapine, the first "atypical" antipsychotic, useful for treating both positive and negative symptoms. Clozapine had serious potential side effects and was withdrawn from clinical trials. The FDA approved no new antipsychotic drugs between 1976 and 1989, finally approving clozapine in 1990, only for certain patients, subject to blood testing. The FDA approved risperidone, an atypical antipsychotic, in 1994, and, since then, has approved seven other atypical antipsychotics, including aripiprazole. These are as effective as typical antipsychotics for treating positive symptoms, while also treating negative symptoms and causing fewer side effects than clozapine. Every approved atypical antipsychotic has chemical structure related either to clozapine or risperidone, except aripiprazole, the active ingredient in "Abilify," marketed by plaintiff for treatment of schizophrenia, bipolar disorder, irritability associated with pediatric autistic disorder, and as add-on treatment for depression. Anticipating expiration of the patent, companies submitted FDA Abbreviated New Drug Applications for approval of generic aripiprazole. The district court ruled in favor of plaintiff on patent infringement, 35 U.S.C. 103. The Federal Circuit affirmed, rejecting claims of obviousness and of nonstatutory double patenting. View "Otsuka Pharm. Co., Ltd. v. Sandoz, Inc." 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

Plaintiff, a physician, sought compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1 to -34, alleging that Hepatitis B vaccination caused her multiple sclerosis. The Special Master dismissed her petition as untimely. The Court of Federal Claims affirmed. The Federal Circuit held that, contrary to precedent, the Act's statute of limitations is not jurisdictional, and that some claims brought under the Act are subject to equitable tolling. The court rejected a discovery rule and concluded that plaintiff's claim did not meet equitable tolling criteria. The Sixth Circuit subsequently remanded for a determination of whether plaintiff should be awarded reason-able attorneys’ fees and costs. Although she did not ultimately prevail on the merits, her appeal prompted a change of law in a limited way that potentially opens the door to certain Vaccine Act petitioners who otherwise would have been precluded from seeking redress. View "Cloer v. Sec'y of Health & Human Servs." on Justia Law

Organizations challenged a rule issued by the Secretary of Veterans Affairs (amending 38 C.F.R 3.304(f)) with respect to claims for service-connected disability benefits for post-traumatic stress disorder. The new rule: allows a veteran to establish PTSD without supporting evidence; applies the lower evidentiary standard only if a VA psychologist or psychiatrist, or one contracted with the VA, confirms the claimed-stressor supports the diagnosis; and defines the veteran’s "fear of hostile military or terrorist activity" as involving a response characterized by "a psychological or psycho-physiological state of fear, helplessness, or horror." The Federal Circuit upheld the rule as not violating the statutory requirement that the Secretary consider all medical evidence and give the benefit of the doubt to the claimant when there is an approximate balance of evidence. There is a rational basis for the distinction between private practitioners and VA associated practitioners.