Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

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 Clozapine had serious potential side effects and was withdrawn from clinical trials.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. View "Nat'l Org. of Veterans' Advocates, Inc. v. Sec'y Veterans Affairs." on Justia Law

The patents at issue relate to balloon-expandable stents, used to treat occluded blood vessels. Following a remand, the district court found that defendants did not literally infringe the patents and rejected claims that the patents were invalid for lack of description or due to inequitable conduct. The Federal Circuit affirmed. Based on the court's proper clarification of its construction of the term "undulating," there was not substantial evidence to support a finding of infringement, nor was there substantial evidence of inequitable conduct.

Plaintiff had no adverse reaction to receiving the hepatitis B vaccine in 1997 until after her third dose. At that time, her chest pain was not attributed to the vaccine. Plaintiff saw other doctors for various symptoms and, in 1998, doctors identified "post vaccine syndrome." Plaintiff has had unrelated medical problems, suffered the loss of a child, and has had jobs that involved working with chemicals and bodily fluids. Her 1999 claim for compensation under the Vaccine Act (42 U.S.C. 300aa-1) was denied. The Federal Circuit affirmed, stating that if was an "unfortunate case," in which plaintiff suffered a multitude of symptoms but could not prove they were caused by the vaccine.

Plaintiff is a physician, disabled by multiple sclerosis, and had no significant medical issues prior to exhibiting symptoms of MS. She received three Hepatitis B immunizations in 1996-1997 and began to experience symptoms. Although she was under medical care, she was not given a provisional diagnosis until 2003. In 2004, she was awarded Social Security disability benefits. Plaintiff first became aware of an association between MS and the Hep-B vaccine in 2004. The Court of Claims affirmed denial of compensation under the Vaccine Injury Compensation Program established by the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1 to -34, as time-barred. The Federal Circuit reverse, holding that the limitations period does not begin running when the claimant first experiences symptoms in cases where the medical community at large does not recognize that the symptom is related to a vaccine and the claimant has not received medical information suggesting a connection.