Justia Injury Law Opinion Summaries

Articles Posted in US Court of Appeals for the Federal Circuit
by
Medytox’s patent is directed to the use of an animal-protein-free botulinum toxin composition that exhibits a longer-lasting effect compared to an animal protein-containing botulinum toxin composition and purportedly can be used to treat both cosmetic and non-cosmetic conditions. Galderma requested post-grant review of claims 1–10, which the Patent Trial and Appeal Board granted. Medytox filed a non-contingent motion to amend seeking to cancel claims 1–10 and substitute claims 11–18 and requested that the Board issue a Preliminary Guidance. Galderma argued that the claims added new matter because the claims covered compounds with a 16-week responder rate between 50-100% but the specification only disclosed responder rates of up to 62%.Reversing its Preliminary Guidance, the Board found that the substitute claims impermissibly introduced new matter with the inclusion of the responder rate limitation and failed to meet the requirements for revised motions to amend; that the proposed substitute claims were unpatentable for a lack of written description; and that the full scope of the claims was not enabled.The Federal Circuit affirmed, upholding the Board’s claim construction of the responder rate limitation as a range. The Board provided adequate explanation for its enablement finding. The Board’s revision of its claim construction of the responder rate limitation made between its Preliminary Guidance and final decision was not arbitrary and capricious, depriving Medytox of a full and fair opportunity to litigate. View "Medytox, Inc. v. Galderma S.A." on Justia Law

by
Lanclos was born in 1982 at the Keesler Air Force Base Medical Center. During childbirth, she was seriously injured and as a result, suffers from Athetoid cerebral palsy. The settlement agreement for Lanclos’s medical malpractice suit required the government to make lump sum payments to Lanclos’s parents and their attorney; Lanclos would receive a single lump sum payment followed by specific monthly payments for the longer of 30 years or the remainder of her life. The government would purchase an annuity policy to provide the monthly payments. The government selected Executive Insurance to provide the monthly annuity payments. Executive encountered financial difficulties and, in 2014, reduced the amount of the monthly payments by 42%. Lanclos estimates that the reduction will result in a shortfall of $731,288.81 from the amount described in the settlement agreement.The Court of Federal Claims reasoned that the “guarantee” language in the Lanclos agreement applies to the scheduled monthly structure of the payments but not the actual payment of the listed amounts and that the government was not liable for the shortfall. The Federal Circuit reversed. Under the ordinary meaning of the term “guarantee” and consistent with the agreement as a whole, the government agreed to assure fulfillment of the listed monthly payments; there is no reasonable basis to conclude that the parties sought to define “guarantee” or to give the term an alternative meaning. View "Lanclos v. United States" on Justia Law

by
Straw claims that he was injured as an infant by contaminated water at Camp Lejeune in North Carolina and that his injury resulted in a mental disability. Straw previously sued under the Federal Tort Claims Act (FTCA). That action was combined with similar cases in a Multidistrict Litigation proceeding in the Northern District of Georgia, which ruled that Straw’s FTCA claims were barred by North Carolina’s 10-year statute of repose. The Eleventh Circuit affirmed; the Supreme Court denied certiorari.Straw then filed suit, seeking $6,000,000 in compensatory damages, arguing that the rulings of the Georgia district court constituted a judicial taking of his tort claims and the damages he sought in that action. The Claims Court dismissed his complaint, citing lack of subject matter jurisdiction. The Federal Circuit affirmed. By claiming that the Georgia district court and the Eleventh Circuit had caused a taking of his personal-injury cause of action, Straw was effectively asking the Claims Court to overturn the decisions of those courts that his FTCA claim was time-barred. The court noted that Straw’s claim sounded in tort, given the underlying personal bodily harm; tort claims are expressly excluded from the jurisdiction of the Claims Court under the Tucker Act, 28 U.S.C. 1491. View "Straw v. United States" on Justia Law

by
Kirby received a flu shot in her arm on October 8, 2013. One week later, she complained of persistent arm pain, numbness, and tingling that began immediately after the injection. On October 16, Dr. Henry diagnosed Kirby with radial neuritis and complications due to vaccination. Two weeks later, Kirby reported that her wrist and hand had become “very weak.” On November 12, Kirby began working with a physical therapist. Her physical therapy discharge summary reported that Kirby’s pain was a “0/10,” she had regained full muscle strength except in right thumb extension, and her numbness had decreased by 80%. On December 12, Kirby reported mild right arm pain in the morning, almost normal strength, and occasional tingling, but no numbness in her thumb. Dr. Henry determined she had achieved maximum medical improvement.Kirby visited a nurse practitioner five times in January 2014-July 2015, for reasons unrelated to her vaccine injury and generally reported “feeling fine.” On October 13, 2015, she complained of mild, intermittent pain in her right arm. She had no imitations due to the pain, and no muscle weakness.The Federal Circuit reinstated Kirby’s compensation award under the Vaccine Act, 42 U.S.C. 300aa–1. A finding that Kirby’s vaccine injury lasted more than six months was not arbitrary. A reasonable fact-finder could conclude that Kirby’s testimony is not inconsistent with her medical records from January 2014 through July 2015. The court also rejected an argument concerning causation. View "Kirby v. Secretary of Health & Human Services" on Justia Law

by
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

by
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

by
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

by
In 2012, Lozano gave birth to a baby. While still hospitalized, Lozano received a tetanus-diphtheria-acellular-pertussis (Tdap) vaccination. Two weeks later, Lozano reported a low-grade fever, body aches, and breast tenderness. Lozano’s symptoms persisted through visits to her physician and the emergency room. She developed abdominal pain, difficulty urinating, weakness, loss of balance, vision changes, neck pain, headache, vomiting, and dizziness. A brain MRI suggested that Lozano possibly had multiple sclerosis (MS), acute disseminated encephalomyelitis (ADEM), or vasculitis. Lozano’s symptoms improved with steroid treatment, following a working diagnosis of MS. After several months, a repeat MRI “showed dramatic improvement, suggesting that ADEM was a more likely etiology, which was confirmed through later serological findings.” Lozano’s doctors opine that ADEM is the likely explanation for her symptoms.Lozano sought compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa. Lozano’s expert opined that Lozano’s ADEM was the result of her receipt of the Tdap vaccine. The special master granted Lozano’s petition, finding that her expert’s testimony and the supporting medical literature demonstrated that the Tdap vaccine can cause autoimmune diseases such as ADEM and that Lozano offered preponderant evidence of a proximate temporal relationship between the vaccine and her injury. The Claims Court and Federal Circuit upheld the award of a lump-sum payment of $1,199,216.86, finding that the decision was neither an abuse of discretion nor contrary to law and that the fact-findings were neither arbitrary nor capricious. View "Lozano v. Secretary of Health and Human Services" on Justia Law

by
In 1980, Langkamp, then a toddler, suffered severe burn injuries on U.S. Army property. In a suit under the Federal Tort Claims Act, the parties entered into a Settlement Agreement. The government agreed to pay $239,425.45 upfront to cover attorney fees and costs, plus a structured settlement: $350.00 per month, 1985-1996; $3,100.00 per month, guaranteed for 15 years, beginning in 1996, and Lump Sum Payments of $15,000.00 in 1996, $50,000.00 in 2000, $100,000.00 in 2008, 250,000.00 in 2018, and $1,000,000.00 in 2028. The government issued a check for $239,425.45 to the parents and a check for $160,574.55 payable to JMW Settlements, an annuity broker. JMW purchased two single-premium annuity policies from ELNY to fund the monthly and periodic lump-sum payments. Until 2013, ELNY sent Langkamp the specified monthly and periodic lump-sum payments. Following ELNY’s insolvency and court-approved restructuring, Langkamp’s structured settlement payments were reduced to 40 percent of the original amount. The Claims Court rejected Langkamp’s argument that the government had continuing liability for the Settlement Agreement payments. The Federal Circuit reversed. The Settlement Agreement contains no reference to the purchase of an annuity from a third party but unambiguously obligates the government to ensure that all future monthly and periodic lump-sum payments are properly disbursed. The court noted that in 1984 it cost the government approximately $160,000 to obtain a promise from an insurance company to fund the future payments specified in the Settlement Agreement. View "Langkamp v. United States" 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