Justia Health Law Opinion Summaries

In this case, the United States Court of Appeals for the Federal Circuit considered whether the defendants' Abbreviated New Drug Applications (ANDAs) infringed two patents owned by the plaintiffs. The patents pertained to the use of the drug vortioxetine in the treatment of patients who had previously taken certain other antidepressant medications and had to cease or reduce use due to sexually related adverse events, and for the treatment of cognitive impairment. The defendants were seeking approval to market vortioxetine for the treatment of Major Depressive Disorder (MDD) in adults, a use not covered by the patents. The plaintiffs sought to block the defendants from marketing a generic version of the drug until after the expiration of the patents.The court held that the defendants' ANDA filings did not infringe the plaintiffs' patents. The court found that the defendants' intended use of the drug, for the treatment of MDD in adults, did not infringe the patents which pertained to other specific uses of the drug.Moreover, the court found no induced or contributory infringement. Regarding induced infringement, the court held that the defendants' proposed labels for the drug did not encourage, recommend, or promote an infringing use. Regarding contributory infringement, the court held that the defendants' sale of the drug would have substantial noninfringing uses, thus there would be no contributory infringement.Additionally, the court rejected Lupin's cross-appeal, which challenged the district court's determination that Lupin infringed a patent concerning a process for manufacturing vortioxetine. The court affirmed the district court's construction of the term "reacting" in the patent and its determination of infringement. View "H. LUNDBECK A/S v. LUPIN LTD. " on Justia Law

The 2010 ACA (Patient Protection and Affordable Care Act; Health Care and Education Reconciliation Act) created a three-year Risk Corridors program with the creation of new health-insurance marketplaces, which presented uncertain risks for participating health-insurance companies. Qualified health-plan issuers (QHP issuers) that offered their products in the new marketplaces were entitled to payments from HHS if they suffered sufficient losses, 42 U.S.C. 18062(b).The government failed to make those payments. QHP issuers sued under the Tucker Act, 28 U.S.C. 1491(a)(1). In two such lawsuits, the Quinn law firm was lead counsel for classes of QHP issuers seeking payments. In the opt-in notices sent to potential class members with court approval, Quinn represented that it would seek attorney’s fees out of any recovery, that it would seek no more than 5% of any judgment or settlement, and that the Claims Court would determine the exact amount by considering how many issuers participated, the amount at issue, and a “lodestar cross-check” (based on hours actually worked). Meanwhile, the Supreme Court, in other cases, held that QHP issuers were entitled to collect ACA-promised payments.The Claims Court entered judgments in favor of the classes, totaling about $3.7 billion, then awarded Quinn 5% of the common funds, rejecting objections. The total fee was about $185 million. The Federal Circuit vacated. The Claims Court’s analysis was inconsistent with the class opt-in notices and did not adequately justify the extraordinarily high award. View "Health Republic Insurance Co. v. United States" on Justia Law

Van Dermark served in the Navy from 1963 until his 1976 honorable discharge. The VA found Van Dermark to be totally and permanently disabled due to service-connected injuries. Van Dermark received treatment in Thailand (where he lived) at non-VA facilities, from physicians and others not affiliated with VA, in 2016 and in 2018, both times for cardiac conditions not related to his service-connected disability. For each of the two instances of treatment abroad, Van Dermark filed a claim with VA under 38 U.S.C 1728 and 1725 seeking VA payment—to him or his medical creditors—for the surgical or other heart-related treatment he received abroad.VA Community Care denied both claims. The Board of Veterans’ Appeals maintained the denials. The Veterans Court and Federal Circuit affirmed. Section 1724(a) prohibits the VA from “furnish[ing] hospital . . . care or medical services” abroad, where the care or services are unrelated to the service-connected disability. The “furnishing” phrase encompasses the payment for a veteran’s hospital care or medical expenses abroad at issue here; sections 1728 and 1725 do not override that prohibition. View "Van Dermark v. McDonough" on Justia Law

DiMasi, then a 47-year-old nurse-practitioner student, received an influenza vaccine on December 4, 2012. She was admitted to the hospital on December 5, 2012, released the next day, and then readmitted on December 8. Almost three years later, DiMasi sought compensation under 42 U.S.C. 300aa-10 to -34 (Vaccine Act). In 2019, a special master denied compensation, noting that the parties agreed on the post-vaccination conditions at issue, ultimately diagnosed in 2016 and 2017: “small fiber neuropathy” and “postural tachycardia syndrome” (POTS), which are related. He also noted that no claim of significant aggravation of a preexisting condition had been presented and found that the vaccine was not the cause in fact of the conditions. DiMasi had 30 days to seek Claims Court review.On September 15, 2020, within a year of the final judgment, DiMasi sent the special master a letter, with medical records and other attachments, requesting that she be allowed to proceed pro se and that her case be reopened. The special master allowed DiMasi to proceed pro se and construed her request to reopen her case as a motion for relief from judgment under Claims Court Rule 60. The special master ultimately vacated the denial. The Federal Circuit appointed counsel for DiMasi and requested additional briefing, noting that it had “more questions than answers” about the findings and proceedings concerning DiMasi’s former counsel’s submissions and choices. View "DiMasi v. Secretary of Health & Human Services" on Justia Law

B.W., a two-year-old in good health, experienced immune thrombocytopenic purpura after receiving his measles, mumps, and rubella vaccine. Later blood tests showed his condition had resolved. More than six months after he was first diagnosed, B.W. presented with bruising, a possible symptom of immune thrombocytopenic purpura, but blood tests showed the condition had not recurred. In a suit under the National Childhood Vaccine Injury Act of 1986, the Claims Court ruled in favor of B.W., holding that those blood tests, occurring more than six months after his initial diagnosis, were “residual effects” of B.W.’s vaccine injury that satisfied the severity requirement of 42 U.S.C. 300aa-11(c)(1)(D).The Federal Circuit reversed. A residual effect must be a change within the patient that is caused by the vaccine injury. B.W.’s later bruising was not caused by his vaccine injury, and his tests did not reveal, constitute, or cause any somatic change. Tests revealed B.W. had no lingering symptoms or recurrence of thrombocytopenic purpura. There was no argument that the testing itself was detrimental to B.W.’s health such that it might qualify under section 300aa-11(c)(1)(D)(i) as a “residual effect” or a “complication” of thrombocytopenic purpura. View "Wright v. Secretary of Health and Human Services" on Justia Law

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

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

In the Patient Protection and Affordable Care Act (ACA), Congress directed each state to establish an online exchange through which insurers may sell health plans if the plans meet certain requirements. One requirement is that insurers must reduce the “cost-sharing” burdens—such as the burdens of making co-payments and meeting deductibles—of certain customers. When insurers meet that requirement, the Secretary of Health and Human Services shall reimburse them for those cost-sharing reductions, 42 U.S.C. 18071(c)(3)(A). In October 2017, the Secretary stopped making reimbursement payments, due to determinations that such payments were not within the congressional appropriation that the Secretary had, until then, invoked to pay the reimbursements. Sanford, a seller of insurance through the North Dakota, South Dakota, and Iowa exchanges, and Montana Health, a seller through the Montana and Idaho exchanges, sued.The trial courts granted the insurers summary judgment, reasoning that the ACA reimbursement provision is “money-mandating” and that the government is liable for damages for its failure to make reimbursements for the 2017 reductions. The court did not reach the contract claim in either case. The Federal Circuit affirmed, citing the Supreme Court’s 2020 “Maine Community,” addressing a different payment-obligation ACA provision. Maine Community indicates that the cost-sharing-reduction reimbursement provision imposes an unambiguous obligation on the government to pay money; that obligation is enforceable in the Claims Court under the Tucker Act, 28 U.S.C. 1491(a)(1). View "Sanford Health Plan v. United States" on Justia Law

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

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