Justia Health Law Opinion Summaries

Plaintiffs, which are self-insured health and welfare trust funds, challenged a statutory requirement under the Patient Protection and Affordable Care Act (ACA) that obligated them to pay contributions to the Transitional Reinsurance Program (TRP) for the 2014, 2015, and 2016 benefit years. They argued that these mandatory payments constituted a taking of their property under the Fifth Amendment, claiming a protected property interest in the specific funds held in their trust accounts, which are maintained solely for providing health and welfare benefits to covered individuals.The United States Court of Federal Claims reviewed the case and granted the Government’s motion for partial summary judgment on the Fifth Amendment takings claim. The Claims Court found that the plaintiffs did not possess a cognizable property interest in the TRP payments, as the obligation was merely to pay money, not to surrender specifically identifiable funds. The court rejected the argument that the trust agreements created a property interest in the sums paid, and also dismissed the alternative claim that the trust accounts themselves were the specific funds at issue. The Claims Court further held that a taking would only occur if the government appropriated the entire fund, which did not happen here. Plaintiffs’ motion for reconsideration was denied.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the grant of summary judgment de novo. The Federal Circuit affirmed the Claims Court’s decision, holding that the statutory obligation to pay TRP contributions did not constitute a taking under the Fifth Amendment because it was an obligation to pay money, not an appropriation of a specific, identifiable fund. The court clarified that a mere requirement to pay money, even from a trust account, does not give rise to a takings claim. The Federal Circuit also found harmless error in the Claims Court’s alternative reasoning regarding appropriation of funds in toto. The judgment was affirmed. View "ELECTRICAL WELFARE TRUST FUND v. US " on Justia Law

The petitioner received a flu vaccine on November 1, 2017. Over a month later, he developed upper respiratory symptoms and, after several days, experienced sudden generalized weakness. He was diagnosed with Guillain-Barré Syndrome (GBS) and also found to have a bacterial infection (H. influenzae pneumonia). During his hospitalization, multiple treating physicians associated his GBS with his respiratory infection, and none suggested a link to the flu vaccine. Upon discharge, his diagnoses included both GBS and H. influenzae pneumonia.The petitioner filed a claim for compensation under the National Childhood Vaccine Injury Act in the United States Court of Federal Claims, alleging that the flu vaccine caused his GBS. The case was assigned to a special master, who found that although the petitioner established a prima facie case for vaccine causation, the government had shown by a preponderance of the evidence that the unrelated H. influenzae infection was the sole substantial factor causing the GBS. The special master explicitly excluded the vaccine as a causal factor. The petitioner sought review in the Court of Federal Claims, arguing that the special master erred in applying the burden of proof and in making certain factual findings. The Court of Federal Claims rejected these arguments and upheld the special master’s decision.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the Claims Court’s decision de novo, applying the same standards of review. The Federal Circuit held that, in a Table case under the Vaccine Act, the government must prove by a preponderance of the evidence that a factor unrelated to the vaccine was the sole substantial cause of the injury, but need not disprove vaccine causation as if it had been affirmatively established. The court found that the special master’s findings were not arbitrary or capricious and that the correct legal standards were applied. The Federal Circuit affirmed the Claims Court’s decision denying compensation. View "WHITE v. HHS " on Justia Law

Nikko Cerrone, a sixteen-year-old, received the Gardasil HPV vaccine, Flumist influenza vaccine, and Hepatitis A vaccine on October 7, 2015. He later reported decreased stamina and blood in his stools, leading to a diagnosis of ulcerative colitis (UC) in March 2016. He received a second HPV vaccine dose in February 2016 and a third in June 2016, with no documented reaction to the third dose.Cerrone filed a petition for compensation under the National Vaccine Injury Compensation Program, claiming the vaccines caused his UC. The Chief Special Master of the National Vaccine Injury Compensation Program denied his claim, finding that Cerrone failed to prove causation by a preponderance of the evidence. The Court of Federal Claims upheld this decision.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the lower court's decision, agreeing that Cerrone did not meet the burden of proof required under the Vaccine Act. The court found that the special master correctly applied the legal standards and that the findings were not arbitrary or capricious. The court noted that the special master found the respondent's experts more credible and persuasive than Cerrone's experts. The court also upheld the special master's conclusion that the evidence did not support a proximate temporal relationship between the vaccinations and the onset of UC. The decision of the Court of Federal Claims was affirmed. View "CERRONE v. HHS " on Justia Law

Acorda Therapeutics, Inc. developed Ampyra®, a drug for multiple sclerosis, and had a licensing agreement with Alkermes PLC, which owned a patent for Ampyra’s active ingredient. The patent expired in July 2018, but Acorda continued to make royalty payments to Alkermes until July 2020, when it began making payments under protest. Acorda initiated arbitration in July 2020, seeking a declaration that the royalty provisions were unenforceable post-patent expiration and a refund of royalties paid since July 2018.The arbitration tribunal agreed that the royalty provisions were unenforceable but ruled that Acorda could only recoup payments made under formal protest. Acorda then petitioned the United States District Court for the Southern District of New York to confirm the tribunal’s rulings except for the denial of recoupment of unprotested payments. The district court rejected Acorda’s arguments, which were based on the tribunal’s alleged “manifest disregard” of federal patent law and a non-patent-law principle, and confirmed the award in full.Acorda appealed to the United States Court of Appeals for the Federal Circuit, seeking to reverse the district court’s denial of the 2018–2020 recoupment. The Federal Circuit concluded that it lacked jurisdiction over the appeal because Acorda’s petition did not necessarily raise a federal patent law issue. The court determined that the petition’s request for confirmation did not require a determination of federal patent law, and the request for modification presented alternative grounds, one of which did not involve patent law. Consequently, the Federal Circuit transferred the case to the United States Court of Appeals for the Second Circuit. View "Acorda Therapeutics, Inc. v. Alkermes PLC" on Justia Law

Abigail Stratton filed a petition with the Office of Special Masters under the National Childhood Vaccine Injury Act, alleging that the Gardasil® vaccine caused her to develop postural orthostatic tachycardia syndrome (POTS) and autonomic dysfunction. These conditions are not listed in the Vaccine Injury Table, requiring her to prove actual causation by a preponderance of the evidence. After filing a Notice of Intent to Withdraw to pursue her claim in federal district court, the Chief Special Master concluded the proceedings on the merits and later awarded her partial attorneys’ fees and costs.The Secretary of Health and Human Services opposed the fee application, arguing that Stratton did not file her petition with the good faith intent of litigating the claim and that there was no reasonable basis for her claim. The Chief Special Master found that Stratton had satisfied both the good faith and reasonable basis requirements and awarded partial fees. The Court of Federal Claims affirmed the Chief Special Master’s decision, concluding that the finding of a reasonable basis was not arbitrary and capricious, and awarded $8,876.86 for attorneys’ fees and costs. The Secretary appealed this decision.The United States Court of Appeals for the Federal Circuit reviewed the case and found that the Chief Special Master failed to adequately explain the determination that Stratton’s petition had a reasonable basis. The court noted that the Chief Special Master acknowledged the Secretary’s concerns about the sufficiency of the medical records but dismissed them without sufficient explanation. The Federal Circuit vacated the decision and remanded the case for further proceedings consistent with its opinion, requiring a more detailed explanation of why the evidence provided a reasonable basis for Stratton’s claim. View "Stratton v. Health and Human Services" on Justia Law

Incyte Corporation and Incyte Holdings Corporation (collectively, Incyte) own U.S. Patent No. 9,662,335, which claims deuterated versions of ruxolitinib, a Janus kinase (JAK) modulator used to treat autoimmune disorders. Sun Pharmaceutical Industries, Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, Sun) secured FDA approval for an oral deuterated ruxolitinib product, branded as Leqselvi, to treat alopecia areata (AA) and planned to launch it in October 2024. Incyte sued Sun for allegedly infringing the ’335 patent and moved for a preliminary injunction to prevent Sun from launching Leqselvi.The United States District Court for the District of New Jersey granted Incyte’s motion for a preliminary injunction, finding that Incyte would suffer irreparable harm if Sun launched Leqselvi. The district court based its decision on the theory that Sun’s launch would give it an unjust head start in the AA market, diminishing the value of Incyte’s investments in developing its own topical deuterated ruxolitinib product.Sun appealed the district court’s decision to the United States Court of Appeals for the Federal Circuit. The Federal Circuit reviewed the grant of the preliminary injunction for an abuse of discretion, focusing on whether the district court made a clear error in its irreparable harm analysis. The Federal Circuit found that the district court clearly erred in its finding of irreparable harm, as it was based on the incorrect assumption that Incyte would be first to market if the injunction were granted. The court noted that Sun’s multi-year head start was inevitable regardless of the injunction, as Incyte’s product would not launch until several years after the ’335 patent expired.The Federal Circuit reversed the district court’s order granting the preliminary injunction, concluding that Incyte failed to provide non-speculative evidence of irreparable harm. View "INCYTE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, LTD. " on Justia Law

Jazz Pharmaceuticals, Inc. and Jazz Pharmaceuticals Ireland Limited (collectively, "Jazz") manufacture and sell sodium oxybate products, Xyrem and Xywav, for treating narcolepsy and idiopathic hypersomnia (IH). Avadel CNS Pharmaceuticals, LLC ("Avadel") sought FDA approval for Lumryz, a sodium oxybate product, for treating narcolepsy. Jazz sued Avadel, alleging that Avadel's FDA submission infringed Jazz's U.S. Patent 11,147,782. The district court found in favor of Jazz, issuing a permanent injunction against Avadel from seeking FDA approval for Lumryz for IH and from marketing Lumryz for that indication.The U.S. District Court for the District of Delaware initially ruled that Avadel's submission of its New Drug Application (NDA) constituted infringement under 35 U.S.C. § 271(e)(2). The court issued a permanent injunction prohibiting Avadel from seeking FDA approval for Lumryz for IH, offering open-label extensions (OLEs) to clinical trial participants, and initiating new clinical trials. Avadel appealed, arguing that the injunction was overly broad and that certain activities were protected under the safe-harbor provision of 35 U.S.C. § 271(e)(1).The United States Court of Appeals for the Federal Circuit reviewed the case. The court reversed the injunction prohibiting Avadel from initiating new clinical trials and offering OLEs, finding these activities to be protected under the safe-harbor provision. The court vacated the injunction preventing Avadel from seeking FDA approval for new indications of Lumryz, remanding the issue to the district court for further consideration. The court instructed the district court to determine whether Avadel's submission of a paper NDA for additional indications would constitute an act of infringement under 35 U.S.C. § 271(e)(2) and to reassess the eBay factors if necessary. View "JAZZ PHARMACEUTICALS, INC. v. AVADEL CNS PHARMACEUTICALS, LLC " on Justia Law

The veteran served in the U.S. Army from March 1944 to May 1945 and was diagnosed with Hodgkin’s lymphoma in 1978. He received radiation therapy at a VA facility, which successfully treated the lymphoma but led to his death in early 1979 due to pulmonary complications. The veteran’s wife, Hatfield, filed a claim for dependency and indemnity benefits, which was denied by the Regional Office (RO) for lack of service connection. Hatfield appealed to the Board of Veterans’ Appeals (the Board), asserting that the veteran’s death was due to negligent VA medical care. In 1980, the Board denied the appeal, finding the VA provided adequate care and the veteran’s reaction was a recognized complication of radiation therapy.Hatfield later filed an application to reopen her claim in 2010, arguing entitlement to compensation under a 2004 regulation requiring informed consent for VA-administered medical care. The Board denied the application, but the Veterans Court reversed, granting benefits from August 1, 2010, due to the VA’s failure to obtain informed consent. In 2020, Hatfield filed a motion to revise the 1980 Board decision, claiming clear and unmistakable error (CUE) for not considering informed consent under 38 U.S.C. § 4131. The Board denied the motion, and the Veterans Court affirmed, stating there was no indication in 1980 that failure to obtain informed consent amounted to a compensable negligence claim.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the Veterans Court’s decision. The court held that Hatfield did not demonstrate that the 1980 Board committed CUE, as there was no undebatable error in the application of the law at that time. The court found no evidence that the failure to obtain informed consent under 38 U.S.C. § 4131 was considered a compensable negligence claim under 38 U.S.C. § 351 in 1980. View "HATFIELD v. COLLINS " on Justia Law

Daniel R. Smith, who is currently blind, underwent medical examinations upon entering military service in August 1964 and upon leaving in June 1965. Both examinations noted poor night and color vision, with vision correctable in both eyes. After his discharge, Smith filed several claims with the U.S. Department of Veterans Affairs (VA) for benefits based on retinitis pigmentosa, an eye disease causing vision loss. An ophthalmologist opined that Smith's condition preexisted his service and did not worsen during service. The VA denied his claim, and the Board of Veterans’ Appeals agreed, finding clear and unmistakable evidence rebutting the presumption of sound health upon entry into service. The Court of Appeals for Veterans Claims affirmed this decision.The United States Court of Appeals for Veterans Claims reviewed the case and affirmed the Board's decision, finding that Dr. Wilson's opinion constituted clear and unmistakable evidence that Smith's retinitis pigmentosa did not increase in severity during service. Smith appealed, arguing that Dr. Wilson's opinion did not meet the clear and unmistakable evidence standard and that it improperly relied on the absence of evidence.The United States Court of Appeals for the Federal Circuit reviewed the case and dismissed Smith's appeal. The court held that it lacked jurisdiction to review the factual determination that Dr. Wilson's opinion met the clear and unmistakable evidence standard. The court also found that the Veterans Court did not rely on an absence of evidence but rather on affirmative evidence comparing Smith's vision tests at entry and separation from service. Therefore, the Federal Circuit concluded that it could not address Smith's legal contention regarding the sufficiency of the evidence. View "SMITH v. COLLINS " on Justia Law

Regeneron Pharmaceuticals, Inc. holds a Biologics License Application (BLA) for EYLEA®, a therapeutic product containing aflibercept, a VEGF antagonist used to treat angiogenic eye diseases. Regeneron also owns U.S. Patent No. 11,084,865, which covers VEGF-trap formulations suitable for intravitreal injection. Several companies, including Samsung Bioepis Co., Ltd. (SB), filed abbreviated Biologics License Applications (aBLAs) seeking approval to market EYLEA® biosimilars. Regeneron sued these companies, including SB, for patent infringement in the Northern District of West Virginia.The district court consolidated the cases and granted Regeneron’s motion for a preliminary injunction against SB, enjoining it from marketing its biosimilar product in the U.S. without a license from Regeneron. The court found it had personal jurisdiction over SB based on SB’s aBLA filing and its distribution agreement with Biogen, which indicated plans for nationwide marketing, including West Virginia. The court also found that Regeneron was likely to succeed on the merits, as SB had not raised a substantial question of invalidity of the ’865 patent for obviousness-type double patenting or lack of written description.The United States Court of Appeals for the Federal Circuit reviewed the case and affirmed the district court’s decision. The appellate court agreed that the district court had personal jurisdiction over SB, as SB’s actions indicated plans to market its biosimilar nationwide. The court also upheld the district court’s findings that SB had not raised a substantial question of invalidity for the ’865 patent. The court found that the patent’s specific stability and glycosylation requirements were patentably distinct from the reference patent and adequately supported by the specification. The court also agreed that Regeneron had established a causal nexus between SB’s infringement and the irreparable harm it would suffer without an injunction. View "REGENERON PHARMACEUTICALS, INC. v. MYLAN PHARMACEUTICALS INC. " on Justia Law