Justia Health Law Opinion Summaries

The case involves Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Mochida Pharmaceutical Co., Ltd. (collectively, “Amarin”) and Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC (collectively, “Hikma”). Amarin markets and sells icosapent ethyl, an ethyl ester of an omega-3 fatty acid commonly found in fish oils, under the brand name Vascepa®. In 2012, the U.S. Food and Drug Administration (“FDA”) approved Vascepa for the treatment of severe hypertriglyceridemia. In 2019, following additional research and clinical trials, the FDA approved Vascepa for a second use: as a treatment to reduce cardiovascular risk in patients having blood triglyceride levels of at least 150 mg/dL.In the United States District Court for the District of Delaware, Hikma moved to dismiss Amarin’s complaint for failure to state a claim. The court granted Hikma’s motion, concluding that Amarin’s allegations against Hikma did not plausibly state a claim for induced infringement.The United States Court of Appeals for the Federal Circuit reversed the decision of the district court. The court held that Amarin had plausibly pleaded that Hikma had induced infringement of the asserted patents. The court noted that the case was not a traditional Hatch-Waxman case or a section viii case, but rather a run-of-the-mill induced infringement case arising under 35 U.S.C. § 271(b). The court concluded that the totality of the allegations, taken as true, plausibly plead that Hikma “actively” induced healthcare providers’ direct infringement. View "AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC. " on Justia Law

Insulet Corp. and EOFlow are medical device manufacturers that produce insulin pump patches. Insulet began developing its OmniPod product in the early 2000s, and EOFlow started developing its EOPatch product after its founding in 2011. Around the same time, four former Insulet employees joined EOFlow. In 2023, reports surfaced that Medtronic had started a process to acquire EOFlow. Soon after, Insulet sued EOFlow for violations of the Defend Trade Secrets Act (DTSA), seeking a temporary restraining order and a preliminary injunction to enjoin all technical communications between EOFlow and Medtronic in view of its trade secrets claims.The U.S. District Court for the District of Massachusetts temporarily restrained EOFlow from disclosing products or manufacturing technical information related to the EOPatch or OmniPod products. The court then granted Insulet’s request for a preliminary injunction, finding strong evidence that Insulet is likely to succeed on the merits of its trade secrets claim, strong evidence of misappropriation, and that irreparable harm to Insulet crystallized when EOFlow announced an intended acquisition by Medtronic. The injunction enjoined EOFlow from manufacturing, marketing, or selling any product that was designed, developed, or manufactured, in whole or in part, using or relying on alleged trade secrets of Insulet.The United States Court of Appeals for the Federal Circuit reversed the district court’s order. The court found that the district court had failed to address the statute of limitations, lacked a tailored analysis as to what specific information actually constituted a trade secret, and found it hard to tell what subset of that information was likely to have been misappropriated by EOFlow. The court also found that the district court had failed to meaningfully engage with the public interest prong. The court concluded that Insulet had not shown a likelihood of success on the merits and other factors for a preliminary injunction. The case was remanded for further proceedings consistent with the opinion. View "INSULET CORP. v. EOFLOW, CO. LTD. " on Justia Law

The case involves a patent infringement dispute between Copan Italia S.p.A. and Copan Diagnostics Inc. (collectively, “Copan”) and Puritan Medical Products Company LLC and its affiliated companies (collectively, “Puritan”). Copan, the holder of several patents on flocked swabs used for collecting biological specimens, filed a patent infringement complaint against Puritan in the District of Maine. Puritan, in response, filed a partial motion to dismiss, claiming immunity under the Pandemic Readiness and Emergency Preparedness Act (“PREP Act”) for a portion of its accused product.The District Court for the District of Maine denied Puritan's motion to dismiss. The court found that Puritan had not shown, as a factual matter, that its flocked swabs were “covered countermeasures” under the PREP Act. The court also granted Puritan’s motion to amend its answer, allowing it to assert PREP Act immunity as a defense, subject to further argument.Puritan appealed the decision to the United States Court of Appeals for the Federal Circuit. However, the appellate court found that it lacked jurisdiction to review the case. The court reasoned that the district court's denial of Puritan's motion to dismiss did not conclusively determine any issue, which is a requirement for the application of the collateral order doctrine. The court suggested that the district court may wish to structure the litigation in a manner that could allow it to make a conclusive determination on Puritan’s PREP Act immunity defense before the case proceeds any further. The appeal was dismissed due to lack of jurisdiction. View "COPAN ITALIA SPA v. PURITAN MEDICAL PRODUCTS COMPANY LLC " on Justia Law

The case revolves around a minor, A.L., who developed immune thrombocytopenic purpura after receiving the DTaP, Hib, and MMR vaccines. Her parents, Victoria and Kevin Leming, filed a petition for compensation under the National Childhood Vaccine Injury Act (the “Vaccine Act”), alleging that the vaccines caused A.L.'s condition. The Lemings argued that A.L.'s condition met the "surgical intervention" severity requirement of the Vaccine Act, as she was hospitalized for two weeks and underwent a bone marrow aspiration and biopsy.The Court of Federal Claims initially ruled that the Lemings could not establish by a preponderance of the evidence that A.L. satisfied the “surgical intervention” severity requirement. The court held that the bone marrow aspiration and biopsy performed on A.L. was purely diagnostic and did not qualify as a "surgical intervention" under the Vaccine Act. On appeal, the case was reassigned to another special master who requested the Lemings offer more evidence to address the “residual effects” prong of the severity requirement. The Lemings failed to prove that A.L. suffered from the “residual effects” of the vaccine injury for more than six months.The United States Court of Appeals for the Federal Circuit reversed the lower court's decision. The appellate court held that the term “surgical intervention,” as used in the Vaccine Act, requires a surgical act or measure, either diagnostic or therapeutic, taken to prevent harm to a patient or to improve the health of a patient. The court found that the bone marrow aspiration and biopsy performed on A.L. was a surgical intervention as it was a surgical act taken to improve the health of and prevent harm to A.L. The case was remanded for further proceedings consistent with this opinion. View "LEMING v. HHS " on Justia Law

This case deals with the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collectively, "Meril") into the United States for a medical conference in San Francisco. The plaintiff, Edwards Lifesciences Corporation and Edwards Lifesciences LLC (collectively, "Edwards"), a competitor medical device company, alleged that this act constituted patent infringement. Meril argued that the importation was covered by the "safe harbor" provision of 35 U.S.C. § 271(e)(1), which exempts certain activities from being considered patent infringement if they are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.The district court granted summary judgment in favor of Meril, and Edwards appealed to the United States Court of Appeals for the Federal Circuit. The Court of Appeals affirmed the decision of the district court, noting that the undisputed evidence showed that the importation of the valve systems was reasonably related to submitting information to the United States Food and Drug Administration. The court rejected Edwards' arguments that the district court had disregarded contemporaneous evidence, applied the safe harbor with an objective standard, and relied improperly on declarations from Meril employees. The court affirmed the district court's conclusion that there was no genuine dispute of material fact and that Meril was entitled to judgment as a matter of law. View "EDWARDS LIFESCIENCES CORPORATION v. MERIL LIFE SCIENCES PVT. LTD. " on Justia Law

In this case, the parents of W.J., a young man with a chromosomal abnormality and autism, brought a case under the National Childhood Vaccine Injury Act of 1986 against the Secretary of Health and Human Services, claiming that the Measles, Mumps, and Rubella vaccine administered to their son had caused or significantly aggravated his health issues. They filed their petition more than 15 years after the vaccine was administered, well beyond the Act's three-year statute of limitations. The parents argued that the statute of limitations should be equitably tolled due to their son's mental incapacitation, his minority status, and the government's alleged fraudulent concealment of a connection between the vaccine and autism.The United States Court of Appeals for the Federal Circuit affirmed the decision of the United States Court of Federal Claims, which had denied the parents' petition for review and confirmed a special master’s decision to dismiss the case as untimely. The court concluded that the mental incapacitation of the son did not qualify as an "extraordinary circumstance" warranting equitable tolling because the parents, as his legal guardians, had failed to demonstrate that they were unable to file a claim on his behalf. The court also rejected the arguments for minority tolling and fraudulent concealment, finding no basis for these in the Vaccine Act or its legislative history. The court further held that the special master had not erred in raising the issue of the statute of limitations, nor in dismissing the claim for failure to state a claim upon which relief could be granted. View "W. J. v. Health and Human Services" on Justia Law

In 2017, Donald Winkler received a Tdap vaccination after stepping on rusted metal. Soon after, he developed symptoms of Guillain-Barré Syndrome (GBS), a type of acute monophasic peripheral neuropathy. Winkler filed a petition for relief under the National Vaccine Injury Compensation Program, asserting the Tdap vaccine caused his GBS. However, the Special Master denied his claim, and this decision was upheld by the United States Court of Federal Claims. Winkler appealed to the United States Court of Appeals for the Federal Circuit.The appellate court affirmed the lower court's decision. The court noted that GBS is not listed as a covered condition for Tdap vaccines, so Winkler had to prove that his GBS was actually caused by the Tdap vaccination. The court applied the three-prong test set forth in Althen v. Secretary of Health and Human Services, requiring Winkler to show a medical theory causally connecting the vaccination and the injury, a logical sequence of cause and effect showing that the vaccination was the reason for the injury, and a proximate temporal relationship between vaccination and injury.The Special Master found that Winkler had not established the second Althen prong, as he failed to provide preponderant evidence of a logical sequence of cause and effect. The court disagreed with Winkler's argument that the Special Master erred by requiring him to disprove that he suffered from a Campylobacter jejuni infection, a known trigger for GBS, stating that Winkler mischaracterized his burden of proof. The court further stated that Winkler failed to establish a prima facie case of causation of his GBS by the Tdap vaccine, not that he failed to disprove evidence of an infection. Therefore, the court affirmed the Special Master's holding that Winkler failed to prove causation of GBS by the Tdap vaccine by preponderant evidence. View "WINKLER v. HHS " on Justia Law

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