Justia Health Law Opinion Summaries

Galderma Laboratories, L.P. and TCD Royalty Sub LP (collectively, Galderma) own and market Oracea®, a doxycycline-based treatment for rosacea. They hold U.S. Patent Nos. 7,749,532 and 8,206,740 (the Asserted Patents), which cover a specific formulation of doxycycline. Lupin Inc. and Lupin Ltd. (collectively, Lupin) filed an abbreviated new drug application (ANDA) to market a generic version of Oracea®, claiming bioequivalence. Galderma sued Lupin for patent infringement under the Hatch-Waxman Act, asserting that Lupin’s product infringed the Asserted Patents.The United States District Court for the District of Delaware held a three-day bench trial and found that Lupin’s ANDA product did not infringe the Asserted Patents. The court concluded that Galderma failed to prove that Lupin’s product met the specific formulation requirements of the Asserted Patents, particularly the immediate release (IR) and delayed release (DR) portions of doxycycline. The court also found that Galderma did not demonstrate infringement under the doctrine of equivalents.The United States Court of Appeals for the Federal Circuit reviewed the case. Galderma argued that the district court erred in disregarding dissolution test data from Lupin’s ANDA, admitting evidence from a rebuttal batch, imposing additional claim limitations, and not finding infringement under the doctrine of equivalents. The Federal Circuit found no clear error in the district court’s findings. It held that the district court correctly determined that the two-stage dissolution test did not represent in vivo behavior and that Galderma did not prove its theory of infringement. The court also found no abuse of discretion in admitting the rebuttal batch evidence and no imposition of additional claim limitations. Finally, the court upheld the district court’s finding that Galderma did not prove infringement under the doctrine of equivalents.The Federal Circuit affirmed the district court’s decision, concluding that Lupin’s ANDA product did not infringe the Asserted Patents. View "Galderma Laboratories, L.P. v. Lupin, Inc." on Justia Law

Chad Sheller, as the personal representative of the estate of his son Daniel Elias Sheller, sought attorneys' fees after voluntarily dismissing a Vaccine Act petition. Daniel passed away at two months old, two days after receiving several vaccinations. Sheller filed for compensation under the National Childhood Vaccine Injury Compensation Program, relying on the "Triple Risk Model" of vaccine-triggered sudden infant death syndrome (SIDS) proposed by Dr. Douglas Miller. This model had previously been accepted in another case, Boatmon v. Secretary of Health & Human Services.The Special Master denied Sheller's request for attorneys' fees, concluding that the Triple Risk Model did not provide a reasonable basis for the claim. The United States Court of Federal Claims affirmed this decision. The Special Master also struck certain medical articles from the record, which were submitted after the petition was dismissed, deeming them irrelevant.The United States Court of Appeals for the Federal Circuit reviewed the case. The court found that the Special Master abused his discretion by not considering whether the Triple Risk Model was a reasonable basis at the time of filing, given its prior acceptance in the Boatmon case. The court noted that the model was plausible and had succeeded before another special master, making it a reasonable basis for the petition when filed. The court also found that the Special Master did not abuse his discretion in striking the medical articles, as he assessed their relevance appropriately.The Federal Circuit vacated the decision and remanded the case for the Special Master to determine, in his discretion, whether attorneys' fees should be granted, considering the Vaccine Act's objective of maintaining access to qualified legal assistance. View "SHELLER v. HHS " on Justia Law

Nevada Health CO-OP, a health insurance provider, received two loans from the Centers for Medicare & Medicaid Services (CMS) under the Affordable Care Act’s CO-OP program. These loans included a start-up loan and a solvency loan. In 2015, Nevada Health faced financial difficulties and was placed into receivership by the Nevada Commissioner of Insurance. CMS subsequently terminated the loan agreement and began offsetting payments owed to Nevada Health against the start-up loan debt.The United States Court of Federal Claims reviewed the case and granted summary judgment in favor of the Nevada Commissioner of Insurance, acting as the receiver for Nevada Health. The court found that the government improperly withheld statutory payments owed to Nevada Health under the ACA. The court also held that the government could not invoke 31 U.S.C. § 3728 to withhold these payments in the future.The United States Court of Appeals for the Federal Circuit reviewed the case. The court affirmed the lower court’s judgment that the government improperly withheld payments owed to Nevada Health. The court held that the loan agreement subordinated the government’s claim to those of policyholders and basic operating expenses, thus precluding the government from asserting offset rights to jump ahead of these senior creditors. However, the appellate court vacated the portion of the lower court’s order that addressed the government’s ability to invoke 31 U.S.C. § 3728, ruling that the lower court exceeded its jurisdiction by addressing this issue, which was not raised by the parties. View "Richardson v. United States" on Justia Law

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