2020 Court Decisions Statute 
FDA Law Blog
JUNE 15, 2022
Circuit, but today, the Supreme Court reversed again and upheld the District Court’s opinion in American Hospital Assn v. Writing for a unanimous court, Justice Kavanaugh explained that the Medicare statute provides CMS a choice between two options on how to set reimbursement rates for drugs provided in the hospital outpatient setting.
FDA Law Blog
SEPTEMBER 30, 2022
Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates.
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FDA Law Blog
APRIL 16, 2024
Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. The statute defines a “line extension” as a “new formulation” of an existing drug, with certain exceptions. Vanda Pharmaceuticals, Inc. 23-1457 (4th Cir.
FDA Law Blog
FEBRUARY 27, 2024
But all kidding aside, some of the recent decisions we found are rather distressing. Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § Despite a rather long history of granting multiple PTEs, in 2020, in an about-face, the PTO took the position that multiple PTEs are no longer supported by the statute.
Conflict of Laws
MAY 17, 2023
There are state courts and federal courts, state statutes and federal statutes, state common law and federal common law. This feeling of pity is compounded when I imagine this same lawyer trying to advise her client as to whether a choice-of-court clause will be enforced by a court in the United States.
FDA Law Blog
SEPTEMBER 29, 2021
Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. HRSA based its opinion on the statute and agency precedents over the last 25 years. Drug Manufacturers Fight Back Against Proliferation of Contract Pharmacy Arrangements. Becerra , No.
SCOTUSBlog
NOVEMBER 29, 2021
Natural Resources Defense Council , determines when a federal court must defer to an agency’s interpretation of a statute it administers. First, under step one, if the court determines Congress’ intent is clear and unambiguous in the statute, the court will interpret the statute according to its terms, without deferring to the agency.
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