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.
Patently O
NOVEMBER 8, 2021
The 2017 Supreme Court decision in TC Heartland gave renewed teeth to the venue statute governing litigation. The FDA is headquartered in Maryland, and that was the office that received the ANDA documents. and probably also in Maryland, but not in N.J. Celgene Corp. Mylan Pharma ( Fed.
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SCOTUSBlog
SEPTEMBER 17, 2022
Share The Petitions of the Week column highlights a selection of cert petitions recently filed in the Supreme Court. Sineneng-Smith , the justices reversed a circuit-court decision that struck down a federal law criminalizing the act of “encourag[ing] or induc[ing]” noncitizens to enter or remain in the United States for financial gain.
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.
Broadcast Law Blog
MAY 15, 2012
What they are really doing is trying to avoid the need to reveal the identity of their contributors, following a US District Court decision in March. By federal statute, sponsors of "electioneering communications" must disclose the names and addresses of each donor who contributed $1000 or more to the sponsoring organization.
SCOTUSBlog
OCTOBER 5, 2023
Several of them are sequels to earlier high court decisions. First Amendment The current court is very solicitous of First Amendment rights. Maryland and Napue v. Below we briefly discuss those 14 cases. So perhaps unsurprisingly, many of the relisted petitions – six of them – implicate the First Amendment.
SCOTUSBlog
APRIL 27, 2022
Animal Legal Defense Fund , involving the constitutionality of a Kansas statute criminalizing trespass by deception at animal facilities with intent to damage the enterprise. McCall , the other case raising the issue, which the court will now hold pending the outcome of Mallory. Next up is Bartenwerfer v.
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