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What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of Mifepristone
Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand name: Mifeprex), a drug used to terminate pregnancies through ten weeks gestation. Avoiding a substantive decision on the merits…
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Developments Toward Standardizing AI ‘Red Teaming’
AI “red teaming” involves simulating attacks on AI systems to uncover vulnerabilities and enhance security. It is becoming an increasingly important practice, as regulatory frameworks—such as the National Institute of Standards and Technology (NIST) AI Risk Management Framework (AI RMF)—emphasize the importance of red teaming….By: Fenwick & West LLP
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Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo® (pegfilgrastim-bmez) / Nyvepria®(pegfilgrastim-apgf) / Fylnetra™ (pegfilgrastim-apgf) / Stimufend® (pegfilgrastim-fpgk) – June 2024
Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple litigations/IPRs are counted more than once. Within each litigation a claim is counted only once. Within each IPR, claims are counted only…
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Litigation Minute: State Statutes and the Private Right of Action (Generative AI Series: Part Two of Three)
What You Need To Know In A Minute Or Less – Class action litigation challenging generative artificial intelligence (AI) has rapidly become a familiar feature of the legal landscape. While early, headline-grabbing complaints were largely based on traditional theories of recovery, many of these have been dismissed, with courts commenting that the lawsuits presented “policy…
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Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) – June 2024
Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they are challenged under § 102, § 103, or both….By: Venable LLP
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Goodwill Staffing Agency, GoodTemps, Confirms Recent Data Breach
Recently, Goodwill Industries of Greater NY and Northern NJ, Inc. d/b/a GoodTemps (“GoodTemps”) filed a notice of data breach with the Attorney General of Massachusetts after discovering that an unauthorized party was able to access information stored on the company’s computer network. In this notice, GoodTemps explains that the incident resulted in an unauthorized party…
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Highland Health Systems Notifies Patients of July 2023 Data Breach
On June 13, 2024, Highland Health Systems filed a notice of data breach with the Attorney General of Montana after discovering that an unauthorized party accessed the company’s computer network. In this notice, Highland Health Systems explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information, which includes their…
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Data Breach at Benefit Management Affects an Unknown Number of Consumers
On June 12, 2024, Benefit Management, LLC (“BML”) filed a notice of data breach with the Attorney General of Massachusetts after discovering that an unauthorized party was able to access an employee’s email account. In this notice, BML explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information, which…
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Liaison Notifies Consumers of Recent Data Breach Affecting Their Personal Information
On June 14, 2024, Liaison International LLC filed a notice of data breach with the Attorney General of Montana after learning about a recent data security incident. In this notice, Liaison explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information….By: Console and Associates, P.C.
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Northern District of Illinois Holds that Seventh Circuit Precedent is Incompatible with Rule 702 as Amended
In explaining the December 2023 amendments to Federal Rule of Evidence 702, the Advisory Committee called out several ways in which “many courts” had “incorrectly” applied Rule 702 and failed to adequately discharge their duty as gatekeepers with regard to expert witness testimony. The import of those comments is that existing precedent on Rule 702…