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Medical Devices › Administrative Law Judge (ALJ)

McDermott Will & Schulte

Federal Court Strikes Down LDT Final Rule

McDermott Will & Schulte on

On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more

Wilson Sonsini Goodrich & Rosati

Home Court Disadvantage: In Illumina/Grail, FTC Loses Another Case Before Its Own Court

Wilson Sonsini Goodrich & Rosati on

The Federal Trade Commission's (FTC's) in-house administrative law judge (ALJ) has handed the FTC a loss in its suit to reverse the completed acquisition of GRAIL, Inc. by Illumina, Inc. This is the FTC's second high-profile...more

Fish & Richardson

ITC Monthly Wrap-Up: October 2021

Fish & Richardson on

It was another busy month at the ITC. A Final Determination was issued by the Commission in three Section 337 Investigations: Certain Laparoscopic Surgical Staplers, Reload Cartridges, and Components Thereof, Inv. No....more

Porter Hedges LLP

Patent Litigation Considerations For The Internet Of Medical Things (IoMT) COVID-19 Boom

Porter Hedges LLP on

The COVID-19 pandemic has been a catalyst for medical technology innovation, especially the Internet of Medical Things (IoMT). IoMT generally refers to the use of network and cloud technologies to connect medical equipment...more

Seyfarth Shaw LLP

Antitrust Pitfalls: FTC Orders Unwinding of Two-Year-Old Acquisition

Seyfarth Shaw LLP on

In a unanimous Opinion and Final Order issued on November 1, 2019, the Federal Trade Commission (“FTC”) upheld an administrative law judge’s determination that the acquisition by one leading US supplier of lower-limb...more

Mintz - Intellectual Property Viewpoints

ITC Issues Public Commission Opinion Clarifying Methodology for Allocating Domestic Industry Expenses and Issuing Exclusion Order...

Mintz - Intellectual Property Viewpoints on

On May 17, 2017, the International Trade Commission (ITC) reversed an ALJ’s ruling and found a violation of Section 337 in Certain Air Mattress Systems, Components Thereof and Methods of using the Same (“Certain Air Mattress...more

Perkins Coie

Commission Holds FTC Unfairness Claim Does Not Require “Probable” or Tangible Injury in LabMD Data Security Case

Perkins Coie on

The Federal Trade Commission unanimously (3-0) ruled on July 29, 2016 that LabMD’s data security practices were “unfair” under Section 5 of the FTC Act, reversing a decision of its Administrative Law Judge (ALJ). As we...more

Baker Donelson

OIG Hospital Compliance Audits: Is Your Number Up? Are You Ready?

Baker Donelson on

In its Work Plan for Fiscal Year 2012, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) announced it would begin reviews of Medicare payments to hospitals to determine compliance...more

McDermott Will & Emery

Quantify Versus Quality Determines Domestic Industry - Lelo Inc. v. International Trade Commission

McDermott Will & Emery on

The U.S. Court of Appeals for the Federal Circuit reversed a finding by the U.S. International Trade Commission (ITC) of a violation of § 337, concluding that the Commission’s use of a qualitative analysis could not meet the...more

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