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Federal Industry Standards

Davis Wright Tremaine LLP

Claims Must Be Substantiated — It Seems So Obvious, but the Who, What, Where, and How Is Not Always So Clear

When we talk about advertising claims (e.g., on product labels, websites, social, etc.), we stress that "claims must be truthful, not misleading, and substantiated." The requirements to be "truthful and not misleading" seem...more

Perkins Coie

CFPB Issues Proposed Open Banking Rule

Perkins Coie on

The Consumer Financial Protection Bureau (CFPB) announced that it was issuing a Notice of Proposed Rulemaking regarding Personal Financial Data Rights on October 19, 2023. The proposed rule (Proposed Rule) would implement...more

Spilman Thomas & Battle, PLLC

Pennsylvania Supreme Court Revisits the Admissibility of Evidence of Product’s Compliance with Governmental Regulations or...

In 2014, the Pennsylvania Supreme Court issued its much-anticipated opinion in Tincher v. Omega Flex, Inc., 628 Pa. 296, 104 A.3d 328 (2014). That case was a product liability action based on a design defect. The defense bar...more

Davis Wright Tremaine LLP

Stay ADvised: 2024, Issue 5

Huggies Diaper Evidence Not a Good "Fit" for #1 Claim, NAD Says - Huggies claimed its diapers were the #1 Best Fitting, a broad claim requiring broad evidence against the market—evidence that the National Advertising...more

Mintz - Antitrust Viewpoints

Commerce Department Launches Cross-Sector Consortium on AI Safety — AI: The Washington Report

The Department of Commerce has launched the US AI Safety Institute Consortium (AISIC), a multistakeholder body tasked with developing AI safety standards and practices. The AISIC is currently composed of over 200 members...more

Dechert LLP

Dechert Re:Torts - Key Developments in Product Liability and Mass Torts - Issue 12

Dechert LLP on

The Phantom-Case Menace: Managing the Use of AI in Court Filings - Last summer, we noted caution regarding two parallel ways generative AI tools are impacting courtroom practice: (1) lawyers using generative AI and...more

Ankura

Benefits of Using Construction Estimates When Executing Successful Projects

Ankura on

What a Construction Estimate Is And What It Is Not - A construction estimate is an educated guess based on experience and industry standards as to what a specific project with a specific scope of work may cost in a...more

Faegre Drinker Biddle & Reath LLP

Pennsylvania Stays in a Minority of Two States in Prohibiting Evidence of Compliance With Government and Industry Standards in...

Just before Christmas, the Pennsylvania Supreme Court delivered a lump of coal to products liability defendants: Sullivan v. Werner Co., 2023 WL 8859656 (Pa. Dec. 22, 2023), affirming a lower court ruling that barred evidence...more

Bradley Arant Boult Cummings LLP

Network Topology and Network Mapping: The NIST Cybersecurity Framework – Part 2

A previous installment discussed the centrality of network topology to an organization’s data security and outlined the legal framework and obligations incumbent upon many organizations in the U.S. The first installment can...more

Neal, Gerber & Eisenberg LLP

White House Issues Executive Order on AI: Charting a Path to Responsible AI Development

On October 30, 2023, recognizing that Artificial Intelligence (AI) holds both extraordinary promise for its commercial applications and advancements and treachery and harm caused by its misuse, the White House issued an...more

Troutman Pepper

Using Expert Witnesses in FCRA Cases - FCRA Focus

Troutman Pepper on

Please join Troutman Pepper Partner Dave Gettings and colleagues Tim St. George and Jessica Lohr as they discuss the use of expert witnesses in FCRA cases. During this episode the team covers a multitude of relevant topics,...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Faegre Drinker Biddle & Reath LLP

5 Major Drug and Device Developments of 2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more

Bradley Arant Boult Cummings LLP

SBA to Increase Size Standards and Program Thresholds Due to Inflation

The U.S. Small Business Administration (SBA) recently published a final rule on its 2019 interim final rule that adjusted monetary-based industry size standards (i.e., receipts- and assets based) for inflation which has...more

Faegre Drinker Biddle & Reath LLP

Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers

On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde...more

Faegre Drinker Biddle & Reath LLP

Not Just a Rubber Stamp: FDA Revises Its 510(k) Refuse to Accept Policy

Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA...more

McDermott Will & Emery

Maryland Comptroller Adopts Digital Advertising Gross Revenues Tax Regulations

McDermott Will & Emery on

On December 3, 2021, the Maryland Comptroller published notice of its adoption of the digital advertising gross revenues tax regulations (which was originally proposed on October 8, 2021). Per the Maryland Administrative...more

Faegre Drinker Biddle & Reath LLP

How the Anti-Drunk Driving Technology Mandated by Recent Legislation May Impact the Liability of Automobile Manufacturers and the...

The Infrastructure Investment and Jobs Act (the “Act”), signed into law on November 15, 2021, has been followed closely by the transportation sector.  One section of the Act has the potential to impact the landscape of...more

Faegre Drinker Biddle & Reath LLP

FDA Posts Draft Guidance for Pharma Companies, Sponsors, and Researchers on Using Real-World Data from Health Records in Clinical...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define...more

Faegre Drinker Biddle & Reath LLP

FDA Approves First Interchangeable Biological Product Under BPCIA

On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine). Under...more

Faegre Drinker Biddle & Reath LLP

FDA Solicits Feedback to Create Consistent Process for Labeling Devices

The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more

White and Williams LLP

Are Industry Standards Beside the Point Where Strict Liability is Claimed?

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It has been almost seven years since Tincher v. Omega Flex Inc. was decided by the Pennsylvania Supreme Court. The Tincher court left much unanswered but called on Pennsylvania’s lower courts, the legal academy and the bar to...more

Faegre Drinker Biddle & Reath LLP

Preemption of Structure/Function Claims

Seen frequently on grocery items, and especially on dietary supplements, structure/function claims describe the role of a nutrient or ingredient in the structure or function of the human body. Examples include “Calcium builds...more

McCarter & English, LLP

Sun Chemical v. Fike: NJ Product Liability Act Claims Can Be Paired With NJ Consumer Fraud Act Claims

The New Jersey Supreme Court recently ruled that claims under the New Jersey Consumer Fraud Act (“NJCFA”) relating to the sale of a product are not per se subsumed by the New Jersey Product Liability Act (“NJPLA”). The...more

Jones Day

JONES DAY PRESENTS® AV 4.0 and the Future of Autonomous Vehicles

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Jones Day partner Jeff Jones talks about Ensuring American Leadership in Automated Vehicle Technologies: Automated Vehicles 4.0. Stakeholders are taking a particular interested in this U.S. Department of Transportation...more

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