Using Expert Witnesses in FCRA Cases - FCRA Focus
JONES DAY PRESENTS® AV 4.0 and the Future of Autonomous Vehicles
Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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