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Experienced trial attorneys. Trusted advisors. Counseling companies across the country and throughout their products' lifecycles.

FDA Approves Second Booster

Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster. The CDC later added its recommendation and said it would include the FDA’s action in its vaccine guidance. See the agency’s announcement here – Coronavirus (COVID-19) Update: […]

| 1 min read

A Deeper Dive into FDA Draft Guidance on the Remanufacturing of Medical Devices

In the medical device industry, there exists a longstanding divide between device manufacturers (i.e., those who design, manufacture, fabricate, or process a finished device) and the third-party entities that service the devices (i.e., those that maintain, restore, refurbish, or repair a finished device after it has been distributed, for purposes of returning the device to […]

| 7 min read

FDA Issues Draft Guidance on Remanufacturing

Yesterday, the FDA published its draft guidance Remanufacturing of Medical Devices to help clarify whether activities performed on devices are likely remanufacturing. The draft guidance includes recommendations as well concerning information that should be included in labeling to help assure the continued quality, safety and effectiveness of devices that are intended to be serviced over their […]

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E-Commerce Marketplace Liablity

Can an e-commerce marketplace be liable in a chain of distribution for injury caused by a defective product sold by a third party? This week, the California Court of Appeal, Second District, in Loomis v. Amazon.com LLC, 2021 WL 1608878, held that yes, Amazon.com LLC (“Amazon”), the online marketplace, may be strictly liable for injuries […]

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SO
Former Counsel

Update on FDA Guidance Pertaining to COVID Variants

As noted, here’s a brief update pertaining to the new and updated guidance for developers of therapeutics, vaccines, and tests for COVID-19. These guidance outline FDA’s vision of a forward-looking, and flexible approach to the evolving nature of the pandemic. In an update to its guidance on EUAs for COVID-19 vaccines, the FDA details the […]

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Virginia Legalizes Marijuana

Virginia lawmakers approved a bill this past weekend that would legalize the sale and recreational use of marijuana beginning in 2024. The move makes Virginia the first Southern state to vote to legalize recreational marijuana, joining 15 other states and the District of Columbia. Per the bill that passed, possession of up to an ounce […]

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FDA Releases New Guidance for Covid-19 Products

At the beginning of this week the FDA unveiled four new and updated guidance targeting vaccines, drugs and biologics, monoclonal antibodies and diagnostic tests. to address the impact of COVID-19 variants on the efficacy and performance of their products. In a recent article, acting FDA Commissioner Janet Woodcock is noted as saying “[t]he purpose of […]

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FDA Provides Coronavirus Testing Update

FDA announced that as of last week, 327 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 243 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular […]

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United States Supreme Court Tackles Personal Jurisdiction

Under current United States Supreme Court precedent, for a court to exercise personal jurisdiction over a manufacturer like Ford, the plaintiff must demonstrate that the court has either general or specific jurisdiction. General jurisdiction is only established where the defendant’s connection to the forum state is so systematic and continuous that the defendant is considered […]

| 5 min read

Coronavirus Solutions Cause Long-Term Changes to Depositions in California

On September 18, 2020, Governor Gavin Newsom (D) signed Senate Bill (“S.B.”) 1146 into law. This act was aimed at amending Sections 1010.6 and 2025.310 of the California Code of Civil Procedure, and to add and repeal Section 599. These sections of Code of Civil Procedure govern discovery deadlines, methods for service, mandatory settlement conferences, […]

| 3 min read