Abigail Luhn

About Abigail Luhn

Abigail M. Luhn is an associate in the Products Liability and Mass Tort Group in our Florham Park, New Jersey, office. Her practice focuses on the defense of major pharmaceutical and medical device companies in product liability cases involving prescription and over-the-counter medications and medical devices. Read Abigail's full bio

The FDA Is in the Doghouse

An unusual pet food case filed this summer in the District Court of Colorado has a pet food manufacturer as the plaintiff rather than a defendant. Lystn, LLC v. FDA, No. 1:19CV01943 (D. Colo. July 5, 2019).

There have been numerous reports of lawsuits involving allegedly contaminated pet food filed against pet food manufacturers or distributors by pet owners claiming that they were deceived by pet food labels and suffered harm either as a result of paying a premium for the food or because their pets were sickened by the food. In contrast, on July 5, 2019, a raw pet food company, Lystn, LLC, brought a civil action against the FDA seeking declaratory and injunctive relief. The complaint challenges the FDA’s ability to enforce what Lystn characterizes as “a nationwide zero-tolerance standard for Salmonella presence in pet food that is unsupported by science and ultra vires of powers properly delegated to it by Congress.”

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Posted in FDA

FDA’s Final Guidance on “Least Burdensome” Principles for Medical Devices

The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should be least burdensome across the total product life cycle.” This means that manufacturers are expected to provide “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time.” The FDA observed that this approach should “ensure that patients have access to high-quality, safe and effective medical devices.”

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Are You Sure You’ve Got Milk?

Alternatives to traditional food products have increased in availability, number, variety and popularity over the last decade.  So where does this leave consumers and the regulators who are tasked with ensuring food safety?  The Ninth Circuit has held that the reasonable consumer can digest the differences between almonds and cows.

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