Yearly Archives: 2018

FDA releases draft guidance on expansion of abbreviated 510(k) Program

On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that a new medical device meets certain performance

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Posted in FDA

The Legality of Cannabidiol and Concerns Regarding False Advertising

The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form.  However, under federal law, marijuana is a Schedule

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Posted in FDA

Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices

The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are devices which contain differently classified

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Posted in Manufacturer

Known to the State of California to Cause Cancer or Reproductive Harm – What is Proposition 65 and What You Need to Know

A majority of California voters in 1986 approved a ballot initiative known as Proposition 65, officially titled California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Prop. 65”).  Prop. 65 seeks to protect California’s drinking water sources from being

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Posted in Prop. 65
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Products Liability Prevention & Defense
Our attorneys represent foreign and domestic designers, manufacturers, and distributors of a diverse array of products, from food and drugs to industrial equipment and building materials. We help clients respond to major personal injury and property damage claims in the form of single-product cases, class actions, mass torts, and multidistrict litigation, as well as all types of congressional, regulatory, or criminal investigations. Our team works closely with corporate counsel to minimize a company’s overall liability and establish efficient protocols for fielding claims and advise on labeling, marketing, manuals and instructions, supply and distribution contracts, and insurance and indemnification issues.
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