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Drug & Device Law

The definitive source for intelligent commentary on the law that matters for drug and device product liability cases

Class II Medical Devices

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One, Two, Three Strikes You’re Out

By Bexis on April 25, 2019
Photo of Bexis

With new grass on the field, the 2019 baseball season is underway and optimism springs eternal.  Here in Philadelphia, the Phillies have actually around the top of the NL east for the first time since, umm…., last year actually.  But this year, having added possibly the best player and best catcher in the league,…

Posted in Class II Medical Devices, Design Defect, Learned Intermediary

Federal Court Rules That 510(k) Clearance Relates To Safety And Effectiveness

By Steven Boranian on June 26, 2018
Photo of Steven Boranian

A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of…

Posted in Class II Medical Devices, Fraud

Mostly Favorable MIL Rulings in IVC Filters Litigation

By Rachel B. Weil on March 15, 2018
Photo of Rachel B. Weil

Here in Philadelphia, less than a week before the first day of Spring, it is sunny and calm, albeit a bit chilly. Not so last week, when we were hit with the second Nor’easter in less than a week.  As much as sixteen inches of snow fell in some suburbs, and thousands of people, some…

Posted in Class II Medical Devices

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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This blog contains the personal views of the Blogging Team (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation.

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