Exclusion of Evidence: The FDA's 510(k) Process
January 01, 2018
In a drug or medical device injury case, one of the defense's most potent arguments is often that the product in question underwent FDA approval, so the balance of its safety and efficacy has already been determined. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
Maximizing Future Medical Damages in Paralysis Cases
January 01, 2018
When you take a catastrophic injury case involving paralysis, it is important to have a thorough understanding of the problems and pitfalls. In this article, the author explores, from personal experience, the different types of future expenses the client can expect to incur.
Genetic Labeling: Legal Uncertainty for Pharma Product Liability
January 01, 2018
The FDA's recent approval of 23andMe's direct-to-consumer genetic test to identify genes associated with 10 common diseases and disorders could result in a widespread expansion of patients armed with individualized health information. This expansion of genetic information in the hands of consumers potentially impacts regulatory and litigation issues for pharmaceutical companies.
Case Notes
January 01, 2018
Discussion of major rulings out of Texas and California.
<i>Zeran v. AOL</i> and Its Inconsistent Legacy
December 01, 2017
<i><b>How the Seminal Fourth Circuit's Ruling Is Applied in Different Circuits</b></i><p>The rule of <i>Zeran</i> has been uniformly applied by every federal circuit court to consider it and by numerous state courts. And it has never been rejected in any precedential opinion. Indeed, it is perhaps a fitting tribute to the viability of <i>Zeran</i> that 20 year later the U.S. Court of Appeals for the Ninth Circuit, in its 12th opinion construing the CDA, barely spent even a sentence affirming dismissal of a defamation claim brought against Facebook over user content, pursuant to the CDA and the rule first developed in <i>Zeran</i>.
Written Opinions Of Counsel: Valuable Tools for Avoiding Willful Patent Infringement
December 01, 2017
Written opinions of counsel are gaining renewed interest as a valuable tool to limit liability for willful patent infringement. A patent opinion that is competently written by a registered patent attorney sets forth the factual and legal basis for finding a patent not infringed, invalid, and/or unenforceable. However, to be effective, the timing of the rendered patent opinion may be critical.
Exclusion of Evidence: The FDA's 510K Process
December 01, 2017
In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent FDA approval. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
The Food Safety Modernization Act
December 01, 2017
<b><i>Part Two of a Two-Part Article</i></b><p>Last month, the author began discussion of the Food Safety Modernization Act (FSMA), which will have a large impact on the food and feed industry in the coming years. The author continues here with an explanation of some of the effects the FSMA is expected to have on equipment manufacturers and on lenders and lessors.
