Arizona Civil Verdicts, 2016

For the past 13 years, I’ve written the cover story of the state bar magazine, Arizona Attorney, about Arizona verdicts. The latest one is out. Here are 2016’s top Arizona verdicts, significant defense verdicts, punitive awards, venue variations and trends. … Continue reading

Posted in verdicts

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Senate Confirms New FDA Commissioner

Dr. Scott Gottlieb was confirmed today as the new FDA Commissioner.  Dr. Gottlieb has promised to put public health first and not do anything “that shakes the public’s confidence in the agency.” He is a former hospitalist who served in the … Continue reading

Posted in FDA

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One in, Two Out: Potential FDA Uncertainty for Medical Device and Pharmaceutical Companies

By Daniel S. Wittenberg, Co-Chair, Medical Device and Pharmaceutical Industry Group On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling … Continue reading

Posted in FDA

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Autonomous Vehicle Industry Advances in Arizona

Uber, the ride-sharing giant, recently announced that it was moving its smart-car operation from California to Arizona, a state with fewer regulations for driverless cars.  The day before the announcement, California’s Department of Motor Vehicles ordered Uber’s driverless fleet off … Continue reading

Posted in automotive, autonomous vehicles

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Location, Location, Location – A Brief Overview of Personal Jurisdiction, Forum Selection Clauses, and Why They Matter

Where a case is heard can make a critical difference to a company that is being sued. Will the company have the “home court” advantage and a jury that will know the company’s business, that the company employs people in … Continue reading

Posted in litigation, Uncategorized

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Best Practices for Cybersecurity in Vehicles

In response to increasing cybersecurity threats in vehicles, in 2015 the Automotive Information Sharing and Analysis Center (Auto-ISAC) was formed.  Its member companies include all automakers operating in North America except for Tesla. The ISAC allows companies to share cyberthreat … Continue reading

Posted in automotive, cybersecurity

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Summary of FDA Draft Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

By Daniel S. Wittenberg and Tim Scalo On June 16, 2016, the Food and Drug Administration (FDA) released a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.  The non-binding draft guidance … Continue reading

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Commercial Drones Set To Take Flight

On June 21, 2016, the Federal Aviation Administration (FAA) unveiled a landmark set of new rules for the commercial operation of small Unmanned Aircraft Systems (sUAS), more popularly known as drones. The new rules will take effect in late August … Continue reading

Posted in unmanned aircraft systems/"drones"

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Product Liability Verdicts in Arizona

Product liability cases in Arizona continue to generate more defense verdicts than plaintiff’s verdicts, though there was a large award in 2016. Since 2012, Arizona juries have given twelve defense verdicts and three plaintiff’s verdicts. -Coulbourn v. Crane Company and … Continue reading

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FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar  –  Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer Inc., for treatment of rheumatoid arthritis, … Continue reading

Posted in biosimilar, FDA, pharmaceutical

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