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Summary of FDA Draft Guidance: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

By Daniel S. Wittenberg and Tim Scalo On June 16, 2016, the Food and Drug Administration (FDA) released a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.  The non-binding draft guidance … Continue reading

Posted in FDA

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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

Posted in verdicts

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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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Arizona Supreme Court Adopts Learned Intermediary Doctrine

The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine was incompatible with the Uniform Contribution Among Tortfeasors … Continue reading

Posted in medical devices, pharmaceutical

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What are Key Issues for the Internet of Things in 2016?

What will be the key issues for the Internet of Things in 2016? JD Supra Business Advisor asked me and other privacy and data security lawyers to comment. Securing these devices is at the top of the list. Here’s the … Continue reading

Posted in Internet of Things

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