Michael C. Zogby

About Michael C. Zogby

Michael C. Zogby co-chairs the firm’s Products Liability and Mass Tort Group and the Pharma and Life Sciences Group. Mike is a trial lawyer who handles a variety of complex, aggregate litigation, including products liability, medical device, life sciences, class action, consumer disputes, intellectual property, trade secrets, toxic tort, multidistrict proceedings, and data collection and privacy inside and outside the United States. Read Mike's full bio

FDA Issues Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food and Drug Administration (FDA) updated its “Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency,” providing specific recommendations for ongoing or upcoming clinic trial activities.

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The Key to a Trade Secret Is Secrecy: Third Circuit Agrees Ownership Is Sufficient but Not Necessary to Maintain a Trade Secret Misappropriation Claim

In a case telling a “sorry story of disloyalty and deception piled upon deception,” the Third Circuit has held that licensees, not only owners, have standing to protect the confidentiality of trade secrets and the right to be compensated for their unlawful use and disclosure.

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En Banc Third Circuit Sends Online Marketplace Liability Issue to Pennsylvania Supreme Court

Last week the Third Circuit made its most recent move in the Oberdorf v. Amazon case: asking the Pennsylvania Supreme Court whether an e-commerce business – such as Amazon – is strictly liable for a defective product that was sold on its platform by a third-party vendor that the e-commerce business did not possess or own. Given the lack of clarity, and the “substantial public importance” of this issue, the Third Circuit asked the Pennsylvania Supreme Court to weigh in.

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Rejection of Improper “Attorneys’ Eyes Only” Disclosure Process Relating to Attorney-Client Privilege Challenges

The attorney-client privilege is one of “the most revered” privileges established to protect certain communications. The Pennsylvania Superior Court recently held that it was improper for a trial court to order the disclosure of information, which a party claimed was privileged work product, on an “attorneys’ eyes only” basis to counsel for the opposing party.

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FDA Funding Opportunity Announcement: “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional”

The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional.” The FOA relates to the FDA’s RWE Framework published in December 2018, and is issued “to support research projects that examine real-world data (RWD), real-world evidence (RWE), and related issues such as data analytics, the use of digital health tools, and innovative trial designs utilizing healthcare settings.”

The FOA specifically seeks the submission of proposed projects that explore the utility of RWD and RWE in the generation of evidence supporting regulatory approval of new indications of use or post-approval study requirements for approved medicines. The FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWE is “clinical evidence about the use and potential benefits or risks of a medical product derived from analysis of RWD.”

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