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.

View the full bio for Michael C. Zogby at the Faegre Drinker website.

Articles by Michael C. Zogby:


District of Delaware Chief Judge’s New Standing Order Requires Disclosure of Third-Party Litigation Funding

The District of Delaware is the latest in a series of courts to require disclosure of third-party funding arrangements, a subject we have previously explored. The Chief Judge in the District of Delaware now joins other courts like the District of New Jersey and the Northern District of California in requiring these disclosures.

On April 18, 2022, Chief District Judge Colm F. Connolly of the United States District Court for the District of Delaware issued a standing order requiring litigants to disclose whether their cases are being financed by third parties. The standing order requires that, “where a party has made arrangements to receive from a person or entity that is not a party (a ‘Third-Party Funder’) funding for some or all of the party’s attorney fees and/or expenses to litigate th[e] action on a non-recourse basis,” either for “a financial interest that is contingent upon the results of the litigation” or “a non-monetary result that is not in the nature of a personal loan, bank loan, or insurance,” the party must disclose certain details of the funding relationship within 45 days of the entry of the standing order (i.e., by June 2, 2022) for existing cases, or within 30 days of the filing of an initial pleading or transfer of a new matter into the District.

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Third Circuit Confirms That Alleged Defect in “Simple” Component of More Complex System Must Be Proven by Expert Testimony When Facts Surrounding Defect Claim Are Beyond Common Knowledge

A plaintiff who alleges that a product is defective usually has to offer expert testimony in support of that allegation.  This should come as no surprise for complex products – if it took a team of scientists and engineers to bring the product to market, then a lay jury should not be asked to evaluate an alleged defect in that product without the aid of expert testimony.  But what if a plaintiff alleges a defect in the design of a relatively simple, more familiar component of a complex product?  The Third Circuit recently addressed that question in an opinion that, although nonprecedential and in some respects peculiar to New Jersey law, illustrates how a court should approach the issue.

In Kuhar v. Petzl Co., 2022 WL 1101580 (3d Cir. Apr. 13, 2022), Plaintiff fell and injured himself while using a safety harness that he had purchased as part of a kit seven years earlier.  He alleged that the fall occurred because a bolt attached to the carabiner of the safety harness had snapped due to a design and/or “indeterminate” or manufacturing defect.  In support of his claims, Plaintiff proffered a metallurgical and materials sciences expert who identified two alleged design defects – a “sharp profile change” and “sharp threads on the bolt” – and machining grooves that the expert deemed a manufacturing defect, some combination of which he claimed had caused the accident.  But some of the expert’s defect and causation opinions were “net opinions” – New Jersey parlance for “ipse dixit” opinions – and were excluded for lack of supporting data.  Other opinions were excluded because the expert failed to define his terms or explain his reasoning.  The Third Circuit agreed with the district court that the expert’s opinions lacked both reliability and fit, and affirmed its exclusion of all of the expert’s opinions.

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Cybersecurity Safeguard Implemented by Superior Court of New Jersey for OUS Web Traffic

Last year, we explored the Federal Judiciary’s new safeguards and procedures to protect sensitive court records in light of the SolarWinds Orion cybersecurity breach.  Now, as a result of increased hostilities between Russia and the United States, the New Jersey Judiciary is taking steps to ramp up cybersecurity by blocking web traffic from outside the United States.

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Eastern District of Virginia Denies Motion to Certify Class, Sheds Light on Rule 23(b)(3) Predominance and Superiority Requirements for Class Actions

The U.S. District Court for the Eastern District of Virginia analyzed Federal Rule of Civil Procedure 23(b)(3)’s predominance and superiority requirements for class actions in a recent decision denying a motion to certify a purported class of motor vehicle purchasers.  The decision underscores that plaintiffs seeking to certify classes asserting claims that will render the process of identifying class members to be a mere series of individualized inquiries will not pass muster under Rule 23.

The Facts in Dispute

Garcia, et al. v. Volkswagen Group of America, Inc., et al. involved a purported class of plaintiffs residing in multiple states who purchased vehicles manufactured by defendants within the last 14 years.  The plaintiffs sued a group of auto manufacturers alleging damages resulting from defendants’ alleged fraudulent misrepresentations about the vehicles, and asserting claims for violations of the Federal Odometer Act, fraud, breach of contract, and unjust enrichment, in addition to state law claims under the laws of California, Colorado, Florida, Illinois, New Jersey, and Washington.

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FDA Issues Draft Guidance for Sponsors and Other Stakeholders on Using Registries as RWD to Support Regulatory Decision-Making

The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drugs and Biological Products, the FDA discusses considerations for sponsors and other stakeholders when designing or using an existing registry as RWD to support a regulatory decision about the safety and effectiveness of a medicine or biologic.

The goal of the RWE program, in part, is to satisfy Congress’s mandate under section 505F of the Federal Food Drug and Cosmetic Act (FD&C Act) for the FDA to provide more guidance about the use of RWE in regulatory decision-making. We discussed the FDA’s first and second guidances, released in August and October 2021, here and here.

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FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts on how sponsors can comply with the Federal Food, Drug and Cosmetic Act (FDCA) when submitting “certain” applications that contain study data derived from real-world data (RWD) sources. The FDA acknowledges that its current study data standards do not necessarily reflect a process derived from RWD sources. However, sponsors will need to convert RWD into established study data standards when submitting this information as part of a regulatory application (a process called “mapping”).

For context, study data standards are documented guidelines to help with the exchange of clinical and nonclinical study data between computer systems. They are used to provide a consistent framework for organizing study data (such as templates for datasets, standard names for variables, how to do calculations with common variables, and so on).

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