Chanda A. Miller

Chanda A. Miller is a Products Liability Partner in our Philadelphia office. Chanda’s practice focuses on defending major pharmaceutical and medical device companies in multidistrict litigation, coordinated state proceedings, and individual cases involving claims of personal injury, price-fixing claims, alleged false claims act violations, and consumer protection claims.

View the full bio for Chanda A. Miller at the Faegre Drinker website.

Articles by Chanda A. Miller:


Passengers on Litigation Tourism Train Get Review from Supreme Court

The United States Supreme Court will soon consider whether the due process clause of the Fourteenth Amendment prohibits a state from requiring that a corporation consent to personal jurisdiction in order to conduct business there.

The question arises from a Pennsylvania Supreme Court case, Mallory v. Norfolk Southern Railroad Co., 266 A.3d 542 (Pa. 2021), which we wrote about here.  In Mallory, plaintiff Robert Mallory attempted to hold the Norfolk Southern Railway Co. liable for the colon cancer he allegedly developed after being exposed to chemicals during the two decades that he worked for the railroad in Virginia and Ohio.

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FDA Finalizes Voluntary Recall Guidance Imploring Companies to Be “Recall Ready”

FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.

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Pennsylvania Rejects Corporate Registration as Basis for Personal Jurisdiction

A recent Pennsylvania Supreme Court opinion provides out-of-state corporations more protection from litigation tourists, bringing the state’s general personal jurisdiction rules in line with U.S. Supreme Court precedent. In Mallory v. Norfolk Southern Railway Co., a unanimous court invalidated part of Pennsylvania’s corporate registration statute, holding that corporations that are not incorporated and do not have a principal place of business in Pennsylvania cannot be subject to general personal jurisdiction simply because they have registered to conduct business in the Commonwealth.

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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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FDA Posts Draft Guidance for Pharma Companies, Sponsors, and Researchers on Using Real-World Data from Health Records in Clinical Studies

The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define guidelines on sourcing RWD, the draft document provides insight into the FDA’s current thinking on the approach that companies should use to support regulatory filings for medications.

The guidance references the Framework for Real World Evidence Program, released in December 2018. The Framework is designed to regulate uses of RWD and Real Word Evidence (RWE), which are used by life sciences companies to investigate how medicines perform beyond clinical trials, and to back up clinical trial results. This draft guidance is the first of the series that have been promised by the FDA to develop the Framework. More information about the FDA Framework can be found on our blog here.

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