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Course Details

Drug Product Liability Litigation (Grossi)

Spring 2024   LAW 642-001  

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Peter T. Grossi

Adjunct Professor of Law

Additional Information

Skills Training
Expository Writing
Other Professional Skills:

10% Participation,
40% Exam,
50% Paper

Take Home,
Open-Book (Take-home; open book. )

Satisfies Senior Writing Requirement



Class meets in person.

Course Continuity
Students are encouraged to stay home if you are ill or experience flu-like symptoms. If you miss a class for any reason, it is still your responsibility to make up the work missed.

I offer the following to students who miss class due to illness:

- Class sessions are regularly recorded. I will make these recordings routinely available on the course site to everyone in the class.

- I will make PowerPoint slides or other class materials routinely available on the course site to everyone in the class.

Meeting Times/Location
W 1:00PM - 2:50PM
Tanenbaum Hall 145



More product liability lawsuits are filed against prescription drug manufacturers than against all other industries combined. As one scholar put it, the pharmaceutical industry is now "in tobacco-land in terms of how much people hate it," and drug product liability litigation is a "growth industry." This course, which has been taught at Penn for the last 10 years by a practitioner with 25 years experience trying such cases, will consider the theory and practice of such litigation before, and especially after, the Supreme Court's landmark decision in Wyeth v. Levine.

At the outset, we will focus on the similarities and differences between pharma cases and other product liability litigation, using the Diet Drug ("Phen-Fen") Cases tried by the instructor as a model, and on the special context of FDA regulation. We will then consider the legal doctrines governing such lawsuits, such a failure to test", inadequate warnings, the Learned Intermediary doctrine, medical causation, and various forms of damages, We will discuss these issues both in their classic formulation in an individual lawsuit, but also the way those principles are applied in the context of mass pharmaceutical litigation where there are often several thousand claimants and multiple trials.

The course will also consider the practical application of these doctrines, including special evidentiary problems when doctors are witnesses; discovery tactics where regulatory agencies are involved; techniques to present complex scientific material to juries; approaches to trial examination; jury selection strategies; and the problems in structuring mass tort settlements. Again, we will review both the legal principles governing these issues and the way they are often mutated in mass claims and trials. The final class will focus on the alternative ways vaccines and pandemic treatments are regulated and litigated.

Course Concentrations

Skills Learning outcomes: Demonstrate an understanding of the individual course skill; Demonstrate the ability to receive and implement feedback; Demonstrate an understanding of how and when the individual course skill is employed in practice.

Health Law Learning outcomes: Demonstrate a core understanding of health law and policy; Perform legal analysis in the context of health law and policy; Communicate effectively on topics related to health law and policy; Demonstrate an understanding of the interconnection among health law and policy and issues of access to services, public and private financing of health industries, and the political and economic issues surrounding issues of health law and health services.