Defending Biologics: How the Unique Attributes of Biological Products Invite Different Approaches to Litigation

At first glance, one would not expect the defense of a biological product in a product liability matter to be any different from that of a traditional small molecule pharmaceutical product. Yet, having defended both small molecule pharmaceuticals and biologicals in product liability actions, distinct differences in litigation themes and theories have become apparent. These differences initially surprised us and may be a surprise to others as well. The unique attributes of a biological product's development, manufacturing, and biological mode of action render such products particularly unsuitable for mass tort litigation.


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