Southwest Minnesota State University. In the presence of such stringent regula- can be liable for damage incurred from the use of tory criteria, one wonders why the pharmaceutical that product: strict liability, warranty, and negli- industry has been the object of such extensive liti- gence. Thus, strict liability subject to certain defenses, the Act created a regime would mean that pharmaceutical companies would of strict liability, although existing common law have to pay damages in some cases, even when they rights have remained unaffected, so that if the Act had researched their drugs impeccably Hunter, does not apply to a particular case, a plaintiff may The con- liability actions vary, based upon the respective cept of a duty of care serves to define the interests common law or statutory provisions of jurisdiction protected by the tort of negligence, by determining in which the action is filed. The damage in question may Regulatory Compliance arise through mis-feasance or non-feasance and may consist of personal injury or damage to prop- The issue of regulatory compliance as a defense in erty, which are categorized as pure economic loss product liability actions, especially those involving under civil law. It should also be noted that manu- pharmaceutical companies, generally arises in con- facturers, but also retailers, bailers, and other sup- nection with allegations of design or manufactur- pliers may be liable to plaintiffs under the ing defects or of failure to comply with federal principles of negligence if they are found to have labeling requirements. However, several states, such as New With regard to product liability claims, there are Jersey, have enacted statutes that allow regulatory two fundamental types of product defects: manu- compliance as a valid defense in pharmaceutical facturing defects and design defects.

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