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The principle of caveat emptor (“the buyer beware”) existed prior to the mid-1900s regarding the consumer’s acquisition and purchasing of a manufacturer’s product. Since the mid-1900s, the principle of strict liability has been one of several theories that has been applied to products liability claims. Essentially, strict liability does not cast fault on a defendant, but rather attempts to attach liability to the product that caused the alleged injury or harm due to some defective characteristic that could only have been made safer by that product’s manufacturer.

Besides strict liability, other major theories that plaintiffs could sue on if they are injured by a manufacturer’s product are negligence and breach of warranty. These different theories will be discussed in reasonable detail so they can be understood within the context of products liability issues for drug products and the pharmaceutical industry.

As products liability cases have been litigated, issues have arisen such as: how are the three or possibly four theories of liability to be applied to these types of casesimage Must the injured party be in privity with the manufacturerimage What constitutes a defective productimage Does the plaintiff or the manufacturer have the burden of proving the product was or was not defectiveimage These questions and a host of other matters have been addressed through court decisions over the latter part of the twentieth century.


Negligence in Products Liability Cases

If the theory of negligence is raised in a products liability related case (eg, where it may be shown that a possible defect was associated with the product), then the plaintiff must address the same issues discussed previously in a negligence analysis:

  1. Did the manufacturer or another party in the chain of distribution have a duty to ensure that the product did not have the defect it possessedimage

  2. Did the manufacturer or another party in the chain of distribution breach its duty in allowing the defective product to come onto the market and into the hands of the plaintiffimage

  3. Was the defective product the actual or proximate cause of the plaintiff’s injuryimage

  4. Was the plaintiff’s injury caused by the defective productimage

The creation of a negligently unsafe product may be the result of a design flaw; the method in which the product was put together during the manufacturing process; or insufficient or incorrect information concerning warnings or directions for use. The latter situation—labeling information—is often the problem associated with drug products in products liability cases.

There is also consideration beyond the manufacturer’s involvement with the product. Often, in products liability cases, all those involved in the chain of distribution may in some way be responsible for negligence. Involved in that chain of distribution, other than the manufacturer, are the provider of raw materials to the ...

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