What is Pharmaceutical Litigation?

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  • Written By: Brittany Golledge
  • Edited By: A. Joseph
  • Last Modified Date: 28 January 2020
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Product liability is the area of personal injury law that deals with injuries caused by defective products. A significant percentage of product liability claims involve medications and prescription drugs. When an individual becomes sick or injured as a result of taking a defective drug, he or she has the right to file a lawsuit against the manufacturer or distributor of the drug. Pharmaceutical litigation is the branch of product liability law that deals with these defective drug lawsuits.

Pharmaceutical litigation has become more high profile in nature because of the publicity surrounding large class action defective drug claims. Pharmaceutical companies are required to put their products through rigorous testing and clinical trials before introducing them to consumers. Despite these precautions, thousands of people are injured each year from taking defective prescription drugs. In some cases, pharmaceutical companies will pull defective drugs from the shelves before they can cause serious harm. It might require legal action from consumers, however, before the safety of a prescription drug is called into question.


The responsibility for the damages caused by a defective drug lies with any party involved in the drug’s chain of commerce. Pharmaceutical litigation claims might involve a range of parties, from the manufacturer of the defective drug to the distributor of the drug. Plaintiffs in pharmaceutical litigation cases can be individual consumers injured by a defective drug, or a lawsuit can be filed as a class action claim on behalf of hundreds or thousands of consumers injured by the drug.

There are several theories of liability that are used in defective drug claims, including strict liability, negligence, and failure to warn. Each state has different laws that guide pharmaceutical litigation actions. Drug company lawsuits may involve claims that a drug was defective in design, mislabeled, contaminated during the manufacturing process, or ineffective for its intended use. Often plaintiffs will allege that the drug company failed to provide proper instructions for use of the drug or failed to disclose side effects or adverse test results.

In many countries, a government agency is responsible for regulating the manufacture and sale of prescription drugs. These agencies typically enforce strict prescription drug testing, labeling and marketing requirements, but their approval of a prescription drug is not a guarantee of safety, nor does it prevent injured consumers from filing pharmaceutical lawsuits. The laws of a jurisdiction often regulate how a consumer can recover damages for injuries caused by a defective drug in that jurisdiction.


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