Additional Information about Medical Injury Lawsuits

Mass Tort vs. Class Action

Product liability claims are sometimes pursued as mass actions and at other times are pursued as class actions. Mass tort actions are matters in which large members of a population suffer injuries from the same product. The product complained of in a mass tort must be widely available or mass marketed and the product must be inherently dangerous or defective in terms of its manufacture, design or intended use. Furthermore, the use, ingestion, implantation or exposure to the product must cause personal injuries in a large number of users.

In a mass tort, all the claims share some common facts and legal theories, and although the damages often differ from person to person, the case values are often interdependent. In these cases, the claims are pursued individually or in small groups of claimants sharing common complaints and adverse events. Mass tort actions will often be consolidated for the pretrial discovery process through the creation of an MDL, or multidistrict litigation.

A class action is a lawsuit in which a large number of people with similar legal claims join together in a group (the class) to sue a particular person or entity, such as a pharmaceutical company. When a claim is pursued as a class action, a single or a few individuals are named as representatives of the class. The litigation is pursued by these select parties for the benefit of all class members or affected parties. Multiple past drug claims were pursued as class actions.

In a class action, when a settlement is reached or a verdict is rendered, a settlement is established to compensate the class as a whole. In doing so, the named representatives may be compensated differently from the unnamed members of the class. Any individual who meets the criteria of a class member, such as someone who used a certain dangerous product and suffered injuries, is included in the global settlement. Steps will be taken to notify potential class members of the settlement terms to allow them the opportunity to participate in the settlement or opt out to pursue their own litigation.

What is an MDL?

MDL stands for Multidistrict Litigation. In mass tort cases, the Judicial Panel on Multidistrict Litigation, or MDL Panel, examines the pending actions in various federal districts to determine if the claims involve one or more common questions of fact that would benefit from transferring the cases to one federal district for coordinated or consolidated pretrial proceedings. The panel then selects the judge or judges and the court assigned to conduct the pretrial proceedings.

The idea behind the MDL process is to avoid duplication of discovery, prevent inconsistencies in pretrial rulings, and to conserve resources of the parties, their attorneys and the judiciary. The creation of an MDL is common in pharmaceutical and medical products liability claims.

When a claim is transferred to a Federal MDL, the case is not permanently moved. It is transferred back to its originating court by the MDL at or prior to the conclusion of the centralized pretrial proceedings.

An MDL process ensures that all parties receive the same discovery, all Plaintiffs present the same background information and support for their claim. It streamlines the process for Plaintiffs and Defendants.

In some instances, individual states will establish their own MDL to consolidate discovery in the mass tort claims filed in various state courts.

What is the role of the FDA?

The Federal Food and Drug Administration, or FDA, regulates almost every step of the process for development, manufacturing, testing and marketing of medical devices and drugs. The FDA examines and reviews research and case studies relative to such products and offers or denies approval for medical devices and drugs. The safety regulation of pharmaceutical products is extremely important due to the potential risk associated with unsafe products.

The FDA will often continue to perform case studies even after approving a drug for sale. These case studies help determine the safety and effectiveness of the product. If extended case studies reveal dangerous side effects or conditions which raise concern about a product’s safety, the FDA may issue a warning or instruct the pharmaceutical company to strengthen the warning in the package labeling and inform medical providers about the potential dangers.

In some instances, the FDA will issue a recall or instruct the pharmaceutical company to issue a recall of the dangerous products and drugs. This drastic step is generally in response to studies reviewed by the FDA indicating severe adverse events related to the use of the product. In these cases, the FDA determines that the risk created of potential harm outweighs any potential benefit derived from use of the product. When a recall is issued, use of the product should be discontinued and the product will be removed from shelves and no longer available to consumers.

Learn more at the FDA Center for Drug Evaluation and Research (CDER).

For a free consultation with an experienced attorney, contact a medical injury attorney online or phone Arnold & Itkin LLP toll free at 1-866-222-2606.