Product Liability Articles

Identifying and Evaluating Injury Claims Involving Drugs or Medical Devices

Drug product liability lawsuits are usually based on the drug company's failure to warn of known or likely dangers in using a prescription drug or medical device. The first element that must be shown in a drug product liability lawsuit is causation. Did the drug or medical device cause the injury? The second question presented is whether the drug company provided adequate warnings about its product.

There are two basic scenarios that occur in injury claims involving prescription drugs and medical devices. The first case is fairly clear-cut. A healthy person takes a drug or uses a medical device and an injury or adverse reaction occurs. The second scenario is more difficult to evaluate. In this case, a person with an underlying disease or medical condition takes a drug or uses a medical device. Because of the person's underlying disease state or medical condition, it is not always easy to determine if the drug or medical device caused the resulting adverse reaction or injury. This article talks about how to identify and evaluate injury claims involving drugs or medical devices.

Complicating Factors

One complicating factor in identifying a drug product liability claim is the fact that the patient has an underlying medical condition or disease. In addition, the patient may be taking more than one prescription drug, so it can be difficult to determine which drug was responsible for the injury. A third complicating factor is the patient's host factors, which are the patient's intrinsic susceptibilities and idiosyncrasies. It can be difficult to separate the effects of a drug or medical device from the patient's inherent idiosyncrasies in proving the cause of an injury. Also, there may be no direct evidence connecting the injury to the use of the drug or medical device, especially in cases involving over-the-counter products. Finally, with so many generic drugs, is may be hard to prove which drug was actually taken.

Evaluating Claims

Once the attorney identifies a potential drug or medical device claim, it is necessary to evaluate the claim. The attorney must determine the applicable statute of limitations and decide whether the claim is time-barred. The statute of limitations is a law that specifies the time period during which a lawsuit has to be filed. If a lawsuit is not filed during the applicable time period, the law prevents any recovery. Generally, courts differ as to when the time period begins to run. Some cases conclude that the time period starts when the drug or medical device was first used. Others hold that the time period starts to run when the injury occurred. There is also a delayed discovery rule, which extends the limitations period in situations where the injuries do not show up for an extended period of time. In those cases, the statute of limitations does not begin to run until the patient discovers the cause of the injury.

It is also necessary for the attorney to research medical information about the drug or medical device suspected of causing the injury or adverse reaction. Drug package inserts can be reviewed to learn dosages, warnings, contraindications, and interactions with other drugs. There is a great deal of medical literature available in libraries and on the Internet. The Food and Drug Administration maintains a database of adverse drug reactions. It also becomes important for the attorney to locate an expert witness. Expert testimony is almost always necessary in drug product liability lawsuits. The expert presents testimony on such issues as defects in the product, the adequacy of the drug company's warning, and causation.

< Back to Articles

Copyright 2008 LexisNexis, a division of Reed Elsevier Inc.]