Millions of Americans use pharmaceutical drugs and medical devices each day, from aspirin to Nexium, stethoscopes to pacemakers. Unfortunately, some people are injured while using defective products. Product liability law allows users who are injured to be compensated for their injuries. The responsible party might be the manufacturer, distributor, or seller.
When Are Prescription Drugs Defective?
There are three ways a product can be defective: by design, manufacturing, or inadequate directions or warnings.
A design defect is an inherent flaw in the design of a product that makes the product dangerous. When the design of a product poses an unreasonable danger, the company that designed the product faces liability. For example, a particular defibrillator was designed in such a way that the paddle surfaces became very hot after several uses. Defibrillators are often used several times in a row, and as a result, the paddles on this defibrillator become so hot that they burned patients.
For a company to face liability for a design defect, many states require the user to show that the company could have reduced the risk of harm, or even avoided it altogether, by using an alternative design. In addition to showing there was an alternative design that would have made the product less dangerous, the user also must show that the alternative design was economically feasible to produce and that the product still would have performed as intended.
Manufacturing defects occur when something happens during the making of a product that results in the final product differing from the intended design. A product with a manufacturing defect can be well-designed but still harm users as a result of the fact that the design was not properly carried out during the manufacturing process. For example, a pacemaker with a frayed wire that electrocutes the user would be a manufacturing defect. The frayed wire was not part of the intended design; rather, it was the result of carelessness during the making of the pacemaker.
Manufacturing defects are becoming less common due to manufacturing controls and regulatory oversight in production facilities. However, products with manufacturing defects still slip through and cause harm to users. When that happens, the manufacturer is liable.
Inadequate directions or warnings.
Manufacturers of a product are under a duty not only to warn users of hidden dangers that may arise when using a product, but also to instruct consumers on how to safely use the product. Manufacturers can face liability for filing to give warnings or instructions that might prevent harm. Generally, drug manufacturers are required to provide warnings for any danger that is not readily apparent to users. Examples of common warnings used on prescription drug labels include, “Do not take this drug if you are pregnant or plan to become pregnant” and “Do not take with other medications without consulting your doctor or pharmacist.” The omission of proper warnings or instructions can make a product unreasonably unsafe. Insufficient warnings or instructions that result in injury can serve as the basis for a products-liability lawsuit. Warnings must be clear, specific, and conspicuously placed so that the user is likely to see it.
Unavoidably Unsafe Products
When a product is, by its very nature, unsafe, then it cannot be considered “defective,” despite the risk of injury it poses. Companies cannot be held liable when someone is injured by an “unavoidably unsafe” product, assuming the product was properly designed and manufactured. An unavoidably unsafe product is one that cannot be made perfectly safe. For example, a kitchen knife is an unavoidably unsafe product. To make the knife completely safe and incapable of causing bodily injury, the blade would have to be blunt; however, a blunt knife would no longer be able to serve its essential purpose of cutting food. Vaccines are another example of a product that is never entirely safe. Vaccines can prevent disease but also can cause mild or serious side effects, from fever to even death.
To determine whether a drug or medical device is unavoidably unsafe, and therefore not able to serve as the basis of a product liability lawsuit, courts consider various factors. First, if a manufacturing defect made the product dangerous in an unexpected way, or if the product was sold with inadequate directions, then the unavoidably-unsafe exception does not apply and a user harmed by the product might still have a valid claim. Courts also consider whether the usefulness of the drug or medical device outweighs the risk of injury. If so, then the exception does not apply. Finally, the exception will not apply if there are alternatives available that are not unsafe.
Pharmaceutical drugs are the most widely-recognized category of unavoidably-unsafe products. In fact, some courts consider all prescription drugs and medical devices to be unavoidably unsafe and immune from product liability lawsuits. Those courts recognize the importance of encouraging companies to continue to develop and improve pharmaceutical drugs and medical devices. If you think you might have a claim relating to a prescription drug or medical device, consult a lawyer to learn the law applied by the courts in your state.
Bianca Ybarra is a Staff Writer for GetLegal.com. She is a graduate of the University of Houston Law Center and a member of the State Bar of Texas.