When is a warning required?
Dangerous drugs and medical devices enter the marketplace on a regular basis. To protect users and patients from potential hazards, the law places a duty on manufacturers to warn users of the potential dangers associated with each product. Generally, manufacturers of medical devices, pharmaceutical drugs, and other products must warn of any danger that would not be obvious to a user.
When is a warning adequate?
Users of medical devices and pharmaceutical drugs must fully understand the dangers associated with use of each product. Manufacturers therefore must give proper warnings of potential dangers and may be liable if such warnings are insufficient. Labels are one of the most effective methods to warn users because they can be attached directly to the product. An adequate warning is one that catches the attention of the user, contains content the user can understand, and conveys the nature and extent of the dangers.
Who can claim liability?
Anyone who supplies products to the public must give adequate warning of potential dangers and can be liable for failing to do so. Anyone reasonably expected to use or come into contact with the product can claim liability if the product causes them injury. Injured claimants might include hospital staff, physicians, patients, and friends or co-workers of those using the product.
What are the user’s responsibilities?
When users receive a warning, they have the responsibility to abide by it and protect themselves from harm. A user who ignores an adequate warning, and is injured as a result, will have a difficult time winning a lawsuit. The most common way pharmaceutical companies win lawsuits involving drugs and medical devices is by showing that the user failed to heed a warning.
Exception for warnings given to physicians
Manufacturers need not warn users of potential dangers associated with a prescription drug or medical device if they give proper warnings to prescribing physicians. In such cases, the prescribing physician has the duty to warn patients of the risks. A physician who receives adequate warnings from a pharmaceutical company should understand the risks associated with a product and be able to explain the risks to patients and advise them of safety precautions they can take. There are cases, though, where this exception does not apply. Manufacturers must always provide warnings to the end-users of oral contraceptives and mass vaccines. In addition, the FDA sometimes requires warnings be given to users regardless of whether the warnings also are given to physicians.
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.