More than 48 percent of Americans have used at least one prescription drug in the past month, according to the Centers for Disease Control and Prevention. Doctors prescribe prescription drugs in approximately 75 percent of all office visits, adding up to 2.6 billion drugs provided in 2010. With so many Americans dependent on pharmaceutical drugs for their health, it is important to hold drug manufacturers to a high standard of excellence when it comes to producing these drugs.
“Product liability” is the legal principle that holds one (or more) part of the manufacturing chain accountable for damage caused by a defective or unsafe product. The liable party depends greatly on the type of defective product and the type of defect involved; in different circumstances, the liable party could be the designer that developed the product, the manufacturer that assembled the product, the distributor who transported it across the country, or even the retailer who stocked it on his shelves.
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Product liability is generally divided into three categories: design defects (products whose initial concepts were flawed), manufacturing defects (products that were assembled incorrectly), and marketing defects (products that did not contain instructions or warnings, or products whose instructions are warnings were not sufficient).
These three categories hold true for product liability claims involving prescription drugs, albeit with slightly different wording. The three categories of prescription drug claims are:
Drugs with Dangerous Side Effects
This category covers drugs with an “improper design.” In other words, despite being manufactured according to product specifications, the drug produces a harmful side effect. It is important to note that not all side effects are grounds for a product liability case; many prescription drugs come with undesirable or uncomfortable side effects, but unless the side effect is severe enough to cause harm, it may not rise to the level of product liability. However, some severe side effects are certainly grounds for a product liability suit.
Sometimes the dangerous side effects of a certain drug are not realized until the drug has been on the shelves for months (or even years). This puts a large number of Americans at risk, as the drug has had time to make its way through the system and reach plenty of medicine cabinets throughout the country. For the most up-to-date information on Food and Drug Administration recalls, visit the FDA Drug Recalls website.
Defectively Manufactured Drugs
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This category covers errors that occur anywhere between the factory and the consumer. Defective manufacturing can include an improper mixture of chemicals, a tainted batch of the drug, improper child safety locks, or one drug mistakenly labeled as another drug. In other words, “defective manufacturing” means any departure from the initial design and plan for the drug, whether it be a chemical defect, packaging defect, or labeling issue.
Improperly Marketed Drugs
Improper or defective marketing of a drug occurs when the warnings, instructions, and recommendations for safe use of the drug are not adequate. This can mean that the product does not contain any warnings against dangerous side effects (even though the manufacturer and/or prescribing doctor knew there were serious side effects) or the drug does not come with instructions for safe use. If any failure to give appropriate warnings, recommendations, or instructions leads to harm, someone in the manufacturing chain could be found liable for the patient’s injuries.