Product Injuries
Each year millions of people are injured, made sick, or killed by unsafe products, vehicles, foods, chemicals, drugs, and medical products. Recalled products (i.e. products withdrawn from the market) kill an estimated 22,000 people each year. Unsafe products or drugs are often the result of a design flaw, a manufacturing defect, or inadequate warning labels or instructions. Courts have held that manufacturers, sellers, and distributors may be held strictly liable (fault need not be shown) for any injury caused by their defective or unsafe products.
The laws protect consumers from unsafe products. When a product is unsafe or does not perform as advertised, the manufacturer of the product and other parties may be held responsible for any injuries cause by the unsafe product.
Drug Injuries and Drug Recalls
In the last decade, approximately 100 million patients took at least one of five drugs subsequently removed from the market because of safety risks, including Vioxx, Rezulin, Baycol, and the diet drugs popularly known as Fen-Phen (Redux). Recalled drugs have been implicated in thousands of deaths over the last decade.
A drug recall is an action taken to remove a prescription or over-the-counter drug from the market. Many countries have a government agency responsible for overseeing the safety and efficacy of pharmaceutical drugs. In the United States, the Food and Drug Administration (FDA) is responsible for a variety of products, including drugs, medical devices and foods. The FDA provides clinical information about safety issues involving prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products, including dietary supplements. The FDA issues and announces recalls, safety alerts, withdrawals, and important labeling changes that may impact the health of consumers.
Drug recalls are often categorized by class.
* A Class I recall occurs where a reasonable probability that the use of or exposure to a product will cause serious injury or death.
* A Class II recall occurs where use or exposure to a product may cause temporary or medically reversible injury.
* A Class III recall are for products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing regulations.
* A safety alert is a notice or warning issued in situations where a product may present an unreasonable risk of substantial harm.
The FDA expects drug makers to take responsibility for product recalls, including follow-up checks. When a product is discovered to pose a safety risk or defect, drug makers or distributors will often carry out recalls voluntarily. In other instances, the FDA may inform a company of findings that one of its products is defective and suggest or request a recall. If the firm refuses to recall the product, the FDA may seek legal action under the Federal Food, Drug, and Cosmetic Act. Such legal action may include seizure of available product, and/or injunction of the company, including a court request for recall of the product.
The recall of a defective or harmful drug is sometimes publicized in the media. Often the drug maker will issue its own press release. The FDA publicizes a recall only when it believes the public needs to be alerted about a serious hazard.
After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.
Tens of millions of consumers have taken at least one of several drugs withdrawn from the market. Highly publicized examples of drug recalls are the withdrawal of the diet drug combination popularly known as fen-phen, the cholesterol drug Baycol, the diabetes drug Rezulin, and the pain drug Vioxx.
In addition to injuries arising from recalled drugs, preventable drug errors by doctors and pharmacists result in at least 1.9 million drug-related injuries each year. According to the Journal of the American Association, adverse drug reactions resulting from correctly administered Federal Food and Drug Administration (FDA) - approved prescription drugs are responsible for over 100,000 deaths per year in the United States making it the fourth leading cause of death in the United States. In addition to the fatal events, there are typically over 2.2 million annual occurrences of non-fatal, but serious, reactions, and millions of complications and disabilities related to the unexpected effects of drugs, chemical compounds and a variety of products.
Vehicles
Cars
According to the National Highway Traffic & Safety Administration, safety defects are usually the result of inadequate design or manufacturing error. The National Highway Traffic & Safety (NHTSA) is responsible for issuing recalls, warnings and safety alerts concerning unsafe or defective automobiles, motorcycles and tires. When there are reports of a possible vehicle problem, the government gathers all information on a problem, government engineers analyze the problem, and where warranted, manufacturers are asked to conduct a recall. If the manufacturer does not initiate a recall, the government can order the manufacturer to issue a recall. Examples of vehicle safety defects include: seatbelts that fail in a collision, airbags that fail to deploy or that deploy unexpectedly, adult and children seats that release in a crash, accelerator control or brake failure or sticking, and fuel system problems that may result in leaks or fires.
Motorcycles
There have been numerous reports of what is commonly referred to as "high-speed wobble" (or "tank-slapper") accidents involving Harley-Davidson motorcycles. High speed wobble motorcycle accidents typically involve shaking or instability in the front end of the motorcycle when traveling at high speeds. In some cases the front wheel of the motorcycle can thrash from side to side causing the driver to lose control of the vehicle. Reports suggest stability problems with the FLH series of Harley-Davidson, also known as the Electra Glide, Road King and Ultra Classic, which are widely used by law enforcement officers nationwide. Some observers have attributed the problem to an offset between the front and rear tires.
Sport Utility Vehicle (SUV) Rollovers
Sports Utility Vehicles (SUVs) are among the most popular and best selling vehicles today. However, many people have the misconception that SUVs are rugged and safe. Various studies and reports have indicated that many SUVs have a dangerous tendency to roll over in a collision or sharp turn, increasing one's risk of serious or fatal injury. SUVs' size, high center of gravity, narrow track width, and top-heavy designs make them up to three times more prone to rollovers than other vehicles. Further aggravating the problem is that SUVs manufactured for consumer use on streets and highways fail to include important anti-rollover features (such as roll bars) found on their off-road counterparts. Additionally weak roof designs (prone to collapsing on occupants in rollovers) and inadequate safety restraint systems increase the risk of severe injury. According to a report by the National Highway Traffic and Safety Administration (NHTSA), about 9,000 people die each year in 227,000 rollover accidents. Moreover, rollovers accounted for more than half of all single-vehicle crashes and that the rate of serious passenger injury in rollover crashes in 36% higher than in non-rollover crashes. Additionally, the NHTSA warns that vehicle rollover crashes are much more likely to result in serious head injuries than other types of accidents.
Tires
According to the National Highway Traffic & Safety Administration (NHTSA) tens of millions of tires have been recalled in recent years, including tires made by Bridgestone-Firestone, Goodyear, and Cooper. The NHTSA requires manufacturers to recall and or replace defective of non-compliant tires. Defectively designed or manufactured tires may suddenly loose their tread or explode (blow-out) causing the driver to lose control of the vehicle, resulting in a collision or accident. The NHTSA has documented at least 200 deaths and more than 700 injuries linked to accidents involving Firestone tires and Ford Explorers.
