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Medical MalpracticeIf You Become Ill or Are Hurt by a Consumer Product, Save the Evidence
When you are suddenly taken ill or unexpectedly injured by a consumer product, your first priority is to seek immediate medical attention – especially if your illness or injury is life-threatening. In an emergency like this, when you are in pain and frantically seeking help, you will likely be confused, and may not have your wits about you.
But if you remember only one thing, remember this: Save the offending product so that you will have evidence of the harm that it caused. In fact, save everything!
Too often, the temptation is to throw away the stray bolt that jammed the lawn mower and caused the gash in your leg, or toss the defective pull-toy that made your child choke, or crumple up the packaging that failed to warn you against hazardous uses of an aerosol shaving cream. If you are injured by a product, you should save and protect from spoilage or tampering:
- The product itself
- Product packaging
- Instructions, including package inserts
- Other labeling
- Warning information
- Warranties
- Mailing packaging and labeling
- Product accessories
- Purchase receipt
- Copy of credit card charge
- Debris or wreckage associated with the incident
- Photos of the product
- Photos of damage and injuries
Why be so meticulous in preserving every piece of evidence related to a dangerous product?
If you are injured or become ill from a product you have ingested or used, you will need to prove that the product was responsible for what happened. Your recollection or speculation does not constitute proof – although you should write down exactly what happened, when, and how. In order to have a potentially-valid claim against a designer, manufacturer, distributor, or retailer of a harmful product, you will need to have evidence to back up your claim.
Why is it just as critical to save the packaging, labeling, and instructions?
Defective products often can be traced to a faulty design or engineering process, or a manufacturer who cuts corners, uses inferior materials, or doesn’t adhere to health and safety standards. Sometimes, however, distributors and retailers fail to warn consumers about possible dangers, such as inappropriate use or, in the case of pharmaceuticals, overdose.
A striking example of the importance of packaging and labeling is the history of fentanyl transdermal pain patches, which contain a strong narcotic distributed gradually over about 72 hours. In 2004, with deaths from overdose on the rise, the FDA warned manufacturers about leakage from defective patches with slits in the drug reservoir. The defective patches, which were leaking into product packaging, were exposing patients and caregivers directly to the potentially-lethal gel. As a result, the FDA initiated a massive recall of the defective patches. At the same time, the agency issued new guidelines for caregiver instructions and warning labels to help prevent accidental overdose.
In the United States, warning labels for potentially dangerous products may be required by government agencies and/or a “duty to warn” based on tort law.
In response to health and safety hazards generated by inaccurate, even fraudulent, information provided by product makers and distributors, in 1966 Congress passed the Fair Packaging and Labeling Act. Designed to protect consumers, the Act requires product labels to disclose truthfully information such as ingredients, quantity, and the manufacturer’s name.
While all consumer products are covered by this Act, its impact has been primarily on textiles and food products. Subsequent legislation, the Nutrition Labeling and Education Act of 1990, empowered the Food and Drug Administration to mandate nutrition labeling on food products. In 1994, Congress passed the Dietary Supplement Health and Education Act requiring makers of dietary supplements to follow a safety review before marketing their products, and to provide “clear and truthful” information in labeling and packaging.
Beyond truth in packaging, many products that are potential health or safety hazards must adhere to warning label requirements .
For example, thanks to the Cigarette Labeling Act of 1965, the Federal Trade Commission requires a “Surgeon General’s Warning” on each pack of cigarettes. The Federal Hazardous Substance Labeling Act of 1960 requires warning labels on household products that contain dangerous chemicals or other toxic ingredients. The Child Protection and Toy Safety Act, enacted in 1969, sets safety regulations for products used by children, including toys. This law specifically prohibits the sale of hazardous products to children.
Tort laws – the civil system through which victims of defective products may seek justice through state courts – imposes upon manufacturers a “duty to warn” of hazardous products by attaching a warning label telling consumers how to minimize the potential for harm.
In addition, the American National Standards Institute (ANSI) has established optional warning symbols such as a lightning bolt for dangerous electrical products; a white triangle with a red exclamation mark, set inside a red square, connoting “Danger;” and a yellow triangle with a black exclamation point symbolizing “Caution.”
The most comprehensive labeling and warning standards are set and enforced by the Food and Drug Administration (FDA), especially for pharmaceuticals.
Theoretically, the FDA approves medications only after an extensive research and evaluation process has demonstrated they are safe . . . or, as an FDA “Guide to Drug Safety Terms” says, “after determining that the drug’s benefits of use outweigh the risks for the condition that the drug will treat.” In practice, every approved drug goes to market with side effects and other risks of which consumers must be aware. So the FDA has developed a complex system of educational and informational materials.
- Prescription drug labeling is usually the drug’s package insert, which contains information about what the medication is designed to do, who should and should not take it, and how to use it. This labeling also must contain warnings about side effects.
- Non-prescription drug labels for over-the-counter medicines are usually in the form of “Drug Facts” printed on the container or its package. In addition to saying what the medicine is, who should take it, and how, Drug Facts include safety information.
- Boxed warnings, also called “black box warnings,” are required on the labels of potentially dangerous prescription drugs to warn of life-threatening risks.
- Medication Guides are prepared by the FDA to be handed out by pharmacies to help patients taking certain drugs avoid serious problems. Medication Guides usually detail risks specific to particular drugs and drug classes.
If you or a loved one has been injured by a defective product, the product liability attorneys at Searcy Denney Scarola Barnhart & Shipley can give you more information about your rights. Please fill in the Contact Form, or call us at 800-780-8607, to arrange a free initial consultation.
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