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Improper Medical Product Instructions & Defective Labeling

Posted on in Defective Prescription Drugs

Products liability covers a large range of products and can include intangible property such as pets, gas leaks, and real estate. Defective medical products are one of the most damaging types of products liability. Examples of defective medical products include those that were not fully vetted for compatibility with the body, those with side effects more severe than the disease they are supposed to alleviate, and those that cause unexpected additional issues for the patient. Product liability for defective medical products does not only refer to the product itself, but also to the way in which the product was distributed and used.

According to the Legal Information Institute at the Cornell University Law School, there are three main types of product defects. These include design defects, manufacturing defects, and marketing defects. A defect in marketing, in regards to a medical device, includes instructions for patient use.

The U.S.Food and Drug Administration (FDA) has strict labeling requirements for medical products, and they vary depending on product type. General requirements entail all products to include adequate instruction for use, meaning, “directions under which the layman can use a device safely and for the purposes intended.” Conditions for which the product shall be used, quantity of adequate dose, duration of dosage, and method of application are all included in this proviso.

Under the same guidelines, the FDA considers all products that include a misleading statement to be misbranded and not in accordance with FDA regulation. Even if the product includes all necessary labeling information, it can be considered insufficient if the label was not placed in a prominent place on the package or if the typeface was too small or in difficult-to-read type.

If you suspect injury or illness due improper product instructions or labeling, you may be eligible for compensation. Contact an Arlington Heights defective medical product attorney today to discuss your case.

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