The Impact of a “Black Box Warning” on Maine Product Liability Claims

The U.S. Food and Drug Administration (FDA) provides leadership and guidance on natural resources, food, agriculture, nutrition, and biological products. Many Maine product liability lawsuits follow consumer complaints to the FDA. While the agency is responsible for protecting the public, many products slip through until consumers suffer an adverse side effect. Some dangerous products even remain available but receive a “black box” warning.

The FDA issues black box warnings to alert the public about prescriptions or medical devices that pose serious and life-threatening side effects. The warnings often include specific warnings to vulnerable populations, such as infants, pregnant women, and older adults. The FDA works in conjunction with pharmaceutical companies to study the products before issuing a warning. These warnings generally follow post-market studies; in other words, the warnings come after significant numbers of consumers have already used the product. Even though the product may pose serious dangers, the benefits may outweigh the risks in some cases. Individuals who consume products with a black box warning should consult with their physician to determine the appropriate amount of monitoring.

While black-box warnings have many implications for prescribing physicians and pharmacies, they may also impact a Maine product liability lawsuit. Drug companies often resist these warnings to preserve sales; however, the warnings may also protect them from certain lawsuits. Many common medicines have black box warnings, such as antidepressants, anticoagulants, diabetes medications, and antibiotics.

Recently, national news sources reported that federal regulators issued a black box warning on some breast implants. The FDA advised manufacturers to sell the products only to medical providers who review the possible risks with patients before surgery. According to studies, the warnings advise patients that studies indicate that breast implants have been linked to cancer and other medical conditions. Unfortunately, patients who have undergone breast cancer, chemotherapy, or radiation, are at a higher risk of serious side effects.

Further, the FDA requires manufacturers to disclose the ingredients used to make the implants. Companies must disclose the information within 30 days, although enforcement is unclear. Medical providers must provide the patient with an opportunity to sign the “checklist” to ensure that they understand the potential risks. The checklist will list that certain conditions might preclude people from getting the implants. Some of the conditions include pregnancy, nursing, pre-cancer, existing cancer, and active infections.

Have You Suffered Injuries Due to a Dangerous or Defective Medical Device or Product?

If you or someone you know has suffered injuries after consuming prescription medication or using a medical device, contact Peter Thompson & Associates. The injury lawyers on our team have extensive experience handling complex personal injury lawsuits on behalf of our Maine clients. Our highly-rated attorneys handle Maine personal injury claims stemming from dangerous products, unsafe medications, motor vehicle accidents, slip-and-falls, animal bites, and medical malpractice. We understand the emotional toll that these types of accidents can have on a person and their loved ones; as such, we work to ensure that our clients recover the compensation the law entitles and deserves. Contact our office at 800-804-2004 to schedule a free initial consultation with an attorney on our team.



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