Black Box Warnings on Dangerous Products

The U.S Food and Drug Administration (FDA) works to protect public health and promote public safety by ensuring the efficacy and safety of human and veterinary products and medical devices. The FDA approves drugs after determining that the benefits outweigh the risks; however, in some cases, the full extent of the risks does not become apparent until after many years of consumer use. While warnings may limit the amount of liability, a manufacturer has, those who have suffered injuries because of an unsafe product should contact a Washington D.C. product liability attorney.

The FDA must provide pre-clinical data to establish that the products have been tested on laboratory animals before moving on to the new drug approval process. Drug companies must report any adverse side effects, especially those that can cause life-threatening injuries such as hospitalization or congenital disabilities. Further, the FDA provides varying information and warnings to consumers ranging from medication guides, consumer medication information, nonprescription drug facts, and boxed warnings. Boxed warnings tend to follow post-market surveillance, which includes evaluating FDA’s computerized database and MedWatch. In some cases, the FDA may recall or withdrawal a medication or device.

For instance, the FDA recently told manufacturers that they must warn patients of the risk of breast implants. According to a national news outlet, regulators placed the black box warnings and told companies that they could only sell the products to medical providers who review the risks with patients before surgery. In addition to the warnings, providers must allow patients to review a new checklist that advises patients of the various risks. The checklist identifies certain types of patients who are at an increased risk for illness after implant surgery. These patients include those who have autoimmune conditions or have undergone chemotherapy or radiation treatments.
In addition to the warnings and checklist, the FDA mandates that manufacturers disclose the ingredients used to make the implants.

The warning comes after the agency received thousands of reports of adverse side effects. The FDA heard testimony from individuals who experienced severe side effects including, cancer and medical problems after implant surgery. Historically, many of these side effects were chalked up as “breast implant illness,” but the severity of the complaints was never fully addressed. There have been mixed reactions to the new requirements, but advocates feel that the warning is a massive step toward patient safety.

Have You Suffered Injuries Because of a Dangerous Medical Device?

If you or someone you love has suffered injuries because of a dangerous or unsafe medical product, the Washington, D.C. product liability attorneys at Lebowitz Mzhen can help you determine your rights and remedies. Our office’s Washington D.C. injury lawyers have extensive experience handling complex personal injury and wrongful death claims. Our attorneys also have extensive experience handling injury claims involving motor vehicle accidents, boating accidents, burn injuries, dog bites, medical malpractice, motorcycle accidents, nursing home negligence, spinal cord injuries, traumatic brain injuries, and uninsured motorists. We have recovered significant amounts of compensation for our clients and their loved ones. Contact our office at 800-654-1949 to schedule a free initial consultation with an attorney on our team.

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