FDA Recalls

Before most pharmaceutical drugs or medical devices are sold to consumers, they must be approved by the U.S. Food and Drug Administration (FDA). This includes both over-the-counter (OTC) and prescription medication. The process usually involves years of testing to make sure the product is safe, including looking for weaknesses in a product’s design, finding ways a product could fail, and determining what consumers can expect when the drug or device is used as prescribed.

In some cases, however, dangers aren’t apparent until some devices or drugs have been used for years, even though they were rigorously tested. In other cases, companies may not thoroughly test the product in the rush to get the product to market. Sometimes, the product may be considered safe if manufactured correctly, but an error occurred, resulting in a contaminated batch of a certain drug or a defective product.

If a certain medical device or drug offers a risk of serious injury or death, the FDA or the manufacturer may recall the product. If the FDA requests a recall, the manufacturer must comply. If a manufacturer recalls a product, it must notify the FDA, submit progress reports, and conduct follow-up checks to make sure the recall was successful.

The FDA groups recalls by the severity of the danger posed by the product. There are three types:

• Class I recall: This is the most serious type of recall, and is issued when there is a reasonable probability that using the device or drug will cause serious health problems or even death.

• Class II recall: These are issued when the use of a product may cause temporary or medically reversible health problems, or when there is a small risk of serious health problems.

• Class III recall: This recall is issued when using a product is not likely to cause adverse health consequences, but the product still violates FDA labeling or manufacturing requirements.

Once a company or the FDA decides to issue a recall, the FDA may contact media outlets, publish press releases and other public notices, and use its own website (www.fda.gov) to publicize the recall, if the product or drug presents a serious risk to consumers.

For a current list of Class I FDA recalls, visit http://www.fda.gov/Safety/Recalls/default.htm. For Class II and Class III recalls, the FDA issues weekly Enforcement Alerts (http://www.fda.gov/Safety/Recalls/EnforcementReports/default.htm).

If you feel that you’ve used an unsafe medical product or taken a drug that caused serious side effects, you should immediately seek medical treatment. Then contact Friedman Rodman Frank & Estrada, P.A.. Serving clients in Miami and across South Florida, our product liability attorneys have the experience you need to help you deal with problems caused by unsafe medical devices and drugs.

A dangerous drug or product can cause long-term health problems or disability that will require ongoing treatment and care. You may qualify for compensation to cover your medical expenses and lost income, including:

• Pain and suffering

• Medical treatment

• Hospitalization

• Lost wages

• Rehabilitation and home care

Cases involving drugs and medical devices can be extremely complicated, and drug manufacturers, hospitals, and insurance companies will frequently use their resources to defend their use of dangerous products and reduce or deny compensation to victims. You need knowledgeable legal representation to protect your rights. For a confidential and free evaluation of your case, call us at 305-448-8585, or complete our online contact form. Our South Miami personal injury attorneys will review your situation and advise you of your legal options, and we offer consultations in English, Spanish, and Creole.