Drug recalls may be issued by the FDA when an unsafe drug or medication reaches the public consumer market.  An unsafe drug recall basically requires the manufacturer of a drug to stop distributing the drug and to withdraw its products from the market.  Drug recalls involve some sort of notification informing the public that a particular product is unsafe.  These notifications may be issued by the company online, through the news or through federal government publications.

Drug safety is mostly monitored by the Food and Drug Administration (FDA).   In particular, the FDA maintains a branch called the Center for Drug Evaluation and Research (CDER).  The CDER conducts some research on drug products to evaluate the product’s safety, quality, and effectiveness.  While it does not actually test the drugs, the CDER does interact with drug manufacturing companies to ensure that drugs and other medicinal products are safe for the general public.

What Does the Process for Drug Recalls Involve?

If the FDA or the CDER determines that a drug is unsafe for public consumption, it will notify the company or organization that manufactures it.  It will usually order the organization to issue a recall.  The company will then be required under law to voluntarily recall its products.

If, for whatever reason, the company does not comply with the recall order, the FDA has the option of seeking legal action according to the Food, Drug and Cosmetic Act.  This may involve obtaining an injunction, which is a court-order containing specific instructions for the company and product being recalled.  The process can also result in a seizure of remaining products by federal authorities.

What if I Have Been Injured From a Defective Drug?

If you have suffered injuries from a defective drug, you may have several options available to you.  In order to recover for your injuries and economic losses, it may be possible for you to:

  • File a private civil lawsuit against the company:  This will require documented proof of your injuries and economic losses (i.e., hospital bills, medical expenses, lost wages, etc.).  It may also involve a complex interaction of several different legal theories, including negligence, product liability, breach of warranty, or strict liability violations.  If many people have been injured by the drug, it might also be possible to initiate a class action lawsuit for defective products.
  • Initiate a drug recall with the FDA:  Reporting a drug defect with the FDA usually involves filling out Reporting Form 3500.  Reporting requirements and forms may be different according to whether the report is being filed by an individual consumer, a medical professional, or a health care organization.

You should be aware that the timing of the injury can sometimes limit the amount of recovery available to you.  For example, if the injury occurred after a public recall was already issued, it may be argued that you assumed the risk by continuing to use the product after it was recalled.  On the other hand, you might be able to recover for losses if the company’s recall notification was issued in a manner that was unclear or difficult for the general public to access.

What Types of Products are Monitored by the FDA?

In general, the FDA monitors the following types of products in relation to drug recalls:

  • Prescription and non-prescription drugs or medicines
  • Vaccines
  • Medical devices, especially radiological products and those that emit radiation
  • Cosmetics

These types of products must usually be approved by the FDA before they can be distributed to public.  However, just because a product has been approved by the FDA does not always mean that it is 100% safe.  For example, even if the product itself is unsafe, it can become dangerous due to other factors, such as a lack of clear warnings or instructions.  Also, FDA-approved products can become unsafe over time or if used in conjunction with other products.

Do I Need a Lawyer for Drug Recalls?

If you have been injured by an unsafe drug or have legal inquiries regarding drug recalls, it is best to speak directly with an attorney.  A consumer lawyer can help you obtain legal recovery for any injuries or losses connected with an unsafe drug or a drug recall.  Laws governing drug recalls can also vary according to state, as each law maintains its own set of product laws in addition to federal laws.  An experienced lawyer can also inform you of the list of products that have recently been recalled.