How Does an FDA Recall Work?

FDA Recall

Strictly speaking, the Food and Drug Administration never recalls a dangerous food, drug, medical device, or other product. Technically, the FDA recommends a recall.

The 2020 Recall Unsafe Drugs Act would give the agency that power. As expected, drug companies and other such companies immediately opposed the bill.

Additionally, an official recall does nothing to compensate injury victims, and the responsible company simply walks away. These victims need compensation, and they deserve justice.

A New York personal injury attorney can help provide these things. Available compensatory damages usually include money for economic losses, such as medical bills, and noneconomic losses, such as pain and suffering.

Justice comes in the form of additional punitive damages. These damages hit reckless companies where it hurts them most.

Product Safety Issues

During new product development or existing product manufacturing, the FDA usually doesn’t take a hands-on approach. Instead, this agency usually relies on the information the manufacturers give it.

Industry user fees account for almost half of the FDA’s budget. In other words, the more medical, food, and other products approved, the more money the agency makes.

Therefore, it’s not surprising that some dangerous products slip through the cracks. These dangerous products usually include:

  • Manufacturing Defects: Most food recall recommendations are manufacturing defects, or more specifically processing defects. A flaw somewhere during the process, like a dirty cutting blade or unsafe packaging, makes something that is normally safe become very unsafe.
  • Design Defects: Most dangerous drug recalls involve design defects. These companies try to make their drugs as strong as possible. As a result, these drugs often have very serious side-effects. Zantac is one of the major exceptions to this rule. Unsafe storage (manufacturing defect) is probably to blame for Zantac’s NDMA contamination.

Sometimes, companies are completely blindsided by these problems, and they quickly do the right thing.

Generally, however, companies suppress negative information as long as possible.

They only take adverse action when they are cornered. Our New York product liability attorneys can usually obtain punitive damages in the latter situations.

The Recall Recommendation Process

Normally, the FDA initiates the recall recommendation process because it receives reports of adverse issues. These issues could be actual or potential injuries.

Health Hazard Evaluation

Initially, the FDA sets up a meeting. A team of scientists gets together to determine things like:

  • Health conditions associated with the dangerous product,
  • Cause (g. whether the product or something else caused the health conditions),
  • Dangers to old people, children, and other vulnerable groups,
  • Severity of the hazard, and
  • Possible long-term consequences.

Technically, the drug company or other product maker does not have a voice during a health hazard evaluation.

Recall Classification

After this team considers all these things and issues a report, the FDA decides on the appropriate recall classification. The categories are:

  • Safety Alert (usually an addition to the product’s instructions and/or warnings),
  • Market Withdrawal (voluntary removal of products that aren’t seriously defective),
  • Class 3 Recall (remote possibility of serious injury),
  • Class 2 Recall (high possibility of serious injury), and
  • Class 1 Recall (reasonable probability of serious or fatal injury).

The FDA notifies the manufacturer of the health hazard evaluation and recall assessment. The next step is up to the manufacturer. Technically, the manufacturer could do nothing.

But since the recall classification is public, most manufacturers respond appropriately. They want to minimize negative publicity.

Recall Strategy

At this point, the FDA works with the manufacturer to develop a recall strategy. This strategy usually includes the point of the recall (wholesale, retail, or consumer) and a requirement for manufacturers to follow up in this area.

On a related note, manufacturers also have a responsibility to submit periodic recall status reports.

The recall strategy also includes a public release strategy. Prior to the social media era, this step was perhaps the most important one in the recall strategy process.

Today, however, by the time the FDA and manufacturer talk about recall strategies, the cat is already out of the bag.

The FDA’s recall recommendation process may not effectively protect victims. The experienced New York personal injury attorneys at Napoli Shkolnik PLLC provide that protection. Reach out to us now for a free consultation.