FREE CONSULTATION • CALL US 24 / 7 212-994-7777

Food, Drug and Cosmetics

Food, Drug and Cosmetics

FDA Law refers to the laws and regulations governing the research, development, manufacturing, promotion, sale, and distribution of foods, drugs, medical devices, cosmetics, and animal drugs. The term “drug” includes both prescription and nonprescription drugs, as well as biotechnology products and vaccines. “Foods” can include traditional foods, as well as medical foods and dietary supplements.

What Types of Products are Monitored by the FDA?

Generally, the FDA monitors numerous types of products in relation to drug recalls, including:

  • Prescription and non-prescription drugs or medications;
  • Vaccines;
  • Medical devices, especially radiological products and devices that emit radiation; and
  • Cosmetics.

Typically, these types of products must be approved by the FDA prior to being distributed to the public. It is important to note that just because a product was approved by the FDA does not mean that it is always 100% safe.

For example, even if a product is safe, it may become dangerous due to other factors such as a lack of clear warnings or instructions on use. In addition, an FDA approved product may become unsafe over time or if it is used in conjunction with other products.

What is an FDA Recall?

An FDA recall occurs when the Food and Drug Administration (FDA) authorizes the removal of a product from distribution in the market. An FDA recall can be initiated through a request by the FDA.

A recall may also be initiated when the FDA exercises its statutory authority to have a product recalled. A recall may affect a product in several ways, including being corrected by a manufacturer or being totally discontinued.

What are FDA Recall Classes?

There are three classes of FDA recalls, including:

  • Class I, where there is a reasonable probability that exposure to or use of a product will result in death or serious adverse health consequences;
  • Class II, where the exposure to or use of the product may cause temporary or medically reversible adverse health consequences. In other words the probability of serious, adverse health consequences is remote; and
  • Class III, where the use of or exposure to the product is not likely to cause adverse health consequences.

A Class I recall involves the most serious risks and injuries. Classes II and III, however, involve less serious risks.

The FDA can also issue a medical device safety alert which informs the public of a dangerous medical device. This type of alert may sometimes be considered a recall.

What Items are Commonly Subject to FDA Recalls?

An FDA recall is commonly issued for a product that presents an immediate danger to the public. This may include:

  • Dangerous foods;
  • Unsafe drugs; and
  • Other similar products.

The FDA can also issue a recall for a non-food or drug item, which may include:

  • Medical implants;
  • Cosmetics;
  • Toxic substances; and
  • Radiation-emitting objects.

What are Drug Recalls?

The FDA may issue a drug recall when an unsafe drug or medication reaches the public consumer marker. An unsafe drug recall requires a manufacturer to cease distributing a drug and withdraw the product from the market.

A drug recall involves some form of notification to the public that a particular product or drug is unsafe. This notification can be issued by the manufacturer in one of several ways, including:

  • Online;
  • Through new publications; or
  • Through federal government publications.

The safety of drugs is closely monitored by the FDA. The FDA maintains a branch that is called the Center for Drug Evaluation and Research (CDER).

The CDER conducts research on drug products in order to evaluate the product's:

  • Safety;
  • Quality; and
  • Effectiveness.

While the CDER does not actually test the drugs, it does interact with the drug manufacturing companies to ensure that the drugs and other medical products are safe for the general public to use.

What Does the Process for Drug Recalls Involve?

If the CDER or the FDA determines that a drug is unsafe for the public to consume, it will notify the organization or company that manufactures it. The organization or company will be ordered to issue a recall.

Then, the company will be required under law to voluntarily recall the product. If, for some reason, the company does not comply with the recall order, the FDA may seek legal action pursuant to the Food, Drug, and Cosmetic Act.

This may involve the FDA obtaining an injunction. An injunction is a court order that contains specific instructions for the company and the product which is being recalled. This process may also result in the seizure of the remaining products by federal authorities.

What if I have been Injured by a Product That was Subject to an FDA Recall?

If an individual has been injured by a product which was recalled by the FDA, the fact that the product was recalled may provide evidence that it was, in fact, dangerous, and may bolster their legal claim. In most cases, FDA recalls occur because many individuals are being injured or adversely affected by the same product.

In these cases, the individuals who were injured by the product may be entitled to legal compensation for economic losses which were caused by the product. A damages award may provide compensation for expenses such as:

  • Medical expenses;
  • Hospital bills;
  • Physical therapy; and
  • Other costs.

Damages can be limited according to various factors, which may include differences in state laws and whether the claim is filed as a class action lawsuit. When a court is calculating damages, it may take into account the date of the recall and whether or not the individual was aware that they were using a recalled product, or assuming the risk of injury.

What if I have been Injured by a Defective Drug?

If an individual has been injured by a defective drug, there may be several options available to them. In order to recover for their injuries and economic losses, it may be possible for an individual to file a private lawsuit against the company or initiate a drug recall with the FDA.

If an individual files a private lawsuit against a company, they will be required to provide documented proof of their injuries and economic losses, which may include:

  • Hospital bills;
  • Medical expenses;
  • Lost wages; and
  • Other losses.

This type of lawsuit may involve a complex interaction of numerous legal theories, including:

  • Negligence;
  • Product liability;
  • Breach of warranty; or
  • Strict liability violations.

If there are multiple individuals who have been injured by a drug, it may be possible to initiate or join a class action lawsuit for defective products. Another possibility is initiating a drug recall with the FDA.

Reporting a drug defect to the FDA typically involves completing Reporting Form 3500. The requirements for reporting can be different depending on whether the report is being filed by an individual consumer, a medical professional, or a healthcare organization.

An individual should be aware that the timing of an injury may, in some cases, limit the amount of recovery that is available to them. For example, if an injury occurs after a public recall was already issued, it may be argued that the individual assumed the risk by continuing to use the product after it was recalled.

On the other hand, an individual may be able to recover for their losses if the company's recall notification was issued in such a way that it was unclear or difficult for the general public to access.

What is the Fair Packaging and Labeling Act?

The Fair Packaging and Labeling Act (FPLA) of 1967 directs the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) to issue regulations that require all consumer commodities to be labeled.  Labels must disclose net contents, the identity of the commodity, and the name and place of business of the product's manufacturer, packer, or distributor.  Also authorized are additional regulations where necessary to prevent consumer deception. 

Why Does the FPLA Exist?

The FPLA was meant to facilitate value comparisons and to prevent unfair or deceptive packaging and labeling of consumer commodities.  The FPLA is administered by the FDA with respect to foods, drugs, cosmetics, and medical devices.  The FTC administers the FPLA with regard to other consumer commodities consumed in the household.  

Are there Exemptions?

There are certain exceptions to the FPLA, including:

  • The FTC's regulations under the FPLA do not apply to industrial or institutional products
  • The Environmental Protection Agency regulates insecticides, fungicides and rodenticides
  • Other products also do not fall under the FPLA (e.g., automotive products, greeting cards, souvenirs, tools, toys)
  • Many exempt products still may fall within the Weights and Measures laws of individual states

What Is the GMP Regulation?

Good Manufacturing Practice (GMP) refers to the Good Manufacturing Practice Regulations declared by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. The legal regulations require that manufacturers, processors, and packagers of drugs, medical devices such as hip implants, some food, and blood take required measures to warrant that their products are safe and effective to consumers.

GMP regulations require a quality approach to manufacturing, enabling companies to decrease and eliminate risks of contamination and errors. These regulations protect the consumer from purchasing a defective product, such as a defective duodenoscope or a defective insulin pump. Failure to follow with GMP regulations can result in very serious penalties including recall, seizure, fines, and even jail time.

What Are Some of the Requirements of This Quality Assurance Program?

When designing the device, the manufacturer should have procedures that require that the user and patient be taken into consideration when the product is designed. The product must be reasonably easy for the operator to use.

Sometimes the operator is the patient herself, so the manufacturer should take this into account when designing the device. In addition, manufacturers should check the ease of use of their product by coming up with tests/surveys that gather information about the use of the device in the real world.

How Can Manufacturers Achieve the Requirements?

Manufacturers can achieve the requirements needed by the Quality Assurance Program by having a group of people who would represent the potential operators in the real world, test out the device and then comment on its ease of use.

Manufacturers must also assess the risk of using the device so that they are aware of the kinds of dangers it could pose to a potential operator or patient. After a basic design analysis, this can be assessed by the same method mentioned above in which the use of the device is tested by a qualified group of potential operators.

Liability in Manufacturing Defects

To bring a lawsuit for a manufacturing defect, you must prove:

  1. There was a defect in manufacture.
  2. The defect caused injury.
  3. There were no alterations to the product by the consumer to cause the defect.

If all these elements are proven by the consumer, the plaintiff may win their case and be awarded appropriate damages that was caused by the product defect.

Companies that knowingly fail to comply with GMP regulations may be in violation of the False Claims Act if false claims for payment were submitted to programs like Medicare, Medicaid, and TRICARE, for the contaminated drugs.

Do I Need a Lawyer for Help with FDA Recall Related Injuries?

It is essential to have the assistance of a defective products lawyer for any FDA recall related injuries you may be facing. A dangerous product can lead to serious injuries or medical complications.

An FDA recall is subject to change and is frequently updated. Your attorney can review your case, research applicable laws to determine what legal remedies may apply to your case, and assist you with obtaining legal relief. If you need to file a lawsuit or a class action lawsuit, your attorney will represent you throughout the process.

Call our office today at 212-994-7777 or complete the convenient online contact form to set up a consultation.