What Role Does the FDA Play in Mass Torts?

June 25, 2020

The Food and Drug Administration (FDA) is a federal government agency that plays an essential role in mass torts. Many of the items that become the subject of mass tort lawsuits fall under the regulation of the FDA.

The FDA’s job is to make sure that products that get sold in the United States are safe for consumers in the following categories:

  • Our nation’s food supply
  • Drugs intended for use by humans
  • Veterinary drugs
  • Tobacco products
  • Medical devices
  • Cosmetics
  • Biological products
  • Radioactive products

The FDA is supposed to regulate how companies make, market, and distribute products.

The FDA can request that a corporation issue a voluntary recall of an item if the company:

  • Produces a product in a shoddy manner to the extent that the item is dangerous when the consumer uses it as directed
  • Contains contaminated ingredients or substances that are inherently harmful
  • Makes deceptive claims in its marketing about how effective the product is
  • Fails to disclose known problems with the product
  • Does not provide accurate information for doctors and patients to make an informed decision about drugs and medical devices

If the corporation refuses to issue a voluntary recall and correct the problems with the product, the FDA can issue a formal recall.

Information the FDA Posts About Recalls, Market Withdrawals, and Safety Alerts

You can glean a wealth of information about a product from this FDA database: “Recalls, Market Withdrawals, & Safety Alerts.” Using the search bar, you can look up items that have been the subject of past recalls.

Upon finding that a product has been recalled, you can review the following information:

  • The date the FDA issued the recall or other action
  • The brand name of the product
  • A description of the product
  • The category, like “Drugs,” “Food & Beverages,” and “Medical Devices”
  • The reason the FDA issued the recall, like the presence of E. coli or an undeclared ingredient that could cause an allergic reaction
  • The name of the company that makes, markets, or distributes the product, depending on the specific problem

Here is an example of an FDA recall:

Date of Recall Publication: 1/10/20

Brand Name: LIFEPAK 15

Product Description: LIFEPAK 15 monitor/defibrillators

Product Type: Medical Devices

Recall Reason Description: Failure to deliver a defibrillation shock after the

“Shock” button on the keypad is pressed

Company Name: Stryker

By clicking on the link in the recall, a reader can get far more information about the situation. For example, in the LIFEPAK 15 recall, the company announced that it issued a “voluntary field action” on some of the units.

Stryker notified specific LIFEPAK 15 customers about the problem and explained a possible cause. Stryker is replacing the keypads. The company urged customers to perform routine daily testing of the device to ensure that it works correctly before and after the keypad replacement.

Stryker provided contact information for people who have questions for the company. The corporation also gave the details a person would need to report adverse reactions or events to the FDA.

This is a perfect example of the role the FDA plays in mass torts.

How a Mass Torts Lawyer Can Use the FDA Website Information

When a lawyer learns about a problem with a product, whether from clients, the news, or some other source, they can perform a search on the FDA website to gather more information relating to that item. This is why the FDA plays a vital role in mass torts. When a company continues to make and sell products with known problems, they put themselves at risk of financial liability for any ensuing damages.

A mass torts lawyer can also stay ahead of the curve by regularly checking the FDA website for reports of problems with products before the competition. It can be an advantage to be one of the first law firms to advocate for people who get hurt by a harmful product.

FDA Information Increases the Mass Tort Lawyer’s Credibility

The FDA requires that the information on its website is accurate and has a scientific basis. The reports also contain some background information on how the issues developed.

Such data is useful in a trial when establishing causation and liability. In addition, a savvy mass torts lawyer will include FDA information when informing the public about a harmful product and advertising for new plaintiffs. The mass torts lawyer who uses FDA data gets to speak with authority rather than relying on general assumptions. It’s clear that the FDA plays an important role in mass torts.

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