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