Atlanta Wrongful Death Lawyers Handle Pharmaceutical Recalls
Recalls of products such as drugs or other pharmaceuticals occur when a product is defective or potentially harmful. A manufacturer may recall a product on its own or after the Food and Drug Administration (FDA) raises a concern. Generally, in a recall, the FDA oversees company recalls and assesses the results on an ongoing basis.
Recall Classifications
The FDA categorizes recalls into three classes, depending on the level of hazard involved. Class I is the most serious category. The FDA defines the classes as follows:
Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. An example is a drug that is under-strength but that is not used to treat life-threatening situations.
Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include a minor container defect and lack of English labeling in a retail food.
The FDA keeps the safety of consumers in mind in all phases of product use, from application through marketing. Besides recalls, the FDA issues safety alerts, notices, and warnings. Once drugs and pharmaceuticals that are approved by the Food and Drug Administration (FDA) are on the market, the FDA continues to monitor them for problems.
In the event of problems with a drug or pharmaceutical, the FDA MedWatch Adverse Event Reporting Program is available either online, by regular mail, by fax, or by phone. The FDA encourages the reporting of health problems by health care professionals and consumers. Reports can include the following:
- Unexpected and undesirable side effects
- Quality problems, such as a drug with an unusual odor or color, or a device with defective parts
- Unclear or confusing instructions
- Failure to deliver the expected benefit
MedWatch reports can lead to FDA action to protect the public from harm, serious illness, or death.
Contact an Atlanta wrongful death lawyer
The lawyers at Henry Spiegel Milling LLP have extensive experience with injury and wrongful death cases including those arising from drugs. Our lawyers recovered over $250 million in verdicts and settlements for our clients. Call to speak to an Atlanta wrongful death lawyer at Henry Spiegel Milling at 866-959-3877 or use our email form and contact us today for a free consultation.