Product Quest Manufacturing, a Florida-based drug manufacturing company, was recently forced to declare bankruptcy and shut down production. Why? Multiple recalls were issued for drugs and consumer products manufactured at the company’s Holly Hill location. The recalls so severely damaged the company’s financial position that it was forced to call it quits.
Why Are Drug Recalls Issued?
Drug recalls can be issued voluntarily or by the urging of the Food and Drug Administration (FDA). Recalls are used when there is evidence to suggest that a product sold to consumers in the United States may pose a threat to their health and/or safety.
A recall does not necessarily mean that a product is defective or dangerous. Instead, it’s a preventative measure that allows companies to look into a problem and protect consumers from potential harm.
Drug recalls can be issued for many reasons, including:
- Defective or mislabeled packaging
- Cross-contamination during manufacturing
- Quality control issues affecting strength, purity, and potency, and
- Reports adverse health events (e.g., allergic reaction, stroke, paralysis, organ damage, death).
Many times, drug recalls are issued when the FDA receives an unusual number of complaints of unexpected and/or dangerous side effects.
Are All Drug Recalls the Same?
No, drug recalls are not all the same. The recall issued will ultimately depend on the potential risk of injury to the public. There are three different FDA drug recall classifications.
Class I Recall: The most urgent drug recall; issued when a dangerous or defective product “could cause serious health problems or death.”
Class II Recall: A moderately urgent drug recall; issued when a dangerous or defective product “might cause a temporary health problem or pose slight threat of a serious nature.”
Class III Recall: The least urgent drug recall; issued when a product violates FDA manufacturing or labeling laws, but is unlikely to cause illness or injury.
Actions taken by the FDA and pharmaceutical company will depend on the type of recall issued. The more serious the threat to the public, the more involved the FDA will be.
Does a Drug Recall Prevent Me From Filing a Lawsuit?
Recalls in no way take away your right to file a lawsuit if you have been injured because of a dangerous or defective product. Remember, a recall doesn’t mean that a product is dangerous. A recall is simply a way to protect the public from a potential danger.
A recall doesn’t prevent you from filing a personal injury lawsuit. While it’s not an admission of guilt or liability, it can be quite helpful if you decide to seek compensation. Recalls can highlight problems and issues that may exist with the drug or pharmaceutical product you use. When a recall is issued, it opens the door to the possibility that a drug company may have been negligent in the design, manufacture, or sale of a pharmaceutical product.
The results of inquiries into the potential problems can be of great use if you decide to file a claim for damages. At the same time, a recall can suggest that you are not the only person to experience adverse health effects while using the drug.
What Should I Do If I’ve Been Injured Because Of A Recalled Drug?
There are certain steps you should take if you believe that you’ve been harmed because of a medication or drug that’s been recalled by the FDA. These steps can help to protect your health and strengthen any legal claims that you may decide to pursue.
- Report Defects. The FDA only issues recalls when it receives information that a product may be dangerous or defective. All adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting program on its website.
- See Your Doctor. Get checked out immediately. Go to the doctor as soon as you begin to experience any unexpected or painful side effects or health issues that may be related to the use of the recalled drug. Early diagnosis and intervention can help to prevent your complication from getting worse.
- Keep a Journal. Write down any side effects or adverse health issues that you’ve experienced since you began taking the recalled drug. This can help you keep track of important details if you decide to file a product liability lawsuit against the pharmaceutical company in the future.
- Contact an Attorney. A drug recall doesn’t mean that you automatically have the grounds to file a lawsuit against a drug company. However, a recall can suggest that you may have a legal case on your hands. Don’t hesitate to contact an experienced attorney if you’ve suffered injuries or complications while taking a pharmaceutical drug. Your attorney can review your case and help you decide on the best legal option for your particular situation.
Have you been injured because of a defective or dangerous drug? Has that drug been recalled by the FDA? If so, you may have the right to file a lawsuit for compensation. The attorneys at Rosen Injury Lawyers can help you maximize your award. Call our law firm today to schedule a free, no obligation consultation and learn more.