If you or a loved one experienced infections or health complications following the use of contaminated Chlorhexidine Gluconate Oral Rinse, you may be entitled to pursue compensation.
At Schmidt & Clark, LLP, we are dedicated to helping individuals who have suffered due to contaminated pharmaceutical products.
Our experienced legal team is here to guide you through the process and fight for the compensation you deserve. Contact Schmidt & Clark, LLP today for a free, no-obligation consultation.
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Table Of Contents
- Oral Rinse Lawsuit Overview
- Latest Oral Rinse Lawsuit Updates
- FDA Reports and Statistics
- Oral Rinse Contamination Dangers & Side Effects
- Do You Qualify for an Oral Rinse Lawsuit?
- Oral Rinse Recall Information
- Statute of Limitations for Oral Rinse Lawsuits
- FAQs
- 1. Can I file an individual lawsuit instead of joining a class action in the Oral Rinse case?
- 2. What should I do if my claim related to an oral rinse product is denied?
- 3. How can an attorney help with an Oral Rinse lawsuit?
- 4. How long does an Oral Rinse lawsuit typically take to resolve?
- 5. What if I don’t have the product packaging or receipt anymore?
- 6. Can I file a lawsuit if I used the contaminated oral rinse but didn’t develop an infection?
- 7. What is Burkholderia lata and why is it dangerous?
- Take Action Now: Time-Sensitive Legal Claims
- References
Oral Rinse Lawsuit Overview
The Oral Rinse lawsuit addresses serious health risks associated with Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free products contaminated with the bacteria Burkholderia lata.
According to the U.S. Food & Drug Administration (FDA), Lohxa LLC recalled multiple lots of this product after being notified by the manufacturer, Sunstar Americas Inc., of potential bacterial contamination [1].
This nationwide recall affects institutional-use oral rinse products that may cause serious oral and systemic infections, particularly in immunocompromised patients where life-threatening conditions like pneumonia and bacteremia could develop.
Latest Oral Rinse Lawsuit Updates
November 9, 2020
– Lohxa LLC initiated a recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free products bearing expiration dates from January 31, 2021, through March 31, 2021, due to potential contamination with Burkholderia lata bacteria. The recall follows notification from the manufacturer, Sunstar Americas Inc., about the contamination issue.
FDA Reports and Statistics
According to the FDA and Centers for Disease Control and Prevention (CDC), healthcare-associated infections from contaminated medical products pose significant health risks.
Key statistics about healthcare-associated infections include [2]:
- Approximately 1 in 31 hospital patients has at least one healthcare-associated infection on any given day
- Healthcare-associated infections result in an estimated 99,000 deaths annually in the United States
- The economic burden of healthcare-associated infections is estimated at $28-45 billion per year
- Immunocompromised patients are 5-10 times more likely to develop serious complications from contaminated medical products
- According to the FDA’s Adverse Event Reporting System, oral care products account for approximately 3% of reported adverse events related to healthcare products
Oral Rinse Contamination Dangers & Side Effects
Using Chlorhexidine Gluconate Oral Rinse contaminated with Burkholderia lata bacteria can lead to various serious health complications, with elevated risks for immunocompromised individuals.
- Oral Infections: Localized infections of the gums, teeth, and oral tissues that may cause pain, swelling, and further deterioration of oral health
- Respiratory Infections: Pneumonia and other respiratory tract infections when bacteria from contaminated oral rinse is aspirated into the lungs
- Bloodstream Infections: Bacteremia (bacteria in the bloodstream) that can lead to sepsis, a life-threatening condition requiring emergency medical treatment
- Systemic Complications: Spread of infection to various organ systems, particularly dangerous in patients with compromised immune systems
- Antibiotic-Resistant Infections: Burkholderia lata bacteria may be resistant to common antibiotics, making infections more difficult to treat
Do You Qualify for an Oral Rinse Lawsuit?
You may qualify for an Oral Rinse lawsuit if:
- You used Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free with one of the following lot numbers:
- T09101A — Expiration Date 01/2021
- T08292A — Expiration Date 02/2021
- T10011A — Expiration Date 02/2021
- M10193A — Expiration Date 03/2021
- T10223A — Expiration Date 03/2021
- You developed an oral infection, pneumonia, bacteremia, or other infection after using the recalled oral rinse
- You sought medical treatment for your infection
- You were prescribed antibiotics or required hospitalization for the infection
- You are immunocompromised and suffered severe complications from using the contaminated product
- You have documentation linking your use of the oral rinse to your infection or illness
Evidence Required for an Oral Rinse Lawsuit
To support your Oral Rinse lawsuit, you will need:
- Proof of use of the recalled Chlorhexidine Gluconate Oral Rinse (prescription records, receipts, packaging)
- Medical records documenting your infection or illness
- Laboratory test results confirming Burkholderia lata or related bacterial infection if available
- Documentation of your treatment course, including antibiotics prescribed
- Medical expenses related to treating the infection
- Documentation of any hospitalization required for the infection
- Records of any long-term health effects resulting from the infection
Damages You Can Recover
In a successful Oral Rinse lawsuit, you may be entitled to compensation for:
- Medical expenses related to the treatment of your infection
- Hospital bills and emergency room costs
- Medications, including antibiotics and other treatments
- Lost wages if you had to miss work due to your illness
- Pain and suffering caused by the infection
- Emotional distress resulting from the illness and treatment
- Long-term health complications resulting from the infection
- In cases of death, wrongful death damages for surviving family members
Oral Rinse Recall Information
The recall affects Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free products from Lohxa LLC.
Key recall details include:
- Recall Date: November 9, 2020
- Product Name: Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol-free
- Product Code: NDC:70166-027-15
- Affected Lot Numbers:
- T09101A — Expiration Date 01/2021
- T08292A — Expiration Date 02/2021
- T10011A — Expiration Date 02/2021
- M10193A — Expiration Date 03/2021
- T10223A — Expiration Date 03/2021
- Contaminant: Burkholderia lata bacteria
- Distribution: Institutional use only, nationwide
- Product Use: Professional program for the treatment of gingivitis
- Manufacturer: Sunstar Americas Inc.
- Distributor: Lohxa LLC
Statute of Limitations for Oral Rinse Lawsuits
The statute of limitations for product liability and personal injury cases, including Oral Rinse lawsuits, varies by state but typically ranges from 1-6 years from the date of injury or discovery of the injury.
Some states have a “discovery rule,” which means the time limit begins when you discover or reasonably should have discovered that your injury was caused by the contaminated product.
In cases where the affected individual is a minor, the statute of limitations may be extended until they reach the age of majority. It’s crucial to consult with an attorney as soon as possible to ensure you don’t miss the filing deadline in your state.
FAQs
Take Action Now: Time-Sensitive Legal Claims
Time is limited to pursue legal action for infections caused by contaminated Chlorhexidine Gluconate Oral Rinse. Most states have a statute of limitations of only 1-6 years from the date of injury or discovery of the injury, so it’s crucial to act promptly to protect your legal rights.
At Schmidt & Clark, LLP, we offer:
- Free, confidential consultations to evaluate your case
- No upfront costs or fees for our legal services
- Payment only if we win your case
Don’t delay in seeking the compensation you deserve. Contact our experienced legal team today to discuss your potential Oral Rinse lawsuit.
References
1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-chlorhexidine-gluconate-oral-rinse-usp-012-due
2.https://pmc.ncbi.nlm.nih.gov/articles/PMC3528178/#:~:text=The%20Centers%20for%20Disease%20Control,obtained%20from%20multiple%20healthcare%20databases.