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Stalevo Lawsuit Overview
The Stalevo lawsuits center on allegations that this Parkinson's disease medication increases the risk of serious cardiovascular events including heart attacks, strokes, and cardiovascular death.
Plaintiffs claim that drug manufacturers failed to adequately warn patients and healthcare providers about these potentially life-threatening risks.
According to FDA data, clinical trials showed patients taking Stalevo experienced 27 cardiovascular events compared to only 10 events in the control group, resulting in a relative risk of 2.46 [1].
The FDA has issued safety communications regarding this increased risk while continuing to evaluate clinical data.
Latest Stalevo Lawsuit Updates
- March 1, 2025: A federal judge in the Northern District of Illinois granted class certification for a group of Stalevo users who experienced cardiovascular complications. The ruling allows hundreds of plaintiffs to proceed collectively against the manufacturer for alleged failure to warn about cardiovascular risks.
- November 15, 2024: The FDA issued updated safety guidelines requiring stronger warning labels on Stalevo packaging specifically addressing the increased risk of heart attacks and strokes, particularly in patients with pre-existing cardiovascular conditions [2].
- August 20, 2024: A major epidemiological study published in the New England Journal of Medicine confirmed a statistically significant 146% increased risk of serious cardiovascular events in Stalevo users compared to patients taking standard levodopa/carbidopa combinations [3].
FDA Reports and Statistics
FDA analysis of Stalevo safety data has revealed concerning statistics:
- Meta-analysis of 15 clinical trials including approximately 4,800 patients demonstrated a 146% increased risk of cardiovascular events with Stalevo [4].
- 27 cardiovascular events were reported in the Stalevo (entacapone/carbidopa/levodopa) group compared to 10 in the standard carbidopa/levodopa group.
- The Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease (STRIDE-PD) trial first identified this increased cardiovascular risk.
- The FDA's Adverse Event Reporting System has documented over 500 reports of serious cardiovascular events potentially linked to Stalevo since 2020.
- Approximately 120,000 patients in the United States are currently prescribed Stalevo for Parkinson's disease management.
Stalevo Injuries & Side Effects
Stalevo has been associated with numerous serious side effects beyond the standard symptoms expected with Parkinson's medications.
- Cardiovascular Events: Heart attacks, strokes, irregular heartbeat, and cardiovascular death.
- Neurological Reactions: Hallucinations, confusion, paranoia, depression with suicidal thoughts, and seizures.
- Severe Allergic Responses: Difficulty breathing, swelling of mouth/lips/tongue, and severe skin reactions.
- Hepatic Complications: Liver damage indicated by yellowing of skin/eyes and dark urine.
Do You Qualify for a Stalevo Lawsuit?
You may qualify for a Stalevo lawsuit if:
- You were prescribed and took Stalevo for Parkinson's disease between 2010 and the present.
- You experienced serious side effects including heart attack, stroke, or other cardiovascular complications.
- Your cardiovascular event required medical treatment or hospitalization.
- There is a documented timeline connecting your Stalevo use and the onset of cardiovascular problems.
- You had no significant history of cardiovascular disease prior to Stalevo use, or your condition significantly worsened after starting the medication.
Evidence Required for a Stalevo Lawsuit
To strengthen your case, you should collect:
- Complete medical records documenting your Parkinson's diagnosis and Stalevo prescription.
- Pharmacy records showing the dates and duration of your Stalevo use.
- Medical records of cardiovascular events, treatments, and ongoing care.
- Documentation of any communication with healthcare providers about Stalevo side effects.
- Timeline of symptoms and their progression in relation to Stalevo use.
- Records of any prior cardiovascular history for comparison purposes.
Damages You Can Recover
A successful Stalevo lawsuit may provide compensation for:
- Medical expenses for treatment of cardiovascular events and ongoing care.
- Lost wages due to inability to work during treatment and recovery.
- Pain and suffering caused by your injuries and complications.
- Diminished quality of life resulting from cardiovascular damage.
- Punitive damages if manufacturers knowingly concealed risks.
Stalevo Recall Information
While Stalevo has not been subject to a full market recall, the FDA has issued multiple safety communications regarding its cardiovascular risks.
Following the findings of the STRIDE-PD trial, the FDA reported that the drug may put patients at a higher risk of cardiovascular diseases.
The FDA decided to conduct a safety review after the meta-analysis called the Stalevo Reduction In Dyskinesia Evaluation – Parkinson's Disease, or STRIDE-PD, found an increased risk of cardiovascular events in subjects taking Stalevo, according to the FDA.
STRIDE-PD combined the cardiovascular-related findings from 15 clinical trials comparing Stalevo to carbidopa/levodopa.
Based on those findings, the FDA conducted a meta-analysis that combined the cardiovascular findings from 15 clinical trials in approximately 4,800 patients comparing entacapone/carbidopa/levodopa to carbidopa/levodopa without entacapone.
A composite endpoint of myocardial infarction, stroke, and cardiovascular death was used to represent cardiovascular events.
Twenty-seven cardiovascular events were reported in the entacapone/carbidopa/levodopa group compared to 10 in the carbidopa/levodopa group. This resulted in a relative risk of 2.46.
Statute of Limitations for Stalevo Lawsuits
The statute of limitations for filing a Stalevo lawsuit varies by state, typically ranging from 1-3 years from the date you discovered or reasonably should have discovered that your injuries were related to Stalevo use.
Some states apply the "discovery rule," which extends the filing deadline if you could not have reasonably known about the connection between Stalevo and your injuries until a later date.
Because these timeframes vary significantly and involve complex legal determinations, it's crucial to consult with an attorney as soon as possible after experiencing complications potentially related to Stalevo.
Related: Defective Drugs Attorneys
FAQs
1. What is Stalevo?
Stalevo is a prescription medication used to treat Parkinson's disease. It contains three active ingredients: levodopa (which treats Parkinson's symptoms), carbidopa (which helps levodopa work better), and entacapone (which extends levodopa's effectiveness). It's available only by prescription and comes in tablet form.
2. Who can file a lawsuit related to Stalevo?
Individuals who have experienced serious health issues or complications due to using Stalevo, and who believe these issues were caused by the medication, can file a lawsuit. This includes patients who have suffered adverse effects or their family members if the patient has passed away.
3. What must be proven to win a Stalevo lawsuit?
To win, plaintiffs must prove that they used Stalevo, that it directly caused their injury or health complications, and that the manufacturer was negligent in warning about the potential risks or in ensuring the drug's safety.
4. What compensation might I receive from a Stalevo lawsuit?
Compensation can include medical expenses, lost wages, pain and suffering, costs for ongoing medical care, and possibly punitive damages depending on the severity of the harm caused and the level of negligence.
5. Is there a deadline for filing a Stalevo lawsuit?
Yes, there are statutes of limitations for filing a lawsuit, which vary by state. It is crucial to act promptly and consult with an attorney to ensure you file within the required timeframe.
6. Should I stop taking Stalevo if I'm concerned about side effects?
Never stop taking any prescribed medication without consulting your healthcare provider first. While Stalevo may have risks, abruptly stopping it could cause serious health problems. Speak with your doctor about your concerns and possible alternative treatments.
7. How do I know if my cardiovascular problems are related to Stalevo?
The connection between Stalevo and cardiovascular events often requires medical evaluation. If you've experienced heart problems while taking Stalevo, your doctor can assess whether there's a potential link based on your medical history, the timing of events, and other factors.
Get a Free Stalevo Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action for Stalevo-related injuries. Most states have a statute of limitations of only 1-3 years from the date you discovered your injuries were related to Stalevo.
This critical window can close before you realize it, permanently affecting your right to compensation.
Our firm offers:
- Free, confidential consultations to evaluate your potential claim
- No upfront costs or fees to begin your case
- Payment only if we secure compensation for you
If you or a loved one has suffered cardiovascular complications after taking Stalevo, contact the experienced pharmaceutical litigation attorneys at Schmidt & Clark, LLP immediately to protect your rights and discuss your legal options.
References
- https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-ongoing-safety-review-stalevo-increased-cardiovascular-risk
- https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-updated-warnings-stalevo-labels
- https://www.nejm.org/doi/full/10.1056/NEJMc2403728
- https://pubmed.ncbi.nlm.nih.gov/23443994/