A Lemtrada lawsuit may be an option for patients who have experienced serious side effects related to the treatment, including rare but serious cases of stroke and tears in the lining of arteries in the head and neck. Lemtrada is a prescription drug used to treat adults who suffer from relapsing forms of multiple sclerosis.
In addition to a possible risk of stroke and arterial dissection, other adverse health risks have been associated with the use of Lemtrada. Affected patients and their families may be able to pursue a claim and recover compensation with the help of a dangerous drug attorney.
If you or a loved one have been adversely affected by a potentially dangerous drug, contact the Johnson Firm to learn about your options. We offer free, no obligation consultations. We can help answer your questions and determine whether you have a claim You can contact us by filling out the form on this page, calling us at 501-777-7777, or emailing us at [email protected].
What is Lemtrada?
Lemtrada (alemtuzumab) is a prescription medication, given intravenously, used to treat patients with relapsing forms of multiple sclerosis. Lemtrada is typically reserved for adult patients who have not responded adequately to two or more other drugs used for the treatment of multiple sclerosis. Lemtrada is given over the course of 4 hours for 2 treatment courses. The first treatment phase is given over a period of 5 consecutive days, and the second phase is given a year later for 3 consecutive days for a total of 8 doses over 2 years. According to the drug’s prescription information, patients are monitored for possible side effects in the months following a patient’s last infusion.
How Is Lemtrada Used to Treat Patients With Multiple Sclerosis?
Multiple sclerosis is a chronic, progressive disease in which the nerve cells in the brain and spinal cord become damaged.
Symptoms of multiple sclerosis may include the following:
- Vision loss
- Loss of balance
- Slurred speech
- Impaired coordination
According to the National Multiple Sclerosis Society, it is estimated that more than 2.3 million people are affected by multiple sclerosis worldwide.
Lemtrada is a type of drug known as a humanized monoclonal antibody (cloned antibodies developed for humans) directed at a protein on the surface of immune cells known as CD52. Alemtuzumab was originally approved, at a significantly higher dose, to treat patients with chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. Early clinical tests suggested that the active ingredient, alemtuzumab, might be useful as a treatment for multiple sclerosis.
Lemtrada Side Effects
According to the drug’s manufacturer, the most common side effects of Lemtrada include:
- thyroid problems
- swelling of your nose and throat
- urinary tract infection
- feeling tired
- trouble sleeping
- upper respiratory infection
- herpes viral infection
- fungal infection
- joint pain
- pain in your arms or legs
- back pain
- sinus infection
- mouth pain or sore throat
- tingling sensation
- stomach pain
- sudden redness in face, neck, or chest
Other Serious Side Effects of Lemtrada
According to the drug’s manufacturer, Lemtrada may cause serious side effects, including:
- Serious autoimmune problems – Some patients may develop a condition in which the immune cells in the body attack other cells or organs in the body, including a condition known as immune thrombocytopenic purpura (ITP), which can potentially lead to excessive bleeding and other life-threatening problems. In addition, kidney problems known as anti-glomerular basement membrane disease may occur, and if not treated, could lead to severe kidney damage, kidney failure or even death.
- Serious infusion reactions – Serious infusion reactions may occur during and up to 24 hours or longer after receiving Lemtrada. These reactions can possibly lead to death. Symptoms associated with these types of reactions may include swelling in the mouth or throat; trouble breathing; weakness; fast, slow, or irregular heartbeat; chest pain; or rash.
- Stroke and tears in the carotid and vertebral arteries – Some patients have had serious and sometimes deadly strokes and tears in the carotid or vertebral arteries within 3 days of receiving Lemtrada.
- Certain cancers – Patients receiving Lemtrada are at an increased risk of getting some types of cancers, including thyroid cancer, melanoma, and lymphoproliferative disorders and lymphoma.
Additional serious health risks associated with the use of Lemtrada may include:
- Thyroid problems, including hyperthyroidism (overactive thyroid) or hypothyroidism (underactive thyroid)
- Low blood counts (cytopenias)
- Serious infections, including herpes viral infections, tuberculosis, hepatitis, and listeria
- Inflammation of the gall bladder without gallstones (acalculous cholecystitis)
- Swelling of lung tissue (pneumonitis)
As a result of these risks, Lemtrada is only available through a program called the Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program.
FDA Safety Announcement
On November 29, 2018, the FDA published a safety announcement warning the public about “serious cases of stroke and tears in the lining of arteries in the head and neck.”
According to the FDA, these problems have occurred in patients with multiple sclerosis shortly after they received the treatment.
Some of the problems reportedly can lead to permanent disability and even death. As a result, the FDA has required that the drug carry a new warning about the risk on the drug’s prescribing information.
Likewise, the FDA suggests that patients or their caregivers seek emergency treatment if the patient experiences signs or symptoms of a stroke or tears in the lining of the head and neck arteries (arterial dissection).
Those symptoms may include:
- Sudden numbness or weakness in the face, arms, or legs, especially if it occurs on only one side of the body
- Sudden confusion, trouble speaking, or difficulty understanding speech
- Sudden trouble seeing in one or both eyes
- Sudden trouble with walking, dizziness, or loss of balance or coordination
- Sudden severe headache or neck pain
Lemtrada was approved by the FDA in 2014, and since the drug’s approval, 13 cases of ischemic and hemorrhagic stroke or arterial dissection have been identified. Twelve of those cases reported symptoms within one day of receiving Lemtrada. Only those cases submitted to the FDA have been included in the warning; the FDA may be unaware of additional cases that may have occurred.
Has There Been a Lemtrada Recall?
A Lemtrada recall has not been issued by the drug’s manufacturer or the FDA. According to the FDA, “a drug recall is the most effective way to protect the public from a defective or potentially harmful product.”
In most cases, drug recalls are voluntary, often taken by a company or the drug manufacturer to remove a potentially dangerous drug from the market. In other cases, however, the FDA will request that a drug be recalled after receiving reports of issues with the defective drug product.
Although Lemtrada has not been recalled or withdrawn from the market, future lawsuits could potentially allege that the drug’s manufacturer failed to disclose known side effects of the drug and that patients suffered injuries as a result. If a drug company fails to warn patients of possible side effects, the company could be legally liable, regardless of whether the drug has been recalled.
Is There a Lemtrada Class Action Lawsuit?
A Lemtrada class action lawsuit action has not been filed on behalf of patients who suffered serious complications related to the treatment. It is doubtful that a class action will be filed on behalf of those who have been affected by the drug.
When a number of dangerous drug lawsuits are filed against the drug manufacturers, it is possible that those lawsuits will be consolidated for discovery as well as other pretrial proceedings.
In the United States, complex cases, including those including potentially dangerous drugs, are often combined in one federal court to more efficiently process cases that may involve hundreds or thousands of plaintiffs across dozens of federal courts. This process is known as multidistrict litigation (MDL), and at the state level the process is known as a state court consolidated proceeding.
Because many dangerous drug lawsuits share common issues, it is generally agreed that this type of legal procedure is more effective in handling claims related to injuries caused by dangerous and defective drugs.
Once an MDL or state court consolidated proceeding begins, a bellwether trial may take place in order to get an idea of the types of evidence and arguments that will be made. Many bellwether trials shape the process for any remaining cases, and attorneys for both sides often want to see how juries will respond to the allegations made in the lawsuits.
Have There Been Any Lemtrada Lawsuit Settlements?
In some cases, dangerous drug lawsuits settle early in the legal process. Attorneys do not expect for any settlements to be reached at this time. Instead, it is possible that any potential Lemtrada lawsuits would be consolidated in federal court.
If this were to happen, the parties involved would be in a better position to determine whether a case can be settled. Lemtrada lawsuit attorneys note that the outcome of any case is never guaranteed, and that the results of other dangerous drug lawsuit do not necessarily ensure future outcomes of other lawsuits.
How a Lemtrada Lawsuit Attorney Can Help
Drug makers have a duty to provide safe products. If there are risks of harm associated with their products, they also must provide adequate warnings. If a drug maker fails to fulfill this duty, it could be held liable in lawsuits for injuries that may result.
People injured by Lemtrada, or other similar drugs containing the active ingredient, may be eligible to recover money for:
- Medical Expenses
- Lost Wages
- Pain and Suffering
The families of those who have died may be eligible to recover money for funeral expenses and the pain that comes with losing a loved one.