A Lemtrada lawsuit may be an option for people who have experienced serious complications associated with the drug, including rare but serious cases of stroke and tears in the lining of arteries in the head and neck. Lemtrada is a prescription medication indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.
In addition to the potential risk of stroke, Lemtrada has been linked to other serious side effect and health risks. 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 Attorney Group to learn about your options. We offer free, no obligation consultations. We can help answer your questions, and if you choose to pursue a claim we can connect you with an affiliated attorney who can assist you throughout the legal process.
Have You Seen a Lemtrada Lawsuit Commercial?
You may have seen a Lemtrada lawsuit commercial on television and wondered whether you or a loved one have been affected by it and similar drugs and, if so, whether you are eligible to pursue a claim against the drug manufacturer or distributor. The purpose of this article is to provide you with additional information about lawsuits and other litigation involving dangerous drugs so that you have a better understanding of your options.
What is Lemtrada?
Lemtrada (alemtuzumab) is a prescription medication used to treat patients who suffer from relapsing forms of multiple sclerosis (MS).
According to the drug’s prescribing information sheet, the use of Lemtrada should generally be reserved for patients who have tried at least two or more drugs to treat MS and who have had an inadequate response. Lemtrada is administered by intravenous infusion.
According to a news release issued by the National Multiple Sclerosis Society, the FDA approved Lemtrada in November 2014 based on the results of two clinical studies that “confirmed its ability to significantly reduce relapse rates over two years” and “suggested that Lemtrada may significantly reduce worsening of disability.” Lemtrada is manufactured by Genzyme, a subsidiary of Sanofi (previously Sanofi-Aventis).
What is Multiple Sclerosis and How Does Lemtrada Treat It?
MS is a disease that affects the central nervous system, disrupting the flow of information between the brain and the body. Symptoms of MS may include vision loss, loss of balance, pain, fatigue, slurred speech, tremors, numbness, paralysis and impaired coordination. According to the National Multiple Sclerosis Society, it is estimated that more than 2.3 million people are affected by MS worldwide.
Lemtrada is a humanized monoclonal antibody (cloned antibodies developed for humans) directed at CD52 (a protein on the surface of immune cells). It causes depletion of lymphocytes (white blood cells). Alemtuzumab was originally approved, at a significantly higher dose, for the treatment of B-cell chronic lymphocytic leukemia. Its ability to target immune cells led investigators to test its potential as a treatment for relapsing MS.
Other Lemtrada Treatment Uses
Alemtuzumab (the active ingredient in Lemtrada) is also used to treat chronic lymphocytic leukemia, cutaneous T-cell lymphoma and T-cell lymphoma under the brand names Campath, MabCampath and Campaht-1H.
In 2012, drug manufacturer Genzyme decided to pull cancer drugs Campath and MabCampath from U.S. and European markets to concentrate on marketing the drug as Lemtrada for MS patients.
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
Serious Side Effects of Lemtrada
Serious, and sometimes life-threatening, side effects associated with the use of Lemtrada may include:
- Serious autoimmune problems, including immune thrombocytopenia (a condition in which the immune system mistakenly attacks platelets potentially causing severe bleeding) and anti-glomerular basement membrane disease (a kidney problem that may result in severe kidney damage).
- Serious infusion reactions that may cause death. Symptoms associated with an infusion react may include swelling in the mouth or throat; trouble breathing; weakness; fast, slow or irregular heartbeat; chest pain; or rash.
- Certain cancers, including thyroid cancer, skin cancer (melanoma), and certain blood cancers (lymphoproliferative disorders and lymphoma).
Additional serious health risks associated with the use of Lemtrada may include:
- Thyroid problems, including overactive thyroid (hyperthyroidism) or underactive thyroid (hypothyroidism)
- 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 Warning Involving Lemtrada
On November 29, 2018, the FDA issued a safety announcement “warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in patients with multiple sclerosis (MS) shortly after they received Lemtrada (alemtuzumab).” According to the FDA, these problems can possibly lead to “permanent disability and even death.” The agency has added a new warning about the risks to the drug’s prescribing information.
The FDA is further suggesting 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), which 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
Since the FDA approved Lemtrada in 2014, 13 cases of ischemic and hemorrhagic stroke or arterial dissection have been identified. Twelve cases reported symptoms within one day of receiving the treatment.
Lauren A. on May 16, 2016
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Has There Been a Lemtrada Recall?
At the time of publication, a recall has not been issued for Lemtrada. In the event of a drug recall, they may be conducted by the drug manufacturer, by FDA request, or by FDA order.
Although Lemtrada has not been recalled or withdrawn from the market, potential litigation could possibly claim that the drug makers failed to disclose known side effects of the drug and that patients suffered damages as a result.
Failure to warn of side effects of a drug can be a basis of drug company liability, regardless of whether the drug has been recalled.
Is There a Lemtrada Class Action Lawsuit?
At the time of this article’s publication, a Lemtrada class action lawsuit action has not been filed on behalf of patients who suffered serious complications. Lemtrada lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the device.
Instead, if multiple lawsuits are filed against the manufacturers, alleging injuries and other damages caused by Lemtrada and similar drugs, it is anticipated that these potential lawsuits will be consolidated for discovery and other pretrial proceedings.
When cases are consolidated in this way in federal court it is called multidistrict litigation (MDL), and on a state level it is known as a state court consolidated proceeding.
MDLs are distinct from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient and effective way of handling claims arising from injuries caused by dangerous drugs.
In most cases that proceed in an MDL or state court consolidated proceedings, after a certain period of time initial trials, also known as bellwether trials, take place. The purpose of these trials is for the parties to get an idea of the types of evidence and arguments that will made, as well as to see how juries will respond to the evidence and arguments.
After a certain number of cases have been tried, the parties are in a better position to determine whether a case can be settled.
Have There Been Any Lemtrada Lawsuit Settlements?
Some dangerous drug lawsuits may settle early in the claims process. However, it is not expected that there will be any Lemtrada lawsuit settlements at this time. Instead, it is expected that Lemtrada lawsuits will be consolidated in federal court through an MDL. Lemtrada lawsuit attorneys note that the outcome of any case is never guaranteed, and past results are not necessarily predictive of future outcomes.
Lemtrada Lawsuit News
- November 2018The FDA issues a safety announcement warning patients and caregivers of the possibility for stroke and arterial dissection that have occurred in patients with multiple sclerosis shortly after they received treatment with Lemtrada.
- November 2014The FDA approves Lemtrada for the treatment of people with relapsing forms of MS.
- August 2012According to a report by PharmaTimes, drug manufacturer Genzyme decides to pull cancer drugs Campath and MabCampath from U.S. and European markets to concentrate on marketing the drug as Lemtrada for MS patients.
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.