Why Are Actemra Lawsuit Being Filed?
An Actemra lawsuit may be an option for patients who took the medication and suffered severe side-effects. New reports suggest that drug makers failed to adequately warn patients in the U.S. of risks of heart failure, life-threatening lung complication or pancreatitis allegedly associated with the medication, which is used for treatment of rheumatoid arthritis and other medical conditions. Affected patients and their families may be able to file a lawsuit and recover compensation for their injuries with the help of a bad drug attorney.
For more information, contact the Attorney Group. We offer free, confidential, no obligation consultations. We can help answer your questions, and if you choose to pursue a case we can connect you with an affiliated Actemra lawsuit attorney who can assist you throughout the legal process.
Have You Seen an Actemra Lawsuit Commercial?
You may have seen Actemra lawsuit commercial on television and wondered whether you or a loved one have been affected by Actemra and, if so, whether you are eligible to pursue a claim against the manufacturer or others. The purpose of this article is to provide you with additional information so that you have a better understanding of your options.
What is Actemra?
Actemra is the trade name for tocilizumab, a biologic drug developed to reduce the effects of a substance in the body that can cause inflammation leading to rheumatoid arthritis. As a biologic drug, it is man-made through genetic engineering, and it is closely related to a protein that occurs naturally in the body. Biologic drugs are used to suppress the immune system in autoimmune diseases.
One such autoimmune disease is rheumatoid arthritis. As an autoimmune disease, rheumatoid arthritis causes the body’s immune system – which normally protects its health by attacking foreign substances like bacteria and viruses – to mistakenly attack the joints. The resulting inflammation causes joint tissue to thicken and results in pain and swelling. Left unchecked, the inflammation can damage cartilage and the bones themselves.
In 2010, the U.S. Food and Drug Administration (FDA) approved Actemra for the treatment of adult patients with moderate to severe rheumatoid arthritis. Since its initial approval, Actemra has been approved for the treatment for other arthritic conditions in both adults and children. Additionally, it is reportedly prescribed “off-label” by doctors for a number of other conditions.
How Does Actemra Work?
Actemra was developed to inhibit the biological activity of a cytokine protein called Interleukin-6 (IL-6). IL-6 is produced in the body wherever there is inflammation, either acute or chronic. This includes inflammation caused by trauma, burns, cancers and infection. The connection between IL-6 and rheumatoid arthritis is not clear, but IL-6, in addition to other cytokines, are found in high concentrations in the joints of people with the disease. As with other autoimmune diseases, in rheumatoid arthritis the normal immune response to the presence of unhealthy factors in the body is somehow directed toward healthy tissue.
Actemra is designed to block the interleukin IL-6 receptor to stop the production of inflammation in the body. It is administered through an injection administered once every 1-2 weeks, or through an IV infusion administered monthly. It may given alone or with other medicines used to treat rheumatoid arthritis
The Actemra label includes a warning for a risk of serious infections, including tuberculosis, bacterial, invasive fungal, viral and other opportunistic infections.
Actemra Side Effects
As with other biologic therapies, a potentially serious side-effect of Actemra is an increased risk of bacterial infection.
Common side-effects of Actemra include:
- Runny or stuffy nose,
- Sinus pain,
- Sore throat,
- Mild stomach cramps, or
- Urinary tract infection (UTI).
In some cases, monitoring by a doctor may be required for persons to whom Actemra is administered.
Other Actemra Risks
In an article published in June 2017, Stat News wrote about Actemra under the headline:
Failure to Warn: Hundreds Died While Taking an Arthritis Drug, But Nobody Alerted Patients
In the article, the first of a two-part series focused on problems associated with monitoring the safety of new drugs, STAT claimed to have:
[A]nalyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs.
Moreover, the article claims that while most of those medications warn about these risks on their labels, Actemra does not.
In addition to the side effects listed in the lede for the story, the article reports on patients who took the drug experiencing:
- Heart palpitations
- “Brain Fog”
- Small strokes
- Hair loss
While the company denies any wrongdoing in connection with the drug, and one company representative is quoted as citing a study he characterizes as “definitive proof” that Actemra does not increase cardiovascular risk, “experts consulted by STAT disputed that claim.”
Moreover, the article noted that
In a review of millions of reports to the FDA involving more than 100 drugs approved since 2010, Actemra stood out. It showed that Actemra patients had experienced an unusually large number of serious side effects that didn’t appear on the drug’s warning label.
STAT also noted that 26 deaths from pancreatitis were reported in patients who took Actemra, out of 132 patients overall who developed the condition.
The article concedes that other risk factors can contribute to the serious conditions experienced by some patients who took Actemra, including those leading to heart problems and pancreatitis, but it questions the decision by the manufacturer to not list those risks on the drug’s label, providing warnings to doctors and patients, as the manufacturers of similar drugs have done.
Finally, the report notes that a condition of the approval of Actemra was that the manufacturer sponsor multiyear studies to monitor for “unseen problems” and cardiovascular events. However, the article points out that “one of the recurring criticisms of our drug safety system is that we rely upon the very companies that are so financially invested in a product’s success to conduct the studies that explore safety concerns.
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Actemra Lawsuit Claims
If news reports on the dangers of the drug are accurate, is anticipated that an Actemra lawsuit will be filed against the manufacturer of the drug alleging that known, severe side-effects and complications associated with the drug were withheld from patients, and that the company failed to properly warn about the dangers of the drug. In other, similar types of cases, the manufacturer is often sued for designing and manufacturing a dangerous and defective drug, for failing to warn of the dangers of associated with the drug, for negligence in the sale and manufacture of the drug, and for consumer fraud related to its sale and promotion.
Has There Been an Actemra Recall?
Although there has not been an Actemra recall, news reports 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 an Actemra Class Action?
There is no Actemra class action pending as of July 2017. Actemra lawsuit attorneys are doubtful that a class action will be certified for patients who are adversely affected by the drug. Instead, if multiple Actemra lawsuits are filed against the drug makers alleging injuries and other damages caused by Actemra, it is anticipated that these 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 pharmaceutical products.
Actemra Lawsuit News
- June 2017News reports claim that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs, but that the manufacturer had failed to include warnings about these risk on the drug’s label
- January 2010The FDA approves the use of Actemra for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
How an Actemra Lawsuit 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 bad drugs may be eligible to recover money for:
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.