Our experienced attorneys believe that thousands of patients, along with families who have lost loved ones to the drug’s potential side effects, may be eligible to file Actemra lawsuits. A significant number of lawsuits may convince Roche that settling the legal actions would be a more effective approach than defending against each individual claim in court. Again, it’s impossible to predict the course of any litigation at such an early stage. We will update this page immediately after any settlements or other developments are announced.
Why Are Patients Filing Actemra Lawsuits?
In court documents, patients report developing major cardiovascular, lung and pancreas disorders after being prescribed the new “biological” medication. Citing a body of growing medical evidence, plaintiffs say that Actemra significantly increases the risk for heart attack, stroke, pancreatitis and a range of interstitial lung diseases.
Many of these risks have been on the FDA’s radar for years. In fact, most of Actemra’s direct competitors, including the blockbuster drug Humira, can cause very similar side effects. The real difference is a matter of warnings. Humira, Remicade and most other competitor products warn doctors and patients about the risk of heart attack, stroke and interstitial lung disease through their labeling materials.
Plaintiffs Cite Lack Of Warnings
Actemra does not. In fact, Roche has always advertised Actemra as the safer option, noting supposedly lower rates of severe complications. The company’s marketing claims are of critical importance. Traditional treatments for rheumatoid arthritis, especially those targeted at the autoimmune disorder’s long-term effects, often carry severe side effects of their own. Methotrexate, a chemotherapy drug, is the current standard-of-care for most patients. Many people come to dread their treatment just as much as their underlying disorder.
In this context, a rheumatoid arthritis medication with substantial benefits and minimal risks could help hundreds of thousands of patients – and make its manufacturer a lot of money. That’s exactly how Roche advertised Actemra – as a rheumatoid arthritis drug that, unlike Humira and Remicade, have never been linked to heart attacks, heart failure or deadly lung diseases.
Sales data compiled by YCharts shows how well Roche’s marketing worked. Since receiving FDA approval in 2010 (European approval came one year earlier), the drug’s overall sales have continued to grow, eventually becoming the fifth best-selling medication in Roche’s stable of drugs.
A “Unique” Drug – With Hidden Risks?
Actemra’s unique mechanism of action was cited as the difference. Humira and Remicade work by blocking the action of tumor necrosis factors, a class of proteins largely responsible for inflammation. Actemra, on the other hand, takes a more selective approach, knocking out a single protein involved in inflammatory responses: interleukin-6. The hope, at the time of Actemra’s approval, was that this targeted technique would lead to fewer complications.
In reality, recent studies have found that Actemra may cause severe side effects just as frequently as Humira, Remicade and other market competitors. An analysis commissioned by medical reporting organization STAT, which reviewed over 500,000 side effect reports submitted to the Food & Drug Administration, found nearly “identical” rates of heart failure and pancreatitis shared by Actemra and Humira. Actemra patients suffered even more cases of interstitial lung disease than people taking Remicade, a drug manufactured by Johnson & Johnson-subsidiary Janssen.
Side Effect Reports Not Reflected In Warning Label
The problem? Both Humira and Remicade, in their packaging materials, come with prominent warnings about these risks. Doctors are advised to use extreme caution before prescribing the drugs to patients with pre-existing cardiovascular conditions. Humira’s labeling clearly indicates that interstitial lung disease has been identified as a potential risk.
The warning label for Actemra bears little resemblance to the materials included along with every prescription of Humira and Remicade. In the FDA-approved label for Actemra, pancreatitis is never mentioned. Neither is interstitial lung disease. Myocardial infarction (the technical name for a heart attack) and stroke are, similarly, left out.
That’s a huge problem, patients say in their recently-filed Actemra lawsuits. Neither the medical community nor the public are being given the full information on Actemra’s risks, the plaintiffs claim. In fact, and in contrast to the results of recent research, Roche is actively marketing Actemra as a safer rheumatoid arthritis, making explicit reference to the horrible side effects associated with methotrexate online and in print advertisements. As a result, many patients have been switched to the “safer” drug, only to suffer the same severe complications they were trying to avoid in the first place.
Who Can File A Lawsuit?
The experienced pharmaceutical attorneys at The Product Lawyers are now consulting patients who developed severe side effects after taking Actemra. We also offer guidance to families who have lost loved ones to Actemra-related complications:
- interstitial lung diseases
- heart attack
Contact our lawyers today to secure a free consultation and learn more about your legal options.