Actemra, also known as tocilizumab, is a drug prescribed to treat adult rheumatoid arthritis and severe arthritis in children. It was first developed in Japan in the late 1990’s and is now sold by the Swiss drug company Hoffmann-La Roche (Roche).
Actemra was approved by the European Medicines Agency in 2009 and by the FDA in 2010. It is administered once a month by IV infusion or through an injection under the skin. The drug is also used to treat the arterial inflammatory disease giant-cell arteritis and is being studied for the treatment of pulmonary arterial hypertension and certain cancers.
The manufacturer of Actemra warns patients that they may experience some minor side effects like stomach pain, coughing, blurred vision, headaches or dizziness. However, recent studies have uncovered more severe risks.
In June, a study of more than 500,000 FDA drug side effect reports among rheumatoid arthritis patients found that more than 1,000 people have died so far from heart attacks, lung disease, stroke or pancreatitis while taking Actemra.
Not only have recent reports discovered higher risks than expected for heart attack, stroke, lung disease or pancreatitis among Actemra users, but the manufacturer didn’t warn these patients of the dangers.
When it was released in 2010, Actemra was heralded as a safer alternative to many of the existing rheumatoid arthritis drugs associated with dangerous side effects. However, it appears this was only because Roche concealed the risks.
Competing drugs like Humira and Remicade warn of the risk of interstitial lung disease and heart attack. Humira even cautions users of a stroke risk. However, the warning label for Actemra mentions none of these, despite similar or greater risks.
In fact, reports show Actemra has more side effects not mentioned on its warning label than most other drugs approved since 2010.
Roche knew of the risks of Actemra as early as 2009, when a study uncovered 15 patient deaths and 221 serious side effects in Japan, but the company has continued selling the drug without proper warnings.
Patients who’ve taken Actemra and experienced any of the following side effects may qualify for a lawsuit:
In addition, the families of anyone who died after taking Actemra should learn about their legal options as soon as possible.
Victims may be entitled to substantial compensation; however, the time to file a claim is limited.
No. Lawsuits against Roche for Actemra side effects are being filed in various state and federal courts around the country. As the number of claims grows, these cases may eventually be consolidated into a special venue called a multidistrict litigation (MDL) court for faster handling.
While MDL lawsuits have most of the benefits of a class action lawsuit, they’re different in that plaintiffs have the ability to pick which lawyer will represent them, and have more control over the handling and settlement of their case. They also usually result in more money going to victims rather than one single class action law firm.
Actemra lawsuits are fairly new and so far, none have reached a court verdict or settlement. Therefore, it is difficult to estimate the value of any individual case. However, any cases related to the life-threatening conditions of heart attack, stroke and lung disease can have substantial value.
Lawyers expect the damages to victims of this drug will reach into the hundreds of thousands of dollars for injuries, and into the millions for deaths. Values will differ based on the degree of injury, length of hospital stay, lost earnings, patient age and damage to family members.
It costs nothing to file a claim unless you receive an award, and the process is simple.
Actemra lawsuits are handled on a contingency fee basis, meaning your lawyer will cover all costs for investigation and filing of your claim, and they do not earn an attorney’s fee or costs unless there is an award. This is guaranteed in the written retainer contract you sign with your lawyer.
Your lawyer will also take care of gathering all necessary records and interviewing expert witnesses for your claim, therefore you will not need to leave your home except in rare situations. You can speak with a lawyer today at no cost and begin the process simply by contacting DrugNews.
This study, published at the American College of Rheumatology 2016 annual meeting, found that patients taking Actemra were 150% more likely to suffer heart attacks or stroke than those taking Enbrel. This, despite the fact that Enbrel contained warnings against use by patients with risks of heart failure or cardiovascular disease, while Actemra did not.
In a case study obtained under the Freedom of Information Act by the investigative journal STAT, a treating physician attributed the stroke and subsequent death of his 73-year-old patient to an Actemra IV treatment he had received two days earlier.
In another case study obtained through the FIA, Roche’s own report to the FDA detailing a heart attack suffered by a 62-year-old woman from Germany in 2014 attributed her condition to taking Actemra.
However, the company failed to alert the public or add any warnings for other patients.
In 2012, a New Jersey jury awarded $25.16 million to Andrew McCarrell, an Alabama man who filed a lawsuit accusing Roche’s Accutane of causing his inflammatory bowel disease.
McCarrell began taking the acne medication in his 20s, and within 15 years developed IBD so severe he had to undergo surgery to remove his colon. The verdict was the 9th Accutane lawsuit verdict loss by Roche, and the largest to date.
Beginning in 2007 and culminating with Roche’s recall of the acne medication Accutane in 2009, more than 6,000 patients filed suit in state and federal courts alleging the drug caused Crohn’s Disease or Inflammatory Bowel Disease. Over $40 million has been awarded to victims by juries so far.
This year, an appeals court revived more than 2,500 of the Accutane lawsuits that were previously dismissed, ruling that Roche will have to answer to victims in court.
In 2016, Indiana-based Econo-Med Pharmacy began a class action lawsuit against Roche alleging they violated the Telephone Consumer Protection Act (TCPA) and the Indiana Deceptive Consumer Sales Act by sending unrequested marketing faxes to pharmacies around the country.
The lawsuit was based on the fact Roche didn’t offer the pharmacies an opportunity to opt-out of the unsolicited marketing. In 2017, Roche agreed to pay a total of $17 million to settle the litigation.
In 1999 Roche agreed to pay $500 million as part of a total $725 million settlement, to resolve charges from the U.S. Department of Justice that they, along with two other companies producing most of the world’s vitamin supply, colluded to fix prices against consumers. At the time, the fine was the largest anti-trust penalty in history.
Study of more than 500,000 rheumatoid arthritis drug side effect reports to the FDA finds more than 1,100 patients have died after taking Actemra, many from undisclosed risks.
Study by Brigham & Women’s Hospital and Roche employees concludes no increased risk of heart attacks or stroke for Actemra compared to competing drugs; fails to mention competing drugs warn of some of these risks while Actemra doesn’t.
Columbia University study finds users of Actemra 1.5 times more likely to suffer a heart attack or stroke than those taking Enbrel, despite heart risk warnings on Enbrel and none on Actemra.
FDA review finds 258 cases or pancreatitis and 185 cases of interstitial lung disease reported among Actemra patients since clinical trials, despite no warnings by manufacturer.
Actemra approved for sale in the United States by the FDA.
Study of patients taking the recently-approved RA drug Actemra in Japan shows 15 already died and 221 reported serious side effects.
Actemra approved for sale in the European Union and Japan.
While the lawsuits against Roche for Actemra side effects are fairly recent, lawyers expect thousands of victims will eventually come forward to file a claim due to the widespread use of the drug.
In addition, the severe nature of the injuries associated with Actemra – heart attacks, stroke, lung disease, GI perforation and death – means the cases will seek significant damages for victims.
As the number of lawsuits grows, it is likely they will be consolidated to a federal multidistrict litigation court for faster handling. This will focus litigation in a special national court rather than in smaller local courts.
Due to the value and specialized nature of defective drug lawsuits, as well as the uniqueness of consolidated MDL courts, it is important for you to choose a law firm with substantial experience in these types of cases, and the resources to fight international drug companies.
The lawyer best qualified to handle your case may be in a different city or state than where you reside, however they should offer to come to you. They will also handle the gathering of all necessary records for your investigation and claim filing.
Your lawyer will likely appear on your behalf for all necessary meetings related to your case, therefore the chances are small that you will have to travel out of town even if your case is filed in a different state. Regardless, you should never be liable for attorney’s fees or case costs unless your lawyer secures compensation for you.
Most importantly, you should feel comfortable that your lawyer is accessible, that they have the ability to handle your case, and that they will keep you updated on the progress of your case.
DrugNews works only with lawyers and law firms that have handled tens of thousands of unique drug and medical device injury lawsuits. Contact us today to speak directly with a lawyer at no cost.