Roche’s Actemra was heralded as a breakthrough therapy for rheumatoid arthritis when it was introduced in 2010.
The drug’s website proclaims that “Actemra works differently” and shows a patient happily scuba diving and walking on a tropical beach. But nowhere does Roche mention certain side effects that may have contributed to more than 1,100 patient deaths.
Research suggests that Actemra patients, compared to those taking competing rheumatoid arthritis drugs, face similar risks for heart attacks, heart failure, strokes, lung disease, and pancreatitis. But unlike the competition, Actemra’s label does not warn about these side effects.
If you or a loved one suffered serious Actemra side effects including heart, lung, or pancreatic side effects while taking Actemra, contact Actemra lawyer Timothy L. Miles today for a free case evaluation to see if you are eligible for an Actemra lawsuit. If you meet the requirements for an Actemra lawsuit you may be entitled to substantial compensation.
WHAT ARE THE ACTEMRA SIDE EFFECTS TO THE HEART AND LUNGS?
A STAT News report and postmarketing studies raise questions about the adequacy of Actemra's safety warnings.
STAT reviewed more than 500,000 adverse event reports on leading rheumatoid arthritis drugs, including Actemra, Humira, and Remicade. STAT found evidence that Roche downplayed Actemra’s cardiovascular, pancreatic, and lung side effects.
According to STAT, from 2010 to 2016 the U.S. Food and Drug Administration (FDA) logged more than 13,500 Actemra adverse event reports, including 1,128 patients who died after taking Actemra.
While safety data indicate the risks of heart attacks, strokes, heart failure, and interstitial lung disease are as high or higher for Actemra patients than for patients taking some similar drugs, Actemra’s warning label—unlike its competition's—does not reflect these risks.
For example, Actemra patients reported more cases of interstitial lung disease than Remicade patients, and nearly the same number as Humira patients. But while Remicade and Humira have interstitial lung disease warnings, Actemra does not.
STAT’s findings are supported by postmarketing studies—clinical studies conducted after a pharmaceutical product goes on the market to better understand drug risks.
The FDA ordered Actemra postmarketing studies because premarket testing revealed potentially worrisome side effects. One such study compared Actemra to another arthritis drug, Enbrel, and found rates of stroke and heart failure were about 1.5 times higher in Actemra users. Enbrel has strong warnings for patients with cardiovascular disease. Actemra does not have similar warnings despite similar or worse cardiovascular risks.
The takeaway from these findings is that doctors and patients may not be getting a complete picture of Actemra’s risk-benefit profile.
DO DRUG MANUFACTURERS HAVE A DUTY TO WARN?
Pharmaceutical products are not expected to be completely without harmful side effects. But if a drugmaker understands that a drug presents a certain risk, it has a duty to put an appropriate warning label on the product. That way patients and their doctors can evaluate all known risks and benefits and make an educated decision about whether a medication is right for them.
While the FDA has authority to demand warning labels, the responsibility ultimately falls on drug manufacturers. Actemra has garnered FDA attention since it was approved in 2010. At one point the agency considered a pancreatitis warning label. But Genetech/Roche talked the FDA out of the warning. The agency then approved broader use of Actemra for giant cell arteritis.
Conflicts of interest between manufacturers and regulators plague the drug safety system. The STAT report details how all 11 authors of an Actemra postmarketing study had financial ties to Roche or Genetech. And a former FDA manager who oversaw Actemra’s approval for rheumatoid arthritis now works for Roche, where he helps gain FDA approval for new uses of the drug.
The drug safety system, in other words, cannot always be trusted to put patient safety first. That’s why, when patients suffer harm from drug side effects, they often must turn to the legal system.
HOW DO I KNOW IF I AM ELIGIBLE FOR AN ACTEMRA LAWSUIT?
We are looking into claims that Genetech/Roche failed to warn about the following Actemra side effects:
Actemra patients who suffered any of these Actemra side effects may be eligible for an Actemra lawsuit.
IF I MEET THE REQUIREMENTS FOR AN ACTEMRA LAWSUIT, WHAT CAN I GET?
If you meet the requirements for an Actemra lawsuit and are successful you can recover money for some of the following damages:
• Past and future medical bills (including medication, hospital stays, and in-home care)
• Pain and suffering
• Lost wages
• Loss of earning capacity
• Funeral expenses (in the event of a loved one’s death)
Broadly speaking, a plaintiff who is eligible for an Actemra lawsuit could be entitled to compensation for any past and future costs associated with their diagnosis if they meet the requirements for an Actemra lawsuit and are successful.
HOW MUCH DOES IT COST TO HIRE AN ACTEMRA LAWYER IF I MEET THE REQUIREMENTS FOR AN ACTEMRA LAWSUIT?
It does not cost anything to hire an Actemra lawyer. We take all cases on a contingency basis which means we do not get paid unless we win your case. An Actemra lawyer can explain the process and answer any questions you may have including whether you are eligible for an Actemra lawsuit.
CALL AN ACTEMRA LAWYER TODAY IF YOU SUFFERED SERIOUS ACTEMRA SIDE EFFECTS?
If you or a loved one suffered serious Actemra side effects including heart, lung, or pancreatic side effects while taking Actemra, contact Actemra lawyer Timothy L. Miles today to see if you are eligible for an Actemra lawsuit. If you meet the requirements for an Actemra lawsuit you may be entitled to substantial compensation.
Timothy L. Miles is a nationally recognized shareholder and consumer rights attorney raised in Nashville, Tennessee. Mr. Miles was recently selected by Martindale-Hubbell® and ALM as a 2023 Top Ranked Lawyer, 2023 Top Rated Litigator. and a 2023 Elite Lawyer of the South. Mr. Miles also maintains the AV Preeminent Rating by Martindale-Hubbell®, their highest rating for both legal ability and ethics. Mr. Miles is a member of the prestigious Top 100 Civil Plaintiff Trial Lawyers: The National Trial Lawyers Association, a superb rated attorney by Avvo, a recipient of the Lifetime Achievement Award by Premier Lawyers of America (2019) and recognized as a Distinguished Lawyer, Recognizing Excellence in Securities Law, by Lawyers of Distinction (2019). Mr. Miles has published over sixty articles on various issues of the law, including class actions, whistleblower cases, products liability, securities fraud, civil procedure, corporate formation, corporate takeover litigation, derivative lawsuits, and more. Visit out website.
The Law Offices of Timothy L. Miles
Tapestry at Brentwood Town Center
300 Centerview Dr., #247
Brentwood, TN 37027
Phone: (855) 846-6529
Email: [email protected]
HOURS OF OPERATION