Actemra Lawsuits: Allegations, Evidence, and Label Warnings

If you took Actemra (tocilizumab) and later suffered a heart attack, stroke, heart failure, pancreatitis, or interstitial lung disease, you may be able to bring an Actemra lawsuit against Genentech and its parent company Roche. The claims are product liability cases built on a failure-to-warn theory: that the manufacturer knew about serious cardiovascular, pancreatic, and pulmonary risks and left them off the drug’s label even though competing arthritis drugs carried those same warnings.¹

Who Can File an Actemra Claim

To pursue a claim, a person generally must have been prescribed Actemra and then developed one of the serious conditions associated with the drug.² The injuries most commonly cited in the litigation are:

Heart attack or heart failure
Stroke
Pancreatitis
Interstitial lung disease and other serious pulmonary conditions
Gastrointestinal perforation

Family members can sometimes bring a claim on behalf of a patient who died. Filing deadlines vary by state, and statutes of limitations for pharmaceutical injury claims can be relatively short, so the window to act closes sooner than many people expect.²

What the Lawsuits Allege

The core allegation is straightforward. Genentech and Roche knew, or should have known, about serious cardiovascular and other risks tied to Actemra and failed to include adequate warnings on the label. A failure-to-warn claim does not require proving in every case that the drug caused a specific injury. It focuses on whether the warnings the company provided matched what the company actually knew.

Three points anchor the claims. Competing drugs in the same treatment category — Humira, Enbrel, and Remicade — carried warnings for heart attacks, heart failure, strokes, and interstitial lung disease. Actemra’s label carried none of those. STAT News reported that in a 2014 case, Roche itself internally assessed a patient’s fatal heart attack as “related to” Actemra. And a head-to-head study comparing Actemra with Enbrel found rates of stroke and heart failure roughly 1.5 times higher in Actemra patients, with no resulting label change.¹

Genentech has defended the drug. In 2012, the company persuaded the FDA that pancreatitis rates in Actemra patients were within expectations for the population being treated. Roche’s medical director for rheumatology products, Dr. Jeffrey Siegel, called a company-funded cardiovascular study “definitive” proof that Actemra does not increase cardiovascular risk, and said adding warnings based on adverse-event reports “would be a disservice to clinicians, because it would raise the concern of something where there really isn’t a risk.”¹

The Evidence Driving the Litigation

The lawsuits gained traction after a June 2017 STAT News investigation by reporter Charles Piller. Piller analyzed more than 500,000 side-effect reports submitted to the FDA’s Adverse Event Reporting System and reported the rate of serious complications among Actemra patients as high as or higher than rates seen with Humira, Enbrel, and Remicade. The FDA had received reports of 1,128 deaths among Actemra patients, along with 132 pancreatitis reports (26 fatal) and at least 185 cases of interstitial lung disease.¹

Internal FDA documents STAT obtained through the Freedom of Information Act showed that by August 2012, regulators had already tracked 118 deaths, 42 of them linked to cardiac arrest or heart attacks. A separate 2013 FDA report acknowledged 91 heart attacks among Actemra users, including 21 deaths. In both years, the agency concluded there was “not sufficient evidence to support causality” to justify new warnings.³¹

The numbers have kept climbing. Between 2010 and 2016, FDA adverse-event reports logged 410 heart attacks, 359 strokes, 224 cases of heart failure, 224 cases of interstitial lung disease, and 132 cases of pancreatitis among Actemra users. By June 2022, the FDA’s database contained 53,184 total adverse event reports for the drug, including at least 2,306 involving death, 4,311 cardiac disorders, 16,243 gastrointestinal disorders, and 9,878 respiratory conditions.³

Adverse-event reports show association, not causation. The FDA has said as much, and does not verify individual submissions.¹ For the litigation, though, the volume and pattern of these reports are what plaintiffs point to when they argue the company had a duty to warn.

What Actemra’s Label Says and Doesn’t Say

As of the most recent prescribing information, Actemra’s label still does not carry specific warnings for heart attacks, strokes, or heart failure. The boxed warning covers the risk of serious infections. The warnings and precautions section addresses gastrointestinal perforations, hepatotoxicity, changes in laboratory values, immunosuppression, hypersensitivity reactions including anaphylaxis, demyelinating disorders, and active hepatic disease.⁴ Hypertension is listed as a common adverse reaction occurring in at least 5% of patients.⁵

The FDA did require a new warning in November 2024 for Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a severe allergic reaction, based on post-marketing reports in the FAERS database.⁶ Cardiovascular warnings, however, still are not on the label, and their absence remains central to the failure-to-warn cases.

How These Cases Are Structured

Actemra cases are filed as individual product liability lawsuits, not class actions.² Each plaintiff pursues a claim tied to their own prescription history and injury.

Plaintiffs may seek compensation for medical expenses, lost earnings, pain and suffering, emotional distress, and loss of enjoyment of life. Some cases also seek punitive damages.²

A few things the litigation does not yet include. The cases have not been consolidated into a federal multidistrict litigation, and no bellwether trials have taken place. No public settlements of failure-to-warn claims by individual patients have been identified. That means there’s no reported settlement average to point to, and each case proceeds on its own facts.

A Different Kind of Actemra Lawsuit

Searches for “Actemra lawsuit” sometimes surface patent cases, which are unrelated to patient injuries. In July 2023, Genentech, Chugai Pharmaceuticals, and Hoffmann-La Roche sued Biogen and Bio-Thera Solutions in federal court in Massachusetts, alleging that Biogen’s biosimilar product infringed 20 U.S. patents covering Actemra. Biogen’s biosimilar, Tofidence, received FDA approval on September 30, 2023, and the patent case settled by October 2023 on undisclosed terms.⁷ Those disputes are between drug companies over market exclusivity and have nothing to do with patient compensation.

If You Think You Have a Case

Gather your prescription records, medical records documenting the injury, and a timeline of when you started and stopped taking Actemra. Because state statutes of limitations can run quickly on pharmaceutical injury claims, speak with a product liability attorney sooner rather than later to find out whether your claim is still viable and what evidence you’ll need to move forward.²

1
STAT News. Hidden Risks of an Arthritis Drug
2
Top Class Actions. Filing Actemra Lawsuit May Help Compensate Injured Patients
3
Drugwatch. Actemra Lawsuits
4
FDA. Actemra Prescribing Information
5
FDA. Actemra Prescribing Information
6
Genentech. Actemra Important Drug Warning
7
Pearce IP. Roche, Genentech, Chugai and Biogen Settle Actemra Tocilizumab Litigation