Humira Lawsuits

Humira lawsuits have been talked about for more than ten years. Over those same ten years, lawyers have increasingly filed mass tort lawsuits claiming a drug or medical device causes cancer. Yet the Humira lawsuits have not gotten off the ground.

This page discusses the issue surrounding these potential claims and why victims’ lawyers are not focused on these cases in 2023.

Humira

Humira is a well-known, blockbuster drug and also a near miracle for thousands of people suffering from autoimmune conditions. Made by Abbott Laboratories, Humira is a tumor necrosis factor-alpha blocker (TNF) that is used to treat autoimmune conditions including ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, moderate to severe chronic psoriasis, juvenile idiopathic arthritis. In 2020 alone, the drug made over $20 billion in revenues for Abbott Laboratories.

TNF blockers are immunosuppressant drugs that cancel TNF-alpha, a protein that can inflame tissues, bones, and cartilage when overproduced because of inflammatory disease. Humira treats chronic conditions by binding to the TNF-alpha protein and preventing it from joining with other cells. During this process, TNF blockers also suppress the body’s autoimmune response. There is evidence that Humira is effective in treating these conditions.

While Humira remains very popular – and Abbott continues to make money hand over fist on it – there have been reports of serious side effects that have caused problems for Humira users. Humira may increase the risk of nerve damage, cancer, and fungal infections. Plaintiff’s Humira lawsuits allege that Humira was negligently developed, produced, and manufactured and, in many states, Abbott is strictly liable for the harms caused.

Nerve Damage

Humira has been linked to nerve problems including neuropathy, central nervous system demyelination, transverse myelitis, vision loss or impairment, and, although it may be a stretch, multiple sclerosis. Consumer advocates contend that Abbott has not offered sufficient warnings regarding potential nerve damage.

This is the real key: keeping people informed of the risks. Within the first two years of Humira’s public release, the FDA had reports of at least nine patients with neurological problems and two cases of optic neuritis. Humira’s warning should better reflect what this information means. For many of these patients that make up the $6.5 million that Abbott is raking in from Humira, they would not have taken the drug had Humira’s warning properly informed patients and doctors.

What does their warning say? It explains that there is a risk of a demyelinating disease. For the average Humira user, “demyelinating disease” does not effectively warn of the real risk. Few people unaffected by this condition even know what it is.

Cancer Risk

Compounding these concerns is an increased cancer risk for Humira patients. A 2006 study published in the Journal of the American Medical Association linked Humira to an increased risk of developing cancer. The drug now carries an FDA warning about the increased risk of cancer in children. About half of the cancers observed in children taking TNFs are lymphomas (cancer of the immune system cells). In adults, doctors have reported organ cancers, melanoma, and leukemia. A recent study found that the higher the Humira dosage, the higher the risk for cancer or tumors.  So it is fair to say that Humira might raise the risk of lymphoma and skin cancers

This is not to say that this risk, or any of these risks, is not worth taking for some using Humira. But a fair warning would give consumers a real chance to decide whether the risk is worth it for them. Why doesn’t Abbott just provide a better warning? Well, strong warnings mean fewer sales. Abbott’s stock price has been going through the roof of late. They want to keep it that way.

Humira Expert Expert Does Not Hold Up

A Humira lawsuit was heading to trial in 2013 in Calisi v. Abbott in federal court in Massachusetts in 2013.  Plaintiff claimed Humira caused her non-Hodgkin’s lymphoma.  Plaintiff’s expert wanted to offer the opinion that Humira should update its warning to strengthen the cancer warning because the current label failed to sufficiently alert healthcare providers to the alleged lymphoma risk associated with the drug.

But he was a regulatory expert with degrees in biochemistry and pharmacology. At his deposition, the expert said he had not conducted any research into whether the Humira warning was meaningful to doctors, and was not aware of any empirical data, published literature, or peer-reviewed study supporting his opinion that the warning downplays the lymphoma risk.  He was not a medical doctor. His opinion was mostly based on his “say so.”  That is rarely enough in a failure to warn lawsuit in federal court. So the trial judge dismissed the case.

• Medical literature in 202o pushes back on the idea that Humira causes cancer

Fungal Infections

Starting in 2008, Humira also carried a warning for an increased risk of fungal infections. Humira users are vulnerable to these infections because the drug targets the inhibition of t-cells that are part of the autoimmune response system. Observed infections have included TB, pneumonia, sepsis, and others. The problem with some of these fungal infections is that they often go undiagnosed because they sometimes look like the simple flu. Legionella and Listeria infections have also been noted. Some of these incidents linked to Humira use have resulted in patient death.

• In 2023, there are lawsuits for Ezri eye drop infections

What Are Abbott’s Legal Defenses?

The frustrating thing about the way Abbott is fighting these cases is that they don’t want a fair fight on the merits of the case. A fair fight on the merits would be “Did Abbott do something wrong in marketing Humira that caused people to harm?” That’s the question, right? Instead, Abbott wants to stop these cases before they get to a jury.

Abbott’s primary defense to these claims is the plaintiffs’ negligent failure to warn claims are preempted by the Federal Food, Drug, and Cosmetic Act. In other words, Abbott is trying to hide behind the FDA to argue essentially that “Even if we screwed up, it does not matter because you can’t bring these claims under the law.” We think this defense is extremely likely to fail.

With respect to some of the “vague for patients” warning claims, Abbott argues that the Learned Intermediary Doctrine should be controlling. Again, Abbott tries to avoid the true merits of the case from being argued by claiming essentially that, “Even if we misled consumers, it is okay because we don’t have to warn our patients, just their doctors.”

This is not to say Abbott does not have other defenses to the true merits of these Humira lawsuits. They do. But our lawyers think juries would not look too favorably upon the “Hey, we told your doctor” defense.

Contacting a Lawyer for Your Humira Lawsuit

We are no longer investigating Humira’s claims. Why? These claims never got off the ground. Stay tuned. The science might eventually catch up to the anecdotal reports we are seeing.

• Humira white coat lawsuit filed in 2023
• Humira and COVID