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, and juvenile idiopathic arthritis. In 2011 alone, the drug made $6.55 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 had 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 really 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 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 for 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.
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 less in sales. Abbott's stock price has been going through the roof of late. They want to keep it that way.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 a simple flu. Legionella and Listeria infections have also been noted. Some of these incidents linked to Humira use have resulted in patient death.What Are Abbott's Defense?
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 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 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 we think juries are not going to look too favorably upon the "Hey, we told your doctor" defense.Contacting a Lawyer for Your Humira Lawsuit
We are no longer investigating Humira claims. Why? These claims have just not been able to get off the ground. Stay tuned. The science might eventually catch up to the anecdotal reports we are seeing.