Humira is a prescription medicine that can be used to reduce the signs and symptoms of psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, chronic psoriasis, and more severe stages of Crohn’s disease. However, Humira also poses some risks. Using Humira may decrease the immune system’s ability to fight infections, in turn leading to possible health issues. Some reports have suggested that using Humira can increase the risk of nerve and vision issues, specifically including Multiple Sclerosis (MS).
As there have been reports of a link between Humira and multiple sclerosis, patients are be advised to avoid Humira if there is a family history of Multiple Sclerosis. Multiple sclerosis is an autoimmune disease that affects both the brain and the spinal cord. There is no known cure for Multiple Sclerosis.
In Maynard v. Abbott Laboratories, No. 12–C–0939 (E.D. Wisconsin 2013), the federal court denied the drugmaker’s motion seeking to dismiss a products liability “failure to warn” lawsuit against the company behind Humira. Jeffrey Joseph Maynard filed the case, alleging he suffered neurological damage from using Humira, manufactured by Abbott Laboratories.
Maynard took Humira “on a continuous basis” between 2003 and 2009. On September 16, 2009, he began experiencing extreme and sudden vision loss in his left eye. He had difficulty with coordination and with keeping his balance while walking. After several examinations and tests, doctors determined he was suffering from demyelination disease resulting from his Humira use, and he exhibited symptoms of optic neuritis and multiple sclerosis. After Maynard was taken off the drug, his symptoms did not progress, but he has not regained vision in his left eye. His lawsuit alleged that while similar brands of TNF blocking drugs warned of optic nerve damage and demyelinating disease, Humira’s label downplayed or omitted any mention of the severity of these neurological risks. His suit contended that the warnings included in the Humira label were inadequate.
Maynard alleged that the label fails to warn about the “very serious potential side effects” of taking Humira, including deterioration of the optic nerves. Had he known the full extent of the possible side effects, he could have made a decision to stop taking Humira sooner, and his injuries would have been less serious. Abbott argued the lawsuit should be dismissed because the failure-to-warn claim was contradicted by the FDA-approved pharmaceutical warning label.
Maynard’s claims were governed by Wisconsin law, which provides that manufacturers have a duty to warn consumers of dangers that they know or should know are associated with the proper use of a product. Generally, the adequacy of a warning presents a factual issue for a jury. The adequacy of a warning depends upon all the circumstances, taking into account factors such as whether the warning is accurate, strong, and clear. The clarity of any warnings that were provided is also important; accompanying a warning with misleading representations of safety may serve to render the warning inadequate. Any ambiguity in the language of a warning is to be construed against the one who chose the words used.
Abbot argued that Humira’s label has at all times specifically warned of the potential association between use of Humira and neurological side effects including development of a demyelinating disease such as multiple sclerosis or vision problems. Maynard did not dispute that the label contained relevant warnings. However, he contended that the warnings were not adequate. He argued the warnings were misleading in that they omitted material information regarding the severity of the potential side effects and were not clear in explaining that patients without preexisting neurological conditions could also be at risk.
Maynard argued that the Humira label’s “WARNINGS” section only cautioned of risks of neurologic events for people with preexisting symptoms of a demyelinating disorder. He alleged that the label thus “made the drug sound safe” for people without such preexisting symptoms. Maynard did not have a recent onset of central nervous system demyelination disorder such as multiple sclerosis or symptoms such as numbness or tingling; as a result, he relied on the label in believing that the neurological side effects warned of would not affect him.
Defendant countered that the label clearly warned of the risks of neurological conditions in all patients, and in any case, the label was changed in 2005 to warn that rare cases of “new onset” of demyelinating disease have also occurred in patients taking Humira. However, the court determined that Maynard’s reading of the label was also plausible; the warning regarding adverse neurological side effects reasonably appears to be applicable only to patients with preexisting demyelinating disorders or other existing symptoms of central nervous system disorders. At the very least, before 2005, the WARNINGS section of the label was arguably unclear.
Maynard also argued that the label inadequately warned about the risks of developing optic neuritis or other permanent optic nerve damage. He claimed that while the label warned that Humira users have developed rare cases of disorders affecting the nervous system, it only warned that signs that a person could be experiencing such problems included “problems with your vision.” He alleged that his vision loss was sudden, and by the time his doctors diagnosed the problem, his vision impairment was permanent. The court found that his contention that the label was misleading was plausible. The patient insert warns that a person taking Humira should seek medical attention if they begin to experience certain “rare” side effects such as vision problems. However, the insert and the label fail to alert patients that permanent vision impairment or optic neurosis are potential risks of taking Humira.
Maynard also alleged that as early as January 2002, other companies manufacturing TNF blocking drugs prescribed for treating rheumatoid arthritis used labels warning that optic neuritis was a side effect, and therefore, it can be inferred that Abbot should have been on notice that optic neuritis and vision loss were risks. Drug manufacturers have an affirmative duty to add new warnings to drug labels ‘as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved. Moreover, proof of compliance with FDA regulations does not necessarily insulate a defendant from liability. Thus, the court ruled that the fact that Humira’s label was FDA-approved did not in itself defeat Maynard’s claims. “If what plaintiff alleges is true, and the risks of developing optic nerve damage associated with repeated use of Humira were known among manufacturers of TNF blockers such as Humira, then a reasonable fact-finder could determine that defendant had a duty to warn of these risks.” the court concluded.
Diagnosed with Multiple Sclerosis after taking Humira?
If you or a loved one have been diagnosed with Multiple Sclerosis after taking the drug Humira, contact Heygood, Orr & Pearson for your free case evaluation and to learn more about your legal right to compensation.
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