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Plaintiff – 1, Humira – 0

Last week a Cook County jury decided against Abbott Labs, the manufacturers of the arthritis medication Humira, and awarded a whopping $2.244 million to the plaintiff. This is the very first lawsuit filed against the major drug company. Legal experts, however, are skeptical as to whether the other 25 similar lawsuits will be equally successful against the same drug company.

The jurors found that Abbott Laboratories Inc., and its sister company AbbVie, did not properly inform hospitals and doctors of potential side effects associated with Humira. The company failed to disclose that a TNF (tumor necrosis factor) blocker, which suppresses the immune system in the course of treatment, is present within the drug. TNF is used in the drug to prevent inflammation in the joints.

Humira was one of the highest profiting medicines worldwide in 2012, with sales of $9.2 billion. Just in the first quarter of this year, the drug reached global sales of more than $2.2 billion. Since Humira’s approval in 2002, an estimated 400,000 patients have used the medication in the treatment of multiple immunological diseases, including rheumatoid arthritis (RA), psoriasis, Crohn’s disease, spondylitis and ulcerative colitis. The annual cost of Humira therapy reaches as high as $26,632, in the United States.

In the following years, however, Humira is predicted to lose its patent protections in the United States, Japan and Europe in 2016, 2017 and 2018, respectively.

The victorious lawsuit mentioned above was filed by Delores and Milton Tietz of North Dakota, with the complaint centered on the twenty month time frame that elapsed between a U.S. Food and Drug Administration order instructing drug companies to notify doctors of the risks of TNF blockers and Abbot’s actual notification to doctors. Medical records show that Delores took Humira for her rheumatoid arthritis from October 2009 through May 2010. She stopped taking the medication when she began to develop long-term flu-like symptoms such as chest pains and fevers. As a result of ingesting the medication, Delores was diagnosed with disseminated histoplasmosis. This a serious infection that may be deadly if left untreated, according to Jim Perdue, the couple’s attorney. Mr. Purdue’s firm, Perdue Kidd & Vickery, is representing all but one of the 26 Humira complaints.

Delores’ ailment worsened as her major organs began to fail, and eventually she went into a coma. She spent 21 long days in the hospital undergoing treatment. After returning from her coma, Delores Tietz began recovering but had to maintain her physical and speech therapy sessions. She spent a total of 13 months in the hospital. “We felt somebody should be held responsible for this,” said her husband, Milton. “It was not really the hospital’s fault and not the doctor’s fault. It was Abbott Laboratories.”

A Dr. Arnold Letnek testified, on direct examination by the plaintiff’s lawyer, that he believed Humira was a significant reason why Delores Tietz’s immune system was declining in the spring of 2010. He said in his opinion that, “the drug was also a substantial factor in her disseminated, or disbursed throughout the body, histoplasmosis.”

Mrs. Delores Tietz unfortunately passed away from a heart attack in March of 2013, just before her trial date. Mr. Purdue did not associate his client’s death with the medication Humira. In court, the Tietzes explained that in 2008, the FDA had issued a directive ordering drug companies to inform doctors and hospitals that TNF inhibitors, such as Humira, carried a heightened risk of developing fungal infections.

Court documents revealed that Abbott waited nearly two years to send out the “Dear Doctor” letter and had the doctors known of the risk, they would have been able to diagnose Delores with disseminated histoplasmosis and provide her treatment much sooner. They demanded $5.5 million in compensatory damages.

Abbott and AbbVie argued that the medical community was in fact aware of Humira’s side effects and that the drug’s label warned users of the risk of serious infections. Michael Foradas, an attorney for Abbott at the firm Kirkland & Ellis, refused to comment. AbbVie spokeswoman Adelle Infante said in a statement that, “Humira would opt to appeal this verdict based in part on the jury’s assessment that the medical community was sufficiently warned about the risk of histoplasmosis.”

This particular type of appeal would most likely center on the argument that there was no basis for causation and that the judge erred by allowing the case to go to trial in the first place. Many of the other cases opposing Humira have been consolidated in County Circuit Court, but litigation is also occurring in federal courts in Massachusetts, Texas, and Tennessee.

Legal experts are unsure as to what the $2.2 million verdict might mean for the remaining plaintiffs, because only some of those claims cover the period before May 17, 2010, when Abbott mailed out its “Dear Doctor” warning letter. The Tietz verdict, however, could substantially help similar cases that occurred before the warning letter was sent out. Despite all of the legal battles Abbot Laboratories is currently facing, the company remains optimistic and projects Humira sales to hit $14 billion by 2017.

If you have been injured as a result of a medication, call the dangerous and defective medication attorneys of the Sibley Dolman Gipe Accident Injury Lawyers, PA today at: (833) 606-DRUG [3784].