CHICAGO (CN) – Abbott Laboratories’ blockbuster arthritis drug Humira gave a woman cancer, she claims in Cook County Court.
Carolyn and Eric Shaw sued Abbott Laboratories for product liability, product defects, failure to warn, misrepresentation, negligence, breach of warranty and loss of consortium.
“Plaintiff Carolyn Shaw was prescribed Abbott’s blockbuster arthritis drug ‘Humira’ and received bi-monthly injections from October 2008 to August 2010 when she was diagnosed with B-cell non-Hodgkin’s follicular lymphoma. She underwent surgery and chemotherapy treatment, and luckily her cancer went into remission. Unfortunately, she will have to undergo treatments every five months for the rest of her life to ensure the cancer will not return,” the complaint states.
The FDA approved Humira to treat arthritis in December 2002. It is Abbott’s best-selling drug, according to the complaint.
“(I)n 2011, Humira’s worldwide sales were $7.9 billion,” the Shaws say.
The complaint states: “the data from Humira clinical trials and other peer-reviewed medical literature show that the rate of malignancies in the group of patients treated with Humira was significantly higher than the rate of malignancies in the group that were treated with placebo. The increased rate of lymphomas was statistically significant. This differential in rate was a significant safety signal. It should have prompted a significant clear warning from Abbott to both physicians and patients about this potential side effect.
“Although the clinical trial data alone should have prompted both a stringent warning and proactive study, instead of conducting further studies and/or otherwise calling attention to the increased risk of life-threatening side effects front and center in the label, and communicating same to Dr. Suarez [Carolyn Shaw’s nonparty rheumatologist] Abbott buried and information regarding malignancies in the label. Further, what ‘warning’ information was mentioned severely downplayed the risk and confused the issue, consistent with its sales message, in RA [rheumatoid arthritis] data.”
The complaint adds: “It is widely recognized within the pharmaceutical industry that adverse side effects of medication are vastly unreported. The industry accepted rule of thumb is that the MedWatch system captures somewhere between 1 percent and 10 percent of real world events. Therefore, the MedWatch reports put Abbott on notice that, in fact, there were somewhere between 250 and 2,500 real world Humira patients who had experienced Humira-related lymphomas or other malignancies.
“Because FDA regulations require the drug manufacturer to add a warning – in the warnings section of the label – whenever there is a ‘reasonable association’ between the drug and a dangerous side effect, and further state that ‘a causal relationship need not be established’ before a warning is required, this information from the adverse event database should have prompted Abbott to issue strong, clear warnings about the risk of lymphomas and other forms of malignancies due to the use of Humira. But Abbott failed to do so until many years later, when the FDA made them do it.”
The Shaws say: “Not until August 4, 2009 – almost a year after Carolyn Shaw began taking Humira – did Abbott put a black box warning on their label alerting patients and doctors of cases of leukemia, hematological cancer, in adults, adolescents, and children.”
Carolyn Shaw developed an enlarged lymph node in her neck in 2010 and was diagnosed with Stage IIA lymphoma. “When Carolyn and Wayne asked Dr. [Mark] Freidman what he thought caused her lymphoma, his answer was ‘Humira,'” the complaint states.
The Shaws claim that Abbott aggressively markets Humira and makes “widespread use of direct payments to physicians utilized by Abbott to both sell more Humira and increase prescriptions across the country.”
“Needless to say, these financial inducements and payments provide incentives, perhaps on a subconscious level but real nonetheless, to skew the ‘informed consent’ discussion in favor of the benefits of Humira, at the expense of the risks. More importantly, patents are not aware of these types of ‘behind the scenes’ payments being made to physicians. … It most certainly was not disclosed by either Abbott or the prescribing physicians to the individual plaintiff and/or patient.”
Abbott Laboratories is the only defendant. Neither of the Shaws’ doctors is a party to the case.
The Shaws claim that Abbott withheld critical information that would have enabled Carolyn to make an informed decision about whether to take Humira: “Although physicians prescribe medications, it is patients who have the ultimate authority to decide whether to put them into their bodies or not. Because of the dangerous side effects of Humira, it is extremely important that both physicians and patients be fully informed – not only about the potential benefits of the drug, but also about the risks of side effects. Neither Carolyn nor her physicians were warned in any meaningful or legally adequate manner about the risk of lymphoma when she began taking Humira,” the Shaws claim.
The Shaws are represented by Gary McCallister.