In February 2009, Fred Delano of the advertising firm Delano & Company claims he was knocking on death's door after taking what he considers the "most dangerous drug in the world."
Delano was prescribed Humira to treat psoriatic arthritis, a chronic inflammatory disease of the joints and skin. The drug is primarily used to treat various types of arthritis, as well as Crohn's disease.
Delano began taking Humira in October 2008. By late December, he started experiencing flu-like symptoms.
"I really started going downhill after Christmas," said Delano, who filed a lawsuit against the makers of Humira this past summer. "I was getting migraine headaches, night sweats, uncomfortable aches and pains."
By January 2009, he was suffering hearing loss and weight loss and was having trouble walking. By the first of February, Delano began experiencing delusions, and he admitted himself to the VA hospital emergency room.
After multiple tests, Delano was diagnosed with disseminated histoplasmosis, a life-threatening fungal infection that's prevalent in Memphis and the Mississippi River Valley.
Delano believes he contracted the disease because Humira weakened his immune system. Michael Gelfand, an infectious disease specialist, said people in Memphis unknowingly inhale histoplasmosis through the air, but it doesn't typically result in sickness.
"Medicines like Humira keep your immune system from killing your own body, and as a result, the overall immune system is weakened," said Gelfand, professor at the University of Tennessee Health Science Center. "One doesn't get an immune response to histoplasmosis, and it is able to progress, spread, and cause trouble."
When Delano was prescribed Humira, he said the medication didn't contain warnings that people living in the Mississippi River Valley were at a higher risk of experiencing bacteria and fungal infections.
According to his lawsuit, the U.S. Food and Drug Administration ordered Abbott Laboratories, the makers of Humira, to warn patients and doctors of an increased risk of potentially fatal Humira-induced histoplasmosis 26 days before he was prescribed the drug. He claims the company waited nearly two years to issue warnings, and he is seeking several million dollars in actual and punitive damages.
Derin Denham, senior manager for Abbott pharmaceutical public affairs, said Abbott's risk plan was submitted to the FDA in December 2008 and approved in April 2010.
"Abbott contacted health-care providers well within the timeframe required by the FDA," Denham said. "The therapeutic risks associated with Humira are well known and documented in the prescribing label."
Furthermore, Denham said prior to the risk plan being approved, patients on Humira were notified of histoplasmosis and other possible health risks.
"The fact that Abbott says it got out the warning within the FDA's timeframe would not automatically insulate them from liability, even if true," said Andrew McClurg, University of Memphis law professor. "A court could still conclude that they unreasonably delayed getting the word out."
Delano was unable to work while was he was sick, and he saw his income take an 80 percent dive. But he said the lawsuit isn't just for monetary gain but also to save lives. Delano said the lawsuit is currently in federal court and may take two years to settle.
"One-third of the country is a breeding ground for histoplasmosis, and Memphis is the epicenter of the problem," Delano said. "I think the dangers of this drug are coming to the forefront, and I'm just trying to accelerate that."