SAN FRANCISCO (CN) – The psoriasis drug Raptiva killed a woman by giving her viral encephalitis, her mother and son claim in Superior Court. Raptiva was pulled from the U.S. market on June 8, 2009 after dangerous side effects and deaths from infections were reported across Europe, Canada and the United States.
Megan Boxell, 26, mother of one, died on June 30, 2006, her mother says.
Megan Boxell, went to the emergency room with flu-like symptoms on June 29 after taking Raptiva for a year. The next day she “went into a coma and died” of viral encephalitis, her mom says.
“Raptiva worked to clear up skin lesions of psoriasis, but once a patient stopped taking the drug, the disease came back, sometimes in a more aggressive form than a patient’s original baseline or pre-Raptiva treatment status,” Shirley Boxell says in her complaint.
Psoriasis skin lesions are caused by the actions of T-cells attracted to inflammation. Raptiva was designed to inhibit the function of T-cells by interfering with their ability to use antigens and molecules to recruit inflammatory cells to the infection site.
But if T-cells do not work properly, the body has a harder time fighting infection.
“It is generally accepted in the medical community that suppression of T-cell function predisposes the body to serious life-threatening infections,” the complaint states.
Without proper T-cell function the body is more susceptible to viral encephalitis, meningitis, neurological complications and lymphoma and malignancies, especially if the cells are suppressed for long periods of time, according to the 38-page complaint.
Xoma and Genentech, the manufacturers of Raptiva, knew the risks associated with continuous immunosuppressive therapy but repeatedly denied the need for patients on Raptiva to undergo monitoring to look life-threatening infections, Boxell’s mother says.
“Defendants made a strategic business decision not to require any baseline blood work or physical exams,” the complaint states. The drug companies “explained away the need for monitoring requirements” by suggesting that though it would make the physician feel better, it might not be good for the patient to monitor their platelets continually, according to the complaint.
Patients could fill prescriptions by calling a 1-800 number and have it delivered, without seeing a doctor, Boxell says.
She says that Xoma had not turned a profit in 20 years before Raptiva, its first attempt at a commercial product, so its success was vital to the company’s future.
Two weeks after the FDA recommended approval, “Xoma sold 9 million common shares and received approximately $67.2 million in net proceeds,” according to the complaint.
The defendants did not place a warning on Raptiva labels until more than 2 years after Boxell died, her mom says. Boxell’s mother and son seek damages for failure to warn, negligence and fraud by concealment.
They are represented by Susan Scovern with Audet & Partners.