Despite living with multiple sclerosis since 1997, Kimberley A. Yout kept a busy schedule, working full time as a money manager for a Boston bank and modeling in her spare time.
That changed on Aug. 28 of last year when Yout, 45, was diagnosed with a rare brain infection that developed as a side effect of Tysabri, a drug she took for six years to keep her MS in check. Yout’s speech became slurred, her gait unsteady, and her future uncertain.
“I was a very successful businesswoman,” said Yout, who lives in Hanover. “Today, I can’t even balance my checkbook, I can’t use an ATM, I can’t see out of one eye. I had to move back in with my mother. I’ve lost my independence. I’ve lost everything.”
Now, she is suing the two companies that marketed Tysabri — Biogen Idec Inc. of Weston and the Irish drug maker Elan Pharmaceuticals Inc. — in Middlesex Superior Court in Woburn. Her complaint, filed Friday, alleges they failed to adequately warn patients of the risks some face from prolonged use of Tysabri.
The lawsuit is one of at least a half-dozen pending in Massachusetts and federal courts in three other states. In each case, plaintiffs are seeking more than $1 million in punitive damages from Biogen Idec and Elan on behalf of patients or their families. After taking Tysabri, the patients developed progressive multifocal leukoencephalopathy, known as PML, an infection of the brain’s white matter that can cause death or severe disability.
Many doctors consider Tysabri highly effective in slowing the progression of relapsing forms of MS, a neurodegenerative disease, in adults for whom other drugs have stopped working. That’s why many of them take it, despite the risks.
Biogen Idec has been working to move beyond nearly a decade of controversy over Tysabri. Last year, it altered the drug’s label to include new safety information and introduced blood tests to help doctors identify patients’ risk level for PML. But the new suit and those pending are again raising questions about the drug’s safety.
Tysabri was approved by the Food and Drug Administration in 2004. But Biogen Idec and Elan pulled it from the market in 2005 after several PML cases, two of which resulted in death. The companies reintroduced the drug in 2006, with the approval of regulators, along with a “risk management” program that trains physicians prescribing Tysabri and requires them to monitor patients monthly under strict guidelines.
The approval for Tysabri, despite its chance of causing brain infections, was not unique. Regulators sometimes allow potentially dangerous drugs on the market if the disease they seek to ameliorate is severe, and they determine the benefits outweigh the risks.
“Based on the available information to date, the FDA continues to believe that the benefits of taking Tysabri outweigh the potential risks,” said FDA spokeswoman Stephanie Yao.
In recent years, Tysabri has become Biogen Idec’s second-largest-selling therapy, generating 2012 revenue of $1.6 billion, and is used by about 118,000 patients globally. But cases of PML continue to turn up in the United States and around the world. As of August, there were 395 confirmed cases of Tysabri-associated PML, including 92 deaths, according to Biogen Idec’s data.
Biogen Idec spokeswoman Kate Niazi-Sai declined to address Yout’s complaint specifically, citing company policy. More generally, she defended Tysabri and Biogen Idec’s response to the brain infection.
“We take PML very seriously,” Niazi-Sai said. “And we’re doing everything we can to educate doctors and patients on the benefits of Tysabri and also the risks. Tysabri is extremely effective for MS, but it’s got to be the right choice for patients in consultation with their physicians.”
Biogen Idec’s studies, resulting in the tests to gauge PML vulnerability, identified three risk factors for MS patients, Niazi-Sai said. The company found those most susceptible to the infection have taken immunosuppressant drugs previously, have used Tysabri for at least two years, or have contracted the JC virus. That virus is latent in as much as half of the general population, but is almost always suppressed by the immune system. Immunosuppressant drugs, such as Tysabri, can compromise the immune system, allowing the virus causing PML to replicate in the brain.
Elan sold its interest in Tysabri to Biogen Idec earlier this year for $3.2 billion, but still collects royalties. A representative of Elan declined to discuss the lawsuit. “The company doesn’t comment on matters of litigation,” said Jamie Tully, a New York-based spokesman.
Yout’s lawsuit levels six charges against the two companies, including failure to warn patients of Tysabri’s risks and negligent and fraudulent misrepresentation of the drug in product information.
“Tysabri was unaccompanied by adequate warnings of the risk of PML, either known or reasonably scientifically knowable at the time of distribution,” her suit alleges.
“It’s important for patients to know the risks of taking this kind of drug,” said Sofia E. Bruera, a Houston lawyer representing Yout and other MS patients who lodged state and federal complaints against Biogen Idec and Elan in Massachusetts, New York, New Jersey, and Utah. “Our clients weren’t adequately warned about the risks, and it ruined their lives.”
One of the other cases filed in Middlesex Superior Court involves Marla Fair, 40, a Greenfield, Ind., woman who was diagnosed with MS in 2002 and five years later began taking Tysabri. Two years after that, she was diagnosed with PML. Today, Fair walks with a cane and uses a wheelchair outside the home. Monday through Friday, she lives with her parents in Frankton, Ind., about 35 miles from her own home, while her husband, Terry, works in an auto parts plant to help pay for her 24-hour care.
“When she tries to talk to you, she’ll say things in a backward manner,” Terry Fair said of his wife. “They did not warn us that the longer you take this drug, the more likely you are to get PML. . . . I just want to get my wife home. I’m not looking to win a billion dollars or anything. I just want them [Biogen Idec and Elan] to help me take care of her.”
Yout and Terry Fair contend Tysabri should not be on the market, arguing that despite its benefits, the risks to some patients can be devastating.
“It’s like playing Russian roulette,” Fair said.