Wrongful death case alleges negligence in Tysabri clinical trial

By Jeffrey Krasner, Globe Staff | July 21, 2005

The widower of a woman who died from a rare brain disease after participating in a clinical trial of Biogen Idec's multiple sclerosis drug Tysabri yesterday sued the Cambridge company and its partner, Elan Pharmaceuticals of Ireland.

The wrongful death suit, filed in Middlesex Superior Court by Walter Smith of Colorado Springs, Colo., charges the companies with negligence, fraud, and violation of state consumer laws in the Feb. 24 death of Anita Louise Smith, 46.

''My wife didn't have to die," Smith said in a statement released by his lawyer. ''If we had all the information we should have had, she'd be with us today."

The suit asks for compensation for Anita Smith's pain and suffering, and also for punitive damages, but doesn't specify a dollar amount.

The complaint centers on the allegation that the companies knew or should have known that Tysabri and Avonex, Biogen Idec's other MS drug, suppress the immune system when taken together, reducing the ability of the body to defend itself against infection. The suit alleges the companies knew of the potential danger, yet recklessly proceeded with tests in clinical trials.

In addition, the complaint alleges, the dangers and risks weren't disclosed to Smith, so she could not have provided true informed consent to participate in the trial.

''When a pharmaceutical company fraudulently conceals a known danger of a drug, a person cannot properly consent to using that pharmaceutical," said Jerrold S. Parker of Parker & Waichman LLP of Great Neck, N.Y., who is representing the Smith family. ''They had knowledge of these issues before Anita Smith took this combination cocktail, yet they never told Anita Smith and they never told Walter Smith."

Biogen Idec spokesman Jose Juves said the company hadn't yet seen a copy of the complaint, filed late yesterday afternoon. ''Our thoughts and sympathies go out to the Smith family during this difficult time," he added. ''This unforeseen event occurred during a clinical trial designed to determine the safety and efficacy of Tysabri. At the first signal of a potential problem, Biogen Idec quickly and decisively halted dosing in the trials and began an extensive ongoing safety evaluation."

Davia Temin, a spokeswoman for Elan, said the company does not comment on litigation. ''However, we do believe we've taken and are taking all appropriate actions to ensure patient safety," she said.

Tysabri was initially developed by a firm that was later acquired by Elan, Ireland's biggest drug company. In 2000, Elan agreed to develop Tysabri with Biogen Corp., which had already developed a multiple sclerosis drug, Avonex.

Pivotal trials for Tysabri alone and Tysabri taken with Avonex yielded such positive results that the firms sought marketing approval from the Food and Drug Administration just one year into a planned two-year trial. The agency gave the drug accelerated review and it was approved for sale last November.

But the drug was sold for only three months before the companies voluntarily suspended sales and clinical trials in February, saying one person had died of a rare disease and a second was suspected of having it. Since then, the companies have attributed a second death to the disease, progressive multifocal leukoencephalopathy, but have declined to comment on additional suspected cases until it completes a full safety review this summer.

The suspension of the drug is a disappointment to patients, who had long-awaited a drug more effective than existing MS treatments. Tysabri proved itself superior in preventing debilitating relapses of the disease. But some doctors now believe the combination of Tysabri and Avonex weakened the immune system and made it possible for opportunistic infections like PML to take hold.

The story of Anita Smith puts a human face on what has so far been discussed in the context of clinical trials, adverse events and arcane medical data.

Smith, a mother of two, received her first dose of Tysabri in April 2002 as part of a trial of Tysabri and Avonex together. In November 2004, she began experiencing problems with speech, mental perception, and hand-eye coordination, according to the complaint, and an MRI scan showed a ''dramatic abnormality" in the left side of her brain.

In early February, she spent nine days in a local health center before being transferred to a Denver hospital, where she was diagnosed with PML. She died at a hospice on Feb. 24 ''after enduring intractable pain and suffering," according to the complaint. Four days later, Biogen Idec and Elan pulled the drug off the market.

A native of Glenwood Springs, Col., Smith moved to Colorado Springs and in 1982 married her husband. They worked together in his towing business. She loved animals and had three Dalmatians. Her interests included gardening, stained glass, interior decorating, crosswords, cooking, the Denver Broncos, ''and driving her red, really fast Jeep," according to an obituary published in The Gazette of Colorado Springs.

''As alleged in the complaint, this is a tragic death resulting from pharmaceutical products whose use was unreasonably dangerous and which never should have been given to Mrs. Smith," said Jason Mark, another lawyer with Parker & Waichman, who also represents the Smith family.

Cases such as the one filed yesterday have proliferated in recent years, said Andrew Finkelstein, managing partner of Finkelstein & Partners LLP, a Newburgh, N.Y., law firm that specializes in product liability.

''Over the last 10 to 12 years, there's been a significant increase in the amount of litigation against pharmaceutical companies that is directly correlated with the FDA's fast-track system of approving drugs with fewer clinical trials," Finkelstein said. ''The net result is there are more adverse events beyond the scope of what was reasonably expected."

Jeffrey Krasner can be reached at krasner@globe.com.

http://www.boston.com/business/globe/articles/2005/07/21/colorado_widower_sues_elan_and_biogen?mode=PF