Yesterday brought an interesting, but not entirely unexpected development in the Tysabri saga-- a lawsuit filed by the widower of one of the two patients who died from PML during the Tysabri-Avonex clinical trials.

The suit alleges that the companies should have known (or already knew) that when Tysabri and Avonex are combined, they reduce body''''s ability to defend itself against infection.

''''''''My wife didn''''t have to die,'''''''' Walter Smith said, ''''''''If we had all the information we should have had, she''''d be with us today.''''''''

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

Sharing many people''''s whispered concerns, Smith''''s attorney said that the Avonex-Tysabri combination therapy may have been a way to extend Avonex''''s market life after the introduction of the newer drug.

''''''''It certainly appears that combination therapy was proposed to maintain the relevance of Avonex in the marketplace following Tysabri''''s introduction,'''''''' Parker said.

A spokesman for Biogen Idec noted that the clinical trial was designed to determine the drug''''s safety and effectiveness, reiterating that the company pulled Tysabri from the market and halted the trial four days after Smith''''s death in late February to begin a thorough safety evaluation.

''''''''Throughout this process, our first and only consideration has been the safety and well being of the patients concerned,'''''''' he said

A spokeswoman for Elan, told the Boston Globe 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.

While this is certainly an emotional case, realistically it will be difficult to prove gross negligence on the behalf of the companies, given that it was an inherently risk-prone clinical trial environment in which the patient needs to sign certain consent forms and waivers acknowledging the grave risk they are undertaking. That accepted risk and pioneer spirit is precisely why we look upon clinical trial participants as everyday heroes. What is more likely is a settlement with the treating doctors and medical facilities, as the woman''''s PML condition was arguably not well understood or appropriately treated until it was too late (contrasted to the 3rd PML patient who survived after diagnosis).