Bristol-Myers Squibb ($BMY) has already taken a $1.8 billion charge for the 094 hepatitis C mess it created. Now comes the expensive post-mortem cleanup.
The Wall Street Journal's Jonathan Rockoff was tipped off that BMS officials will begin talks today on settling more than $500 million in claims from the patients and families of the disastrous clinical trial that provided conclusive evidence that 094 is dangerous. Last summer Bristol was forced to slam the brakes on their study after one patient taking the drug died and several others were seriously injured. And now they've put themselves in the hands of Robert Hilliard and one other attorney to seek some stratospheric settlements.
Rockoff's source puts these initial talks in Philadelphia, with a mediator on site to see if the two parties can start to move toward an agreement that would defuse the confrontation ahead of a trial. And Bristol's representatives are not in an enviable position. The plaintiffs are alleging that in the red-hot race to develop a new, leading hep C therapy, the drug developer threw aside caution and rushed pell-mell into the study soon after paying $2.5 billion to Inhibitex for the drug.
Texas nurse Janet Vella was one of several patients who suddenly found themselves in the hospital. In her case, her heart and kidney started to fail. Pharmalot tracked down Vella's lawsuit, which claims that investigators continued to dose her with the drug despite detecting clear signs of heart damage.
"In their quest to be first and to grab a portion of the $20 billion a year market, Bristol-Myers rushed BMS094 to Phase II clinical trials without fully evaluating the risks and benefits of the drug," states the lawsuit. "Further, defendants pushed ahead with the clinical trials despite clear signs of heart damage for those enrolled in the trial."
In Vella's case physicians detected a "slight ST segment depression" indicative of heart failure, but she was advised to continue therapy.
"I don't think I'll ever go back to work," Vella told the Journal. "Even standing up in the kitchen or taking a shower tires me out."
If the damage she and others suffered can be directly tied to 094, she won't need to work again.
- here's the story from The Wall Street Journal (sub. req.)