A major part of Merck's legal strategy has been to continuously point out that Vioxx had been approved by the FDA. Experts say, Dr Graham's testimony will throw a monkey-wrench into that strategy because it will reveal the long-fought battles over the deliberate concealment of the safety risks of Vioxx within the FDA itself.
Judge Fallon said the deposition would be limited to material relevant to the up-coming federal trial in July 2006, and Dr Graham's previous public statements. In the deposition, Dr Graham alleged that Merck dragged its feet about changing the label on Vioxx to warn of the increased risk of heart attacks.
So now in their latest run-up-the-costs tactic, Merck attorneys have filed a motion to limit the use of Dr Graham's deposition claiming it goes beyond anything Dr Graham previously said and therefore portions of it should not be heard by a jury.
But this statement is not new. Dr Graham publicly discussed the failure by Merck and the FDA to warn the public and add a new label to Vioxx while testifying at a congressional hearing a couple years ago on November 18, 2004.
In regard to the death and injuries caused by those failures, he in fact said: "I strongly believe that this should have been, and largely could have been, avoided."
Maybe Merck would rather have the jury listen to how Dr Graham put the number of people injured by Vioxx into perspective, when he told members of the Senate committee that instead of side-effects from Vioxx, to picture the number of people as if it were airline crashes.
"If there were an average of 150 to 200 people on an aircraft," he told the panel, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky."
"This translates to 2-4 aircraft every week," he noted, "week in and week out, for the past 5 years."
Merck also does not want the jury to hear Dr Graham say that Vioxx should not have been approved to begin with and that after learning the results of the VIGOR study in 2000, that Merck should have done a large study to determine whether Vioxx damaged the heart or blood vessels; and that an FDA official had recommended "at least" a warning label for the drug.
There is nothing new about these allegations either. Dr Graham made basically the same charges when he told the committee that the FDA "views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards and disrespects drug safety."
Dr Graham also pointed out that even when the FDA did try to take measures to limit harm, the agency lacked the enforcement authority to make companies comply. In the case of Vioxx, he said it took more than 2 years to get Merck to add the increased risk of heart attack and stroke to its label.
In their memorandum, Merck attorneys complained because: "Much of Dr. Graham's testimony is an elaboration of why and how he believes the FDA is 'broken,'"
"However," they wrote, "Congress (not the jury) is the only body that can address Dr. Graham's concerns."
Well then perhaps Merck should call members of congress to testify at future Vioxx trials to explain how Merck got top FDA officials to protect Vioxx profits by concealing the health risks associated with Vioxx that were revealed in damaging studies as far back as 2000.
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
