A recall of generic Lipitor had already devastated Ranbaxy Laboratories' market share and entangled it in litigation. Now it has sparked a war of words between the Indian drugmaker and lawyers for consumers who say they were injured by products believed to have been tainted by glass particles.
In a response to a lawsuit, the Indian drugmaker says the claims of one plaintiff that she had internal bleeding, holes in her stomach and colon and blood loss, are unbelievable, reports Pharmalot, which links to the court filing. Ranbaxy's brief says, "It is simply not credible to suggest that particles the size of grains of sand would cause the injuries… Nor is it believable that the FDA would have entirely missed the risk of such injury when it oversaw the… recall process."
Ranbaxy, which was already operating under an FDA consent decree for problems at plants in India, in November voluntarily recalled 41 lots of its version of the cholesterol-fighting pill Lipitor. It then stopped production to investigate the possibility that a piece of glass broke from some machinery and was ground up during processing. The FDA said at the time that the risk of injury was minimal.
But lawyers for plaintiffs claiming injuries want a judge to order the Indian generic drugmaker to recall all of the generic Lipitor it distributed in the U.S. Ranbaxy says if there had been a real danger, the FDA would have done that in the first place. Consumers "are not entitled to a judicially mandated recall that would contradict the FDA's expert judgment in advance of any judicial determination on the merits that a safety risk exists," Ranbaxy said in its court filing, quoted by Pharmalot.
The recall debacle has been hard on Ranbaxy's sales, which had started strong last year as it rode a wave of demand for the generic cholesterol-lowering drug. It has been reported that since it halted production on the pills, its market share for the product has fallen to 3% from the 43% it held before the recall.
- read the Pharmalot post
- here is the brief (pdf)
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