The lawsuit, which was filed in federal court on the same day that Ranbaxy stopped producing generic Lipitor, came in response to the November 9 recall of some 40 lots of the pill. However, the recall was only made at the pharmacy level, which means that consumers were not directly notified of the problem or how to respond if they became aware.
Although pharmacies were alerted (see this), Ranbaxy did not make any public statement until a brief notice - with a link to a list of recalled lots - was placed on its web site on November 23, prompting media coverage (see this). The ensuing ruckus, however, spurred the drugmaker to place a press release on its web site on November 28.
Through this episode, Ranbaxy has maintained that it has informed the FDA of its moves, dating back to October. For its part, the FDA has noted that agency officials work with drugmakers to determine recall steps to be taken and the agency has indicated there is a "remote possibility" of patients experiencing adverse events (see this).
An FDA spokeswoman explained that, after November 9, the agency received and reviewed additional information about the recall, which led the FDA on November 30 to classify the recall as a Class II, which means the risk to patients is extremely low. And there had been no reports of injury. She noted that Class II recalls are conducted at the pharmacy level and not the consumer level. A Class II recall may cause temporary or medically reversible health problems, or the probability of serious health problems is remote. A "recall may extend to the consumer or user level, the retail level, or the wholesale level," according to the chapter on recall procedures in the FDA Regulatory Procedures Manual. "In urgent situations, consideration should be given to the need for a press release that could be nationwide or to affected geographical areas only."
"...In reviewing or developing a recall strategy, the (FDA's Center Recall Unit) should take into account the health hazard evaluation, type or use of the product, the ease in identifying the product, the degree to which the product's deficiency is obvious to the consumer or user, the amount of product remaining unused in the marketplace, distribution pattern, validated salvage or rework plan, and the continued availability of essential products" (here is the manual).
So far, Ranbaxy is aware of one patient complaint of an adverse event. Nonetheless, the lawsuit argues that Ranbaxy should have taken the initiative to alert consumers directly and promptly, and also maintains that the drugmaker should have provided instructions on how to respond to the recall and information on obtaining a refund (here is the lawsuit). A Ranbaxy spokesman declined to comment.
“Defendants either knew, recklessly disregarded or reasonably should have known about the dangerous nature of its product at the time of sale of the product and thereafter,” the lawsuit states. “Even when defendants announced that (their) product was tainted, there was no notice to consumers concerning the dangers or how to obtain a refund.”
As we wrote previously, this comes at a delicate time. In January, a consent decree was signed for a permanent injunction that prevents the Indian drugmaker from making medicines for the US market until certain facilities meet US standards (read here). Ranbaxy set aside $500 million to cover all potential civil and criminal liability, but the final amount of any settlement has not yet been decided.
Ranbaxy maintains the generic Lipitor was made in a plant in India, according to an e-mail that we received from a spokeswoman for the drugmaker. However, Venkat Krishnan, who heads the Ranbaxy Americas business, sought to clarify that statement in an interview with The Wall Street Journal.
He explained that the active ingredient is made in Tonasa, India, and glass lining in tanks may have splintered. But he insisted the episode "has nothing to do with US manufacturing," an apparent reference to finished product. Some pills are made in India and some at its Ohm Laboratories facility in New Brunswick, New Jersey, where workers discovered foreign particles in late September during routine quality checks of the active ingredient before use, according to the story.
refund pic thx to ben husmann on flickr