Ranbaxy Labs Trashes Consumers Consumers on Lipitor Recall

Ranbaxy Labs Trashes Consumers Consumers on Lipitor Recall

February 21st, 2013 // 5:28 pm @ jmpickett

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Last November, Ranbaxy Laboratories recalled more than three dozen lots of generic Lipitor because some contained tiny glass particles and the generic drugmaker then halted all production of the cholesterol pill. Not surprisingly, the move prompted lawsuits, even though the FDA indicated the likelihood of patient harm appeared to be “extremely low” (back story hereand here).

But several consumers are asking a federal judge to order a complete recall and Ranbaxy is arguing vociferously against such a move. And as part of its argument, the generic drugmaker – which is already operating under a consent decree because of serious manufacturing problems – is questioning the credibility of several of the consumers who say they suffered harmful side effects after taking its version of Lipitor.

Before we continue, some background: the November 9 recall was made at the pharmacy level, which means consumers were not directly notified or told how to respond if they became aware. And 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. A press release was not issued until November 28. And while the lots were not made in plants cited in the consent decree, Ranbaxy initially refused to discuss the source of the damaged product.

The FDA, meanwhile, intially advised consumers who were concerned about their supplies to stop taking the pill and seek alternatives. A day later, though, the agency then advised consumers that they could continue taking the Ranbaxy version of Lipitor unless their physician instructed them otherwise.

Despite this confusing chain of events, Ranbaxy maintains that appropriate procedures were followed, which included consulting with the FDA about what is described as a voluntary recall. Moreover, the drugmakers asserts FDA has the authority to issue a complete recall. The 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 argues (here is the court filing).

The drugmaker then proceeds to cast doubt on the assertions made by several of the consumers who filed the lawsuit. Three of the consumers filed declarations saying they experienced what Ranbaxy called “minor irritations,” such as loose stools, diarrhea and upset stomach. And the drugmaker adds such reactions could have occurred to the medicine normally, since these are listed as common adverse events.

Ranbaxy then dismisses two other declarations from consumers who expressed fears for their health and another who maintained she suffered internal bleeding, holes in her stomach and colon, and blood loss. Since the consumer did not state when she took generic Lipitor, Ranbaxy argues “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.”

The consumers argue that, given the confiicting advice from the FDA, they are left with a choice between taking “adulterated pills and or skipping their medication. Neither option is a good one.” And because the recall was made at the pharmacy level, they also maiintain that replacments or refunds were not made available
(here is their filing). Express Scripts, the pharmacy benefits manager, is also named as a defendant.

Ranbaxy, however, responds that enough time has passed that credible consumer injuries would have surfaced by this time and also argues that consumers have every opportunity to obtain replacement pills since other generic drugmakers now produce additionals versions of Lipitor. Ranbaxy also notes that only one consumer complaint was received by the FDA Medwatch program as of last November. However, Law 360 recently reported that more than 50 adverse events, including internal hemorrhages and abdominal pain were reported in recent months.