LawyersandSettlements (LAS): Can you speculate how the double dose could have happened?
Roger Drake (RD): We have seen cases in the past where pharmaceutical companies have had mechanical problems. There have been instances where companies fail to properly inspect pharmaceutical drugs during the manufacturing process. We have also seen occasions where the manufacturing process is not switched over properly for a change in dose of the tablets.
LAS: Is it possible that the double dose could have been on the market well before April's recall?
RD: According to FDA documents, it looks like this manufacturing problem occurred in 2007 but possibly it went back to 2006 and earlier. The FDA had investigated the plant and then issued warning letters.
In similar cases where we had adulterated drugs, warning letters go out and the FDA issues inspection reports that detail manufacturing problems. We suspect that FDA inspection reports will detail the various problems the maker had that resulted in the double dose defect.
LAS: Why did the FDA take so long in acting upon reports of illness linked to Digitek, even with Actavis' past warnings?
RD: It has been our experience that the FDA gives pharmaceutical companies three or even four chances to correct their problems before a recall is issued. When there is a manufacturing problem the consumer is at extreme risk, especially with a type of tablet such as Digitek because there is a very small margin of error: If there isn't enough active ingredient it doesn't work and too much results in toxicity.
LAS: Did Actavis know of the defect before the recall?
RD: I suspect that Actavis knew of manufacturing problems for a long time prior to the recall. Often, the manufacturer cannot find the root cause of an adulterated drug and this leads to delay in revealing the problems associated with them—a long process that puts the public at risk.
LAS: At what stage is the lawsuit?
RD: Since the recall on April 25, cases began pouring in. The litigation is in the early stages. I attended a court hearing yesterday in San Francisco where the judicial panel on multi-district litigation heard arguments to decide where the federal cases will be consolidated and that decision will likely be made in the next 30 days or so. There are a number of potential venues for the consolidation in federal court including West Virginia, Louisiana and Ohio.
Typically, the judicial panel tries to pick an experienced judge who has handled large-scale litigation, somewhere centralized and easy to get to in terms of travel. I would like any of those venues they are considering. We are also investigating some state court actions where the defendants have their headquarters. Mylan Pharmaceuticals, the distributor of Digitek, is located in West Virginia--which may be where a lot of these cases end up. Both Actavis and Mylan are defendants.
LAS: What criteria are required to join?
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A lot of people have been exposed to this double dose and they should be compensated whether their injuries are substantial or minor. And they should seek an attorney to help them prosecute their lawsuit.
The recall requests that consumers return tablets to the pharmacy, presumably to avoid accidental ingestion. But, to prove these cases, the lawyers will have to prove that plaintiffs were administered a double dose. So, it is not entirely clear why the FDA wants people to turn their pills over to the pharmacy instead of to their lawyers. We, of course, prefer to have the prescription bottle and at least one exemplar tablet.