Imagine a large bloated beast called Big Pharma slipping into a stream and suddenly attacked by thousands of piranha lawyers and plaintiffs, a satisfying image that happens to be occuring now in the legal world. But unfortunately, it’s not all of Big Pharma. There are two key players involved though.
Takeda Pharmaceuticals and Eli Lilly were in that piranha filled stream over their controversial drug Actos, brand name for pioglitazone, which has been a drug prescribed to reduce diabetes type 2 blood sugar. The potential side effects include: bladder cancer, congestive heart failure, edema, eye edema, fluid in the lungs, and spontaneous fractures.
Amazing, all those risks in exchange for lowering blood sugar with a pill instead of diet and exercise.
The jury believed Alan’s contention that the drug companies knew of the bladder cancer risks from using Actos but never gave sufficient warning. Terrence had been using Acto from 2006, and his bladder cancer diagnosis was given in 2011.
That was the year when the FDA ordered black box bladder cancer warnings in exchange for allowing Acto back on the market after it was pulled off momentarily due to mounting adverse reaction reports. Acto was banned completely in France and Germany and it’s still off the market there.
These two Big Pharma bulls had managed to survive three of the earlier piranha attacks, mostly on technicalities. Later in 2013, and appeals court threw out one of those decisions and reinstated the verdict to the plaintiff of $6.5 million. Then Takeda and Eli Lily were overwhelmed by a jury’s decision to pay plaintiffs Terrence and Susan Alan $1.475 million in compensatory damages and a whopping $9 billion in punitive damages.
But the judge lowered that amount to $38.6 million total, of which Takeda was responsible for two-thirds and Eli Lily the remaining one-third. Since then, several other cases in different states have awarded plaintiff’s large sums on their claims with hardly and cases going Actos pharmaceutical companies way.
There are over 3,000 suits filed against Actos with hearings pending throughout the nation. And now it’s expected that up to 10,000 individual suits will be eventually filed. This goes without considering a class action suit, although some speculate that an international class action suit my evolve out of the preponderance of individual legal actions being filled against the same defendants for the same reason.
Takeda Caught Trying to Pull a Fast One; No End in Sight for Takeda or Lily
Gee, what about those studies that led to FDA’s initial approval? Maybe some negative study documents didn’t make it there, but they were among those that “couldn’t be found” or were “missing” after having been requested by the plaintiffs’ attorneys prior to jury trial.
These were files that had been compiled by 46 current and former employees involved with the development, marketing, and sales of Actos. One of them was forced into a whistle blower position to report that he and the other 45 employees had been ordered to permanently remove the documents from their internal computer files when the suits started being filed. Two of those employees were directors.
The federal judge, U.S. District Judge Rebecca Doherty, had decided to allow plaintiff attorneys to expose the defendants’ “Spoliation of Evidence” to jurors and permit the jury to infer the documents were damaging to the companies’ defense. Technically, she had sufficient reason to call a default in favor of the plaintiff. But then perhaps the plaintiff’s award would have been much less.
In January of 2014, Judge Doherty entered this statement into the record: “The breadth of Takeda leadership whose files have been lost, deleted or destroyed is, in and of itself, disturbing.” One of plaintiff Alan’s attorneys, Paul J. Pennock, commented, “I think that a verdict like this declares just how outrageous the evidence was regarding Lilly’s and Takeda’s behavior.”
Alan’s case was picked out of a cluster of around 3,000 Acto cases pending that were amassed in an MDL (multidistrict litigation) arrangement to be heard in the Louisiana federal district court. The purpose of an MDL is to include several pretrial hearings on similar cases simultaneously and avoid further dragging out the hearings to resolve different individual pretrial decisions from several different judges.
The attorneys for the plaintiffs’ strategy is to allow one major case to determine the outcome of others in the defendants’ mind and perhaps force settlements on the case in the MDL more as a huge blanket award for a class actions suit. It worked as planned.
By 2015, Takeda settled about 9,000 Actos related lawsuits for $2.4 billion in 2015, it became one of the largest Big Pharma settlements in U.S. history. At least 97 percent of plaintiffs opted to settle in September 2015 instead of continuing litigation.