CBS News reported last year that seventy percent of Americans take at least one prescription drug each day. Whether the drugs are for depression, high cholesterol, chronic pain, to battle infection, or for any of a host of other medical conditions, Americans rely on those medications. Americans also rely on the pharmaceutical companies who create and manufacture these medications to make them as safe as possible. And when the mediations come with risks of side effects, Americans expect to be warned about those side effects. We expect them to provide the pros and cons of the medication, so we can make an informed decision about whether to take them. Unfortunately, sometimes that does not happen, and patients are injured, or even lose their lives.
One group of such cases involves a prescription drug called Pradaxa, which is also known as dabigatran. ABC News reports that its German manufacturer, Boehringer Ingelheim, has agreed to pay $650 million to settle roughly 4,000 claims regarding the drug’s marketing and safety. The average payout per case is $162,500.
The FDA approved Pradaxa in 2010. It was to be used to reduce patients’ risk of stroke when they had irregular heartbeats. The drug stops an enzyme involved in blood clotting, and is an alternative to the more commonly known and much older warfarin However, there is a big difference between warfarin and Pradaxa. There is a reversal agent or antidote that can be given after warfarin is given, to mitigate its effects. There is no such reversal agent or antidote for Pradaxa.
What this means is that the drug puts patients at risk of severe bleeding, which can be fatal. Now, in some cases, that may be an acceptable risk. A patient who is told how great the risk is, and who is given a fair picture of both the benefits and risks of the drug can make an informed intelligent decision about whether to allow a doctor to administer it. However, when a manufacturer hides or downplays the risks of a drug, and oversells the benefits, it prevents the patient from making an informed decision. The plaintiffs in the Pradaxa suit claimed that is exactly what happened here.
The thing is, the Pradaxa suit never went to trial. It was settled before trial. What this means is that neither a judge nor a jury ever got to hear all of the facts of the Pradaxa case and determine whether or not the drug company was misleading patients about the risks and rewards of the medication. The manufacturers of the drug are still publicly proclaiming that the drug is safe, and are even moving toward getting it approved for additional uses. They claim that they settled the case because of the unpredictability of juries and because settling “eliminates the distraction and uncertainty of possibly years of litigation” according to ABC News. This means they were willing to spend over half a billion dollars to avoid further litigation. Future patients should take this into account.