Right now, “blood thinners” Xarelto (rivaroxaban) and Pradaxa (dabigatran) are locked in a competition – but not necessarily for market share. In fact, the honor of winning this particular competition is a rather dubious one; it’s all about which product will be the cause of action for the most litigation.
Presently, Xarelto (from our old friends at Bayer) is targeted in over 300 lawsuits across the country, which has been consolidated before a federal court in Louisiana under the Honorable Judge Eldon E. Fallon. An additional 180 cases have been filed in Pennsylvania. By way of comparison, at the height of the Pradaxa litigation, German-based drugmaker Boehringer-Ingelheim faced 9,000 lawsuits (4,000 of which were settled in May 2014 for approximately $650 million). So, at the moment, Bayer and Xarelto are running a distant second. However, Xarelto litigation has just started; and according to Brian Barr (co-lead counsel in the national, federal Xarelto litigation), there is serious speculation in the legal community that ultimately the number of Xarelto lawsuits could rival the amount of Pradaxa claims.
Let’s get one thing straight: neither Xarelto nor Pradaxa (nor rival Eliquis, nor the drug they were designed to replace, Coumadin) are “blood thinners.” Technically, that description would be more applicable to statin drugs used to inhibit the production of cholesterol (sometimes described as “blood sludge”). Xarelto and its competitors are actually designed to inhibit clotting in the blood. They are prescribed to patients who are at risk of blood clots that can lead to stroke. Coumadin, originally sold as a form of rat poison known as warfarin, was the standard treatment for sixty years. It was inexpensive, but difficult to administer; there were many interactions with other medications. In addition, frequent (and expensive) patient monitoring was necessary.
Xarelto, Pradaxa and Eliquis were hailed as the “next generation” of anti-coagulants. There were few interactions to worry about and dosage was easily determined on a “one-size-fits-all” basis. They were also very profitable for the manufacturers. Whereas warfarin costs around $80 – $100 per year, Xarelto carries an annual price tag of $3,000. (That is in the U.S., by the way; in the U.K., patients get the drug at about 1/6th of that price – demonstrating something about the profit margin on Xarelto.)
All three of these “next generation” anti-coagulants also have serious side effects. In the case of Xarelto and Pradaxa, the most serious of these is uncontrolled hemorrhaging. At present, there is no antidote for this, due to the mechanism of action. The clotting process requires Vitamin K, which is found in foods such as leafy green vegetables. Warfarin inhibits the action of Vitamin K; therefore, such uncontrolled bleeding can be treated by dosing the patient with that vitamin (it is also the reason why warfarin patients must avoid foods like spinach).
There is no such cure for bleeding with Pradaxa and Xarelto (a San Francisco biotech firm, Portola, announced in January that they may have come up with a reversal agent, but it is still undergoing tests). Lawsuits against Boehringer-Ingelheim and Bayer allege that these risks were known to the manufacturer and the information deliberately withheld from the public. This should come as little surprise, given that anti-coagulant medications represent a $10 billion market worldwide – a market that will continue to grow as the percentage of elderly patients increase.
If the executives at Bayer did know about the risks of their highly-profitable product, it would not be surprising. Bayer AG has a record of human rights violations and corporate criminal behavior that goes back almost a century, yet it has never been held truly accountable in any meaningful way. Janssen Pharmaceutica, which markets Xarelto, has a checkered past as well; that company has had to pay out nearly $2 billion to settle charges of deceptive marketing of the drug Risperdal and has been under investigation by the U.S. Department of Justice for paying bribes in order to get its product into nursing homes. The Attorney General of Arkansas was correct when he said that Janssen “puts profits before people.”
That can easily be said about Bayer AG and virtually every other large pharmaceutical corporation on the planet. This is particularly true in the U.S. health care market. Under health care systems and regulations in other industrialized democracies (including Germany), pharmaceutical companies are forbidden to make profits. However, in the U.S., these corporate vultures are allowed and even encouraged to maximize their profits – even when it costs human lives.
After all, what’s a few million dollars in judgments in a $10 billion market?