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First Xarelto Bellwether Trial to Start After Drugmaker Loses Preemption Defense

Internal Bleeding on XareltoNext week the first bellwether trial begins in the Xarelto multidistrict litigation. Bellwether trials are important events in the life-cycle of MDLs. Both sides select several representative cases and submit those cases to the MDL judge, who then makes the final selection for a list of bellwether cases to try. From there, these cases are tried one after another. Along the way, the plaintiffs and defendants get a real sense of what juries think of the common issues raised in the MDL. This can lead to global settlements and ultimately to the resolution of hundreds or thousands of cases.

So as I said, the first Xarelto bellwether trial starts on Monday (April 24, 2017), unless the parties settle the case between now and then, which sometimes happens. If not, in a few weeks we will all get to see what the first jury thinks of the first Xarelto case.

I have written about Xarelto several times on this site, but to recap briefly, Xarelto (rivoroxaban) was supposed to be a game-changer as a blood thinning drug medication when it was first approved for sale in 2011. Blood thinning medications are important drugs to treat certain conditions in patients, as they can prevent pulmonary embolism, deep vein thrombosis, and even strokes. These serious conditions often arise after surgery, when blood clots are more likely to occur. Xarelto was later approved to treat people with atrial fibrillation (irregular heartbeat).

Sadly, the side effects of taking Xarelto became apparent (and alarming) soon after the drug reached the market. Patients were bleeding internally at a higher rate, and there appeared to be no treatment to stop the internal bleeding. With older drugs like warfarin, vitamin K could often stop the internal bleeding. But vitamin K does not work with Xarelto. So patients on Xarelto often simply bleed internally until the drug dissipates from their bodies. Many people who were prescribed Xarelto have been injured. Some of these people have died. And many of those injured have now filed lawsuits.

The First Xarelto Bellwether Trial

On Monday, the trial of Joseph Boudreaux will begin. In his lawsuit Mr. Boudreaux alleges that he began taking Xarelto in 2014 to manage symptoms of atrial fibrillation. He states that a few weeks after taking the medication he was hospitalized for severe gastrointestional bleeding, which ultimately required blood transfusions. Among other allegations, Mr. Boudreaux claims that the drugmakers, Bayer and Janssen Pharmaceuticals, misrepresented the drug’s safety.

But Before We Get to Trial . . .

In every civil case both sides file pretrial motions with the judge. These motions may attempt to have the entire case thrown out (in a motion to dismiss or a motion for summary judgment), or the motions may attempt to limit the evidence to be presented to the jury (motions in limine). In the first Xarelto bellwether case, the drugmakers filed motions for partial summary judgment on certain claims brought by Mr. Boudreaux on the grounds that the claims were “preempted” by federal law. This can get complicated and pointy-headed, but I need to stop here and briefly explain preemption.

What is Preemption?

Federal PreemptionIn a nutshell, this means that when laws are in conflict, federal law trumps or preempts state and local law. If a state law conflicts with a federal law, the state law cannot be enforced. Federal preemption is a principle of constitutional law that attempts to organize and reconcile the powers of federal, state, and local governments. Preemption is derived from the Supremacy Clause in the United States Constitution, which states in relevant part:

This Constitution, and the laws of the United States which shall be made in pursuance thereof; and all treaties made, or which shall be made, under the authority of the United States, shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding.

Whether preemption strips a state law of its authority requires a careful reading of the statutes in play in any given case.

So how does it work? I’ll give you an over-simplified example: State X attempts to deny voting rights to a particular minority group. This law would be preempted by federal statute and the U.S. Constitution, both of which ensure the right to vote. Of course, in this example the attempted law is also plainly unconstitutional and unlawful. In many legal disputes over preemption, however, an otherwise valid state law may be preempted by existing federal law.

This explanation of federal preemption is terribly inadequate. Law professors spend careers writing painstaking law review articles and legal textbooks on preemption. I will write more about preemption in a later post because the issue comes up often in medical device and drug cases.

MDL Judge Tosses Xarelto Makers’ Preemption Defense

In the Xarelto bellwether case, the drugmakers argued that the (federal) regulations from the United States Food and Drug Administration prevented them from revising or updating drug labels or altering guidelines for doses of Xarelto. Judge Fallon (who presides over the Xarelto MDL) didn’t buy it and denied the defendants’ motions in orders issued last week. He stated that the defendants did not show that federal regulations prevented the drug manufacturers from updating their drug warning labels. In this case, the federal regulations and the Louisiana Products Liability Act can work together rather than in opposition. Thus, preemption did not prevent the plaintiff (Mr. Boudreaux) from bringing valid claims against the Xarelto drugmakers for violation of the Louisiana statute.

Now What?

Barring a settlement in the next few days, the first Xarelto bellwether trial will begin on April 24. It will be beneficial to get this first case tried to get a sense of where the Xarelto MDL may be headed. But a word of caution: this is only one trial, with one jury. It will take several bellwether trial verdicts to get a good indication of the future of Xarelto injury claims. Stay tuned.

The Xarelto MDL is in the U.S. District Court for the Eastern District of Louisiana (New Orleans) with Judge Eldon E. Fallon presiding.