By Emily Cox
It appears that Xarelto manufacturers may have stacked the deck against early trial plaintiffs in the multidistrict litigation (MDL) over the companies’ failure to adequately warn about the blood thinner’s dangerous bleeding risks.
Xarelto manufacturers first sought to centralize the litigation on home turf in corporate-friendly New Jersey. However, the Judicial Panel on Multidistrict Litigation (JPML) chose to consolidate federal Xarelto lawsuits in Louisiana instead. Following this decision, Xarelto manufacturers quickly devised a way to regain the upper hand in the litigation, while limiting its scope.
Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), holds that MDL district judges lack the authority to try cases that originate outside of the transferee court. However, this ruling strikes at the very judicial efficiency that is at the heart of MDL formulation and the bellwether trial process. Consequently, the ruling also provides for Lexecon waivers that must be signed by both plaintiffs and defendants so that the bellwethers represent patients across the country rather than just the MDL district. Generally, these waivers are signed with little fanfare. But, they are not compulsory. Consequently, Xarelto manufacturers Johnson & Johnson and its Janssen unit used these waivers to choose their battlefields for the bellwether trial process.
Xarelto Manufacturers Refuse to Sign Lexecon Waivers
Refusing to sign the Lexecon waivers was a calculated move to limit the scope of the early trial process. According to the Lexecon ruling, Xarelto manufacturers could have hypothetically limited the litigation to only Louisiana cases. However, in an effort to keep the court’s favor, the drug makers consented to allowing plaintiffs from the entire 5th circuit. This consists of Louisiana, Mississippi, and Texas. Judge Fallon noted this concession during oral arguments on limiting the bellwether trial pool so severely.
The associated case management order also indicated that plaintiff attorneys were free to choose seven plaintiffs from states of their choosing. However, this was more of a symbolic gesture. Without the defendants signing off on Lexecon, cases outside of the 5th circuit were inherently illegible for the bellwether process regardless. Judge Fallon indicated as much during the hearing. He indicated that he would simply wash his hands of these cases, remanding them back to their original courts.
“If they [Xarelto manufacturers] don’t agree, it doesn’t matter whether or not you should try a case filed in New York or whatever,” Judge Fallon said.
“I’m going to just send them back to wherever they came from, and let you try them.”
This put plaintiff attorneys between the proverbial rock and a hard place by essentially limiting their trial picks to the 5th circuit’s three states. Their only chance for success was to pick the best defendants from those states, rather than the best overall cases. Furthermore, in conceding to accept Texas and Mississippi cases, Xarelto manufacturers not only appeased the court enough to reject plaintiff attorney objections. They also ensured these cases landed in courts that may provide some of the more favorable outcomes for the defendants in the nation.
Xarelto Manufacturers Steered MDL Litigation Toward Favorable Outcomes
Allowing Mississippi and Texas cases into the bellwether process was by no means a gesture of goodwill. All three states in the 5th circuit have provisions that could ensure that the bellwether process goes smoothly for the drug makers.
The Louisiana Learned Intermediary Doctrine absolutely annihilated the first two bellwether trials. The doctrine holds drug makers only need to inform doctors of risks, negating labeling issues. Unfortunately, plaintiff doctors vigorously defended the Xarelto manufacturers rather than their patients. Testimony depositions from the doctors in both trials read like primers for “How a prescribing physician should testify to support a learned intermediary doctrine defense.” Doesn’t sound like the drug makers had a hand in that at all…
In August, the MDL moves to Mississippi. While plaintiff attorneys stand a better chance at winning here, the victory will be marginal. Mississippi imposes a $1 million cap on noneconomic damages. Most of the plaintiffs are elderly and do not work. Consequently, noneconomic damages pretty much encapsulate the entirety of their compensation. Furthermore, these early trials help establish future settlement amounts. A Mississippi victory will undoubtedly lower the potential value of these settlements.
The final bellwether trial will take place in Texas. Unfortunately, the state requires evidence of FDA fraud to bring failure to warn claims. Granted, this is a product liability litigation. However, Xarelto manufacturers’ failure to warn is the very basis of the litigation.
Consequently, due to the drug makers’ maneuvers, the Xarelto bellwethers could very well paint a bleak, if incomplete, picture of the litigation’s potential. Plaintiffs and attorneys would do well to remember that, regardless of the bellwether outcomes, they are only a fraction of the bigger picture.
Lawsuits Against Xarelto Manufacturers
The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce blood clot risks. The agency has expanded the drug’s indications several times since then despite the fact that the drug has no reversal agent to stop emergency bleeding. Other anticoagulants, like Coumadin (warfarin) have antidotes to reverse their blood thinning effects in emergency situations. However, patients were never warned of these life-threatening risks. Regardless, Xarelto still quickly became one of the drug makers’ star performers.
Xarelto made $582 million in sales during its first full year on the market. In 2013, this figure rose to $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product. It brought in $2.5 billion in sales in 2015 and $3.24 billion in 2016. It is third on Johnson & Johnson’s product roster, generating $2.29 billion for the company in 2016. Like many meteoric climbs to come before it, sacrifices were made. Unfortunately, these sacrifices may have been the health of the very patients Xarelto was purportedly designed to help.
More than 18,000 individuals have filed product liability lawsuits against Xarelto manufacturers after suffering from uncontrollable, life-threatening bleeding. They allege that the drug makers knew about the substantial risks of the anticoagulant but never warned patients. Instead, the companies downplayed the risks to boost sales.