J&J’s Loses Again In First California Talc-Cancer Trial As Jury Award Plaintiffs $417 million
Los Angeles jurors decide Johnson & Johnson failed to warn about risks
The Eva Echeverria trial is first of 300 cases in California alleging ovarian cancer
“Eva Echeverria v. Johnson & Johnson, number BC628228, in the Superior Court of California for Los Angeles County”
Johnson & Johnson (J&J) found out earlier today, August 21, 2017 that California is no friendlier than Missouri when fighting allegations that its talc powder causes ovarian cancer in women, as a Los Angeles Superior Court awards plaintiff Eva Echeverria $417 million after 3 days of deliberations.
J&J has lost four out of five recent talc cases that went to trial in St. Louis, and is the first trial before a jury in Los Angeles, and is the first case to go to a state-court jury outside Missouri and one of more than 300 similar cases pending in California. This trial follows the US Supreme Court ruling in June 2017 that made it harder for mass tort lawyers to try cases in St. Louis and other cities that have been a destination of choice for litigation against companies that do business nationwide.
The jury verdict shows that J&J is liable for failing to warn Eva Echeverria, 62, about the alleged cancer risks of using its talcum products, which she started using when was 11. She was diagnosed with ovarian cancer in 2007. The Monday morning verdict followed last Wednesday’s closing arguments, with the California jury deliberations coinciding with J&J’s jury trial in the Xarelto blood thinner Mississippi federal trial, which resulted in a defense verdict for J&J on August 18, 2017. J&J was hoping the Mississippi Xarelto jury verdict was a precursor to the California Talc verdict, which it was not. Ms. Echeverria’s case was chosen as the first bellwether trial due to the onset of final stage ovarian cancer and her failing health, with doubts in some circles that she may not have survived until the trial start.
There are more than 4,800 Talc claims in federal and state U.S. courts accusing J&J, the world’s largest health-care company, of ignoring studies linking its baby powder and Shower to Shower talc products to ovarian cancer and failing to warn customers about the risk, with cases pending in Missouri, New Jersey and California.
In June, the Missouri judge halted the Talc trial there mid-trial in St. Louis, following a U.S. Supreme Court decision, earlier in the day limiting out-of-state plaintiffs joining lawsuits in state court, in the Bristol-Myers (Plavix) state court jurisdictional ruling, Bristol Myers California Plavix Ruling. Up to then, J&J had been hit with verdicts as high as $110 million by Missouri juries, a favored location for Talc litigation, totaling more than $300 million and J&J, a New Brunswick, New Jersey-based company is appealing these verdicts.
J&J claims the plaintiffs’ allegations aren’t supported by scientific evidence, pointing to a New Jersey state court decision last year tossing out two cases set for trial, due to lack of expert witness supporting evidence. That judge found evidence linking talc to ovarian cancer was inadequate, however, J&J just happens to be a New jersey based corporation.
The case is Eva Echeverria v. Johnson & Johnson, BC628228, Los Angeles County Superior Court.
(Dora Mingo vs. Janssen Research & Development, LLC et al. Case No. 2:15-cv-03469)
DEFENDANTS’ MOTION FOR JUDGMENT AS A MATTER OF LAW AT THE CLOSE OF PLAINTIFF’S CASE-IN-CHIEF
The third Xarelto MDL 2592, bellwether trial is proceeding in US District Court of Mississippi in front of MDL Judge Eldon Fallon, where plaintiff Dora Mingo resides, see Xarelto MDL 2592 Mass Tort Nexus Briefcase. At the close of plaintiff’s case-in-chief on August 16, 2017 defendants Janssen Research & Development and Bayer Pharma AG, et al, moved the Court for judgment as a matter of law on Plaintiff’s design-defect and failure-to-warn-or-instruct claims under the Mississippi Product Liability Act (“MPLA”) see, Defendants Motion for Judgment as a Matter of Law.
Plaintiff have asserted two causes of action under Miss. Code Ann. § 11-1-63. Plaintiff first asserts that Xarelto is defectively designed because it was brought to market without an accompanying rivaroxaban-specific anti-Factor Xa assay. Plaintiff also claims that Xarelto is unreasonably dangerous due to inadequate warning or instruction because Defendants failed to instruct physicians to use Neoplastin PT at the initiation of therapy to identify patients at an increased risk of bleeding.
Defendants state in their assertions that they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because an adjunct rivaroxaban-specific anti-Factor Xa assay to be used with Xarelto is not an alternative anticoagulant design and is therefore not a feasible alternative design under the MPLA.3 See Elliot v. El Paso Corp., 181 So. 3d 263, 273 (Miss. 2015); Clark v. Brass Eagle,Inc., 866 So. 2d 456, 461 (Miss. 2004). In their second assertion, they claim they are entitled to a trial win on Plaintiff’s design-defect claim because Plaintiff has presented no evidence that Xarelto failed to function as expected. See Austin v. Will-Burt Co., 361 F.3d 862, 872 (5th Cir. 2004).
Defendants further plead, they are entitled to judgment as a matter of law on Plaintiff’s design-defect claim because Plaintiff has made clear that her design-defect claim is based on a theory that Xarelto should have had a different design at the time it was released to the market (Trial Transcript. 141:19–142:11, 144:1–17), and the Court’s preemption decision so requires. See Order & Reasons on Defs.’ Preemption MSJs (Doc. 7110), at 11 (plaintiff’s “pre-market design-defect claims under the MPLA are not preempted”).
Defendants also include in their request for judgment, plaintiffs abandonment of various claims that were not presented at trial or withdrawn before trial, including the “failure to include the Rocket AF trial data” on participant bleeding rates and that Xarelto was designed without a reversal agent.
Mass Tort Nexus will provide additional Dora Mingo trial updates as they become available.
A federal jury in Louisiana found that Janssen Pharmaceuticals Inc. and Bayer Corp., makers of blood thinner Xarelto, adequately warned about the risk of unstoppable bleeding and that it did not cause the plaintiff to suffer a stroke that killed her.
The case was Joseph Orr Jr. v. Janssen Pharmaceuticals, Inc., et al., No. 15-3708, E.D. LA. Some 17,097 cases are pending before US District Judge Eldon E. Fallon in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.
The jury returned itsverdict on June 12 in the second bellwether trial in the Xarelto multidistrict litigation.
Plaintiff Sharyn Orr took Xarelto to prevent blood clots due to atrial fibrillation. She died after suffering a stroke in 2015. Her husband and children filed the acting, charging that Janssen and Bayer failed to adequately warn that it could cause uncontrolled brain bleeding.
The manufacturers argued successfully that the Xarelto label sufficiently addressed the risk of uncontrolled bleeding.
The plaintiff attorneys were Thomas C. Wicker III, James A. Watkins and Vincent E. Odom of Capitelli & Wicker in New Orleans and Albert J. Nicaud of Nicaud & Sunseri in Metairie, Louisiana.
Bayer is represented by Susan M. Sharko, a morbidly obese attorney with Drinker, Biddle & Reath in Florham Park, N.J.
In damning testimony against drugmakers Janssen Pharmaceuticals and Bayer, an expert cardiologist testified at the second Xarelto bellwether trial that of all the anticoagulants, Xarelto is “the worst.”
“So Xarelto, of all the new oral anticoagulants, is the worst. And that’s well established in the medical literature and even by the FDA. The FDA said that Xarelto was equal to Coumadin. The other drugs which would be apixaban or Eliquis, dabigatran or Pradaxa and edoxaban or Savaysa are in one shape or form superior either in anticoagulation effect or in bleeding or in both,” testified Frank W. Smart, MD, a board-certified doctor in cardiology at LSU School of Medicine.
The case is In Re: Xarelto (Rivaroxaban) Products Liability Litigation, Joseph Orr v. Janssen Research, Case No. 2:15-CV-3708, before US District Judge Eldon Fallon in the Eastern District of Louisiana. Plaintiff attorney Anthony Birchfield, Jr. of Beasley Allen Crow Methvin Portis & Miles in Montgomery, AL, led the direct examination.
Dr. Smart’s opinion was based on his own research plus internal company e-mails from drug manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of FDA reviewers’ opinions FDA where the Xarelto was discussed.
Stops precribing Xarelto
Xarelto is a NOAC or new oral anticoagulant. Instead of blocking clotting factor Vitamin K, Xarelto is an inhibitor of Factor Xa, and it too stops the prothrombin-to-thrombin conversion and thins a person’s blood.
“I read an article that was in one of the Canadian journals that was very impressive to me, and I started transitioning people off of Xarelto at that time and have completely abandoned the use of it,” he testified. “It was a twice-a-day drug crammed into a once-a-day prescription, and I thought that that was a poor idea. I still think it’s a poor idea.”
“A practicing cardiologist sees people six, seven days a week “and they don’t have time. They don’t physically have time to chase down information like this.”
“Coumadin has a black box warning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and then things like that. Xarelto, I believe, should have a black box warning as well because all the literature and the FDA said that there’s no difference,” he testified.
An FDA Black Box Warning is the strongest warning that the US Food and Drug Administration (FDA) puts on a drug. For example, addictive opioids have black box warnings.
After reading FDA transcripts, Smart said, “The conclusion seemed to be that if the FDA had had their druthers, the company would have tested a twice-a-day dose, but they went on to say that they didn’t have the capacity to force the company into doing that, and the only thing that they could do was to consider the information that had been presented to them at the once-a-day dose.
Xarelto worst drug in its class
The ROCKET-AF trial of Xarelto on 7,000 patients with atrial fibrillation (Afib) found that “Xarelto was the worst in the class of these drugs. It was never shown to be superior to warfarin for either stroke or bleeding. But Eliquis, or apixaban, was shown to be superior for both,” Smart testified.
Q. (by attorney Anthony Birchfield) So when we look at these drugs, if we look at Eliquis. Eliquis in the clinical trial, is it shown to be superior in both safety and efficacy?
A. (by Dr. Smart) Yes, sir. To warfarin.
Q. So Eliquis is superior to them both. And then, when we look at Pradaxa compared to warfarin, was Pradaxa — was it superior to either — in either safety or efficacy?
A. Yes, sir. It was superior in safety.
Q. What about efficacy?
Q. And then, when we look at Xarelto was Xarelto superior in safety?
A. No, sir.
Q. Was it superior in efficacy?
A. No, sir.
“I think, again, playing Monday morning quarterback, I think had Eliquis been released at the time, there was no way that Xarelto would have been approved,” by the FDA, Smart testified.
“It’s worst in class among the NOACs. That’s pretty accepted. I mean, it’s a four-horse race, and they are the fourth horse. This adds concern that the approval was maybe less grounded in great science.”
The outcome of the second bellwether trial over the dangers of Xarelto, a blood thinner sold by Janssen Pharmaceuticals and Bayer, boils down to what killed plaintiff Sharyn Orr, a 67-year-old grandmother with a host of medical problems.
The plaintiffs say it was Xarelto. The defense says it was her uncontrolled high blood pressure. The jury will decide in In Re: Xarelto (Rivaroxaban) Products Liability Litigation, Joseph Orr v. Janssen Research, Case No. 2:15-CV-3708, before US District Judge Eldon Fallon in the Eastern District of Louisiana.
Massive brain hemorrhage
In his opening argument, plaintiff attorney Brian H. Barr of Levin Papantonio of Pensacola, FL, argued Xarelto caused a massive brain hemorrhage that killed her in on May 4, 2015, after she was rushed to the hospital with a severe headache and vomiting.
“Hypertension and diabetes, they did not slow Mrs. Orr down. What slowed her down, what took her life was Xarelto, a pill that she was taking to reduce her risk of stroke,” Barr told the jury in his opening statement. “Sharyn should have never been put on the drug Xarelto.”
“Defendants learned that for every million people who take Xarelto for one year, 36,000 of those people will have a major bleeding event. 5,000 of those bleeding events will be brain bleeds like Ms. Orr had, and 2,000 of those events will be fatal,” he argued.
In this failure to warn case, the drug companies failed to state on the label that a simple test — a “prothrombin time” or “PT” test — would have revealed how much Xarelto was in her blood. In the hospital, neurosurgeon Dr. Bui delayed operating on her skull because he didn’t know how much Xarelto was circulating in her.
“Her chance of survival would have been about 60 percent had Dr. Bui been able to immediately operate. You will hear that Ms. Orr could have been saved had these companies told her doctors the truth,” Barr said.
“There was no scientific reason for not telling doctors in the drug label to actually measure blood levels with PT when considering emergency surgery. The evidence will be that the defendants chose a marketing advantage over good science and patient safety,” he said.
Plaintiff witnesses include:
Video testimony of several company executives who will testify about internal company documents that PT is a useful test to inform doctors in cases of urgent surgery.
Dr. Peter Liechty, a neurosurgeon, trained at the University of Alabama, who practices in Thibodaux, Louisiana. He will testify that had Dr. Bui been able to immediately operate, Ms. Orr most likely would have survived and had a meaningful recovery.
Dr. Scott D Berkowitz, a Bayer vice president, who will testify that there was the need for an indicator test and that PT could give the information that was needed for emergency surgery.
Dr. Frank Smart, a professor of medicine and the chief of cardiology at the LSU School of Medicine. “He is going to explain to you that Xarelto is the worst, most dangerous of all the NOACs,” Barr said. A NOAC is a novel oral anticoagulant.
Defense: aged plaintiff was very sick
Defense attorney Beth A. Wilkinson of Wilkinson Walsh + Eskovitz, LLP in Washington, DC, argued in her opening statement that the plaintiff “had type 2 diabetes, which was causing damage to her body. She had sustained high cholesterol. She had horrible kidney disease, stage 3 kidney disease. And then she had atrial fibrillation — or AFib — in 2011 and heart failure, cardiac heart failure, that same year. All of these conditions, as you’ll see, contributed to difficulties that she was having on a day-to-day basis.”
“So she had a drug for diabetes. She had five different drugs for her blood pressure. She had a drug for neuropathy, which is when you lose the feeling, and that often happens, unfortunately, to diabetics. She was on aspirin. She was on Xarelto for AFib. She was on cholesterol and gout medication. So even though she was only 67 years old and she lived a full life and she exercised, she got the real short end of the stick. She did everything she was supposed to, but her body wasn’t working,” she argued.
The death certificate says Orr died from hypertension — uncontrolled high blood pressure which was the cause of a brain hemorrhage. On the day she died her blood pressure was 200/90.
“Now, Xarelto doesn’t even cause hemorrhages. Even Dr. Smart, their cardiologist, and Dr. Khatib, who will be our cardiologist who has the specialty of electrophysiology, they both tell you that Xarelto doesn’t cause a bleed,” she argued.
She blamed the FDA for removing text about the PT test. “We do talk about PT in the label. That is the Xarelto label. We do say what we believe we can say. We tried, as you will see in evidence, to say more and we submitted it to the FDA. And guess what the FDA said? They crossed it out of the label. And you are going to see that strikeout,” she said.
Other defense witnesses include:
Dr. Mahanna, who filled out the death certificate.
Dr. St. Martin, her treating cardiologist, who prescribed Xarelto for her in February 2014. “He still believes it was the right decision to prescribe her Xarelto,” Wilkinson said. “Dr. St. Martin and others feel like this is a good drug is because it has been so thoroughly tested.”
The second bellwether trial involving bleeding risks with the blood thinner Xarelto is slated to begin today. The trial is part of the multidistrict litigation (MDL) pending in the United States District Court for the Eastern District for Louisiana before Judge Eldon Fallon.
The Jere Beasley Report explains that Xarelto is an anticoagulant (blood thinner) initially approved in 2011 to reduce the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) following knee and hip replacement surgery. It was later approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation (A-fib) and for treatment of DVT and PE. Xarelto carries a significant risk of severe, uncontrolled internal bleeding and has been linked to bleeding-related deaths.
The second trial involves Joseph Orr, Jr., a Louisiana resident, who filed suit on behalf of his deceased wife, Sharyn Orr. Mrs. Orr suffered a fatal brain bleed while taking Xarelto. She was 67 years old at the time of her death and had been taking the drug to treat A-fib for just over a year when she suddenly become severely ill.
Mrs. Orr was transported to the hospital where a CT scan of her head revealed she was suffering from an extensive, acute hemorrhage in her brain and a hemorrhagic stroke. Although she needed a surgery, she was not stable enough until the next day when Xarelto had the chance to clear her system. Unfortunately, the procedure came too late and Mrs. Orr’s neurologic condition continued to worsen until May 4, 2015, when she passed away.
More than 16,000 Xarelto lawsuits have been filed in the federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana.
German drug manufacturer Bayer AG and Johnson & Johnson’s Janssen Pharmaceuticals developed and marketed Xarelto as a blood thinner that does not require coagulation monitoring, the Plaintiffs assert. They argue that the Defendants failed to develop a monitoring test specific to Xarelto and failed to instruct doctors on how to use currently available tests to measure Xarelto’s anticoagulant effect on patients’ blood. Such monitoring would allow doctors to assess whether patients benefited from the use or were at risk of severe internal bleeding.
By Joseph VanZandt, a Medical Devices and Drugs attorney with Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. in Montgomery, AL.
Xarelto litigations have also been established in state courts in Pennsylvania, Delaware, California and Missouri, while class action lawsuits have been filed in Canada.
Xarelto is an oral anticoagulant jointly marketed by Bayer and Johnson & Johnson. The blood thinner was approved by the FDA in 2011, and is currently indicated for the prevention of strokes in atrial fibrillation patients; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee implant surgery.
Xarelto plaintiffs allege that Bayer and Johnson & Johnson failed to provide adequate warnings about bleeding that may occur with its use, and wrongly promoted the blood thinner as a superior alternative to warfarin, says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs.
Among other things, plaintiffs note that bleeding associated with warfarin can be reversed via the administration of vitamin K. However, there is no approved antidote to stop Xarelto bleeding events.
The multidistrict litigation underway in the Eastern District of Louisiana houses at least 16,670 Xarelto lawsuits. The second bellwether trial beings on May 30 in New Orleans. Verdicts in these trials may provide insight into how juries could rule in similar Xarelto claims. Johnson & Johnson and Bayer prevailed in the first Xarelto trial, which concluded earlier this month. (In Re: Xarelto Products Liability Litigation, No. 2592).
Xarelto patients who allegedly experienced bleeding-related complications may be entitled to compensation for their medical bills, lost wages, pain and suffering, and more.
Within minutes of the defense verdict being handed down in the first Xarelto bellwether trial, (Boudreaux vs Bayer et.al., Case No. 2:14-cv-02720) the phone lines at Mass Tort Nexus began ringing like a Salvation Army donation site at Christmas.
The primary inquiry was the same: “What effect does the Boudreaux defense verdict have on the overall prospects of the Xarelto litigation?”
Our website www.masstortnexus.com already contained all of the pretrial documents for the Boudreaux case and we ordered an expedited copy of the Boudreaux transcript so that our researchers could get the complete picture and start an autopsy of the case.
If you are a Mass Tort Nexus subscriber you may obtain all documents, including the 1,600+ page transcript from the Boudreaux bellwether trial here.
Before going further, it is important to say to any plaintiff lawyer representing clients in the Xarelto litigation who may be freaking out due to the defense verdict in the first bellwether trial: put the cap back on the Xanax.
In fact, the plaintiff may well lose the second bellwether trial as well, because it appears that the Dr. St. James, the prescribing physician in the Orr case (the second Xarelto bellwether trial set for May 30, Joseph Orr, Jr., Case No. 2:15-cv-03708), is likely to testify in a very similar manner to Dr. Wong, (the prescribing physician in the Boudreaux bellwether case).
Regardless, keep your feet firmly planted on the rail of that bridge you may be thinking of jumping off of. Panic would be extremely premature.
Mass Tort Nexus became aware of how Dr. Wong and Dr. St. James were likely to testify as a result of the motion for summary judgment based on the learned intermediary doctrine filed by the defense revealing deposition testimony of Dr. Wong and Dr. St. James. Both prescribing physicians testified as if someone had given them a script entitled “How a prescribing physician should testify to support a learned intermediary doctrine defense.”
The defense motion for summary judgment was denied as under Louisiana’s version of the learned intermediary doctrine, because the relevant issues are considered matters for a jury to decide under Louisiana Law. Louisiana law applied because both the Boudreaux and the Orr case state of “original jurisdiction” was Louisiana. This had nothing to do with the fact that the MDL is consolidated in Louisiana nor will Louisiana law apply to cases where other states would be the state of “original jurisdiction.”
The Answer to the $64,000 Question
The simple answer to the question, regarding the defense verdict in the first Xarelto bellwether, is that the Boudreaux verdict has no direct impact on any other case other than the case brought on behalf of Joseph Boudreaux.
As to the indirect impact Boudreaux verdict on the overall Xarelto litigation, the analysis must be broadened.
First, the fact that defense based its entire strategy on the learned intermediary doctrine, could be somewhat telling about the defendants and their counsel’s belief that they would prevail under other defense theories. The learned intermediary doctrine is considered by many to be a defense of last resort. When possible, the goal of defendants in pharmaceutical and medical device cases should be to obtain dismissal of every single plaintiff’s case in a mass litigation via preemption or other universal case-killer legal theory. This goal will never be achieved through the learned intermediary doctrine defense.
The learned intermediary doctrine provides that a manufacturer of a product has fulfilled his duty of care when he provides all the necessary information to a “learned intermediary” who then interacts with the consumer of a product.
Although most states have codified some version of the doctrine and the reasoning behind it has been applied in individual cases in all 50 States, it is safe to say that not all states have applied the doctrine in the same manner.
More important is that the learned intermediary doctrine defense is entirely dependent on the testimony of the individual prescribing physician in any given plaintiff’s case. To prevail with the learned intermediary doctrine defense, the prescribing physician must testify, very specifically, in one of two manners:
That the doctor was aware of all the risks associated with the drug and continued to believe that the benefits outweighed the risks with regard to the individual plaintiff (patient).
That any risk not known at the time the doctor prescribed the drug, if known, would not have changed her decision with regard to prescribing the drug for the individual plaintiff patient.
16,285 additional complaints
Plaintiffs and their counsel can safely assume that many of the prescribing physicians for the 39 remaining scheduled Xarelto bellwether cases will not all testify in a manner supporting a learned intermediary doctrine defense. Beyond the 39 bellwether cases, defense has 16,285 (and climbing) additional complaints to contend with. Are all the prescribing physicians in the other 17,000 plus complaints going to fiddle to the music of the learned intermediary doctrine defense? Not bloody likely.
In the Xarelto bellwether trial selection, Judge Eldon Fallon allowed the defense to pick 10 cases, allowed the plaintiffs to pick 10 cases and Judge Fallon selected the remaining 20 cases himself. Plaintiffs are not facing a situation where defense was able to load the bellwether selection with cases in which the individual prescribing physicians gave depositions or otherwise indicated that they would eventually testify by the script the defendants need to prevail under a learned intermediary defense.
In cases where the prescribing physician cannot be counted on to follow the defendants’ learned intermediary doctrine script, the defendant and counsel will be forced to base their arguments on the merits of the case. Without the learned intermediary doctrine knockout, the merits of the Xarelto case favor defense looking as if it was in a fight with Joe Frazier followed by a fight with Mike Tyson.
Putting aside the foregoing, a review of past MDL pharmaceutical product liability bellwether verdicts in which defense has prevailed in the first trial and often in the majority of the bellwether cases may allow some plaintiff lawyers to put the first Xarelto bellwether defense verdict in perspective and take comfort.
39 bellwethers to go
Note: If the prescribing physician takes the stand wearing a Rolex with the defendants’ logo inscribed on the back, no matter how good the case or counsel may be, the plaintiff is probably not going to fare well. Fortunately, in the Xarelto litigation, there are 39 more bellwether trials to go.
If the defense does not settle those 39 cases, there will likely be more bellwethers scheduled. If Judge Fallon at some point determines that the litigation is not going to result in settlement, he could remand all remaining cases for trial.
The only other possible outcome is for the defense to find a way to get all Xarelto cases dismissed on a creative legal theory (which does not exist in the Xarelto case). It is safe to say, we are past the point where all Xarelto cases will be universally dismissed under any legal theory.
Anyone who has attended the Four Days to Mass Tort Success Course has heard me say, “The decisions made in the boardroom of pharmaceutical companies with regard to settling mass litigation cases often have very little to do with the ‘legal’ aspects of the case and although bellwether trials results are not insignificant, they are not as significant as one might assume.”
What is the likely future of the Xarelto bellwether trials? The defense will win some, the plaintiffs will win some and in the final analysis, these wins and losses will not be the primary factor in the defendant’s decision to settle the case. We apologize to anyone who was under the false impression that Big Pharma makes any decision that is not based on the bottom line, including their decision to put dangerous products on the market in the first place. Ultimately it is unlikely that a scenario will appear where the math for the defendant will not favor mass settlement.
Below is a sampling of cases where the first bellwether trial resulted in a defense verdict or the majority of bellwether trials resulted in defense verdicts and yet, the litigation ended in mass settlement.
Bellwether Defense Wins and Settlements
Vioxx MDL 1657
Of the six bellwether trials that occurred in the Vioxx MDL the first bellwether trial ended in a defense verdict. The other five bellwether trials ended in three more defense verdicts, one trial ended in a hung jury and the plaintiffs won only one of the six bellwether trials. Ten additional trials occurred outside of the MDL. Of the total 16 trials that occurred in the Vioxx product liability litigation, 11 resulted in defense verdicts.
The defendant ultimately agreed to settle the vast majority of Vioxx cases for an estimated $4.8 billion.
72 Defense firms participated in the Vioxx product liability defense. According to documents filed on behalf of these firms, the total hours billed for all firms was 350,000 hours. Using a blended rate including averages for partners, associates and other personnel of $475 per hour. The defendant’s legal fees were about $165,550,000.
If you are doing the math, inclusive of the legal fees paid for the defendant’s legal fees in the MDL and the 16 Vioxx trials, the defendant spent on average $10,343,750 per tried case. Winning does not feel that great when your own lawyers dip their hands deeper into your pocket than the opposition.
MDL 1355 Propulsid
The first bellwether trial resulted in a defense verdict. The second and third bellwether trials resulted in defense motions for summary judgment being granted.
The defendant Johnson & Johnson ultimately settled with the majority of the plaintiffs in the Propulsid litigation for an estimated $100 million.
Prempro Product Liability Litigation
The first bellwether trial resulted in a defense verdict. The defendant went on to win the majority of the 15 bellwether trials.
Ultimately the defendant settled the vast majority of the plaintiffs’ cases for about $1 billion.
Defense summary judgment granted in all Group I bellwether cases. The defendant agreed to settle the majority of NuvaRing cases for approximately $100 million.
Traysol Product Liability Litigation MDL 1928
The first two bellwether trials were dismissed on a defense motion for summary judgment. The defendant Bayer ultimately settled the Traysol Litigation for an average of approximately $400,000 per plaintiff.
Actos Product Liability Litigation MDL 2299
The first three bellwether trials resulted in plaintiff’s verdicts with jury awards of $6.5 million, $1.76 million and $2.05 million. The fourth bellwether trial resulted in a defense verdict. Takeda settled Actos cases for a total of approximately $2.4 billion.
Fen-Phen Product Liability Litigation MDL 1023
Despite having prevailed in many bellwether trials including Weston v. Wyeth, No. 03-CV-679878 (Jasper Co., Mo., Cir. Ct. 2006). Geers v. Wyeth, No. MO-03-CA-107-H (W.D. Texas 2006), Townley v. Wyeth, Nos. 0402-03094 and 0402-03171 (Philadelphia Co., Pa., Ct. C.P. 2006), Smith v. American Home Products, No. 97-55545 as well as others — Wyeth ultimately settled the Fen-Phen Litigation for approximately $2.74 billion.
A federal jury in Louisiana ruled that Johnson & Johnson and Bayer AG provided adequate instructions for the safe use of Xarelto to the doctors who prescribed it to the plaintiff, who suffered severe gastrointestinal bleeding and survived only because of several blood transfusions.
It was the first verdict in the first test case of 16,285 lawsuits, and it has no bearing on future trial outcomes. The plaintiff Joseph Boudreaux, Jr., age 75, of Lafourche Parish, Louisiana. He was prescribed Xarelto in 2014 for atrial fibrillation. He only took the drug for 21 days before he suffered severe gastrointestinal bleeding.
The drug is Bayer’s top-selling product, generating $3.24 billion in sales last year and $2.5 billion in 2015 for the German pharmaceutical company. Xarelto is J&J’s third-largest seller, bringing in $2.29 billion in 2016 as the New Brunswick, New Jersey.
Doctors sink plaintiff’s case
The fatal element for the plaintiff was that his doctor – cardiologist Dr. Kenneth Wong – testified that they stood by their decision to prescribe Xarelto. Further, both doctors testified that they would have used a test to monitor anticoagulation, but only if it were FDA-approved. The defense argued that this test does not exist (although this claim is not accurate).
Xarelto advertised that its predecessor drug warfarin required testing and monitoring — and that Xarelto did not. The makers of Xarelto had to test the prothrombin time (PT)/international normalized ratio (INR) in their clinical trials, so a test does exist.
Accepting the defense argument that there was no approved test means that the makers of Xarelto put a product on the market for which testing/monitoring was needed — yet no test existed and the drug companies didn’t warn of this.
In the Boudreaux case, the defendants argued that the plaintiff was administered a different PT test which showed him in the normal range. Accordingly, the defense argued there is no causal connection between the plaintiffs’ injuries and the failure to warn, and the arguments are barred by the learned intermediary doctrine.
Janssen was represented by Susan Sharko of Drinker Biddle & Reath LLP and Richard Sarver and Celeste Coco-Ewing of Barrasso Usdin Kupperman Freeman & Sarver. Bayer’s attorneys are Beth Wilkinson of Wilkinson Walsh Eskovitz, David Dukes of Nelson Mullins Riley & Scarborough and William Hoffman of Arnold & Porter Kaye Scholer LLP.
The defense succeeded in its argument that the drug label is legally adequate because it prominently warns of the risk of bleeding and the prescribing physicians testified that they were aware of that risk.
The defense succeeded in its argument that the drug label is legally adequate because it prominently warns of the risk of bleeding and the prescribing physicians testified that they were aware of that risk.
The plaintiff emphasized that there is no antidote to Xarelto, unlike warfarin. Therefore, in the event of hemorrhagic complications, there is no available reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section.
The pharma companies face more bellwether trials in federal court presided over by US District Judge Eldon Fallon in New Orleans. :
May 30, 2017 – Eastern District of Louisiana
To Be Set in June 2017 – Southern District of Mississippi
To Be Set in July 2017 – Northern District of Texas
Independently, the drug companies face 1,390 lawsuits over Xarelto in the Philadelphia Court of Common Pleas.
In a new-user cohort study of 118,891 patients, rivaroxaban (Xarelto) treatment was associated with greatly increased intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding.
In this observational study published in JAMA Internal Medicine, Xarelto use was associated with increased intracranial and major extracranial bleeding events compared with Pradaxa use.
Xarelto and Pradaxa are non–vitamin K oral anticoagulants approved for stroke prevention in patients with nonvalvular atrial fibrillation (AF). There are no randomized head-to-head comparisons of these drugs for stroke, bleeding, or mortality outcomes.
German drug maker Boehringer Ingelheim settled 4,590 cases involving Pradaxa (Dabigatran) for a total of $650 million in May 2014. Patients and their families claimed that Boehringer failed to properly warn them that the drug, which is used to prevent blood clots, caused serious and sometimes fatal bleeding that could not easily be reversed.
The JAMA study compared risks of thromboembolic stroke, intracranial hemorrhage intracranial hemorrhage, major extracranial bleeding including major gastrointestinal bleeding, and mortality in patients with nonvalvular AF who initiated dabigatran (Pradaxa) or rivaroxaban treatment for stroke prevention.
The study found that treatment with Xarelto 20 mg once daily was associated with statistically significant increases in intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding, compared with Pradaxa 150 mg twice daily.
The researchers also noted that, in 2014, rivaroxaban was prescribed two to three times more often than Pradaxa for AFib patients in the U.S., and they said that may be due to doctors falsely believing that Xarelto posed less risk of major bleeding events than Pradaxa.
The lawsuits stem from allegations that the anticoagulant Xarelto could cause uncontrollable bleeding in some people. They accuse the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — of failing to warn about Xarelto’s potential risks.
The first bellwether trial involves a Louisiana man with atrial fibrillation, who took Xarelto and suffered life-threatening gastrointestinal bleeding. Joseph Boudreaux Jr. took Xarelto for just under one month in 2014 before he was hospitalized for severe internal bleeding, according to the lawsuit. Boudreaux, Jr. et al v. Janssen Research & Development LLC et al (2:14-cv-02720)
He needed several blood transfusions and was hospitalized for five days as a result of his Xarelto bleeding episode. He then required follow-up medical treatment following his stay in the hospital.
Boudreaux filed a Xarelto lawsuit against Janssen and Bayer in December 2014, accusing the two manufacturers of concealing their knowledge of Xarelto’s defects from physicians and patients like himself.