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.
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.
As a bellwether trial is looming in federal court in New Orleans, the makers of Xarelto are facing $2.5 billion in potential liability from patients who suffered uncontrollable internal bleeding.
Xarelto is a drug designed to thin the blood to prevent clots in patients who have an abnormal heart rhythm, who are at risk of stroke, or who have had hip or knee replacement surgery. However the drug has no antidote and the makers ignored years of danger signals.
There has been an explosion in Xarelto products liability cases against manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson and Bayer, which co-markets the blood thinner.
The Xarelto docket in MDL 2592 was created in 2014 with only 21 cases, and by the end of the year, more than 400 cases were filed. By December 2015, it had exploded to 2,400 cases, six months later in April, 4,500 cases. The litigation really took off in 2016 and there are now more than 15,600 cases.
Possible $500,000 settlement value
The first bellwether (test case) trial is on April 24, 2017, and the second is set for on May 30. The two defendant companies are facing a potential liability of $2.5 billion, based on settlements in Pradaxa cases in 2014. The settlement value could be up to $500,000 in a wrongful death case, and the average settlement could be in the neighborhood of $160,000.
Xarelto was designed to replace an older drug called warfarin (Coumadin). Warfarin still in use today. It was originally approved in 1954 by the FDA, it can easily be reversed with Vitamin K, the blood element that causes clotting.
Warfarin requires the doctor who prescribed it to monitor a patient’s diet and dosage carefully. Xarelto, on the other hand, was marketed as a once-a-day dose, despite that it has a short half life: between 5-9 hours.
There was a strong profit motive to create a new drug when warfarin became generic. The lowest available price of 30 standard warfarin tablets is $4. The lowest price for 30, 5 mg Xarelto tablets? — $405.
It is clear why Xarelto became a blockbuster drug for Johnson & Johnson: In 2014, the company had sales totaling $3.7 billion for Xarelto alone.
Xarelto has no reversal agent
The FDA approved Xarelto as a once-a-day blood thinner to reduce the risk of blood clots after hip or knee replacement surgery in July 2011. A few months later in November 2011, it was approved to reduce the risk of stroke from atrial fibrillation. Then in November 2012, the agency expanded it to treat deep vein thrombosis and pulmonary embolism.
Since Xarelto went on the market, the manufacturers ignored the dangers of Xarelto. It has no reversal agent or antidote, and can cause uncontrollable internal bleeding. Also, the plaintiffs allege that Xarelto can actually cause strokes and blood clots if discontinued abruptly. The plaintiffs also charge that the makers of the drug failed to warn users and actually concealed the fact that Xarelto causes uncontrolled internal bleeding.
Meanwhile, Janssen and Bayer continue to advertise Xarelto aggressively. One TV commercial featured comedian Kevin Nealon, NASCAR driver Brian Vickers and Hall of Fame golfer Arnold Palmer. The 87-year old Palmer wore a pink sweater and said, “Treatment with Xarelto was the right move for us.” Many people are wondering if that is true in the wake of his death on September 25, 2016, which was preceded in August 2016 by surgery for gastrointestinal bleeding. See Did Xarelto, the Drug Arnold Palmer Promoted, Lead to His Death?
Xarelto Litigation Overview
The vast majority of Xarelto cases are in multidistrict litigation Eastern District of Louisiana before Judge Eldon Fallon, where the bellwether trial is coming up.
The plaintiff in the April 24 bellwether trial is Joseph Boudreaux, Jr. in 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, and he survived only because of several blood transfusions.
Companies Ignored Danger Signals About Xarelto
Evidence will be presented at the trial how Bayer and Janssen ignored many danger signals.
Studies began showing as early as 2008 that Xarelto was more dangerous than other blood-thinning drugs. The New England Journal of Medicine published articles in 2008, 2011 and 2012 all of which discussed an increased risk of adverse events.
In 2012, the FDA recorded “serious adverse events” reports about Xarelto. This was the first year after the drug was on the market and there were 2,081 serious adverse events. 151 of those were deaths, compared to only 56 deaths from warfarin.
In 2013 and 2014, the FDA required that Xarelto drugmakers include boxed warnings.
In 2013, the FDA required that Xarelto include a warning that premature discontinuation of Xarelto® increases the risk blood clots.
In 2014, the FDA required that Xarelto include a warning that it can cause internal bleeding. The warning must also state that a specific antidote is not available for Xarelto.
The prevailing view about a settlement is that nothing will happen until the litigation affects the stock price of Bayer and Johnson & Johnson. This may happen this year, based on settlements involving a similar blood thinner called Pradaxa.
Pradaxa was approved in 2010 before Xarelto and it was a commercial success, generating huge sales for Boehringer-Ingelheim. Unfortunately, like Xarelto, Pradaxa didn’t have an antidote for bleeding. Thousands of lawsuits were filed, and in 2014, Boehringer-Ingelheim settled 4,000 cases in state and federal courts for $650 million. Individual settlements ranged from $500,000 to $12,000.
For purposes of calculating how big a settlement for Xarelto might be, lawyers can start with the average Pradaxa settlement of $162,500. When multiplied by the 15,611 cases that are currently filed in the federal MDL, this produces a potential liability of $2.53 billion.
This is why Xarelto is an attractive addition to a personal injury practice.
How do you get more clients?
To learn about attracting potential clients for Xarelto cases, watch the webinar below sponsored by LawLytics. Do you have questions about marketing a mass torts practice? LawLytics can help. Call at 800-713-0161 or schedule our call.
At this point, it’s easy to get involved in Xarelto litigation. The court has established both short and long-form complaints. So essentially, all an attorney needs to do is find a client and fill in the blanks as appropriate.
The court has approved a plaintiff fact sheet that goes through questions about the medical history of the patient, and it’s also a fill-in-the-blanks form.
With more than 15,000 cases already, attorneys might be asking, are there any more plaintiffs out there to find? And the answer to that is yes. More than 7 million people worldwide have been prescribed Xarelto, and at least 2 million Americans have atrial fibrillation that’s treated with Xarelto. All of these people are potential plaintiffs.
Even as Xarelto litigation grows ahead of the first bellwether trial in federal court MDL No. 2592, some plaintiff attorneys are mistakenly turning down cases if the death certificate does not specifically mention internal bleeding or ischemic stroke.
In our consulting practice at Mass Tort Nexus we are often asked if the cause of death listed on a death certificate does not mention bleeding or ischemic stroke deal — is that a fatal obstacle to filing a wrongful death case related to Xarelto, Pradaxa or Eliquis?
The federal lawsuits stem from allegations that the anticoagulant Xarelto could cause uncontrollable bleeding and hemorrhagic strokes. They accuse the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — of failing to warn about Xarelto’s potential risks.
In parallel state court litigation in Pennsylvania, Judge Arnold L. New in the Philadelphia Court of Common Pleas amended the master and short form complaint to allow for Ischemic Stroke Claims to be made in that court.
What a death certificate is — and isn’t
A death certificate is document that serves primarily as a public record of an individual’s death. These records are often used in a variety of statistical analysis.
The cause of death (COD) noted on a death certificate is not intended to be an expansive diagnostic review of all medical events that led to the death. In some cases, the person who issued the death certificate may not even be a medical practitioner.
In reviewing blood-thinners Xarelto, Pradaxa and Eliquis cases, the COD listed on the death certificate may not mention bleeding or any other condition known to directly occur as a result of using these drugs however, this does not necessarily mean that it cannot be determined by a preponderance of the evidence that the given anticoagulant did not cause or contribute to the death.
Example: The cause of death on a death certificate may list heart attack, myocardial infarction or cardiac insult as well as other terms that fall under the more general term “heart attack.”
Should one automatically assume that the death, under this circumstance, cannot be attributed to the use of Xarelto, Pradaxa or Eliquis? No!
Bleeding can cause heart attack
Do not allow the cause of death listed on a death certificate be the final determining factor in whether you continue to pursue a wrongful death action.
There is ample evidence in the medical literature “heart attacks” can be secondary to bleeding events. Heart attacks can be caused by sudden significant increases and decreases in blood pressure as well as the heart being deprived of oxygen, delivered by adequate blood flow.
If the death certificate lists any form of “heart attack” as the cause of death, further investigation is warranted to determine whether the use of any of the aforementioned drugs could have reasonably caused or contributed to the heart attack.
A significant bleed within two or three weeks before the heart attack resulting in death will have more likely than not caused or contributed to the heart attack.
A significant bleed can lead to permanent heart damage and can cause or contribute to a heart attack months or even years after the bleeding event. Obviously, the less time there is between the bleeding event and the heart attack makes for a less difficult argument.
It should be noted that in cases where the patient had a history of heart attacks or conditions which are known to lead to heart attacks such as late stage diabetes, for example, may make it more difficult to prevail in your argument.
When analyzing whether the bleeding event may have caused or contributed to the cause of death listed on the death certificate, it is important to understand a basic fact:
Bleeding is never the actual cause of death — events secondary to bleeding are the actual cause of death.
This statement can be difficult to wrap one’s head around as the term “bled to death” is so commonly used and is not inaccurate in the broadest sense. However, from a physiological perspective the true cause of death is always secondary to loss of blood. If insufficient blood volume exists vital organs that are highly dependent on oxygen and fluid volume can quickly fail resulting in death.
The takeaway from this article is: Do not allow the cause of death listed on a death certificate be the determining factor in whether you continue to pursue a wrongful death action.
Once you have a death certificate in hand, review the cause of death listed on the death certificate. After ascertaining the COD listed on the death certificate, as a first step simply Google “Can Bleeding Result in (insert cause of death listed).”
If the cause of death listed a condition that can be attributed to bleeding, then further review of the patient’s pre-death medical records is warranted to determine if there is a strong argument that the bleeding event caused or contributed to the condition listed on the death certificate.
Late-stage cancers, particularly pancreatic and liver cancer, often result in bleeding regardless of whether the patient is receiving anticoagulant therapy or not. If the cause of death listed is a type of cancer that has a high mortality rate in late stages, then is would be far more difficult to argue that it was more likely than not that the anticoagulant caused the death versus the cancer.
In some cases, the cause of death may be listed as “natural causes” or even “old age.” Although no one dies of natural causes or old age, if such terms are listed as the COD, it may be more difficult, although not impossible, to show that the death was caused by the use of the anticoagulant. To demonstrate that the anticoagulant more likely than not caused or contributed to the death, medical records demonstrating a circumstance that would almost certainly lead to death would be needed.
This article is not intended to be medical or legal advice. Our goal is to provide issues to consider when evaluating Xarelto, Pradaxa and Eliquis cases as well as other cases in which the content of this article may apply.
Xarelto, a “New Generation” anti-coagulant, was supposed to have been the ideal replacement for warfarin, the standard treatment for patients at risk for embolism and thrombosis due to blood clots.
The FDA approved Xarelto in 2011, and it was on pharmacy shelves by July of that year. However, within little over a year, the Institute for Safe Medication Practices (ISMP) was sounding the alarm about the abnormally high number of adverse events.
According to the report that was published in October 2012, there had been nearly 160 cases of serious side effects during the first three months of that year alone. Meanwhile, the U.S. Food and Drug Administration had reported an additional 360 such cases between the beginning of January and the end of April.
Those cases reported that Xarelto actually increased the risk of blood clots when the medication was discontinued, particularly in younger patients (65 years of age and under). Also known as rivaroxaban, this drug also increases the risk of fatal internal hemorrhaging as well as serious infections.
As a result, Johnson & Johnson faces over 16,000 lawsuits alleging that the company failed to warn doctors and patients about the associated risks. A significant number of plaintiffs are also alleging that the drug was inadequately tested before it was rushed through the approval process.
At this point, there is no antidote. Although a small California biotech firm, Portola, has been working on developing a reversal agent, that product has not yet received FDA approval. Currently, the only viable option for treatment of a Xarelto patient at risk for fatal bleeding is to administer emergency dialysis.
Of course, the pharmaceutical industry does not call such payments “bribes;” they are officially listed as payments for promotional speaking and/or consulting, travel and meals, gifts and royalties. Although members of the medical community deny that such payments affect their professional judgment when it comes to prescriptions, an analysis of ProPublica’s data shows that the more money a doctor receives from a drug company, the more likely s/he is to prescribe that company’s brand name products.
For the fifth time since the federal Xarelto products liability MDL No. 2592 was created, US District Judge Eldon E. Fallon issued a pretrial order addressing the plaintiff’s fact sheets (PFS), which are used instead of interrogatories, because of alleged deficiencies by claimants in completing them properly.
The sprawling nationwide litigation has produced 14,935 lawsuits since the federal MDL was created in 2014 in New Orleans. Even more cases have been filed in state courts in Philadelphia and Los Angeles.
In response to complaints by the defendants — Janssen Research, Johnson & Johnson and Bayer Healthcare — the judge set out a protocol in pretrial order No. 31 to deal with the late filing of PFSs, non-compliant responses and incomplete responses:
Where the PFS has not been filed on time, the defendants will send a letter to the plaintiff’s counsel requesting it be served within 20 days.
Where the PFS is timely but deficient because it doesn’t comply with the judge’s PFS orders, the defendant will send a letter to plaintiff’s counsel requesting the deficiencies be cured within 20 days.
By the first business day of the month, the companies will send the Plaintiff’s Liaison Counsel a list of cases with untimely responses, or a failure to provide medical records proving the use of Xarelto or other deficiencies.
After that, the Plaintiff’s Liaison Counsel has 30 days to provide comments or objections.
Five days after the comments are received, the defendants must file motions requesting orders to show cause why the cases should not be dismissed.
In January, California Superior Court Judge Kenneth R. Freeman in Los Angeles appointed the plaintiffs’ liaison counsel in the state’s Judicial Council Coordinated Proceedings (JCCP) for all Xarelto cases in the state courts. There are 31 cases pending involving 52 plaintiffs. A status conference was held on Dec. 12, when the parties agreed to submit plaintiff and defendant fact sheets.
Remember Arnold Palmer? He advertised blood-thinner Xarelto, which he took daily, in TV commercials until his death September 25, 2016 from gastrointestinal bleeding. Plaintiffs in thousands of lawsuits charge that the makers of the drug failed to warn and actually concealed that Xarelto causes uncontrollable internal bleeding. Meanwhile the defendants continue to promote the blockbuster drug aggressively as the cases mount in two courts. No settlement expected until the litigation affects stock price.
Xarelto is Rivaroxaban, approved by the FDA on July 1, 2011 to reduce stroke and blood clots — deep vein thrombosis (DVT) and pulmonary embolism (PE) — in patients with atrial fibrillation, a heart disorder. It has been prescribed to more than 4 million US patients, generating sales of $2 billion by fiscal year 2013.
The drug has no antidote to stop internal bleeding. The current label reads: Risk of bleeding: XARELTO can cause serious and fatal bleeding. For 2012 a total of 2,081 “Serious Adverse Event” reports filed with the FDA it its first full year on the market, and 151 were deaths.
Approximately 1,100 claims have been docketed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date, and the number of claims before Judge Arnold New is increasing. We believe the increase Xarelto being filed can be attributed to two primary factors.
Judge Arnold New in PTO 10 ordered that the Master Complaint in the Xarelto Pa. Court Consolidation be amended to allow for Ischemic Stroke claims in addition to bleeding related claims. Judge Eldon Fallon, overseeing the Xarelto Federal MDL 2592 is not considering allowing Ischemic Stroke claims to be brought in Xarelto MDL 2592 . Our impression from reading a status conference transcript from Judge Fallon’s court is that he does not think it is necessary to change the allowed claims in the Xarelto MDL he presides over because these claims can be filed in Judge News court.
An issue arose over whether “total lack of diversity” existed during the Bellwether Selection process in Xarelto MDL 2592 where the defendants attempted to eliminate claims filed in certain states from the Bellwether Pool. Although the defendants’ efforts failed, the issue may be brought up again in individual cases. Some attorneys are filing cases from states in which a total lack of diversity issue exists in the Philadelphia Consolidation in an effort to eliminate the potential issue. The States in question are: California, Delaware, Indiana, New Jersey and Pennsylvania.
Because many firms that are not members of the Pennsylvania bar may need to file Xarelto Claims in the Philadelphia Court Consolidation, we have compiled a list of firms that are in a position to act as local counsel or co-counsel for filing in the Xarelto Pa. Consolidation. Our criteria for compiling this list was :
The attorney must be a member of the Pennsylvania Bar.
The attorney or firm must have filed a significant number of cases in the Pa. Xarelto Consolidation.
Potential Local Counsel and Co-Counsel Firms For Pa. Court Xarelto Litigation
WILLIAM H BARFIELD POTTS LAW FIRM
HOUSTON TX 77007
(713)583-5388 – FAX email@example.com
Pennsylvania Judge Arnold L. New set 10 cases for bellwether trials next year and outlined discovery deadlines for In Re: Xarelto Products Liability Litigation, where hundreds of plaintiffs charge that the blood-thinning drug caused gastrointestinal bleeding, hemorrhagic strokes or death.
In Case Management Order No. 11 issued October 14, Judge New of the Philadelphia Court of Common Pleas organized 24 of the cases for a Core Discovery Pool into three categories:
Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a gastrointestinal or rectal bleed or death due to a gastrointestinal or rectal bleed and was between the ages of 50 and 90 at the date of the alleged event.
Plaintiff took Xarelto to treat deep vein thrombosis (DVT), to treat pulmonary embolism (PE), to reduce the risk of recurrence of DVT or PE, or for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery and alleges a gastrointestinal or rectal bleed or death due to a gastrointestinal or rectal bleed and was between the ages of 40 and 80 at the date of the alleged event.
Plaintiff took Xarelto® in order to reduce the risk of stroke and systemic embolism due to nonvalvular atrial fibrillation and alleges a brain bleed/hemorrhagic stroke or death due to a brain bleed/hemorrhagic stroke and was between the ages of 50 and 90 at the date of the alleged event.
Ten cases are set for trial starting September 29, 2017, at two-week intervals as follows:
Source of Case
September 29, 2017
October 13, 2017
October 27, 2017
November 10, 2017
November 27, 2017
December 11, 2017
After the first six cases, the remaining four will be selected randomly. Dismissal of a trial set case shall not impact the remaining trial dates and cases set for those dates.
Separately, defendants in a federal multidistrict litigation (MDL) before US District Judge Eldon E. Fallon, In RE: Xarelto (Rivaroxaban) Products Liability Litigation, include Bayer Healthcare, the designer and manufacturer of Xarelto. Janssen Pharmaceuticals (a Division of Johnson & Johnson) sells Xarelto in the United States under a licensing agreement with Bayer.
Nearly 11,000 cases have been filed in the federal MDL, and bellwether trials have been set between March 13 and May 30 in the Eastern District of Louisiana in New Orleans.
In the Philadelphia cases, the parties will confer whether cases should be added or subtracted from the list. If a case is dismissed, the party that selected the original case for inclusion in the Core-Discovery Pool will offer a replacement.
Discovery in the selected cases will begin immediately and must be completed by April 3, 2017. Core-discovery will consistof only the following depositions:
Plaintiff and spouse or significant other;
The health care provider(s) who prescribed Xarelto to the Plaintiff;
One physician who provided care related to Plaintiff’s alleged physical injuries; and
One detail representative who detailed Plaintiffs prescriber before the prescription(s) at issue.
Plaintiffs will identify the one detail representative per case whose custodial file and deposition they want in connection with the Core-Discovery Pool cases by November 14, 2016.
Defendants may take up to 10 additional fact witness depositions, including both medical and non-medical witnesses in the Trial-Pool Cases. Defendants may seek additional depositions by leave of Court for good cause shown.
We have received numerous inquiries regarding the potential impact on the Xarelto Litigation(s) relating to the FDA Oct 11th publication of its findings after re-evaluating (re-analysis study) related to the Rocket AF study in relation to the INR Testing Device “InRatio.”
International Normalized Ratio (INR) is a metric which is tested to determine how long it takes for blood to clot in a given individual as compared to a standard range.
The InRatio was used in the Rocket AF Study to measure INR. After the Rocket AF Study was published and used as the primary study considered by the FDA in granting market approval for Xarelto. Then the InRatio device was subjected to a Class 1 Recall due to inaccuracy.
As a result of the recall of the device used to measure INR in the Rocket AF study, the FDA conducted a re-analysis of the Rocket AF study, using data and information provided by Janssen Pharmaceuticals. The re-analysis was for the limited purpose of determining whether or not the use of the defective “InRatio” device skewed the results of the Rocket AF study to a sufficient extent to invalidate the results and conclusion of that study.
On October 11, 2016 the FDA published a short notice with a link to the re-analysis study: See excerpt below:
[10/11/2016] In July 2016, the Alere INRatio device was recalled due to the potential to generate inaccurate results. This device was used to monitor warfarin therapy in the control group of the ROCKET-AF clinical trial, which provided the primary data to support the 2011 approval of the blood thinner drug Xarelto (rivaroxaban). Xarelto is indicated to reduce the rates of stroke and blood clots in patients with non-valvular atrial fibrillation.
Because of the concern about the Alere INRatio device, the FDA has completed a variety of analyses to assess the impact that this faulty monitoring device had on the ROCKET-AF study results. The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal. The FDA concludes that Xarelto is a safe and effective alternative to warfarin in patients with atrial fibrillation.
Concerns Related to the FDA Notice
This FDA notice has generated concern among some attorneys representing clients in the Xarelto Litigation and gives rise to the question: Will this FDA notice negatively impact the Plaintiffs Claims in the Xarelto Litigation(s)?
The re-analysis was limited to answering a single question: Could the FDA conclude that the use of the defective “InRatio” device skewed the results (which were already highly questionable) of the Rocket AF study to warrant rescinding of the market approval granted by the FDA based on Rocket AF study?
It should be noted that an inconclusive outcome of the re-analysis would not have prompted the FDA to rescind approval. In order for the FDA to rescind approval the re-analysis would have needed to show conclusively that the use of the InRatio Device skewed the results of the Rocket AF Study to such an extent as to make the study results completely invalid .
We concluded that the FDA notice and the re-analysis should not impact the Xarelto Litigations based on the following:
The re-analysis was not conclusive and did not use commonly accepted scientific methodology.
The re-analysis contains multiple instances of terms such as “were likely” and “it is unclear how relevant the results are” indicating a lack of conclusiveness.
“However, the effects of this increased intensity of anticoagulation on clinical outcomes were likely to have been quite modest.”
There is a moderately large margin for error on safety. Xarelto could increase the rate of major bleeding by as much as 50% compared to warfarin and it would still be considered an approvable therapy
To be complete in describing FDA’s pharmacovigilance efforts involving rivaroxaban, this study of rivaroxaban vs. warfarin in Medicare is presented. However, without inclusion of a control/warfarin arm, it is unclear how relevant these results are to the investigation of INR device issues in the ROCKET trial.
“With the limited data provided, a reliable estimate of variability seems unlikely.”
3. The re-analysis admits a large margin for error as well as a lack of reliability.
4. The re-analysis was an unscientific flawed analysis of a flawed study. See excerpt below from the FDA initial summary review of the Rocket AF study:
Excerpt from Initial FDA Review of Rocket AF Study:
At each site audited, how many violations involved each of the following specific issues? For each specific violation, list the clinical sites involved and provide a breakdown by treatment group for each site and overall for the four RECORD studies.
Enrollment of subjects that did not meet study eligibility criteria.
Failure of the Principal Investigator to ensure that all associates and colleagues assisting in the investigation were meeting the commitments of the study protocol.
Failure to report adverse events and serious adverse events.
Failure to randomize subject preoperatively.
5. The re-analysis addressed a very narrow issue not related the the majority of claims made in the Xarelto litigation while only being only marginally related to narrow issues to limited number of plaintiff claims.
Concerns Related to Implied Preemption Arguments
Some concern has been expressed due to the language in the FDA announcement and the re-analysis wording related to “No label change being required”. See excerpt below:
“No changes in rivaroxaban labeling to reflect the impact of use of the INRatio device in ROCKET are warranted. No other major regulatory action should be taken with respect to rivaroxaban.”
This language gives rise to the question: Could the defendants prevail in an implied preemption argument claiming that the FDA would not have allowed changes to the Xarelto label had the manufacture attempted to make changes though the Changes Being Effected (CBE) process?
We do not think an implied preemption of this nature would prevail. The FDAs decision not to require a label change was due to the fact that the re-analysis was limited in scope and made determination regarding a very narrow issue and was not conclusive. Given the lack of conclusiveness of the re-analysis, it was not sufficiently conclusive to warrant any action by the FDA, that same lack of conclusiveness makes the re-analysis worthless from an evidentiary stand point.
Although defense may raise an implied preemption argument, claiming that the FDA would not have allowed label changes made via the CBE process, related to broader issues than those observed within the limited scope of the re-analysis, would not be likely to prevail. An argument that the FDA statements related to the re-analysis indicates anything beyond the scope of the narrow focus of the re-analysis would not be supported by fact.
Guidance from Wythe v. Levine may be applicable to this scenario: “Wyeth argued that this Vermont law was federally preempted because it was in “actual conflict [with] a specific FDA order” regarding drug labeling. The trial court rejected this argument, as did the Supreme Court of Vermont, holding that the FDA requirements merely provide a floor, not a ceiling”
In that FDA approval of a pharmaceutical product does not create an affirmative defense under Wyeth v Levine, the FDA deciding not to rescind a previously granted approval should not create an affirmative defense either.
In Wyeth v Levine the court took note of FDAs approval processes in granting market approval for a pharmaceutical product largely relying on information and data supplied by the applicant. In this instant matter related to the FDA re-analysis of the Rocket AF study, the FDA again relied on information and data from the applicant, rendering any determinations made from the re-analysis no more of an affirmative defense than the initial FDA approval.
Other Xarelto Claims Not Affected
Among the claim being made against the manufacturers(s) of Xarelto are those related to over promotion and misrepresentations made in the promotion of the product. The FDAs enforcement division issued a warning letter on Judge 6, 2013 to Johnson and Johnson related to false and misleading advertisement. See excerpt below.
RE: NDA #202439 XARELTO (rivaroxaban) tablets MA #215
Dear Ms. McGregor-Beck:
Minimization of Risk Information
Promotional materials are false or misleading if they fail to present risks associated with a drug with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of the drug. Factors impacting prominence and readability include typography, layout, contrast, headlines, paragraphing, white space, and other techniques apt to achieve emphasis. The Print ad prominently presents various efficacy claims for Xarelto, such as, but not limited to, the following, that are presented in large, bolded and/or colorful text and graphics (emphasis original):
“If you have atrial fibrillation (AFib)” • “Ready to break your AFib routine?” • “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke—without routine blood monitoring.” • “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”
The Print Ad includes the following claim (emphasis original):
“And there are no dosage adjustments…”
The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI, the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a CrCL of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy.
Despite the FDAs prior warning to the makers of Xarelto, misleading claims in Television Advertisements continue to be made. The frame from a Xarelto Television Commercial below shows the statement “No Blood Monitoring Required” is still included in Xarelto Advertising.
Although this Xarelto advertisement did not use the language “no dosing adjustments” required, the ad does include the wording “Xarelto has no regular blood monitoring”. In that the FDA has already determined statements regarding “no dosing adjustments” are misleading as dosing adjustments are needed for many Xarelto patients, the statement “Xarelto has no regular blood monitoring”, indicating that none is needed, is also arguably misleading in that dosing adjustments cannot be made without some form of monitoring.
We invite comments as well as dissenting opinions on this subject.
Nothing contained herein is intended to constitute legal advice.