Xarelto Trial Opening Statements — What Killed Sharon Orr?

Sharyn Orr of Kenner, LA, She was an academic advisor for Tulane University for over 40 years.
Sharyn Orr of Kenner, LA, was an academic advisor for Tulane University for over 40 years.

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 LitigationJoseph 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.”

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Philadelphia Court Sets 10 Xarelto Cases for Bellwether Trials

xarelto internal-bleedingPennsylvania 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:

Trial Date Trial Category Source of Case
September 29, 2017 1 Plaintiff Pick
October 13, 2017 1 Defense Pick
October 27, 2017 2 Plaintiff Pick
November 10, 2017 2 Defense Pick
November 27, 2017 3 Plaintiff Pick
December 11, 2017 3 Defense Pick
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.

Discovery schedule

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:

  1. Plaintiff and spouse or significant other;
  2. The health care provider(s) who prescribed Xarelto to the Plaintiff;
  3. One physician who provided care related to Plaintiff’s alleged physical injuries; and
  4. One detail representative who detailed Plaintiffs prescriber before the prescription(s) at issue.
  5. 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.

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PA Court Now Allows Ischemic Stroke Claims in Xarelto Litigation

Ischemic strokeIn an important new ruling, 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.

The court covered several topics when it issued Case Management Order #10 on June 6:

Ischemic Stroke Cases Instituted By The Filing Of Long Form Complaints

  • All Plaintiffs who have previously filed Xarelto cases alleging ischemic stroke using a long form complaint shall file a Second Amended Long Form Complaint in the form within 20 days of this Order.

Expert John Ray, a leading consultant to the Mass Tort industry, explained the significance, saying, “these ischemic stroke cases are related to Xarelto being marketed as a one-time per day drug. All that the drug manufacturers did was double the dose and say you only need to take it once per day. They did this for a marketing advantage.

“The problem is that the patient is over-anticoagulated the first half of the day and under-anticoagulated the remaining time before next dose. This leaves the patient unprotected from what Xarelto is suppose to protect them from for the last half of the dose day and more likely to bleed in the first half of the day.”

The defendants in the state litigation include:

  1. Janssen Research & Development LLC
    2. Janssen Pharmaceuticals. Inc.
    3. Janssen Ortho LLC
    4. Johnson & Johnson.
    5. Bayer Healthcare Pharmaceuticals. Inc.
    6. Bayer Pharma AG.
    7. Bayer Corporation.
    8. Bayer Healthcare LLC.
    9. Bayer Healthcare AG.
    10. Bayer AG.

Second Amended Master Long Form Complaint

  • The Court Directs that Plaintiffs’ Second Amended Master Long-Form Complaint and Jury Demand to this Order shall be filed on the Master Docket.
  • The Second Amended Master Long-Form Complaint and Jury Demand will substitute for and supersede all Complaints filed in individual Xarelto cases pending in the Philadelphia County Court of Common Pleas.
  • Defendants (other than those relieved from any answer obligation under CMO-3
    shall have 60 days from the entry of this Order to answer or plead to the Second Amended Master Long-Form Complaint.

Short-Form Complaint–Previously Filed Cases

  • All Short Form Complaints previously filed on or before the date that the Clerk files the Second Amended Master Long-Form Complaint and Jury Demand pursuant to this Order are hereby deemed to incorporate the Second Amended Master Long-Form Complaint and Jury Demand without the need of any plaintiff to take any action to amend their Short Form Complaints that already been filed in this case.

Short-Form Complaint–Newly Filed Cases

  • All Xarelto cases filed after the date of this Order shall be instituted by the filing of a Writ of Summons or a Second Amended Short Form Complaint. If suit is instituted by a Writ of Summons, the Writ of Summons must denote the case to be part of this Mass Tort Program and any named Defendant may file a Rule to File a Complaint, which shall apply to the benefit of all named Defendants.

“This is very important news,” Ray said. “The Ischemic Stroke claims, often referred to as ‘efficacy’ claims, cannot be brought in the Federal multidistrict litigation docket (MDL) because the argument was not made there. Only hemorrhagic  strokes can be brought in the federal MDL.”

US District Judge Eldon E. Fallon is overseeing Xarelto Products Liability Litigation MDL 2592 , based in New Orleans, LA. Click to find out more about Xarelto MDL 2592 Important Developments.

 

 

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