WEEKLY MDL UPDATE by MASS TORT NEXUS for Week of November 13, 2017

The week in mass torts around the country:

By Mark York, Mass Tort Nexus (November 16, 2017)

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MASS TORT NEXUS

 Verdicts on November 16, 2017: 

J&J gets hit hard again, in a $247 million Pinnacle hip implant verdict, DePuy Orthopaedics Pinnacle Implant MDL 2244, in bellwether trial of 3:15-cv-03489 Alicea et al v. DePuy Orthopaedics Inc et al. (DePuy Pinnacle Hip Implant MDL 2244 Briefcase)

Drug maker Auxilium won a defense verdict in their Testim product bellwether trial, where plaintiffs claimed it caused a heart attack in a verdict reached in the US District Court Northern District of Illinois, Judge Kennelly, in MDL 2545 Testosterone Replacement Therapy. (Testosterone Therapy MDL 2545 USDC ND Illinois)

Johnson & Johnson Wins a Defense Verdict in Los Angeles Court Talcum Powder Mesothelioma Trial, Jury Finds J&J Not Liable in Tina Herford et al. v. Johnson & Johnson Case number BC646315, consolidated in LAOSD Asbestos Cases, case number JCCP4674, in the Superior Court of the State of California, County of Los Angeles.  (J&J Talcum Powder Cancer Litigation Briefcase)

Senator Bob Menendez  judge declares a mistrial in New Jersey federal court trial, after a hung jury cannot agree unanimously on charges. Question is- Are the Senator and his doctor friend in Florida, just that-were they just friends or was there active bribery taking place?

Recent Case Updates:

>Plaintiff in DePuy Pinnacle Hip Implant Trial Asks Texas Jury For A Hundred Million + In Punitive Damages

At the close of arguments in the latest DePuy MDL 2244 trial on Monday November 13, 2017, six New York plaintiffs asked a Texas federal jury to hit Johnson & Johnson and it’s DePuy subsidiary, with at least a nine-figure punitive damages award. Attorneys asked that J&J and DePuy be punished for making and marketing their Pinnacle model hip implants, an alleged defective line of metal-on-metal hip implants, that have caused many thousands of injuries to unsuspecting patients. If this jury follows suit on prior Pinnacle bellwether jury awards, then J&J and DePuy should be ready for a massive verdict, as the last jury awarded California plaintiffs over one billion dollars in December 2016, sending a clear message that the company’s Pinnacle design and subsequent marketing policies have failed.

METALLSOIS DAMAGE

Closing arguments wrapped up on the two-month bellwether trial, where plaintiffs claimed they suffered “metallosis” which caused tissue damage and negative reactions to the Pinnacle Ultamet line of metal-on-metal hip implants made by J&J’s DePuy Orthopaedics Inc. unit. Depending on the jury verdict, perhaps J&J will consider coming to the settlement table if another massive verdict is awarded, or they may continue the aggressive “we’ve done no wrong stance” resulting in more plaintiff verdicts in the future..

 >Travelers Insurance Wins Declaratory Judgment Suit Over Defense Coverage In Orange County and Chicago Opioid Lawsuits:

“California Appeals court says Watson not covered”

Watson Pharma, Inc. and it’s parent Activis, Inc. were denied insurance coverage in a November 6, 2017 ruling by the California State Court of Appeals in the 2014 Declaratory Judgment action filed by Travelers Insurance in an Orange County, CA court where Travelers successfully asserted claims that they were not required to defend or indemnify Watson in the underlying opioid based litigation filed by Santa Clara and Orange County against opioid manufacturers, due to Watson’s “intentional bad conduct” in their business practices related to sales and marketing of it’s opioid products. The Appeals Court also excluded Watson’s coverage in a similar opioid lawsuit against them in a Chicago, Illinois federal case where the City of Chicago filed similar claims against Watson over opioid marketing abuses in 2014. Perhaps other insurance carrier will take notice and look closer at denying policy coverage for many other opioid manufacturers who have been sued across the country in cases with almost the exact claims as those alleged by Santa Clara County and the City of Chicago.

>NEW XARELTO TRIAL:

Former FDA Commissioner Testifies in Philadelphia Xarelto Trial-

“Xarelto Warnings Are Inadequate”

— Former head of the Food and Drug Administration, Commissioner David Kessler testified during the first state court trial in Philadelphia, telling the jury on Tuesday that “warning labels for the blood thinner Xarelto failed to provide adequate information to doctors and consumers about the risk of bleeding that some patients could face when using the drug”.

David Kessler, FDA Commissioner under President George H.W. Bush and President Bill Clinton, told jurors that Bayer AG and Johnson & Johnson’s warning labels for the medication understated the risk of significant bleeding events that had been seen in television and print ads across the country for years, and failed to disclose the true risks associated with prescribing the blockbuster drug. This trial, expected to take six weeks, is the first state court bellwether trial for the blood thinner Xarelto, in the Philadelphia Court of Common Pleas, the prior trials took place in federal courts in Louisiana and Mississippi where the defense prevailed in all 3 trials earlier this year. Those trials were all bellwether trials, as part of the Xarelto MDL 2592 in front of Judge Eldon Fallon, US District Court, ED Louisiana. Will the change of venue to Pennsylvania State Court have a different outcome than the three prior Xeralto trial losses?

>Luzerene County, Pennsylvania Files RICO Suit Over Opioid Marketing Against Drug Makers

Luzerne County in Northeast Pennsylvania has filed a federal RICO based lawsuit accusing pharmaceutical companies including Purdue, Pharma, Endo, Janssen and Teva of violating the Racketeer Influenced and Corrupt Organizations Act by illegally marketing highly addictive painkillers that have contributed to a costly national opioid epidemic. The suit filed in US district Court of Pennsylvania by Luzerne County is one of many cases opioid drugmakers and distributors are facing as state and local governments seek to recoup costs they’ve incurred in the increased marketing and prescribing of opioid painkillers, and the resultant spikes in addiction and overdose.

OPIOID MARKETING ABUSES

“The manufacturers aggressively pushed highly addictive, dangerous opioids, falsely representing to doctors that patients would only rarely succumb to drug addiction,” the complaint, which was filed on Wednesday, said. “These pharmaceutical companies … turned patients into drug addicts for their own corporate profit.”
“The lawsuit accused the drugmakers of using false and deceptive marketing practices over the course of the last two decades, including pushing the opioid painkillers for treatment of chronic pain, to boost prescriptions for the drugs

COMMON CLAIMS AGAINST ALL OPIOiD MAKERS

Among the companies’ primary claims, cited by Luzerne county and others, evidence the manufacturers intentionally misled consumers, was that the drugs were not addictive when prescribed to treat legitimate pain. This is one of the key claims used by all parties filing suit against the opioid manufacturers, across the entire country.

Case heading is: Luzerne County v. Purdue Pharma LP et al., case number 3:17-cv-2043, in the U.S. District Court for the Middle District of Pennsylvania.

>Opioid Litigation Roundup: An Overview Of Recently Filed Cases and MDL 2804

In addition to the many counties and other communities from across the country that have filed lawsuits against opioid manufacturers in MDL 2802, set for a JPML consolidation hearing November 30, 2017 a new group of plaintiffs have joined the increasing pool of parties filing suit against Big Pharma opioid manufacturers and their distributors. Unions are now joining in the suits alleging that the business practices of the opioid makers and distributors caused catastrophic healthcare and related labor problems everywhere in the country over the last 15 years. Locals from the Electrical Workers; Commercial Food Service and Teamsters are now plaintiffs in the MDL 2804, which if approved at the upcoming JPML hearings in St Louis, will probably cause a flood of additional filings by unions across the country.

State attorneys general, a Native American tribe and individual consumers are among the ever increasing pool of plaintiffs who’ve brought lawsuits against drugmakers, pharmacies and distributors allegedly responsible for epidemic levels of opioid abuse. As word spreads among the network of local governments, and discussion take place about the municipal opioid lawsuits being filed, there will be a flood of new complaints filed, that will match or exceed the number of cases filed in the massive “Tobacco Litigation” which is quickly gaining comparison as the opioid case filings are looking to be comparable in size and probably exceed the tobacco litigation in damages.

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XARELTO in Philadelphia Court: Will The BMSQ “California Plavix” SCOTUS Ruling Affect Out of State Plaintiffs?

XARELTO in Philadelphia Court of Common Pleas: Will The “California Plavix” Supreme Court Ruling Affect Out of State Plaintiffs?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

Bayer, which has a headquarters in Pennsylvania, recently used a June 2017 U.S. Supreme Court decision on out of state plaintiffs and court jurisdictions to dismiss dozens of lawsuits from a Missouri federal court in the “Essure” birth control litigation. It remains to be seen if Bayer will use the same strategy in other jurisdictions, like Philadelphia, where the Xarelto blood thinner cases are piling up, see XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase.

Thousands of out-of-state plaintiffs flocked to Philadelphia recently to file lawsuits over prescription drugs, but a recent U.S. Supreme Court decision might deter that practice in the future, see  June 19, 2017 Bristol-Myers v. Superior Court of California (Plavix Jurisdiction).

The many claimants who have brought their lawsuits in Philadelphia will have to see if pharmaceutical companies like Bayer, Johnson & Johnson and others who are facing many thousands of other claims from out-of-state plaintiffs, will rely on the June 19th U.S. Supreme Court ruling that states an out-of-state plaintiff couldn’t file suit in California, due to a lack of jurisdiction.

The Supreme Court justices ruled 8-1 in favor of Bristol Myers-Squibb after the company argued plaintiffs living outside California who alleged injury from BMS’s blood thinner Plavix, should not be able to sue the company in that state.

The Supreme Court ruled that, essentially the “all inclusive view of personal jurisdiction by non-resident plaintiffs has come to an end.” Plavix was not designed or made in California, and the company is headquartered in New York. The ruling may simply force thousands of pending cases across the country to be refiled in other venues, as plaintiff firms are not likely to simply withdraw the cases as massive losses, without having their day in one court or another.

A non-residents plaintiff can file suit in the Philadelphia County Court of Common Pleas, if the defendant is either incorporated in Pennsylvania, or has a principal place of business in Pennsylvania, which limits the legal options for Bayer, based on their corporate headquarters in the state.

Two of the biggest mass tort programs in the Philadelphia Complex Litigation Center docket are the Risperdal litigation, which is produced by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) and allegedly causes males to develop breasts, Janssen has been hit with several large multi-million dollar verdicts in Risperdal trials. The other is Xarelto, a blood-thinner made by Bayer and Johnson & Johnson that allegedly causes uncontrolled bleeding events, and the makers failed to warn of the dangers. The Xarelto MDL 2592 in US district Court ED Louisiana . see Xarelto MDL 2592 Mass Tort Nexus Briefcase, where close to twenty thousand additional Xarelto cases are pending.

Bayer will be having a much harder time using the BMS Plavix decision to dismiss non-resident plaintiffs from the Philadelphia courtroom, given it’s headquarters in Pittsburgh, Pennsylvania.

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Plaintiffs Denied New Xarelto Bellwether Trials After Orr and Boudreaux Hearings Over Trial Losses in MDL 2592

Judge Fallon Denies Plaintiffs New Xarelto MDL 2592 Bellwether Trials After Hearings Last Week

 

 

 

 

 

Xarelto MDL 2592 Judge Eldon Fallon ruled Tuesday September 19th at the close of motion hearings, that plaintiffs Joseph Orr and Joseph Boudreaux would not be granted new trials. The plaintiffs were on the losing side in the first two bellwether trials in the Xarelto multidistrict litigation versus Janssen and Bayer over claims that the blockbuster blood thinner Xarelto caused unstoppable bleeding, see Xarelto MDL 2592 Briefcase.

TRANSCRIPT EXCERPTS

In denying the motions, Judge. Fallon once again stated that he “had given a lot of thought to these issues prior to trial, and I don’t shoot from the hip” on such rulings and added “I realy feel the decisions I made were, made properly” refencing the prior Orr and Boudreaux trial rulings in the hearing transcripts, see Xarelto MDL Hearing Transcript Denying New Bellwether Trials. His hearing comments weer further clarified in the court’s 9.22.2017  order where Judge Fallon outlined his prior trial rulings and the denial of new trials for Orr and Boudreaux, Judge Fallon 9.22.17 Order Denying Bellwether Retrials.

PLAINTIFF MOTIONS

The main argument raised by plaintiffs related to exclusion from trial of data determined inadmissible by the court due to materials having international based information.

The court’s decision to exclude evidence from a peer-reviewed publication was based on the false premise that the publication included foreign regulatory standards that could confuse the jury, Boudreaux counsel argued. The exclusion of this evidence influenced the jury to believe that no medical associations or peer-reviewed publications backed a diagnostic test that would determine whether emergency room patients had recently taken Xarelto, in their June filing for the retrial.

The court also should have allowed statements from foreign labels into evidence so that Boudreaux could demonstrate that foreign regulatory authorities back the prothrombin time test, Boudreaux also claimed in June. Boudreaux further argued the court’s instructions to the jury were too broad, as they indicated the companies were required to disclose to patients only tests that were FDA approved, implying the companies weren’t required to disclose a prothrombin time test that was not FDA approved.

“The fight against Xarelto is a marathon not a sprint,” per Andy Birchfield, of the Beasley Allen firm and co-lead counsel for the plaintiffs, who also stated “There are more than 19,000 victims who are relying on the courts for justice. We will continue fighting for the thousands of innocent victims injured or killed by Xarelto.”

Janssen issued a statement agreeing with the court ruling.
“We believe the court correctly denied plaintiff’s motions for new trials and that the verdicts returned by the juries in Orr and Boudreaux were amply supported by the evidence,” Janssen spokesperson Sarah Freeman said in a statement.

FOURTH BELLWETHER TRIAL MOVED TO 2018

In a related case development, the fourth bellwether trial of William Henry, initially set for trial in October 2017 in the US District Court ND Texas has been continued until early 2018, William Henry vs. Janssen et al Complaint. Perhaps this long break between trials signals potential settlement discussions will begin.

 

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Dora Mingo vs Janssen and Bayer (Xarelto) Trial Update: Plaintiff Closes Her Case on August 16, 2017

(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.

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Xarelto Bellwether Trial #2 also Ends with Defense Verdict

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.

It was a weak case to begin with. The plaintiff Sharyn Orr, was a 67-year-old grandmother who had a host of medical problems. See No Cause for Panic in Defense Verdict in the First Xarelto Bellwether Trial.

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, an attorney with Drinker, Biddle & Reath in Florham Park, N.J.

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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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Jury Selection Starts Today for Second Xarelto Bellwether Trial

By Joseph VanZandt.

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.


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Xarelto Lawsuits Near 19,000 as Second Bellwether Trial Starts Next Week

Johnson & Johnson and Bayer AG have been named defendants in at least 18,900 Xarelto lawsuits, most of which are pending in multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana, according to a May 3 filing with the U.S. Securities and Exchange Commission.

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 Litigation

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.

See No Cause for Panic in Defense Verdict in the First Xarelto Bellwether Trial

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.

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Defense Verdict in First Xarelto Bellwether Trial

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.

The defense verdict arrived in the first bellwether trial of the blood-thinning drug in In Re Xarelto Products Liability Litigation, U.S. District Court, Eastern District of Louisiana, No. 14-md-2592.

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.

Janssen is represented by Susan Sharko of Drinker Biddle & Reath LLP
Janssen was represented by Susan Sharko of Drinker Biddle & Reath LLP

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. :

  1. May 30, 2017 – Eastern District of Louisiana
  2. To Be Set in June 2017 – Southern District of Mississippi
  3. 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.

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4 Key Plaintiff Experts Admitted in Next Weeks’ Xarelto Trial

Former FDA Commission David A. Kessler, M.D., will testify in the Xarelto trial.
Former FDA Commission David A. Kessler, M.D., will testify in the Xarelto trial.

Ruling in several Daubert motions, US District Judge Eldon E. Fallon admitted four of the plaintiff’s key expert witnesses in two upcoming bellwether trials (test cases), the first of which starts next week in the Eastern District of Louisiana.

Judge Fallon is supervising 16,285 cases in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.

Defendants Janssen and Bayer are scrambling to exclude or limit testimony from key plaintiff experts — unsuccessfully. The Judge admitted said three important plaintiff witnesses passed muster:

  • Dr. Suzanne Parisian. She is one of the few people who specializes in the complexities of FDA regulation. Based in Phoenix, AZ, Dr. Parisian will assist the jury in understanding the regulatory requirements applicable to pharmaceutical manufacturers and drug labeling within the context of the FDA.

She is a former Chief Medical Officer of the Food and Drug Administration (FDA), as well as physician, Board Certified Pathologist, past researcher in genetics and developmental biology, author of FDA Inside and Out, and President of Medical Device Assistance, Inc., a regulatory and clinical consulting firm.

  • Dr. Laura Plunkett. She will testify about drug pharmacology, general causation, regulatory matters and the adequacy of labels for both prescription and non-prescription drugs.

Dr. Plunkett is a pharmacologist and toxicologist who has substantial experience as an expert witness. She is a Diplomate of the American Board of Toxicology and a registered patent agent. She is neither a medical doctor nor a regulatory agent for the FDA, but has extensive experience consulting and advising as to regulatory matters, including label content.

  • Dr. David Kessler. He is uniquely qualified to offer opinions on the conduct of pharmaceutical companies.

He is a medical doctor, the former Commissioner of the Food and Drug Administration, a professor of food and drug law, and an advisor to pharmaceutical companies. He has testified before Congress on multiple occasions and has published many articles in legal, medical, and scientific journals on the federal regulation of drugs and medical devises as well as the intersection of federal regulation and state law. Currently, Dr. Kessler is a senior advisor to a global private equity firm that owns pharmaceutical and biomedical companies and serves on the boards of two pharmaceutical companies. He advises corporates on the proper standard of care under both state and federal law.

  • Dr. Nathaniel Winstead. He will testify that the probable cause of the plaintiff’s gastrointestinal bleed was Xarelto.

Dr. Nathaniel Winstead, MD, is a general gastroenterologist and hepatologist with clinical experience with Warfarin, and is double-board-certified in gastroenterology and internal medicine. In researching for and writing his expert report, Dr. Winstead attests that he used the same methods he uses to evaluate and treat his patients. From 2008-2013, Dr. Winstead was the Director of Gastroenterology Research and the Medical Director of the Inflammatory Bowel Disease Center at Ochsner. He was the principal investigator or sub-investigator in multiple clinical trials for various drug manufacturers, including Defendant Janssen.

Some rulings for the defense

The court also allowed the plaintiffs’ expert witnesses to express opinions that if physician monitored the concentration of Zarelto in their patients, bleeding risk would be reduced. “Because of Xarelto’s short half-life and the variability in patients, some patients will retain more Xarelto in their system and will be subject to a greater bleeding risk,” the judge said.

Judge Fallon also excluded defense expert Dr. James A. Reiffel, who would have testified that patients might have abruptly stopped taking Xarelto due to attorney advertising.

Ruling for the defense, the judge said that its experts could testify about what might have happened to the plaintiffs if they had taken a different anticoagulant. The court also allowed defense expert D. J. Michael Gaziano to testify.

Gaziano has been a physician for 30 years. He received his MD from Yale and his MPH with a concentration in cardio-epidemiology from Harvard. He is a cardiologist in Boston where he teaches and sees patients including those who require anticoagulant therapy.

The testimony of defense experts Drs. Scott Boniol and William Franklin Peacock IV was limited to exclude opinions about the early detection of cancer because of anticoagulant-related bleeding events.

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