Johnson & Johnson Loses Again In First California Talc-Cancer Trial As Jury Awards Plaintiff $417 million

J&J’s Loses Again In First California Talc-Cancer Trial As Jury Award Plaintiffs $417 million

  • Los Angeles jurors decide Johnson & Johnson failed to warn about risks
  • The Eva Echeverria trial is first of 300 cases in California alleging ovarian cancer

“Eva Echeverria v. Johnson & Johnson, number BC628228, in the Superior Court of California for Los Angeles County”

Johnson & Johnson (J&J) found out earlier today, August 21, 2017 that California is no friendlier than Missouri when fighting allegations that its talc powder causes ovarian cancer in women, as a Los Angeles Superior Court awards plaintiff Eva Echeverria $417 million after 3 days of deliberations.

J&J has lost four out of five recent talc cases that went to trial in St. Louis, and is the first trial before a jury in Los Angeles, and is the first case to go to a state-court jury outside Missouri and one of more than 300 similar cases pending in California. This trial follows the US Supreme Court ruling in June 2017 that made it harder for mass tort lawyers to try cases in St. Louis and other cities that have been a destination of choice for litigation against companies that do business nationwide.

The jury verdict shows that J&J is liable for failing to warn Eva Echeverria, 62, about the alleged cancer risks of using its talcum products, which she started using when was 11. She was diagnosed with ovarian cancer in 2007. The Monday morning verdict followed last Wednesday’s closing arguments, with the California jury deliberations coinciding with J&J’s jury trial in the Xarelto blood thinner Mississippi federal trial, which resulted in a defense verdict for J&J on August 18, 2017.  J&J was hoping the Mississippi Xarelto jury verdict was a precursor to the California Talc verdict, which it was not. Ms. Echeverria’s case was chosen as the first bellwether trial due to the onset of final stage ovarian cancer and her failing health, with doubts in some circles that she may not have survived until the trial start.

There are more than 4,800  Talc claims in federal and state U.S. courts accusing J&J, the world’s largest health-care company, of ignoring studies linking its baby powder and Shower to Shower talc products to ovarian cancer and failing to warn customers about the risk, with cases pending in Missouri, New Jersey and California.

In June, the Missouri judge halted the Talc trial there mid-trial in St. Louis, following a U.S. Supreme Court decision, earlier in the day limiting out-of-state plaintiffs joining lawsuits in state court, in the Bristol-Myers (Plavix) state court jurisdictional ruling, Bristol Myers California Plavix Ruling.  Up to then, J&J had been hit with verdicts as high as $110 million by Missouri juries, a favored location for Talc litigation, totaling more than $300 million and J&J, a New Brunswick, New Jersey-based company is appealing these verdicts.

J&J claims the plaintiffs’ allegations aren’t supported by scientific evidence, pointing to a New Jersey state court decision last year tossing out two cases set for trial, due to lack of expert witness supporting evidence.  That judge found evidence linking talc to ovarian cancer was inadequate, however, J&J just happens to be a New jersey based corporation.

The case is Eva Echeverria v. Johnson & Johnson, BC628228, Los Angeles County Superior Court.

Read More

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.

Read More

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, a morbidly obese attorney with Drinker, Biddle & Reath in Florham Park, N.J.

Read More

Witness: Xarelto is “The Worst” of All Anticoagulents

Frank W. Smart, MD
Frank W. Smart, MD, testified that Xarelto should have an FDA Black Box Warning — the strongest warning.

In damning testimony against drugmakers Janssen Pharmaceuticals and Bayer, an expert cardiologist testified at the second Xarelto bellwether trial that of all the anticoagulants, Xarelto is “the worst.”

“So Xarelto, of all the new oral anticoagulants, is the worst. And that’s well established in the medical literature and even by the FDA. The FDA said that Xarelto was equal to Coumadin. The other drugs which would be apixaban or Eliquis, dabigatran or Pradaxa and edoxaban or Savaysa are in one shape or form superior either in anticoagulation effect or in bleeding or in both,” testified Frank W. Smart, MD, a board-certified doctor in cardiology at LSU School of Medicine.

The case is  In Re: Xarelto (Rivaroxaban) Products Liability LitigationJoseph Orr v. Janssen Research, Case No. 2:15-CV-3708, before US District Judge Eldon Fallon in the Eastern District of Louisiana. Plaintiff attorney Anthony Birchfield, Jr. of Beasley Allen Crow Methvin Portis & Miles in Montgomery, AL, led the direct examination.

Dr. Smart’s  opinion was based on his own research plus internal company e-mails from drug manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of FDA reviewers’ opinions FDA where the Xarelto was discussed.

Stops precribing Xarelto

Xarelto is a NOAC or new oral anticoagulant. Instead of blocking clotting factor Vitamin K, Xarelto is an inhibitor of Factor Xa, and it too stops the prothrombin-to-thrombin conversion and thins a person’s blood.

“I read an article that was in one of the Canadian journals that was very impressive to me, and I started transitioning people off of Xarelto at that time and have completely abandoned the use of it,” he testified. “It was a twice-a-day drug crammed into a once-a-day prescription, and I thought that that was a poor idea. I still think it’s a poor idea.”

“A practicing cardiologist sees people six, seven days a week “and they don’t have time. They don’t physically have time to chase down information like this.”

“Coumadin has a black box warning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and then things like that. Xarelto, I believe, should have a black box warning as well because all the literature and the FDA said that there’s no difference,” he testified.

An FDA Black Box Warning is the strongest warning that the US Food and Drug Administration (FDA) puts on a drug. For example, addictive opioids have black box warnings.

After reading FDA transcripts, Smart said, “The conclusion seemed to be that if the FDA had had their druthers, the company would have tested a twice-a-day dose, but they went on to say that they didn’t have the capacity to force the company into doing that, and the only thing that they could do was to consider the information that had been presented to them at the once-a-day dose.

Xarelto worst drug in its class

The ROCKET-AF trial of Xarelto on 7,000 patients with atrial fibrillation (Afib) found that “Xarelto was the worst in the class of these drugs. It was never shown to be superior to warfarin for either stroke or bleeding. But Eliquis, or apixaban, was shown to be superior for both,” Smart testified.

Q. (by attorney Anthony Birchfield) So when we look at these drugs, if we look at Eliquis.  Eliquis in the clinical trial, is it shown to be superior in both safety and efficacy?

A. (by Dr. Smart) Yes, sir. To warfarin.

Q. So Eliquis is superior to them both. And then, when we look at Pradaxa compared to warfarin, was Pradaxa — was it superior to either — in either safety or efficacy?

A. Yes, sir. It was superior in safety.

Q. What about efficacy?

A. Equal.

Q. And then, when we look at Xarelto was Xarelto superior in safety?

A. No, sir.

Q. Was it superior in efficacy?

A. No, sir.

“I think, again, playing Monday morning quarterback, I think had Eliquis been released at the time, there was no way that Xarelto would have been approved,” by the FDA, Smart testified.

“It’s worst in class among the NOACs. That’s pretty accepted. I mean, it’s a four-horse race, and they are the fourth horse. This adds concern that the approval was maybe less grounded in great science.”

Read More

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.”

Read More

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.


Read More

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.

Read More

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.

Read More

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.

Read More

Court Shoots Down Preemption Claim as Xarelto Bellwether Trial Nears

xarelto-bleedingShooting down a preemption argument in a defense summary judgment motion, US District Judge Eldon E. Fallon allowed plaintiffs’ state-law design-defect claims against Xarelto to go ahead against Janssen Pharmaceuticals and Bayer Parma Inc.

The plaintiffs’ success came IN RE: Xarelto (Rivaroxaban) Products Liability Litigation, consolidated in MDL 2592 in Louisiana were 16,285 case are pending. 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.

Impossibility argument

The defendants argued that the defective design claims are preempted by federal law, and that it would be impossible for them to simultaneously comply with both federal and state law. But the judge didn’t buy the argument.

“Impossibility pre-emption is a demanding defense,” the court said. “While this Court acknowledges that pharmaceutical companies generally cannot take unilateral action or alter an FDA-approved drug, Defendants are stretching the law beyond its current bounds.”

“The Court in Levine [Wyeth v. Levine, 555 U.S. 555 (2009)] held that a state failure to warn claim against a brand-name drug manufacturer was not preempted by federal law, finding that Congress had clearly intended the judicial branch to work in concert with the FDA to protect against unnecessary risk,” the court held.

It added, “The court in Guidry [Guidry v. Janssen Pharms., Inc., No. 15-4591, 2016 U.S. Dist. LEXIS 115447, at *48 (E.D. La. Aug. 29, 2016)], relying on Wyeth, found that Plaintiff’s pre-market defective design claims under the LPLA [Louisiana Products Liability Act] were not preempted. “Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable, and perhaps necessary to protect the public health and assure the safety, effectiveness, and reliability of drugs.”

One size fits all?

Janssen and Bayer market Xarelto as a one-size-fits-all anticoagulant. Patients take one 20-milligram dose of Xarelto once a day and do not need to undergo routine monitoring. The plaintiffs contend that, because each person processes and metabolizes Xarelto at a highly-individualized rate, each patient’s reaction to the drug is decidedly variable, causing some patients to experience major bleeding events.

The plaintiffs acknowledge that the FDA approved Xarelto’s dosing and monitoring scheme. However, they claim that, given the high inter-patient variability, Xarelto is unreasonably dangerous in design because:

  1. Defendants should have designed, but failed to design, a Xarelto-specific Anti-Factor Xa assay so doctors could monitor Xarelto’s anticoagulation effect on each patient and could, along with the patient, weigh the risks and decide whether to continue taking Xarelto.
  2. Defendants have not designed and marketed an antidote to counteract a major bleeding event.
  3. In the absence of a Xarelto-specific Anti-Factor Xa assay, Xarelto’s label should have warned doctors about the availability of the Neoplastin PT test to measure patient’s anticoagulation.

“Because Defendants did not take any of the above three actions, Plaintiffs claim Xarelto is unreasonably dangerous under the LPLA,” the judge said.

 

Read More