PA Superior Court Reverses Risperdal Defense Verdict as Court Strikes Janssen Pharmaceuticals Only Favorable Jury Verdict

“Johnson & Johnson Hit With Another Trial Verdict Reversal”

By Mark York (November 17, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS) The Superior Court of Pennsylvania reversed the single defense verdict reached in favor of Janssen Pharmaceuticals, the manufacturer of anti-psychotic drug Risperdal. The reversal and order for a new trial stemmed from a 2015 trial that resulted in the one Risperdal defense verdict to date. The case is part of the mass tort docket for Risperdal cases in the Philadelphia County Court of Common Pleas, (see RISPERDAL Case No 296 PHILADELPHIA COURT OF COMMON PLEAS BRIEFCASE), where more than 6,000 Risperdal cases are pending.

The 22-page unanimous Superior Court decision by Judge Jack Panella, reversed the Janssen defense win in the Risperdal trial where plaintiff William Cirba filed suit against Janssen Pharmaceuticals and lost, as well the subsequent denial of Mr. Cirba’s request for a retrial based on “erroneous evidentiary rulings.”

The ruling ordered a new trial and will now be limited to the issues of causation and damages.

LAYPERSON AT TRIAL IS NOT AN EXPERT

The Superior Court stated the trial court made a reversible error at trial, by allowing physician’s assistant Michelle Baker’s testimony to be weighed on the same level as that of a medical expert. Ms. Baker was involved in the treatment of Mr. Cirba from 2005 to 2013, as a physician’s assistant.

During the Cirba trial, a videotaped deposition from Baker was played in which she stated an opinion that Cirba’s gynecomastia (the development of breast tissue) was the result of “extreme weight gain” rather than negative side effects from Risperdal. Cirba had been prescribed the drug to treat oppositional defiant disorder.

Cirba’s counsel objected that it was improper that Baker’s layperson testimony was considered equal to that of an expert, since she was not designated or qualified prior to trial – while the defense believed Baker’s deposition did not cross over into expert testimony and “constituted permissible lay opinion testimony, as it was rationally based on her perception of plaintiff during treatment.” Which the Superior Court has obviously disagreed with.

The jury returned a verdict in favor of Janssen in March 2015, although the jury at that time believed Janssen failed to properly warn Cirba’s physicians of gynecomastia risks associated with Risperdal, it stopped short of finding Janssen negligent in directly causing Cirba’s gynecomastia.

The Superior Court sided with the plaintiff in believing admitting Baker’s testimony was an attempt to enter the realm of expert knowledge.

Defendants’ experts opined that weight gain rather than Risperdal ingestion caused plaintiff to appear to have gynecomastia. Baker’s testimony, in which she opined that plaintiff’s weight gain, rather than his Risperdal usage, caused him to appear to have gynecomastia, was causation testimony offered by a witness who personally treated the plaintiff” Panella said.

Panella added Baker’s opinion was “offered without the proper vetting and safeguards surrounding expert testimony.”

“Further, this opinion was introduced into evidence due to the trial court’s improper application of the law, which is clearly an abuse of discretion. Therefore, we find that the trial court abused its discretion in denying plaintiff’s request for a new trial, limited to the issues of causation and damages,” the panel stated, in reversing the judgment and remanding the case for further proceedings.

SAME PANEL STRIKES RISPERDAL SOL CLAIMS

In a separate 18-page ruling also issued Nov. 13, the exact same three-judge panel upheld the trial court’s striking down of arguments that the statute of limitations in two Risperdal cases, featuring plaintiffs Jonathan Saksek and Joshua Winter, should have been tolled until 2013.

Saksek and Winter were prescribed Risperdal in 1997 and 1998, allegedly began developing gynecomastia in 1998 and 2002, respectively, but didn’t file suit until 2014. Both plaintiffs brought suit after seeing television advertising connected to Risperdal litigation in 2013.

The defense agreed with the trial court that the statute of limitations mandated the grant of summary judgment, but contended if the discovery rule applied, it would have only tolled the statute of limitations until October 2006, when Risperdal’s prescribing label was changed to include a warning about gynecomastia.

In January 2015, Judge Arnold New granted a defense motion for summary judgment and ruled an applicable statute of limitations applied to both Saksek and Winter’s cases, feeling that they should have known of Risperdal’s gynecomastia-related injury risks by June 30, 2009.

Both plaintiffs appealed, and the appeals were consolidated, but the higher court agreed with the trial court.

“Plaintiffs were aware of their injuries when they began experiencing unexplained weight gain – and breast growth – after starting Risperdal treatment in 1998 and 2002. However, from 1998 and 2002 until 2013, when plaintiffs were notified of the commercial claiming a link between gynecomastia and Risperdal, they did nothing to uncover the cause of their unexplained breast growth and weight gain. Plaintiff cannot hope to establish that they acted with reasonable diligence, when they admit that they failed to act at all,” Panella stated.

Their breasts were there, and had been there, for years. And then, in October 2006, the label on Risperdal changed, expressly linking usage of the drug to gynecomastia. Their breasts were clearly not temporary by 2006. Accordingly, by that date, ‘reasonable minds would not differ in finding that’ plaintiffs knew, or should have known, of their injuries and the cause of those injuries by this point,” Panella added.

RULING AFFECTS OTHER CASES

Kline commented on the Superior Court’s statute of limitations ruling, indicating it could be far-reaching beyond merely the instant cases.

“We believe [this] harsh ruling, which may bar the claims of thousands of claimants who could not possibly have known of their gynecomastia injury and its cause, is legally and factually wrong. We plan to appeal further, seeking to reopen the courthouse doors to them,” Kline said.

Janssen’s stated:  “We are pleased the Superior Court affirmed Judge New’s ruling on the application of statute of limitations.

MASS TORT DOCKET GROWING

More than 6,400 Risperdal lawsuits – most from out-of-state plaintiffs – will be handled in Philadelphia’s Complex Litigation Center. The CLC has several mass tort programs, including cases over Xarelto  (See Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation PA State Court) and asbestos, and the percentage of claims belonging to out-of-state plaintiffs has traditionally been in the high 80s. In 2016, the percentage for pharmaceutical lawsuits dropped to 74 percent.

However, in 2017, the most recent CLC stats show that figure has jumped to an unprecedented 94 percent.

Appeal Docket: Superior Court of Pennsylvania case 2451 EDA 2015 & 576 EDA 2015

Trial Docket: Philadelphia County Court of Common Pleas case 130301803, 140200183 & 140301170

 

 

 

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

John Ray
“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.”

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:

  1. 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).
  2. 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.

NuvaRing Litigation Product Liability Litigation MDL 1964

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.

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JAMA Study: Xarelto Causes More Bleeding Than Pradaxa

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.

Plaintiffs have filed 16,285 lawsuits in IN RE: Xarelto (Rivaroxaban) Products Liability Litigation, consolidated in MDL 2592 in Louisiana. As a bellwether trial is underway 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 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.

Pradaxa settlement

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 average case settled for $160,000 in 2014, with some settlements valued up to $500,000, according to a grid created by US District Judge David R. Herndon.

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.

Uncontrollable bleeding

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.

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With Trial Coming Up, Xarelto Makers Face $2.5 Billion in Potential Liability

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.

Meanwhile, a smaller cluster of 1,100 claims have been filed in the Philadelphia Court of Common Pleas in Pennsylvania state court before Judge Arnold New. Finally, there’s a small group of 31 cases in California Superior Court before Judge Kenneth Freeman in Los Angeles.

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.

Settlement

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.

Xarelto Marketing For Lawyers: How To Add Xarelto To Your Law Firm’s WebsiteAt 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.

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Attorneys Mistakenly Turn Down Xarelto Cases When Death Certificate Omits Internal Bleeding

John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.
John Ray has been a leading consultant to the Mass Tort industry for over a decade. His unique skill sets make him well suited to both teaching and consulting in the Mass Tort arena.

By John Ray.

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 simple answer is, possibly but often not.

Many mass tort lawyers see the upcoming bellwether trials on April 24 and May 30 as an opportune time to start or expand a Xarelto product liability practice. So far 15,611 cases lawsuits have been filed before US District Judge Eldon E. Fallon in Louisiana, up from 10,769 cases in September 2016. 

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.

Two Cautions

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.

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Facing 11,000 Xarelto Lawsuits, Johnson & Johnson Doubles Down on Physician Bribes

xarelto-bleedingBy KJ McElrath. This article is reprinted from The Ring of Fire Network.

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.

A total of 15,291 lawsuits have been filed against Janssen Research & Development LLC (a Johnson & Jonson subsidiary) in Xarelto products liability MDL No. 2592. Over 1,000 more have been docketed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation.

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.

Physician bribes

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.

Despite the increasing number of lawsuits and growing number of adverse event reports, Johnson & Johnson spent a whopping $28.4 million in physician bribes during 2015 alone in order to get them to write prescriptions for Xarelto. In fact, that particular drug was at the top of ProPublica’s “Dollars for Docs” list for that year.

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.

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Judge in Xarelto Litigation Addresses Deficiencies in Plaintiff Fact Sheet Compliance

xarelto bleedingFor 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.

Non-compliant responses

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.

In parallel litigation, some 1,100 claims have been filed in the Philadelphia Court of Common Pleas Xarelto Consolidated Litigation to date before Judge Arnold New. For more, read Two Reasons That More Attorneys File Xarelto Claims in Philadelphia Court. The first trial is scheduled for September 2017.

Did Xarelto kill Arnold Palmer?

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.

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