Essure Litigation Against Bayer Survives Preemption Challenge – Cases Remanded to Pennsylvania State Court

Philadelphia Court of Common Pleas Is Now The Venue for Filing “Essure” Cases

By Rosemary Pinto, Esq. Feldman & Pinto

And Mark A. York, Mass Tort Nexus

(September 27, 2018)

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) Bayer Corp. and its entities, the makers of Essure, a permanent contraceptive implant subject to thousands of injury reports and repeated safety restrictions by regulators ,said  recently that it will stop selling the device in the U.S., the only country where it remains available.

On July 23, 2018, U.S. District Senior Judge, John R. Padova of the Eastern District of Pennsylvania, ruled  that the federal court did not have jurisdiction over the cases against Bayer Healthcare Pharmaceuticals Inc., and the legal claims over the Essure contraceptive device.

The cases were originally filed in Philadelphia court but were removed by Bayer with the company claiming the removals were proper because the plaintiffs’ claims involved an interpretation of federal law, including Food and Drug Administration regulations.

The company cited a 2017 ruling by a U.S. District Court in North Carolina in another Essure case, Burrell v. Bayer, in which it found that it had federal question jurisdiction because “the labeling of FDA-approved medical devices is governed by the FDA under the MDA, and [the] state law is generally pre-empted under 21 U.S.C. Section 360k.”

But Padova instead followed the lead of courts in the Eastern District of Kentucky and the Eastern District of Missouri, finding that “Congress intended for the state courts to resolve cases such as this one, which ask whether a defendant violated state laws that parallel federal requirements applicable to Essure.”

Bayer argued that the cases were of federal concern because the Essure devices were subject to “stringent federal scrutiny” as Class III medical devices.

“We certainly agree with Bayer that Congress has a significant interest in the regulation of Class III medical devices,” Padova said. Nevertheless, Padova added, the Medical Device Amendments of 1976 “permit individuals to bring state law causes of action alleging violations of duties that parallel the federal requirements. It would be entirely inconsistent with this structure to conclude that Congress intended all such state law causes of action to be brought in federal court.”

Padova also said Bayer failed to identify any disputed federal issue, noting that “the central claims in the complaints are that Bayer violated state law and the complaints merely reference federal law to rebut any argument that their state law claims are preempted.

Feldman Pinto In Philadelphia Provides Insight

Essure Litigation Survives Preemption Challenge, Cases Remanded to State Court

Essure is a birth control device composed of two metal coils implanted in a patient’s fallopian tubes. Women injured by the device have filed more than 16,000 lawsuits against Bayer Healthcare, alleging, among other things, that Bayer failed to provide adequate warnings of severe Essure complications suffered by plaintiffs from device breakage, migration, and / or expulsion. Complications include perforation of fallopian tubes, uteri, rectums, colons, and other organs; severe and chronic pelvic or abdominal pain; and autoimmune diseases.

Essure Claims for Negligent Misrepresentation and Negligent Failure to Warn Survive Preemption Challenge

All of the approximately 16,000 Essure lawsuits in state and federal court exist as individual legal actions rather than class actions or multidistrict litigation. Five such cases were consolidated in the U.S. District Court for the Eastern District of Pennsylvania. Defendants filed motions in all five cases, requesting dismissal of plaintiffs’ claims on the basis of express or implied preemption, failure to state a plausible claim, or failure to plead fraud with particularity.

In March 2016, the court denied defendants’ motions to dismiss plaintiffs’ claims of negligent misrepresentation and negligent failure to warn, holding that the state law claims set forth plausible claims for relief and were not preempted by federal law.

Consolidated Essure Cases Remanded to State Court

In July 2018, the Eastern District of Pennsylvania remanded 19 Essure injury cases to the Philadelphia Court of Common Pleas. The district court found that it lacked both diversity of citizenship and federal question subject-matter jurisdiction over the consolidated individual actions and remanded them to state court.

 Essure Statute of Limitations

Defendants in Essure personal injury cases may argue that the statute of limitations period in all Essure cases should begin on November 18, 2016, the date the FDA approved a black box warning (its strongest warning level) for Essure. In reality, the dates triggering Essure limitation periods will vary. The beginning of each plaintiff’s limitation period will depend on the plaintiff’s individual claims and state law applicable to the particular case.

Bayer Stops USA Sales

Bayer announced in June 2018 that it would voluntarily discontinue U.S. sales of Essure by the end of this year “for business reasons” but earlier this month affirmed the safety profile of the device. Last week, Bayer took Netflix to task over the accuracy of its medical device documentary “The Bleeding Edge.” The tide was turning for Bayer at that point, sales were already down 70% after the 2016 FDA warning and the public became aware of the risks of using Essure.

Bayer received FDA approval to sell Essure in 2002 and promoted it as a quick and easy permanent solution to unplanned pregnancies. Essure consists of two thin-as-spaghetti nickel-titanium coils inserted into the fallopian tubes, where they spur the growth of scar tissue that blocks sperm from fertilizing a woman’s eggs.

Because of the reported complaints, the FDA added its most serious warning to the device in 2016 and ordered the company to conduct a 2,000-patient study. FDA Commissioner Scott Gottlieb said Friday, the agency would work with Bayer to continue the study, but noted “Bayer will not be able to meet its expected enrollment numbers” for new patients. The study was designed to follow patients for three years to better assess complications.

Gottlieb said the FDA will continue to monitor adverse events reported to its database after Essure is removed from the market.  He stated “I also want to reassure women who’ve been using Essure successfully to prevent pregnancy that they can continue to do so,” and added “Those who think it’s causing problems, such as persistent pain, should consult with their doctors,” with Gottlieb further noting that device removal “has its own risks.”

Essure’s original label warned that the device’s nickel can result in allergic reactions. Its current labeling lists hives, rash, swelling and itching as possible reactions.

But many women have attributed other problems to the implant, including mood disorders, weight gain, hair loss and headaches. Those problems are listed in the current FDA labeling for the device, with the qualifier: “It is unknown if these symptoms are related to Essure or other causes.”

Informational material Bayer supplied to doctors and patients lists potential problems and states the devices are meant to be permanent. It also says removal may require complicated surgery, including a hysterectomy, that might not be covered by insurance.

Non-Profit Weighs In

Diana Zuckerman, president of the nonprofit National Center for Health Research, said Essure is among medical devices approved without “clear evidence of safety or effectiveness. As a result, when thousands of women reported serious complications from Essure, there was no unbiased long-term research to refute or confirm those reports” she also stated, “If patients had been listened to when the first clinical trials were conducted on Essure, better research would have been conducted to determine exactly how safe and effective Essure is.”

 Feldman & Pinto is Representing Plaintiffs in Essure Litigation

The Philadelphia personal injury firm of Feldman & Pinto concentrates its practice in plaintiffs’ drug and medical device injury litigation. Each of the firm’s attorneys has more than 20 years’ experience trying personal injury and wrongful death cases in state and federal court. Feldman & Pinto currently represents plaintiffs in approximately 20 Essure injury cases in the Philadelphia Court of Common Pleas.  Attorney Rosemary Pinto can be contacted at rpinto@feldmanpinto.com.

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Monsanto “Roundup” Cancer Trial Closing: Was There Proof of Monsanto Collusion to Stop Release of Cancer Link to Roundup?

 

Monsanto Collusion to Stop Release of Cancer Link Now Known

By Mark A. York (August 8, 2018)

 

 

 

 

 

 

 

 

 

 

DeWayne Johnson vs. Monsanto Is The First Lymphoma Cancer Trial

Case is DeWayne Johnson vs. Monsanto Company Case No. CGC-16-550128 in the  SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, Judge Bolanos.

Johnson Trial Transcripts: Monsanto-roundup-lawsuit/dewayne-johnson-v-monsanto-transcripts(baum-hedlund)

Here is the day one opening statement by Brent Wisner, plaintiff trial counsel with Baum Hedlund Aristei & Goldman.

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(MASS TORT NEXUS MEDIA) Glyphosate is the most widely used agricultural based chemical product in history, starting when Monsanto introduced it in 1974, and worldwide use exploded after 1996 when Monsanto began selling “Roundup-ready” seeds- engineered to resist the herbicide, with now possibly catastrophic consequences in the United States.

More than 2.6 billion pounds of the chemical has been spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey. Roundup traces have been detected in over 50% of the food products being consumed in the US marketplace in numerous independent studies.

Monsanto earns $1.9 billion a year from Roundup and $10.2 billion from “seeds and genomics,” most of that category being Roundup-ready seeds.

In June, German pharmaceutical giant Bayer completed its $63 billion acquisition of Monsanto after approval by U.S. and European regulators, even though the Monsanto name may disappear, the link between cancer and glyphosate will remain long after the merger. Will Bayer decide to settle or take the thousands of lawsuits to trial that are pending in federal and state courts across the country? Although U.S. and European regulators have concluded Roundup’s active ingredient glyphosate is safe, the World Health Organization’s International Agency for Research on Cancer classified it in 2015 as a probable human carcinogen, triggering over 5,000 lawsuits against Monsanto in the United States.

Plaintiff DeWayne Johnson’s skin-based non-Hodgkin lymphoma, was caused by his use of Monsanto’s “Roundup Weed Killer” and Monsanto has gone to great lengths to suppress any links between Roundup and cancer.

The current state court trial in California has shown the extraordinary lengths that Monsanto has gone to in order to suppress and manipulate hard core science and research results around the world that showed clear links between Glyphosate and Cancer, specifically non-hodgkins lymphoma.

To show the high level of interest in the Monsanto “Roundup” abuses, last week musician Neil young and actress Darryl Hannah were in the DeWayne Johnson courtroom, which reflects Young’s ongoing campaign against the many abuses of Monsanto placed upon the US farmers and others around the world. He even released a 2015 album titled “The Monsanto Years” along with a documentary “Seeding Fear” of which Young co-produced related to Monsanto legal action against Alabama farmer Michael White, over its GMO patented seeds. Link to “Seeding Fear can be found here.

In addition to the Johnson state court case, there is the Monsanto Roundup Multidistrict Litigation No. 2741 in the US District Court of California, Northern District where the same cancer links are claimed. Documents released in the Johnson trial and in the MDL ( see Roundup (Monsanto) MDL 2741 USDC ND California) have raised many new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the thelitigation against Monsanto and Roundup, pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

  1. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from Forbes.com and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction,  however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

The Johnson vs. Monsanto trial verdict will be posted as soon as it becomes available.

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Second Xarelto Drug Trial Starts in Philadelphia Courtroom

Will this be a long hot summer of trials for Xarelto defense counsel?

 By Mark A. York (April 9, 2018)

 

XARELTO – a drug jointly created by Bayer and J&J subsidiaries Janssen R&D et al

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The second Xarelto bellwether drug trial over dangers related to internal bleeding linked to the anticoagulant blockbuster drug, started Friday April 6, 2018 in the Philadelphia Court of Common Pleas, in front of Judge Michael E. Erdos. This trial, where plaintiff Daniel Russell, of New Jersey claims that after being prescribed Xarelto, for Atrial Fibrillation or Afib, the drug caused massive internal bleeding and other serious medical complications. Mr. Russel’s trial follows the December 2017 verdict where a jury had awarded plaintiff Lynn Hartman $28 million for failure to warn of the dangers of Xarelto, a verdict later reversed in post trial arguments by Judge Erdos.

In opening statements by lead counsel Brian Barr of the Levin Papantonio firm,(see Russell v Bayer et al Trial Transcript Opening Statements April 6, 2018) the jury was told on Friday, that drug makers Bayer AG and Johnson & Johnson units (Janssen Pharmaceuticals, et al) failed to warn doctors about the risk the medication posed when used in combination with other drugs, which include internal bleeding, ischemic strokes and other adverse events. Offering that the companies had known that combining Xarelto with antiplatelet medications including Plavix and even aspirin, the combination would significantly increase the risk of internal bleeding, but that they ultimately opted to keep the information to themselves, and would not offer a formal FDA approved warning.

In the initial Phila bellwether trial, Lynn Hartman and her husband had filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with claims very similar to Mr. Russell, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in the Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi in 2017, which took place in federal courts.

The Phila Court Xarelto docket is the hot mass tort ticket now as Judge Fallon decided there will be no more MDL trials in front of him, and started the remand process in the Xarelto MDL 2592 cases, where he’s sending the cases back to original jurisdictions for trial.

The Lynn Hartman trial was just one of about 21,400 lawsuits against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and was the first case selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court. Daniel Russel’s case is the second bellwether trial to go forward in the Xarelto docket, with several additional trials set to follow in the coming months.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, Xarelto MDL 2592 Briefcase (US District Court ED Louisiana) heard in front of Judge Eldon Fallon,  all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the bellwether trials scheduled there. This trail will be closely watched by all arties, as the impact of the initial plaintiff’s trial win followed by the Judge Erdos reversal in January during post-trial hearings, was not anticipated by those on the plaintiff bench. Will the Hartman verdict reversal ruling, as well as the peripheral trial conduct issues that were also addressed post-trial by Judge Erdos have any impact on this current Russell trial and the remaining scheduled trials in the Phila Xarelto docket? That is a question that remains to be seen over the course of the upcoming trials in the Philadelphia Court of Common Pleas Xarelto docket

Mass Tort Nexus will be providing daily updates on the Russell vs. Bayer & Janssen trial.

 

 

 

 

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Xarelto Federal Court Hearing – Judge Fallon “Need to devise an end game for this MDL”

Xarelto MDL 2592 – Judge Fallon “I need to devise an end game for this MDL”

Are Settlement Talks Coming to Xarelto Litigation?

By Mark A. York (January 30, 2018)

 

XARELTO: A BAYER CORP. AND JANSSEN PHARMACEUTICALS JOINT EFFORT

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) During the January 30, 2018 monthly status conference hearing in Xarelto products liability MDL No. 2592, US District Court Judge Eldon Fallon stated that this MDL is nearing its end, and “I need to devise an end game,” as he now seems to be pushing both sides toward a resolution. He also referred to selection of cases to remand where 400 cases each will be selected by plaintiff and defense counsel and 400 more by the court, for a total of 1200 cases being designated for remand back to the court of original jurisdiction for trial or settlement.

Judge Fallon also referred to resolving any lingering discovery issues that remain in certain cases to avoid mounting discovery costs in getting those case resolved, while trying to put a time frame on the proposed process of winding down the Xarelto MDL.

The sprawling nationwide litigation has produced over 21,000 lawsuits since the federal MDL was created in 2014 in New Orleans, and the number of new cases filed each month remains the same at about 400 per month. Even more cases have been filed in state courts in Philadelphia and Los Angeles, with there being about 1200 cases in the Philadelphia Court of Common Pleas docket in front of Judge Arnold New.

Michael Weinkowitz, lead plaintiff counsel in the recent Philadelphia trial verdict of $29 million, awarded to plaintiff Lynn Hartman, provided an update to the court, including a discussion on the January 9, 2018 ruling that overturned the Hartman verdict in a contentious post trial hearing, where Judge Michael Erdos granted a defense Motion for Judgement Notwithstanding the Verdict. The Philadelphia court post-trial issues of attorney misconduct were also interjected into Judge Fallon’s courtroom by defense counsel, which seemed to be totally unwarranted and out of place in the MDL hearing, when Bayer defense counsel felt the need to advise the federal court of “allegations of trial misconduct” that were heard at the January 9th hearing, even though the Hartman verdict was overturned based on proximate cause issues, not in any way related to plaintiff attorney misconduct,” as defense counsel seemed to offer to the court.

CASE DEMOGRAPHICS

Jacob Woody, of Brown Greer’s MDL Centrality program provided current data as to case numbers and plaintiff demographics including 21,465 cases currently filed into the Xarelto MDL, averaging 450 new filings each month. As well as:

  • Texas, Florida and California having the most plaintiffs with over 1,000 each
  • Hawaii having the fewest at just fourteen
  • Plaintiff age groups: age 60 – 69 = 20%, age 70 – 79 = 30% and age 80 – 89 = 30%
  • 48% of plaintiffs allege a gastrointestinal bleed as the primary medical issue
  • The number of new case filings per month has remained steady for the last 3 years

PHILADELPHIA XARELTO DOCKET

While Judge Fallon is seeking an apparent end to the federal Xarelto MDL in New Orleans, Judge Arnold New in the Philadelphia Court of Common Pleas, has set a rather aggressive trial schedule in the Xarelto docket there, including trial start dates of March 19th, April 16th and June 11, 2018 with additional trials being set at “one to two trials per month for perpetuity” quoting Judge Fallon on his interaction with the Philadelphia court. The appeal of Judge Erdos’ January 9th reversal of the Lynn Hartman $29 million verdict was filed today as well, on January 30 2018 in the Superior Court of Pennsylvania.

PROBLEMS WITH XARELTO

The Food & Drug Administration (FDA) approved Xarelto in 2011 for prescriptions, written to patients suffering from a rhythmic heart disorder called atrial fibrillation and to prevent blood clots that can lead to heart attacks, strokes and pulmonary embolisms.

Plaintiffs and their counsel charge Xarelto’s manufacturers with failing to properly warn patients that Xarelto use presented increased risks for cranial and gastrointestinal bleeding when taken once daily and not properly monitored.

Plaintiffs assert claims against Xarelto makers Bayer, Janssen and Johnson & Johnson of strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud as well as violation of consumer protection laws where permitted by state statutes and loss of consortium when possible.

The GI bleed issue which is the most common allegation in the Xarelto complaints is by no means the only medical issue to arise in litigation over the block-buster blood thinner, with claims of both hemorrhagic and ischemic strokes, sudden uncontrolled internal bleeding, lack of an antidote to stop traumatic bleeding events related to trauma as well as thousands of deaths related to taking Xarelto after being prescribed the drug by doctors.

Bayer and Janssen have aggressively defended the safety of Xarelto and proclaim the previous three defense verdicts in the Xarelto bellwether trails that took place in 2017, show that Xarelto is a safe drug. Medical and scientific data do not seem to support that position, but the 21,000 remaining lawsuits waiting to be returned to federal court dockets across the country may well force the defendants to rethink their legal strategy due to the catastrophic costs associated with defending and preparing cases for that number of potential trials.

XARELTO CALIFORNIA JCCP DOCKET

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, JCCP Case No. 4862. The California Xarelto docket is moving forward as cases filed there continue to increase monthly, with almost 300 cases currently pending in the California state courts. A recent status conference was held in December, when the parties agreed to submit plaintiff and defendant fact sheets.

XARELTO MDL 2592 FUTURE

Even though Judge Fallon has determined that there will be no more bellwether trials in his court as a sitting MDL judge, there are individual Xarelto cases that will remain in the US District Court of Louisiana docket that he may be ruling on. He will also have to address the various housekeeping and legal issues that will arise in winding down such a large MDL docket where the cases are still active and viable and both sides don’t seem to be looking toward a quick settlement at this point.

The thousands of cases being placed in front of federal judges across the country could possibly force the parties to come to the settlement table sooner as opposed to later, with a push here and there from individual courts, as already overloaded federal courts are probably not readily agreeable and inviting of this large a number of cases that are returning to home venues.

At this point the ball rests with defense counsel and their primary clients Bayer Pharma AG and Janssen Pharmaceuticals et al, and the corporate decision makers who are also facing the recently started Opiate Prescription Drug MDL 2804, which may require defense legal talent to switch from the Xarelto docket to the Opioid crisis litigation. The Opiate Prescription MDL may easily dwarf the prior Tobacco Litigation, to which it’s being compared. Big Pharma has some key decisions to make when it comes to where and how they will assign future resources and capital in defending past decisions in the manufacture and marketing of their prescription pharmaceuticals.

 

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$28 Million Xarelto Jury Verdict Reversed by Judge in Philadelphia Court

Defense gets fourth win in the four Xarelto bellwether trials

By Mark York (January 11, 2018)

 Xarelto Blood Thinner Developed by Bayer and Janssen

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The December 2017 Xarelto jury verdict of $27.8 million awarded to an Indiana couple, was overturned earlier this week, when the trial judge vacated the verdict. The plaintiffs had accused Bayer AG and Janssen Pharmaceuticals, Inc., a Johnson & Johnson subsidiary, of failing to warn of internal bleeding risks of their drug Xarelto.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, heard arguments on January 9, 2018 in a motion hearing to reverse the December verdict, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592, (see XARELTO MDL 2592 US District Court ED Louisiana briefcase) in front of Judge Eldon Fallon, US District Court of Louisiana.

Judge Erdos issued his ruling from the bench after the hearing on defense motions for a new trial or alternatively, for a judgement notwithstanding the verdict, and at the close of a full day of arguments stating, “a new trial is not necessary because plaintiff did not adequately demonstrate responsible cause,” and he then entered judgement for the defendants.

“J&J’s Janssen Pharmaceuticals Inc and Bayer, which jointly developed Xarelto, welcomed the decision and issued statements saying they will continue to defend against the allegations in all Xarelto litigation, with a total of more than 20,000 pending lawsuits now in both state and federal Xarelto dockets.

Bayer stated “Bayer stands behind the safety and efficacy of Xarelto and will continue to vigorously defend it.”

The December 5, 2017 verdict came in a lawsuit filed by Lynn Hartman, who was prescribed Xarelto as treatment for an irregular heartbeat also known as atrial fibrillation, to prevent strokes. The testimony and opinions of Ms. Hartman’s treating physician and views on continued willingness to prescribe Xarelto, had a significant impact on the final ruling to overturn the verdict by Judge Erdos.

Hartman claimed she was prescribed the drug for a little more than a year, starting in February 2013, and was hospitalized with severe gastrointestinal bleeding in June 2014, at age 72, with the bleed attributed to taking Xarelto. The court record reflected that Ms. Hartman has since recovered from the hospitalization.

Lynn Hartman and her husband filed their complaint against the drugmakers in 2015, (see XARELTO Case No. 2349 Philadelphia Court of Common Pleas briefcase) with the six week trial starting the first week of November 2017, resulting in the jury awarding $1.8 million in compensatory damages and $26 million in punitive damages. This verdict was seen as a high note for plaintiff counsel in the Xarelto litigation, after three prior trial losses, in Xarelto MDL 2592 bellwether trials in Louisiana and Mississippi.

The Hartman trial is just one of about 21,400 against Bayer and Janssen pending in federal and state courts blaming injuries on Xarelto, and the first selected for trial from more than 1,400 Xarelto cases pending in the Complex Litigation docket of the Philadelphia court.

Plaintiff trial counsel Michael Weinkowitz, said the decision related to a “very narrow issue related to Mrs. Hartman’s prescribing physician.” He said he looked forward to trying the next series of Xarelto-related cases in Philadelphia. The post trial legal arguments were related to the “learned intermediary doctrine and proximate cause” and was raised by defense in post trial motions and aggressively argued, which plaintiff counsel was unable to overcome in the full day hearing.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Plaintiffs in the Hartman trial as well as in thousands of other Xarelto lawsuits, alleged that the drug was unreasonably dangerous and that Janssen (J&J) and Bayer failed to warn patients about a serious risk of uncontrollable, irreversible bleeding in emergencies and were aware of adverse events for a long period of time. These allegations will be argued aggressively by defense in all forthcoming trials, as the defendants do not seem to be willing to bend on their winning trial strategy.

Bayer and Janssen have defended Xarelto’s label stating that the label adequately warns of bleeding risks. After four trials verdicts, all in their favor, defense seems to be using an effective trial strategy that has worked in venues across the country.

The three bellwether trials in the Xarelto MDL 2592, all resulted in defense wins for Bayer and Janssen, with this Philadelphia trial shifting the focus from the federal Xarelto docket to the Philadelphia court and the Hartman trial. What impact the initial plaintiff’s trial win followed by the Judge Erdos reversal this week has on both Xarelto dockets remains to be seen.

 

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$29 Million XARELTO Jury Verdict Against Bayer AG, Janssen Pharmaceuticals (Johnson & Johnson) in Philadelphia

XARELTO TRIAL VERDICT FOR PLAINTIFF: BAYER AND JANSSEN PHARMACEUTICALS (J&J) LOSE  $29 MIILLION IN XARELTO TRIAL VERDICT BY PHILADELPHIA JURY

  

 

 

 

 

A state court jury in Philadelphia delivered a first-of-its-kind verdict on Tuesday as it awarded $29 million in damages against a pair of Johnson & Johnson and Bayer AG units after finding the companies had provided inadequate warnings about the risks of bleeding associated with the blood thinner Xarelto,(see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court).  In the first bellwether trial outside the Xarelto Federal MDL 2592, plaintiff counsel scored a win in a $29 million verdict, when plaintiff Lynn Hartman showed that Xarelto caused severe bleeding after she was prescribed the drug by her doctor. The 3 prior federal court trials in the Xarelto MDL 2592 docket (see XARELTO MDL 2592 US District Court ED Louisiana) were all won by the defense and this trial was watched closely by both legal and drug industry observers to see if the 3-0 defense win streak continued. Now that Ms. Hartman has shown that the Xarelto prescription caused her internal bleeding, with no warnings by manufacturers Bayer and J&J, the remaining 22,000 Xarelto cases pending in courts across the country will begin preparations for a legal battle that to date has gone in favor of defense counsel.

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New Round of Essure Lawsuits Filed vs. Bayer Healthcare Pharmaceuticals, Inc in Pennsylvania Federal Court

“Bayer Facing New Litigation Over Essure Birth Control Device”

By Mark York (November 20, 2017)

Mass Tort Nexus

 

 

 

 

 

 

(MASS TORT NEXUS)  On November 2, 2017, fifty-three plaintiffs from Florida, Illinois, Texas and other states across the country have filed a lawsuit over allegations that Bayer’s Essure permanent female birth control device caused serious injuries. This filing is another in a series of ongoing Essure lawsuits against Bayer in different federal and state venues across the country, including the  Bayer Essure Litigation USDC Missouri Case No. 4:17-cv-00865.

The primary claims against Bayer, that upon insertion of the device, by insertiing micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage. However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.

Maria Gonzalez, Israel Gonzalez, and the other plaintiffs filed a multi-plaintiff complaint on Nov. 2 in the U.S. District Court for the Eastern District of Pennsylvania against Bayer Healthcare Pharmaceuticals Inc. alleging negligence and other counts under case number 2:17-cv-04936-JP, U.S. District Court for the Eastern District of Pennsylvania. Additionally there are other multi-plaintiff actions against Bayer, where Essure is the product in suit, see California JCCP Complex Litigation Docket consolidated Essure cases pending there, under Essure Product Cases and Actions, JCCP Proceeding No. 4887, Alameda County Superior Court.

According to the most recent federal complaint, the plaintiffs or their partners were implanted with defendant’s Essure device. They allege that the devices “migrated, fractured, punctured internal organs and/or caused other serious injuries.” The company has long been aware of the adverse events and concerns raised over the Essure products, but have yet to admit liability, and have vigorously defended all claims against the company and Essure.

The plaintiffs state that Bayer Healthcare Pharmaceuticals Inc. is responsible because the defendant “manipulated their reports to the FDA and presented false and misleading information, which, in turn, resulted in plaintiffs’ consent to implant not being informed because critical facts regarding the nature and quality of side effects from Essure were concealed from plaintiffs and their physicians,” as cited in the complaint.

The plaintiffs seek past and future general damages, economic and special damages, medical expenses, punitive and exemplary damages, court costs, interest and any further relief the court grants.

These 53 plaintiffs, combined with the other lawsuits filed in various courts across the country now total more than 1500 claims against Bayer, where women have asserted that the company was aware of the damage and healthcare risks of it’s Essure products, and has intentionally disregarded the ever growing evidence that shows the product to be dangerous. If Bayer Healthcare is taking the same position in this new round of claims as in others, plaintiffs will be in for a long and protracted legal fight, with Bayer being an unwilling party to come to the table for any worthwhile discussions. To follow this emerging litigation see Mass Tort Nexus Essure Litigation Case No. 2:17-cv-04936-RBS.

Case Docket: U.S. District Court for the Eastern District of Pennsylvania case number 2:17-cv-04936-JP

 

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JOHNSON & JOHNSON ACCUSED OF WITNESS TAMPERING IN TWO DIFFERENT TRIALS CURRENTLY UNDERWAY

Does Win At Any Cost Apply to J&J Legal Strategy Even At Trial?

By Mark York (November 7, 2017)

 

 

 

 

 

(Mass Tort Nexus)  Federal Judge Edward Kinkeade has requested the US Attorneys Office and the Federal Bureau of Investigations (FBI) open an investigation and question witnesses regarding potential witness tampering in a currently underway DePuy Pinnacle hip implant trial. The trial is taking place in the US District Court of Texas in Dallas. The trial is the third bellwether trial in Multidistrict Litigation No. 2244, where thousands of plaintiffs have filed suit in the DePuy Orthopaedics MDL 2244 Pinnacle Hip Implant Litigation. The last trial resulted in a massive initial verdict of $1 billion, subsequently reduced by Judge Kinkeade to just over $500 million.

DePuy, a subsidiary of Johnson and Johnson, has been sued along with J&J for their metal-on-metal Pinnacle hip devices, due to the release of cobalt and chromium metals into a patient’s body, resulting in the onset of metallosis, pseudotumors, and other adverse medical conditions which require surgery to remove the defective device, as well as ongoing treatment to address the related side effects.

As to J&J’s alleged witness tampering, Judge Kinkeade stated the potential witness tampering was “disturbing and disconcerting to me”. The issue revolves around interaction between am upcoming trial witness Dr. David Shein and a sales representative for DePuy. Dr Shein claims that during a surgical procedure he was warned of business ramifications,  in connection with his planned appearance as a witness during the DePuy Pinnacle trial.

Lead plaintiff trial attorney Mark Lanier noted:

“It is extremely concerning to me when there are requirements under the federal law, as well as state law, that witnesses not be tampered with, that—that it’s a serious felony, that it involves prison time, that it cuts to the core of who we are as a people and what our courts are about”

In the other witness tampering allegation during a current trial, J&J subsidiary Janssen Pharmaceuticals is accused of interfering with a treating physician and witness in the just started Xarelto trial in the Philadelphia Court of Common Pleas, see XARELTO Case No. 2349 in Philadephia Court of Common Pleas – Complex Litigation (PA State Court). This trial is the first state court Xarelto trial, where plaintiff Lynn Hartman filed suit against Janssen and Bayer over claims that Xarelto caused a major gastrointestinal bleed. The trial start was delayed by word that a meeting took place between a key witness, Dr. Timothy Aldridge, the plaintiff’s treating physician, and a Janssen sales representative.

Hartman’s lawyers said that scheduled testimony from Dr. Aldridge had essentially changed from indicating that Hartman had suffered a gastrointestinal bleed complicated by Xarelto, to denying whether he knew Hartman had suffered from a gastrointestinal bleed and being hostile to Hartman’s attorney.

Janssen claimed the meeting was routine, but opposing counsel claims that this contact, as well as the DePuy Pinnacle trial witness contact show a pattern of interference and a willingness of Johnson & Johnson employees to attempt to influence legal proceedings in ways that are often consider illegal.

In unsuccessful legal maneuvering, J&J requested a gag order to prevent the public from knowing about the DePuy trial witness tampering issue, but the judge denied their request. Prior verdicts against DePuy for Pinnacle Hip Implant cases included jury awards of $1.4 billion and $498 million in the two prior bellwether trials. The Xarelto trial tampering issue is still being reviewed by the court.

 

 

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

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

By Mark A. York

Mass Tort Nexus (September 26, 2017)

 

 

 

 

 

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

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

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

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

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

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

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

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

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

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

 

 

 

 

 

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

TRANSCRIPT EXCERPTS

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

PLAINTIFF MOTIONS

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

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

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

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

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

FOURTH BELLWETHER TRIAL MOVED TO 2018

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

 

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