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rhodeislandcaraccidentatorney · 7 years ago

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Canadians may file individual Hernia Mesh Claims in United States - Hernia Mesh Recall Attorney | Individual Lawsuits

Control your own Ethicon PHYSIOMESH™ individual lawsuit with a hernia mesh attorney in the US rather than being marginalized in a Canadian Class Action.

David Slepkow's insight:

We are currently reviewing hernia mesh lawsuits for individuals who are interested in pursuing compensation, justice and accountability in the United States Federal Courts. The Ethicon Physiomesh™ Hernia Mesh lawsuits in the United States are individual lawsuits. These individual lawsuits in the United States are now multi district litigation (MDL) consolidated in the Northern District of Georgia in front of the Honorable Honorable Richard W. Story, “for coordinated or consolidated pretrial proceedings.” ***

Hernia mesh settlement 2017

In Canada, the Ethicon Physiomesh™ Flexible Composite Mesh litigation constitutes a class action. Many Canadian victims may be unaware of their potential right to utilize the Federal Courts in the United States to pursue justice and accountability as a result of defective hernia mesh.

Can Canadian Ethicon Physiomesh™ hernia mesh victims file a lawsuit in the United States of America (USA)? Certain Canadian citizens, who are victims, may be able to file a lawsuit in the United States.

Hernia mesh attorneys

We are not attorneys in Canada. If you need legal advice concerning the law in Canada related to the Canadian product liability class actions or the Ethicon Physiomesh Class Action, contact a Canada hernia mesh lawyer.

Hernia mesh settlement 2016

The author of this article is attorney David Slepkow. David Slepkow is an attorney licensed to practice in front of the United States Supreme Court. David is also a personal injury lawyer licensed to practice In Rhode Island and Providence Plantations as well as the Commonwealth of Massachusetts. David was a longtime member of the bar for The U.S. Federal Court, First Circuit, District of Rhode Island.

ETHICON PHYSIOMESH™ Hernia Mesh: Recall in Canada | Market removal in The United States

The laws in the United States and Canada are different as far as product liability and defective hernia mesh litigation is concerned. On May 25th, 2016, Health Canada recalled Ethicon Physiomesh™ Flexible Composite Mesh from the Canadian markets. Recall and Safety Alerts PHYSIOMESH FLEXIBLE COMPOSITE MESH (2016-05-25) “Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances” About Health Canada “According to our mission and vision, Health Canada’s goal is for Canada to be among the countries with the healthiest people in the world.” Id.

Canada Class Action

According to cbc, “Siskinds, a law firm from London, Ont., is applying to certify a class action lawsuit on behalf of Canadian patients who have had problems with Physiomesh™” cbc According to cbc, “What happens is, we allege, is that it triggers major complications” Id. “It moves, and then people have mesh that’s either pulled apart or moved, and isn’t doing the job it was put in to do.” Id.

“According to the class action’s statement of claim in Canada, the plaintiffs allege that there is a “design defect” in the Physiomesh™ that causes it to contract, tear, or migrate, leading to such injuries as perforations, abscess and adhesion formations, infections, and the need for further surgery.” CTV

“These Canadian victims assert that there were not properly warned of the dangers of the device.” Id.

According to CTV news, “The device at the center of the claims is Ethicon’s Physiomesh™ Hernia Mesh which Health Canada recalled in 2016. The Canadian agency’s action came after it learned that recurrence and reoperation rates with the device were higher than those of other meshes.” CTV NEWS, Canaadian news

Supreme Court of Canada: “Fair and efficient resolution”

The Supreme Court of Canada underscored the importance of Class actions in Canada stating: “While the class action has existed in one form or another for hundreds of years, its importance has increased of late. Particularly in complicated cases implicating the interests of many people, the class action may provide the best means of fair and efficient resolution.” Western Canadian Shopping Centres Inc. v. Dutton, [2001] 2 SCR 534, 2001 SCC 46 (CanLII), <http://canlii.ca/t/520c>, retrieved on 2017-06-10.

Some provinces in Canada have enacted comprehensive legislation related to class action causes of action “And in Canada, the provinces of British Columbia, Ontario, and Quebec have enacted comprehensive statutory schemes to govern class action practice: see British Columbia Class Proceedings Act, R.S.B.C. 1996, c. 50; Ontario Class Proceedings Act, 1992, S.O. 1992, c. 6; Quebec Code of Civil Procedure, R.S.Q., c. C-25, Book IX.” https://www.canlii.org/en/ca/scc/doc/2001/2001scc46/2001scc46.html

If there is no comprehensive legislation,” Absent comprehensive codes of class action procedure, provincial rules based on Rule 10, Schedule, of the English Supreme Court of Judicature Act, 1873 govern. Western Canadian Shopping Centres Inc. v. Dutton, [2001] 2 SCR 534, 2001 SCC 46 (CanLII) https://www.canlii.org/en/ca/scc/doc/2001/2001scc46/2001scc46.html

ETHICON Physiomesh™ hernia mesh used in Canada since 2010

Physiomesh™ Flexible Composite Mesh has been surgically implanted into patients in Canada since September 2010. CTV Some Canadian victims in Canada have filed a class action against Ethicon Inc. Ethicon is a subsidiary of Johnson and Johnson.

Victims across Canada

Victims across Canada including victim’s from: Toronto, Montreal, Vancouver, Ottawa, Calgary, Edmonton, Quebec City, Winnipeg, Halifax and Hamilton may find the Hernia Mesh lawsuit information in this blog helpful in making important decisions concerning their claim for compensation. There may be thousands of victims across the following provinces: Canada: Ontario, Quebec, British Columbia, Manitoba, Manitoba, Newfoundland and Labrador. Victims in Canada should consult with hernia mesh attorneys in the United States as well as Canadian Class action lawyers.

The 411 on the Canada Ethicon Physiomesh™ recall

“Starting date: May 25, 2016 | Posting date: June 13, 2016 | Type of communication:Medical Device Recall | Subcategory: Medical Device | Hazard classification: Type II | Source of recall: Health Canada | Issue: Medical Devices |Audience: General Public, Healthcare Professionals, Hospitals | Identification number: RA-58846” http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/58846r-eng.php

Ethicon’s Market removal in The United States

In the United States, on May 26th, 2016, Ethicon issued an “urgent” field safety notice concerning ETHICON PHYSIOMESH™ Flexible Composite Mesh (All Product Codes). Ethicon is a subsidiary of Johnson and Johnson. These product codes are: PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, PHY3050R. In that notice, Ethicon stated: “We have initiated a worldwide medical device removal of ETHICON PHYSIOMESH™ Flexible Composite Mesh (for laparoscopic use) (“ETHICON PHYSIOMESH™ Composite Mesh”).

The lawsuits in the United States are individual lawsuits that are part of Multi District Litigation

The Panel on Multi District Litigation in the United States (US) ordered that “IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside the Northern District of Georgia are transferred to the Northern District of Georgia and, with the consent of that court, assigned to the Honorable Richard W. Story for coordinated or consolidated pretrial proceedings. Transfer order

More in depth information about the United States Individual lawsuits

What is Physiomesh™Flexible Composite Mesh by Ethicon?

According to medline.com, “ETHICON PHYSIOMESH™ Flexible Composite Mesh is a sterile, low profile, flexible composite mesh designed for the repair of hernias and other fascial deficiencies. The mesh product is composed of a nonabsorbable, macroporous polypropylene mesh laminated between two polyglecaprone-25 films. An undyed polydioxanone film provides the bond between the polyglecaprone-25 film and polypropylene mesh. The polypropylene component is constructed of knitted filaments of extruded polypropylene. An additional dyed (D&C Violet No. 2) polydioxanone film marker has been added for orientation purposes.”http://www.medline.com/product/PHYSIOMESH-Flexible-Composite-Mesh-by-Ethicon/Z05-PF47325

Canadian citizens may be unaware of their rights to pursue justice in the United States’ Court system

Apparently, the vast majority of aggrieved Canadian Ethicon Physiomesh™ victims are not aware that they have the option of utilizing the United States Judicial system for compensation* “As Americans continue to file hernia mesh lawsuits, Canadians began their hernia mesh class action claiming they weren’t warned of the implant’s risks.” More info

In United States Ethicon Physiomesh™ claims are individual lawsuits , not class actions!

This is a very important distinction. These Ethicon Physiomesh™ in The U.S. are not a “class action” under United States law as defined by the Federal Rules of Civil Procedure, 28 U.S.C.A. § 23

We are reviewing potential cases of defective hernia mesh, made of non-absorbable polypropylene that may have caused injuries, including:

Ethicon Physiomesh™

Atrium C-QUR

Composix® Kugel® mesh patches (manufactured by C.R. Bard subsidiary Davol)

All C.R. Bard mesh patches made of Marlex polypropylene

Problems with class actions

Class actions can be very problematic since individual claimants do not have control over their own case. Individual claimants may not have control over a settlement. Lawinfo sets forth one of the main problems with class actions: “Lack of decision making control. Class action lawsuits are, by definition, representative rather than group litigation. That means that representatives of the affected class make the important litigation decisions – including when to settle. A plaintiff who is not a representative does not have a say in whether to settle or continue to litigation.” Lawinfo Resource

What is the purpose of a class action

“Class actions are a mechanism designed to provide access to the courts for claims that are too small to be prosecuted economically on their own,” said Robb, a partner in class actions at Siskinds LLP in London, Ont.” https://www.theglobeandmail.com/globe-investor/personal-finance/household-finances/thinking-of-joining-a-class-action-lawsuit-know-your-options/article19777681/

“Class actions lump together all those who might meet the stated criteria for the class. A certified action has two phases. A first phase sorts out the “common issues” for all the class members, and the second looks at the individual circumstances for each class member. So while class actions do eventually look at an individual’s situation, this doesn’t happen until much later in the case. That “common issues” phase can take a long, long time. The controversy is whether it’s fair, post certification, to make all class members wait until that common issues phase wraps up before individual class members can settle their own claims.” http://business.financialpost.com/legal-post/the-opt-out-option-controversy

Do I need to opt out of a Canadian class action?

Please consult with a Canadian class action hernia mesh lawyer whether you have to opt out of the class action. A Canada Ethicon Physiomesh™ hernia mesh attorney can explain your legal rights in Canada regarding whether you need to opt out of the Canadian Hernia mesh class action.

“Ontario is an “opt-out” jurisdiction. That means if a representative plaintiff succeeds in getting an action certified, potential members of the class are given a window of time during which they can declare that they want out. After this “opt-out” period expires, qualified members of the class action are in, whether they like it or not. Cue the Eagles … and welcome to the Hotel California.” Opt out info

“Canadian jurisdictions have adopted opt-out regimes subject to one exception to be discussed. The opt-out regime was adopted because of the widely held view that most class members are passive in the proceedings. Thus, to have an opt-in regime would have the effect of greatly diminishing the size of most classes in many instances because potential members would not take the necessary steps to have themselves included in the class or they might not have obtained actual notice at all. At the same time, opt-out regimes do permit class members who are actively opposed to the proceedings to exclude themselves if they are so inclined; few have done so. Class action

“Since the same witnesses and authorities will be relevant in each case, consolidating them makes sense. It also allows a Defendant to settle knowing that they will then not face individual claims later for the same thing. Once a class action is brought everyone who has a similar claim becomes a member of the class and subject to the findings in the class action lawsuit unless they specifically choose to opt out of the class action so they can bring their own claim.” http://adrworks.com/class-action-lawsuit/

Class actions in Canada

“Most class action claims settle and all settlements must be approved by the court and found to be in the best interests of the members of the class who are claiming. Individual class members may give input to the court when a settlement is proposed. This may include opposing the settlement especially if they would not benefit from it or if they believe the compensation is not adequate. Once a settlement is approved by the court people who are entitled then file claims which are assessed by a claims administrator in accordance with the settlement agreement. Once all claims are assessed it can be determined how much any person will receive as compensation. It may still take a long time from settlement to payment as many of our clients have experienced with the Vioxx case which settled with an agreement in January 2012, with court approval given in September 2012 and claims still being assessed almost to the end of 2015. Payment of those claims is now expected early in 2016.” http://adrworks.com/class-action-lawsuit/

Referring to transvaginal tape litigation, “Matthew Baer, a lawyer with the Siskinds Law firm in Ontario tells MDND they don’t have Multidistrict litigation in Canada, instead a person can file an individual claim or join a class action. In Canada, we file on behalf of one person and get that certified as it applies to everyone else. The individual issues will be sorted out down the road. It can take two years to be certified and we don’t get access to discovery until the case is certified. It is only after the class is certified that a Canadian law firm can move ahead on discovery getting documents from the other side. As the case proceeds individual are brought forward to represent the class like a mini-trial.” http://www.meshmedicaldevicenewsdesk.com/canadian-courts-take-aim-at-ethicon/

What are the complications

According to CLG.org, “The alleged injuries, conditions and complications suffered due to hernia mesh products include, but are not limited to:

– Hernia recurrence – Chronic pain – Mesh contraction – Mesh migration – Scarring – Adhesions – Infection and abscess formation – Pain with sex – Testicle removal – Bleeding – Intestinal blockage – Fistulas – Hematomas – Seromas – Liver abnormalities – Perforations – Bowel obstructions – Dental problems – Autoimmune disorders” https://www.clg.org/Class-Action/List-of-Class-Actions/Hernia-Mesh-Injury-Canadian-Class-Action

*** The U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all Ethicon Psyiomesh hernia mesh causes of action are transferred to the Northern District of Georgia. “IT IS THEREFORE ORDERED that the actions listed on Schedule A and pending outside the Northern District of Georgia are transferred to the Northern District of Georgia and, with the consent of that court, assigned to the Honorable Richard W. Story for coordinated or consolidated pretrial proceedings.” Transfer order

The Court reasoned that “We are also not persuaded that informal coordination is a practicable solution here. Almost 70 actions are pending in 36 district courts, and dozens of law firms are involved in this litigation. Section 1407 centralization will place all actions before one judge who can structure pretrial proceedings to enhance efficiency and more effectively minimize overlap.” Id. ” Centralization will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel, and the judiciary.” Id.

ATTORNEY DAVID SLEPKOW AT SLEPKOW SLEPKOW & ASSOCIATES INC., ESTABLISHED IN 1932, IS RESPONSIBLE FOR THE CONTENT OF THIS WEBSITE. SS &A’ S PRINCIPAL OFFICE IS LOCATED AT: 1481 WAMPANOAG TRAIL EAST PROVIDENCE RI. CLIENTS WILL BE NOT ACCEPTED IN THOSE STATES IN WHICH STATE BAR RULES DO NOT ALLOW. DAVID IS LICENSED TO PRACTICE LAW IN RHODE ISLAND AND PROVIDENCE PLANTATIONS, THE COMMONWEALTH OF MASSACHUSETTS AND THE UNITED STATES SUPREME COURT. DAVID SLEPKOW WAS A LONGTIME MEMBER OF THE FEDERAL COURT FIRST CIRCUIT DISTRICT OF RI. THE HIRING OF AN LICENSED ATTORNEY IS A VERY CRUCIAL DECISION FOR A CLIENT. THIS IMPORTANT DECISION SHOULD NOT BE SOLELY MADE BASED ON ADVERTISING OR ON A WEBSITE. THIS WEBSITE IS NOT INTENDED TO BE AN ADVERTISEMENT OR SOLICITATION. INFORMATION, ARTICLES, CONTENT AND OPINIONS ON THIS WEBSITE AND BLOG IS FOR GENERAL INFORMATION ONLY AND DOES NOT CONSTITUTE LEGAL ADVICE OR SOLICITATION OF LEGAL SERVICES. INFORMATION FROM THIS SITE OR IT’S TRANSMISSION IS NOT INTENDED TO CREATE AN ATTORNEY CLIENT RELATIONSHIP.

THE RECEIPT OF SUCH HERNIA MESH INFORMATION DOES NOT CONSTITUTE, AN ATTORNEY-CLIENT RELATIONSHIP BETWEEN SLEPKOW SLEPKOW & ASSOCIATES INC. AND THE READER OR VISITOR. IN THE EVENT THAT ANY INFORMATION ON THIS WEBSITE DOES NOT FULLY CONFORM TO REGULATIONS, LAWS OR CASE LAW IN ANY JURISDICTION, THIS LAW FIRM WILL NOT ACCEPT SUCH CLIENTS.. IN CERTAIN STATES THIS HERNIA MESH ATTORNEY BLOG MAY BE DEEMED ATTORNEY ADVERTISING. WE AT SLEPKOW SLEPKOW ASSOCIATE’S INC..HAVE MADE EVERY EFFORT TO COMPLY WITH ALL ADVERTISING LAWS AND RULES. THE RHODE ISLAND SUPREME COURT LICENSES ALL LAWYERS AND ATTORNEYS IN THE GENERAL PRACTICE OF LAW, BUT DOES NOT LICENSE OR CERTIFY ANY LAWYER / ATTORNEY AS AN EXPERT OR SPECIALIST IN ANY FIELD OF PRACTICE. WHILE THIS FIRM MAINTAINS JOINT RESPONSIBILITY, MOST CASES OF THIS TYPE ARE REFERRED TO OTHER ATTORNEYS FOR PRINCIPLE RESPONSIBILITY. David Slepkow is not licensed to practice law in Canada. This website does not constitute legal advice in Canada. David Slepkow is not an Ethicon Physiomesh™ Class Action lawyer in Canada.

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lindamcsherry · 7 years ago

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Hernia Mesh Infection Lawsuit Alleges Ethicon Physiomesh Defectively Designed

Problems with the design of Ethicon Physiomesh used during a hernia repair allegedly caused a South Carolina man to require additional surgery to remove the mesh after it became infected, according to a product liability lawsuit filed last week against the manufacturers.

The complaint (PDF) was filed by Larry Slice in the U.S. District Court for the District of South Carolina on July 6, indicating that Johnson & Johnson and its Ethicon subsidiary sold a defectively designed and manufactured hernia mesh product, which was not safe for its intended purpose.

Slice had a 15cm by 20cm Physiomesh patch implanted for hernia repair in December 2013. However, due to an infection following surgery, he required revision surgery to remove the patch in August 2016.

The lawsuit indicates that a multi-layered film which covers Ethicon Physiomesh patch was one of the main reasons for the hernia mesh infection.

“When affixed to the body’s tissue, the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation and other complications,” Slice’s complaint states. “The multi-layer coating provides a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”

In June 2016, Ethicon recalled Physiomesh products from the market worldwide, due to a high rate of problems and revisions among individuals who had the patch implanted, since the manufacturer was unable to identify or correct the underlying cause of the complications.

Although the action was classified as a “market withdrawal” in the United States, Ethicon asked hospitals to return all unused implants and indicated that it does not intend to return the product to the market.

Given the similar questions of fact and law presented in dozens of Ethicon Physiomesh lawsuits pending throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) decided to establish coordinated pretrial proceedings in the federal court system last month, transferring all cases filed nationwide to U.S. District Judge Richard Story in the Northern District of Georgia to reduce duplicative discovery, avoid contradictory pretrial rulings and to serve the convenience of the parties, witnesses and the courts.

As hernia mesh lawyers continuing to review and file additional lawsuits in the coming weeks and months, it is expected that several thousand complaints will be included in the MDL proceedings.

The post Hernia Mesh Infection Lawsuit Alleges Ethicon Physiomesh Defectively Designed appeared first on AboutLawsuits.com.

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cassandradodds · 7 years ago

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Xarelto Fatal Bleeding Lawsuit Goes to Trial in New Orleans

Janssen, Bayer Face Xarelto Wrongful Death Claim

Johnson & Johnson’s Janssen unit and Bayer are facing a Xarelto wrongful death claim in New Orleans. Like other Xarelto bleeding claims, the plaintiffs allege that the anticoagulant caused uncontrollable bleeding. J&J and Bayer are accused of failing to disclose the risks, including the lack of an antidote. Xarelto lawsuits allege gastrointestinal and brain hemorrhaging.

Parker Waichman LLP is a national personal injury law firm that represents numerous clients in drug injury lawsuits. The firm continues to offer free legal consultations to anyone with questions about filing a Xarelto lawsuit.

According to FiercePharma, this is the second Xarelto bellwether case going to trial. Jurors found for Bayer and Janssen in the first trial. The current lawsuit being tried is a wrongful death claim brought by a widower and children of a woman who died after taking Xarelto. The decedent was a 67-year-old grandmother who suffered a fatal brain hemorrhage in May 2015.

Bellwether cases are considered test cases in a mass tort because they are the first to go to trial. Plaintiffs selected as bellwether cases are typically representative of most of the litigation. The outcome of bellwether trials is used to predict how most of the litigation would proceed.

Jurors were told that the woman’s death was “completely avoidable,” FiercePharma reports. Plaintiff’s attorneys said that drug makers hid the risks of the blood thinner, omitting crucial safety information. The plaintiffs allege that she would not have taken the drug if Bayer and Janssen adequately disclosed the risks.

According to the U.S. District Court for the Eastern District of Louisiana’s website, the third Xarelto bellwether trial is slated for early August.

In a recent quarterly filing, Johnson & Johnson disclosed that it is facing about 18,400 Xarelto bleeding lawsuits. Simultaneously, the filing shows that J&J is also facing roughly 3,900 talcum powder lawsuits alleging ovarian cancer.

Xarelto bleeding injury lawsuits are consolidated in the Eastern District of Louisiana as part of a federal multidistrict litigation (MDL). The U.S. Judicial Panel on Multidistrict Litigation (JPML) creates MDLs when there are a significant number of lawsuits sharing common factual allegations. Consolidating these similar cases together in one court before one judge makes complex litigation move along faster and more efficiently because it streamlines the legal process and eliminates the need for duplicate discovery.

Plaintiffs in the Xarelto MDL similarly allege that the anticoagulant caused uncontrollable bleeding, such as gastrointestinal or brain hemorrhaging. Suits allege drug makers aggressively promoted Xarelto while failing to disclose the risks.

One lawsuit was recently filed on behalf of a New York man who suffered an acute gastrointestinal bleed. He took Xarelto between April and August 2016 to prevent stroke and heart attack related to atrial fibrillation, the complaint states. The suit was filed into the MDL. The plaintiff is suing on multiple counts, including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express and implied warranties, negligent misrepresentation, and fraud.

Lawsuits filed over Xarelto bleeding injuries seek damages for economic losses, including medical bills and lost wages, in addition to physical, mental and emotional pain and suffering.

The Journal of the American Medical Association (JAMA) Internal Medicine published a recent study suggesting that Xarelto is linked to higher rates of brain bleeding compared to Pradaxa, another new generation anticoagulant. Researchers found that Xarelto “was associated with significantly increased intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding, and nonsignificantly reduced risk of thromboembolic stroke and increased risk of mortality. The absolute increase in intracranial hemorrhage with rivaroxaban treatment exceeded its reduced rate of thromboembolic stroke.”

Xarelto Lawsuit Background

Xarelto (generic: rivaroxaban) was approved in 2011; it is among a class of drugs known as New Oral Anticoagulants (NOAC). Other NOACs include Pradaxa, which was the first to be released in 2010, and Eliquis.

NOACs are anticoagulants. As such, they are used to prevent the formation of blood clots and reduce the risk of blood clot complications, such as stroke and heart attack in patients with atrial fibrillation, deep vein thrombosis, and patients undergoing knee or hip replacement surgery. Deep vein thrombosis is a condition where a blood clot gets stuck in one of the deep veins, usually the legs. If the clot breaks free, it can lead to a life-threatening complication known as pulmonary embolism, where a clot gets stuck in the lungs.

Atrial fibrillation is an abnormal heart rhythm that increases the risk of a blood clot.

Prior to drugs like Xarelto, warfarin was the main anticoagulant medication prescribed to patients.

Warfarin is sold under the brand name Coumadin. It has been on the market for decades, but requires regular blood monitoring and dietary restrictions. Plaintiffs note that while Xarelto and other NOACs do not have these limitations, there is no antidote to reverse bleeding if it begins. Lawsuits allege drug makers marketed the benefits while failing to disclose the lack of a reversal agent, leading to uncontrollable bleeding.

There is some risk of bleeding with all blood thinners. Patients take these medications when healthcare professionals have determined that the benefits outweigh the risks due to their condition. While anticoagulants are necessary to prevent a life-threatening blood clot, it is also sometimes necessary to reverse these effects, such as during an emergency situation.

If a patient taking warfarin suddenly suffers from gastrointestinal bleeding, doctors have a reversal agent to counteract the anticoagulant and stop the bleeding. With Xarelto and Eliquis, there is no such antidote. Pradaxa initially also lacked a reversal agent, but the FDA approved an antidote in 2015.

Xarelto lawsuits allege that drug makers should have warned patients and their physicians about the lack of an antidote, which implies a risk of uncontrollable bleeding. Plaintiffs allege that, by failing to inform about this fact, manufacturers prevented patients and their healthcare professionals from making a fully informed decision. Lawsuits allege that plaintiffs would not have taken Xarelto if they were fully informed of the risks.

Parker Waichman notes that similar lawsuits have been filed over Pradaxa and Eliquis. In 2014, Boehringer Ingelheim settled Pradaxa lawsuits on the eve of trial for $650 million.

Filing a Xarelto Lawsuit

If you or someone you know suffered uncontrollable bleeding related to the use of Xarelto, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/xarelto-fatal-bleeding-lawsuit-goes-trial-new-orleans/

from WordPress https://parkerwaichman.wordpress.com/2017/06/09/xarelto-fatal-bleeding-lawsuit-goes-to-trial-in-new-orleans/

#Xarelto Fatal Bleeding Lawsuit Goes to Trial in New Orleans

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parkerwaichmanlaw · 7 years ago

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Xarelto Fatal Bleeding Lawsuit Goes to Trial in New Orleans

Janssen, Bayer Face Xarelto Wrongful Death Claim

According to the U.S. District Court for the Eastern District of Louisiana’s website, the third Xarelto bellwether trial is slated for early August.

Lawsuits filed over Xarelto bleeding injuries seek damages for economic losses, including medical bills and lost wages, in addition to physical, mental and emotional pain and suffering.

Xarelto Lawsuit Background

Atrial fibrillation is an abnormal heart rhythm that increases the risk of a blood clot.

Prior to drugs like Xarelto, warfarin was the main anticoagulant medication prescribed to patients.

Parker Waichman notes that similar lawsuits have been filed over Pradaxa and Eliquis. In 2014, Boehringer Ingelheim settled Pradaxa lawsuits on the eve of trial for $650 million.

Filing a Xarelto Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/xarelto-fatal-bleeding-lawsuit-goes-trial-new-orleans/

#Xarelto Fatal Bleeding Lawsuit Goes to Trial in New Orleans

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cassandradodds · 8 years ago

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New Xarelto Lawsuit Alleges Acute Gastrointestinal Bleeding

New York Man Sues Janssen over Xarelto Gastrointestinal Bleed

Johnson & Johnson’s Janssen unit is facing a new lawsuit over its anticoagulant Xarelto. The suit was filed on behalf of a New York man who suffered an acute gastrointestinal bleed, allegedly due to Xarelto side effects. The plaintiff, like others suing over Xarelto bleeding injuries, alleges that Janssen failed to adequately warn patients and their physicians about the risks of Xarelto.

Xarelto is an anticoagulant, used to reduce to the risk of blood clots and related complications, such as stroke and heart attack in certain patients. According to the complaint, the plaintiff took Xarelto between April and August 2016 to prevent stroke and heart attack related to atrial fibrillation. Patients with atrial fibrillation have an abnormal heart rhythm that is associated with an increased risk of blood clots.

The plaintiff states that, after only a few months of taking Xarelto, he was hospitalized for acute gastrointestinal bleeding. He stayed in the hospital due to Xarelto bleeding injuries for several days, where physicians told him to discontinue the medication.

According to court records, the Xarelto lawsuit was filed in the U.S. District Court for the Eastern District of Louisiana. The plaintiff is suing on multiple counts, including strict liability, manufacturing defect, design defect, failure to warn, negligence, breach of express and implied warranties, negligent misrepresentation, and fraud.

Parker Waichman notes that there are over 16,000 Xarelto bleeding injury lawsuits pending in the Eastern District of Louisiana as part of a federal multidistrict litigation (MDL). The U.S. Judicial Panel on Multidistrict Litigation (JPML) creates MDLs when there are a significant number of lawsuits sharing common factual allegations. Consolidating these similar cases together in one court before one judge makes complex litigation move along faster and more efficiently because it streamlines the legal process and eliminates the need for duplicate discovery.

In the Xarelto MDL, plaintiffs allege that the blood thinner caused bleeding injuries and that Bayer and Janssen failed to warn of the risks. In particular, lawsuits allege that the drug makers failed to warn about the lack of an antidote to reverse the drug’s blood-thinning effects. Some lawsuits are wrongful death claims filed on behalf of users who suffered fatal bleeding after taking Xarelto. Xarelto plaintiffs are seeking damages for economic losses, including medical bills and lost wages, in addition to physical, mental and emotional pain and suffering.

A recent study published in the Journal of the American Medical Association (JAMA) Internal Medicine found that Xarelto was associated with higher rates of brain bleeding compared to Pradaxa. Researchers found that Xarelto “was associated with significantly increased intracranial hemorrhage and major extracranial bleeding, including major gastrointestinal bleeding, and nonsignificantly reduced risk of thromboembolic stroke and increased risk of mortality. The absolute increase in intracranial hemorrhage with rivaroxaban treatment exceeded its reduced rate of thromboembolic stroke.”

Xarelto Lawsuit Background

The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011. The drug is used to prevent blood clot, stroke and heart attack in patients with atrial fibrillation, deep vein thrombosis, and patients undergoing knee or hip replacement surgery. Deep vein thrombosis is a condition where a blood clot gets stuck in one of the deep veins, usually the legs. If the clot breaks free, it can lead to a life-threatening complication known pulmonary embolism, where a clot gets stuck in the lungs.

The generic name for Xarelto is rivaroxaban. It is part of a class of drugs known as New Oral Anticoagulants (NOAC); Pradaxa and Eliquis also fall into this category. Pradaxa, approved in 2010, was the first to be introduced. Before these medications were released, warfarin was the main anticoagulant medication prescribed to patients.

Warfarin is sold under the brand name Coumadin. It has been on the market for decades for preventing blood clots. When Xarelto and other NOACs were introduced, drug makers touted the fact that these new drugs came with fewer limitations. Unlike warfarin users, patients taking Xarelto do not need to undergo regular blood testing to make sure medication levels are within therapeutic range in the blood. Xarelto, Pradaxa and Eliquis also do not require patients to adhere to certain dietary restrictions.

However, plaintiffs suing over bleeding injuries with Xarelto allege that drug makers failed to warn about the lack of an antidote, or reversal agent. All blood thinners carry some increased risk of bleeding; but in certain patients, healthcare professionals have determined that the benefits outweigh the risks due to their condition. While anticoagulants are necessary to prevent a life-threatening blood clot, it is also sometimes necessary to reverse these effects, such as during an emergency situation.

Similar lawsuits have been filed over Pradaxa and Eliquis. In 2014, Boehringer Ingelheim settled Pradaxa lawsuits on the eve of trial for $650 million. According to legal experts, plaintiffs in the Xarelto litigation are hoping for a similar outcome.

Filing a Xarelto Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/new-xarelto-lawsuit-alleges-acute-gastrointestinal-bleeding/

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#New Xarelto Lawsuit Alleges Acute Gastrointestinal Bleeding

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parkerwaichmanlaw · 8 years ago

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New Xarelto Lawsuit Alleges Acute Gastrointestinal Bleeding

New York Man Sues Janssen over Xarelto Gastrointestinal Bleed

Xarelto Lawsuit Background

Filing a Xarelto Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/new-xarelto-lawsuit-alleges-acute-gastrointestinal-bleeding/

#New Xarelto Lawsuit Alleges Acute Gastrointestinal Bleeding

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cassandradodds · 8 years ago

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Xarelto Lawsuit Alleges Blood Thinner Caused Internal Bleeding

Lawsuit Alleges Bayer, J&J Failed to Warn of Xarelto Bleeding Risk

Bayer and Johnson & Johnson’s Janssen unit continue to face Xarelto bleeding injury lawsuits. Plaintiffs in the litigation suffered bleeding complications, such as gastrointestinal bleeding or brain hemorrhaging, allegedly due to Xarelto side effects. Lawsuits allege that drug makers failed to adequately warn patients and physicians about this risk. Xarelto bleeding injury claims have been consolidated into a federal multidistrict litigation (MDL).

Court records indicate that a new Xarelto lawsuit was filed on behalf of an Arkansas woman who started taking the anticoagulant in April 2015. According to the complaint, she took the medication as directed. On Jul. 4, 2016, the plaintiff was hospitalized with life-threatening internal bleeding, allegedly due to taking Xarelto.

The plaintiff alleges that Bayer and Janssen failed to warn about the risk of life-threatening bleeding with Xarelto. The suit contends she would not have taken the anticoagulant if she were fully informed of the risks.

Parker Waichman notes that Xarelto makers are facing a growing number of product liability lawsuits in the Xarelto MDL. According to court documents, the MDL contains over 13,000 lawsuits alleging the anticoagulant caused bleeding injuries. Cases are consolidated in the U.S. District Court for the Eastern District of Louisiana.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the Xarelto MDL in December 2014. MDLs are created when there are a growing number of lawsuits with common questions of fact. When cases are consolidated into an MDL, it means they are all transferred to one court before one judge. The goal is to make the litigation proceed faster and more efficiently. Certain pre-trial processes, such as the discovery phase, can take place once and apply to all cases.

Plaintiffs in the litigation similarly allege that Xarelto caused bleeding injuries and that drug makers failed to warn about the risks. Specifically, Janssen and Bayer allegedly marketed Xarelto as superior to other drugs while failing to warn that it lacks an antidote.

Another recent Xarelto lawsuit was filed on behalf of a Wisconsin man whose wife died, allegedly due to Xarelto bleeding complications. The wrongful death lawsuit alleges that Xarelto manufacturers were liable for “negligent and wrongful conduct in connection with the design, development, manufacture, testing, packaging, promoting, marketing, advertising, distribution, labeling, and/or sale of the pharmaceutical drug Xarelto.”

Lack of Reversal Agent, Antidote with Xarelto

Xarelto is part of a new generation of blood thinners, alongside Pradaxa and Eliquis. The first of these to emerge was Pradaxa, which was approved in 2010. Xarelto was approved in 2011. Before these anticoagulants hit the market, warfarin was the main form of treatment to prevent blood clots and stroke in patients with atrial fibrillation. Patients with this condition have an abnormal heart rhythm that increases the risk of a blood clot.

Xarelto is also prescribed to prevent blood clots, stroke and heart attack in patients with deep vein thrombosis and in patients undergoing a knee or hip replacement surgery. Deep vein thrombosis is when a blood clot forms in one of the deep veins, usually the legs. If a piece of the clot breaks off, it can get stuck in the lungs and cause a life-threatening condition known as pulmonary embolism. These conditions frequently occur together, and are collectively referred to as venous thromboembolism.

Compared to Xarelto, Pradaxa and Eliquis, warfarin is a much older drug. It is an effective anticoagulant, but it also requires patients to undergo regular blood monitoring and adhere to certain dietary restrictions. Newer medications do not have these limitations. One caveat, however, is the lack of an antidote to reverse the drug’s blood-thinning effects. This means that doctors do not have an effective way to stop irreversible bleeding that occurs in patients taking Xarelto or Eliquis (a Pradaxa reversal agent was approved in 2015). However, warfarin can be reversed with vitamin K.

Plaintiffs in the Xarelto litigation allege that Bayer and Janssen failed to warn patients and the medical community about the lack of a reversal agent.

Xarelto plaintiffs also question the integrity of clinical data in the ROCKET AF study, which was used to approve Xarelto. Plaintiffs claim that the data did not accurately compare the risks of warfarin to Xarelto. During the trials, a now-recalled device was used to measure how fast a patient’s blood is clotting.

The device, the Alere INRatio and INRatio2, were recalled in 2014 and withdrawn in 2016. The recall was initiated because the device may give inaccurately low readings. “The Alere INRatio Monitor System (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips) may provide an INR result that is lower than expected result obtained using a laboratory INR method,” according to the recall alert. “Incorrect results can also occur if a patient has certain medical conditions. These conditions include, anemia, conditions associated with elevated fibrinogen levels, or unusual bleeding or bruising. Incorrect results can also occur if the instructions in the labeling for performing the test are not followed.”

The recall was labeled as Class I by the FDA, indicating that exposure to the recalled device can lead to serious injury or death. Questions have been raised about whether the recalled devices could have inadvertently skewed data to favor Xarelto over warfarin.

The Xarelto warning label was updated in 2014 to disclose the lack of an antidote. “Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement,” the revised section states.

Parker Waichman notes that similar product liability lawsuits have also been filed over Pradaxa and Eliquis. Boehringer Ingelheim settled Pradaxa lawsuits on the eve of trial for $650 million.

Filing a Xarelto Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/xarelto-lawsuit-alleges-blood-thinner-caused-internal-bleeding/

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#Xarelto Lawsuit Alleges Blood Thinner Caused Internal Bleeding

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parkerwaichmanlaw · 8 years ago

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Xarelto Lawsuit Alleges Blood Thinner Caused Internal Bleeding

Lawsuit Alleges Bayer, J&J Failed to Warn of Xarelto Bleeding Risk

Lack of Reversal Agent, Antidote with Xarelto

Plaintiffs in the Xarelto litigation allege that Bayer and Janssen failed to warn patients and the medical community about the lack of a reversal agent.

Parker Waichman notes that similar product liability lawsuits have also been filed over Pradaxa and Eliquis. Boehringer Ingelheim settled Pradaxa lawsuits on the eve of trial for $650 million.

Filing a Xarelto Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/xarelto-lawsuit-alleges-blood-thinner-caused-internal-bleeding/

#Xarelto Lawsuit Alleges Blood Thinner Caused Internal Bleeding

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cassandradodds · 8 years ago

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Emails Show Monsanto Conspired to Ghostwrite Glyphosate Studies

In Monsanto Roundup Litigation, Unsealed Court Documents Raise Questions

Newly unsealed court documents show that Monsanto colluded to ghostwrite studies on glyphosate, the main active ingredient in the company’s Roundup herbicide. Court documents also indicate that a high-ranking official at the U.S. Environmental Protection Agency (EPA) may have played a questionable role in preventing a government review of glyphosate. Monsanto continues to face lawsuits alleging that its Roundup herbicide caused cancer, specifically non-Hodgkin’s lymphoma.

The personal injury attorneys at Parker Waichman LLP are closely monitoring events in the Monsanto Roundup herbicide litigation. The firm, which has decades of experience representing clients in lawsuits over environmental health risks, continues to offer free legal consultations to individuals with questions about filing a Roundup lawsuit.

Prior to a regulatory hearing on the safety of glyphosate, Monsanto searched for studies showing that the ingredient is safe for human use. In an email dated Feb. 19, 2015, Monsanto executive William “Bill” Heydens suggested that company employees ghostwrite the studies to save on cost. “…we would be keeping the cost down by us doing the writing and they would just edit & sign their names so to speak,” he wrote. Heyden, who is the Regulatory Product Safety Assessment Lead, references another instance where the company used this approach for a study published in 2000.

The U.S. Public Interest Research Group (PIRG), a consumer advocacy group, commented on these documents in a Mar. 15, 2017 press release. “Monsanto tells us that Roundup is safe because scientists say it is safe. But apparently scientists sign their names, while Monsanto signs the checks,” said U.S. PIRG Toxics Director Kara Cook-Schultz. “This calls into question multiple studies written, or possibly ghostwritten, by agricultural scientists.” The email correspondence also suggests that Monsanto regularly collaborates with other chemical companies to publish scientific papers.

U.S. PIRG is advocating to ban Roundup until data can show that the chemical is safe. “Recent studies from the World Health Organization have linked the chemicals in Monsanto’s weedkiller Roundup to serious health risks. And yet, nearly 250 million pounds of glyphosate-based herbicides like Roundup are used on U.S. farms each year,” the group states on its website.

The emails were unsealed as part of a federal multidistrict litigation (MDL) underway in the U.S. District Court, Northern District of California.

Other unsealed documents are also raising questions. Emails suggest that retired EPA official Jess Rowland helped stop the Agency for Toxic Substances and Disease Registry (ATSDR) from reviewing glyphosate. In an email dated Apr. 28, 2015, Monsanto Regulatory Affairs lead Dan Jenkins recounts Rowland saying something along the lines of “If I can kill this I should get a medal,” referring to the government glyphosate investigation.

U.S. District Judge Vince Chhabria has indicated he plans to have Rowland testify in the Roundup cancer litigation against Monsanto. “My reaction is when you consider the relevance of the EPA’s reports, and you consider their relevance to this litigation, it seems appropriate to take Jess Rowland’s deposition,” he said at a hearing in San Francisco.

The International Agency for Research on Cancer (IARC), a branch of the World Health Organization (WHO), declared glyphosate a probable carcinogen in 2015. Court records suggest that, in addition to blocking a glyphosate review, Rowland informed Monsanto of the review ahead of time, giving the company adequate time to strategize their defense.

What is Medical Ghostwriting?

When a medical study is ghostwritten, it usually means that someone (a corporate employee or a medical communications company, for example) wrote the content and an academic then signs off on the paper. According to the nonpartisan watchdog group Project on Government Oversight (POGO), the scientist sometimes only makes minor adjustments to the ghostwritten content.

POGO notes that medical ghostwriting is unethical because there is a clear conflict of interest. Pharmaceutical companies are paying for studies to be written, when these papers are supposed to be based on independent science alone. When drug makers ghostwrite studies, it can misrepresent the safety and efficacy of a drug to patients and their healthcare providers. The context of an academic paper can be read differently if readers are aware that the original author was a pharmaceutical employee, for instance.

Dr. Francis Collins, director of the National Institutes of Health, wrote in a letter to POGO that medical ghostwriting may be considered plagiarism in some cases. “[A] case of ghostwriting involving NIH-funded researchers may be appropriate for consideration as a case of plagiarism; i.e., the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit; or fabrication, i.e., making up data or results and recording or reporting them,” he wrote to POGO.

Monsanto Roundup Cancer Litigation Moves Forward

Parker Waichman notes that litigation continues to mount against Monsanto alleging that its Roundup herbicide causes cancer. Judge Chhabria is overseeing the Roundup MDL in California. The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidates federal lawsuits into an MDL when there are a growing number of lawsuits with common questions of fact.

Transferring similar cases into an MDL makes complex litigation proceed more quickly and efficiently. Similar cases are transferred to one court before one judge, eliminating the need to duplicate pretrial proceedings. In the Roundup MDL, plaintiffs allege that the weed killer caused non-Hodgkin’s lymphoma and that Monsanto failed to warn about the risks.

After the IARC released its glyphosate report, California announced plans to list glyphosate as a carcinogen under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65 (Prop 65). In response, Monsanto filed a lawsuit against the State of California’s Office of Environmental Health Hazard Assessment (OEHHA) alleging that the cancer listing invoked several constitutional violations. The California Superior Court however, disagreed and sided with the state.

Filing a Monsanto Roundup Herbicide Lawsuit

Parker Waichman has spent years representing clients in lawsuits over alleged environmental health risks. If you or someone you know is interested in filing a Monsanto Roundup Herbicide lawsuit, speak with one of our environmental attorneys today. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).

from Parker Waichman http://www.yourlawyer.com/blog/emails-show-monsanto-conspired-ghostwrite-glyphosate-studies/

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#Emails Show Monsanto Conspired to Ghostwrite Glyphosate Studies

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parkerwaichmanlaw · 8 years ago

Text

Emails Show Monsanto Conspired to Ghostwrite Glyphosate Studies

In Monsanto Roundup Litigation, Unsealed Court Documents Raise Questions

The emails were unsealed as part of a federal multidistrict litigation (MDL) underway in the U.S. District Court, Northern District of California.

What is Medical Ghostwriting?

Monsanto Roundup Cancer Litigation Moves Forward

Filing a Monsanto Roundup Herbicide Lawsuit

from Parker Waichman http://www.yourlawyer.com/blog/emails-show-monsanto-conspired-ghostwrite-glyphosate-studies/

#Emails Show Monsanto Conspired to Ghostwrite Glyphosate Studies

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