Xarelto Settlement Not So Fast Gentlemen

Those Aggrieved by the Proposed Xarelto Settlement

May Still Get a Chance to be Heard

Thus far firms representing absent plaintiffs (those not represented by leadership) have yet to be given an opportunity to be heard by the court regarding any aspect of the proposed Xarelto settlement.  I previously addressed this issue in another article.

https://www.masstortnexus.com/mass-torts-news/xarelto-settlement-judicial-activism-vs-judicial-tyranny/

Due Process Refresher 

The Fifth and Fourteenth Amendments to the United States Constitution each contain a due process clause. Due process deals with the administration of justice and thus the due process clause acts as a safeguard from arbitrary denial of life, liberty, or property by the government outside the sanction of law. The Supreme Court of the United States interprets the clauses broadly, concluding that these clauses provide four protections: procedural due process (in civil and criminal proceedings), substantive due process.

The core of these requirements is notice and a hearing before an impartial tribunal.

Fuentes v. Shevin, 407 U.S. 67, 81 (1972). At times, the Court has also stressed the dignitary importance of procedural rights, the worth of being able to defend one’s interests even if one cannot change the result.

Mathews v. Eldridge, 424 U.S. 319, 333 (1976). “Parties whose rights are to be affected are entitled to be heard.” Baldwin v. Hale, 68 U.S. (1 Wall.) 223, 233 (1863).

Picking Up Where We Left Off

Without Regard to the points made in the prior article, even if the proposed Xarelto settlement agreement reaches the required participation numbers, it should not be a done deal. For Judge Fallon to grant specific common benefit fee requests, it will arguably be necessary to form a “Settlement Class Action” under FRCP 23. Once this occurs, his honor will not have the option of ignoring FRCP 23(e), the requirement to conduct fairness hearings before final approval of the settlement. This will be the time at which firms representing absent plaintiffs may get their chance to be heard and I believe these firms will have much to say.

If Judge Fallon allows the proposed Xarelto settlement to impact plaintiffs, without ever having engaged in any act to protect the rights of absent parties, this egregious failure may well define his legacy, overshadowing and otherwise admirable judicial career.

Note: Nothing would prevent a firm representing a non-settling client from moving to form a Class Action for non-settling plaintiffs, aggrieved by the settlement.

Due to the fact that the proposed Xarelto Settlement did not follow the “opt in” reasoning (see article by Judge Fallon below), the only way the necessity of creating a settlement class could be avoided would be if 100% of all Xarelto plaintiffs accepted the settlement. Even under this circumstance, jurisdictional issues would still exist. I will address this subject more thoroughly later in this article.  First, I will cover recent developments.

Latest Spin on the Xarelto Settlement

I have learned that leadership claims that 26,000 enrollment packages have been received by Brown Greer and they are very confident that they will reach 98% participation. MTN can not verify leaderships statements with Brown Greer as they seem to have been gagged by leadership. Regardless, the proposed settlement only covered 25,000 plaintiffs. The total number of complaints on file in the MDL and Philadelphia Court of Common Pleas has ballooned to over 31,339 plaintiffs since the proposed settlement was first announced. The foregoing begs the question “98% of what”.  26,000 is 82.96% of 31,339. If we take leadership at their word and believe 26,000 plaintiffs have accepted the settlement, then we must assume that the settlement is going to include more than 25,000 plaintiffs and base on “participation calculus” on the total number of cases on file, which is at least 31,339.

Settling 26,000 cases would leave 5339 remaining. I do not believe that the defendants can sell a settlement to their stockholders that leaves 5339 cases (unknown risks) unresolved.

A reliable source has informed me that the “98% participation claim” was based on 98% of the 70% of plaintiffs that have returned the enrollment package, not 98% of all plaintiffs. Maybe leadership is counting on using the “dismissal machine” they have arguably created in co-operation with defense, to get rid of the non-enrollers and therefore do not think these plaintiffs need be counted.

Though I can not verify the foregoing (Brown Greer gagged), I believe the 26,000-enrollment number may be significantly exaggerated or at minimum skewed. Leading non leadership firms to believe the proposed settlement will consummate would be a good way to get firms reluctant to encourage plaintiffs to except the settlement to change course. A self-fulfilling prophecy (stated as fact) if you will.

The Chance and Right to be Heard

I stated, in the previous article (link above) that Judge Fallon arguably lacks subject matter jurisdiction to issue orders related to an MDL settlement. I also stated that since Judge Fallon is an MDL judge that subscribes to the MDLs as Quasi  Class Actions theory and therefore should have held FRCP 23(e) fairness hearings before or currently with issuing in order related to settlement as His Honor did in Vioxx and other MDLs in the past.

Putting aside the above, absent Xarelto plaintiffs (those not represented by leadership firms) may still have a chance to be heard.

How an MDL Judge can properly involve  themselves in settlement:

  1. Plaintiff Leadership and Defense reach a settlement agreement without seeking orders from the court.
  2. Plaintiff Leadership presents the settlement to firms representing absent plaintiffs and if enough those plaintiffs opt into the settlement to meet the required participation threshold, then the settlement can be consummated (only for those that opted in).
  3. Only after the foregoing, would it be proper for the court to become involved. Plaintiff Leadership and Defense can present the consummated agreement (with all opt ins) to the Judge and seek to form a Settlement Class Action (under FRCP 23).

Obviously the ship has sailed with regard to Judge Fallon conducting FRCP 23(3) fairness hearings before or concurrently with issuing orders related to settlement however, it would be inconceivable for His Honor to issue orders granting specific Leadership and PSC Firms common benefit fees without a “Settlement Class Action” being formed.

Why? Without a Settlement Class Action in place, Judge Fallon will have no control over or authority to grant any order related to the global proceeds of the mass settlement.

The Opportunity to Be Heard- Finally?

If the proposed Xarelto Settlement reaches the required participation numbers and is consummated, Judge Fallon will only be able to take control of the global proceeds (in order to grant common benefit fees) via a Settlement Class Action. This will be the point at which firms representing absent plaintiff firms will (as required FRCP 23(e) to be heard). If Judge Fallon neglects to conduct fairness hearings before granting fees, an appellate court is likely to overturn any order granting common benefit fees.

The link below is from a 9th Circuit in the Hyundai Kia MDL. A settlement was reached in this MDL and a Settlement Class Action was granted by the MDL Judge. Suit was filed by firms representing absent plaintiffs related to the common benefit fees awarded arising from the settlement. The

https://www.consumerfinancialserviceslawmonitor.com/wp-content/uploads/sites/501/2019/06/In-re-Hyundai.pdf

Excerpts from Ruling:

On December 23, 2013, the settling parties sought preliminary approval of the nationwide class settlement and moved to certify a settlement class. The district court ordered multiple rounds of briefing concerning the fairness of the settlement, sufficiency of the class notice, the claims process, class certification, choice of law, and other issues. At four hearings held between December 2013 and August 2014, the parties addressed concerns raised by the court sua sponte as well as by objectors and other non-settling plaintiffs. In response to these concerns, the settling parties twice revised the settlement agreement and notice provisions.

After issuing several detailed written rulings, the district court granted preliminary approval of the settlement and certified the class for settlement purposes on August 29, 2014. The court appointed Hagens Berman and McCuneWright as settlement class counsel. In September and October 2014, the district court held four additional hearings, at which it requested that the parties make additional changes to the settlement notices and website, such as adding information about the Reimbursement Program, and rewording the notices to make them easier to understand.

A binding settlement must provide notice to the class in a “reasonable manner” and otherwise be “fair, reasonable, and adequate.” Fed. R. Civ. P. 23(e)(1), (2)

Before the district court approves a class settlement under Rule 23(e), it is “critical” that class members receive adequate notice. Hanlon, 150 F.3d at 1025. To satisfy Rule 23(e)(1), settlement notices must “present information about a proposed settlement neutrally, simply, and understandably.” Rodriguez v. W. Publ’g Corp., 563 F.3d 948, 962 (9th Cir. 2009). “Notice is satisfactory if generally describes the terms of the settlement in sufficient detail to alert those with adverse viewpoints to investigate and to come forward and be heard.’” Id. (quoting Churchill Vill., LLC v. Gen. Elec., 361 F.3d 566, 575 (9th Cir. 2004)).

Rule 23(e) ensures that unnamed class members are protected “from unjust or unfair settlements affecting their rights.” Amchem, 521 U.S. at 623 (1997).

Over the course of several years, the district court performed an admirable job of managing this complex litigation. After the settlement was announced, the district court held multiple status conferences and requested several rounds of briefing to ensure that all of the litigants’ concerns were heard and addressed.

Note: The 9th circuit ruling leave little doubt that had the settlement court failed to comply with FRCP 23(e), that courts grant of attorney’s fees  to “Class Counsel”  would not have withstood appeal.

End Excerpts

 

 

Moving Forward -Two Possible Outcomes

  1. Judge Fallon moves forward with a settlement class (if the settlement consummates) without the required FRCP 23 (e) fairness hearings, in which case any grant of common benefit fees arising from the court would likely be overturned on appeal.

 

  1. Judge Fallon moves forward with a settlement class and does (as required) conduct fairness hearings per FRCP 23(e). Although belated, this would give firms representing absent class members to object to the terms of the settlement as well as any common benefit fees being awarded from the settlement proceeds. Even those plaintiffs that rejected the settlement or were subject to dismissal arising from a settlement related order would arguably have standing (the right to be heard).

 

  1. Leadership Self-Dealing (subject of a future article).
  2. Leadership Conclusion with defense to create a “dismissal machine.
  3. Unwarranted Discounts.
  4. Overly Complex processes created by settlement orders, leading to denial of due process.
  5. Settlement related orders issued absent jurisdiction over the subject matter.

The article below, written by Judge Fallon

COMMON BENEFIT FEES IN MULTI-DISTRICT LITIGATION

https://judicialstudies.duke.edu/sites/default/files/centers/judicialstudies/mdl2014/Common_Benefit_Fees.pdf

By: The Honorable Eldon E. Fallon

Note:. In the article, Judge Fallon, as he has on numerous occasions, referred to “private mass tort settlements” as opt in (vs class actions which are opt outs). His Honors reference to these settlements as Opt In vs Opt Out seems to imply that his jurisdiction over settlement arises from the agreement of the parties that Opt In. By Implication this would mean that any party that does not opt in should not be negatively impacted by the given settlement. This has obviously not held true in the proposed Xarelto Settlement.

The following excerpt from the article by His Honor express the same view he expressed in Vioxx, which involved a settlement very similar to the proposed Xarelto Settlement (with 4 billion additional dollars for roughly the same number of plaintiffs) . In Vioxx, Judge Fallon conducted the Rule 23(e) hearing he references below to allow absent plaintiffs a voice in the settlement. I have yet to discern why His Honor believes Xarelto plaintiffs are less deserving of due process than Vioxx Clients.

Excerpt

The argument used by the courts supporting their equitable authority to review attorneys fees is that Rule 23 of the Federal Rules of Civil Procedure expressly provides that a district court presiding over a class action has a duty to scrutinize the attorneys fees of class counsel to assure that they are reasonable. The transferee judge in MDLs should have the same responsibility because MDLs are quasi class actions since their purpose and function is the same as the traditional class action namely efficiency and coordination before a single court. Furthermore, many MDLs contain multiple class actions along with the individual claims and it is not unusual to utilize the settlement class vehicle provided by Rule 23(e) to resolve the entire Thus Rule 23 is often an integral part of the MDL process.

End Excerpt

 

Has Judge Fallon Became to Chummy with Xarelto Leadership?

Just out of curiosity I have submitted a Form A0 10A to the Judicial Committee on Financial Disclosures, requesting Judge Fallon’s financial disclosures for 2013-2018. I already have copies of his disclosures through 2012 and His Honor discloses that his travel and other expenses are paid by third parties when he attended conferences 2012 and prior. I am curious to find out if MTMP paid Judge Fallon’s expenses when he attended MTMP conferences over the past few years. Paying for trips to lavish resorts in sin city for a Federal Judge before whom a firm currently has matters subject to litigation, is something I find worth exploring.

 

Required Reading for those wanting to improve their knowledge of all things MDL settlement.

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation

But this book, it may shock even the most cynical!

https://www.amazon.com/Mass-Tort-Deals-Bargaining-Multidistrict-ebook/dp/B07S7DMN7Z

By: Elizabeth Chamblee Burch

Elizabeth Chamblee Burch is the Fuller E. Callaway Chair of Law at the University of Georgia. Her teaching and research interests include mass torts, class actions, and civil procedure. She has been a Visiting Professor at Harvard Law School.

Other worthwhile reading authored by Professor Burch:

Monopolies in Multidistrict Litigation

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=2113&context=fac_artchop

Repeat Players in Multidistrict Litigation

https://scholarship.law.cornell.edu/cgi/viewcontent.cgi?article=4737&context=clr

DISAGGREGATING

https://openscholarship.wustl.edu/cgi/viewcontent.cgi?article=6002&context=law_lawreview

Judging Multidistrict Litigation 

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1993&context=fac_artchop

Morphing Case Boundaries in Multidistrict Litigation Settlements

By: Margaret S. Thomas

http://law.emory.edu/elj/_documents/volumes/63/6/responses/thomas.pdf

About Professor Thomas: https://www.law.lsu.edu/directory/profiles/margaret-s-thomas/

 

Once Size Doesn’t Fit All: Multidistrict Litigation, Due Process and the Dangers of Procedural Collectivism

http://www.bu.edu/bulawreview/files/2015/02/REDISH.pdf

By: MARTIN H. REDISH & JULIE M. KARABA

Martin H. Redish is the Louis and Harriet Ancel Professor of Law and Public Policy at the Northwestern University Pritzker School of Law. Redish has written 19 books and over a hundred law review articles in the areas of civil procedure and constitutional law.

About Professor Redish: http://www.law.northwestern.edu/faculty/profiles/MartinRedish/

Julie Karaba (Siegal is) currently a Clerk for Chief Justice John Roberts, United States Supreme Court.

https://www.sesp.northwestern.edu/news-center/news/2018/03/sesp-alumna-to-clerk-for-chief-justice-of-the-united-states-john-g.-roberts,-jr..html

 

Judicial Review of Private Mass Tort Settlements

By: Jeremy T. Grabill

https://scholarship.shu.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1418&context=shlr

About Jeremy Grabill: https://www.phelps.com/jeremy-grabill

TAKING A SECOND LOOK AT MDL PRODUCT LIABILITY SETTLEMENTS: SOMEBODY NEEDS TO DO IT

https://kuscholarworks.ku.edu/bitstream/handle/1808/25557/Mueller_FINAL.pdf;jsessionid=DFE28872C148C01DAF73FED1CD91E292?sequence=1

By: Christopher B. Mueller

About Professor Mueller: https://lawweb.colorado.edu/profiles/profile.jsp?id=38

 

DUBIOUS DOCTRINES: THE QUASI-CLASS Action

https://scholarship.law.uc.edu/cgi/viewcontent.cgi?article=1095&context=uclr

By: Linda S. Mullenix

 

AGGREGATE LITIGATION AND THE DEATH OF DEMOCRATIC DISPUTE RESOLUTION

https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=1063&context=nulr

Also by: Linda S. Mullenix

About Professor Mullenix: https://law.utexas.edu/faculty/linda-s-mullenix

Books by Professor Mullenix: https://www.amazon.com/Linda-S.-Mullenix/e/B001HML766

Managing Related Proposed Class Actions in Multidistrict Litigation

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

By: Catherine R. Borden

Government of the United States of America – Federal Judicial Center

GLOBAL SETTLEMENTS IN NON-CLASS MDL MASS TORTS

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

 

https://law.lclark.edu/live/files/25156-saackreadyforwebsitepdf

By: Amy L. Saack

About Amy Sacck: http://www.davisrothwell.com/attorney/amy-saack/

 

 

STANDARDS AND BEST PRACTICES FOR LARGE AND MASS-TORT MDLS

BOLCH JUDICIAL INSTITUTE, DUKE LAW SCHOOL

https://judicialstudies.duke.edu/wp-content/uploads/2018/10/standards_and_best_practices_for_large_and_mass-tort_mdls-Bolch-Judicial.pdf+

 

Disclaimer: The author of this article, John Ray, is not an attorney. Nothing in this article should be considered legal advice. The opinions expressed in this article are those of John Ray. Publication of this article by any third party should not be considered endorsement of nor agreement with the opinions expressed by the author.

Read More

Xarelto Settlement Judicial Activism vs Judicial Tyranny

Xarelto Proposed Settlement 

The death MDL settlements as we know and love them?

 

Foreword: Non leadership firms representing Xarelto plaintiffs facing potential dismissal from orders issued related to the proposed Xarelto settlement might find this article very beneficial.

Although it is still doubtful that the proposed Xarelto settlement will consummate, it appears that Judge Fallon is set to dismiss individual cases for failure to comply with orders arising from the proposed settlement. Such dismissals would arguably be ripe for appeal.

Spoiler Alert: MDL Judges arguably Lack Subject Matter Jurisdiction to issue orders arising from MDL settlements. Any case dismissed for failure to comply with an order issued absent jurisdiction over the subject matter giving rise to the order, would also be a juridical act undertaken without proper jurisdiction. Parties can not wave Subject Matter Jurisdiction, by act nor agreement. There is no time limit to file an appeal related to an order issued in the absence of jurisdiction over the Subject Matter. Orders issued lacking subject matter jurisdiction  are null from the onset and void on their face. Res Judicata does not apply to orders issued in want of jurisdiction over the subject matter.  See Citations of Relevant Law at the end of this article).

The Road to Hell and Good Intentions 

Certain well intended MDL Judges, including Judge Eldon Fallon have subscribed to the theory that “MDLs are Quasi Class Actions” and despite the fact the USC 1407 provides MDL judges with no jurisdiction to participate in MDL settlements, MDL judges could none the less exercised the powers of their court and involved themselves in MDL settlements, reasoning that MDLs are merely Quasi Class Actions. MDL judges ascribing to the “MDLs as Quasi Class Actions” theory have reasoned intra alia that  Federal Judges have jurisdiction over Class Action Settlements and therefore Federal Judges presiding over MDLs (Quasi Class Actions by their  reasoning) have the same jurisdiction as a Federal Judge Presiding over a Class Action, so long as they comply with the requirements of FRCP 23, in particular the requirements of FRCP 23(e) .

MDL Judges willing to arguably overstep their jurisdiction and exercise the power of their courts in MDL settlements, have justified doing so by  simultaneously complying with duties imposed under FRCP 23(e).

FRCP 23(e) requires Federal Judges presiding over Class Actions to conduct fairness hearings and approve any Class Settlement. These fairness hearings are intended in part to provide class action “absent plaintiff parties” protection from would be unscrupulous self-dealing lead class counsel.

Xarelto Settlement Where Activism turned to Tyranny 

Prior to the Xarelto Settlement, all MDL judges who have inserted themselves into MDL settlements have complied with FRCP 23(e) by conducting fairness hearings to allow parties not represented by plaintiffs leadership a voice before imposing any order related to the settlement that might negatively impact any absent plaintiffs case. Judge Fallon conducted extensive fairness hearings in the settlement of the Vioxx litigation. For reasons unknown to the author, Judge Fallon apparently does not view Xarelto plaintiffs as being deserving of the same protections provided Vioxx plaintiffs.

Although Quasi Class Actions do not actually exist, (MDLs are not Quasi Class Actions) and MDL judges arguably have no jurisdiction to involve themselves in MDL settlements, the Judicial Activism undertaken by Quasi Class Actions MDL judges has arguably been beneficial to defendants as well as plaintiffs desiring efficient mass settlement. Neither defendants nor plaintiffs have complained in the past however, Judge Fallon’s failure to conduct fairness hearings related to the proposed Xarelto Settlement may result in an end to the long running gravy train of MDL settlements achieved by activist MDL Judges willing to overstep their jurisdiction to assist parties in effectuating settlement.

In addition to failing to conduct fairness hearings related to the proposed Xarelto settlement, Judge Fallon also appears to be set to dismiss individual plaintiffs’ cases for failure to comply with orders arising from the settlement. These  orders were arguably issued absent jurisdiction over the subject matter. Any future order arising from the settlement orders, including an order dismissing a case for failing to comply with the settlement related orders, would also be issued without jurisdiction over the subject matter.

Appeals arising from the forgoing, may result in the creation of case law that puts an end to MDL judges inserting themselves into MDL settlements, making reaching mass settlement in MDLs a far more difficult task.

It should be noted I (John Ray) hold Judge Fallon in high esteem. I believe Judge Fallon is wise and fair minded. Despite the foregoing, even wise and fair-minded Judges can err.  I do not view Judge Fallon as a tyrant in general however, acts of tyranny are acts of tyranny, without regard to the general character of those that commit the acts.

 

Back Ground

MDL Judges presiding over Class Actions (FRCP 23) not only have jurisdiction over settlement, Judges presiding over Class Actions have a duty to insure than any proposed settlement is fair to all parties including “absent” parties. FRCP 23(e) Requires Judges presiding over Class Actions to conduct fairness hearings, and rule on the fairness of a class action settlement.

Rule 23(e) is the only safeguard provided to absent class members under Rule 23, protecting these vulnerable parties from self-dealing class action lead counsel that might be inclined to act to the common detriment of absent class members vs the common benefit of those absent parties.

Conversely USC 1407, passed by Congress in 1968, formerly codifying Multidistrict Litigation as a means by which very Federal Jurisdiction can be imposed, provided no jurisdiction for MDL judges to oversee, assist in, issue orders related to or arising from, mass settlement. Additionally, USC 1407, having extended no “settlement jurisdiction” to MDL judges also provided no protection from would be self-dealing lead counsel in MDLs that might act to the common detriment of absent plaintiffs (those not represented by leadership firms).

How Can This Be?

Common Misconception: MDL Judges Have Jurisdiction of the Subject Matter as Well as Personal Jurisdiction to oversee or enter orders to assist mass settlement.

Jurisdiction over the Subject Matter: Arguably does not exist!

Personal Jurisdiction: Arguably does not exist, except for cases that arose in the MDL Courts home State and then only if that court would otherwise have jurisdiction.

Wait a Second!

Wait a Second – MDL Judges frequently involve themselves in MDL mass settlements, how do they justify acting in excess of their Jurisdiction? How could the question of these judges jurisdiction over MDL settlement remained unresolved?

No party to an MDL to date,  has been so aggrieved by an MDL Judges overreach on settlement to force higher courts to deal with the issues. The Xarelto settlement is likely to change the foregoing.

 

The Birth of MDLs as Quasi Class Actions

Judge Jack B. Weinstein, presiding over the Zyprexa Litigation (MDL 1596), was the first MDL Judge (that we are aware of) to presume jurisdiction over settlement matters in Multidistrict Litigation under the “MDLs as Quasi Class Actions“ theory.

Weinstein reasoned that MDLs are “Quasi Class Actions” and cited (inter alia), his inherent authority under the “All Writs Act 28 U.S.C 1651” as providing him “inherent authority” over MDL settlements.

Judge Eldon Fallon, while presiding over the Vioxx Litigation, llowing Judge Weinstein’s Quasi Class Actions theory exerted his self-claimed inherent authority to wade into settlement of that litigation. Other MDL Judges (but not all) have also subscribed to Judge Weinstein’s “MDLs as Quasi Class Actions” theory.

Judge Eldon Fallon in Vioxx, as well as other “MDLs as Quasi Class Action  Judges” have reasoned that their involvement in MDL settlements is equitable, so long as the provisions of FRCP 23(e), are observed.  FRCP 23(e) is intended to provide protection from would be self-dealing lead Class Counsel. FRCP 23(e) obligates Federal Judges overseeing Class Actions to conduct fairness hearings (giving absent class members a chance to be heard) as well as rule on the fairness of any propose class settlement prior to approving the settlement and issuing any order related to the settlement that might negatively impact any individual plaintiff.

Judge Fallon in Vioxx as well as other “Quasi Class Action MDL judges” prior to the current Xarelto settlement have in fact held fairness hearings per FRCP 23(e) in all MDL mass settlements in which the court has involved itself via settlement related orders or other oversight.

Judge Fallon did not conduct fairness hearings before issuing orders related to the Xarelto settlement.

These “fairness hearings” are intended (according to “Quasi Class Action MDL judges”) to provide extend the protections provided absent parties in Class Action to absent parties in MDLs. In the MDL context “absent parties” would be all plaintiffs not represented by plaintiff’s leadership (retained by the leadership firms)

Why Do Xarelto Plaintiffs deserve Less Judicial protection than Vioxx Plaintiffs?

Only Judge Fallon could explain why he neglected to follow his own past reasoning (the requirement to conduct fairness hearings) and denied absent Xarelto Plaintiffs the same rights and protections as Vioxx plaintiffs.

Although the proposed Xarelto settlement is repeatedly referred to as a “Private Settlement” (extra udicial) reach by the parties, the label is inaccurate. The settlement was reached after negotiations between defense counsel and plaintiffs’ leadership. Plaintiffs leadership is not a party, nor do they represent any party (plaintiff) other than those retained by their respective firms.

Furthermore, the proposed Xarelto “Private Settlement” ceased to be Private (extrajudicial) the minute the “parties” crossed the threshold of the court seeking an order related to the settlement.

If the courts excuse for not conducting fairness hearings is “because this is a private settlement”, that dog simply won’t hunt.

Any contention that the court is acting under authority agreed to by the parties also fails. Plaintiff Leadership nor Defense Counsel all the “parties”. Plaintiff lead counsel can enter agreements binding on the clients retained by their firms (those parties) however, leadership does not represent all “parties” and therefore cannot stipulate to jurisdiction on behalf clients they do not represent. Additionally, issues related to subjected matter jurisdiction  cannot be waived by stipulation or agreement by the parties.

Jurisdiction Under the “All Writs Act”?

[A]ll courts established by Act of Congress may issue all writs necessary or appropriate in aid of their respective jurisdictions and agreeable to the usages and principles of law.”  28 U.S.C. § 1651(a).

In should be noted that Judge Weinstein, Judge Fallon  and “Quasi Class Action MDL Judges” never appear to claim to have  actual jurisdiction over MDL settlements, they instead cite their inherent authority, which would arise under the “All Writs Act”:

“All courts established by Act of Congress may issue all writs necessary or appropriate in aid of their respective jurisdictions and agreeable to the usages and principles of law.”  28 U.S.C. § 1651(a).”

The All Writs Act however, only provides “inherent authority” over subject matter for which the given Federal Court otherwise has jurisdiction. Absent Jurisdiction over the Subject Matter of MDL settlement, MDL Judges have no inherent authority  arising under 28 U.S.C. § 1651 related to the same subject matter (MDL settlements).

 

Judicial Activism Morphing into Tyranny

Judge Fallon, as well as other MDL judges who subscribe to the quasi-class action theory within the restraints of FRCP 23(e), have in the past been potentially guilty of well-intended judicial activism even when judicial acts arising from that activism may have strayed beyond their  jurisdiction.

The inherent problem always accompanying judicial activism is the risk of activism turning into tyranny.

Xarelto Plaintiffs aggrieved by the proposed settlement, with no forum in which to voice their grievances, while plaintiff leadership arguably acting to their common detriment and a court turning a deaf ear to their plight, might justifiably feel they are victims of judicial tyranny.

Many Judicial Scholars have expressed concern over the possible negative consequences of judicial activism. Many of the concerns expressed by these judicial scholars have now been realized in the proposed Xarelto Settlement.

The Author would argue that Judge Fallon’s failure to conduct fairness hearings, while issuing orders related to the Xarelto settlement, that may negatively impact individual plaintiffs, crossed the line from judicial activism to  judicial tyranny.

 

Don’t Take My Word for It

Due to the fact several members of Xarelto leadership directly threatening me and attempting to lead attorneys representing absent Xarelto plaintiffs (non-leadership) firms, to believe they are somehow at risk of ethical violations if they take the opinions of a non-lawyer (me) into consideration, I will provide the several links below to scholarly papers and articles written by judicial scholars who are actually attorneys. Draw your own conclusions.

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation

Elizabeth Chamblee Burch

https://www.amazon.com/Elizabeth-Chamblee-Burch/e/B00G61EI2I/ref=dp_byline_cont_ebooks_1

About Professor Burch: http://www.law.uga.edu/profile/elizabeth-chamblee-burch

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation is available for purchase on Amazon. Professor Burch has been conducing research related to MDL settlements for many years. Her most recent work “Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation” is an eye opening read even for those that believe they are already familiar with all of the “dirty little lies and secrets” of mass torts.

Other work by Professor Burch includes “Monopolies in Mass Torts”

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=2113&context=fac_artchop

 

You can obtain a copy of Monopolies in Mass Torts free at the link above. This paper is somewhat of a prequel to Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation. If you read the prequel you will want to buy the book.

 

DUBIOUS DOCTRINES: THE QUASI-CLASS ACTION  by Linda Mullenix

https://scholarship.law.uc.edu/cgi/viewcontent.cgi?article=1095&context=uclr

Note: This article written by Linda Mullenix in 2012 is as apt today as the day it was written.

About Professor Mullenix:  https://law.utexas.edu/faculty/linda-s-mullenix

Excepts:

In the past few years, the term ―quasi-class action has been appearing with increasing, uncritical frequency in a spate of federal court decisions. While it may be premature to characterize these sporadic references as a trend, it is perhaps soon enough to call attention to the misuse of loose labels that carry with them significant consequences. Before the quasi-class action gains any further traction, there are several valid reasons for definitively quashing this quasi

Before the inspired fabrication of the quasi-class action, global agreements accomplished under MDL auspices had to be settled pursuant to formal class requirements and due process protections. By engrafting the label quasi-class action onto MDL procedure, self-interested actors have created a perfect staging ground for negotiating back-room deals that carry a false aura of judicial legitimacy, liberated from the constraints of the formal class action rule.

MDL judges, in turn, by endorsing the concept of the quasi-class action have greatly expanded the scope of their authority and have become complicit in allowing private parties to accomplish the very backdoor settlements that the Supreme Court and federal courts have disallowed for decades. The quasi-class action, then, represents an ultimate, cynical expression of an aggregate claims-resolution model that enables self-interested actors to resolve claims in the actors‘ best interests rather than the interests of injured claimants.

At first blush, the sheer frequency of federal use of the term quasi-class action would seem to suggest that the quasi-class action is a well-recognized and well-established doctrine in federal jurisprudence. Since 1946, sixty-eight federal cases have cited the label. However, careful reading of this case law suggests an entirely different conclusion: the quasi-class action is a phantasm. None of these cases actually discussed the concept of the quasi-class action, and rarely-cited authority is inapposite or inaccurate.

Important Case Law

Although SCOTUS has yet to address the question : Does and MDL Judge (like a Class Action Judge) have jurisdiction over settlement, as the question has yet to be presented to SCOTUS, the high court has ruled on other questions in a manner which may be of value to any firm representing a plaintiff in the Xarelto litigation if said plaintiff case is dismissed or otherwise prejudiced by any of the orders related to or arising from the prosed Xarelto Settlement.

Lexecon v Milberg (Scotus)

https://www.oyez.org/cases/1997/96-1482

Note: Lexecon did not directly address the question of an MDL Judges jurisdiction over MDL settlement however, SCOTUS made it clear that USC 1407 does not extend an MDL judges jurisdiction beyond the exact language codified by Congress in 1407.

Federal Judges have broad discretion over many matters however, Federal Judges have no discretion in any matter (subject matter nor personal) beyond the specific grant of jurisdiction by Congress under which the court acts.

Question

May a federal district court conducting “pretrial proceedings” under 28 USC section 1407(a) invoke section 1404(a) to assign a transferred case to itself for trial?

No. In an opinion delivered by Justice David H. Souter, the Court held that a district court conducting pretrial proceedings pursuant to section 1407(a) has no authority to invoke section 1404(a) to assign a transferred case to itself for trial. The Court noted that the Panel’s section 1407(a) instructions are crouched in the word “shall,” which “creates an obligation impervious to judicial discretion.” Justice Souter wrote for the Court that, “the straightforward language imposing the Panel’s responsibility to remand… bars recognizing any self-assignment power in a transferee court.” The opinion was unanimous except insofar as Justice Antonin Scalia did not join Part II-C.

Lexecon Inc. was a defendant in a class action lawsuit. Under 28 USC section 1407(a), the lawsuit was transferred for pretrial proceedings to the District of Arizona. Section 1407(a) authorizes the Judicial Panel on Multidistrict Litigation to transfer civil actions with common issues of fact “to any district for coordinated or consolidated pretrial proceedings,” but provides that the Panel “shall” remand any such action to the original district “at or before the conclusion of such pretrial proceedings.” After claims against it were dismissed, Lexecon brought suit against Milberg Weiss Bershad Hynes & Lerach and others (Milberg) in the class action lawsuit in the Northern District of Illinois. Ultimately, the Panel, under section 1407(a), ordered the case transferred to the District of Arizona. Afterwards, Lexecon moved for the Arizona District Court to remand the case to Illinois. Milberg filed a countermotion requesting the Arizona District Court to invoke section 1404(a) to “transfer” the case to itself for trial. Ultimately, the court assigned the case to itself and the Court of Appeals affirmed its judgment.

 

AMCHEM PRODUCTS, INC., et al., PETITIONERS v. GEORGE WINDSOR et al.

Note: AMCHEM arose from the asbestos litigation, the ruling addressed attempts to settle cases filed in MDLs as well as cases filed in Class Actions. SCOTUS did not address the question of MDL Courts jurisdiction (nor lack thereof) over MDL settlement as this issue was not raised. SCOTUS ruling in AMCHEM did however make it clear that any mass tort judge, whether presiding over an MDL or a Class Action, has a duty to protect the interest of “absent plaintiffs”.

Excepts from AMCHEM

This case concerns the legitimacy under Rule 23 of the Federal Rules of Civil Procedure of a class action certification sought to achieve global settlement of current and future asbestos related claims. The class proposed for certification potentially encompasses hundreds of thousands, perhaps millions, of individuals tie d together by this commonality: each was, or some day may be, adversely affected by past exposure to asbestos products manufactured by one or more of 20 companies. Those companies, defendants in the lower courts, are petitioners here.

Rule 23(e), on settlement of class actions, reads in its entirety: “A class action shall not be dismissed or compromised without the approval of the court, and notice of the proposed dismissal or compromise shall be given to all members of the class in such manner as the court directs.” This prescription was designed to function as an additional requirement, not a superseding direction, for the “class action” to which Rule 23(e) refers is one qualified for certification under Rule 23(a) and (b). Cf. Eisen, 417 U. S., at 176-177 (adequate representation does not eliminate additional requirement to provide notice). Subdivisions (a) and (b) focus court attention on whether a proposed class has sufficient unity so that absent members can fairly be bound by decisions of class representatives. That dominant concern persists when settlement, rather than trial, is proposed.

The settling parties, in sum, achieved a global compromise with no structural assurance of fair and adequate representation for the diverse groups and individuals affected. Although the named parties alleged a range of complaints, each served generally as representative for the whole, not for a separate constituency. In another asbestos class action, the Second Circuit spoke precisely to this point:

[W]here differences among members of a class are such that subclasses must be established, we know of no authority that permits a court to approve a settlement without creating subclasses on the basis of consents by members of a unitary class, some of whom happen to be members of the distinct subgroups. The class representatives may well have thought that the Settlement serves the aggregate interests of the entire class. But the adversity among subgroups requires that the members of each subgroup cannot be bound to a settlement except by consents given by those who understand that their role is to represent solely the members of their respective subgroups.” In re Joint Eastern and Southern Dist. Asbestos Litigation, 982 F. 2d 721, 742-743 (CA2 1992), modified on reh’g sub nom. Inre Findley, 993 F. 2d 7 (CA2 1993).

The Third Circuit found no assurance here–either in the terms of the settlement or in the structure of the negotiations–that the named plaintiffs operated under a proper understanding of their representational responsibilities. See 83 F. 3d, at 630-631. That assessment, we conclude, is on the mark.

The argument is sensibly made that a nationwide administrative claims processing regime would provide the most secure, fair, and efficient means of compensating victims of asbestos exposure. Congress, however, has not adopted such a solution. And Rule 23, which must be interpreted with fidelity to the Rules Enabling Act and applied with the interests of absent class members in close view, cannot carry the large load CCR, class counsel, and the District Court heaped upon it. 

Subject Matter Jurisdiction Case Law 

Note: There are literally thousands of appellate rulings related to Lower Courts (Federal) issuing judgments and orders in excess of their jurisdiction. The citations below are merely examples of the vast number of rulings on the subject.

Void judgment is one entered by court that lacks the inherent power to make or enter the particular order involved, and it may be attacked at any time, either directly or collaterally; such a judgment would be a nullity, People v. Rolland 581 N.E.2d 907, Ill.App. 4 Dist. 1991)..

Invalidity need to appear on face of judgment alone that judgment or order may be said to be intrinsically void or void on its face, if lack of jurisdiction appears from the record, Crockett Oil Co. v. Effie, 374 S.W.2d 154 (Mo.App. 1964).

Note: MDL Court Judges imposing themselves into MDL settlements never seem to actually claim to have jurisdiction in the record, instead they  claim to have “inherent authority”. No authority exists absent jurisdiction.

Decision is void on the face of the judgment roll when from four comers of that roll, it may be determined that at least one of three elements of jurisdiction was absent: (1) jurisdiction over parties, (2) jurisdiction over subject matter, or (3) jurisdictional power to pronounce particular judgment that was rendered, B & C Investments, Inc. v. F & M Nat. Bank & Trust, 903 P.2d 339 (Okla. App. Div. 3, 1995).

A void judgment which includes judgment entered by a court which lacks jurisdiction over the parties or the subject matter, or lacks inherent Power to enter the particular judgment. or an order procured by fraud,can be attacked at any time, in any court, either directly or collaterally, provided that the party is properly before the court. Long v. Shorebank Development Corp., 182 F.3d 548 ( C.A. 7 Ill. 1999).

A void judgment is one which from its inception was a complete nullity and without legal effect, Lubben v. Selective Service System Local Bd. No. 2 7, 453 F.2d 645, 14 A.L.R. Fed. 298 (C.A. 1 Mass. 1972).

A void judgement is one which from its inception and forever continues to be absolutely null. without legal efficacy, ineffectual to bind the parties or to support a right, of no legal force and effect whatever, and incapable of enforcement in any manner or to any degree – Loyd v. Director, Dept. of Public Safety, 480 So. 2d 577 (Ala. Civ. App. 1985).

A judgment shown by evidence to be invalid for want of jurisdiction is a void judgment or at all events has all attributes of a void judgment, City of Los Angeles v. Morgan, 234 P.2d 319 (CaLApp. 2 Dist. 1491).

Res judicata consequences will not be applied to a void judgment which is one which from its inception is a complete nullity and without legal effect, Allcock v. Allcock 437 N.E. 2d 392 (Ill. App. 3 Dist. 1982).

Void judgment is one which has no legal force or effect whatever, it is an absolute nullity, its invalidity may be asserted by any person whose rights are affected at any time and at any place and it need not be attacked directly but may be attacked collaterally whenever and wherever it is interposed, City of Lufkin v. McVicker, 510 S.W. 2d 141 (Tex. Civ. App. – Beaumont 1973 1991)..

Disclaimer: The author of this article, John Ray, is not a lawyer. Nothing in this article should be taken as legal advice. The opinions expressed in this article are the opinions of the author. Publication of this article by any third party should not be considered an endorsement of nor agreement with the opinions expressed by the author.

 

 

 

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Did Trump and Epstein Rape Two Underage Girls?

Did Trump and Epstein Rape Two Underage Girls?

Before we address the question, Did Trump and Epstein Rape Two Underage Girls” we will first discuss Attorney General Bob Barr’s highly unusual decision to un-recuse himself from the Epstein case and actually take direct control over the case, despite have previously announced he was conflicted from having anything to do with the matter.

 

Why did Barr Un-Recuse?

Mass Tort Nexus researcher, Mark York, discovered a civil lawsuit filed in 2016 by Katie Johnson (now an adult), she accuses Trump and Epstein of committing multiple acts of sexual violence against herself (13 at the time) as well as a 12-year-old. (see excerpts below or download the complaint at:

Donald Trump – Jeffrey Epstein Federal Complaint (USDC California 2016) Re: Minor Sex Abuse

Given Epstein’s history of secretly taping famous people taking sexual advantage of young women procured by Epstein, if the allegations in the Johnson complaint are true, Trump has every reason to be concerned that tapes might exist which would prove Johnson’s allegations.

Would Bob Barr Obstruct Justice to protect Trump?

Evidence to date would suggest that Bob Barr is more than willing to pervert our justice system and even defy elected officials to protect his boss.

Would Trump ask Barr to Un-Recuse Himself?

The Presidents history (in his own words) related to Jeff Session’s recusal from the Russia Probe and subsequent refusal to un-recuse himself provide strong evidence that the President would ask an attorney general to un-recuse himself despite any previously addressed conflicts.

Why would Trump want his loyal Protector in Chief (Barr) in charge of the Epstein matter?

The remainder of this article will provide information on which the reader can draw their own conclusions as to why Trump may need Barr to interfere in the Epstein Case.

White House Initial Reactions to Epstein Indictment

Kellyanne Conway took the airways shortly after the new Epstein indictment was announced claiming that the president had not talked to nor seen Epstein in 10 to 15 years. If this claim was intended give the impression that the President and his hold friend had not cross paths in over a decade, the Lawsuit filed by Katie Johnson against Trump and Epstein in 2016 (co-defendants) accusing the pair of committing multiple acts of sexual violence against Johnson (then 13) and another girl (12 at the time) makes the statements made by Kellyanne Conway highly questionable. (see excerpts from complaint below)

 

Also See:

https://www.politico.com/story/2019/07/09/trump-jeffrey-epstein-kellyanne-conway-1402997

NOT FAKE NEW’s

After reading the excepts provided below from the Johnson complaint, you decide is Trump may need someone (Barr) to run interference on his behalf before the Epstein matter spills over and creates yet another potential reason Trump may have to be concerned about his future, not just as President but also as total loss of his choice of clothing (being restricted to a single orange jumpsuit).

 

Excerpts from Complaint:

FACTUAL ALLEGATIONS

The Plaintiff, Katie Johnson, alleges that the Defendants, Donald J. Trump and Jeffrey E. Epstein, did willfully and with extreme malice violate her Civil Rights under 18 U.S.C. ; 2241 by sexually and physically abusing Plaintiff Johnson by forcing her to engage in various perverted and depraved sex acts by threatening physical harm to Plaintiff Johnson and also her family. The Plaintiff, Katie Johnson, alleges that the Defendants, Donald J. Trump and Jeffrey E. Epstein, also did willfully and with extreme malice violate her Civil Rights under 42 U.S.C.; 1985 by conspiring to deny Plaintiff Johnson her Civil Rights by making her their sex slave.

The Plaintiff, Katie Johnson, alleges she was subject to extreme sexual and physical abuse by the Defendants, Donald J. Trump and Jeffrey E. Epstein, including forcible rape during a four month time span covering the months of June-September 1994 when Plaintiff Johnson was still only a minor of age 13.

The Plaintiff, Katie Johnson, alleges she was enticed by promises of money and a modeling career to attend a series of underage sex parties held at the New York City residence of Defendant Jeffrey E. Epstein and attended by Defendant Donald J. Trump.

On the first occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was forced to manually stimulate Defendant Trump with the use of her hand upon Defendant Trump’s erect penis until he reached sexual orgasm.

On the second occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was forced to orally copulate Defendant Trump by placing her mouth upon Defendant Trump’s erect penis until he reached sexual orgasm.

On the third occasion involving the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson was forced to engage in an unnatural lesbian sex act with her fellow minor and sex slave, Maria Doe age 12, for the sexual enjoyment of Defendant Trump. After this sex act, both minors were forced to orally copulate Defendant Trump by placing their mouths simultaneously on his erect penis until he achieved sexual orgasm. After zipping up his pants, Defendant Trump physically pushed both minors away while angrily berating them for the “poor” quality of their sexual performance.

On the fourth and final sexual encounter with the Defendant, Donald J. Trump, the Plaintiff, Katie Johnson, was tied to a bed by Defendant Trump who then proceeded to forcibly rape Plaintiff Johnson. During the course of this savage sexual attack, Plaintiff Johnson loudly pleaded with Defendant Trump to “please wear a condom”. Defendant Trump responded by violently striking Plaintiff Johnson in the face with his open hand and screaming that “he would do whatever he wanted” as he refused to wear protection. After achieving sexual orgasm, the Defendant, Donald J. Trump put his suit back on and when the Plaintiff, Katie Johnson, in tears asked Defendant Trump what would happen if he had impregnated her, Defendant Trump grabbed his wallet and threw some money at her and screamed that she should use the money “to get a fucking abortion”.

On the first occasion involving the Defendant, Jeffrey E. Epstein, the Plaintiff, Katie Johnson, was forced to disrobe into her bra and panties and to give a full body massage to Defendant Epstein while he was completely naked. During the massage, Defendant Epstein physically forced Plaintiff Johnson to touch his erect penis with her bare hands and to clean up his ejaculated semen after he achieved sexual orgasm.

On the second occasion involving the Defendant, Jeffrey Epstein, the Plaintiff, Katie Johnson, was again forced to disrobe into her bra and panties while giving Defendant Epstein a full body massage while he was completely naked. The Defendant, Donald J. Trump, was also present as he was getting his own massage from another minor, Jane Doe, age 13. Defendant Epstein forced Plaintiff Johnson to touch his erect penis by physically placing her bare hands upon his sex organ and again forced Plaintiff Johnson to clean up his ejaculated semen after he achieved sexual orgasm.

Shortly after this sexual assault by the Defendant, Jeffrey E. Epstein, on the Plaintiff, Katie Johnson, Plaintiff Johnson was still present while the two Defendants were arguing over who would be the one to take Plaintiff Johnson’s virginity. The Defendant, Donald J. Trump, was clearly heard referring to Defendant, Jeffrey E. Epstein, as a “Jew Bastard” as he yelled at Defendant Epstein, that clearly, he, Defendant Trump, should be the lucky one to “pop the cherry” of Plaintiff Johnson.

The third and final sexual assault by the Defendant, Jeffrey E. Epstein, on the Plaintiff, Katie Johnson, took place after Plaintiff Johnson had been brutally and savagely raped by Defendant Trump. While receiving another full body massage from Plaintiff Johnson, while in the nude, Defendant Epstein became so enraged after finding out that Defendant Trump had been the one to take Plaintiff Johnson’s virginity, that Defendant Epstein also violently raped Plaintiff Johnson.

After forcing Plaintiff Johnson to disrobe into her bra and panties, while receiving a massage from the Plaintiff, Defendant Epstein attempted to enter Plaintiff Johnson’s anal cavity with his erect penis while trying to restrain her. Plaintiff Johnson attempted to push Defendant Epstein away, at which time Defendant Epstein attempted to enter Plaintiff Johnson’s vagina with his erect penis. This attempt to brutally sodomize and rape Plaintiff Johnson by Defendant Epstein was finally repelled by Plaintiff Johnson but not before Defendant Epstein was able to achieve sexual orgasm. After perversely sodomizing and raping the Plaintiff, Katie Johnson, the Defendant, Jeffrey E. Epstein, attempted to strike her about the head with his closed fists while he angrily screamed at Plaintiff Johnson that he, Defendant Epstein, should have been the one who “took her cherry, not Mr. Trump”, before she finally managed to break away from Defendant Epstein.

The Plaintiff, Katie Johnson, was fully warned on more than one occasion by both Defendants, Donald J. Trump and Jeffrey E. Epstein, that were she ever to reveal any of the details of the sexual and physical abuse that she had suffered as a sex slave for Defendant Trump and Defendant Epstein, that Plaintiff Johnson and her family would be in mortal danger. Plaintiff Johnson was warned that this would mean certain death for herself and Plaintiff Johnson’s family unless she remained silent forever on the exact details of the depraved and perverted sexual and physical abuse she had been forced to endure from the Defendants.

 

MATERIAL WITNESSES

Tiffany Doe, a former trusted employee of the Defendant, Jeffrey E. Epstein, has agreed to provide sworn testimony in this civil case and any other future civil or criminal proceedings, fully verifying the authenticity of the claims of the Plaintiff, Katie Johnson. Witness Tiffany Doe was employed by the Defendant, Jeffrey E. Epstein, for more than 10 years as a party planner for his underage sex parties. Despite being subject to constant terroristic threats by Defendants Epstein and Trump to never reveal the details of these underage sex parties at which scores of teenagers, and pre-teen girls were used as sex slaves by Defendant Epstein and Defendant Trump, witness Tiffany Doe refuses to be silent any longer. She has agreed to fully reveal the extent of the sexual perversion and physical cruelty that she personally witnessed at these parties by Defendants Epstein and Trump.

Material witness Tiffany Doe fully confirms all of Plaintiff Katie Johnson’s allegations of physical and sexual abuse by Defendants Donald J. Trump and Jeffrey E. Epstein. Tiffany Doe was physically present at each of the four occasions of sexual abuse by Defendant Trump upon the person of Plaintiff Johnson, as it was her job to witness all of the sexual escapades of Defendant Epstein’s guests at these underage sex parties and later reveal all of the sordid details directly to Defendant Epstein. Defendant Epstein also demanded that Tiffany Doe tell him personally everything she had overheard at these parties explaining to her that “knowledge was king” in the financial world. As a result of these underage sex parties, Defendant Epstein was able to accumulate inside business knowledge that he otherwise would never have been privy to in order to amass his huge personal fortune.

Material witness Tiffany Doe will testify that she was also present or had direct knowledge of each of the three instances on which Defendant Jeffrey E. Epstein physically and sexually abused the Plaintiff, Katie Johnson. Tiffany Doe will testify to the fact that the Plaintiff, Katie Johnson, was extremely fortunate to have survived all of the physical and sexual horrors inflicted upon her by Defendants Epstein and Trump.

(end excerpts from Johnson Complaint)

Would Trump Do Such Things? 

 

“The fact that Donald Trump had a friendly relationship with Epstein — he told New York Magazine in 2002 that “(Epstein’s) a lot of fun to be with … It is even said that he likes beautiful women as much as I do, and many of them are on the younger side”

http://nymag.com/nymetro/news/people/n_7912/

Not Just Locker Room Talk

 

Is it Normal to Agree that your Daughter is a “Hot Piece of Ass? 

More Creepy Daddy Moments 

 

Do You Enjoy Kissing Your Daughter More than Kissing  your Wife?

 

 

 

 

Daddy Really Loves His Little Girl

 

 

 

Trump and Epstein Like Them Young

10 Creepy Things Donald Trump Has Said About Ivanka

Conclusion

Do you think Trump has a reason to want Bob Barr heading up the Epstein case?

Do you think Barr would be willing to run interference for Trump, even if it meant giving Epstein a break?

Do you think Trump might engage in the acts alleged in the Johnson Complaint?

Will Trump Supporters be OK with this?

More Background Information 

 

In case you have not been following the Epstien Case, the following should get you up to speed:

 

Other News and Links:

Donald Trump and Prince Andrew met up in London ahead of Jeffrey Epstein’s arrest on new sex trafficking charges

 

 

 

 

 

 

 

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The Definitive Guide to Opioid Litigation

The Definitive Guide to the “Opioid Litigation”

If you believe your firm is not big enough to be involved in the “Opioid Litigation”, you are wrong. If you believe it is too late to get involved in the “Opioid Litigation”, you are so very wrong. The opioid lawsuits, filed mostly by government entities thus far, represent the tip of an extremely large iceberg. A vast number of entities both public and private, with potentially viable claims against opioid defendants, remain unrepresented. Recent actions by the FDA, the Surgeon General, and the DEA support potential product liability claims on behalf of individuals harmed by opioids. These mass litigations on behalf of individuals are in the inception phase. The total number of clients with claims in the “Opioid Litigation” could rival the Tobacco Litigation.

Mass Tort Nexus announces the upcoming release of “Volume 1 of the Definitive Guide to Opioid Litigation.”  A very limited number of  “pre-release”  copies will be provided to attendees of the October 18-20, Mass Torts Made Perfect Conference in Las Vegas.

To receive one of the limited “pre-release” copies at MTMP, contact Jenny Levine jenny@masstortnexus.com or (954) 520-4494.

Over the past two years, the research and technical divisions of Mass Tort Nexus have worked in conjunction with educational institutions, government entities and private organizations, to establish a comprehensive archive of documents, data and knowledge relevant to “The Opioid Litigation”.  Thus far, we have used our archive of documents as well as our databases to educate government entities, as well as private organizations that may have claims against the manufacturers, distributors and other co-conspirators that took part in causing the “Opioid Epidemic.”

Mass Tort Nexus also uses our document archive, data and our knowledge base to assist select law firms in identifying entities, both public and private, that have incurred the most significant financial damages related to opioids. After an entity client has been retained, Mass Tort Nexus then assists with establishing the direct connection between the actions of specific opioid defendants and the damages caused by those actions specific to given state, city, county or other entity.

Using “Big Data”  in the Opioid Litigation

Between 2013 and 2015,  68,177 doctors accepted a total of $46 million dollars in payments from opioid manufacturers. Using our collection of databases, Mass Tort Nexus can identify doctors in specific cities, counties and states that accepted payments from opioid Manufacturers. Mass Tort Nexus can then cross reference that data with the specific doctor’s opioid prescribing habits, as compared to the benchmark for their specialty.

Opioids “The Trillion Dollar Epidemic”

The damages caused by the Opioid defendants to government entities, as well as private business and individuals is in excess of 1 trillion dollars by our estimates. Although we have no expectation that the defendants will pay for all of the damage they have caused, Mass Tort Nexus intends to do its part to make sure the opioid defendants do not get off easy.

Only a Fraction of Government Entities Have Filed Claims

Of the 45,789 State, City, County, Territory and reservation governments that potentially have claims against opioid manufacturers, less than one percent have filed claims to date. Of course, not all government entities were damaged equally, some cities or counties may have suffered very little financial damage. Understanding how to identify and account for damages caused by opioids to a given city or other government entity is vital for the potential entity client, as well as the lawyers that represent them.

Mass Tort Nexus Definitive Guide to the Opioid Litigation First 6 Volumes

 

Volume 1

Volume 1:  The Definitive Guide to Opioid Litigation provides the history of the defendants bad acts, statistics related to which government entities (Cities, States and Counties) suffered the most significant financial damage directly related to the opioid defendants actions. Volume 1 also critiques entity complaints to date, as well as defense strategies employed related to those complaints. (Limited Pre-Release at October MTMP)

 

Volume 2

Volume 2: The Definitive Guide to Opioid Litigation provides guidance for identifying entity clients, both government and provide sector, with significant damages  related to the actions of the opioid clients. This volume also delves into how law firms undertake retaining these entity clients.

 

Volume 3

Volume 3: The Definitive Guide to Opioid Litigation takes the massive amount of statistical data, documents and other information most important to clients and their attorneys and summarizes the information for ease of use. Mass Tort Nexus has collected well over one million pages of documents and billions of data points related to the opioid litigation for our internal use, in our efforts to assist entity clients and law firms we work with directly. Although it would be impossible to provide all of these documents and data in a single resource, we hope that volume three of the guide provides a road map for those who wish to undertake the monumental task of collecting the data and documents needed to be in the best position possible, to represent any client they retain.

Volume 4

Volume 4: The Definitive Guide to the Opioid Litigation records the criminal convictions of opioid manufacturers, employees and executives that have occurred to date and makes some predictions of what may occur in the near future. Hint, unlike the three Purdue Pharma Executives that paid a $65 million dollar fine and agreed to probation to resolve criminal charges, future charges against opioid executives are likely to result in their receiving an all orange wardrobe.

On the record, admissions stemming from the criminal cases already prosecuted in addition to those to come will be very useful in the ongoing opioid civil litigations.

Volume 5

Volume 5: The Definitive Guide to the Opioid Litigation is intended to tie all of the pieces and players together referenced in Volumes 1-4.  The Mass Tort Nexus research staff has been amazed by the connections that they have uncovered between supposedly independent organization that contributed to the development of the “echo chamber” that was used to convince doctors that opioids were safe, despite the fact that over a thousand years of history indicated otherwise.

 

Volume 6

Volume 6: The Definitive Guide to the Opioid Litigation  provides a comparison and contrast between three mass litigation’s with many similarities:

  1. The Tobacco Litigation
  2.  The BP Oil Spill Litigation
  3. The Opioid Litigation

 

 

 

 

 

 

 

 

 

 

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Opioid Manufacturers Break the “Don’t Kill White People Rule”

Government Inaction Turns to Obsession

The FDA, DEA, and the CDC, as well as numerous other government agencies have known for years that prescription opioids were killing people and took no significant action to confront the problem. Only after the CDC began correlating the data, that had always been at their disposal, did inaction turn into obsession and give birth to the Feds recognition of the opioid epidemic.  The word epidemic was not even in the government’s opioid lexicon, until it was discovered that opioids were killing white people at an alarming rate.

Although the correlation mentioned above is not likely to be made issue of in the “Opioid Litigation,” we found it interesting that the Feds discovery that Opioids were killing middle class, white suburban soccer moms, as well as other privileged white folks temporally coincided with the Feds sudden obsession with the problem noteworthy. Better late than never.

The Definitive Guide to the “Opioid Litigation”

Mass Tort Nexus will release the first volume of the “Definitive Guide to the Opioid Litigation” in October 2017. Contact Jenny Levine at jenny@masstortnexus.com to find out how to get a free copy of volume one. If your firm is interested in becoming involved in the Opioid Litigation, the guide should be your Bible, Koran, Torah etc. for the case.

The first volume is intended to provide plaintiff attorneys with a basic understanding of the multifaceted litigation, past, present and future. In reality, the term  “Opioid Litigation” is somewhat misleading, as it implies a far more limited scope to the “case” than is accurate.

Much attention has been given to the lawsuits filed on behalf of State, Federal and Local Governments against the makers of Opioid’s; however, these types of entity cases are only a fraction of those which can and should be filed.  Cases filed on behalf of individuals based on varied causes of actions should be far more numerous that those filed on behalf of entities. Firms of all sizes will be in a position to represent clients in the many niches that make up the “Opioid Litigation.”

  Back to the “Killing White People Rule”

“The wise do not take part in baseless conspiracy theories nor do they ignore reality regardless of the offense that may be given for its recognition. ”

John Ray

Circa 2017 🙂

 

Anyone who believes  that harming white people will not evoke action from our government far more quickly than harming non whites is ignoring history.

In the early 1930’s, the U.S. government conducted experiments on black men, which involved leading black men with Syphilis to believe they were being treated, when in fact they were being given a placebo. The government did not acknowledge or admit its actions for over 50 years. This is not a conspiracy theory, it is a fact.

This is Ancient History, Right?

More recently, one of  President Richard Nixon’s closest aides (and Watergate Co-Conspirator), years after being released from prison, admitted that Nixon created the “War on Drugs,”  in part to create an excuse to jail young black men. Every single President since Nixon has continued the war on drugs, resulting in a massive number of  black youth incarcerations, despite the fact that white people use illegal drugs at a higher rate than non whites.

 

 

The Reality 

Did the government’s realization that Opioids were killing white folks have an effect on turning inaction into obsession? Did the same factors turn an almost ignored problem into an epidemic?

The time line of the CDC getting around to correlating data, which had been at their disposal for almost 20 years, revealed a violation of the “Don’t Kill White People Rule.” The birth of the Feds obsession with the “Opioid Epidemic” would lead a wise man to conclude the two things are related.

 

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Actemra Research Suggest Congestive Heart Failure Warning Needed

A clinical study conducted by the maker of Actemra (tocilizumab), comparing the drug to its competitor, Enbrel (Etanercept), strongly indicates that a warning on the Actemra Label related to congestive heart failure is warranted.

In the study (see below) Hoffman La Roche compared Actemra to Enbrel. The goal of the study was to demonstrate that Actemra was not inferior to Enbrel.


 

The study demonstrated that patients using Enbrel suffered less adverse events in general however, for the purpose of this article one particular adverse event caught our attention.  The Hoffmann-La Roche study demonstrated that patients taking Actemra experienced congestive heart failure at essentially the same rate as those taking Enbrel with a statistically insignificant difference. One should also take into account that Hoffman-La Roche or those in their employ designed the rules of this “contest” as well as served as “referee”.

 

Whats the big deal?

The study conclusions become significant upon a review of the Black Box Warnings and Warnings and Precautions sections of Actemra and Enbrels FDA approved labels.  Enbrel  warns of Congestive Hearth Failure risks in the Warnings and Precautions section of their warning label and Acterma does not.  Given the fact that Hoffman La-Roache took it  upon themselves to stage this contest against Enbrel (with no input from the makers of Enbrel) and in the process discovered that their product carried essentially the same risk of Congestive Heart Failure (CHF) as Enbrel, Hoffman La-Roache would need to add the same warning related CHF in order not to be inferior to Enbrel.

Reasonably, if two competing drugs put patients at essentially the same risk of an AE and one drug warns potential users related to that AE and the other drug does not, the drug that does not warn is inferior. Given Hoffman La-Roache purpose was to prove non-inferiority to Enbrel, it would seem they may have achieved the opposite. Can theActemra Label be considered truthful and non misleading without a congestive heart failure warning given these facts or are they gaining an unfair advantage over Enbrel by withholding information from their warnings?

From out observations, it would appear that the study demonstrated higher risks for Actemra in most of the cardiac events observed. CHF caught our attention because Enbrel warns and Actemra does not.

Other important observations arose from the research conducted by Mass Tort Nexus specific to the study as well as the differences in the two product labels. Other observations will be covered in separate articles.

See the Black Box and Warnings and Precautions sections of the labels for both drugs below.  We believe these to be the most current versions.

 

 

 

 

 

 

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Actemra Adverse Events

Actemra Emerging Mass Tort Litigation Preliminary Adverse Event Reports

The following article addresses reports related to adverse events and  medical conditions potentially related to the use of the Rheumatoid arthritis drug Actemra. The article will cover a report published by STAT which identified 5 major adverse events (AEs)  and medical conditions  (MCs) potentially caused by Actemra. We will also cover a larger number  serious AEs and MCs potentially related to the use of Actemra identified by Mass Tort Nexus using our proprietary adverse event indicator algorithm.

The AEs and MCs identified by Stat as well as Mass Tort Nexus only include those arguably not warned of on the product label in the Unitied States.

The report  from Stat was recently published in June 2017. The stat report linked Actemra to the following AEs and MCs:

  • Heart Attack
  • Stroke
  • Heart Failure
  • Interstitial Lung Disease
  • Pancreatitis

The Mass Tort Nexus (MTN) investigation has thus far identified the following AEs and MCs potentially linked to Actemra.  It should be noted that the MTN report is based on a partially automated process in addition to traditional research as a result, the MTN investigation into any medical device or drug is essentially always ongoing. The following is MTNs list:

  • Interstitial lung disease
  • Death
  • Stroke
  • Myocardial infarction, Congestive Heart Failure and other Cardiac Disorders
  • Acute Myelomonocytic Leukemia
  • Bone marrow failure
  • Synovitis
  • Increase in required knee replacements resulting from synovitis
  • Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome
  • Psoriasis
  • Psoriatic arthritis
  • Pancreatic cancer
  • Malignancies

The remainder of this article will briefly define the conditions (not commonly known) we have identified as being potentially caused by the use of Actemra as well as our reasoning for the inclusion of theses AEs and MCs on our current list.

Interstitial lung disease

Interstitial lung disease describes a wide range of disorders which result in progressive scarring of the tissues of the lungs. Common among all of these disorders is decreased profusion (inability to breathe).

Mass Tort Nexus included Interstitial lung disease in our findings primarily based on the extremely large number of adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries.

It should be noted that Interstitial lung disease is a common co-morbidity factor in RA patients. Although early indications lead us to believe that the use of Actemra increases the risk of Interstitial lung disease above the baseline for RA patients in general, our research into this matter is ongoing.

Death

Although it is unclear why Actemra users experience a higher death rate than RA patients using other therapies, there is a strong indication that death does in fact occur more frequently in the Acterma user group. This conclusion was based on adverse event reports which have been filed with the FDA as well as  regulatory agencies in other countries as well as other factors.

Myocardial Infarction, Congestive Heart Failure and other Cardiac Disorders

The inclusion of MI, CHF and Cardiac Disorders in general was based in part on the drug manufacturers on Clinical Research used to gain FDA approval as well as case reports from sources world wide. This research is also supported by adverse event reporting data.

Acute Myelomonocytic Leukemia

Acute myelomonocytic leukemiais a form of acute myeloid leukemia that involves a proliferation of CFU-GM myeloblasts and monoblasts. Acute myeloblastic leukemia  is a group of malignant bone marrow neoplasms of myeloid precursors of white blood cells.

The inclusion of Acute myelomonocytic leukemiais is based on adverse event report reviews and case reports as well as other published literature deemed reliable.

Synovitis and Increased Knee Replacements

Synovitis describes inflammation of the synovial membrane. This membrane lines joints cavities, known as synovial joints.

Our inclusion of Synovitis and Increased Knee Replacements on this list was a result of adverse event report reviews as well as other data that we believe demonstrates a correlation between the use of Actemra and Synovitis leading to an increased number of knee replacements.

Bone Marrow Failure

Bone marrow failure occurs in individuals who produce an insufficient number of red blood cells, white blood cells or platelets.

Our inclusion of Bone Marrow Failure on this list is based on our adverse event report reviews as well as other indicators. Our inclusion on this list is also based on the significance of the disorder itself. Bone Marrow Failure can lead to a vast number of secondary conditions, may of which are fatal. If further research demonstrates that Actemra causes bone marrow failure (not simply is correlated to bone marrow failure), the significance for existing Actemra users as well as future potential Actemra users could actually be life or death.

Psoriasis and  Psoriatic arthritis

It is worth noting that other drugs such as Humira, also approved to treat RA are additionally approved for the treatment of Psoriasis. In the case of Actemra, there is some indication from case studies, adverse event report reviews as well as published articles from authoritative sources that Actemra may increase the risk of developing psoriasis. This may explain why Roche has not sought approval (as is the case with many RA drugs) for the treatment of Psoriasis given that the market for Psoriasis treatments is exponentially larger than the market for RA treatments.

The inclusion of  Psoriatic arthritis on our list is based solely on the well established fact that a significant percentage of patients that develop Psoriasis will eventually develop Psoriatic arthritis as a secondary condition.

Demyelinating Disorders such as Multiple Sclerosis and Guillain-Barre syndrome

Demyelinating disorders include  any condition that results in damage to the protective covering (myelin sheath) that surrounds nerve fibers in your brain and spinal cord. Damage to the myelin sheath results in the slowing of nerve impulses and can lead to a number of neurological problems.

Our inclusion of Demyelinating Disorders is based on a Dear Health Care Provider Letter sent to health care providers in 2013, warning of several conditions potentially related to or caused by the use of Actemra. All but two of these conditions have been added to the Actemra Label with the exclusion of Demyelinating Disorders and malignancies.  Indications from our review of adverse event reports also justifies Demyelinating Disorders inclusion in this list.

Malignancies

A malignancy is simply the presences of a cancerous tumor.

Our reason for inclusion of Malignancies in this list is in part based on the Dear Health Care Provider Letter referenced above for the same reasons we included Demyelinating Disorders. There is also support for AEs related to Cancer and Actemra in the review of adverse events, case reports and other reliable literature.

Pancreatitis and Pancreatic Cancer

Our inclusion of Pancreatitis in this list is based on a review of adverse event reports, case reports as well as literature from sources deemed to be reliable.

Our inclusion of pancreatic cancer in this list is based on the well established fact that patients that suffer from Pancreatitis are at an increased risk for pancreatic cancer. Although the number of patients that develop pancreatic cancer secondary to pancreatitis is relatively small, the fact that pancreatic cancer is generally fatal, we feel its inclusion on this list is warranted.

Correlation vs Causation

It is important to note that neither the Stat Report nor the information reported in this article are sufficient to indicate that Actemra causes any of the AEs or MCs listed.  The report and this article observe correlations.  Discovering correlation is a necessary step towards determining causation however, correlation alone does not prove causation.

Even if Actemra does cause every AE and MC listed in the Stat Report and this article, the evidence to prove this causation may never come into existence.  The drug maker has little incentive to fund clinical studies to prove their product causes an adverse event. Developing proof of causation for any AE or MC is largely dependent unintended  outcomes of studies the drug maker may still have motive to publish or information developed by the FDA or FDA equivalents in other countries.

In our opinion, to date,  the strongest causation evidence exists for the following AEs and MCs:

Heart Disorders, including Congestive Heart Failure and Myocardial Infarction.

Demyelinating Disorders

Malignancies

Pancreatitis

As our investigations continue, we are highly likely to find additional evidence related to the AEs and MCs listed as well as others. We expect to be publishing information related to Actemra for the next several years.

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

John Ray
“The decisions made in the boardroom of pharmaceutical companies with regard to settling mass litigation cases often have very little to do with the ‘legal’ aspects of the case, and although bellwether trials results are not insignificant, they are not as significant as one might assume.”

Within minutes of the defense verdict being handed down in the first Xarelto bellwether trial, (Boudreaux vs Bayer et.al., Case No. 2:14-cv-02720) the phone lines at Mass Tort Nexus began ringing like a Salvation Army donation site at Christmas.

The primary inquiry was the same: “What effect does the Boudreaux defense verdict have on the overall prospects of the Xarelto litigation?”

Our website www.masstortnexus.com already contained all of the pretrial documents for the Boudreaux case and we ordered an expedited copy of the Boudreaux transcript so that our researchers could get the complete picture and start an autopsy of the case.

If you are a Mass Tort Nexus subscriber you may obtain all documents, including the 1,600+ page transcript from the Boudreaux bellwether trial here.

Before going further, it is important to say to any plaintiff lawyer representing clients in the Xarelto litigation who may be freaking out due to the defense verdict in the first bellwether trial: put the cap back on the Xanax.

In fact, the plaintiff may well lose the second bellwether trial as well, because it appears that the Dr. St. James, the prescribing physician in the Orr case (the second Xarelto bellwether trial set for May 30, Joseph Orr, Jr., Case No. 2:15-cv-03708), is likely to testify in a very similar manner to Dr. Wong, (the prescribing physician in the Boudreaux bellwether case).

Regardless, keep your feet firmly planted on the rail of that bridge you may be thinking of jumping off of. Panic would be extremely premature.

Mass Tort Nexus became aware of how Dr. Wong and Dr. St. James were likely to testify as a result of the motion for summary judgment based on the learned intermediary doctrine filed by the defense revealing deposition testimony of Dr. Wong and Dr. St. James. Both prescribing physicians testified as if someone had given them a script entitled “How a prescribing physician should testify to support a learned intermediary doctrine defense.”

The defense motion for summary judgment was denied as under Louisiana’s version of the learned intermediary doctrine, because the relevant issues are considered matters for a jury to decide under Louisiana Law.  Louisiana law applied because both the Boudreaux and the Orr case state of “original jurisdiction” was Louisiana. This had nothing to do with the fact that the MDL is consolidated in Louisiana nor will Louisiana law apply to cases where other states would be the state of “original jurisdiction.”

The Answer to the $64,000 Question

The simple answer to the question, regarding the defense verdict in the first Xarelto bellwether, is that the Boudreaux verdict has no direct impact on any other case other than the case brought on behalf of Joseph Boudreaux.

As to the indirect impact Boudreaux verdict on the overall Xarelto litigation, the analysis must be broadened.

First, the fact that defense based its entire strategy on the learned intermediary doctrine, could be somewhat telling about the defendants and their counsel’s belief that they would prevail under other defense theories. The learned intermediary doctrine is considered by many to be a defense of last resort. When possible, the goal of defendants in pharmaceutical and medical device cases should be to obtain dismissal of every single plaintiff’s case in a mass litigation via preemption or other universal case-killer legal theory. This goal will never be achieved through the learned intermediary doctrine defense.

The learned intermediary doctrine provides that a manufacturer of a product has fulfilled his duty of care when he provides all the necessary information to a “learned intermediary” who then interacts with the consumer of a product.

Although most states have codified some version of the doctrine and the reasoning behind it has been applied in individual cases in all 50 States, it is safe to say that not all states have applied the doctrine in the same manner.

More important is that the learned intermediary doctrine defense is entirely dependent on the testimony of the individual prescribing physician in any given plaintiff’s case. To prevail with the learned intermediary doctrine defense, the prescribing physician must testify, very specifically, in one of two manners:

  1. That the doctor was aware of all the risks associated with the drug and continued to believe that the benefits outweighed the risks with regard to the individual plaintiff (patient).
  2. That any risk not known at the time the doctor prescribed the drug, if known, would not have changed her decision with regard to prescribing the drug for the individual plaintiff patient.

16,285 additional complaints

Plaintiffs and their counsel can safely assume that many of the prescribing physicians for the 39 remaining scheduled Xarelto bellwether cases will not all testify in a manner supporting a learned intermediary doctrine defense. Beyond the 39 bellwether cases, defense has 16,285 (and climbing) additional complaints to contend with. Are all the prescribing physicians in the other 17,000 plus complaints going to fiddle to the music of the learned intermediary doctrine defense? Not bloody likely.

In the Xarelto bellwether trial selection, Judge Eldon Fallon allowed the defense to pick 10 cases, allowed the plaintiffs to pick 10 cases and Judge Fallon selected the remaining 20 cases himself. Plaintiffs are not facing a situation where defense was able to load the bellwether selection with cases in which the individual prescribing physicians gave depositions or otherwise indicated that they would eventually testify by the script the defendants need to prevail under a learned intermediary defense.

In cases where the prescribing physician cannot be counted on to follow the defendants’ learned intermediary doctrine script, the defendant and counsel will be forced to base their arguments on the merits of the case. Without the learned intermediary doctrine knockout, the merits of the Xarelto case favor defense looking as if it was in a fight with Joe Frazier followed by a fight with Mike Tyson.

Putting aside the foregoing, a review of past MDL pharmaceutical product liability bellwether verdicts in which defense has prevailed in the first trial and often in the majority of the bellwether cases may allow some plaintiff lawyers to put the first Xarelto bellwether defense verdict in perspective and take comfort.

39 bellwethers to go

Note: If the prescribing physician takes the stand wearing a Rolex with the defendants’ logo inscribed on the back, no matter how good the case or counsel may be, the plaintiff is probably not going to fare well. Fortunately, in the Xarelto litigation, there are 39 more bellwether trials to go.

If the defense does not settle those 39 cases, there will likely be more bellwethers scheduled. If Judge Fallon at some point determines that the litigation is not going to result in settlement, he could remand all remaining cases for trial.

The only other possible outcome is for the defense to find a way to get all Xarelto cases dismissed on a creative legal theory (which does not exist in the Xarelto case). It is safe to say, we are past the point where all Xarelto cases will be universally dismissed under any legal theory.

Anyone who has attended the Four Days to Mass Tort Success Course has heard me say, “The decisions made in the boardroom of pharmaceutical companies with regard to settling mass litigation cases often have very little to do with the ‘legal’ aspects of the case and although bellwether trials results are not insignificant, they are not as significant as one might assume.”

What is the likely future of the Xarelto bellwether trials? The defense will win some, the plaintiffs will win some and in the final analysis, these wins and losses will not be the primary factor in the defendant’s decision to settle the case. We apologize to anyone who was under the false impression that Big Pharma makes any decision that is not based on the bottom line, including their decision to put dangerous products on the market in the first place. Ultimately it is unlikely that a scenario will appear where the math for the defendant will not favor mass settlement.

Below is a sampling of cases where the first bellwether trial resulted in a defense verdict or the majority of bellwether trials resulted in defense verdicts and yet, the litigation ended in mass settlement.

Bellwether Defense Wins and Settlements

Vioxx MDL 1657

Of the six bellwether trials that occurred in the Vioxx MDL the first bellwether trial ended in a defense verdict. The other five bellwether trials ended in three more defense verdicts, one trial ended in a hung jury and the plaintiffs won only one of the six bellwether trials. Ten additional trials occurred outside of the MDL. Of the total 16 trials that occurred in the Vioxx product liability litigation, 11 resulted in defense verdicts.

The defendant ultimately agreed to settle the vast majority of Vioxx cases for an estimated $4.8 billion.

72 Defense firms participated in the Vioxx product liability defense. According to documents filed on behalf of these firms, the total hours billed for all firms was 350,000 hours. Using a blended rate including averages for partners, associates and other personnel of $475 per hour. The defendant’s legal fees were about $165,550,000.

If you are doing the math, inclusive of the legal fees paid for the defendant’s legal fees in the MDL and the 16 Vioxx trials, the defendant spent on average $10,343,750 per tried case. Winning does not feel that great when your own lawyers dip their hands deeper into your pocket than the opposition.

MDL 1355 Propulsid

The first bellwether trial resulted in a defense verdict. The second and third bellwether trials resulted in defense motions for summary judgment being granted.

The defendant Johnson & Johnson ultimately settled with the majority of the plaintiffs in the Propulsid litigation for an estimated $100 million.

Prempro Product Liability Litigation

The first bellwether trial resulted in a defense verdict. The defendant went on to win the majority of the 15 bellwether trials.

Ultimately the defendant settled the vast majority of the plaintiffs’ cases for about $1 billion.

NuvaRing Litigation Product Liability Litigation MDL 1964

Defense summary judgment granted in all Group I bellwether cases. The defendant agreed to settle the majority of NuvaRing cases for approximately $100 million.

Traysol Product Liability Litigation MDL 1928

The first two bellwether trials were dismissed on a defense motion for summary judgment. The defendant Bayer ultimately settled the Traysol Litigation for an average of approximately $400,000 per plaintiff.

Actos Product Liability Litigation MDL 2299

The first three bellwether trials resulted in plaintiff’s verdicts with jury awards of $6.5 million, $1.76 million and $2.05 million. The fourth bellwether trial resulted in a defense verdict. Takeda settled Actos cases for a total of approximately $2.4 billion.

Fen-Phen Product Liability Litigation MDL 1023

Despite having prevailed in many bellwether trials including Weston v. Wyeth, No. 03-CV-679878 (Jasper Co., Mo., Cir. Ct. 2006). Geers v. Wyeth, No. MO-03-CA-107-H (W.D. Texas 2006), Townley v. Wyeth, Nos. 0402-03094 and 0402-03171 (Philadelphia Co., Pa., Ct. C.P. 2006), Smith v. American Home Products, No. 97-55545 as well as others — Wyeth ultimately settled the Fen-Phen Litigation for approximately $2.74 billion.

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Holding Brand Name Drug Makers Liable for Generic Versions

Today, nearly 8 in 10 prescriptions filled in the US are for generic drugs, according to the FDA. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent.

But who is liable when a generic drug makes sells a bioequivalent drug to a patient who suffers a personal injury from taking it?

Two US Supreme Court cases insulate the generic makers from responsibility, so long as they included the branded drug maker’s warnings. But now courts in California, Vermont, and Illinois have accepted the notion of “innovator liability,” imposing liability on the branded drug maker for injuries caused by a generic drug equivalent.

Research shows that generics work just as well as brand-name drugs. A study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. See JAMA. 2008;300(21)2514-2526.

The FDA says that any generic drug modeled after a single, brand name drug must perform about the same in the body as the brand-name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product.

Immunizing generic drug makers

California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.

Two notorious US Supreme Courts rulings have immunized generic drug makers from liability in product liability and failure to warn claims.

  • PLIVA, Inc. v. Mensing, 564 U.S. 604  (2011), holds that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, state-law tort claim alleging a failure to provide adequate warning labels.
  • Mutual Pharmaceutical Co. v. Bartlett, 570 US 2468 (2013), holds that generic drug manufacturers cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.

However, in California, Vermont, and Illinois, these rulings did not protect branded manufacturers from innovator liability claims, because the companies controlled the text of the warning labels.

Plaintiffs argue that the physicians “reasonably and foreseeably” relied on the representations of branded manufacturers when prescribing a generic drug, because physicians understood that generics are bioequivalent to and have the same labeling as branded drugs.

In the event that the branded manufacturer made misrepresentations or engaged in other unlawful activities such as “off-label” marketing, plaintiffs further argue that physicians relied on the branded manufacturers’ misrepresentations, understood that generics are bioequivalent to the branded product, and prescribed the generic based on the branded manufacturers misrepresentations.  

Innovator liability

Only California, Vermont, and Illinois state law rulings impose liability on the original drug company innovator for injuries caused by a generic drug equivalent.

California

Conte v. Wyeth, 168 Cal.App.4th 89, 85 Cal.Rptr.3d 299 (2008), involved a user of generic metoclopramide who brought an action against Wyeth, the manufacturer of Reglan, the name-brand form of metoclopramide, for fraud, fraud by concealment, and negligent misrepresentation.

The court of appeals held that Wyeth’s common-law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent.

In T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768 (Cal. App. 2016), the court of appeals imposed innovator liability in perpetuity − for injuries occurring even after an innovator manufacturer had sold all rights and left the relevant market altogether.

Note: This decision is currently under appeal. If Novartis wins this appeal Conte would not be overturned, innovator liability would simply end at the point (if) the brand manufacturer discontinued the marketing of the brand drug.

Vermont

Vermont chose to recognize innovator liability in Kellogg v. Wyeth, 762 F. Supp.2d 694 (D. Vt. 2010). The plaintiff filed suit against the brand name and generic manufacturers of metoclopramide for strict product liability, breach of express and implied warranties, negligent misrepresentation, fraud and fraud by concealment.  

A federal court interpreted state law, imposing a duty on Wyeth because it was “fair” to do so, and there is no reason, under Vermont law, to limit defendant’s duty of care to physicians by the pharmacist’s choice of a generic bioequivalent.

Illinois

Dolin v. SmithKlineBeecham Corp., 62 F. Supp.3d 705, was a wrongful death action against SmithKline Beecham Corporation involving a man who committed suicide after taking paroxetine, the generic version of Paxil.

A federal court interpreted Illinois law to impose a duty of reasonable conduct upon GSK. The plaintiff’s common law negligence and negligent misrepresentation claims survived summary judgment.

Note: Under Illinois law a product liability claim under an innovator liability theory would likely fail where as a negligence claim would survive.

Innovator Liability and Zofran

In an unusual move, Judge Dennis Sailor presiding over MDL 2657, has approved two master complaints, one for branded drug use and a separate Master Complaint for plaintiffs that wish to pursue GSK under innovator liability theories.

Judge Sailor is overseeing 364 lawsuits in MDL 2657 in federal court in Massachusetts, IN RE: Zofran (Ondansetron) Products Liability Litigation.

The most significant difference in the Zofran Brand Master Complaint and the Zofran Generic Master Complaint is in paragraph 101 of the generic master complaint:

101. Defendants knew or should have known that consumers such as Plaintiffs would foreseeably use the generic bioequivalent of Zofran and rely upon representations and omissions of Defendants as the holders of the NDA for Zofran.

Although the Master Complaint does not contain language that limits its use to claims governed by the laws of the three “innovator liability states,” the defense is free to argue these claims based on the laws of the state of original jurisdiction.  For states that do not have settled caselaw related to innovator liability, it is likely that the defense will prevail in most cases.  

Mensing and Bartlett both turned on an “impossibility preemption argument,” in that is not possible for a generic manufacturer to legally alter the warning label. The generic label most conform exactly to brand label.

What if the brand drug manufacturer also makes a generic version of its own drug?  Obviously, the brand manufacturer would control both the brand label as well as the generic label under this circumstance and the impossibility preemption reasoning of Mensing and Bartlett would not apply.

Novartis purchased GlaxoSmithKline’s oncology division in March of 2015. Along with Glaxo’s cancer business came the right to sell Zofran. Novartis also owns Sandoz, which manufacturers a generic version of Zofran. Therefore there is a strong argument that Mensing and Bartlett do not provide protection for Zofran Generics made by Sandoz after May 2015.

 

 

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FDA Recommends Against the Use of Ovarian Cancer Screening Test

Ovarian-CancerOn September 7, 2016 the FDA issued a letter to physicians as well as the public recommending against the use of screening tests for Ovarian Cancer. Below are excerpts from the FDA recommendation:

“The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. Based on currently available information, the FDA recommends against using currently offered tests to screen for ovarian cancer.”

“Despite extensive research and published studies, there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer without a high number of inaccurate results. However, over the years, numerous companies have marketed tests that claim to screen for and detect ovarian cancer. For example, recently, Abcodia Incorporated began marketing the Risk of Ovarian Cancer Algorithm (ROCA) test in the United States, with claims that the ROCA test can screen for and detect ovarian cancer before symptoms appear and increase the chance for survival. Yet, available data do not support its claims.”

“Some women may receive test results that suggest ovarian cancer even though no cancer is present (a false­ positive). These women may undergo additional medical tests and/or unnecessary surgery, and may experience complications related to both. Or, test results may not show ovarian cancer even though cancer is present (a false­ negative), which may lead women to delay or not seek surgery or other treatments for ovarian cancer.”

How many women Have Been Harmed by Inaccurate Test?

Ovarian Cancer Test Kits have been added to the Mass Tort Nexus Watch List for Emerging Litigations for 2017. This topic will be discussed at the November 11th-14th 2016  Mass Tort Nexus “Four Days to Mass Tort Success Course . ”

 

 

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