Xarelto Settlement Faces Legal Challenge

As the Xarelto Defendants continue to move to dismiss plaintiffs cases, utilizing the dismissal machine, created by Case Management Orders,  apparently stipulated to by certain members of the Xarelto Plaintiffs Steering Committee, other attorneys continue to aggressively fight for their clients.

Despite the fact that it appears these certain members of the Xarelto Plaintiff Steering Committees interest are now more aligned with the defendants than the Plaintiffs they purport to represent, other firms not on the PSC are pushing back.

Below is a copy of a motion that was filed challenging the propriety of  dismissals with prejudice based on the various “settlement orders” as well as the fact that the “settlement orders” have in essences created an unlawful opt in requirement. These arguments might be useful to firms in filing motions for reconsideration under FRCP 60 related to cases that have already fallen victim to the dismissal machine.

Motions have also been filed challenging the Xarelto MDL Courts subject matter jurisdiction (asserting the MDL Court lacks subject matter jurisdiction) over the private settlement agreement and thus lacks subject matter jurisdiction to enter orders to assist the parties in effectuating the terms of the settlement agreement (those orders I refer to as the “dismissal machine”.) I will cover the subject matter jurisdiction issues in other posts.

Below is the text of the motion mentioned above:

 

PLAINTIFFS’ OBJECTIONS TO SHOW CAUSE ORDERS

INTRODUCTION

In its Show Cause orders, this Court has stated that the Plaintiffs’ causes of action will be dismissed with prejudice as a penalty for Plaintiffs’ failure to submit an Enrollment Election Formand/or a Notice of Intent to Proceed. [Doc. 16218, Order Rescheduling Hearing to Show Cause; Doc. 15416, Order to Show Cause Regarding Plaintiffs Who Have Failed to Comply with CaseManagement Order 12A; Doc. 14877, Case Management Order 12A]. Pursuant to CMO 12A, only voluntary dismissals with prejudice are allowed. [Doc. 14877, Page 2 of 2.]

Plaintiffs on the attached Exhibit 1 (“Objecting Plaintiffs”), through undersigned counsel, object to the dismissal of their cases. Exhibit 1-A is a list of Plaintiffs who need more time to make an election, and Exhibit 1-B are a list of Plaintiffs who have made an election deemed deficient by BrownGreer. Objecting Plaintiffs’ cases should not be dismissed for four reasons. First, the prerequisites for the harsh remedy of dismissal with prejudice have not been met. Second, because there is no class certification, Plaintiffs are non-parties to the settlement and have no obligation to respond. Third, requiring that Plaintiffs undertake procedural hoops or face dismissal is akin to imposing an “opt in” class requirement, and as such is forbidden by operative law. Fourth, requiring a category of individuals in ill health to appear, in addition to the appearance of their counsel, as a penalty for not responding to a settlement offer not directed to them or presented in their individual cases is unreasonable.

ARGUMENT AND AUTHORITIES

The Prerequisites for Imposing the Harsh Remedy of Dismissal with Prejudice Have Not Been Met.

Federal Rule of Civil Procedure 41(b) provides, “if the plaintiff fails to prosecute or to comply with these rules or a court order, a defendant may move to dismiss the action or any claim against it.” Interpreting the Federal Rules of Civil Procedure, the jurisprudence has strictly circumscribed the instances in which a case can be dismissed with prejudice.

Dismissal with prejudice is “an extreme sanction that deprives a litigant of the opportunity to pursue his claim.” Gonzalez v. Firestone Tire & Rubber Co., 610 F.2d 241, 247 (5th Cir.1980). “Dismissal with prejudice is appropriate only when there is ‘a showing of (a) a clear record of delay or contumacious conduct by the plaintiff, and (b) where lesser sanctions would not serve the best interests of justice.’” Griggs v. S.G.E. Mgmt., L.L.C., 905 F.3d 835, 844 (5th Cir. 2018) (quoting Gates v. Strain, 885 F.3d 874, 883 (5th Cir. 2018); further citation omitted). These are long standing requirements recognized in this Circuit. Rogers v. Kroger Co, 669 F.2d 317, 320 (5th Cir. 1982) (“This circuit has consistently held that Rule 41(b) dismissals with prejudice will be affirmed only upon a showing of a clear record of delay or contumacious conduct by the plaintiff, …, and where lesser sanctions would not serve the best interests of justice.”) (collecting cases; internal quotes omitted); Gonzalez, 610 F.2d at 247 (“we have consistently held that dismissal with prejudice is warranted only where a clear record of delay or contumacious conduct by the plaintiff exists, . . . and a lesser sanction would not better serve the interests of justice.”) (collecting cases; quotation marks omitted). “Because this test is conjunctive, both elements must be present.” Coleman v. Sweetin, 745 F.3d 756, 766 (5th Cir. 2014) (footnote omitted).

“In addition, [the appeals court] generally affirm[s] dismissals with prejudice only upon a finding of at least one of three aggravating factors: ‘(1) delay caused by [the] plaintiff himself and not his attorney; (2) actual prejudice to the defendant; or (3) delay caused by intentional conduct.’” Coleman, at 766 n. 9 (quoting Price v. McGlathery, 792 F.2d 472, 474 (5th Cir.1986)); see also Millan v. USAA Gen. Indem. Co., 546 F.3d 321, 326 (5th Cir. 2008) (“where this Court has affirmed dismissals with prejudice, it has generally found at least one of three aggravating factors: ‘(1) delay caused by [the] plaintiff himself and not his attorney; (2) actual prejudice to the defendant; or (3) delay caused by intentional conduct.’”) McGlathery, 792 F.2d at 474). Put another way, “[b]efore an action can be dismissed with prejudice under Rule 41(b), two ‘requisite’ factors must be present and a third ‘aggravating’ factor usually should be present.” Springboards to Educ., Inc. v. Kipp Found., 325 F. Supp. 3d 704, 710 (N.D. Tex. 2018) (quoting Sealed Appellant v. Sealed Appellee, 452 F.3d 415, 417-18 (5th Cir. 2006)).

“Generally, where a plaintiff has failed only to comply with a few court orders or rules, [the appeals court has] held that the district court abused its discretion in dismissing the suit with prejudice.” Berry v. CIGNA/RSI-CIGNA, 975 F.2d 1188, 1192 n.6 (5th Cir. 1992) (collecting cases); see also Vafaiyan v. Target Inc., 251 F. App’x 862, 864 (5th Cir. 2007) (quoting same and finding that dismissal was abuse of discretion where plaintiff failed to correct deficiency).

The Objecting Plaintiffs’ cases cannot be dismissed with prejudice for three, independent reasons: 1) a clear record of delay or contumacious conduct does not exist; 2) lesser sanctions would serve the best interests of justice; 3) there are no aggravating factors, making this remedy impermissibly draconian.

Plaintiffs are not guilty of clear delay or contumacious conduct.

“[D]elay which warrants dismissal with prejudice must be longer than just a few months; instead, the delay must be characterized by significant periods of total inactivity.” Bullard v. Burlington N. Santa Fe Ry. Co., 368 F. App’x 574, 581 (5th Cir. 2010) (quoting Millan v. USAA Gen. Indem., supra, 546 F.3d at 326-27; further citation and quotation marks omitted). The Bullard court found that, notwithstanding the district court’s evident frustration with plaintiffs, the court could not affirm a de facto dismissal with prejudice because there was an insufficient record of contumacious conduct. 368 F. App’x at 581-82. The court explained that “it is not a party’s negligence—regardless of how careless, inconsiderate, or understandably exasperating—that makes conduct contumacious.” 368 F. App’x at 581 (quotingMillan, 546 F.3d at 327).

The Coleman court reversed a dismissal with prejudice where the plaintiff failed to provide an address for the defendant, explaining that “negligent behavior” fails to rise to the level of material delay or contumacious conduct so as to justify dismissal with prejudice. 745 F.3d at 767. The Millan court similarly reversed dismissal, where the plaintiff failed to effect timely service, explaining that, “it is not a party’s negligence—regardless of how careless, inconsiderate, or understandably exasperating—that makes conduct contumacious; instead it is the ‘stubborn resistance to authority’ which justifies a dismissal with prejudice.” 546 F.3d at 327 (quoting McNeal v. Papasan, 842 F.2d 787, 792 (5th Cir.1988); further citation omitted).

The Gonzalez court reversed the trial court’s dismissal, reasoning that, “[t]he failure of plaintiffs counsel to obtain admission to the bar of court and to appear at the pre-trial conference did not amount to a clear record of delay or contumacious conduct.” 610 F.2d at 248 (quotation marks omitted). See also Hurman v. Port of Houston Authority, 990 F.2d 626 (5th Cir. 1993) (district court abused its discretion by involuntarily dismissing suit for failure to prosecute where plaintiff had failed to file a pretrial order and had failed to appear at docket call); Mosher v.

Keanster, 343 F. App’x 994, 995 (5th Cir. 2009) (failure to appear for a scheduling conference did not warrant dismissal; dismissal vacated and remanded).

Dismissal with prejudice does not serve the best interests of justice.

Even assuming for the sake of argument that the plaintiffs’ omissions could be characterized as “contumacious,” this does not compel the conclusion that the conduct requires immediate resort to the harshest of sanctions. Raborn v. Inpatient Mgmt. Partners Inc., 278 F. App’x 402, 406 (5th Cir. 2008) (“Even if it could be characterized as ‘contumacious,’ it is not the type of conduct that requires immediate resort to ‘the harshest of sanctions….’”) (quoting Porter v. Beaumont Enterprise and Journal, 743 F.2d 269, 272 (5th Cir.1984)). Failure to comply with a district court order does not establish that a lesser sanction would be futile. See Campbell v. Dretke, 261 F. App’x 702, 704 (5th Cir. 2008) (where plaintiff failed to comply with court order to re-file his complaint in compliance with proper form, court vacated and remanded dismissal, noting that there was no determination that lesser sanctions would not prompt diligent prosecution).

No aggravating factors exist.

There is no basis for finding that the victims of Xarelto have caused the delay here, or that they have acted intentionally. In stark contrast, they are not aware of the proceedings and/or are unable to complete the requisite paperwork due to factors other than intentional recalcitrance. See Exhibit 1, Declaration of Charlotte Long. Exhibit 1-A hereto identifies efforts to reach Objecting Plaintiffs, illustrating that their failure to comply with the Court-ordered procedures is not deliberate, and that the strong majority of these cases have only been on file for approximately six months. Exhibit 1-B hereto identifies Objecting Plaintiffs who intend to make an election that has been communicated to Brown Greer, but whose response has been deemed deficient. Under these circumstances, dismissal with prejudice as a penalty for failing to comply with the procedural requisites of the Show Cause order would be unduly harsh.

There is no showing of prejudice to the Defendants. The mere fact that reinstatement of the plaintiff’s case will require defendants to “expend funds necessary to present a defense” is not sufficient to establish prejudice. Raborn, 278 F. App’x at 407 (court abused its discretion in dismissing claim effectively with prejudice). See also Raymond v. Univ. of Houston, 275 F. App’x 448, 450 (5th Cir. 2008) (finding no aggravating factor and reversing dismissal notwithstanding negligence and a period of inactivity from April 16, 2006 to November 27, 2006; and from January 10, 2007 to March 26, 2007).

Because There Is No Certified Class, There Is No Obligation for Plaintiffs in Individually Filed Cases to Respond to a Global Settlement Agreement that Was Not Entered in, and Is Not Specific to, Them or Any of their Individual Cases.

Here, each Plaintiff has filed an individual case. The settlement is not a class action settlement. Moreover, there are serious constitutional impediments to certifying a class of individuals who have sustained personal injuries and/or death. See, generally, Amchem Products, Inc. v. Windsor, 521 U.S. 591 (1997); Ortiz v. FibreboardCorp., 527 U.S. 815 (1999).

In the absence of a certified class, the settlement documents at issue are not binding on these individual plaintiffs. Indeed, the Objecting Plaintiffs are non-parties to the settlement. The Defendants in the individually filed cases have not filed or presented a settlement offer addressed to, tailored to, or specific to the individual Objecting Plaintiffs or their cases. The settlement provides a grid. The Objecting Plaintiffs have not been informed where, on that grid, they fall according to the Defendants and according to BrownGreer. Therefore, there is no sum certain offer made to them at this time. There is no authority allowing dismissal as a penalty for failing to complete certain paperwork, to BrownGreer’s satisfaction, in response to a settlement offer that was not entered into the individual cases.

The Procedural Requirements Are Akin to Imposing an Opt-In Class Requirement, which Is Forbidden.

The Show Cause orders seek to punish the Objecting Plaintiffs for not satisfying the procedural requirements of a one-sided settlement offer that was not specifically directed toward any of the Objecting Plaintiffs, or their cases, individually. The law does not allow for certification of an “opt in” class imposing procedural hoops for class inclusion. Ackal v. Centennial Beauregard Cellular L.L.C., 700 F.3d 212, 216 (5th Cir. 2012) (quoting Kern v. Siemens Corp, 393 F.3d 120, 124 (2d Cir. 2004)). See also Clark v. Universal Builders, Inc., 501 F.2d 324, 340 (7th Cir. 1974) (“The requirement of an affirmative request for inclusion in the class is contrary to the express language of Rule 23(c)(2)(B).”); Shepardson v. Midway Indust., Inc., No. 3:18-CV-3105, 2019 WL 2743435, at *3 (W.D. Ark. July 1, 2019) (citing Ackal and Clark, and refusing to approve class settlement and notice); Dallas County, Tex. v. MERSCORP, Inc., 2012 WL 6208385, No. 3:11-cv-02733-0 (N.D. Tex. Dec. 13, 2012) (denying certification and citing Ackal as controlling authority); Maciel v. Bar 20 Dairy, LLC, No. 117CV00902DADSKO, 2018 WL 5291969, at *8 (E.D. Cal. Oct. 23, 2018) (applying Ackal, Kern, and Clark, and rejecting the plaintiffs’ argument that class members could be required to opt in to the Rule 23 action). The failure of the Objecting Plaintiffs to comply with the procedural hoops promulgated in this Court’s orders cannot be a basis for dismissal, because this is akin to imposing affirmative procedural actions to “opt in” to a class.

  1. The Appearance of Counsel at the Hearing Should Be Sufficient.

The Objecting Plaintiffs are elderly individuals in ill health, and it would not be easy, if even possible, for them to travel to New Orleans for a hearing. See Exhibit 1, Declaration of Charlotte Long. Even were each Objecting Plaintiffs’ individual case subject to a pretrial conference in his or her individual case, under Federal Rule of Civil Procedure 16, “the court may order the attorneys and any unrepresented parties to appear for one or more pretrial conferences.” FED. R. CIV. P. 16(a) (emphasis added). “If appropriate, the court may require that a party or its representative be present or reasonably available by other means to consider possible settlement.” Fed. R. Civ. P. 16(c)(1) (emphasis added). The Court’s Show Cause orders do not accept reasonable availability in that they require personal presence. This is not appropriate, particularly considering that the Defendants have not appeared in their individual cases to make an individual settlement offer in the first instance. Moreover, dismissal with prejudice is an unduly draconian penalty for a failure to appear in person. See, e.g., Hurman v. Port of Houston Authority, 990 F.2d 626 (5th Cir. 1993) (district court abused its discretion by involuntarily dismissing suit for failure to prosecute where plaintiff had failed to file a pretrial order and had failed to appear at docket call).

CONCLUSION AND PRAYER FOR RELIEF.

Wherefore, Objecting Plaintiffs on the attached Exhibit 1 respectfully request that this Honorable Court not dismiss their actions with prejudice, and for such other relief to which they may be entitled.

The case law cited in the motion can be accessed at the links below:

Amchem Products, Inc. v. Windsor

521 US 591, 117 S. Ct. 2231, 138 L. Ed. 2d 689 – Supreme Court, 1997 – Google Scholar

The United States District Court for the Eastern District of Pennsylvania certified the class for
settlement only, finding that the proposed settlement was fair and that representation and notice
had been adequate. That court enjoined class members from separately pursuing asbestos-related
personal-injury suits in any court, federal or state, pending the issuance of a final order. The Court
of Appeals for the Third Circuit vacated the District Court’s orders, holding that the class certification
failed to satisfy Rule 23’s requirements in several critical respects. We affirm the Court of …

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Ortiz v. Fibreboard Corp.

527 US 815, 119 S. Ct. 2295, 144 L. Ed. 2d 715 – Supreme Court, 1999 – Google Scholar

Like Amchem Products, Inc. v. Windsor, 521 US 591 (1997), this case is a class action prompted
by the elephantine mass of asbestos cases, and our discussion in Amchem will suffice to show
how this litigation defies customary judicial administration and calls for national legislation.
[1] In 1967, one of the first actions for personal asbestos injury was filed in the United States District
Court for the Eastern District 822 of Texas against a group of asbestos manufacturers. App. to
Pet. for Cert. 252a. In the 1970’s and 1980’s, plaintiffs’ lawyers throughout the country, particularly …

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Ackal v. Centennial Beauregard Cellular LLC

700 F. 3d 212 – Court of Appeals, 5th Circuit, 2012 – Google Scholar

On September 11, 2001, a group of cellular telephone customers filed suit in Louisiana state
court against its members’ respective service providers, including Defendants-Appellants Centennial
Beauregard Cellular LLC and its related entities (“Centennial“). The suit — which alleges causes …

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Kern v. Siemens Corp.

393 F. 3d 120 – Court of Appeals, 2nd Circuit, 2004 – Google Scholar

Rudolph KERN, And on behalf of the Estate of Erich Kern, Angela Kern, And on behalf of the
Estate of Erich Kern, John S. Habblett, LTC (Ret.), and on behalf of the Estates of Jennifer Kirkpatrick
Habblett Goodridge, Michael Jonclair Goodridge and Kyle William Goodridge, Suzanne K …

Cited by 91    How cited Related articles

 

 

Clark v. Universal Builders, Inc.

501 F. 2d 324 – Court of Appeals, 7th Circuit, 1974 – Google Scholar

… 1970), cert. denied, Universal BuildersIncvClark, 400 US 821, 91 S.Ct. 40, 27 L.Ed.2d
49 (1970) … Diamond v. Terminal Railway Alabama State Docks, 421 F.2d 228, 235-236 (5th
Cir. 1970) … [1] The builder of the homes was Universal BuildersInc …

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Clark v. Universal Builders, Inc.

706 F. 2d 204 – Court of Appeals, 7th Circuit, 1983 – Google Scholar

… See Clark, 501 F.2d at 337-39 … V … [1] Because of our acceptance of the district court’s finding as
to lack of comparability, we need not reach defendants’ contention that the Deerfield homes were
sold by a company which was not a predecessor of the defendant Universal …

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Clark v. Universal Builders, Inc.

409 F. Supp. 1274 – Dist. Court, ND Illinois, 1976 – Google Scholar

… The Court of Appeals, in Clark vUniversal BuildersInc., 501 F.2d 324 (7th Cir. 1974), reversed
Judge Perry and accepted Judge Will’s “exploitation theory” of § 1982 … Clark vUniversal
BuildersInc., 419 US 1070, 95 S.Ct. 657, 42 L.Ed.2d 666 (1974)) …

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Shepardson v. MIDWAY INDUSTRIES, INC.

Dist. Court, WD Arkansas, 2019 – Google Scholar

… the classes’ FLSA and AMWA claims, the Settlement Agreement notes that Midway agrees to …
being allocated to settlement class members, $2,000.00 being allocated to Dale Shepardson
as a … See, eg, Thompson v. Costco Wholesale Corp., 2017 WL 697895, at *8 (SD Cal. Feb …

 

Shepardson v. MIDWAY INDUSTRIES, INC.

Dist. Court, WD Arkansas, 2019 – Google Scholar

DALE SHEPARDSON, Individually and on Behalf of All Others Similarly Situated Plaintiff,
vMIDWAY INDUSTRIESINC.; TOOL STEEL SERVICE, INC; and TOOL STEEL SERVICE
OF CALIFORNIA, INC., Defendants. Case No. 3:18-CV-3105 …

 

Gonzalez v. Firestone Tire & Rubber Co.

610 F. 2d 241 – Court of Appeals, 5th Circuit, 1980 – Google Scholar

610 F.2d 241 (1980). Herman GONZALEZ, etc., Plaintiff-Appellant, vFIRESTONE TIRE &
RUBBER CO. et al., Defendants-Appellees. No. 77-3170. United States Court of Appeals, Fifth
Circuit. January 21, 1980. 242 David T. Lopez, Houston, Tex., for plaintiff-appellant …

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Gonzalez v. Firestone Tire & Rubber Co.

512 F. Supp. 1101 – Dist. Court, ED Texas, 1981 – Google Scholar

… within 90 days of the second right to sue letter, and that it was an abuse of discretion to dismiss
the plaintiff’s Section 1981 claim because his neglect did not amount to a “`clear record of delay
or contumacious conduct.'” Gonzalez vFirestone Tire & Rubber Co., 610 F.2d 241 …

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Griggs v. SGE MANAGEMENT, LLC

905 F. 3d 835 – Court of Appeals, 5th Circuit, 2018 – Google Scholar

… If the district court had not dismissed the case, it is unlikely that the parties would have understood
that Grigg’s response to … district court was well within its discretion to dismiss this case for want
of prosecution in response to Griggs’s disobedience to … [1] See Torres vSGE Mgmt …

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Griggs v. SGE MANAGEMENT, LLC

Court of Appeals, 5th Circuit, 2018 – Google Scholar

… If the district court had not dismissed the case, it is unlikely that the parties would have understood
that Grigg’s response to … district court was well within its discretion to dismiss this case for want
of prosecution in response to Griggs’s disobedience to … [1] See Torres vSGE Mgmt …

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Maciel v. BAR 20 DAIRY, LLC

Dist. Court, ED California, 2018 – Google Scholar

… Bar 20 DairyLLC, a California limited liability company, Defendant, represented by Jared Hague,
Sutton Hague Law Corporation, PC, Joseph Vidal Macias, Sutton Hague Law Corporation, PC,
S. Brett Sutton, Sutton Hague Law Corporation, PC & Wesley Lawrence Carlson …

 

Maciel v. BAR 20 DAIRY, LLC

Dist. Court, ED California, 2019 – Google Scholar

… Bar 20 DairyLLC, a California limited liability company, Defendant, represented by Jared Hague,
Sutton Hague Law Corporation, PC, Joseph Vidal Macias, Maxim Integrated Products, Inc., S.
Brett Sutton, Sutton Hague Law Corporation, PC & Wesley Lawrence Carlson, Sutton …

Coleman v. Sweetin

745 F. 3d 756 – Court of Appeals, 5th Circuit, 2014 – Google Scholar

Freddie R. COLEMAN, Plaintiff-Appellant v. David SWEETIN; Gregory Oliver; Richard
Cowan; Roy Brown, Sued in his official and individual capacity; Shelia Dale, Sued in her official
and individual capacity; Mae Cobbs, Sued in her official and individual capacity; Debbie
Erwin, Sued in her official and individual capacity; Craig Fisher, Sued in his official and individual
capacity; Blake Lamb, Sued in his official and individual capacity; Unknown McManus, Sued
in her official and individual capacity; Brenda Hough, Sued in her official and individual …

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Coleman v. Sweetin

Dist. Court, ED Texas, 2011 – Google Scholar

The lawsuit concerns the Plaintiff falling in the shower and his efforts to obtain medical care for
his injuries. The Plaintiff initially fell in the shower at the Eastham Unit trusty camp on June
14, 2009. He fell again in the same shower on June 20 and June 23, 2009. He testified that the
floor to the shower was slimy and unsafe. Before he ever fell, he submitted letters (“I-60s”) to
Maintenance Specialist Richard Cowan and Maintenance Supervisor Roy Brown about the conditions
in the showers, but they did not take steps to correct the problem. Wardens Sweetin and Oliver …

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Coleman v. Sweetin

Dist. Court, ED Texas, 2011 – Google Scholar

On October 5, 2011, the Plaintiff was ordered to submit the current address for McManus. He
was given twenty days from the receipt of the order to comply with it. He was informed that the
claims against McManus would possibly be dismissed if he failed to comply with the order. The
Court received an acknowledgment from the Plaintiff indicating that he received the order on
October 12, 2011. The Plaintiff was obligated to provide the current address for McManus by
November 1, 2011. He has not, however, provided her current address … On October 24 …

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Port of Houston Auth. v. INTERNATIONAL ORG. OF M., M. & P.

456 F. 2d 50 – Court of Appeals, 5th Circuit, 1972 – Google Scholar

… Bertram Perkel, New York City, Herman Wright, W. Arthur Combs, Houston, Tex., Schulman,
Abarbanel, Perkel … The exception sought by the Port Authority here is not within any existing
exception and is … freely to come with their vessels and cargoes to all places, ports and waters …

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Mosher v. KEANSTER

Dist. Court, SD Texas, 2010 – Google Scholar

Pending before the Court is pro se Plaintiff Gary Mosher’s (“Mosher“) motion for recusal.
(Doc. 36.) Also before the Court is pro se Defendant Douglas Jones’ (“Jones”) motion to dismiss
(Doc. 6), as well as Plaintiff Mosher’s response (Doc. 9) and Jones’ reply (Doc. 10). Although …

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Mosher v. KEANSTER

Dist. Court, SD Texas, 2010 – Google Scholar

Although Mosher’s motion for reconsideration requests relief pursuant to Rule 60 of the Federal
Rules of Civil Procedure, because Mosher filed his motion for reconsideration within twenty-eight
days of the Court’s order dismissing the case, the Court will apply the more liberal standard of …

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Mosher v. KEANSTER

Court of Appeals, 5th Circuit, 2011 – Google Scholar

The timing of Mosher’s notice of appeal raises an issue regarding this court’s jurisdiction, which
we must examine sua sponte. See Bailey v. Cain, 609 F.3d 763, 765 (5th Cir. 2010), cert.
denied, 131 S. Ct. 931 (2011). In a civil case, the filing of a timely notice of appeal is a jurisdictional …

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Mosher v. KEANSTER

Court of Appeals, 5th Circuit, 2009 – Google Scholar

We review a sua sponte dismissal for want of prosecution, which is authorized by Rule 41 of
the Federal Rules of Civil Procedure, for abuse of discretion. See McNeal v. Papasan, 842
F.2d 787, 789-90 (5th Cir. 1988). Because the judgment of dismissal did not specify whether …

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Dallas County, Tex. v. MERSCORP, INC.

2 F. Supp. 3d 938 – Dist. Court, ND Texas, 2014 – Google Scholar

Before the Court are the parties’ cross-motions for summary judgment filed November 12,
2013, on Plaintiffs’ request that this Court issue a declaratory judgment interpreting Section 192.007
of the Texas Local Government Code, the only remaining claim in this lawsuit. See Plaintiffs Harris …

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Coleman v. Sweetin

745 F. 3d 756 – Court of Appeals, 5th Circuit, 2014 – Google Scholar

Freddie R. COLEMAN, Plaintiff-Appellant v. David SWEETIN; Gregory Oliver; Richard
Cowan; Roy Brown, Sued in his official and individual capacity; Shelia Dale, Sued in her official
and individual capacity; Mae Cobbs, Sued in her official and individual capacity; Debbie
Erwin, Sued in her official and individual capacity; Craig Fisher, Sued in his official and individual
capacity; Blake Lamb, Sued in his official and individual capacity; Unknown McManus, Sued
in her official and individual capacity; Brenda Hough, Sued in her official and individual …

Cited by 147 How cited Related articles All 2 versions

Coleman v. Sweetin

Dist. Court, ED Texas, 2011 – Google Scholar

The lawsuit concerns the Plaintiff falling in the shower and his efforts to obtain medical care for
his injuries. The Plaintiff initially fell in the shower at the Eastham Unit trusty camp on June
14, 2009. He fell again in the same shower on June 20 and June 23, 2009. He testified that the
floor to the shower was slimy and unsafe. Before he ever fell, he submitted letters (“I-60s”) to
Maintenance Specialist Richard Cowan and Maintenance Supervisor Roy Brown about the conditions
in the showers, but they did not take steps to correct the problem. Wardens Sweetin and Oliver …

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Coleman v. Sweetin

Dist. Court, ED Texas, 2011 – Google Scholar

On October 5, 2011, the Plaintiff was ordered to submit the current address for McManus. He
was given twenty days from the receipt of the order to comply with it. He was informed that the
claims against McManus would possibly be dismissed if he failed to comply with the order. The
Court received an acknowledgment from the Plaintiff indicating that he received the order on
October 12, 2011. The Plaintiff was obligated to provide the current address for McManus by
November 1, 2011. He has not, however, provided her current address … On October 24 …

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Attendees of the Mass Tort Nexus Four Days to Mass Tort Success Course (Friday, November 8 – Monday, November 11, 2019)  will benefit from a comparison and contrast presentation related to the differences and similarities between the IVC Filter Litigation and the Emerging Surgical Stapler Litigation.  Contact Anne Marie Kopek by email at annemarie@masstortnexus.com, or call her at 954-837-3432 for more information. You may also request course information by filling out the form at https://www.masstortnexus.com/Course/Enroll.

 

Will Defendants Fear of Additional Multi-Million Dollar Awards Lead to Mass Settlement?

The $33.7 Million jury verdict could potentially motivate Bard, Cook and Cordis to bring more to the settlement table when verdicts in the $3 Million range did not seem to provide adequate motivation. The fact that the Philadelphia Jury saw fit to award $33.7 Million should make all IVC Filter defendants realize that the next jury might award hundreds of millions or verdicts in excess of $1 Billion.

The threat of the “Billion Dollar Verdict” is a recent phenomenon in Mass Tort cases however, the fact that multiple juries in different mass litigations have handed down massive verdicts over the past several years, should make any defendant realize that a “Billion Dollar Verdict” is not a realistic possibility in any jury trial they face.

Moving forward, the IVC Filter defendants may prevail at trail in certain cases however, Plaintiffs have already demonstrated that they will prevail in a number of cases as well. The cumulation of multiple verdicts in the $3 Million Dollar Range, the $30 Million range and higher will rapidly add up to an amount that is greater than the amount these defendants could put on the table to settle these cases in mass. In addition to the foregoing, the defendant’s litigation costs for each case tried can easily reach the 7-figure range (Mass Tort Defense Counsel does not come cheap).

 

IVC Filter Litigation Settlement Progress

Rex Medical is a minor player in the IVC Filter market and therefore faces far fewer individual complaints than Cook, Cordis and Bard (now Becker Dickinson) however, there is little doubt that the three major players in the IVC Filter market took note of the verdict against Rex. Given the relatively small number of cases filed against Rex, this defendant may elect to continue allow cases to proceed to jury trials however, Cook, Cordis and Bard are in a very different position.

Settlement talks with Bard/ Becker Dickinson began as early as 10/30/15, however Becker Dickinson has yet to offer settlement terms acceptable to Plaintiffs Leadership and now face remand of Bard IVC Filter Cases. Becker Dickinson is not an “experienced” defendant in mass medical device litigation and this lack of experience may explain why the company may have overplayed their hand at the negotiating table a now face the prospect of remand and trial of potentially hundreds of individual Bard IVC Filter cases. On a side not, Kudos to the Bard IVC Filter MDL Plaintiffs leadership for sticking to their guns in vigorously fighting for all plaintiffs in the litigation.  The attorneys appointed to leadership in Bard MDL 2641 are to be commended.

Cook Medical, (MDL 2570) a privately held company, has settled numerous individual IVC filter cases but like Bard, has yet to offer settlement terms enough to resolve complaints in mass.

The majority of cases on file against Cordis (a Johnson and Johnson Company) are consolidated in in Alameda County California under Rule of the Judicial Council of California Civil Case Cordination Proceedings (JCCP).

Whether or not the $33.7 Million verdict handed down in the Rex case will motivate the major defendants to get serious about mass settlement is yet to be seen however, the verdict definitely gives plaintiffs more clout in the negotiations.

Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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Understanding the Expanding Talcum Powder and Asbestos Litigation

The original Asbestos litigation began with a small number of defendants and grew to become the largest product liability litigation in history. MTN believes the Talcum Powder litigation may expand in similar manner. This article will focus on potential retailer liability in the expanding Talcum Powder litigation.

If you did not read our prior article, click here to get up to speed: Will the Recall of J&J Baby Powder Breathe New Life into Asbestos Litigation?

Attendees of the Mass Tort Nexus Four Days to Mass Tort Success Course (Friday, November 8 – Monday, November 11, 2019)  will receive and in depth presentation as well all of the information needed, including Qualifying and Disqualifying criteria, to start accepting Talcum Powder Mesothelioma Cases as well as other types of Talcum Powder clients.  Contact Anne Marie Kopek by email at annemarie@masstortnexus.com, or call her at 954-837-3432 for more information. You may also request course information by filling out the form at https://www.masstortnexus.com/Course/Enroll.

 

RECENT BACKGROUND

On October 18, 2019, the FDA announces that Johnson and Johnson has recalled a single lot of its Talcum powder after https://www.fda.gov/news-events/press-announcements/baby-powder-manufacturer-voluntarily-recalls-products-asbestos

“Since 2018, the FDA has been conducting an ongoing survey of cosmetic products for asbestos and to date has tested approximately 50 cosmetic products. As part of this testing, two samples of Johnson’s Baby Powder were tested: one sample from lot #22318RB was found to be positive for asbestos a second Johnson’s Baby Powder sample, lot #00918RA, tested negative for asbestos.”

 

LIVE TESTING HAND GRENADES

The FDAs method of testing sample from individual lots of Baby Powder is akin to pulling the pin on a sample of hand grenades from a box, and determining that the entire box are all “duds” because no grenade from which the pin was pulled blew up and killed everyone in the room.

The only way to be certain that any given bottle of baby powder sitting on a retail shelf or on the bathroom counter of a Talc user is completely free of asbestos would be to test every single bottle.

 

FEELING LUCKY?

 

RETAILERS PULL SOME TALCUM POWDER FROM SHELVES

After the FDA announced the single lot voluntary recall of one lot of J&J Talcum Powder, major retailers, including Walmart, Target, CVS and Right aide began pulling 22-ounce bottles of J&J Talc from their shelves. The recall involved this size bottle of Talcum Powder.

https://www.cnbc.com/2019/10/24/cvs-pulls-all-jj-22-ounce-baby-powder-from-shelves-after-fda-finds-sub-trace-levels-of-asbestos.html

 

HOW DO THESE RETAILERS KNOW THAT OTHER SIZE BOTTLES DO NOT CONTAIN ASBESTOS?

The short answer to the above question is that retailers have no means by which to know if the Talcum Powder remaining on their shelves, do not also contain asbestos.

Although retailers are already potentially liable under a “Strict Liability”  theory form simply conveying these products into the stream of commerce, one could argue, that with all that is now known, these retailers crossed the line into “negligent liability” when they failed to pull all Talcum Powder products from

Putting Aside the evidence that Talc itself can cause cancer, including but not limited to Ovarian Cancer, this article will focus on why every retailer that offers Talc Products should know that it is more likely than not, that every bottle of Talc they sell, contains asbestos and why retailers should assume the foregoing to be true.

 

Understanding the Link Between Talc and Asbestos

Asbestos is a commercial name assigned by industry to a group of minerals. The most common type of asbestos found in commercial products is Chrysotile Asbestos.

Both Talc and Chrysotile Asbestos are formed from the same four basic elements. Magnesium (8th most common element in the Earths rust) , Silicon (Most Common Element in the Earths crust)  Hydrogen and Oxygen (in the form of water).

The elemental structure of Talc and Chrysotile Asbestos are nearly identical.

Talc Mineral: Mg3Si4O10(OH)2

Chrysotile Asbestos:  Mg3Si2O5(OH)4 (most common type of asbestos in commercial use)

All that is required for given Talc deposit to initiate formation of asbestos as well, is a change in the temperature of the water supply necessary for the formation of both minerals. It may be useful to think of the earth crust as a “mineral factory”. The same individual factories (deposits) that produce Talc can also produce Chrysotile Asbestos, all that is required for the naturally occurring Talc factor to being producing Chrysotile Asbestos is for someone (something) to change the thermostat.

Talc and Chrysotile Asbestos deposits form over thousands and in some cases, over millions of years. Earth is a highly thermodynamic planet, the temperature of any given water supply found in the earths crust if far more increase and decrease over these long periods of time versus remaining stable.

In that it is unlikely that any naturally occurring Talc deposit would not also contain some asbestos. Combine the foregoing with the fact that there is no practicable and economical means by which to separate Asbestos from Talc, it is reasonable to conclude that, it is more likely than not, that all Talc contains Asbestos.

Given that the foregoing is basic science and geology, easily understood by any high school student, it would be difficult for any retailer of Talcum Powder products to claim ignorance of the fact that it is highly probable that any given bottle of Talcum Powder on their shelves, likely contains Asbestos.

Which Grenade is live and which one is a dud?  Nobody knows. Would you want to be the one to pull the pin and find out?

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Will the Recall of J&J Baby Powder Breathe New Life into Asbestos Litigation?

Will the Johnson and Johnson Talcum Powder Asbestos issue breath new life into “Asbestos Mesothelioma Practice Area”? The events of the past few days may lead one to believe that it is very possible that the need for plaintiffs lawyers to represent mesothelioma victims who allege their cancer was caused by Johnson and Johnson Talcum Powder, may breath new life into a practice area that was in decline.

On October 18, 2019 the FDA Announced” Johnson’s Baby Powder voluntarily recalled after testing positive for asbestos: Johnson & Johnson voluntarily recalled one lot of baby powder, after a sample tested positive for asbestos. The recalled product is Johnson’s Baby Powder Lot #22318RB. The lot number can be found on the back of the bottle, directly underneath the cap. https://www.fda.gov/cosmetics/cosmetics-recalls-alerts/fda-advises-consumers-stop-using-certain-cosmetic-products.

The FDA is inspecting other lots of Johnson & Johnson talcum powder and MTN expects further recalls to be forth coming.

Does the Problem End With A Single Lot?

Johnson & Johnsons problems are not likely to end with one or even a few recalled lots of baby powder.

It may (likely will be) possible to prove that Johnson & Johnson products, sold at specific retail locations over the past few decades contained asbestos. So, no, it is not likely that Johnson & Johnsons problems arising from a small number of recalled lots will represent the extent of their potential liability.

Would You Like to Be Ahead of the Curve This Time?

Attendees of the Mass Tort Nexus Four Days to Mass Tort Success Course (Friday, November 8 – Monday, November 11, 2019)  will receive and in depth presentation as well all of the information needed, including Qualifying and Disqualifying criteria, to start accepting Talcum Powder Mesothelioma Cases.  Contact Anne Marie Kopek a by email at annemarie@masstortnexus.com, or call her at 954-837-3432 for more information. You may also request course information by filling out the form at https://www.masstortnexus.com/Course/Enroll.

Qualifying (or disqualifying) Talc Mesothelioma cases will be particularly challenging given that the disqualifying factors are more numerous that the qualifying factors however, considering the likely jury verdicts that may arise from meritorious, Talc Mesothelioma cases are worth the extra effort. The average Mesothelioma verdict comes in at approximately $2.4 million and the largest Mesothelioma Verdict Mass Tort Nexus is aware of to date was $250 million. Given the b

Not all-natural Talc deposits contain asbestos. The geological circumstances under which the talc was formed, determine whether any given Talc deposit also contains asbestos. Mass Tort Nexus will provide November Course attendees with the information they need to determine whether an individual potential client used Talc likely sourced from a mine containing asbestos.  In most cases, it should be possible to determine if an individual was exposed to Talc containing asbestos even if the exposure occurred decades in the past.

Does the Stock Market Think the Problem Ends with a Single Lot?

On October 8, the market got the news that Johnson & Johnsons was hit with an 8-Billion-dollar verdict, the pharma giants stock took a down word turn.

On October 15th Johnson & Johnson announced 3rd quarter results that exceeded market expectations and their stock began to trend upward.

On October 18th, the FDA announces the recall of a single lot of Johnson & Johnson Talcum Powder.  By 3:50 pm the Pharma Giants stock had dropped by 5.89% and by 4:00 (closing bell) the stock had sunk by 6.23% to $127.72 per share as compared to the previous day’s closing price of $136.18.  If we have our math right, Johnson & Johnson took a hit to their market capitalization of around $18 billion, in a single day, after the FDA recall of a single lot of Johnson and Johnson Baby powder due to asbestos found in the individual lot.

So, no, it does not appear that the market believes that Johnson and Johnson’s Talc/ Asbestos problem begins nor ends with a single recalled lot and if you are a plaintiffs lawyer, you may want to get ahead of the curve on the new breath of life that may have been given to the asbestos mesothelioma practice area.

 

 

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Should Taxotere Plaintiffs be Concerned After First Bellwether Trial? Absolutely Not.

Taxotere Trial Defense Strategy

“The Devil Did It”

A jury in Louisiana federal court handed the defendant a victory in the first Taxotere Bellwether presided over by U.S. District Judge Jane Triche Milazzo in New Orleans. The case, filed in December 2016 by Louisiana resident Barbara Earnest, had been designated as a Bellwether in a multidistrict litigation consolidated before Judge Milazzo.

http://www.laed.uscourts.gov/case-information/mdl-mass-class-action/taxotere

https://www.reuters.com/article/products-liability-taxotere/sanofi-wins-first-bellwether-trial-in-taxotere-litigation-idUSL2N26I1P6

Should other Taxotere Plaintiffs be concerned about this initial trial loss? Not really, and we will explain why.
Barbara Earnest’s case was unusual in that she required more than one round of chemotherapy to treat her cancer. She received a round of Taxotere and round of Doxorubicin.

Doxorubicin is a cytotoxic chemotherapy drug and an antitumor antibiotic; it deservedly has been nicknamed the Red Devil. Doxorubicin is a bright, almost florescent, red color.

Despite Doxorubicin not being associated with significant incidents of permanent hair loss, unlike Taxotere, defense counsel took full advantage of the Doxorubicin nick name “Red Devil” and was able to persuade the jury that it was not Taxotere that caused Barbara Earnest permanent hair loss, it was the Devil that did it.

The next Taxotere case up for trial does not involve a dual Taxotere followed by Doxorubicin or vice versa, circumstance. Defense counsel will not be able to claim the devil did it, in the next case.

So, in answer to the question, “Should other Taxotere Plaintiffs be concerned about this initial trial loss?” the answer is no. There are more trials to come and the “facts” of the first case tried are, by no means, the same as those in the majority of other Taxotere plaintiffs’ cases.

If making reference to Bayer’s past connection to Nazis is so inflammatory and prejudicial to be uttered before a jury, where Bayer is a defendant, one would think that using the term “Red Devil” to describe Doxorubicin, the drug’s actual name, in the Barbara Earnest case should equally qualify as too inflammatory and prejudicial for the jury to hear. Plaintiffs counsel objected to the use of “Red Devil”; however, Judge Milazzo nonetheless allowed the Louisiana jury to be led to believe that the Devil had worked some Voodoo, and that was the actual cause of Barbara Earnest’s permanent disfigurement, vs the drug Taxotere, that has actually been shown to cause the type of injuries suffered by Barbara Earnest.

If Judge Milazzo presides over another Taxotere trial in which Doxorubicin was also administered, the Honorable Judge may consider making the defendant refer to the drug by its proper name rather than leading a jury to believe the devil did the deed.

In light of the recent $8 Billion dollar verdict in a Risperdal trial, and multiple other recent Billion Dollar verdicts in mass litigation cases, Sanofi, the maker of Taxotere, may want to think twice about how many times it rolls the dice with a jury trial. If they can’t blame the devil in other cases, they may find that one or more juries find them liable and award more to a single plaintiff that it would take to settle the entire litigation, disposing of all plaintiffs’ cases.

Read the ALM Taxotere Defense Verdict

Learn the Business of Mass Torts, How to Avoid Getting Screwed in an MDL, the Behind-the-Curtain Information on Taxotere, Truvada, Hernia Mesh, and Other Emerging and Current Litigations… Register Today for the Only Mass Tort Immersion Course.

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error). It is better to learn from the mistakes of others than to make those same mistakes yourself.

If you are interested in working smarter versus harder, and achieving the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to register for the November course. You may also call or email Barbara Capasso or Anne-Marie Kopek at 954-530-9892, email barbara@masstortnexus.com or annemarie@masstortnexus.com

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The 3 Keys to Success in Mass Torts

Multi-billion dollar jury verdicts are becoming common in Mass Tort litigations, and these verdicts make headlines and create “hype”; however, the majority of “Mass Tort Billionaires” did not achieve their success from individual jury verdicts, these firms “made it big” through involvement in numerous mass tort cases over many years.

Over 50% of the entire Federal Judiciary Docket is within Multidistrict Litigation cases. Most of these individual client cases are essentially plucked from the “State Court Litigation Market Place”. This fact alone has generated an ever-increasing interest in Mass Torts, from personal injury firms, at least in part wanting to “reclaim” a portion of the client cases being “plucked” from their “State Court”, market.

More simply stated, PI firms are increasingly interested in Mass Torts because that is where the clients are.

Mass Torts, however, is not a get rich quick scheme. As with any other “business”, understanding the keys to success as well as the keys to avoiding failure is of paramount importance when considering expanding your personal injury practice to include mass torts. You do not want to be the firm that jumps into the mass tort practice area blind and ends up disappointed.

 

Mass Tort Success Key #1

Ignore the Cheerleaders or At Least Take the Cheers with A Grain of Salt

It is common for leadership firms, the firms that generally file the first claims and assume leadership positions in Multidistrict Litigations to hold conferences in which they encourage other law firms to get involved in the “their” litigations. Generally, firms conducing these “Mass Tort” conferences hope to receive referrals from other firms they convince to follow them into a litigation. This comment is no way meant to be disparaging, simply factual.

The inherent problem with deciding to become involved in a mass tort based on information provided by firms already involved in a litigation is not difficult to understand. Once a law firm is involved in a litigation, they are advocates for the cause (cause of action). It would be unreasonable to expect any law firm involved in a mass litigation to be anything less than a “cheer leader”. Again, this comment is no way meant to be disparaging, simply factual.

To be clear, there is value in hearing what the cheerleaders for a litigation have to say however, deciding to take a financial risk on a given litigation based solely on the “cheers” voiced by those already advocating for the litigation, is unwise.

 

Mass Tort Success Key #2

Conduct Independent Reasoned Analysis

Undertaking an, independent, systematic, reasoned analysis of the legal and business metrics relevant to a given mass litigation, is the key to success in mass torts. This process does not differ, in principle from the “due diligence” that should be employed prior to making any type of business investment.

Applying basic business principles to Mass Torts by identifying metrics and factors specific to the business and financial aspects of Mass Torts.

There are certain immutable laws of business, if you think they do not apply to your specific business, you are wrong, you simply have yet to realize how these immutable laws of business apply to your specific business.

Recognizing how the immutable laws of business apply to a specific type of business, and then applying those laws to their fullest advantage is how billionaires are made. The “Mass Tort Practice Area” has produced more billionaire attorneys than any other. The primary difference in these “Mass Tort” billionaires and other attorneys has little to do with their skills as an attorney and far more to do with their understanding of how to apply the business metrics relevant to mass torts.

 

Mass Tort Success #3

Take The Course

The Mass Tort Nexus Four Days to Mass Tort Success Course is designed to provide Personal Injury attorneys with the knowledge and tools used by “Mass Tort Billionaires” as well as a road map for applying the knowledge and using these tools.

The Course begins at the most rudimentary level, beginning with explaining the difference in a Class Action and MDL. Once the basics are covered, we quickly move to defining and providing an understanding of the basic metrics which must be considered prior to making an investment in each mass tort case.

The goal of the Mass Tort Nexus Four Days to Mass Tort Success Course is to demystify the practice area and provide not only the tools and knowledge needed to be successful in Mass Torts but also the confidence that comes from having a base of knowledge that “levels” the playing field.

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JUUL MDL 2913 DESIGNATED BY JPML

“E-cigarette docket transferred to USDC ND California”

Mark A. York (October 3, 2019)

See Mass Tort Nexus Briefcase MDL 2913 for the full docket:

https://www.masstortnexus.com/Briefcases/JUUL-MDL-2913-(E-Cigarettes)-USDC-ND-California-(Judge-William-Orrick)/5160/Court-Orders/Documents

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The JPML heard Juul arguments on Sept. 26 in Los Angeles, and on October 2, 2019 they issued the MDL 2913 transfer order, consolidating the Juul e-cigarette docket in the U.S. District Court, Northern District of California in front of Judge William Orrick.

In a move to get out in front of plaintiffs, JUUL Labs Inc. filed a motion on Aug. 29 to stay all cases in the litigation and requested the JPML assign the docket to the court in California

JUUL is accused of deceptive marketing practices and failing to warn consumers about the risks of its e-cigarette products. Lawsuits allege JUUL unlawfully marketed its products to teens, and failed to disclose the true amount of nicotine contained in its products.

See Mass Tort Nexus Briefcase MDL 2913 for the full docket

https://www.masstortnexus.com/Briefcases/JUUL-MDL-2913-(E-Cigarettes)-USDC-ND-California-(Judge-William-Orrick)/5160/Court-Orders/Documents

FDA WARNING ISSUED

FDA Warning Letter to JUUL Labs, Inc. (September 9, 2019)  https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth

In November 2018, the FDA revealed that vaping had increased nearly 80% among high schoolers and 50% among middle schoolers since a year earlier. Public health experts have said that Juul has largely propelled the rise, commanding about 75% of the e-cigarette market in the United States.

There were communications between FDA officials in mid-October 2018, which detailed allegations of seizures related to Juul use The FDA found “no proof of causality, but at a minimum, an association with Juul,” Mitch Zeller, the director of the FDA’s Center for Tobacco Products, wrote to Scott Gottlieb, the FDA commissioner at the time. In an interview, Zeller said that the FDA had not been able to confirm that Juul use was associated with the seizures in two of the three initially reported cases

Although Juul demands age verification upon navigating to its website and holds a firm stance against minors’ use of Juuls, these vapes are still wildly popular with teens.

Depending on the state, no one under 18 or 21 is supposed to be able to purchase e-cigarettes or any tobacco products. But according to a report from the CDC, e-cigarette use is rising among middle school and high school students, and more than 3.5 million of them used e-cigarettes in 2018.

  1. Juul delivers massive doses of nicotine, putting youth users at greater risk of addiction
    The manufacturer has stated that each Juul “pod” (cartridge of nicotine) delivers as much nicotine as a pack of 20 cigarettes. However, research by Truth Initiativehas found that many young Juul users don’t know the product always contains nicotine.
  2. Nobody ever disclosed this comparative and now there are thousands of addicted young people who had no clue.
  3. In addition to the patented formula, juul pods contain a greater amount of benzoic acid, 44.8 mg/mL, compared to other e-cigarette brands, which are in the range of 0.2 to 2 mg/mL.

Advertising is part of the problem. According to the CDC, more than 18 million high school and middle school students combined were exposed to e-cigarette ads in 2014. And Stanford researchers point out that Juul’s marketing hasn’t been congruent with its adults-only stance.

PHILLIP MORRIS SHUTS DOWN JUUL MERGER

What had once looked like a smart pair-up to rejoin the international cigarette giant with its former domestic parent has now crumbled under the weight of doubts about where the regulatory fist would fall. Altria owns a 35% stake in Juul Labs, the leading e-cig maker by far and the primary scapegoat for industry criticism because it is the face of the vaping market.

After careful consideration, Philip Morris CEO Andre Calantzopoulos said in a statement that it and Altria “have agreed to focus on launching IQOS in the U.S. as part of their mutual interest to achieve a smoke-free future.” All that other stuff they were discussing could be forgotten.

Juul said it’s suspending all broadcast, print and digital product advertising in the U.S., and will refrain from lobbying the Trump administration on its draft guidance. The announcement comes after a crackdown on e-cigarettes by the U.S. Food and Drug Administration, that has accelerated following a recent outbreak of severe lung disease that appears to be related to vaping. More than 530 Americans have been diagnosed with the illness and at least eight people have died. Juul is now the subject of a criminal probe in California.

FDA investigators are looking at the use of vitamin E acetate, a compound often used as a cutting agent to allow black market operators to use less pure cannabis oil when filling cartridges. While vitamin E is considered to be safe as a dietary or health supplement ingested in capsule or pill form, it can cause respiratory illness including pneumonia when inhaled.

About 55 lawsuits brought against Juul across the country were among the matters before the JPML panel at the hearing.

Recently,  Juul announced that CEO Kevin Burns would step down immediately and the company would suspend all advertisements of its products. The new CEO, K.C. Crosthwaite, comes from Philip Morris USA parent corporation Altria Group Inc., which has a 35% stake in Juul.

Recent developments include stores like Walmart have stopped selling e-cigarettes and vaping products and cities and states have banned the products. Juul also faces mounting regulatory pressure from the U.S. Food and Drug Administration, which is investigating Juul’s marketing claims to children, as have many state attorneys general.

JPML panel chairwoman Sarah Vance, who sits on the Eastern District of Louisiana, started by announcing this would be her last hearing as head of the MDL panel. U.S. District Judge Karen Caldwell of the Eastern District of Kentucky a current panelist, will be the new chairwoman.

Juul counsel, Austin Schwing, a partner at Gibson, Dunn & Crutcher in San Francisco, argued for the cases go to a court near his client’s headquarters in San Francisco before U.S. District Judge William Orrick of the Northern District of California, but was also open to U.S. District Judge Brian Martinotti of the District of New Jersey, while some plaintiffs counsel also supported Orrick.

In briefs before the panel, there was an initial request for two MDL’s to be created, with plaintiff’s counsel initially advocating for Orrick to oversee the Juul litigation related to misleading marketing that failed to disclose the nicotine in its products. While also requesting that Judge  Martinotti  hear the personal injury cases whose claims focused on pulmonary disease, seizures and other serious health problems.

Judge Vance clarified the denial quickly in the hearing, stating the cases were too massive and complex to be divided. “Events in the past few minutes have overtaken me,” she said.

Andy Birchfield, of Beasley Allen, also changed his mind about dividing the cases, said “we need an experienced hand” as a judge. He initially supported Martinotti, a judges who had overseen dockets New Jersey state court’s Multicounty Litigation Center before his appointment to the federal bench.

MDL No. 2913 – IN RE: Juul Labs, Inc., Marketing, Sales Practices, and Products Liability Litigation JPML Initial Transfer Order

Judge Orrick entered Pretrial Order No. 1 on the same day the JPML designated his court as the home of MDL 2913.

See Mass Tort Nexus Briefcase MDL 2913 for the full docket

https://www.masstortnexus.com/Briefcases/JUUL-MDL-2913-(E-Cigarettes)-USDC-ND-California-(Judge-William-Orrick)/5160/Court-Orders/Documents

JUUL Changed Nicotine Disclosures

Juul measures nicotine content by weight, which is different from most brands, which usually measure by volume. Juul originally only sold pods with 5% nicotine by weight, but started offering 3% pods in August 2018.

According to an older version of Juul’s FAQ page, one 5% pod contains roughly the same amount of nicotine as one pack of cigarettes, or about 200 puffs. However, this information is no longer available on Juul’s website, and there’s no precise information about 3% pods, either. However, an article in the New England Journal of Medicine says that the 5% pods contain a concentration of 59 milligrams of nicotine per milliliter of liquid.

In contrast, prior to the Juul frenzy most vapes contained roughly 1 to 3% nicotine by volume. A study in the journal Tobacco Control notes that the new average seems to be rising to that 5% mark. Juul’s creators increased the nicotine because they felt other vapes on the market couldn’t compare to the sensations delivered by regular cigarettes.

In the FDA warning letter to JUUL Labs, Inc. of September 9, 2019 the following “unauthorized marketing claims” were cited:
The warning letter identifies several statements, including statements discussed in testimony from a July 2019 Congressional hearing on JUUL. According to that testimony, a JUUL representative speaking with students at his presentation in a school stated that:
  • JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”
  • JUUL was “totally safe.”
  • A student “…should mention JUUL to his [nicotine-addicted] friend…because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
  • “FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon….”

Additionally, a “Letter from the CEO” that appeared on JUUL’s website, and also in an email that JUUL sent to a parent in response to her complaint that the company sold JUUL products to her child, states: “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”

 

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JUUL: The unregulated killer of teens for profit!

How the FDA missed a deadly corporate marketing campaign–AGAIN!

MASS TORT NEXUS MEDIA (September 23, 2019) 

  • Juul’s popularity was fueled by the company’s social media marketing that featured attractive young people in fun, trendy settings
    A report by Stanford University researchers concluded that Juul’s launch marketing was “patently youth oriented” and “subsequently Juul’s principal advertising themes have been closely aligned with that of traditional tobacco advertising.”

Why is Juul so popular among teens?

Although Juul demands age verification upon navigating to its website and holds a firm stance against minors’ use of Juuls, these vapes are still wildly popular with teens.

Depending on the state, no one under 18 or 21 is supposed to be able to purchase e-cigarettes or any tobacco products. But according to a report from the CDC, e-cigarette use is rising among middle school and high school students, and more than 3.5 million of them used e-cigarettes in 2018.

  • Juul delivers massive doses of nicotine, putting youth users at greater risk of addiction
    The manufacturer has stated that each Juul “pod” (cartridge of nicotine) delivers as much nicotine as a pack of 20 cigarettes. However, research by Truth Initiativehas found that many young Juul users don’t know the product always contains nicotine.
  • Nobody ever disclosed this comparative and now there are thousands of addicted young people who had no clue.
  • In addition to the patented formula, juul pods contain a greater amount of benzoic acid, 44.8 mg/mL, compared to other e-cigarette brands, which are in the range of 0.2 to 2 mg/mL.

Advertising is part of the problem. According to the CDC, more than 18 million high school and middle school students combined were exposed to e-cigarette ads in 2014. And Stanford researchers point out that Juul’s marketing hasn’t been congruent with its adults-only stance.

One can guess it’s so popular for a few reasons:

  • It’s relatively inexpensive: You can buy Juul’s “starter kit,” which includes the e-cigarette, USB charger and four pods for $50. After that, packs of four pods cost $21.
  • It’s discreet:People may be more inclined to use Juul because its compact design is easy to hide from parents, teachers and other authority figures.
  • It doesn’t smell like a cigarette:Cigarette smoke permeates the air in a relatively large radius. Juuls, on the other hand, don’t give off the smell of tobacco or smoke.
  • It comes in many flavors: Juul’s sweet flavor options make it a more palatable option than regular cigarettes and many other e-cigarette options. One CDC survey notes that 31 percent of survey respondents(all students in grades 6 to 12) chose e-cigarettes because of  “flavors such as mint, candy, fruit, or chocolate.”

The explosive popularity of Juul and others like it among kids is particularly troubling because they often do not see it as harmful. A report showed that 63% of people aged 14 to 25 aren’t even aware that vaporizers like Juul contain nicotine at all.

To a remarkable degree, a single company is front and center in one of the biggest public-health crises facing the country: the sharp rise in vaping among teenagers and young adults. In 2018, 30% of the nation’s 12th-graders reported vaping nicotine at least once in the past year, according to a January 2019 study sponsored by the National Institute on Drug Abuse. The study said the increase in vaping last year was “the largest ever recorded for any substance in the 44 years” that it has tracked adolescent drug use.

The issues have escalated recently. More than 530 people in the US have been either hospitalized, and seven have died from vaping and developing mysterious lung injuries, according to the CDC. Both the FDA and the CDC are working together to find potential causes.

  • Top Juul Labs investor Altria has lost $31 billion in market value since April, when the Food and Drug Administration launched a new investigation into vaping.
  • Altria bought a $12.8 billion stake in Juul back in December.
  • A litany of setbacks have weighed on Juul and Altria since, including a growing number of illnesses and deaths related to vaping and e-cigarette use. 

Top Juul Labs investor Altria Group has gone down in smoke since the Food and Drug Administration launched a new probe into vaping in April.

The traditional tobacco company has seen $30 billion in market valuation since the FDA announced a new investigation into the link between vaping and seizures. That translates to roughly one-third of Altria’s market value wiped out. For context, the S&P 500 has climbed 5% over the same period.

Altria is vulnerable to such negative developments in the vaping space after paying $12.8 billion in December for a major stake in Juul, a leading vape company responsible for roughly 70% of the e-cigarette market. The company’s products are particularly popular with teens

Given the possible risks to the nation’s youth, Juul’s rapid growth has been accompanied by remarkably little oversight or regulation. And while there is a legitimate debate over whether e-cigarettes are safer for adult smokers than traditional cigarettes, and whether they can help addicts quit smoking, critics argue that Juul has assiduously followed Big Tobacco’s playbook: aggressively marketing to youth and making implied health claims a central pillar of its business plan. Juul maintains that it is not Big Tobacco 2.0. In eight months, unless e-cigarette companies can prove to the FDA that vaping is “appropriate for the protection of public health,” the products could be pulled from the market. That would curtail youth use, but some fear it could also cut off adult smokers’ access to a potentially beneficial product.

Vaping has become one of the biggest public health issues of our time, and at the center of it is San Francisco-based e-cigarette company Juul. While there are many nicotine vapes on the market, Juul has gained popularity (especially among teenagers) for its sleek design and easy-to-use pods. Even after the company was forced to shutter its social media presence while the FDA investigated concerns that Juul was promoting underage use of tobacco products, Juul continues to prove popular with rising sales and affectionate nicknames, such as the “iPhone of vaporizers.”

But what is a Juul, and is it safe to use one? Here’s everything you need to know about Juul, including what’s in the e-juice, the long-term health effects and how Juul compares to regular cigarettes.

What is Juul?

Juul is like many other e-cigarettes, but with a couple of caveats that set it apart. First, this vape is sleek and hardly noticeable: Its USB-drive design can be enclosed in the palm of a hand, and it doesn’t produce a massive plume of vapor like some other e-cigarettes. Second, the nicotine content in its cartridges, or “pods,” set a new precedent for the e-cigarette market.

E-cigarettes work by converting liquid nicotine into a vapor that the user inhales. They’re battery-operated and intend to provide a similar stimulus to that of smoking regular cigarettes.

Developed by two former smokers, Juul’s mission is to “improve the lives of 1 billion adult smokers by eliminating cigarettes.” One way the company encourages the switch from cigarettes to Juul is with its Juul calculator, where people can estimate how much money they’d save if they used a Juul instead.

Juul vs. other e-cigarettes: What’s the difference?

Juul’s high nicotine content used to be an anomaly in the e-cigarette market, but now researchers note it seems to be the rule. After Juul’s surge in popularity, other e-cigarette manufacturers began bumping up the nicotine content in their products.

Juul uses a closed system, which means users can’t refill the pods themselves, a helpful factor for quality control.  Some e-cigarettes, such as the Suorin Drop, use open systems that allow users to refill the vape themselves with bottles of e-liquid or e-juice.

Juul’s small size, compact design and minimal plume make it more discreet than many other brands. With no buttons or switches — just disposable, snap-on cartridges — Juul is simple, and its built-in temperature regulation prevents you from experiencing a “dry hit.” Dry hits occur when vape cartridges get too low on liquid or when they overheat, producing a burnt taste and throat irritation.

What are the main ingredients in Juul pods?

The Juul comprises two parts. There’s the e-cigarette itself, which contains the battery, temperature regulator and sensors that read the charge level. Then there’s the pod, which contains Juul’s patented e-liquid formula. A mixture of nicotine salts, glycerol, propylene glycol, benzoic acid and flavorings.

  • Glycerolserves as a humectant, which means it adds moisture to the solution. Glycerol is classified as “generally recognized as safe” by the FDA, so it’s approved for consumption.
  • Propylene glycolis a synthetic compound commonly used in polyester production, but it’s also approved as an additive for food, cosmetic and pharmaceutical products.
  • Benzoic acidoccurs naturally in many plants, but its synthetic form is also widely used as a food additive and preservative. It’s “generally recognized as safe” for those uses, but can be an environmental and health hazard in large quantities.
  • Flavoringsis an ambiguous term, but most often refers to various natural and synthetic ingredients that companies use to flavor their products. For example, Juul doesn’t specify what’s in its mint-flavored pod, but it probably contains peppermint extract or oil.

The nicotine salts in Juul vape juice are a type of nicotine that supposedly feels more like a cigarette when inhaled, as opposed to other vapes that use freebase nicotine. Freebase nicotine, which can cause coughing and leave a film in people’s throats, is harsher and commonly found in cigars.

Juul pods currently come in eight flavors; cucumber, creme, mint, mango, menthol, fruit, Virginia tobacco and classic tobacco. It’s worth noting that the FDA’s Family Smoking Prevention and Tobacco Control Act banned flavored cigarettes in 2009, so it’s possible that this might come into play for vapes one day, too.

How much nicotine is in a Juul pod?

Juul measures nicotine content by weight, which is different from most brands, which usually measure by volume. Juul originally only sold pods with 5% nicotine by weight, but started offering 3% pods in August 2018.

According to an older version of Juul’s FAQ page, one 5% pod contains roughly the same amount of nicotine as one pack of cigarettes, or about 200 puffs. However, this information is no longer available on Juul’s website, and there’s no precise information about 3% pods, either. However, an article in the New England Journal of Medicine says that the 5% pods contain a concentration of 59 milligrams of nicotine per milliliter of liquid.

In contrast, prior to the Juul frenzy most vapes contained roughly 1 to 3% nicotine by volume. A study in the journal Tobacco Control notes that the new average seems to be rising to that 5% mark. Juul’s creators increased the nicotine because they felt other vapes on the market couldn’t compare to the sensations delivered by regular cigarettes.

An older version of Juul’s FAQ page disclosed precise information about the nicotine content in Juul pod—But, his information is no longer on the site.

 

 

 

 

 

 

 

 

 

Is Juul addictive? Is Juul more addictive than cigarettes?

Nicotine is a known addictive substance, and Juul is no exception. There are currently no studies that prove whether or not Juul is more addictive than regular cigarettes, simply because e-cigarettes are a relatively new phenomenon. However, I certainly know people who seem as addicted to their Juul as they are to their iPhones, and I’ve watched friends throw fits when their pod runs dry.

Nicotine is a harmful drug, regardless of delivery method. It’s linked to various changes in the body and brain, and public health officials worry that most people, especially youths, aren’t aware of the potential consequences.

What are the health effects of vaping?

People incorrectly consider vaping a safer alternative to smoking because it eliminates tobacco, which is a known carcinogen. But cigarettes contain many chemicals beyond tobacco, and e-cigarettes contain some of the same. Much of this is based on false-marketing by the tobacco companies.

Studies have detected acetamide (a compound used in industrial solvents), formaldehyde and benzene (another known carcinogen) in various e-cigarettes brands.

Not all e-cigarette liquids contain all of these toxic compounds, and even in those that do contain them, the concentration isn’t always high enough to cause concern. One study looked at the benzene formation of Juul and two other vaping systems versus traditional cigarettes, finding that traditional cigarettes present a higher risk of benzene exposure. However, the study authors note that the benzene exposure created by e-cigarettes is not negligible — that is, there’s still a health risk.

Another study looked at adolescents who use e-cigarettes and found that their urine contained significantly higher amounts of five different chemicals, compared to adolescents who never use e-cigarettes.

Another issue arises when companies don’t disclose what’s in their products. Juul openly states its e-liquid ingredients, but research has found that e-cigarette products aren’t always labeled accurately, which can cause people to inhale more nicotine and chemicals than they think they’re breathing in.

Nicotine is a highly addictive substance that causes cravings and bona fide withdrawal symptoms when those cravings are ignored. Whether or not vaping is a “gateway” to cigarette smoking is irrelevant because vaping itself is an addictive habit.

Nicotine isn’t just addictive, but it’s also toxic. It stimulates your adrenal glands, spiking adrenaline production and leading to a series of bodily reactions: People who use nicotine experience a release of glucose and an increase in heart rate, breathing rate and blood pressure.

The drug seems to act as both a stimulant and a depressant at the same time, as it’s linked to increased alertness but also increased relaxation.

Use of nicotine is also associated with a number of side effects on organs and organ systems, including:

  • Increased risk of blood clots
  • Atherosclerosis
  • Peptic ulcers
  • Changes in heart rhythm
  • Lung spasms

Nicotine can also alter or harm the development of the brain in children and teens.

“The prefrontal cortex, the area of the brain responsible for decision-making, logic, personality expression and many other traits integral to one’s personality, is not fully mature until around the age of 25,” Dr. Lawrence Weinstein, chief medical officer of American Addiction Centers, told CNET. “Introducing nicotine to the brain 10 years prior to that, without speaking of the massive amount of nicotine contained in each cartridge, will undoubtedly alter that developing brain.”

Looking beyond nicotine, using e-cigarettes — Juul or otherwise — comes with many health risks, including the possibility for seizures, heart attacks, lung damage and birth defects.

Dentists have also been noticing that their patients who vape are experiencing more cavities, tooth damage and dental issues. Especially when it comes to the enamel on your teeth, once damage is done it cannot be reversed.

Lastly, e-cigarettes work by heating a liquid into an aerosol that the user inhales. While the amount of aerosol in a single puff isn’t likely to harm anyone, it’s worth noting that inhaling aerosols is associated with impaired judgment and functioning.

As for the long-term health effects of Juul and other vapes, doctors and scientists aren’t sure yet. E-cigarettes are too new for health professionals to make any correlative claims like they can with traditional cigarettes. But with so much research in progress, new claims will certainly surface.

What’s the FDA’s stance on Juul?

Well, the FDA hasn’t monitored Juul very well at all, permitting the teen marketing campaigns to run amok at will. never considering whate “tobacco compinies might do, once again” given the opportunity to craete addicts and and make maoney at the same time. In April 2018, the FDA demanded that Juul submit marketing and research documents, and explain what Juul knows about the use of its products among teens. A month later, as part of the FDA’s Youth Tobacco Prevention Plan, the agency also requested information from several other e-cigarette manufacturers. And in October 2018, the FDA visited Juul’s San Francisco headquarters to gather information on the company’s sales and marketing tactics.

Despite the fact that selling tobacco products to minors is illegal, the FDA has so far uncovered 40 violations for illegal sales of Juul products to young people. Warning letters were issued for those violations. The company also shut down its Facebook and Instagram accounts in November 2018 to avoid promoting its product to teens and nonsmokers — two groups that Juul specifically says it does not want to become customers.

In a statement, FDA Commissioner Scott Gottlieb said, “…the nicotine in these products can rewire an adolescent’s brain, leading to years of addiction.”

But, he continues: “Make no mistake. We see the possibility for electronic nicotine delivery systems (ENDS) products like e-cigarettes and other novel forms of nicotine-delivery to provide a potentially less-harmful alternative for currently addicted individual adult smokers … But we’ve got to step in to protect our kids.”

The FDA continues to monitor Juul and vaping in general, recently calling Juul out for marketing the device as safer than it really is, as well as investigating the 120-plus vape-related seizure cases.

The Centers for Disease Control and Prevention (CDC) isn’t a fan of Juul or other e-cigarettes, either. The CDC says outright that e-cigarettes aren’t safe, especially for children and teens, and is currently investigating cases of lung disease associated with vaping.

While federal government bodies have been warning people about the health risks of vaping for years, e-cigarette use has become such an epidemic that state and local government bodies are finally taking note. San Francisco — the headquartering city of Juul — became the first city to ban e-cigarette sales completely.

How did Juul get its start?

Juul Labs spun off from Pax Labs in 2015. Founders Adam Bowen and James Monsees co-founded the company when, as former smokers, they decided they wanted a better alternative to cigarettes than anything that was already on the market.

Their idea of “better” manifested as Juul’s high nicotine content and slim design that gives off very little vapor compared to other vapes. Since its debut, Juul has grown to dominate more than 50 percent of the market share.

In December 2018, Altria — one of the world’s largest tobacco products companies — bought a 35% stake of Juul for $12.8 billion dollars. Altria owns Phillip Morris, which owns the brands Marlboro, Virginia Slims, Parliament and other cigarette brands.

Juul copycats

Candy- and dessert-flavored e-juice is enticing to kids who might be otherwise turned off by vaping or smoking.

Zonk E Liquid

Juul’s staggering success prompted many e-cigarette brands to follow suit with high nicotine content and new designs. The FDA isn’t happy with these copycat brands, and neither is Juul, which filed a complaint with the US International Trade Commission for patent infringement.

Everyone should be concerned about copycat Juuls, especially those that openly market to children using enticing flavors like Blue Slushie Lemonade and strawberry whipped cream.

The attributes of these vapes — attractive, compact and free of odor — make them popular with young people because they can easily hide them from authority figures, like teachers and parents.

Juul’s popularity and the influx of similar products raises concern that this new “pod mod” class of e-cigarette products is not just a trend and will influence the decisions and habits of adolescents for their entire lives.

Staying true to its stance on nicotine use among minors, Juul announced that it is going after companies that do market to children and teens, but the FDA warns that this is an ongoing battle that now carries over into the courtrroms across the country.

The JUUL litigation is heating up very quickly and just as Bayer AG soon realized the Mosanto purchase included the now staggering stock-droping Roundup litigation; Altria will quickly see that the $30 billion JUUL buy-in was just the start of a massive litigation debacle that was and will be based on corporate greed and ingmnoring the dangers of yet another drug.

 

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OPIATE MDL 2804 RICO CLAIMS STAY IN BELLWETHER TRIAL NEXT MONTH: Opinion /s/Dan Aaron Polster September 10, 2019

“TRIPLE DAMAGES AND ATTORNEYS FEES NOW PART OF DEFENSE TRIAL PREP”

 

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF OHIO

EASTERN DIVISION

 

IN RE: NATIONAL PRESCRIPTION OPIATE LITIGATION

 THIS DOCUMENT RELATES TO:

 All Cases

MDL 2804

)     Case No. 1:17-md-2804

)     Judge Dan Aaron Polster

)     OPINION AND ORDER REGARDING

)     DEFENDANTS’ SUMMARY

)     JUDGMENT MOTIONS ON RICO AND OCPA

 

Before the Court are two related motions for summary judgment filed by Defendants regarding Plaintiffs’ claims under the Racketeer Influenced and Corrupt Organizations (RICO) Act 18 U.S.C. § 1961 et seq. and Ohio’s Corrupt Practices Act (OCPA),1 Ohio Rev. Code § 2923.31 et seq.. They are: (1) Distributors’ Motion for summary judgment on Plaintiffs’ RICO and OCPA Claims, (Doc. #: 1921); and (2) Manufacturers’ Motion for summary judgment on Plaintiffs’ RICO, OCPA, and Conspiracy Claims. (Doc. #: 1930). Only the RICO and OCPA portions of these motions are addressed in this opinion and order.2 Plaintiffs filed an omnibus response (Doc. #: 2182) and Manufacturers and Distributors each filed a Reply (Doc. ##: 2533 and 2547, respectively). Plaintiffs’, with leave of the Court, filed a Sur-Reply (Doc. #: 2500). For the reasons set forth below, Defendants’ summary judgment motions are DENIED.

1 “Ohio’s RICO statute, O.R.C. § 2923.31 et seq., is patterned after the federal RICO statute. Thus, courts “have found that the elements for an [Ohio RICO] violation are the same as those for a [federal] RICO claim.” Robins v. Glob. Fitness Holdings, LLC, 838 F. Supp. 2d 631, 651 (N.D. Ohio 2012) (citing Foster v. D.B.S. Collection Agency, 463 F.Supp.2d 783, 811 (S.D.Ohio 2006)).

2 The Manufacturers’ arguments regarding Civil Conspiracy are addressed in a separate opinion. (Doc. #: 2562).

1.

The Court hereby incorporates the legal standards set forth in the Court’s Opinion and Order regarding Plaintiffs’ Summary Judgment Motions Addressing the Controlled Substances Act, see Doc. #: 2483.

II.

Under the RICO statute, it is “unlawful for any person employed by or associated with any enterprise . . . to conduct or participate, directly or indirectly, in the conduct of such enterprise’s affairs through a pattern of racketeering activity.” 18 U.S.C.A. § 1962. Defendants articulate two principal arguments for summary judgment on Plaintiffs’ RICO and OCPA claims: (1) no evidence of any enterprise and (2) no evidence of causation. Distributors also advance a threshold argument regarding their alleged racketeering activity, which the Court addresses first below.

The RICO statute expressly lists those violations that constitute predicate acts of racketeering activity. See 18 U.S.C.A. § 1961(1). Distributors assert, in a footnote,3 that the Magistrate   Judge’s   Report   &   Recommendation—finding   that   a   violation   of   21 U.S.C.

  • 843(A)(4)(a) can constitute a predicate act—is “wrong as a matter of law.” Dist. MSJ on RICO at 16 n.14 (Doc. #: 1921-1). No party objected to the Magistrate’s finding and it was subsequently adopted by the Court. See Dec. 19, 2018 Order re MTD Summit (Doc. #: 1203). Although the Magistrate Judge expressed that “whether § 842, § 843, or neither was violated is ultimately an issue of fact that cannot be resolved  on  a  motion  to  dismiss,”  Summit  R&R  at  46-47  (Doc. #: 1025), Distributors here do not meaningfully develop any factual bases that convince the Court either to conclude as a matter of law that Distributors did not violate § 843, or to revisit itsprior legal conclusion (that such a violation, if committed, can constitute racketeering activity). In fact, Distributors acknowledge they drafted their summary judgment motion based on the assumption that “the failure to report a suspicious order can constitute a predicate act of racketeering  for  purposes  of  RICO  and  the  OCPA.”  Dist.  MSJ  on  RICO  at  16  n.14  (Doc. #: 1921-1) (emphasis added). Thus, the Court reaffirms its legal conclusion that a violation of 21 U.S.C. § 843(A)(4)(a) can constitute a predicate act under 18 U.S.C. § 1961(1)(D); and the Court further concludes that, at a minimum, Distributors have failed to demonstrate there is no genuine dispute of material fact regarding whether they violated § 842, § 843.

3 It appears that Distributors only raise this argument in a footnote as an aside to their primary argument that, to the extent their alleged failure to report suspicious orders constitutes a racketeering activity, it did not cause Plaintiffs’ injuries. The broader causation elements of Distributors’ argument are addressed further below.

Distributors also imply for the first time in their reply brief that, because Plaintiffs argue in opposition to summary judgment that “Distributor Defendants flatly failed in their obligation not to ship suspicious orders” pursuant to 21 U.S.C. § 823(b), that Plaintiffs abandoned their prior assertions of various categories of racketeering activity including mail fraud, wire fraud, and failure to report suspicious orders (as a potential violation of § 843). Pls. Opp. Resp. re RICO & Civ. Con. at 114 (Doc. #: 2182) (emphasis in original). As stated above in footnote 3, Distributors’ arguments regarding the viability of Plaintiffs’ assertions of predicate acts was made in the broader context of their proximate causation arguments. Thus, Plaintiffs response, which was intended to address proximate cause and not predicate acts, was appropriate under the circumstances. The Court does not construe Plaintiffs’ opposition response as disclaiming any assertion of predicate acts previously made and argued.

A.  The Existence of An Enterprise

“[A]n association-in-fact enterprise is ‘a group of persons associated together for a common purpose of engaging in a course of conduct.’” Boyle v. United States, 556 U.S. 938, 946 (2009) (quoting United States v. Turkette, 452 U.S. 576, 583 (1981)). To satisfy the enterprise requirement, “an association-in-fact enterprise must have at least three structural features: a purpose, relationships among those associated with the enterprise, and longevity sufficient to permit these associates to pursue the enterprise’s purpose.” Id. The concept of an enterprise is intended to be broad and “[s]uch a group need not have a hierarchical structure or a ‘chain of command’; decisions may be made on an ad hoc basis and by any number of methods.” Summit R&R at 36 (Doc. #: 1025) (citing Boyle, 556 U.S. at 944). The Court has previously observed that “[a]n enterprise includes any group of individuals associated together for a common purpose of engaging in a course of unlawful conduct.” Robins, 838 F. Supp. 2d at 651.

Of course, just because an enterprise’s common purpose may include unlawful conduct does not mean the enterprise’s common purpose must be unlawful. In fact, both the Supreme Court and the Sixth Circuit have made clear that the purpose of the enterprise need only be common to its members, and “must be separate from the pattern of racketeering activity in which it engages.” Frank v. D’Ambrosi, 4 F.3d 1378, 1386 (6th Cir. 1993) (citing Turkette, 452 U.S. at 583). That is, if a group of individuals associate together for the common purpose of committing a series of unlawful acts (and those unlawful acts are also RICO predicate acts), the common purpose is not separate from the pattern of racketeering activity, and there is no RICO violation (there is likely just a conspiracy to commit a crime). If, however, the series of unlawful acts is not the ultimate goal of the group of individuals, but instead merely an unlawful method to achieve that goal, then the enterprise can be described as “separate from the pattern of racketeering activity in which it engages,” and may constitute a RICO violation. Id. There is no requirement, however, that the ultimate goal also be unlawful.

Defendants assert there is no evidence of coordination sufficient to form an association in fact. The Court has already concluded, however, that Plaintiffs have produced sufficient evidence for a reasonable jury to conclude that all Defendants, which includes RICO Marketing Enterprise Defendants and RICO Supply Chain Enterprise Defendants, associated together for the common purpose of expanding the prescription opioid market. See Order Re Civ. Con. (Doc. #: 2562). Plaintiffs have produced evidence to raise genuine issues regarding whether and to what extent the various Defendants coordinated (relationship prong) with one another to expand the opioid market and protect the supply chain (common purpose prong), and that it has been going on long enough to pursue the common purpose (longevity prong). Id. at 6-10. Thus, Defendants have not shown an absence of any essential element as described in Turkette and Boyle such that no reasonable jury could find the existence of an enterprise.

Defendants also assert there is no evidence that they directed or controlled the enterprise. The Supreme Court has said that, “[i]n order to ‘participate, directly or indirectly, in the conduct of such enterprise’s affairs,’ one must have some part in directing those affairs.” Reves v. Ernst & Young, 507 U.S. 170, 179 (1993). The Sixth Circuit further clarified that, “[a]lthough Reves does not explain what it means to have some part in directing the enterprise’s affairs, subsequent decisions from our sister circuits have persuasively explained that it can be accomplished either by making decisions on behalf of the enterprise or by knowingly carrying them out.” United States

  1. Fowler, 535 F.3d 408, 418 (6th Cir. 2008). Thus, in order to show that a Defendant “conduct[s] or participate[s], directly or indirectly, in the conduct of such enterprise’s affairs,” Plaintiffs must show that Defendants made decisions or knowingly carried out acts that helped to further the common purpose of the enterprise. 18 U.S.C.A. § 1962(c).

In its September 3, 2019 Opinion and Order regarding Civil Conspiracy, the Court reviewed the evidence produced by Plaintiffs and determined that various decisions made and actions taken by Manufacturers and Distributors ‒ which, again, include the Marketing Enterprise and Supply Chain Defendants ‒ are sufficient to create a genuine issue of material fact as to whether these Defendants conspired with one another to expand the opioid market and protect the opioid supply chain. See Order re Civ. Con. at 6-10 (Doc. #: 2562). The Court now concludes that these same facts create a genuine issue as to whether Marketing Enterprise and Supply Chain Enterprise Defendants participated in the conduct of these enterprises’ affairs. Defendants have failed to demonstrate that no reasonable juror could conclude, based on the evidence, that they did not.

B.  Causation

 Defendants also assert Plaintiffs have produced no evidence that the alleged predicate acts are causally tied to Plaintiffs alleged RICO injuries. The Court has addressed Defendants causation arguments at some length. See Summit R&R at 24-36 (Doc. #: 1025); Order re MTD Summit at 7-10 (Doc. #: 1203); Order re Causation (Doc. #: 2561). In all instances, the Court has concluded that Plaintiffs will be allowed to test their aggregate theory of causation and have produced enough evidence to raise a genuine dispute  of  material  fact.  See  generally,  Order  re  Causation  (Doc. #: 2561).

C.  Other Arguments

 Manufacturers also assert that RICO damages are not available, as a matter of law, for the marketing of their branded products. Manufacturers assert their marketing was independent, competitive behavior and not the conduct of the enterprise. This argument appears to confuse the alleged common purpose of the enterprise with the alleged pattern of racketeering activity. Plaintiffs have alleged that the purpose of the Marketing Enterprise was to expand the opioid market and that the pattern of racketeering activity by which they accomplished this goal was the use of mail and wire communications in the fraudulent marketing of prescription opioids. Defendants’ argue that their alleged unlawful conduct (fraudulent marketing of opioids), cannot— at the same time—benefit both them individually (increasing market share) and the enterprise collectively (expanding the opioid market). Defendants, however, cite no case law that persuades the Court that racketeering conduct cannot serve both the member and the enterprise at the same time.

Finally, Manufacturers assert Plaintiffs have not done enough to demonstrate that their alleged RICO damages do not flow from the personal injuries of their citizens. In its Opinion and Order adopting the Magistrate Judge’s R&R on the motions to dismiss, the Court concluded that Plaintiffs had sufficiently alleged “categories of costs . . . that cannot be said to arise directly out of Plaintiffs’ residents’ personal injuries.” Order re MTD Summit at 16-17 (Doc. #: 1203). Defendants’ argument now urges the Court to reconsider its supposedly too-broad application of Jackson v. Sedgwick Claims Mgmt. Servs., Inc., 731 F.3d 556 (6th Cir. 2013).4 The Court declines to do so.

Accordingly, Distributors’ Motion for summary judgment on Plaintiffs’ RICO and OCPA Claims, (Doc. #: 1921); and Manufacturers’ Motion for summary judgment on Plaintiffs’ RICO, OCPA, and Conspiracy Claims (Doc. #: 1930) are both DENIED.

IT IS SO ORDERED.

  

/s/Dan Aaron Polster September 10, 2019

DAN AARON POLSTER

UNITED STATES DISTRICT JUDGE

 

 

 

 

 

 

 

 

 

 

 

 

4 Notably, Manufacturers do not assert that the Court’s application is incorrect; merely that it is broad. See Man. MSJ on RICO & Civ. Con. at 27 (Doc. #: 1930-1).

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Medical Error Is Not Included On Death Certificates Or CDC Rankings Of Cause Of Death

 

 

 

 

 

 

 

 

 

By Mark A. York (August 30, 2019)

Medical Errors Are Third Leading Cause of Death in the U.S.

Are 10 percent of U.S. deaths due to preventable medical mistakes?

Medical errors are an “epidemic” that claim hundreds of thousands of lives annually, according to medical reports.

MEDICAL ERRORS ARE THE third leading cause of death in the U.S., after heart disease and cancer, causing at least 250,000 deaths every year, according to recently released data indicating that patient safety efforts fall far short.

Medical error—the third leading cause of death in the US – British Medical Journal

Types of PAEs

The cause of PAEs in hospitals may be separated into these categories:

  • Errors of commission,
  • Errors of omission,
  • Errors of communication,
  • Errors of context, and
  • Diagnostic errors

https://www.pbs.org/newshour/show/is-fatal-medical-error-a-leading-cause-of-death

“People don’t just die from heart attacks and bacteria, they die from system-wide failings and poorly coordinated care,” says the study’s lead author, Dr. Martin Makary, a professor of surgery and health policy at Johns Hopkins University School of Medicine. “It’s medical care gone awry.”

Medical errors rank behind heart disease and cancer as the third leading cause of death in the U.S., Johns Hopkins researchers say. … Based on an analysis of prior research, the Johns Hopkins study estimates that more than 250,000 Americans die each year from medical errors.

Historical analysis of papers that focused on mortality due to medical errors in 1999-2000, took  a number of different approaches and perspectives, summarized in, “To Err is Human” which estimated that 44,000 to 98,000 deaths per year were due to medical error. There was an uproar, and many pundits dismissed it out of hand. Using a weighted average of four previous studies, a meta-analysis in 2013 “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care” estimated more than 400,000 deaths due to medical error per year. In 2016, “Medical error—the third leading cause of death in the US” estimated 251,454 deaths, based on 35,416,020 hospitalization.

Objectives Based on 1984 data developed from reviews of medical records of patients treated in New York hospitals, the Institute of Medicine estimated that up to 98,000 Americans die each year from medical errors. The basis of this estimate is nearly 3 decades old; herein, an updated estimate is developed from modern studies published from 2008 to 2011.

Methods A literature review identified 4 limited studies that used primarily the Global Trigger Tool to flag specific evidence in medical records, such as medication stop orders or abnormal laboratory results, which point to an adverse event that may have harmed a patient. Ultimately, a physician must concur on the findings of an adverse event and then classify the severity of patient harm.

Results Using a weighted average of the 4 studies, a lower limit of 210,000 deaths per year was associated with preventable harm in hospitals. Given limitations in the search capability of the Global Trigger Tool and the incompleteness of medical records on which the Tool depends, the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year. Serious harm seems to be 10- to 20-fold more common than lethal harm.

Conclusions The epidemic of patient harm in hospitals must be taken more seriously if it is to be curtailed. Fully engaging patients and their advocates during hospital care, systematically seeking the patients’ voice in identifying harms, transparent accountability for harm, and intentional correction of root causes of harm will be necessary to accomplish this goal.

In a Mayo Clinic study with the American College of Surgeons, 8.9% of participating U.S. surgeons reported the belief that they’ve made a major medical error within the last 3 months — and 1.5% believe their error resulted in a patient’s death, according to Tait Shanafelt. “When you think about that for a minute, it’s a staggering number,” Shanafelt says. Suicide ideation doubles in that 3-month window as well, he notes, independent of depression — the risk of which triples. “So when we make mistakes — and all physicians will make mistakes during the course of their career — it has a substantial toll on us. And there’s a strong link there with burnout.”

Preventing Hospital Medical Errors/sciencedaily

The magnitude of the death toll – roughly 10 percent of U.S. deaths annually – is striking coming, as it does, in an era dominated by efforts to reform the health system to ensure safe, high quality, high-value medical care. Patient

no systematic effort to study medical errors or to put effective safeguards in place.

“Throughout the world, medical error leading to patient death is an under-recognized epidemic,” Makary and his co-author, Dr. Michael Daniel, also of Johns Hopkins, write in Tuesday’s British Medical Journal. They define medical errors as lapses in judgment, skill or coordination of care; mistaken diagnoses; system failures that lead to patient deaths or the failure to rescue dying patients; and preventable complications of care.

Their report comes nearly two decades after “To Err is Human,” a report by the Institute of Medicine, asserted that medical mistakes are rampant in health care. The IOM, a quasi-public think tank made up of leading scientists, drew on existing data to estimate that 44,000 to 98,000 people die in U.S. hospitals each year. Even then, some researchers claimed the estimates were low and based on outdated information.

The new estimate is drawn from more-recent studies indicating the number may be much higher. For instance, a report published in the journal Health Affairs in 2011 calculated that just over 1 percent of hospital patients die each year because of medical errors. When applied to the more than 35 million people hospitalized each year, Makary and Daniel say, this would “translate into 400,201 deaths per year, more than four times the original IOM report estimate.”

The Hopkins team used evidence from four studies that analyzed medical death rate data from 2000 to 2008, including one by the U.S. Department of Health and Human Services’ Office of the Inspector General and the Agency for Healthcare Research and Quality. Using these data, they were able to calculate a mean death rate for medical errors in U.S. hospitals. Applying this rate to the 35 million admissions in 2013, they calculated that 251,454 deaths resulted from medical mistakes.

The researchers acknowledge that this figure most likely represents an undercount, because they were unable to capture data from deaths that occur in outpatient clinics, nursing homes and other non-hospital settings where health care workers care for fragile patients who need complex care.

“It’s fair to say that this number is controversial,” says Dr. Robert Wachter, a professor of medicine at UCSF School of Medicine. “I wouldn’t take this number to the bank.”

Dr. Ashish Jha, a patient-safety expert and director of the Harvard Global Health Institute, agreed that many researchers will be temped to debate which of the estimates are the most accurate.

“It doesn’t matter,” he says, “because all these numbers are so big. They’re a reminder of how big the problem is and how little is being done to address it.”

Much of the effort put into patient safety and performance improvement over the last two decades has been misdirected or ineffective, Jha says. “If you called the CEO of a big hospital and asked, ‘How many medical errors did you have last month? How many falls? How many falls that resulted in serious injury?’ They won’t know.”

Another issue, Wachter says, is that patient safety is being crowded out by newer initiatives. “My concern,” he says, “is that patient safety efforts, which gained so much momentum following the publication of the IOM report, have lost ground in recent years, defused by all the other performance improvement mandates that have come down the highway.”

Makary and Daniel are calling for reforms that would improve the reporting of medical errors, which in turn could inform prevention efforts. In a letter dated May 1, they asked the Centers for Disease Control and Prevention, which gathers births, deaths and other vital statistics, to rank medical errors on the list of leading causes of death. They also asked CDC to alter death certificates so that doctors, medical examiners and coroners can routinely report medical errors that contribute to a patient’s death.

The letter takes pains to point out that the U.S. government and private sector spend “a lot of money” on heart disease and cancer research and prevention. “It is time for the country to invest [a proportional amount] in medical quality and patient safety,” it says.

So far, the researchers have not received an official response, but CDC officials acknowledged that errors are under-reported and that there are ways to capture the data, Makary says. CDC experts were not available for comment.

Wachter is skeptical that the practice of using death certificates to report medical errors will take hold among doctors. “The idea they’ll begin recording this faithfully, or without concern for a malpractice suit, doesn’t strike me as very plausible,” he says.

Makary adds that it was his perception that medical-error research is “underfunded and under-appreciated” that prompted him to embark on an analysis that would elevate fatal mishaps to their proper place near the top of the list of all causes of death.

The findings, Jha says, illustrate that the policies and practices we’re putting in place “are completely inadequate to the size of the problem we have.”

“We can do this,” Jha says. “This is not beyond the creativity and ingenuity of the health care community. We’ve just got to make it a real priority.”

At what point do US consumers start to realize that the healthcare system in the United states is not geared toward “health care” but toward making profits for the medical industry as a whole. Which includes- Big Pharma, For-profit hospitals (owned by non-profits), insurance companies, third party benefit providers, pharmacies that pay and receive rebates (pay to play kickbacks) from drug makers and distributors, doctors paid by Big Pharma to author slanted medical papers and the list goes on and on.

 

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