WEEKLY MDL and MASS TORT UPDATE by MASS TORT NEXUS for Week of November 27, 2017

By Mark A. York (November 30, 2017)

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This week in mass torts around the country:

Opioid Crisis: See Mass Tort Nexus Briefcase Re: OPIOID CRISIS MATERIALS INCLUDING: MDL 2804 OPIATE PRESCRIPTION LITIGATION

> Superseding indictments of Insys Therapeutics Executives Unsealed in USDC of Massachusetts

BOSTON — A federal indictment against seven high-ranking officers of opioid maker Insys Therapeutics Inc. was unsealed Oct. 26 in a Massachusetts federal court charging the men with racketeering, mail fraud and conspiracy for a scheme to pay kickbacks to doctors for, and to fraudulently induce health insurers into approving, off-label prescriptions for the company’s addictive Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

>Doctor Pleads Guilty To Opioid Health Care Fraud, Taking Kickbacks From Insys

PROVIDENCE, R.I. — A Rhode Island doctor on Oct. 25 pleaded guilty to health care fraud and taking kickbacks for prescribing the opioid Subsys to unqualified patients (United States of America v. Jerrold N. Rosenberg, No. 17-9, D. R.I.).

 > Opioid Distributors Support MDL While Municipalities Oppose

WASHINGTON, D.C. — The “Big Three” national drug distributors on Oct. 20 told a federal judicial panel that they support centralization of more than 60 opioid lawsuits filed against them by various cities and counties (In Re:  National Prescription Opiate Litigation, MDL Docket No. 2804, JPML).

Related Mass Tort Nexus Opiod Articles:

>California Appeals Court Denies Insurance Coverage For Opioid Drug Makers Defense: Will other insurers say no to opioid coverage? Nov 15, 2017

>Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA Nov 3, 2017

For more Mass Tort Nexus Opiod Crisis Information See: Mass Tort Nexus Newsletters and MDL Updates

IVC FILTERS:

Cook Medical IVC: See Mass Tort Nexus Briefcase Re: Cook Medical IVC Filter MDL 2570

>First Cook IVC Bellwether Trial Starts in USDC SD of Indiana

INDIANAPOLIS — The first bellwether trial in the Cook Medical Inc. inferior vena cava (IVC) filter multidistrict litigation got under way on Oct. 23 in Indianapolis federal court (In re:  Cook Medical, Inc., IVC Filters Litigation, MDL Docket No. 2570, No. 14-ml-2570, Elizabeth Jane Hill v. Cook Medical, Inc., No. 14-6016, S.D. Ind., Indianapolis Div.).

Cordis IVC Filters: See Cordis IVC Filter Litigation Alameda County, California Superior Court

>Cordis IVC Filter Plaintiffs Tell Supreme Court Trial Proposal Is No ‘Mass Action’

WASHINGTON, D.C. — Plaintiffs in an inferior vena cava (IVC) filter case on Oct. 18 told the U.S. Supreme Court that their suggestion of individual bellwether trials does not convert their actions into a mass action under the Class Action Fairness Act (CAFA), 119 Stat. 4 (Cordis Corporation v. Jerry Dunson, et al., No. 17-257, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4013).

Taxotere: See Taxotere MDL 2740 (US District Court Eastern District of Louisiana)

>Taxotere MDL Judge Denies Statute of Limitations Motion by Sanofi

NEW ORLEANS — The Louisiana federal judge overseeing the Taxotere multidistrict litigation on Oct. 27 denied without prejudice a motion by defendant Sanofi-Aventis U.S. LLC to dismiss claims barred by applicable statutes of limitations (In Re:  Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740, No. 16-md-2740, E.D. La.).

Pelvic Mesh: Boston Scientific TVM Litigation MDL 2362

>Exclusion of 510(k) Defense in Boston Scientific Pelvic Mesh Case:

ATLANTA — The 11th Circuit U.S. Court of Appeals on Oct. 19 said multidistrict litigation court judge did not err in consolidating four pelvic mesh cases for a bellwether trial and in excluding the so-called 510(k) defense raised by defendant Boston Scientific Corp. (BSC) (Amal Eghnayem, et al. v. Boston Scientific Corporation, No. 16-11818, 11th Cir., 2017 U.S. App. LEXIS 20432).

PLAVIX: See Mass Tort Nexus Briefcase Re: PLAVIX MDL 2418 USDC NEW JERSEY

>Plaintiff Loses Plavix Case on Summary Judgment Over Late “Learned Intermediary” Declaration

TRENTON, N.J. — The judge overseeing the Plavix multidistrict litigation on Oct. 26 granted summary judgment in a case after ruling that the plaintiff’s “eleventh hour” declaration by one treating physician did not overcome California’s learned intermediary defense for defendants Bristol-Myers Squibb Co. (BMS) and Sanofi-Aventis U.S. Inc. (In Re:  Plavix Products Liability Litigation, MDL Docket No. 2418, No. 13-4518, D. N.J., 2017 U.S. Dist. LEXIS 177588).

Abilify MDL 2734: Mass Tort Nexus Briefcase Re: Abilify MDL 2734

 >Abilify MDL Judge Orders Defendants To Name Settlement Counsel

PENSACOLA, Fla. — The Florida federal judge overseeing the Abilify multidistrict litigation on Oct. 25 ordered the defendants to engage settlement counsel for monthly settlement conferences (In Re:  Abilify [Aripiprazole] Products Liability Litigation, MDL Docket No. 2734, No. 16-md-2734, N.D. Fla., Pensacola Div.).

Mirena IUD: Related-Federal Court Reopens Mirena IUD Product Liability MDL Nov 3, 2016

>2nd Circuit Affirms Exclusion Of Mirena MDL Experts, Termination Of Litigation

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re:  Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir., 2017 U.S. App. LEXIS 20875).

Hip ImplantsSee Mass Tort Nexus Briefcase Re: Wright Medical, Inc. MDL 2329 Conserve Hip Implant Litigation

>Wright Medical Settles Remaining Wright Hip Cases; Judge Closes MDL 2329

ATLANTA — Wright Medical Technology Inc. and plaintiffs in a multidistrict litigation have entered two additional agreements settling the remainder of the litigation, a Georgia federal judge said Oct. 18 (In Re:  Wright Medical Technology, Inc., Conserve Hip Implant Products Liability, MDL Docket No. 2329, No. 12-md-2329, N.D. Ga., Atlanta Div

Testosterone Replacement Therapy: See Mass Tort Nexus Briefcase Re: TESTOSTERONE MDL 2545 (AndroGel)

>Testosterone Bellwether Out and Pre-emption Denied

CHICAGO — An Illinois multidistrict litigation judge on Oct. 23 granted summary judgment in one of two testosterone replacement therapy bellwether cases but denied preemption in the second case (In Re:  Testosterone Replacement Therapy Litigation, MDL Docket No. 2545, No. 14-1748, N.D. Ill., Eastern Div., 2017 U.S. Dist. LEXIS 176522).

 

>AbbVie, AndroGel Plaintiff Spar Over Mixed Verdict In 1st Bellwether Trial Verdict

CHICAGO — AbbVie on Oct. 25 urged the judge overseeing the testosterone replacement therapy multidistrict litigation to not disturb a bellwether trial verdict where a jury awarded $0 compensatory damages (In Re:  Testosterone Replacement Therapy Products Liability Litigation, MDL Docket No. 2545, No. 14-1748, Jesse Mitchell v. AbbVie, No. 14-9178, N.D. Ill.).

Fosamax MDL 1789: See Mass Tort Nexus Briefcase Re: MDL 1789 Fosamax Products Liability Litigation USDC New Jersey

>Fosamax Femur Plaintiffs Urge Supreme Court To Deny Preemption Review

WASHINGTON, D.C. — Counsel for more than 500 Fosamax femur fracture plaintiffs on Oct. 25 urged the U.S. Supreme Court to deny certiorari to Merck Sharp & Dohme Corp., arguing that their claims are not preempted by “clear evidence” that the Food and Drug Administration would have rejected stronger warnings for the osteoporosis drug (Merck Sharpe & Dohme Corp. v. Doris Albrecht, et al., No. 17-290, U.S. Sup., 2017 U.S. S. Ct. Briefs LEXIS 4064

 

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Generic Taxotere Lawsuits Allowed in Federal MDL

The U.S. Judicial Panel on Multidistrict Litigation (JPMDL) has allowed claims involving generic docetaxel, a chemotherapy drug, to be included in the Taxotere MDL now underway in the Eastern District of Louisiana.

Judge Sarah S. Vance, Chair of the JPMDL, stated in a letter that the consolidated litigation does include lawsuits against both name-brand and generic forms of the drug.

The panel’s letter was in response to District Judge Kurt D. Engelhardt, who wrote to the panel for clarification in December. Judge Engelhardt is overseeing 1,006 lawsuits filed in 2740, IN RE: Taxotere (Docetaxel) Products Liability Litigation.

Half of cases against generics

Taxotere, manufactured by Sanofi, lost its patent protection in late 2010. Half of the cases in the MDL involve generic and quasi-generic manufacturers, whose products obtained FDA approval under 21 USC Sec. 505(b)(2) and not through the more traditional generic approval under 21 USC Sec. 505(j).

The plaintiffs charge that they experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy.

It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to each patient and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”

Back in December 2016, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.

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Taxotere Judge Sets Science Day

US District Judge Kurt D. Engelhardt ordered the parties in Taxotere litigation in MDL 2740, where 949 cases are filed in the Eastern District of Louisiana, charging that the chemotherapy drug caused disfiguring, permanent and total hair loss among patients.

Defendants include Sanofi S.A., Aventis Pharma S.A., Sanofi US Services Inc. f/k/a Sanofi-Aventis U.S. Inc., and Sanofi-Aventis U.S. LLC.

“Science Days” have become a tradition in mass tort litigation. In the last few years, there is a Science Day somewhere, in some courtroom, going on.  Trial judges have welcomed tutorials in the form of “Science Days,” to help them learn the methodologies and vocabularies of the scientific disciplines that are involved in the litigations before them.

Taxotere and Hair Loss

A total of 799 Taxotere lawsuits have been filed by plaintiffs who experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia (hair loss) was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to

It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information about the potential for permanent alopecia to each patient and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back.”

Back in December 2016, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.

In other orders, the judge:

  • Scheduled a follow-up meeting with the settlement committees on May 12, 2017, after the conclusion of the general status conference scheduled for this date.
  • Approved an exemplar Short Form Complaint to use when filing new cases.

The plaintiffs’ Plaintiffs’ Co-Liaison Counsel are:

  • Dawn M. Barrios of Barrios, Kingsdorf & Casteix, New Orleans, LA.
  • Palmer Lambert of Gainsburgh Benjamin David Meunier & Warshauer, New Orleans, LA.

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Taxotere Judge Issues Orders for Common Benefit and Special Master

Lawsuits filed on behalf of individuals who allegedly experienced permanent alopecia due to the Taxotere chemotherapy medication continue to move forward in the multidistrict litigation underway in the U.S. District Court, Eastern District of Louisiana.

Judge Kurt D. Engelhardt issued two Pretrial Orders, including Pretrial Order 16 outlining a proposed Common Benefit Order previously submitted by the parties.

Pretrial Order 17 addresses the Court’s intent to appoint a Special Master for management, oversight, and substantive review of matters related to the common benefit, as well as any other matters or recommendation as directed by the Court. (In Re: Taxotere (Docetaxal) Products Liability Litigation – MDL No. 2740)

“The matters addressed in the Court’s latest Pretrial Orders will help ensure that the proceeding continues to move forward efficiently,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs.

Taxotere and Hair Loss

A total of 755 Taxotere lawsuits have been filed in the Eastern District of Louisiana on plaintiffs who experienced permanent hair loss following treatment with the chemotherapy agent. While Taxotere was first approved to treat breast cancer in 1996, it wasn’t until December 2015 that mention of permanent alopecia was included on the drug’s U.S. label. It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to

It is true that alopecia is a common side effect of chemotherapy. However, plaintiffs claim that Taxotere is more likely to result in the permanent loss of hair compared to other equally effective drugs. They also claim that Sanofi-Aventis has long provided information regarding the potential for permanent alopecia to individual patients and regulatory agencies overseas. Yet Taxotere’s U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back”.

Back in December, when only 267 cases were filed in the MDL, Judge Engelhardt appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.

 

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Doc Who Promoted Testosterone Must Reveal Payments from Drug Defendants

Dr. Abraham Morgentaler, the Director of Men’s Health Boston
Dr. Abraham Morgentaler, the Director of Men’s Health Boston.

US District Judge Matthew F. Kennelly in the Northern District of Illinois ordered a notorious doctor who promoted testosterone replacement therapy for 30 years to turn over his tax records showing how much he was paid by the drug’s manufacturers.

The case is In Re: Testosterone Replacement Therapy Products Liability Litigation, MDL No. 2545.

The plaintiffs charge that the drug makers misrepresented that AndroGel is a safe and effective treatment for hypogonadism and a condition they referred to as “low testosterone,” when in fact the drug causes serious medical problems, including life-threatening cardiac events, strokes, and thrombolytic events.

AndroGel, a testosterone drug manufactured by AbbVie, causes the hematocrit level to increase, thereby thickening the blood. This effect, if not monitored and controlled properly, can lead to life-threatening cardiac events, strokes and thrombolytic events. Defendants failed to adequately warn physicians about the risks associated with the AndroGel and the monitoring required to ensure their patients’ safety.

The hormone has been used off-label to treat a range of symptoms such as loss of energy, decreased muscle mass and reduced libido.

Must reveal payoffs

Morgentaler must now reveal:

  • Written agreements and 1099 tax statements about money received from defendants AbbVie Inc., Abbott Laboratories Inc., Eli Lilly and Co., Actavis, Inc., Auxilium Pharmaceuticals, Inc., and Pfizer, Inc.
  • Powerpoint slides and presentation notes referring to testosterone replacement therapy (TRT) going back 7 years.
  • All documents and communications relating to the risks and benefits of TRT with the defendants going back 3 years.

Judge Kennelly’s ruling ends Morgantaler’s battle against a subpoena from the plaintiffs’ steering committee, which has portrayed the doctor as actively shaping “the science, marketing, and use of TRT products involved in these MDL proceedings.”

Abbvie alone spent $20 million from August 2013 to December 2015 in payments to doctors to promote TRT, according to ProPublica’s Dollars for Docs database. During the same time period, Morgentaler took $73,056 in payments from various drug companies.

Morgentaler founded the Androgen Study Group, which reviews studies about TRT. He must now produce all documents regarding the Group as well as a March 29, 2014 letter to Howard Bauchner, MD, Editor-in-Chief of JAMA recommending retraction of an article “Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men with Low Testosterone Levels.” The article by Rebecca Vigen, MD was published anyway in JAMA’s Nov. 13, 2013 issue.

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Unexpectedly, Judge Appoints Settlement Lawyers in Taxotere Chemo Litigation

Chief Judge Kurt Engelhardt
Chief Judge Kurt D. Engelhardt

In an unusual move, US District Judge Kirk D. Engelhardt overseeing In Re: Taxotere (Docetaxel) Products Liability Litigation – MDL No. 2740 appointed plaintiff and defense settlement committees, calling on them to focus less on preparing for trial and more on resolving the case.

The Plaintiffs’ Liaison Counsel and Steering Committee were only appointed in November and the MDL was created only in October. Pressing the attorneys on the case is in step with the judge’s character. See Crusading Judge Takes Over Taxotere Products Liability Litigation.

He told the lawyers to be “engaging in continuous general settlement discussions on a regular basis, as opposed to participating in detailed discovery, trial preparations, and presentation at trial, wherein those time-consuming tasks would distract counsel from pursuing avenues for potential resolution of some or all of the issues in this multi-district litigation.”

“The settlement committees are expected to hold regular discussions, in an attempt to establish common understandings, potential ground rules, component parts and concepts, anticipated relief, necessary approvals, and ultimately financial details, including drafting of all pertinent documents, in an attempt to resolve this matter prior to remand of some or all of the member cases,” the judge wrote in Pretrial Order No. 6.

To date 267 cases have been filed in the MDL. Plaintiffs in these actions each allege that they experienced permanent hair loss as a result of using Taxotere. All actions will require discovery regarding the design, testing, manufacturing, marketing, and labeling of Taxotere. The defendant is Sanofi-Aventis U.S. LLC.

All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.

For further information read FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

Plaintiff Settlement Committee:

Ben W. Gordon, Jr.
Levin Papantonio
316 S. Baylen Street, #600
Pensacola, Florida 32502
(Phone): 850-432-7274
Email: bgordon@levinlaw.com

Mark R. Niemeyer
Niemeyer, Grebel & Kruse, LLC
10 S. Broadway, Suite 1125
St. Louis, Missouri 63102
(Phone): 314-241-1919
Email: niemeyer@ngklawfirm.com

Irving J. Warshauer
Gainsburgh, Benjamin, David, Meunier & Warshauer, L.L.C.
2800 Energy Centre
1100 Poydras Street
New Orleans, Louisiana 70163
(Phone): 504-522-2304
Email: iwarshauer@gainsben.com

Dennis C. Reich
Reich and Binstock LLP
4265 San Felipe #1000
Houston, Texas 77027
(Phone): 713-622-7271
Email: dreich@reichandbinstock.com

Ashlea G. Schwarz
Paul McInnes LLP
601 Walnut Street, Suite 300
Kansas City, Missouri 64106
(Phone): 816-984-8100
Email: ashlea@paulmcinnes.com

Defendant Settlement Committee:

Anand Agneshwar
Arnold & Porter
399 Park Avenue
New York, New York 10022-4690
(Phone): 212-715-1107
anand.agneshwar@aporter.com

Bruce H. Nagel
Nagel Rice LLP
103 Eisenhower Parkway
Roseland, New Jersey 07068
(Phone): 973-618-0400 (Ext. 110)
bnagel@nagelrice.com

Harvey L. Kaplan
Shook, Hardy & Bacon
2555 Grand Boulevard
Kansas City, Missouri 64108
(Phone): 816-559-2214
Email: hkaplan@shb.com

John Strongman
Shook, Hardy & Bacon
2555 Grand Boulevard
Kansas City, Missouri 64108
(Phone): 816-559-2430
Email: jstrongman@shb.com

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Taxotere MDL Gets Plaintiffs’ Liaison Counsel and Steering Committee

taxotere2US District Judge Kurt D. Engelhardt in the Eastern District of Louisiana issued Pretrial Order 2 on Nov. 17, 2016 appointing the Plaintiffs’ Liaison Counsel, Defendants’ Liaison Counsel, and the Plaintiffs’ Steering Committee (PSC) for 180 actions in In Re: Taxotere (Docetaxel) Products Liability Litigation – MDL No. 2740.

Plaintiffs’ Liaison counsel: Dawn Barrios of Palmer Lambert Barrios LLP of New Orleans, Louisiana and Palmer Lambert of Gainsburgh Benjamin David Meunier & Warshauer, LLC, also of New Orleans.

Defendants’ liaison counsel: Douglas J. Moore of Irwin Fritchie Urquhart & Moore LLC of New Orleans, Louisiana.

Plaintiffs’ Steering Committee:

Andrew Lemmon                                                  Emily Jeffcott
Lemmon Law Firm, LLC                                     The Lambert Firm, PLC
Hahnville, Louisiana 70057                                New Orleans, Louisiana 70130

Christopher Coffin                                                J. Kyle Bachus
Pendley, Baudin & Coffin, LLP                           Bachus & Schanker, LLC
New Orleans, Louisiana 70112                           Denver, Colorado

Anne Andrews                                                            Karen Barth Menzies
Andrews Thornton Higgins Razmara, LLP          Gibbs Law Group LLP
Irvine, California 92606                                           El Segundo, California

Hunter J. Shkolnik                                               Genevieve Zimmerman
Napoli Shkolnik PLLC                                         Meshbesher & Spence LTD
New York, New York                                            Minneapolis, Minnesota

Abby E. McClellan                                                Lawrence J. Centola, III
Stueve Siegel Hanson LLP                                   Martzell, Bickford, & Centola
Kansas City, Missouri                                           New Orleans, Louisiana

Alexander G. Dwyer                                             David F. Miceli
Kirkendall Dwyer LLP                                         Simmons Hanly Conroy
Houston, Texas 77002                                        Alton, Illinois 62002

Rand P. Nolen                                                       Daniel Markoff
Fleming, Nolen & Jez, LLP                                 Atkins & Markoff Law Firm
Houston, Texas                                                     Oklahoma City, Oklahoma

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Initial Conference Set for Taxotere Hair Loss Litigation

taxotere2Federal multi-district litigation is about to get underway in the US District Court in New Orleans for recently consolidated product liability lawsuits alleging that Taxotere caused permanent hair loss.

US District Judge Kurt D. Engelhardt in the Eastern District of Louisiana issued Pretrial Order 1 on October 13, 2016, announcing that he will convene the Initial Case Management Conference on November 10. About 90 cases are pending in In Re: Taxotere (Docetaxel) Products Liability Litigation – MDL No. 2740.

The order directs that the parties submit proposed discovery plans under Rule 26(f) that contain expert discovery deadlines, and a suggested schedule under Rule 16(b) for joinder of parties, amendment of pleadings, and consideration of class action allegations by November 2nd.

Applications and nominations for appointment to the Plaintiffs’ Steering Committee must be filed electronically in the master docket by October 24.

Also read: Crusading Judge Takes Over Taxotere Products Liability Litigation

Initially approved to treat breast cancer, Taxotere (docetaxel) has since been cleared by the U.S. Food & Drug Administration (FDA) for use in patients with head and neck cancer, gastric cancer, prostate cancer and non-small cell lung cancer. Though Taxotere has been on the market for two decades, it was only in

Disfiguring hair loss

Though Taxotere has been on the market for two decades, it was only in December 2015 that the U.S. label was updated to note that chemotherapy patients who had treated with the medication reported suffering permanent alopecia.

Product liability actions are proliferating in federal courts across the country, charging that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not.

The plaintiffs charge that defendants Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. failed to update the warnings for Taxotere, failed to show the results of additional studies despite learning the facts about the risks of Taxotere, fraudulently concealed the fact that Taxotere caused permanent alopecia unlike other taxanes used for the treatment of breast cancer, and engaged in a fraudulent marketing scheme, which involved paying kickbacks and providing other unlawful incentives to entice physicians to use Taxotere,” the motion says.

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Crusading Judge Takes Over Taxotere Products Liability Litigation

Chief Judge Kurt Engelhardt
Chief Judge Kurt D. Engelhardt

Judge Kurt D. Engelhardt, who courageously investigated the New Orleans US Attorney’s Office for misconduct in a police murder prosecution, will apply his no-nonsense approach to dozens of mass tort lawsuits against Sanofi S.A. over its chemotherapy drug, Taxotere.

Judge Engelhardt, age 56, has been on the federal bench for 15 years and ascended to Chief Judge in the US Eastern District of Louisiana in New Orleans in 2015. Previously he has supervised two product liability MDLs:

  • Franck’s Lab. Inc. Product Liability Litigation MDL 2454, which was closed on May 21, 2016, when all the parties settled. The MDL was created in 2013. The lab compounded pharmaceutical products that were contaminated by fungus and toxins, which caused rare eye infections and blindness.
  • FEMA Trailer Products Liability Litigation MDL 1873, which was closed on October 26, 2015, after three waves of settlements. Companies that manufactured mobile homes for the Federal Emergency Management Agency after Hurricane Katrina agreed to pay $2.6 million to resolve claims that the mobile homes emitted formaldehyde

Engelhardt will supervise the new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation consisting of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

The plaintiffs charge that the Taxotere breast cancer drug causes unexpected, permanent and disfiguring hair loss in women. Although hair loss is a common temporary side effect of chemotherapy drugs, permanent alopecia is not. The lawsuits allege that Sanofi was aware of this possible side effect and failed to warn patients, and that the defendants marketed Taxotere as more effective than similar drugs when other drugs were equally effective without causing permanent hair loss.

“Grotesque Misconduct” in Federal Prosecution

A notorious criminal trial in New Orleans illustrates the importance that the judge places on the integrity of the courts. From 2012-2013 Judge Engelhardt investigated gross misconduct in the US Attorney’s office in New Orleans in its prosecution of five policemen who were charged in the 2005 killing of two people and injury of four others on the Danziger Bridge after Hurricane Katrina. The cops were convicted of civil rights and other charges in 2011.

The judge threw out the convictions in 2013 after determining that three federal prosecutors improperly attacked the judge, the police and defense lawyers in anonymous online postings, and leaked confidential information. Two investigations by the US Attorney’s office — one led by a guilty prosecutor — were cover-ups of “grotesque prosecutorial misconduct,” according to the judge.

“The public must have absolute trust and confidence in this process,” Engelhardt wrote in overturning the verdicts. “Re-trying this case is a very small price to pay in order to protect the validity of the verdict in this case, the institutional integrity of this court and the criminal justice system as a whole.”

The 5th Circuit upheld Judge Engelhardt’s decision in 2015, and the case finally ended on April 20, 2016, when the five Danziger Bridge cops pleaded guilty.

The Fifth Circuit ruled that the prosecutors’ “insidious” cyberbullying created a mob mentality against the defendants. “[p]rejudice here was shown both from this pattern of misconduct and evasion and from other abusive prosecutor actions,” it said. “A miscarriage of justice harms the substantial rights of a defendant, and it may consist of errors and omissions considered for their cumulative effect on the trial proceedings.”

Judge Engelhardt’s skepticism of the Department of Justice was also highlighted in the three-year sentence he imposed on a corrupt local prosecutor, St. Charles Parish District Attorney Harry Morel Jr. An FBI agent had sent the judge a 31-page letter about ethical lapses in the Justice Department. Engelhardt refused to release the letter but said it was “particularly interesting (and troubling, to say the least).”

The Justice department had ended an investigation into serious allegations that he traded leniency in court for sex from defendants, but let him plead guilty to obstruction of justice. Judge Engelhardt gave Morel the maximum sentence allowed.

Recently he sentenced once-fugitive real estate financier Robert Durst to 7 years and 1 month on a weapons charge that cleared the path for him to face murder charges in California. Durst will serve more than 4 ½ times the maximum under federal guidelines based on a plea deal with prosecutors in Houston, Manhattan and Orleans Parish not to prosecute him on a variety of offenses.

Cited for excellence

As an MDL judge, Engelhardt can be expected to be an efficient stickler for deadlines and details. In 2004 he was appointed by US Supreme Court Chief Justice Rehnquist to serve on the Judicial Conference Committee on Federal-State Jurisdiction, where he served two terms, which may be beneficial in the MDL case management. His work on the Judiciary Commission has been cited for its excellence by the Louisiana Supreme Court.

On the bench, had actually has few criminal case opinions. Most of his rulings focus on insurance coverage disputes, contract actions, legal malpractice and immigration.

In the 2,059 opinions that he’s written since 2002, Judge Engelhardt cites frequently to the 5th Circuit, and often relies on deposition and trial testimony to support his decisions. He writes matter-of-fact and direct opinions and doesn’t stray from the issues of the case.

In scheduling order dates, he does not permit waivers from the dates absent substantive notice to the court by timely motion.

In personal injury cases, he tends to rule in favor of summary judgment defendants where there is any question as to causation or future damages for injuries. In personal injury cases where remand is requested, prior settlement language as to co-defendants is strictly interpreted as to who remains in the case.

Prior to becoming a judge he handled commercial litigation disputes over contracts and insurance coverage disputes. He practiced at Hailey, McNamara, Hall, Larrman & Papale, an insurance defense firm in Metarie, LA. 

The Hailey firm does not appear to have been involved in representing any pharma or drug device clients, there is a brief reference to products liability defense work in the practice summary, but no cases listed to date.

 

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New MDLs Consolidate Cases for Abilify, Roundup, Talc and Taxotere

Consolidating thousands of lawsuits involving Abilify schizophrenia drug, Roundup herbicide, Talc powder and Taxotere cancer drug, US Judicial Panel on Multidistrict Litigation (JPML) in Washington, DC, created new multidistrict litigation (MDL) dockets for the mass tort cases.

This is good news for plaintiffs. In due course the assigned courts will create short-form complaints and plaintiff fact sheets, facilitating the filing of new actions. Each litigation will be led by a plaintiff’s steering committee appointed by the judge, who will set a discovery schedule and select representative cases for bellwether trials.

abilifyAbilify (Aripiprazole)

Responding to a motion from all the parties, the JPML created new MDL 2734, In re: Abilify Products Liability Litigation, supervised by US District Judge M. Casey Rodgers in the Northern District of Florida. The ruling consolidates 22 actions filed in 12 district courts against Bristol-Myers Squibb Company, Otsuka Pharmaceutical Co., Ltd. and Otsuka America Pharmaceutical, Inc.

Plaintiffs allege that Abilify, an atypical anti-psychotic medication commonly prescribed to treat schizophrenia, bipolar disorder, depression, and Tourette syndrome, can cause compulsive gambling behaviors. All the actions involve factual questions relating to whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

For more information read FDA Links Abilify to Compulsive Gambling, Eating, Shopping and Sex

WHO-says-Roundup-probably-causes-cancerRoundup (Glyphosate)

Granting the plaintiffs’ motion, the JPML created the new MDL No. 2741, In Re: Roundup Products Liability Litigation, supervised by Judge US District Vince Chhabria in the Northern District of California. Monsanto opposed consolidation. There are 21 actions pending in 14 districts. Including the potential tag-along actions, there are now 37 actions pending in twenty-one districts. More than ten different law firms represent plaintiffs in these actions, which are spread across the country.

These actions share common factual questions arising out of allegations that Monsanto’s Roundup herbicide, particularly its active ingredient, glyphosate, causes non-Hodgkin’s lymphoma. Plaintiffs each allege that they or their decedents developed non-Hodgkin’s lymphoma after using Roundup over the course of several or more years. Plaintiffs also allege that the use of glyphosate in conjunction with other ingredients, in particular the surfactant polyethoxylated tallow amine (POEA), renders Roundup even more toxic than glyphosate on its own.

For more information read New Illinois Lawsuit Charges Monsanto’s Roundup Causes Cancer

talc johnson & johnsonTalcum Powder

The JPML created the new MDL 2738, In Re: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation, supervised by US District Judge Freda L. Wolfson in the District of New Jersey. There are 10 actions in 8 districts.

The plaintiffs allege that they or their decedents developed ovarian or uterine cancer following perineal application of Johnson & Johnson’s talcum powder products (namely, Johnson’s Baby Powder and Shower to Shower body powder). Two of the actions are consumer class actions brought on behalf of putative classes of women who allege that defendants deceptively marketed the talcum powder products for feminine hygienic use without disclosing talc’s carcinogenic properties. All the actions involve factual questions relating to the risk of cancer posed by talc and talc-based body powders, whether the defendants knew or should have known of this alleged risk, and whether defendants provided adequate instructions and warnings with respect to the products.

For more information read Behind the $55 Million Talc Verdict: J&J Knew About Cancer Risks Since the 1970s

taxotere hair lossTaxotere (Docetaxel)

The JPML created new MDL No. 2740, In Re: Taxotere (Docetaxel) Products Liability Litigation, supervised by Chief US District Judge Chief Judge Kurt Engelhardt in the Eastern District of Louisiana. The litigation consists of 33 actions pending in 16 districts. The panel also has been notified of 56 related actions pending in 25 districts.

Plaintiffs in these actions each allege that they experienced permanent hair loss as a result of using Taxotere. All actions will require discovery regarding the design, testing, manufacturing, marketing, and labeling of Taxotere. The defendant is Sanofi-Aventis U.S. LLC.

All the actions share common factual questions arising out of allegations that Taxotere (docetaxel), a chemotherapy drug, causes permanent hair loss, that defendants were aware of this possible side effect and failed to warn patients, and that defendants marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.

For further information read FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

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