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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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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Hearing Sept. 29 on Forming Taxotere MDL

taxotere bagJudicial Panel on Multidistrict Litigation set arguments on Sept. 29 for a motion to centralize 33 federal lawsuits where breast cancer patients allege that chemotherapy drug Taxotere causes permanent hair loss. In Re: Taxotere [Docetaxel] Products Liability Litigation, MDL Docket No. 2740).

Two lead plaintiffs in the Taxotere (Docetaxel) Products Liability Litigation have filed a motion with the US Judicial Panel on Multidistrict Litigation to consolidate cases filed before 30 different federal judges into one MDL in the Eastern District of Louisiana.

Plaintiffs Veronica Smith and Kelly Gahan filed the Taxotere MDL Motion (PDF), citing 33 cases pending in 16 federal district courts before 30 different judges.

“Movants anticipate that the number of Taxotere cases will grow exponentially and that thousands of Taxotere cases will be filed in the federal courts, particularly because, at the direction of the FDA, Defendants recently modified the prescribing information for Taxotere to indicate, for the first time in the U.S. label, that the drug may cause permanent hair loss,” the motion says.

Disfiguring hair loss for women

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.

“Defendants failed to update the warnings for Taxotere, failed to disclose the results of additional studies despite learning the facts with respect to 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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FDA Releases New Patient Info for Taxotere (Docetaxel) Cancer Drug

taxotere2The FDA Center for Drug Evaluation and Research approved new safety labeling changes for the Taxotere (Docetaxel) breast cancer drug in July 2016, adding the following to the list of adverse reactions:

  • Acute Myeloid Leukemia
  • Cutaneous Reactions
  • Neurologic Reactions
  • Eye Disorders
  • Asthenia
  • Alcohol Intoxication

The agency noted that additional of cases of permanent alopecia have been reported, and lawsuits are proliferating that the Taxotere cancer drug causes permanent hair loss.

Mass Tort Nexus has prepared a briefcase of files about Taxotere litigation.

The emerging litigation is ripe for a motion to consolidate them into a federal multi-district litigation docket, because complaints involving Taxotere (Docetaxel) have been filed in multiple jurisdictions, including US District Courts in Illinois, North Carolina, Florida, Mississippi, Kansas, Louisiana and Colorado.

  • Defendant Sanofi S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Paris, France.
  • Defendant Aventis Pharma S.A. is a corporation or Société Anonyme organized and existing under the laws of France, having its principal place of business in Antony, France.
  • Defendant Sanofi-Aventis U.S. LLC is a Delaware limited liability company, which has its principal place of business at 55 Corporate Drive, Bridgewater, New Jersey.

Taxotere is a drug used to treat various forms of cancer, including but not limited to breast cancer. It is a part of a family of drugs commonly referred to as Taxanes.

Disfiguring permanent alopecia

A leading The California case is Ami Dodson v. Sanofi S.A, Case 4:16-cv-01251-PJH. US District Judge Phyllis J. Hamilton ordered that lead counsel shall confer and file a joint case management statement addressing jurisdiction and service, facts, legal issues, motions, amendment of pleadings and evidence preservation.

Following a March 3rd, 2010 left breast biopsy, Dodson met with her oncologist to discuss further treatment. Neither she nor her treating healthcare providers were aware of or informed by defendants that disfiguring permanent alopecia can occur following treatment with Taxotere. Accordingly, she  underwent chemotherapy that included Taxotere. Following the chemotherapy, she lost all of her hair as a result of receiving chemotherapy with Taxotere.

A study published in 2008 in the New England Journal of Medicine concluded that Taxol (paclitaxel) was more effective than Taxotere (docetaxel) for patients undergoing standard adjuvant chemotherapy with doxorubicin and cyclophosphamide. Despite the publication of these studies, the defendants continued to make false and misleading statements promoting the “superior efficacy” of Taxotere over the competing product paclitaxel Taxol, according to the complaint.

Defendants’ statements in a “reprint carrier” marketing the conclusions of the 2005 JCO study were false and misleading in light of the 2007 and 2008 studies finding that Taxotere was not more effective than paclitaxel in treating breast cancer. As a result of these false and misleading statements, in 2009, the FDA issued a warning letter to Sanofi-Aventis.

Defendants knew or should have known that the rate of permanent alopecia related to Taxotere was far greater than with other products available to treat the same condition as Defendants’ product. Permanent baldness (permanent alopecia) is a disfiguring condition, especially for women. Women who experienced disfiguring permanent alopecia as a result of the use of Taxotere suffer great mental anguish as well as economic damages, including but not limited to loss of work or inability to work due to significant psychological damage.

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