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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New Motion to Form MDL for Taxotere Cancer Drug that Causes Permanent Alopecia

taxotereTwo 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.

The plaintiffs have brought numerous identical claims against the defendants, including products liability for negligence, strict products liability for design and manufacturing defects, strict products liability for failure to warn, breach of express warranty, breach of implied warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, strict products liability for misrepresentation, fraud and deceit, and extreme and outrageous conduct/intentional infliction of emotional distress.

The motion argues that the US District Court in New Orleans is the most appropriate because:

  1. Five cases are currently pending in the Eastern District of Louisiana.
  2. The Eastern District of Louisiana is home to many respected jurists who have expeditiously and successfully handled multidistrict and complex litigation.
  3. The District has sufficient capacity to adjudicate this litigation, as many of the larger MDL cases within the District have been resolved or are drawing to a close.
  4. New Orleans is an easily accessible and convenient forum for the anticipated number of geographically dispersed cases that are on file and expected to be filed.
  5. The Clerk of Court has done a remarkable job in efficiently managing complex multidistrict litigations, many of which involved large numbers of daily filings.

Warnings overseas, but not in the US

Thousands of women of never got the chance to make an informed decision about their cancer treatment because the words “permanent alopecia” or “permanent hair loss” did not appear in any Taxotere information available in the U.S. — even though Sanofi had provided such information to doctors and patients in other countries.

As a direct result of defendants’ fraudulent marketing scheme, the defendants dramatically increased revenue on sales of Docetaxel from $424 million in 2000 to $1.4 billion in 2004.

The best-developed action is Kally Gahan v. Sanofi. The “Sanofi defendants” include:

  • Sanofi S.A. headquartered in Paris, France
  • Aventis Pharma S.A. headquartered in Antony, France
  • Sanofi-Aventis US, Inc. headquartered in Bridgewater, NJ
  • Sanofi-Aventis U.S. LLC headquartered in Bridgewater, NJ
  • Sanofi US Services Inc. Winthrop US (a subsidiary of Sanofi-Aventis US) headquartered in Bridgewater, NJ.

The product liability action is Case No. 1:16-cv-03038, filed on May 26, 2016 in US District Court in Colorado.

 

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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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Emerging and Ongoing Mass Tort Litigation Update

MTN

You can’t miss this!
 

Mass Tort Nexus has added the hottest emerging litigation to its September Course: RoundUp Litigation. This could be the biggest mass tort since asbestos.

In addition to the hands-on practical knowledge all course attendees receive, we are privileged to have an all-star panel of attorney speakers discussing current, emerging and ongoing Mass Tort litigations.

Best of all, this program will be interactive.  There will be ample Q&A after each presentation.

Whether you have dabbled in Mass Torts or are new to the practice area, the “Four Day Mass Tort Success Course” will help you avoid common mistakes, while giving you a road map to success in Mass Torts.  We teach you a step by step process to make sure you understand the methods and metrics of this practice area.

Please join us  Sept 23rd  – Sept 26th for the “Four Days to Mass Tort Success Course” in Fort Lauderdale.  Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com for more information.

RoundUp Cancer Emerging Litigation 
 
timothy-litzenburg-200x300

Timothy Litzenberg will be addressing the emerging RoundUp Cancer litigation. Timothy filed one of the original complaints in district court on behalf of a client who developed cancer after exposure to RoundUp. He is also one of the attorneys supporting the Plaintiffs’ motion to consolidate and transfer (i.e., to form an MDL) currently before the Judicial Panel on Multidistrict Litigation.

In district court, Monsanto failed to derail the RoundUp litigation. Monsanto, as well as Plaintiffs attorneys including Tim have now separately moved to support the formation of an MDL. This emerging Toxic Tort may involve more plaintiffs than any in history. Do not miss out on the chance to get information on this litigation in its early
stages. 
IVC Filter Product Liability Litigation

John Dalimonte now serves on the Steering Committee of the Cook Medical IVC filter litigation and the Bard IVC filter Litigation. He will be speaking about  the Cook and Bard IVC litigations, as well as other ongoing and emerging IVC Filter Litigation, which involve more IVC manufacturers. John has served in leadership positions on a number of MDLs and was Co-Lead Counsel in the Vioxx product liability litigation.

The IVC filter litigation may be one of the largest mass product liability litigation’s of all time, with respect to the number of plaintiffs and payouts. This litigation puts the “complex” in complex litigation and the opportunity to interact with one of the leading attorneys in this case is invaluable.
Proton Pump Inhibitor Product Liability Litigation

Bryan Aylstock will present the emerging Proton Pump Inhibitor litigation. Bryan is currently serving as one of three coordinating Co-Lead Counsel members charged with overseeing five separate Multi-District Litigations (MDLs), involving the use of TVM products. Additionally, Bryan has served in leadership positions in the Zoloft product liability litigation, the Avandia product liability litigation, as well as other MDLs.

Bryan is an outstanding lawyer and arguably one of the best business minds in Mass Torts. The opportunity to get in on the ground floor of an emerging litigation with guidance from a tested Mass Tort gladiator is worth the trip to Fort Lauderdale.

 Risperdal Product Liability Litigation

Derek Braslow will be speaking about the Risperdal product liability litigation. Derek now serves as Liaison Counsel in the Risperdal litigation and has served in many Court-appointed leadership positions in other pharmaceutical litigations. He has been in leadership positions on many MDLs, including Co-Liaison Counsel Zimmer Durom Hip Cup, as well as leadership positions in the Levaquin product liability litigation and the Paxil suicide litigation.

The Risperdal litigation is not a typical Mass Tort litigation. Derek’s insights on the Risperdal case will give knowledge and information that will be useful far beyond this single litigation.
 
Talcum Powder Product Liability Litigation
 
James Onder will be speaking on the subject of the Talcum Powder litigation. He is one of the lead attorneys in the City of Saint Louis consolidation, which has already produced multiple Jury verdicts exceeding fifty million dollars each.
James, and other members of his firm, have served as co-lead counsel and in various leadership positions on many MDLs. The opportunity to hear James speak about a difficult litigation, that he and his co-counsel firms managed to achieve massive jury awards in will be  an opportunity you won’t want  to miss.  
 
Xarelto Litigation
&
Stryker Hip Litigation “Life After the MDL”
 

Joseph Osborne will be speaking on the Stryker Hip Litigation, as well as other Hip Implant litigation. Long after other firms stopped accepting or seeking clients for the metal on metal hip implant litigations, Joseph continued to accept clients who were, and continue to be, injured by these defective products.He served in leadership positons on the Stryker Nexgen Knee MDL, the Biomet M2 Hip MDL, the Stryker Hip MDL, the American Medical System TVM MDL, as well as many other multidistrict litigations.

Joe also serves on the Science Committee in the Xarelto MDL and will be providing information about this litigation.
 
Taxotere, Onglyza and Fluoroquinolones
 
Ryan Thompson will round out the panel speaking and answering questions about three litigations every firm should be considering.  Not yet forty years old, Ryan has already achieved a record of achievements, that most lawyers would consider a stellar lifetime career. He served as Co-Lead Counsel on the Incretin Memetics Litigation, as well as in leadership positions on many MDLs. Ryan is often involved in emerging litigations in a major way. His grasp of the science involved in pharmaceutical and medical device litigation and his willingness to take risks have resulted in his incredible rise in the world of Mass Tort litigation.
One of Ryan’s early victories involved taking on a major credit reporting agency and collecting 28 Million dollars, in a litigation other firms had overlooked. Ryan brings a unique perspective to mass torts. It is a privilege to hear Ryan speak and even more of a privilege to get to know him.

Contact Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com for information and to book your seat for the September Course.

 

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Taxotere Chemo Drug Lawsuit Now filed in California Federal Court

taxotere hair loss
It is generally understood that temporary baldness may be a side effect of chemotherapy, women were not warned of the risk of permanent baldness.

Gomez Trial Attorneys of San Diego filed one of the first Taxotere chemotherapy drug lawsuits in a Southern California federal court yesterday on behalf of a woman who is suffering from its permanent effects (US District Court – Southern District of California Case No. 16CV1861).

The lawsuit alleges that the drug’s manufacturer, Sanofi-Aventis, failed to disclose and warn women and their doctors of Taxotere®’s increased risk of permanent baldness (alopecia) following chemotherapy.

The case is the latest in a string of over 30 cases filed across the country against the French drug manufacturer. Gomez says his firm plans to file more cases to hold the manufacturer accountable for its actions. Defendants include Sanofi S.A., Aventis Pharma S.A. and Sanofi-aventis U.S. LLC.

“While our clients battled and survived breast cancer, they now must live out their lives with a disfiguring reminder of what they went through. When they were in crisis and most vulnerable, they were robbed of the opportunity to make an informed decision about their healthcare,” says John Gomez, founder and CEO of Gomez Trial Attorneys.

Permanent baldness

While it is generally accepted and understood that temporary baldness may be a side effect of chemotherapy, women were not warned of the risk of permanent baldness despite an alternative and equally effective drug being available.

In 1996 the US Food and Drug Administration (FDA) approved Taxotere as an intravenous chemotherapy treatment for metastatic and adjuvant breast cancer. Its uses would eventually be expanded to include a range of cancers, including prostate, stomach, and head and nec, according to Salient News. Taxotere is administered every three weeks over the course of an hour, in the manner of traditional chemo treatments, and most patients undergo four cycles of Taxotere. Since being approved, more than 1.5 million patients have used Taxotere as a cancer treatment.

The lawsuit cited to a 2009 warning letter issued to the drug’s manufacturer by the FDA as a result of false or misleading statements about unsubstantiated claims of Taxotere®’s superior efficacy. According to the lawsuit, and as early as 2005, Sanofi-Aventis had knowledge based on their own study of Taxotere®’s increased risk of permanent baldness. The lawsuit alleges that despite this knowledge warnings of permanent alopecia in Canada and Europe, the drug’s U.S. label contained no mention of permanent hair loss until the label was changed in January 2016.

Taxotere® is widely prescribed for the treatment of early-stage breast cancer and other cancers. It is estimated that a majority of breast cancer patients receive Taxotere® as part of their chemotherapy regimen. According to the Susan G. Komen Foundation, nearly 250,000 cases of invasive breast cancer will be diagnosed in the U.S. in 2016.

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North Carolina Woman Sues Sanofi & Aventis Pharma Over Taxotere Side Effects

taxotereA North Carolina woman who took Taxotere has filed suit against the makers of cancer drug Taxotere, alleging that it caused her disfiguring permanent alopecia.

The case is Kathy Mottola v. Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. LLC, Case 3:16-cv-00255-RJC-DCK. 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.

Partial mastectomy

On January 4th, 2013, Plaintiff Kathy Mottola underwent a right breast partial needle mastectomy performed by Richard White at Carolinas Medical Center in Charlotte, North Carolina. A biopsy had demonstrated invasive mammary carcinoma in her right breast. Following the mastectomy, she met with her oncologist to discuss further treatment.

Neither Mottola 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 completion of chemotherapy on May 23, 2013, she suffered from disfiguring permanent alopecia.

Despite the fact that Defendants disclosed risks associated with Taxotere and permanent alopecia to patients and regulatory agencies in other countries, they  failed to either alert Plaintiff, the public, and the scientific community in the US or to perform further investigation into the safety of Taxotere. Defendants failed to update the warnings forthe drug, and failed to disclose the results of additional studies as Defendants learned new facts regarding the defects and risks of their product.

Thousands of women were exposed to the risk of disfiguring permanent alopecia without any warning and without any additional benefit.

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Judges Call Conferences over Taxotere Cancer Drug that Causes Permanent Hair Loss

taxotere2A case management conference is scheduled for June 30, 2016, in US District Court for the Northern District of California in Oakland, in a product liability case against Sanofi S.A., 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. Cases are proliferating that the Taxotere cancer drug causes permanent hair loss. Sanofi S.A. is a French multinational pharmaceutical company and as of 2013 is the world’s fifth-largest by prescription sales.

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.

  • 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, having its principal place of business in Antony, France.
  • Defendant Sanofi-Aventis U.S. LLC has its principal place of business in Bridgewater, New Jersey 08807.

(In another case, Magistrate Judge Michael Watanabe has also scheduled a planning conference on June 30 in US District Court in Denver, Colorado. That case is Melissa Leith v. Sanofi, Case No. 16-cv-00741-MJW.)

Disfiguring permanent alopecia

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 completion of chemotherapy, Dodson suffered from disfiguring permanent alopecia 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, Defendants continued to make false and misleading statements promoting the “superior efficacy” of Taxotere over the competing product paclitaxel Taxol.

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 the treatment of breast cancer. As a result of these false and misleading statements, in 2009, the FDA issued a warning letter to Sanofi-Aventis (the same company as Defendant Sanofi S.A. before SanofiAventis changed its name in 2011).

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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Cases Proliferating that Taxotere Cancer Drug Causes Permanent Hair Loss

Image credit: Dr. Shezad Malik Law Firm
Image credit: Dr. Shezad Malik Law Firm

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 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.

In one case Magistrate Judge Michael Watanabe has scheduled a planning conference on June 30 in US District Court in Denver, Colorado. The case is Melissa Leith v. Sanofi, Case No. 16-cv-00741-MJW.


Mass Tort Nexus has compiled a  Taxotere Lawsuit Emerging Litigation Briefcase for subscribers with 120 sub folders and documents as of June 2016.


Warnings overseas, but not in the US

Thousands of women of never got the chance to make an informed decision about their cancer treatment because the words “permanent alopecia” or “permanent hair loss” did not appear in any Taxotere information available in the U.S. — even though Sanofi had provided such information to doctors and patients in other countries.

As a direct result of defendants’ fraudulent marketing scheme, the defendants dramatically increased revenue on sales of Docetaxel from $424 million in 2000 to $1.4 billion in 2004.

The best-developed action is Kally Gahan v. Sanofi. The “Sanofi defendants” include:

  • Sanofi S.A. headquartered in Paris, France
  • Aventis Pharma S.A. headquartered in Antony, France
  • Sanofi-Aventis US, Inc. headquartered in Bridgewater, NJ
  • Sanofi-Aventis U.S. LLC headquartered in Bridgewater, NJ
  • Sanofi US Services Inc. Winthrop US (a subsidiary of Sanofi-Aventis US) headquartered in Bridgewater, NJ.

The product liability action is Case No. 1:16-cv-03038, filed on May 26, 2016 in US District Court in Colorado.

The Gahan case also alleges breach of warranty, fraudulent misrepresentation, fraudulent concealment and violation of the Colorado Consumer Protection Act. The plaintiff suffered damages including medical expenses, psychological counseling and therapy expenses, loss of earnings, impairment of earning capacity, permanent disfigurement mental anguish severe and debilitating emotional distress and increased risk of future harm.

Negligence and failure to warn

Allegations are that the defendants were negligent in the designing, researching, supplying, manufacturing, promoting, packaging, distributing, testing, advertising, warning, marketing, and selling of Taxotere in that they:

  • Failed to use due care in designing and manufacturing Taxotere so as to avoid the risks to individuals when Taxotere was used for the treatment of breast cancer.
  • Failed to accompany their product with proper and/or accurate warnings.
  • Failed to warn the plaintiff, physicians and the public of the severity and duration of adverse effects.
  • Failed to conduct adequate testing, including pre-clinical and clinical testing and post-marketing surveillance, to determine the safety, dangers, and risks associated with Taxotere.

The FDA approved Taxotere on May 14, 1996 for“the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.” It was designed as an increased potency Taxane. This increased potency resulted in increased toxicity, which can be directly related to increased adverse events. The most likely reason defendants designed the increased potency Taxane was to enable the manufacturers to get a patent (and the concurrent market advantage) on a product that in fact was not novel but instead only more dangerous.

Kickbacks and Off-Label Sales

A Qui Tam lawsuit was also filed against Sanofi-Aventis and its affiliates in the US District Court for the Eastern District of Pennsylvania by a former employee accusing Sanofi-Aventis and its affiliates of engaging in a fraudulent marketing scheme, paying kickbacks, and providing other unlawful incentives to entice physicians to use Taxotere. See U.S. ex rel. Gohil v. Sanofi-Aventis U.S. Inc., Civil Action No. 02-2964 (E.D. Pa. 2015).

Beginning in 1996, Sanofi S.A., Aventis Pharma S.A., and Sanofi-Aventis U.S. LLC launched a marketing scheme that promoted Taxoterefor off-label uses not approved by the FDA. The scheme took two forms:

First, defendants trained and directed their employees to misrepresent the safety and effectiveness of the off-label use of Taxotere to expand the market for Taxotere in unapproved settings.

Second, defendants paid healthcare providers illegal kickbacks in the form of sham grants, speaking fees, travel, entertainment, sports and concert tickets, preceptorship fees, and free reimbursement assistance to incentivize healthcare providers to prescribe Taxotere.

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