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Sanofi Must Face Cancer Drug FCA Claims
November 12, 2020 - A Pennsylvania federal judge handed drug manufacturer, Sanofi U.S. Services Inc., a win on some allegations in a whistleblower’s 18-year-old False Claims Act lawsuit, but allowed other claims that it misleadingly promoted off-label uses for its cancer therapy drug.
U.S. District Judge Anita B. Brody trimmed claims accusing Sanofi predecessor Aventis Pharmaceuticals of engaging in false advertising and issuing kickbacks to physicians who promoted its cancer drug, Taxotere.
Between 1996 to 2004, the drug manufacturer allegedly paid doctors to attend advisory boards that focused on advertising Taxotere prescriptions. After receiving kickbacks, doctors then prescribed Taxotere to their patients over other cancer drugs or promoted off brand uses of the cancer drug, according to details of the memo.
In her decision the judge ruled that evidence likely indicates that Sanofi knew its advisory boards clashed with its internal compliance policies.
The international drug manufacturer managed to nix a false advertising claim and allegations that it ran a scheme in which sales representatives shadowed doctors. Sanofi also managed to dodge an allegation that it engaged in kickbacks, through a provision related to the drugmaker doling out meals and gift baskets in violation of the FCA survived.
Counsel for Sanofi said that the judge’s ruling suggests similar outcomes for the remaining allegations.
“We are pleased that the case has been narrowed significantly and believe that this ruling foreshadows what we will see at trial – the relator lacks the evidence necessary to prove his case,” Richard Scheff, an attorney at Armstrong Teasdale LLP, said. “We look forward to our day in court.”
An attorney for the whistleblower declined to comment.
If you or a loved one developed Alopecia or suffered hair loss due to Taxotere, you may be entitled to compensation through a Taxotere lawsuit. Contact TorHoerman Law for a free, no-obligation case consultation with a Taxotere lawyer today! If you are a woman who has suffered injuries or losses resulting from Taxotere, you deserve financial compensation for these losses.
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Taxotere (active ingredient: docetaxel) is manufactured by Sanofi-Aventi and was first approved by the U.S. Food and Drug Administration in May 1996. Taxotere is used to treat an array of cancers but is most commonly prescribed to treat patients with locally advanced or metastatic breast cancer, which had progressed during anthracycline-based therapy or relapsed during anthracycline-based adjuvant therapy. The drug is also used as an adjuvant treatment in combination with doxorubicin and cyclophosphamide for individuals with operable node-positive breast cancer. Taxotere works in stopping the spread of cancerous cells by cutting off the dividing and multiplying of cells in and around a cancerous clump. Taxotere falls under a specific class of chemotherapy treatments called taxane drugs – made from plant alkaloids.
Taxotere has also been approved to treat non-small cell lung cancer (NSCLC), prostate cancer, head and neck cancers, and stomach cancer (gastric adenocarcinoma).
Of the drugs used to treat breast cancer, Taxotere is the most prescribed drug in its class (taxane) – some sources estimate that 75% of breast cancer patients will receive Taxotere as a form of treatment.
Unlike similar chemotherapy drugs with weekly treatment plans, Taxotere’s treatment plan runs at three-week intervals. Fewer trips to the doctor for treatment makes Taxotere more attractive to both patients and doctors.
Taxotere has also been approved for administration outside of the hospital (in 60-100 mg/m2 doses). Similar chemotherapy treatments require hospitalization to cope with extended infusion times.
As is warned on the Taxotere label, toxic death occurs in around 2% of metastatic breast cancer patients and about 11.5% of patients with other tumor types with abnormal liver function who are using Taxotere.
Along with the more common side effects, there are also more life-threatening adverse effects associated with Taxotere.
Taxotere carries a black box warning for several known adverse health effects associated with the drug.
These black box adverse health effects include:
Increased risks for patients with abnormal liver function, patients prescribed higher doses, patients suffering from NSCLC and prior platinum-based therapy recipients.
Liver damage caused by chemical exposure due to Taxotere treatment. Common in patients with abnormal liver function or elevated LFT, hepatotoxicity can because of severe complications and even be life-threatening.
Taxotere’s label warns that the condition may reach severe levels for some patients.
A low neutrophils (specific white blood cell) count makes patients more likely to contract bacterial infections. If gone untreated, these bacterial infections can cause severe health conditions and even death. Patients with neutrophil counts under 1500 cells per 3 cubic millimeters of blood volume are more susceptible to develop neutropenia and are advised against using Taxotere unless necessary. Doctors are advised to frequently check blood counts for these patients who do use Taxotere.
Reactions like a rash, low blood pressure, and fatal anaphylaxis. Patients who received dexamethasone premedication are most susceptible to developing these conditions.
Temporary hair loss is a common side effect of most chemotherapy treatments. However, most do not cause a complete loss of hair or hair loss does not become permanent. Studies find that among all of the side effects associated with chemotherapy, temporary hair loss has the greatest impact on a patient’s quality of life. Taxotere has been linked to Alopecia, permanent hair loss, in those who take the drug for chemotherapeutic treatment.
Alopecia is a permanent and irreversible hair loss disease which affects all body hair, including eyebrows, eyelashes, facial hair, and pubic hair. Multiple studies have found that Taxotere use can result in Alopecia.
Evidence of Alopecia occurring in Taxotere patients includes:
Alopecia can severely affect a person’s quality of life, affect body image, and cause depression and distress. For women who already have to struggle with the burden of breast cancer and chemotherapy, developing Alopecia can be devastating.
For breast cancer survivors, Alopecia is more than a cosmetic effect. The disease is a constant reminder of the struggle to fight breast cancer. The 2012 study published in the Annals of Oncology found that women who suffered from Alopecia due to Taxotere suffered “significant impairment” to their quality of life.
TorHoerman Law is accepting for women who have experienced permanent thinning or loss of hair following the use of Taxotere. If you or a loved one used Taxotere and subsequently developed permanent thinning or hair loss, contact TorHoerman Law to discuss your legal options today, including the possibility of filing a Taxotere lawsuit.
A growing number of women and their families have filed lawsuits against Taxotere manufacturer Sanofi and against certain generic manufacturers, claiming that the manufacturers were aware of the increased risks of Alopecia, but failed to warn consumers. The plaintiffs also claim that Sanofi hid data and research that linked Taxotere to these adverse side effects.
In fact, Sanofi did warn consumers outside of the U.S. that Taxotere could be linked to “permanent hair loss” and even Alopecia but failed to warn U.S. consumers
Evidence presented in litigation against Sanofi indicates that the manufacturer tried to downplay the known risks in order to get the drug approved in 1996. Plaintiffs have made accusations that employee training incorporated teaching misrepresentation of safety and effectiveness, and alleged illegal payments in the form of “kickbacks” to doctors who prescribed Taxotere.
Lawsuits claim that Sanofi actually misled the U.S. public through advertising and marketing that assured Taxotere users that hair loss was only temporary and that there was no threat of permanent hair loss.
Plaintiffs allege that Sanofi also failed to recognize in-house data collected from the GEICAM 9805 study, which indicated that around 9.2% of patients suffered hair loss that lasted more than 10 years, and that Sanofi did not recognize the findings of Dr. Scott Sedlack of the Rocky Mountain Cancer Centers, whose findings indicated that 6% of women using Taxotere developed permanent Alopecia.
While studies indicate that Taxotere is an effective chemotherapy treatment, lawsuits allege that other treatments, which are at least as effective as Taxotere, do not subject consumers to the same risks of permanent hair loss.
Currently, there is multidistrict litigation consolidated in the Eastern District of Louisiana. The Taxotere lawsuit is comprised of women who developed Alopecia after using Taxotere.
If you currently suffer from a permanent hair loss disease and were previously prescribed Taxotere, contact the office of TorHoerman Law for a free, no-obligation evaluation and Taxotere lawsuit consultation today.
Our dedicated team of bad drug lawyers will be here to help you every step of the way, answer any questions you may have, and walk you through the steps of your Taxotere lawsuit.
If you believe that you may qualify to participate in a Taxotere lawsuit, the first step you should take is to mitigate injuries and future potential damages. In order to properly mitigate costs, seek proper medical treatment right away, follow your doctor’s orders.
You should then familiarize yourself with the civil litigation process, so that you know what is to come of your Taxotere lawsuit.
Hiring a personal injury lawyer to act as your Taxotere lawyer is an important step. Be sure to ask plenty of questions about your potential lawyer’s experience, payment structure and anything else you deem to be important.
Your Taxotere lawyer will work to build a strong case to prove that liability for your injuries falls on the manufacturer.
Your Taxotere attorney will work to gather evidence to show liability, assess damages that you incurred from your injuries, file legal documents on your behalf, and work to gain you compensation for your injuries in the form of a settlement or verdict.
Your state’s statute of limitations limits the time you have to file a Taxotere lawsuit after your injuries first became apparent and/or were diagnosed, so be sure to reach out to a Taxotere lawyer as soon as possible to start the litigation process.
TorHoerman Law has a dedicated team of bad drug lawyers who are experienced at litigating on behalf of individuals who suffered injuries and losses at no fault of their own. Our firm offers free, no-obligation case consultations to anyone who needs legal advice and guidance related to Taxotere hair loss and other Taxotere injuries. We operate on a contingency fee basis, so our clients do not ever pay any legal fees until after they have been awarded compensation – no compensation? no fees.
So contact TorHoerman Law, your Taxotere hair loss lawyer, and learn how we can serve you today.
May 28, 2020 - A federal judge dismissed nearly 200 lawsuits by patients claiming Sanofi SA’s cancer treatment Taxotere caused them to suffer permanent hair loss, saying a change in the drug’s warning label in 2015 clearly explained its risks.
U.S. District Judge Jane Triche Milazzo in New Orleans on Wednesday ruled the updated Taxotere label was legally adequate as it warned patients about the precise risk of the permanent hair loss they suffered.
She said the label “clearly and consistently” after December 2015 explained the risk by noting reports of permanent alopecia, or hair loss, in a section about adverse reactions and by advising doctors to inform patients of the side effect.
Milazzo added that the plaintiffs’ lawyers presented no evidence to support their contention the hair loss risk needed to be included in a specific “warnings and precautions” section of the label.
“The Court will not allow plaintiffs to shield these nearly 200 cases from dismissal under this logic,” Milazzo wrote.
The U.S. Food & Drug Administration first approved Taxotere for the treatment of breast cancer in 1996, but only in 2015 ordered its warning label be updated to include risks of permanent hair loss.
Around 12,690 product liability cases are now pending before Milazzo in the MDL against drug manufacturers including Sanofi. The company as of March said it faced lawsuits by 10,628 plaintiffs in federal court as well as state courts in New Jersey, California, and Delaware.
In September, a federal jury ruled in Sanofi’s favor in the first bellwether, or test, trial in the litigation to allow the parties to gauge the value of the remaining claims and inform potential settlement talks.
Actively Working to Move Cases Forward
February 2019 - Thousands of claims are on file. Work on the generic case continues. A change in judge has brought streamlined procedures for handling discovery disputes, and the judge and parties are actively working to move cases forward.
The start of the first bellwether trial was delayed until September 16, 2019.
August 2018 - As a result of a new bellwether trial, the first Taxotere trial will begin in May 2019, under a new judge, Jane Triche Milazzo in the Eastern District of Louisiana. We have been filing cases since April 2018. If you have any questions regarding a Taxotere lawsuit, please contact us.
June 2018 – As a result of the re-assignment of the Taxotere MDL, a new bellwether trial schedule is published. The first trial is set for May 2019. Four additional trials are set through 2019 and 2020.
May 2018 – Judge Engelhardt, who had been presiding of the Taxotere MDL from its inception, was elevated to the United States Court of Appeals for the Fifth Circuit Judge. The Taxotere MDL was assigned to the Honorable Jane Triche Milazzo, another United States District Judge for the Eastern District of Louisiana.
April 2018 - We are filing cases regarding branded and generic Taxotere. Bellwether trials are scheduled to start in 2019.
October 2016 - More than 30 lawsuits were consolidated in the Eastern District of Louisiana as the initial Taxotere multidistrict litigation (MDL). This consolidation will allow the individual cases to proceed in an efficient and organized manner, ensuring consistent rulings and preserving the resources of the parties and the court.
December 2015 – The potential side effect of alopecia was included on the Taxotere label for the first time.
June 2014 – The FDA issued a safety communication about the potential for patients to experience intoxication during or after the use of Taxotere due to the presence of ethanol in docetaxel.
May 2012 – A study published in the Annals of Oncology revealed that, of the 20 female participants who received Taxotere, 19 developed permanent hair loss. One participant who was being treated for reoccurring breast cancer had previously undergone chemotherapy with a different drug and had complete hair regrowth, but after using Taxotere, she suffered from permanent hair loss.
December 2010 – A release of documents from the Sanofi-funded GEICAM 9805 study revealed that around 9.2% of patients suffered hair loss that lasted more than a decade.
December 2006 – A study conducted by the Rock Mountain Cancer Centers found that Taxotere caused 6% of women to suffer permanent alopecia.
October 2006 - Taxotere was approved for use in combination with cisplatin and fluorouracil for patients being treated for inoperable, locally advanced squamous cell carcinoma of the head and neck (SCCHN).
March 2006 - Taxotere was approved for use in combination with cisplatin and fluorouracil for patients being treated for advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy.
August 2004 - Taxotere was approved for use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of women with operable node-positive breast cancer.
May 2004 – Taxotere was approved for use in combination with prednisone for the treatment of metastatic, androgen-independent prostate cancer.
December 1999 – The drug was approved for use as an injection to treat patients suffering from locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
June 1998 – Taxotere was approved for first-line treatment of metastatic breast cancer in subjects whose disease had recurred despite adjuvant therapy.
May 1996 – Taxotere was initially approved for use by the U.S. Food & Drug Administration.
Sanofi Must Face Cancer Drug FCA Claims At Trial. (n.d.). Retrieved November 19, 2020, from https://www.law360.com/trials/articles/1328289/sanofi-must-face-cancer-drug-fca-claims-at-trial
Last Modified: December 29th, 2020 @ 06:25 pm
Taxotere is a popular chemotherapy drug that is commonly prescribed to breast cancer. The drug works in stopping the spread of cancerous cells by cutting off the dividing and multiplying of cells in and around a cancerous clump. Taxotere has been linked to Alopecia, a disease which causes permanent hair loss. Other adverse side effects include Hepatotoxicity, fluid retention, neutropenia, hypersensitivity reactions, and toxic death. A Taxotere lawsuit has been filed against the manufacturer for failing to warn users of the risks associated with the chemotherapy drug.
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