Category: Defective Drugs

Taxotere Lawsuits Over Permanent Hair Loss Swell to More Than 850 Cases

By Emily Cox
Taxotere Lawsuits
Photo by Skye D.

A recent court filing indicates that more than 850 women have filed Taxotere lawsuits, alleging the controversial breast cancer drug’s manufacturer failed to warn about Taxotere’s permanent hair loss risk, while fraudulently marketing the drug as more effective than other treatments that do not have the same risks.

Parties in the litigation filed the joint status report March 17. The report indicates that there are already at least 857 Taxotere cases pending in the new multidistrict litigation (MDL). There are also additional cases proceeding in California, Missouri, and Delaware state courts.

These Taxotere lawsuits allege that Sanofi S.A. knew and concealed the drug’s permanent hair loss risk from American breast cancer patients. In fact, the company updated its warning labels in Canada and Europe in 2005 and 2012 respectively. Sanofi did not update U.S. warning labels until late 2015. Furthermore, the company actively promoted the high-potency taxane as more effective than other less toxic treatments, such as Taxol, even though research has shown that these less toxic treatments were equally effective and do not cause permanent hair loss. The FDA even had to issue a warning to Sanofi to stop fraudulently marketing Taxotere as being more effective than other treatments.

Hair loss is a known and accepted side effect of chemotherapy. However, plaintiffs claim that Sanofi provided false and misleading information that suggested hair regrows after Taxotere treatments. However, this is not the case for many women.

Taxotere Lawsuits

In October 2016, the U.S. Judicial Panel for Multidistrict Litigation (JPML) centralized all federal Taxotere lawsuits for pretrial proceedings before U.S. District Judge Kurt Engelhardt in the Eastern District of Louisiana. This centralization reduces duplicate discovery and conflicting rulings, promoting judicial efficiency. Experts expect that Taxotere lawsuits will number in the several thousands in the coming years.

Judge Engelhardt has scheduled the next status conference for all parties on May 12.

 

FDA Bends to Big Pharma and Postpones Off-Label Marketing Final Rule

By Emily Cox
Big Pharma Off-Label Marketing
Photo by Mike Licht

In response to a petition filed by pharmaceutical groups, the Food and Drug Administration (FDA) has delayed implementing a final rule that would give the agency greater leeway to regulate off-label marketing.

While drug makers requested an indefinite stay on the rule, the FDA delayed executing this final rule until March 2018. The rule would require drug makers to update product labeling if there is evidence that the company intended people to use its medicine for off-label uses or for an unapproved use. Doctors can prescribe drugs for any reason. However, court rulings have determined that pharmaceutical companies can only engage in off-label marketing if the information is truthful and not misleading.

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO), filed the Petition to Stay and for Reconsideration on February 8, 2017. These groups expressed outrage over the FDA’s unexpected publishing of the rule in January.

“FDA’s revisions were not communicated to the public prior to the Final Rule published on January 9, 2017, which deprived stakeholders of fair notice and an opportunity to be heard in violation of the Administrative Procedure Act (APA),” the petition states.

Furthermore, the trade groups claim the rule gives the FDA too much leeway.

“The final rule would give the FDA an extraordinarily wide leeway to gauge how a company intended its medicine to be used, which can then be used to assess whether illegal promotion occurred,” the groups said.

The FDA asserts that these groups misunderstood the ruling. However, the agency still relented, extending the March 21, 2017 deadline by almost a year.

Taxotere Off-Label Marketing Lawsuit

The ruling delay comes as Sanofi S.A. faces a Qui Tam lawsuit for off-label marketing of Taxotere. The lawsuit claims the company used fraudulent and illegal off-label marketing to drive sales and expand its market share. The FDA approved the high-potency taxane to treat advanced breast cancer when other treatments have failed.

Sanofi S.A. allegedly trained and directed their employees to misrepresent the safety and effectiveness of off-label Taxotere. This expanded its market into unapproved settings like first line treatment and less advanced cancer. The lawsuit claims that the company also paid doctors illegal kickbacks to get them to prescribe Taxotere for off-label uses. These kickbacks included entertainment, sports, concert tickets, sham grans, speaking fees, travel preceptorship fees, and fee reimbursement assistance.

These illicit measures dramatically increased the breast cancer drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. It also exposed thousands of women to Taxotere’s increased toxicity and its more severe side effects, including permanent hair loss.

Additional civil lawsuits continue to mount rapidly as more women discover Taxotere unnecessarily disfigured them.

 

 

 

Taxotere Side Effects Linked to Five Deaths in France

By Emily Cox
Taxotere Side Effects
Photo by Matt Bachelor

Taxotere side effects may be responsible for at least five deaths in France, leading the nation’s product safety agency to urge doctors to avoid using the controversial chemotherapy drug to treat certain cases of breast cancer.

All five women passed away since August 2016 and were 46 to 73 years old. Researchers began investigating the issue after the third death. As a result, they have concluded that Taxotere side effects played at least some part in these women’s deaths.

The French National Drug and Health Product Safety Agency (ANSM) issued a warning to oncologists last month. The letter indicated that Taxotere side effects may have caused several deaths. The chemotherapy treatment appears to have caused neutropenic enterocolitis. This condition causes inflammation of the mucosa of the colon and small intestines. The agency went on to recommend that doctors use Abraxane instead to treat localized, operable breast cancer.

Researchers note that all deaths were associated with generic Taxotere (docetaxel). However, they found no irregularities with the generic drug. Accord Healthcare, an Indian drug company, supplied the drug, and tests showed that it meets quality standards.

The ANSM is continuing this investigation. The agency expects to release the results on March 28.

Taxotere Side Effects Lawsuits

Sanofi-Aventis, the maker of brand-name Taxotere, is facing a growing number of Taxotere side effect lawsuits. These lawsuits allege that the company knew and concealed the risk of permanent hair loss from women and the medical community.

The company updated Taxotere warning labels in Canada and Europe to include this risk in 2005 and 2012 respectively. However, it didn’t update American warning labels until late 2015.

Sanofi-Aventis introduced Taxotere in 1996. It is a high-potency taxane cancer drug. The company marketed it as superior to existing low-potency taxanes like Taxol. However, researchers and the FDA have found that it is no more effective. Furthermore, it has been linked to permanent hair loss and other side effects not associated with other taxanes.

These women allege that they would have chosen a different breast cancer treatment if they had known about Taxotere side effects and true efficacy.

Eliquis Bleeding Permanently Damages Man

By Emily Cox
Eliquis Bleeding
Photo by gurmit singh

A recent product liability lawsuit against the anticoagulant manufacturers alleges that Eliquis bleeding permanently damaged a New York man.

David Reed filed the complaint in Delaware Superior Court on February 27. He claims that Bristol-Myers Squibb and Pfizer misrepresented Eliquis as safe and effective, while concealing the significant uncontrollable bleeding risks.

According to the complaint, Reed began taking Eliquis on January 8, 2015, after vascular surgery. He was hospitalized for bleeding complications by January 26, 2015. He was hospitalized again March 30, 2015, due to gastrointestinal bleeding. Reed claims he has suffered severe pain and permanent damages that could have been avoided if the companies had provided adequate warnings and information about the risk of Eliquis bleeding.

“Had Plaintiff known the true facts with respect to the dangerous and serious health and safety concerns of Eliquis, Plaintiff would not have purchased, used, and relied on Defendant’s drug Eliquis,” the claim states.

According to the lawsuit, the drug makers concealed their knowledge of Eliquis’ defects, defrauding and deceiving the public, FDA, and medical community.

Eliquis received FDA approval in 2012. The lawsuit alleges that the ARTISTOTLE clinical trials were a determining factor for Eliquis’ approval. However, it further claims that the drug makers chose “incompetent and untrustworthy” agents in China to conduct the study to cut costs. Allegedly, the companies concealed side effects in test users, including Eliquis bleeding and a death. There are also allegations of major dispensing errors where subjects were not even receiving Eliquis, poor quality control, and record destruction, as well as changing and falsifying records. In a February 2012 meeting with the FDA and company executives, the FDA characterized the companies as showing a pattern of inadequate supervision.

Eliquis Bleeding Risks

Eliquis is part of a new group of oral anticoagulants, known as factor xa medications. This group also includes Xarelto and Pradaxa.

While manufacturers aggressively marketed these drugs as a replacement for Coumadin (warfarin), manufacturers released them without antidotes for bleeding incidents. Whereas vitamin K can reverse Coumadin’s anticoagulant effects. Consequently, a large number of individuals have reported Eliquis bleeding problems.

“Before and after marketing Eliquis, Defendants became aware of many reports of serious hemorrhaging in users of its drug,” the complaint states.

The claim asserts that the side effect data generated obvious signals that Eliquis bleeding was a serious concern. However, manufacturers never alerted the public and scientific community. They also never performed further investigation into Eliquis’ safety.

In February, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all Eliquis proceedings in the Southern District of New York.

Pradaxa and Xarelto Lawsuits

The JPML has centralized litigation for Xarelto and Pradaxa as well. Pradaxa maker Boehringer Ingelheim agreed to pay $650 million in 2014 to resolve about 4,000 cases. Xarelto has more than 15,000 lawsuits pending in its centralized litigation over uncontrollable bleeding.

Class Action Restriction Bills Passed by House

By Emily Cox
Class Action
Photo by Joey Gannon

Washington, DC — Despite Democratic objections that class action restrictions would hurt the public’s ability to hold corporations accountable, the House of Representatives passed a pair of bills Thursday to make it harder to bring class actions and keep suits in state courts.

The Fairness in Class Action Litigation Act of 2017 and Innocent Party Protection Act radically limit the scope for class actions, while expanding the scope for finding fraudulent joinder in suits.

Republicans claim these bills will adjust the balance between “abusive plaintiffs” and “innocent defendants.” However, Democrats argue the bills are designed to protect corporate wrongdoers by making it harder for victims to band together. Democrats allege that these bills would make it almost impossible for victims injured by consumer rip-off, fault product design, and pharmaceutical drug mistakes, as well as lead and asbestos poisoning to bring class-action lawsuits.

“I oppose these misguided legislations, because it sends another huge valentine and wet kiss to large corporate polluters and tort-feasors but gives the finger to millions of American citizens who suffer injuries from these defendants,” Rep. Jamie Raskin (D-Md) said.

Democrats are joined by a large group of legal, environmental, disability, labor, civil rights, and consumer protection organizations in their opposition. They claim the bills would limit the ability to join a class action suit against defendants with exponentially greater resources.

“Christmas has certainly come early for corporate-America,” said Teddy Basham-Witherington, a spokesman for The Impact Fund, a nonprofit public interest law organization.

He went on to that, if passed, the class action restriction bills would “restrict ordinary people from accessing justice, emboldening the worst actors in corporate America.”

Class Action Restriction Bill (H.R. 985)

The class action bill would require plaintiffs to prove potential members have the same type and scope of injury. It also requires asbestos trusts to make details of trust claimants public.

“This doesn’t formally abolish the class-action mechanism,” Rep. Jamie Raskin (D-MD) said. “It’s not the guillotine, but it’s a straight jacket.”

Opponents also argue that the bill provides easy access to asbestos victims’ personal information for scam artists, employers, potential insurers, and debt collectors to potentially exploit.

The bill’s predecessor, the Fairness in Class Action Litigation Act of 2015 (H.R. 1927), passed the House but was not even considered by the Senate. According to opponents, this bill was far less damaging than the current legislation. Basham-Witherington described the new bill as “H.R. 1927 on steroids.”

Innocent Party Protection Act

This bill would prevent attorneys from adding defendants to a lawsuit to keep the case in state court. Democrats like Jerrold Nadler (NY) feel that it gives corporations another tool to transfer suits to corporate-friendly federal courts.

“The preliminary determination of jurisdiction would become a baseless time-consuming mini-trial before a second trial on the merits,” Nadler said. “While large corporations can accommodate such costs, injured workers, and parents cannot.”

Take Justice Back

The American Association for Justice has established a movement to help individuals take a stand against class action restriction. Take Justice Back has numerous websites to help people act against this unconstitutional legislation.

 

Taxotere Illegal Marketing Lawsuit Receives Another Extension for Written Discovery

By Emily Cox

The judge overseeing the Taxotere illegal marketing lawsuit issued an order Thursday, extending the deadlines for written discovery from March 13 to May 12.

The original deadline was July 11, 2016. Mitigating circumstances have pushed this deadline back four times now. However, this is the shortest extension that U.S. District Judge Lawrence F. Stengel has granted.

Qui Tam Lawsuit

A former employee is joined by the U.S. in the Qui Tam lawsuit against the manufacturers of Taxotere, Sanofi S.A.. A Qui Tam lawsuit is brought on behalf of the government against companies that may have defrauded the government.

In this case, Sanofi S.A. is accused of defrauding Medicare and Medicaid programs to approve payments for off-label Taxotere treatments. Medicare and Medicaid will only pay for FDA-approved applications of med
ications.

Taxotere is a highly potent breast cancer chemotherapy treatment. The drug has recently come under fire for not disclosing its severe side effects, including permanent baldness, also called alopecia. It has also received scrutiny from the FDA. It received a warning from the agency for claiming superiority over other treatments when studies clearly show less toxic treatments to be just as or more effective than Taxotere.

Furthermore, the FDA only approved Taxotere to treat advanced breast cancer where previous chemotherapy had failed. However, Sanofi S.A. allegedly embarked on an aggressive, fraudulent, and illegal marketing campaign to expand Taxotere’s market share beyond its indicated use.

Taxotere Illegal Marketing

The Taxotere illegal marketing lawsuit is accusing the manufacturer of engaging in fraudulent marketing, providing illegal kickbacks, and providing other illegal incentives to encourage doctors to use Taxotere as a first line treatment for less aggressive cancers since 1996.

Allegedly, Sanofi S.A. trained and directed employees to misrepresent the safety and effectiveness of off-label Taxotere use. The company also paid healthcare providers illegal kickbacks such as entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and free reimbursement to get doctors to prescribe Taxotere for off-label uses.

Taxotere’s fraudulent marketing increased the drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. Consequently, it exposed thousands of women to the increased toxicity of Taxotere and its more severe side effects, including permanent baldness, also called alopecia.

Taxotere Lawsuits

Taxotere Illegal Marketing Exposed Women to Permanent Side Effects
Photo by Christina Spicuzza

The number of Taxotere lawsuits against Sanofi S.A. has exploded recently. These women allege that Sanofi S.A. knew about the alopecia risk for more than a decade. However, the company cho
se to hide it from American consumers until 2015. Sanofi S.A. updated its warning labels to include permanent alopecia in Canada and Europe in 2005 and 2012 respectively. The company didn’t update U.S. warning labels until late 2015.

Many of these plaintiffs claim that they may have chosen a different treatment if they had known about the side effects and that other, less toxic treatment were equally or more effective.

 

 

 

 

 

New Research Links Heartburn Drugs to Chronic Kidney Disease

By Emily Cox
Heartburn Drugs Linked to Kidney Disease
Photo by Tareq Salahuddin

In a new study, researchers found Nexium, Prilosec, and other proton pump inhibitor (PPI) heartburn drugs increased risk of chronic kidney disease (CKD) and kidney failure.

The research was published in this week’s Kidney International medical journal. Researchers looked at U.S. Department of Veterans Affairs’ data on 144,032 new users of PPIs and H2 blockers, including Zantac, Tagamet, and Pepcrid. According to the study, PPI users had a 26 percent increased risk of chronic kidney disease and a 30 percent increased risk of kidney failure. Individuals with no history of acute kidney injury produced similar numbers. Furthermore, the other heartburn drugs did not show these same risks.

Consequently, researchers suggested exercising vigilance in PPI use and for users to pay careful attention to kidney function.

These finding provide further support for the growing number of lawsuits brought by former users of Nexium, Prilosec and other PPI drugs. They claim that the manufacturers failed to warn users and the medical community about the risks associated with their heartburn drugs.

PPI Heartburn Drugs – Injuries and Lawsuits

Plaintiffs allege that the PPI manufacturers knew or should have known about the kidney risks for years. Instead of warning consumers, these companies continued to market these drugs as safe and effective to protect profits. Most users remain on these heartburn drugs for extended periods of time due to these marketing tactics.

Although Nexium, Prilosec, and other PPI drugs have been on the market for more than a decade, the FDA did not require manufacturers to include kidney warnings until December 2014. The new warnings indicated that users may have an increased risk of acute interstitial nephritis (AIN). This is the sudden inflammation of the kidneys and can lead to more serious problems. However, plaintiffs allege that these warnings are inadequate.

CMAJ Open published a study in April 2015 that showed users may be three times more likely to develop AIN and two and a half times more likely to suffer acute kidney injury.

Another study appeared in the JAMA Internal Medicine medical journal in February 2016. It found that PPI users may be 50 percent more likely to develop chronic kidney disease.

In April 2016, the Journal of the American Society of Nephrology published yet another study. It showed Nexium, Prilosec, and other PPIs put users at a 96 percent increased risk of kidney failure and 28 percent increased risk of developing chronic kidney disease after five years of use.

PPIs are a very popular treatment choice for heartburn. Their over-the-counter availability only adds to this popularity. Consequently, experts expect that the drug makers may ultimately face thousands of lawsuits.

Eliquis Shown to Have Higher Risks of Stroke and Embolism than Warfarin

By Emily Cox

While manufacturers have promoted the new-generation blood thinner Eliquis as more effective than the long-standing treatment warfarin, new research indicates that the anticoagulant may actually increase the risk of stroke and embolism.

The study, published this month in The BMJ medical journal, compared various new atrial fibrillation blood thinners, called novel oral anticoagulants (NOACs), with warfarin. The risk of ischaemic stroke is already elevated in atrial fibrillation patients. Warfarin has long been the traditional treatment to prevent strokes from the common heart condition. However, since Eliquis, Xarelto, Pradaxa, and other NOACs require less monitoring to maintain proper dosage than warfarin, manufacturers have aggressively marketed them as easier to use.

Researchers compared data from more than 55,000 patients in national registries to determine the benefits and risks of Eliquis (apixaban), Xarelto (rivaroxaban), and Pradaxa (dabigatran) compared to warfarin.

After one year of treatment, 4.8 percent of Eliquis patients suffered either an ischemis stroke or systemic embolism. This is almost 30 percent higher than the 3.7 percent risk found with warfarin. Researchers also found the risk for all cause mortality with Eliquis to be dramatically higher at 25.4 percent than warfarin’s 8.6 percent risk. Xarelto did not perform much better in this respect with a 21.2 percent all cause mortality risk.

NOAC Bleeding Risk Compared with Warfarin

Along with the elevated stroke risk, reports have linked all NOACs to uncontrollable bleeding problems. When Eliquis, Xarelto, and Pradaxa were introduced, there were no safe and effective antidotes to stop bleeding when it occurred. Whereas, vitamin K reverses the effects of Warfarin

to stop bleeding.

Based on these factors, researchers suggest that a reevaluation of safety concerns for NOACs might be necessary.

“Along these lines, it might be important to review concerns about safety of oral anticoagulant treatment in atrial fibrillation: ineffective or insufficient treatment for stroke prevention should be viewed as a safety issue itself, while the increase in the risk of bleeding is an inevitable consequence of a necessary treatment,” the study stated.

As NOACs increase in popularity and use, patients, doctors, and thousands of lawsuits have raised safety concerns regarding these drugs.

In 2014, Pradaxa manufacturer Boehringer Ingelheim agreed to pay $650 million to settle about 4,000 lawsuits involving dangerous bleeding. In 2015, the FDA approved Praxbind to reverse the effects of Pradaxa, making the drug significantly safer.

A series of Xarelto bellwether trials are expected to begin next year. These may influence eventual settlements from Bayer and Janssen Pharmaceuticals.

The Judicial Panel of Multidistrict litigation consolidated the growing number of Eliquis lawsuits before U.S. District Judge Denise L. Cole in the Southern District of New York. The consolidated pretrial proceedings will help prevent duplicative discovery and conflicting rulings, saving all parties time and money.

Sanofi S.A. Taxotere Lawsuits Move Forward With Approved Plaintiff Fact Sheet

By Emily Cox

New Orleans, LA — The U.S. District Judge presiding over Taxotere’s multidistrict litigation (MDL) approved the fact sheet that plaintiffs will use going forward against Sanofi S.A., the manufacturer of the controversial breast cancer drug, alleging that they experienced permanent hair loss, or alopecia, because of the drug.

While hair loss is expected with any chemotherapy, it is usually temporary. Plaintiffs claim that Taxotere caused permanent and disfiguring hair loss, and Sanofi S.A. did not warn them of the risk. Although studies show there are equally effective breast cancer treatments without Taxotere’s risks, plaintiffs claim Sanofi S.A. overstated the effectiveness of the drug while minimizing risks.

U.S. District Judge Kurt Engehhardt issued the pretrial order February 14. It includes a copy of the approved fact sheet. The MDL’s fact sheet will provide details about each plaintiff, including medical information, Taxotere use, and descriptions of alleged injury. The court requires plaintiffs to provide this information under oath.

Master Complaint in Sanofi S.A. Taxotere MDL

Judge Engelhardt approved the form days after he set a March 31 deadline to create a Master Complaint to streamline proceedings. The Master Complain allows future Taxotere plaintiffs to use the much faster Short Form Complaint. The Short Form Complaint lets plaintiffs adopt factual allegations and legal claims from the Master Complaint as they relate to their individual claim.

This practice is common in multidistrict litigations (MDLs) like Taxotere, where all pending lawsuits have similar allegations and are centralized in one U.S. District Court in order to reduce duplicate discovery into common issues and conflicting pretrial rulings, saving time and money.

The Judicial Panel on Multidistrict Litigation (JPML) centralized Taxotere proceedings under Judge Engelhardt in the Eastern District of Louisiana in October 2016. In December 2016, 267 lawsuits were pending in the MDL. Since then, the MDL has swollen to more than 850 cases.

Taxotere Hair Loss Risk and Effectiveness

Sanofi S.A. Taxotere Alopecia
Photo by S.A. Ledie

Studies indicate that one out of every 10 patients treated with Taxotere experiences alopecia complications. Sanofi S.A. knew about this risk since at least 2005 when the company updated its warning labels in Canada to include it. Sanofi S.A. didn’t update U.S. warning labels until late 2015.

The lawsuits allege permanent hair loss can substantially affect a woman’s overall quality of life and mental health.

Clinical studies showed Taxotere was no more effective than other less toxic treatments. However, Sanofi S.A. continued to aggressively market the breast cancer drug’s superiority.

In 2009, the FDA issued a warning to Sanofi S.A. to stop using promotional materials that suggested that Taxotere was better than any other taxane, including Taxol. The FDA called the company’s claims of superiority “false and misleading” and accused Sanofi S.A. as misbranding Taxotere.

The lawsuits claim that these women may have chosen a different treatment if they had known all the facts.

Breast Cancer Drug Manufacturer Engaged in Fraudulent Marketing Practices According to New Lawsuit

By Emily Cox
Breast Cancer Drug Box
Photo by Haukeland

 

New Orleans, LA – A new claim alleges that Taxotere developer Sanofi S.A. used illegal methods to drive sales and expand market share for its controversial breast cancer drug that is now known to pose an increased risk of permanent alopecia, or hair loss.

The lawsuit, filed this past week, indicates that Angela Abel underwent Taxotere (docetaxel) treatments between November 2011 and February 2012. The claim alleges that Abel now suffers from disfiguring, permanent alopecia, as a result of these treatments.

Sanofi S.A. has known about this side effect for more than a decade and updated warning labels in Canada and Europe to include it in 2005 and 2012 respectively. The company didn’t update U.S. warning labels until late 2015. Neither Abel or her oncologist were aware of the side effect.

Sanofi S.A. Overstated Effectiveness of Taxotere

Perhaps worse than hiding the risks of the breast cancer drug is that Sanofi S.A. misrepresented Taxotere’s effectiveness. Despite various clinical studies that suggested otherwise, the company continued to aggressively market the drug as being more effective than other less toxic treatment options.

In 2009, the FDA issued a warning to Sanofi S.A. that its claims of superiority were false and misleading. The agency requested that the company stop its unsubstantiated promotional materials that suggested Taxotere was better than any other Taxane, including Taxol.

The lawsuit asserts that Abel may have chosen a different breast cancer drug if she had known about
the side effects and that other, less toxic treatments were equally or more effective. This sentiment is echoed throughout the growing number of lawsuits being filed against the company.

Fraudulent Marketing for the Breast Cancer Drug

However, the company didn’t stop at hiding information and overstating the quality of Taxotere to increase sales. It allegedly took fraudulent measures to expand its market share.

A former employee and the U.S. have filed a Qui Tam lawsuit against Sanofi S.A. A Qui Tam lawsuit is a claim brought by a “whistle blower” on behalf of the government against a company who is believed to have defrauded the government.

The Qui Tam lawsuit, cited by Abel’s case, is accusing Sanofi S.A. of engaging in a fraudulent marketing scheme, paying illegal kickbacks, and providing other unlawful incentives to encourage doctors to use Taxotere. These marketing practices started in 1996 and promoted Taxotere for off-label uses not approved by the FDA.

The breast cancer drug is only approved to treat advanced breast cancer when other treatment options have failed. However, Sanofi-S.A. trained and directed their employees to misrepresent the safety and effectiveness of off-label use of Taxotere to expand its market in unapproved settings, such as first line treatment for breast cancer and less advanced cancer. The company also paid healthcare providers illegal kickbacks in the form of entertainment, sports, concert tickets, sham grants, speaking fees, travel, preceptorship fees, and free reimbursement assistance to get doctors to prescribe Taxotere for off-label uses.

This fraudulent marketing scheme dramatically increased the breast cancer drug’s revenue from $424 million in 2000 to $1.4 billion in 2004. It also exposed thousands of women to the increased toxicity of Taxotere and its more severe side effects, including permanent alopecia.

Permanent Alopecia from Breast Cancer Drug
Photo by Christina Spicuzza

Yoash Gohil, who was assigned to promote and sell Taxotere in this manner, initially brought the suit. In 2002, Gohil resigned from Sanofi S.A. and initiated a wrongful termination action. He alleged that Aventis retaliated against him when he objected to sales activities that violated federal and state laws, including FDA regulations.

Lawsuits continue to mount against the company as more women discover that they were permanently disfigured by Taxotere unnecessarily.

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