Although Taxotere has been on the market for about 20 years, consumers and doctors in the United States have only recently become aware of some of the drug's unique dangers and side effects. Now, hundreds of chemotherapy patients who have taken the drug during its period of approval have filed claims against the multinational pharmaceutical company Sanofi-Aventis for manufacturing and pushing a drug using false claims and concealing vital information which could have diminished profits.
The most commonly litigated complaint associated with the drug is its propensity for causing permanent hair loss, or alopecia, although there are other allegations as well. Lawsuits claim, for example, that Sanofi knew of the link between the drug Taxotere and permanent hair loss since it completed the first round of clinical trials in 1996, yet it failed to report this information to physicians and patients because the company knew that this side effect would prevent patients from choosing this particular chemotherapy. Lawsuits are therefore alleging that Sanofi de-emphasized the risks of the drug in order to profit off of sales.
Central to this coverup is the fact that there is an alternative taxane chemotherapy called Taxol. This drug is, chemically, nearly identical to Taxotere, yet Sanofi made claims that their drug, Taxotere, was more clinically effective. Lawsuits all over the country are arguing that Sanofi falsely marketed Taxotere by claiming that Taxotere was more effective and safer than the alternative, Taxol. Many patients are now questioning whether or not this claim was ever substantiated through long-term, independent studies.
When patients fail to regrow their hair months or even years after being treated with Taxotere, many of them begin to realize the permanent effects of a product which they were told was safe and temporary. While hair loss in an of itself is a traumatic experience, when patients begin to do further research, they often find that hair loss is only one part of Taxotere's contentious history and that they may have been exposed to many unnecessary risks through the use of this drug. Many feel violated by the fact that they were not given all the information about a drug that they believed was thoroughly tested, safe, and absolutely necessary for treatment of their life-threatening condition.
Timeline of Litigation
Taxotere's toxic side effects, often presented as long term or permanent hair loss, were well-documented from the first clinical trials of the drug. In Europe, the drug Taxotere began to include warnings of potential permanent hair loss back in 2009. In Canada, the warning was included on the drug label in 2012, although the risk of permanent hair loss was widely discussed and covered by the media before that date. Obviously, women around the United States had, for decades, been reporting cases of permanent hair loss after their course of Taxotere treatment had ended. The warnings were not included on the FDA labels for Taxotere sold in the United States until December of 2015.
Soon after this change in labeling, women across the country, who finally felt that their claims were legitimized, began filing lawsuits against Sanofi.
Ami Dodson v. Sanofi SA et al
In March of 2015, only a few months after the FDA changed Taxotere's label to represent the possibility of permanent hair loss caused by the drug, Ami Dodson of Mississippi filed a lawsuit against Sanofi for promoting a drug that they knew to be dangerous and purposefully concealing information that might have decreased Taxotere's sales. She alleged that Sanofi's scheme exposed thousands of women to a more dangerous alternative than the generic drug Taxol, which uses a slightly different compound and has a much smaller, almost insignificant, risk of permanent hair loss.
In her lawsuit, Dodson was very direct about how she believed the company took advantage of cancer patients who trusted doctors and drug companies to care for them. “Defendants [preyed] on one of the most vulnerable groups of individuals at the most difficult time in their lives,” her lawsuit states. She added that the defendants “obtained billions of dollars in increased revenues at the expense of unwary cancer victims simply hoping to survive their condition and return to a normal life.”
The lawsuit went on to allege that the drug company purposefully trained their employees to downplay the risks of Taxotere and claim its superior effectiveness, a claim which had not been supported through clinical evidence and research. In fact, multiple studies have even shown that Taxotere is less effective than its competitor and the original, Taxol. The results of these studies were not acknowledged by Sanofi, which continued to push its own formulation as superior.
In total, Dodson argued that Taxotere was a completely unnecessary and, in fact, more damaging drug than the original. The only reason that it was so widely distributed and administered was due to Sanofi's faulty marketing and aggressive sales through false advertising and concealment of disfiguring side effects. “Although women might accept the possibility of permanent baldness as a result of the use of Taxotere if no other product were available to treat their cancer, this was not the case,” Dodson said. “There were already similar products on the market that were at least as effective as Taxotere and did not subject female users to the same risk of disfiguring permanent alopecia.”
Number of Plaintiffs Increases
As the media began to report on the dangers of Taxotere and the possibility for compensation through litigation, hundreds of women began to file individual complaints against Sanofi. Over the course of just one and a half years, almost 90 more patients filed individual suits against the multi-billion dollar company in courts all over the country. This, however, was just the beginning. It is estimated that over a quarter of a million cases of breast cancer will be diagnosed in the United States alone in the year 2017, and around 1 in 8 women will develop the disease over the course of their lifetime. Since as many as 75% of eligible breast cancer patients are treated with Taxotere, there is an astounding number of women that this coverup effects all over the country.
Consolidation into Multidistrict Litigation (MDL)
In October of 2016, the courts began to feel the administrative pressure of handling nearly 100 of individual cases against Sanofi involving the same concerns reiterated over and over. Lawyers began to argue that the issue might be better addressed through the process of multidistrict litigation. The 89 cases concerning Taxotere were thus consolidated by the US Judicial Panel on Multi-District Litigation (JPML). This organization argued that there was one defining the “common question of fact” in all these different cases. The JPML stated that all the plaintiffs had a common argument, which was that Sanofi “marketed Taxotere as more effective than other chemotherapy drugs when other drugs were equally effective without the associated permanent hair loss.”
What is the Difference between Multidistrict Litigation and Class Action?
Multidistrict litigation is a system that was created in the sixties to handle a particular common judicial issue that is being litigated frequently across the country in multiple courts. This process consolidates all ongoing cases in all fifty states and sends them to one particular federal court. In the case of Taxotere, all cases are being sent through the Eastern District of Louisiana under U.S. District Judge Kurt D. Engelhardt. Multidistrict litigation means that all the cases against Sanofi for their production and marketing of Taxotere are automatically referred to the Eastern District of Louisiana for pretrial streamlining and discovery. After the cases are organized, compared, and developed, they are sometimes sent back to the courts from which they came for the trial.
This is different from a class action lawsuit because, in those proceedings, one group with similar claims files one legal action together, as joint plaintiffs. The plaintiffs come together and file on behalf of a proposed class of individuals and business who they believe to have been affected by the actions or negligence of a particular defendant. In multidistrict litigation, plaintiffs file only on behalf of themselves, not a class of people. Because of this distinction, multidistrict litigation is often more flexible, accommodating different kinds of complaints and the individual's cases and needs of each plaintiff, and compensating each plaintiff for their personal suffering. It also carries some of the benefits of class action lawsuits, such as pooling resources from the hundreds of unique plaintiffs and invested attorneys. When fighting billion dollar industries, multidistrict litigation can provide strength in numbers. Consolidation can also speed up the process of litigation considerably, cutting court and attorney fees for hundreds of victims.
Growing Numbers through MDL
Since the consolidation of Taxotere litigation into a multidistrict affair, the number of cases which have been filed has skyrocketed. In mid-December of 2016, just two months after consolidation, there were 262 pending claims. Just a month later, 443 new cases had been added, for a total of 705 in January of 2017. 50 more had been added only a few weeks later for a total of 755, and additional lawsuits are filed every day.
United States ex. rel. Gohil v. Aventis
Another lawsuit currently making its way through the courts may be of particular importance for victims of Sanofi's marketing claims about Taxotere. The plaintiff, Mr. Yoash Gohil, is a former employee of the pharmaceutical company Sanofi-Aventis. He claims that the multi-billion dollar corporation “falsely marketed its cancer drug Taxotere and provided doctors with illegal kickbacks for prescribing the drug for off-label uses.” This means that Sanofi-Aventis may have given doctors financial perks in exchange for prescribing the drug Taxotere over their competitors or for symptoms and diseases that the drug had not yet been approved to treat. The perks allegedly include things like “sham unrestricted grants, speaking fees, entertainment, sports and concert tickets, free samples, and free reimbursement assistance.” The claims concern various incidents that occurred between 1996 and 2000, the period when Taxotere was first approved and aggressively marketed to doctors, hospitals, and patients as a more effective alternative to Taxol.
The federal government is involved in the case because federal insurance programs often paid for reimbursement of the drug when it was being used off-label by doctors. The case argues that this may not have been medically necessary, but lucrative for Sanofi-Aventis who was accruing profits for a drug that was being administered without evidence of its effectiveness. Gohil cites the increase in profit from the sale of Taxotere between 1996 and 2000 from $424 million to $1.4 billion, allegedly due to the promotion of off-label use. The case is being filed through the Eastern District of Pennsylvania, under the direction of U.S. District Judge Lawrence F. Stengel.
If You've Taken Taxotere
Sanofi-Aventis is currently under a lot of pressure from both the multidistrict litigation concerning patients who were given Taxotere and the federal government which is concerned about the legality of Sanofi's marketing practices. In January of 2017, the Eastern District Court of Pennsylvania rejected Sanofi's argument that the case was past the statute of limitations, allowing for the government's case against the company to move forward. Hundreds of women across the country are filing lawsuits alleging the same issues: false marketing, safer alternatives, and failure to disclose side effects. With each lawsuit that is filed, the case against Sanofi becomes stronger.
If you have taken Taxotere and are suffering the unforeseen, long-term side effects of the drug, you may be wondering how you can take action. In order to be compensated for your suffering, you must file a lawsuit, which will then be directed to the multi-district litigation court for this issue, the Eastern District of Louisiana. You will not have to travel to Louisiana for trial, and you will not pay anything in attorneys fees unless you recover compensation. The current situation is moving quickly, and court dates to present medical and scientific evidence will most likely come in the next few months.