Cancer is rough. It is a disease that has caused massive suffering, and virtually every family will be affected by it at some point. Doctors and scientists have tried to treat or cure cancer in patients ever since humans have existed as a species. In fact the name of this disease originates from ancient doctors who treated cancer and observed how a tumor’s appearance reminded them of crabs (cancer is Latin for crab).

Despite these efforts at fighting cancer over thousands of years, there is no complete cure and many current treatments, such as chemotherapy, have severe side effects.

Because of chemotherapy’s significant side effects and a general inability to completely cure the patient, a cost benefit analysis has always been important for cancer patients. Many cancer patients have to ask themselves if going through several weeks or months of misery is worth adding months or years to their lives. It’s an awful choice to make.

In making these decisions, cancer patients must rely on information from cancer drug companies, as well as their own doctors, to understand a chemotherapy drug’s effectiveness and side effects. Unfortunately, it appears one particular cancer drug maker, Sonafi SA, may have covered up the truth about its chemotherapy drug Taxotere in order to boost profits, regardless of what harm the drug may have caused to patients taking it.

What Is Taxotere?

Taxotere is the brand name for the cancer drug Docetaxel. It works by damaging the physical structure of cells so that cells cannot divide and reproduce. Taxotere has been used largely to treat breast cancer, but it has also been used to treat:

• Lung cancer
• Stomach cancer
• Neck and head cancer
• Prostate cancer

Like other chemotherapy drugs, Taxotere attacks both “good” and cancerous cells. This often leads to notable side effects, including:

• Fatigue
• Nausea and vomiting
• Diarrhea
• Muscle and joint pain
• Fingernail and toenail damage
• Shortness of breath
• Mouth sores
• Swollen hands and feet
• Loss of appetite
• Hair loss, both temporary and permanent

The side effect of hair loss is not initially notable because it’s one of the most common chemotherapy drug side effects. What is notable is that the hair loss can sometimes be permanent, despite Sonafi SA’s assertions to the contrary.

What Sonafi SA Did Wrong?

The alleged wrongs of Sonafi SA revolve around misinforming cancer patients in two primary ways. First, it is alleged that Sonafi SA covered up data from studies that showed that Taxotere not only caused permanent hair loss, but did so at a rate much higher than comparable chemotherapy drugs.

Second, it is also alleged that Sonafi SA falsely marketed Taxotere as being more effective than other chemotherapy drugs. Basically, similar chemotherapy drugs worked just as well as Taxotere, but they also did so with a smaller likelihood of permanent hair loss. Sonafi SA allegedly went to great lengths to prevent cancer patients from learning this fact.

Taxotere Litigation

As a result of the above allegations, thousands of cancer patients have sued Sonafi SA and its affiliated business entities. Currently, there are over 1,000 lawsuits involving Taxotere in the multi-district litigation or MDL located in the Eastern District of Louisiana. This number is expected to rise because the MDL consolidation effort will also include cases that involve generic versions of Taxotere.

The Taxotere MDL is currently in the early stages of litigation, although it has been reported that Judge Kurt D. Engelhardt overseeing the MDL has pushed the attorneys involved to focus on settling the cases and less on preparing for trial. We will see how that takes shape.

If the Taxotere MDL cases settle, it may take a while, but Judge Englehardt has a reputation of making settlements happen. I will let you know if there are any significant developments.

Pregnancy brings with it many physical challenges, including nausea and vomiting which impact about 80% of pregnant women. It can range from being a minor issue to a potentially serious health risk, depending on the severity of the nausea and health of the mother. The drug Zofran is designed to limit nausea but it was not approved for use by pregnant women and it may cause birth defects. Although medical causation is not settled on the issue, many women who took Zofran during pregnancy gave birth to children with birth defects. Because of that potential link hundreds of lawsuits have been brought against the maker of Zofran, seeking compensation for the harm possibly done by the drug.

Intended Uses

Zofran (or ondansetron hydrochloride) helps prevent nausea and vomiting by blocking the effects of serotonin, a chemical in the body that can trigger nausea and vomiting. It was originally designed to help cancer patients dealing with the side effects of chemotherapy but is also approved by the Food and Drug Administration (FDA) for those suffering nausea due to radiation therapy, anesthesia and surgery.

more Recent Medical Study

There are conflicting studies of the possible harmful side effects of Zofran but one 2014 article on the use of Zofran by pregnant women in the American Journal of Obstetrics & Gynecology made a strong recommendation against using the drug. Gideon Koren, MD, of the Motherisk Program at the Hospital for Sick Children and the University of Toronto wrote:

• The use of Zofran in the U.S. for nausea and vomiting during pregnancy increased from about 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues concerning fetal safety and FDA warnings about serious negative heart effects.
• A Danish study presented in August of 2013 showed the results of a study using the Danish birth registry covering 1997 to 2010 and 897,018 pregnancies. This study found a two-fold increased risk of heart defects in infants when their mothers used Zofran during their pregnancies, leading to an overall 30% increased risk of major congenital malformations.
• The FDA approved the use of a combination of doxylamine and pyridoxine in April 2013 specifically for nausea and vomiting during pregnancy. Since this safe and effective drug is available, there is no reason for women to be exposed to Zofran due to safety concerns for the mother and child.

Lawsuits Mounting

More than 200 lawsuits have been filed by plaintiffs claiming that their children were harmed by Zofran during pregnancy and that the manufacturer, GlaxoSmithKline (GSK), is to blame. These legal claims have been consolidated in federal court in Massachusetts. Plaintiffs claim the drug caused heart defects, cleft palates and other birth defects.

This isn’t the only issue involving Zofran that’s gotten GSK in trouble. The company agreed to plead guilty and to pay $3 billion to resolve criminal and civil liability due to their unlawful promotion of certain prescription drugs (including Zofran), its failure to report certain safety data and its civil liability for alleged false price reporting practices in 2012.

Part of the allegations was that GSK promoted some forms of Zofran for the treatment of morning sickness in pregnant women which is a use not approved by the FDA. GSK agreed to settle claims that it paid kickbacks to health care professionals to encourage them to promote and prescribe Zofran and other drugs. This resulted in $1.043 billion in false claims payments to the federal and state governments. The settlement money went to the federal government, several states, the District of Columbia and to plaintiffs involved in GSK whistleblower lawsuits.

GSK has shown it wasn’t afraid to bend the law when it comes to generating sales of Zofran. The drug may also be the cause of serious health problems for possibly thousands of children, leaving parents to care for them and pay a lifetime of medical bills.

If you believe your child has been harmed by Zofran and would like to learn more, the drug’s possible side effects and the growing litigation, feel free to call me so we can talk about your case, how the law may apply and your best options for obtaining compensation.