A new class-action lawsuit has been launched against the makers of Bravelle after couples unsuccessfully used the infertility drug to conceive. The Swiss company Ferring Pharmaceuticals recalled several batches of urofollitropin in 2015 since they proved to be ineffective. Now plaintiffs who used this drug to treat their fertility issues are asking for refund and compensation, claiming they wasted all chances to conceive a child. If you failed to have a baby after using Bravelle between March 2014 and October 2015, you might file a litigation against the drugmaker to seek compensation for the whole infertility treatment.
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What is Bravelle and how it works?
Bravelle (urofollitropin) is a purified hormone used during In Vitro Fertilization (IVF) and as an infertility treatment to stimulate the production and development of follicles (eggs) in the women’s ovaries. It is administered as a subcutaneous injection to increase fertility by assisting the ovulation process. Pregnancy occurs when one of the ovaries releases an egg, which is then united with a sperm inside the fallopian tube. Bravelle contains follicle stimulating hormone (FSH) and has a luteinizing hormone (LH) activity. Its dosage varies on individual needs. Since this medication’s effect causes the induction of ovulation, it may lead to ovarian hyperstimulation syndrome (OHSS) as well as weight gain, hypotension, electrolyte imbalances, and vascular complications. Other side effects reported with the use of this drug include abdominal and pelvic pain, skin rash, alopecia, and a heightened risk of endometrial cancer
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Did you fail to achieve pregnancy after one or more full cycles of Bravelle? Fill out our Free Case Review form to find out your possible legal options.
Why was Bravelle recalled and why you need to file a lawsuit?
In September 2015, Ferring Pharmaceuticals found that the potency of several batches of Bravelle was reduced, and thus decided to voluntarily recall them from the market. The Swiss drugmaker later sent out letters to the patients who purchased any lot sold in the U.S. between March 2014 and October 2015, offering them to reimburse the drug’s price. However, the company did not offer compensation for the significantly higher expenses that many couples had to face to pay for the whole IVF treatment. Also, Ferring Pharmaceuticals later recalled all the other lots from the U.S. markets, although patients had no way to know whether they were injected with an urofollitropin dose which was ineffective. The product’s website never warned consumers about the fact that some batches were not working, and failed to provide any reliable way to let them know whether they were purchasing a dose included in the recalled lots.
What is Infertility?
Infertility is defined as the inability to conceive a child (get pregnant) after at least 12 months of regular unprotected sex. Up to 80% of fertile couples generally need one year before they achieve pregnancy. After that period, even if the couple is medically defined as infertile, there is a 95% chance that a baby can be conceived after another full year of repeated unprotected intercourses. The remaining 5% of the population may still have a chance of success by switching to a healthier lifestyle or changing the dietary habits. According to data from the Centers for Disease Control and Prevention (CDC) in the United States, roughly 6% of women aged 15 to 44 years is infertile, and up to 12% has difficulties getting pregnant (impaired fecundity).
Is infertility a women’s problem?
Actually, this is just a myth. Statistically, women show a slightly higher percentage of infertility compared to men (35-45% v. 20-30%). However, this number also includes all those subjects who cannot carry a pregnancy to full term, so even if a mother was still able to give birth to a child after suffering from multiple miscarriages, she is still computed as infertile.
What are the causes of infertility?
The reason why male and female individuals may be infertile can be different, although some risk factors are common for both genres. For example, while a diet lacking in folic acid, Vitamin A, B and D, zinc, or iron may contribute to infertility in both men and women, a reduced quality of the seminal liquid is a risk factor that affects only males.
Common risk factors
- Sedentary lifestyle
- High alcohol consumption
- Stress and anxiety
- Obesity and overweight
- Old age
- Nutritional deficiencies
Male risk factors
- Oligospermia (lack of sperm cells in the seminal liquid)
- Azoospermia (absence of sperm cells)
- Varicocele (swollen testicular veins)
- Prostatitis (inflammation of the prostate)
- Erectile dysfunction
Female risk factors
- Hormonal imbalances
- Irregular ovulation
- Primary ovarian insufficiency
- Polycystic ovary syndrome (PCOS)
- Aging over 30s
- Congenital malformations of the uterus
What are the treatments for infertility?
Couples who cannot find a solution just by changing their lifestyle or dietary habits may try some pharmacological solutions. These include treatments with drugs that induce or regulate the woman’s ovulation such as clomiphene, urofollitropin or other FSH-based medications. If nothing works, families affected by infertility can still be helped with assisted reproductive technologies such as in vivo fertilization (IVF). During an IVF cycle, a technician collects the mature eggs from a woman’s ovary and fertilizes them with a sperm cell in a laboratory. The fertilized embryo is then implanted in the uterus, and the process is repeated until pregnancy is achieved. However, IVF is often an expensive and time-consuming procedure that may require many cycles over the course of several months.
Bravelle Class-action Lawsuit
On February 2016, Amanda and Joep Olthuis filed a Bravelle class-action lawsuit in a British Columbia court against Ferring Pharmaceuticals after the woman was injected with an alleged ineffective dose of the infertility drug. The Canadian couple claims that the pharmaceutical company only offered a $2,500 refund, but they had to face an expenditure of about $14,000 to pay the IVF treatment. The two plaintiffs saved money for two years to give Amanda a chance to become pregnant and now cannot afford another cycle. The couple claims they have never been adequately warned about the possible problems with the lot, and would have never completed the whole several-months-long treatment if they were aware of the risks. Since they had to travel from their hometown Port Moody to the Genesis Fertility Centre in Vancouver, the Olthuis are also asking for additional compensation to repay them for all the out-of-pocket costs they had to face. To date, at least 20 other families who shared similar stories joined the class-action.
Article by Dr. Claudio Butticè, Pharm.D.
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