How did this happen?

When a dangerous product causes harm to you or someone you care about, you naturally want to know how the terrible situation was allowed to come about. Manufacturers of consumer products are interested in making as much money as possible, like any company. But this can lead to corners being cut. And that can lead to injuries. So who keeps an eye on these companies? Who looks out for you?

In the United States, the federal Food and Drug Administration (FDA) is responsible for protecting public health by ensuring that human and veterinary drugs (including prescription and over-the-counter drugs), vaccines, medical devices, food, dietary supplements, cosmetics, and products that emit radiation are safe. Before a manufacturer may market a drug to the public, the drug must obtain FDA approval. The drug must go through a series of clinical trials that are intended to determine whether a drug is both safe and effective as a treatment for a condition or disease. It is important to note, however, that absolute safety is never guaranteed. The FDA merely determines that, overall, the benefits of a drug outweigh its risks.

Sold under the brand names “Yaz,” “Yasmin,” and “Ocella,” the drug drospirenone is an oral contraceptive also used to treat symptoms of premenstrual dysphoric disorder (PMDD), including irritability, depression, and joint and muscle pain. The FDA approved Yasmin in 2001, Yaz in 2006, and Ocella in 2008. (In advertisements, the manufacturer of Yaz implied that the drug could be used to alleviate symptoms of premenstrual syndrome (PMS) and also treat acne, even though the FDA had not approved the drug for either use. The FDA brought this to a stop.)

In November of 2009, the FDA recalled more than 33,000 boxes of Yaz, citing improper manufacturing practices. This led to more than 2,000 lawsuits nationwide. These suits were eventually consolidated into a single action, focusing on the claim that the companies that manufactured Yaz, Yasmin, and Ocella had not adequately researched the drugs and had negligently and fraudulently failed to inform the public of the risks associated with the drugs.

In 2011, the FDA stepped up its investigation of Yaz. In May, it issued a Drug Safety Communication informing the public that the British Medical Journal published two articles on Yaz’ alleged tendency to cause deep vein thrombosis and pulmonary embolism in women. The studies found that women were two to three times more likely to suffer venous thromboembolic events while taking Yaz as opposed to levonorgestrel. These findings contrasted with studies conducted in 2009 that determined no difference between the two contraceptives. The FDA said it would analyze the two studies and inform the public of its conclusions and if it would take further action related to Yaz and Yaz side effects.

On September 26, 2011, the FDA released a second Drug Safety Communication, this time stating that it had not reached a conclusion on the studies’ results on Yaz’ alleged side effects. The FDA continued its research and announced its findings in an October 27, 2011 Drug Safety Communication, the third in one year. It stated it would convene the Drug Safety and Risk Management Advisory Committee’s and Reproductive Health Drugs Advisory Committee’s Joint Meeting held on December 8, 2011.

The Joint Meeting resulted in two votes by the committees’ members. According to Reuters, they voted 21 to five endorsing a statement that Yaz’ current label inadequately warned doctors and users of the drug’s risks. However, they also voted 15 to 11 advising the FDA that the risk of Yaz side effects did not outweigh the benefits of preventing unwanted pregnancies. Joint Meeting members commented that only Bayer’s studies showed Yaz to be equally safe to other forms of hormonal birth control.

If you are suffering now or have suffered previously from severe side effects while (or after) taking Yaz, Yasmin, or Ocella—of if someone in your family died after being prescribed one of these dangerous drugs—let the Rottenstein Law Group know. Our lawyers have many years of experience with products liability litigation, and we can make the process of demanding compensation from a blameworthy manufacturer more efficient. The knowledge, experience, and preparation of RLG’s lawyers will make seeking compensation for your pain as painless as possible. Because you’ve taken enough, so we’ll take it from here.

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