Articles Posted in Prescription Drug Injuries

The U.S. Food and Drug Administration (FDA) recently announced that it would take actions to provide women with information about the risks of using Essure, a form of permanent birth control. This form of birth control involves inserting flexible coils through the cervix and vagina into the fallopian tubes. After about three months, scar tissue forms around the coils and makes a barrier in order to prevent conception.

The FDA recognized that there are potential complications related to these types of implantable forms of sterilization and that it should take actions in order to address these risks. These actions include requiring a clinical study to assess the risks and requiring warnings on the product labels. The FDA stated that the actions recognize that “more rigorous research is needed to better understand if certain women are at heightened risk of complications.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring that food and drugs are safe for people to use. The FDA’s position is that while Essure is safe for most women, some women may be at risk for complications. Those complications may include pain, tears, bleeding, and allergic reactions.

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According to a news article, the U.S. Supreme Court recently refused to hear a drug-maker’s appeal in a case that cost the drug company $124 million for falsely marketing a prescription medication. By declining the appeal, the court affirmed a South Carolina Supreme Court ruling that reduced the company’s damages from $327 million to $124 million, but it did not overturn a jury’s verdict that the drug company had improperly marketed the medication.

How Cases Get to the Supreme Court

Cases come to the supreme court in one of two ways. First, a case can be appealed to the court from a lower federal court ruling. These courts are called federal circuit courts. Second, a case can come to the supreme court from a state’s highest court. In either case, if the supreme court does not accept the appeal, the lower court’s decision stands.

What Happened in This Case?

The drug at issue in the South Carolina case is called Risperdal. Risperdal was introduced in 1994 for the treatment of schizophrenia and bipolar disorder. It is also given to patients with autism who suffer from irritability and aggressiveness. Side effects of the medication include diabetes, stroke, and weight gain.

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