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FDA Issues a “Black Box” Warning for Birth-Control Device Essure

Posted in Firm News

Throughout someone’s life, it is very likely that they will be prescribed medication to treat a condition or illness. When a medication is prescribed, it is important that doctors explain the risks and course of treatment to the patient. In many situations, however, doctors do not fully disclose risks and assume that patients will read the lengthy warnings prepared by the pharmaceutical companies that often come attached to their prescriptions.

When an individual has been injured or killed because of a medication side-effect, they will often attribute negligence to the prescribing physician. Treating physicians are often thought to have the primary duty to warn patients of the risks of ingesting certain drugs. In some circumstances, physicians will try to shift responsibility onto the prescription manufacturer.

Many states follow the “learned intermediary” doctrine. This doctrine explains that the prescribing physician acts as the intermediary between the manufacturer and the patient. This means that the manufacturer is supposed to advise the physician of the risks and the physicians should convey these to the patient prior to prescribing them medication. Some steps physicians should take to make sure their patient is aware of all of the risks involve reading the FDA guidelines, reviewing the patient’s medical history to determine any risks, and advising patients of available alternatives.

Although many states follow this learned intermediary doctrine, New Mexico courts have recently began engaging in discussions that may usher in a change in the application of this doctrine. In 2008, a federal district court made statements that indicated that the New Mexico Supreme Court would not adopt this doctrine. They actually went as far as not applying it in a product liability suit that was brought under state law. The court explained that the doctrine was archaic and “outdated”, and cited the amount of research patients do on their own and how it is important that manufactures and doctors understand this potentially damaging trend.

Producers of Permanent Birth Control Required to Provide Stricter Warnings to Patients

Recently a drug safety watch group published an article that indicated that the U.S. Food and Drug Administration (FDA) released a statement that it will be requiring stronger warnings for a popular permanent birth control device.

Apparently, this birth control device is made up of two coils that are implanted into a woman’s fallopian tubes that eventually cause scar tissue, which is supposed to block any eggs from being fertilized. However, thousands of women have reported serious complications linked to the device. Evidently, some women are facing organ tears, suffering severe pain, and ectopic pregnancies.

Following all of these reports, the FDA reviewed the device and determined that it requires a “black box” warning. This warning is the strongest required of medications of this nature. Even with this warning, women who have been injured by this device are not satisfied. They argue that the manufacturers should be held liable for the injuries it caused, and that the product should be recalled and removed from the shelves. Many of these women have initiated lawsuits against the pharmaceutical company.

Have You Suffered Injuries Because of Medication You Were Prescribed?

From a young age, people are taught to trust medical professionals and heed their advice. This is why it is particularly devastating when a person suffers injuries after following such advice. As you can see, the consequences of inadequate warnings and labels can result in terrible injuries. If you or a loved one has been injured or killed after using a dangerous product, it is important that you contact an attorney. An attorney at the Fine Law Firm can assist you in determining who the liable parties are and what steps you might take. If you are successful, you may be entitled to monetary compensation for the injuries you suffered. Contact an attorney at the Fine Law Firm today at 505-243-4541 for your free initial consultation.

More Blog Posts:

State Supreme Court Rules in Favor of Accident Victims Injured at Gas Station Walk-Up Window, New Mexico Personal Injury Lawyer Blog, March 1, 2016.

Appellate Court Affirms Denial of Plaintiff’s Medical Malpractice Claim Based on Lack of Expert Witness Testimony, New Mexico Personal Injury Lawyer Blog, February 22, 2016.