According to the United States Constitution, federal law must be followed by every state in the nation. That means that states can only enact laws that do not contradict federal law. This frequently complicated and nuanced legal concept is known as preemption, and it is often relevant in medical device injury cases.
Preemption in Medical Product Injury Cases
Preemption is a defense raised by medical device manufacturers in some medical device injury cases. The medical device makers argue that they cannot be sued if they followed the requirements of the U.S. Food and Drug Administration (FDA).
Specifically, the preemption defense is often used when the medical device in question was approved through the FDA’s premarket approval (PMA) process. Before marketing a Class III medical device, the medical device manufacturer can get premarketing approval from the FDA. The medical device makers argue that as long as they follow all of the FDA’s requirements, they should not be legally responsible for injuries that result from their products.
A 2008 U.S. Supreme Court case established that the preemption doctrine applies to medical devices that the FDA decides are safe and effective during the PMA process. According to the court, once a medical device has PMA approval, state safety regulations that are different from or more stringent than federal safety regulations cannot be enforced. However, the court left open the possibility that state regulations that are the same as federal regulations may be enforceable if someone is hurt by a defective medical device.
Preemption of Essure Claims
In 2002, Essure got conditional pre-market approval from the FDA, and many women were given the option of a permanent form of birth control without surgery. Instead, during a doctor’s office visit, a woman could have a coil implanted in each fallopian tube. Over a few months, scar tissue would develop around the coils and prevent pregnancy.
Unfortunately, Essure had potentially dangerous side effects that many women didn’t know about before they consented to the procedure. Some of these women suffered significant pain, perforation of the uterus or fallopian tubes, migration of the coils into other parts of the body, and unintended pregnancies.
Some women began to file injury lawsuits. Bayer argued, however, that their claims should be preempted and not heard because Essure had PMA approval from the FDA.
Judges in California and Pennsylvania held that some claims against Bayer could move forward according to state laws because the state laws were the same as federal laws. These decisions allowed women to bring lawsuits against Bayer claiming negligent failure to warn, breach of warranty, fraud, and negligent misrepresentation.
Does Preemption Apply in Your Case?
Preemption is a powerful defense that could prevent you from making a fair legal recovery in your medical device injury case. Before you pursue a claim, you deserve to know about the strengths and weaknesses of your potential claim so that you can decide whether or not to seek justice.
The lawyers of Keefe Disability Law are committed to providing you with a thorough and honest review of your Essure or other medical device claim. The medical device manufacturer did not give you all of the information that you needed to consider all of your options and make a sound decision that was in your best interest—that shouldn’t happen to you again.
Therefore, we will provide you with an honest review of your potential claim so that you can decide whether you want to join or move forward with a mass tort medical device lawsuit. If you do have a case against a medical device maker, then we will fight hard to get you the compensation for your past and future medical expenses, lost income, out-of-pocket costs, physical pain, emotional suffering, and other damages that you deserve.
Call us or start a live chat with us at your earliest convenience to schedule a free, no-obligation consultation with an attorney in our Natick law office.