The FDA Has A “Free Card” When It Comes To Liability

How many of you are familiar with the case Riegel v. Medtronic? If we had to guess, we would say that very few, if not all of you, have never heard of this case before. But its implications are exponential when it comes to medical device companies getting a “free way out” in terms of any legal liability when their products malfunction.

Sure, you could Google this case, but it would most likely be explained with a bunch of legal jargon that would just leave you more confused than before you opened your browser. So allow us to take the time to break it down for you in a way that you can coherently follow, just to see how serious this issue really is.

Back in 1996, Charles Riegel was having angioplasty surgery, when a catheter broke while still inside of Riegel’s artery. This burst caused complete heart blockage, and Riegel lost consciousness. Riegel was put on advanced life support and emergency coronary bypass surgery, but survived.

Riegel, along with his wife, filed a product liability claim against Medtronic, Inc., the manufacturer of the defective catheter.

However, this lawsuit was dismissed by a federal district court, because of the fact that the Medical Device Amendments (“MDA”) preempted their claims. What this really means is that the MDA does not allow for state courts to impose any requirements in regards to medical devices that receive premarket approval from the U.S. Food and Drug Administration (FDA), since the FDA is a federal agency.

Because Riegel’s complaint would include state law, the court, in hearing this case, would basically be pushing FDA power aside. However, the whole point of preemption is to accept and acknowledge a “hierarchy”, if you will, of controlling laws.

In the United States, all federal laws trump all state laws. This is a Constitutional provision, which establishes one court system (the United States Supreme Court), and allows for – but does not mandate – each individual state to create their own ways of governing their residents. These laws are not mandated, so they could never trump federal laws. Since the FDA (a federal-run agency) trumps state law, the court could not rely on state law, and thus, they had no choice but to dismiss the lawsuit.

State requirements are preempted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law.

This case was brought before the U.S. Court of Appeals of the Second Circuit after the federal district court dismissed the suit. However, the Court of Appeals affirmed the dismissal. The Riegels then appealed to the U.S. Supreme Court, the highest court system in the country.

Mrs. Riegel was substituted as the plaintiff upon her husband’s death. She argued that although Congress allowed for the FDA to regulate medical devices, it was never meant to prevent citizens from suing manufacturers for their negligence.

Under federal law, the catheter in question here, the Evergreen Balloon Catheter, was considered a Class III medical device. If the FDA imposes device-specific requirements on a Class III device (which they currently have the authority to do), the states are prohibited from imposing additional or differing requirements without approval beforehand.

A medical device is ranked as a Class III medical device when it poses the greatest risk of serious injury to the consumer. Because of this high risk, the FDA must approve these devices via the premarket approval (“PMA”) process, which is the FDA’s most rigorous testing protocol.

The U.S. Court of Appeals for the Second Circuit ruled that the FDA did impose such a device-specific requirement on the Evergreen Balloon Catheter. Their reasoning was that the damages that would be awarded to the Reigel’s if they won would equate to a state “requirement” which was different from the FDA requirements. Essentially, that would mean that the state laws were favored over the federal laws, which cannot happen, since federal law preempted this lawsuit.

Riegel’s widow claims that preempting the lawsuit at such an early stage in the litigation is unlawful and unjust, since there are significant areas of debate to be addressed should this case continue to trial.

For instance, the defendant, Medtronic, can escape liability by proving negligence by the doctor who performed the surgery, as there is significant debate as to whether the doctor inflated the catheter past its limits, or whether the catheter was just defective.

Here comes the scary part: the United States Supreme Court affirmed the judgment of the United States Court of Appeals, siding with Medtronic. This means that any patients injured by a medical device that received FDA premarket approval would be prevented from bringing action in state court.

This leaves injured consumers with no legal action in court, and manufacturers immune from liability for their defective products. THIS IS HUGE!!! If you truly understand what this article set out, then you can understand how faulty this system really is.

The reason we broke this down for you is because earlier this week, we broke news about Bayer’s Essure, the permanent birth control procedure, and its devastating side effects.

Women forced to undergo hysterectomies, developing softball-sized abscesses, and abdomen infections. Women who may have died, or bled, or had ectopic pregnancies as the result of taking this product, and its unwarned dangers. And what can these women or their widows do about it? NOTHING!!!!

Is this fair? Is this justice? Is this really what the government was looking to do in establishing preemption? Who can be held accountable? How can we change this flawed system? Hopefully after reading this blog, these are some of the questions going through your head. But more importantly, we hope that in reading this article, you share this knowledge with your loved ones, with your friends, coworkers, etc., and pose a serious question: before undergoing this surgery or procedure or taking this drug, do you really have any way of holding someone accountable if things go wrong? Often, the answer will be “no.” If this doesn’t sit well with you, we encourage you to call your congressperson or senator to have this bad law changed.

Feel free to leave comments on this blog post. For more information, contact a Gacovino Lake attorney at 1-800-246-HURT (4878).

Related Posts