The Medical Device Safety Act 2019 H.R. 2669

The Medical Device Safety Act 2019 H.R. 2669 #MDSA19

The Medical Device Safety Act of 2019 was introduced in the house on May 10, 2019. It is a bipartisan bill currently co-sponsored by Congresswoman Rosa DeLauro, Congresswoman Jan Schakowsky and Congressman Brian Fitzpatrick. The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to, essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants. This bill is identical to The Medical Device Safety Act of 2009 that Senator Ted Kennedy introduced after the 2008 Riegel vs. Medtronic ruling, which had 23 co-sponsors. Kennedy immediately recognized that the supreme court’s interpretation of the The Medical Device Amendment was inappropriate. However, when Kennedy passed away, the bill never went to vote.

There are hundreds of Class III medical devices currently on the market in the United States. Class III medical devices currently fall under federal preemption protection. This is due to the Riegel vs Medtronic supreme court ruling in 2008, when a United States Supreme Court case held that the preemption clause of the Medical Device Amendment bars state common-law claims that challenge the effectiveness or safety of a medical device marketed in a form that received premarket approval from the Food and Drug Administration. The same does NOT apply to Class I or II devices, or drugs!

What does this mean? It means that patients who are harmed by Class III medical devices have a very difficult, if not impossible, time pursuing litigation if injured, disabled, or killed by a Class III medical device. The manufacturers are, in essence, protected. Most Class III cases get thrown out on the grounds of Federal Preemption.

The purpose of this bill is to restore a patient’s right to litigation should he/she be harmed by a Class III medical device. Even decades after the FDA’s pre market approval of a Class III device, if it is proven to be ineffective or proven to cause harm, individuals still cannot hold the manufacturer liable for injury, even in the case of a recall. This bill would motivate manufacturers to withdraw or recall devices that were causing harm, or proving to be ineffective or defective. Currently, that is not the case, and without accountability, manufacturers have no incentive to fix a problem device. It would also promote that manufacturers remain innovative, continuing to correct or improve upon medical devices on the market.

We are asking for your support of The Medical Device Safety Act 2019, H.R.2669, as our representatives. Please consider co sponsoring in the House, or introducing/sponsoring in the Senate! We are hundreds of thousands of consumers who have been harmed by, disabled by, or lost a loved one to, a Class III medical device. We all deserve the same rights as consumers. Help restore our rights by supporting this bill! Thank you.

#MDSA19 The Medical Device Safety Act H.R.2669