Possible Nullification of Medical Device Preemption

Defective Medical Devices


After the Supreme Court made the cynical decision last February to disallow patients from suing the manufacturers of faulty medical devices, thousands of consumers found they had no recourse for compensation in the event of an injury or death that could be blamed on these products. This decision for preemption, trumpeted as a success by the Bush administration, has now found itself caught up in the sea-change going on in Washington. This is because several Democratic senators are looking into ways to nullify the decision. Both these senators and consumer rights advocates believe that the FDA’s inability with keeping dangerous products off the market – something we’ve seen again and again – as well as the Supreme Court leaving victims and their families powerless has no business being law.

The company whose name comes up time and again in news about preemption is Medtronic due to the manufacturing of flawed heart devices, in particular the leads on implanted defibrillators. It was found that these leads could fracture, causing either a shock to the patient, or denying them a life-saving jolt when they needed one. What’s more, these devices were never tested on human patients prior to their introduction to the market. This is something the FDA allowed, though they knew there were no tests prior to giving it the green light. As a result, over two hundred thousand patients were carrying around these defective parts. Medtronic also knew that at least five patients died as a result of the defective lead. So, they issued a recall.

However, for some patients, even having the lead removed was risky. This is because the lead’s cables are threaded through blood vessels and can become ingrown. Ideally, the faulty lead would be disconnected and a new one placed along side it to minimize any risks, especially in older patients. If there are mistakes made in the surgical removal, the thin cables can puncture the heart, causing a patient to bleed to death. If this happens, the victim’s family should have the right to receive compensation from both the doctors who made the mistake, as well as the company who manufactured the device in the first place.

Predictably, the thought that Congress may overturn the Supreme Court’s decision has the manufacturers, their lobbyists, and conservative legal groups concerned. They seem to believe that this will “undermine” the FDA’s decision. A device industry trade group called the Advanced Medical Technology Association believes the FDA is the right federal agency to be making decisions to set safety standards, and that overturning preemption will allow juries “to second guess” the FDA and “stifle product innovation.”

What this comes down to, regardless of what trade industry groups and their companies think about product innovation, is simply allowing the families of those who have been severely injured or killed as a result of faulty medical devices the chance for justice. This is certainly an area where punitive damages should be considered, but it is also an area where young children, widows and widowers should be able to know their futures are a little more secure because the government actually cares about its citizens.


Related articles:

This law review article dealing with preemption and the ability of generic drug manufacturers to update their labels - scholarship.shu.edu

This article explores the scope of FDA jurisdiction and the relationship between the FDA and states - papers.ssrn.com

This law review article explores whether the courts have given the FDA too much deference - scholarship.law.edu