Federal Preemption and Sudden Cardiac Arrest
23 February 2009, 2:00 PM EST
Over the last two years, the U.S. Supreme Court has heard a number of significant cases regarding preemption — the Constitutional principle that says federal laws “trump” state laws when state and federal laws conflict. While this may sound like an obscure issue for SCAA members, it has the potential to be extremely significant and influence the cost and availability of certain medical devices as well as the types of lawsuits that patients may bring.
Christopher L. White answered questions on the topic of federal preemption. White is the executive vice president and general counsel at the Advanced Medical Technology Association (AdvaMed). In 2007, he was the first recipient of the PricewaterhouseCoopers Award for Leadership in the Advancement of Ethics in the Medical Device Industry.
Read more about Christopher White
Transcript
Jess:
Can you explain the process that the FDA goes through to approve a medical device? Are there ways to improve the process, rather than changing the law(s)?
Christopher White:
Preemption applies to devices that have gone through the PMA process which accounts for less than 2 percent of devices approved by FDA each year. These devices undergo the FDA’s premarket approval (PMA) process of scientific and regulatory review evaluates for safety and effectiveness. This is the most rigorous device approval process undertaken by the FDA. In the PMA process, The FDA spends an average of 1,200 hours to review each PMA submission. Once a device is approved through the PMA process, the manufacturer is required to report annually to the FDA on any changes to the device and provide a summary of any new information about the device from scientific literature, unpublished reports and any other sources. Manufacturers must also collect and report all information on certain adverse events related to the device to the FDA.
The entire process for regulating and approving all medical devices is extremely complex; there are three classes of medical devices, and they are subject to different standards and varying methods of review.
The entire process for regulating and approving all medical devices is extremely complex; there are three classes of medical devices, and they are subject to different standards and varying methods of review.
Rebecca:
How do national physician groups such as AMA or ACC stand on preemption? Have they taken a position?
Christopher White:
National medical groups have generally not taken a position on the medical device preemption issue to date.
Lamont:
I have an ICD, but it is not one that has been the subject of recalls, etc. over the past several years. I have heard radio advertisements from law firms looking for people with ICDs to join class-action lawsuits. Under what laws are those people suing the manufacturer, and how would a change in the law impact that?
Christopher White:
If you have questions about the health information that you hear in a personal injury lawyer advertisement, consult with your doctor. Under no circumstances, should anyone make personal healthcare decisions solely based only on what you hear in an advertisement.
For decades, patients have been able to sue and recover damages from a medical device manufacturer. Nothing about the Supreme Court’s decision changed that fact.
Patients can recover damages if a product was manufactured improperly or if the manufacturer misled or withheld information from the FDA regarding the safety and effectiveness of the product.
The proposed law would allow patients to bring lawsuits against device manufacturers for risks warned against in the product’s FDA-approved label for devices that have gone through the PMA process which accounts for less than 2 percent of devices approved by FDA each year.
For decades, patients have been able to sue and recover damages from a medical device manufacturer. Nothing about the Supreme Court’s decision changed that fact.
Patients can recover damages if a product was manufactured improperly or if the manufacturer misled or withheld information from the FDA regarding the safety and effectiveness of the product.
The proposed law would allow patients to bring lawsuits against device manufacturers for risks warned against in the product’s FDA-approved label for devices that have gone through the PMA process which accounts for less than 2 percent of devices approved by FDA each year.
Gina:
I'm a manager with a local EMS agency. How does law apply to AEDs that are approved by the FDA? Most of the discussion was about devices for patients -- what about devices used by hospital and emergency medical agencies?
Christopher White:
Preemption applies to medical devices that have been through the Premarket Approval (PMA) review process, including devices that are used by healthcare providers, like AEDs. The FDA categorizes medical devices into three classes The PMA review process is for Class III devices which receive the highest level of scrutiny in order to assure safety and effectiveness. Preemption applies to devices that account for less than 2 percent of devices approved by FDA each year.
Cindy:
So my husband has an ICD with the Fidelis leads that were recalled. He's not had any problem with them. How does the law as currently written impact his legal rights? What about if Congress changed the law?
Christopher White:
While we can’t furnish you with legal advice, we can address the policy aspects of your question.
Since the Medical Device Amendments were enacted in 1977, patients have been able to sue and recover damages from a medical device manufacturer. Nothing about the Supreme Court’s 2008 decision changed that fact.
The proposed law would allow patients to bring lawsuits against device manufacturers for risks warned against in the product’s FDA-approved label for devices that go through the FDA’s most rigorous device approval process, and currently enjoy limited legal protection for submitting to this process.
If Congress changes the law, juries/courts essentially will establish separate device approval and labeling standards -- potentially for the same product.
Since the Medical Device Amendments were enacted in 1977, patients have been able to sue and recover damages from a medical device manufacturer. Nothing about the Supreme Court’s 2008 decision changed that fact.
The proposed law would allow patients to bring lawsuits against device manufacturers for risks warned against in the product’s FDA-approved label for devices that go through the FDA’s most rigorous device approval process, and currently enjoy limited legal protection for submitting to this process.
If Congress changes the law, juries/courts essentially will establish separate device approval and labeling standards -- potentially for the same product.
Sandra J.:
I understand the argument that the FDA has the expertise, but sometimes even the experts are wrong. We have people afraid to eat peanut butter, and last year, the FDA scared everyone about eating tomatoes when the they had nothing to do with the salmonella outbreak. Did the FDA file a petition with the Supreme Court? Have they testified in front of Congress or taken any formal position to elaborate on why the law shouldn't be changed?
Christopher White:
There is no institution, public or private, that can’t be made better— the FDA included. But for more than 30 years the current system for regulating medical devices has worked to balance patients’ needs for new treatments against the risks inherent in any device. The current law also provides for FDA-approved warning labels to ensure that patients and physicians can make informed decisions about the risks and benefits of every device.
Regardless of the recent food safety issues, the FDA’s decisions about medical devices are driven by valid scientific data. It is a process that cannot be replicated in a single state, or in any courtroom.
On behalf of the FDA, the Solicitor General filed the government’s amicus brief (a legal filing common in Supreme Court cases that allows individuals and organizations not directly involved in a case to share views with the Court) in support of upholding express preemption for PMA devices. The amicus brief argued, in part, that removing preemption will weaken FDA at a time when Congress has invested hundreds of millions of dollars to make the agency stronger.
Congress gave FDA the authority to oversee medical device approvals with the Medical Device Amendments of 1976.
Regardless of the recent food safety issues, the FDA’s decisions about medical devices are driven by valid scientific data. It is a process that cannot be replicated in a single state, or in any courtroom.
On behalf of the FDA, the Solicitor General filed the government’s amicus brief (a legal filing common in Supreme Court cases that allows individuals and organizations not directly involved in a case to share views with the Court) in support of upholding express preemption for PMA devices. The amicus brief argued, in part, that removing preemption will weaken FDA at a time when Congress has invested hundreds of millions of dollars to make the agency stronger.
Congress gave FDA the authority to oversee medical device approvals with the Medical Device Amendments of 1976.
That concludes our interview today. Thanks to Christopher White and all our participants. This has been a great discussion.
To learn more about this discussion, view the latest issue of Power Points HERE.
