Unveiling the Principles of Law during Public Health Emergencies
Moderator:Leticia R. Davila
Presenter:Heather Horton, JD, MHA
Date/Time:April 23, 2013 2:00 pm ET
NOTE:This transcript has not been reviewed by the presenter and is made available solely for your convenience. A final version of the transcript will be posted as soon as the presenter’s review is complete. If you have any questions concerning this transcript please send an email to email@example.com
Welcome and thank you for standing by. At this time all participants are in a listen-only mode. To ask a question during the question-and-answer session, please press star 1 on your touchtone phone. Today’s conference is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the meeting over to Leticia Davila. You may begin.
Thank you, (Julie). Good afternoon. I am Leticia Davila and I’m representing the Clinician Outreach and Communication Activity -- COCA -- with the Emergency Communication System at the Centers for Disease Control and Prevention.
I am delighted to welcome you to today’s COCA webinar Unveiling the Principles of Law During Public Health Emergencies.
We are pleased to have with us today Heather Horton to discuss underlying legal authorities that permit the government to take actions during public health emergencies.
You may participate in today’s presentation by audio only, via webinar, or you may download the slides if you are unable to access the webinar. The PowerPoint slide set and the webinar link can be found on our COCA page at Emergency.CDC.gov/coca. Click on COCA calls. The webinar link and slide set can be found under the call in number and call passcode.
At the conclusion of today’s session, the participant will be able to describe the state and federal government’s role in responding to a public health emergency, state the underlying legal authorities that permits the government to take specific actions and describe CDC’s legal response to specific public health emergencies -- including H1N1.
In compliance with continuing education requirements all presenters must disclose any financial or other associations with the manufacturers of commercial products, suppliers of commercial services or commercial supporters as well as any use of an unlabeled product or products under investigational use. CDC, our planners and the presenter for this presentation do not have financial or other associations with the manufacturers of commercial products, suppliers of commercial services or commercial supporters. This presentation does not involve the unlabeled use of a product or products under investigational use. There is no commercial support for this activity.
At the end of the presentation, you will have the opportunity to ask the presenter questions. On the phone dialing star 1 will put you in the queue for questions. You may also submit questions through the webinar system at any time during the presentation by selecting the Q&A tab at the top of the webinar screen and typing in your question.
Our presenter for today is Heather Horton. She is a Senior Attorney with the Department of Health and Human Services at CDC. She is a member of the Infectious Diseases and Terrorism Response Legal Team and primarily provides legal advice to CDC’s Office of Infectious Diseases, National Center for Emerging and Zoonotic Infectious Diseases and National Center for Immunization and Respiratory Diseases. She earned her undergraduate degree from Duke University, a Master of Health Administration from Tulane University School of Public Health and Tropical Medicine and her JD from the Ohio State University College of Law. She has been an attorney with CDC since 2000.
Again the PowerPoint slide set and webinar link are available from our COCA Web page at Emergency.CDC.gov/coca.
At this time please welcome Heather Horton.
Thank you, Leticia, and hello everybody. Thanks so much for participating. I am going to be talking for the next 45 minutes about recent public health emergencies and the public health response to such emergencies. And in particular I’m going to be talking about the government’s authority to act at all in a public health emergency situation.
The slide you’re looking at now shows some of the public health responses to some recent emergencies, potential emergencies or just potential public health situations for which there might have been an emergency.
And there really have not been very many, only a handful really of official legally declared public health emergencies. And those include a public health emergency declared on 9/11, a public health emergency declared in response to H1N1 and there was a public health emergency declared in response to Hurricane Katrina, among other things.
I’m sure that most of you on the call have heard about the recent situation involving a new influenza strain -- H7N9. H7N9 has not yet and hopefully will never be a public health emergency. But it is something that CDC’s paying attention to and I’ll talk a little bit more about H7N9 in just a few minutes.
Recent examples of CDC’s response to some public health challenges I just wanted to briefly go through some of these. Just during the year 2010 through 2011, CDC participated in more than 750 outbreak and field investigations in 49 states, 59 U.S. Trust Territories and 35 countries. CDC has helped to investigate just in 2011, 222 foodborne outbreaks.
And during H1N1 CDC helped prevent somewhere between 713,000 and 1.5 million influenza cases, 12,000 to 23,000 hospitalizations and somewhere between 620 and over 1100 deaths that CDC’s work helped to prevent.
As an example of public health emergency for which CDC issued a legal response, I’d like to talk a bit about monkeypox. Monkeypox is a rare viral disease. It’s related to smallpox but it’s much, much less infectious and a milder than smallpox.
Monkeypox was introduced into the U.S. in 2003 through a shipment of African rodents -- specifically giant Gambian rats. Believe it or not, there are people in the U.S. who like to have giant Gambian rats as pets. And in a minute I’ll show you what such pets look like and you can decide for yourself whether they would be something cute and cuddly or something to maybe be more fearful of.
In the United States, prairie dogs became infected by these rodents from Africa and prairie dogs therefore became vectors for transmitting the virus to humans.
So here is a picture of a Gambian giant rat. And so monkeypox is actually endemic to Gambian giant rats. It is not something endemic to the U.S., but what’s thought to have happened is that a shipment of African rodents were placed nearby a shipment of prairie dogs in the same pet store. And giant Gambian rats can easily spread monkeypox to prairie dogs and prairie dogs can pretty easily spread as we’ve learned monkeypox to humans.
And so the legal response to this monkeypox outbreak was that on June 11, 2003, CDC and FDA together issued a joint order announcing an immediate embargo on the importation of all rodents from Africa and prohibiting the transportation, distribution or release of prairie dogs and also other African rodents within the U.S.
Since then though this embargo has been lifted. And by the way, the reason it was a joint order is the way the legal authorities work. CDC is responsible for the importation of rodents and other animals and I’m talking about the importation from some place outside the U.S., where FDA is responsible for the interstate and intrastate transfer and sale and distribution of such rodents and other animals.
So there needed to be a joint order because it was CDC who had the authority to prevent the importation of rodents from Africa, but it was FDA who had the legal authority to prohibit the transportation, distribution or release of prairie dogs within the U.S. So that’s why there was a joint order.
The embargo though has since been lifted. Currently CDC’s embargo is still in place. Even today there is an embargo on the importation of all rodents from Africa. But the FDA embargo was lifted.
And currently if you in the U.S., if anyone in the U.S. wants to purchase or transport or distribute or release prairie dogs, there is no federal law that would prohibit that. There could be some state statutes that govern the sale or transport of prairie dogs -- which are also common pets it turns out. But there’s no federal law currently in place because this embargo was lifted.
And that makes sense because monkeypox is endemic again to giant Gambian rats and so the thought is if we prevent these giant Gambian rats from entering the U.S., then we’ll prohibit and prevent the spread of monkeypox because the monkeypox won’t then infect prairie dogs who would then infect humans.
So that is one example of the federal government’s legal response to a public health emergency. And monkeypox was never an officially legally declared public health emergency, but nonetheless it was still considered a public health emergency, (kind of the lowercase E).
So I want to talk now a bit more about CDC’s legal authority to respond to public health emergencies. I did just give an example of one of CDC’s legal authorities -- the legal authority to issue an embargo against the importation of giant Gambian rats. I want to talk about some additional authorities however.
So in general - and I need to talk about actually the U.S. Constitution before I get in to CDC’s authorities. In general, under the U.S. Constitution it is states not the federal government that’s primarily responsible for controlling disease spread within their borders and that’s because of the Tenth Amendment to the U.S. Constitution.
The U.S. Constitution states that the police power, that is the power to protect the health and welfare of citizens, rests with the states. And in fact all powers belong to state governments not the federal governments unless there is a specific enumerated power.
And the idea is that states have what is called plenary power -- P-L-E-N-A-R-Y. States have plenary power -- which means most or plenty of power -- and the federal government is a government of very limited powers and the federal government can only act in ways that are specifically enumerated or listed in the U.S. Constitution.
And you can read the U.S. Constitution as closely as you’d like and you will not find public health mentioned. Public health is not a power enumerated in the Constitution. It’s not a power given to the federal government. So then the natural question is well how does the federal government have any right at all to act or react or assist or take action to a public health emergency.
Well while states are primarily responsible for controlling disease spread within their borders because of the U.S. Constitution and the Tenth Amendment, the federal government is still responsible for controlling disease spread from foreign countries and also interstate and that’s because there are a couple of other clauses in the Constitution that give the U.S. federal government those powers.
There’s something called the Commerce Clause -- which allows the federal government to regulate and act in situations where interstate commerce could be affected. And certainly diseases being spread between states and of course the fact that state borders don’t really recognize diseases and because diseases do or can easily spread from state to state the federal government has a role -- a public health role -- in controlling disease spread between states because of this interstate Commerce Clause.
Additionally the federal government has what’s called the spending power or the power of the purse and that means that the federal government can issue grants, cooperative agreements, contracts. CDC as a federal agency can give away money to state governments with conditions placed on the use of such funds.
So the federal government can act by giving state and local governments or even private entities funds and the federal government can say if you would like these funds, then they must be used in the following ways. So that’s another way that CDC and the federal government in general can act in a public health emergency situation.
I want to talk now about legal authorities in general for the federal government or state government to act in a public health emergency situation. And first I’d like to talk about one very special case. The case is called Jacobson Massachusetts and I call it a very special case because it is almost universally considered the very first public health case that the U.S. Supreme Court ever decided.
It is the very first time that the U.S. Supreme Court ever opined on the government’s right to interfere with an individual’s liberties in a way that would be necessary to protect the public’s health.
And in this case, Jacobson versus Massachusetts, this involved Reverend Henning Jacobson and he was a gentleman who simply did not want to be vaccinated against smallpox. He lived in Massachusetts. At the time in 1905 there was a smallpox outbreak in Massachusetts and around the country.
Mr. Jacobson or Reverend Jacobson refused to be vaccinated and because of his refusal he was fined 5 dollars. Well he challenged that fine and he appealed and the case went all the way up to the U.S. Supreme Court. And the U.S. Supreme Court actually ruled that in a case such as this where there was an outbreak of smallpox that the public’s health and the public’s right to be safe from the disease of smallpox was more important or outweighed Reverend Jacobson’s right to be free from vaccination.
So this was a very important public health law case. And in fact there may not even be today an area of law called public health law but for this court decision -- which really kind of opened the doors very wide to allowing the government -- state government, federal government, government in general -- to take public health action even when such public health action might impinge or interfere with individual liberties and an individual’s right to be free from being touched for example by the U.S. government or by a state government.
In this case Reverend Jacobson was still he was fined 5 dollars. He had to pay the fine. There never was a question about whether or not the government could forcibly require Reverend Jacobson to be vaccinated. And actually even today in 2013 it’s unclear whether the government -- either the state government or federal government -- could forcibly require someone to be vaccinated or if that would simply going too far.
It’s not clear what a court would say and fortunately and we can all knock wood we’re not faced with that situation. But presumably if there was a disease scary enough, if there was a something like a reemergence of smallpox, a legal argument could be made that the government would have a right to forcibly compel someone to be vaccinated. It’s a possibility but that hasn’t been brought before a court yet, so it hasn’t been legally decided upon.
So the case of Jacobson versus Massachusetts, that’s an example of case law and case law means any law decided by a court -- a state or federal court. Another form of law is statutory law and statutory law means law passed by Congress or a state legislature or even in the case of regulations law passed by agencies.
Some examples of statutory laws that impact CDC and that allow CDC and the federal government to respond to public health emergencies are largely found in a statute called the Public Health Service Act.
The Public Health Service Act is a compilation of hundreds of smaller statutes that give CDC and other public health agencies at the federal level to take public health actions in emergencies and non-emergencies.
Section 319 of the Public Health Service Act for example allows the secretary of the Department of Health and Human Services to declare that a public health emergency exists. And we’ll talk in a few minutes about why that’s important -- why it’s important for the federal government to be able to make the determination of a public health emergency.
The federal government also by statute has quarantine authority and later in this presentation we’ll talk more specifically about what quarantine authority entails.
Another example of a statute that gives CDC specific authorities is Section 311 of the Public Health Service Act and this is the authority that allows the federal government to cooperate with state government to take public health actions in emergencies and non-emergencies.
And finally the Public Health Service Act Section 307 is the portion of the Public Health Service Act that allows the CDC and the Department of Health and Human Services generally to act internationally.
And I’m pointing out these four authorities -- the public health emergency determination authority, quarantine authority, federal-state cooperation authority and international cooperation authority -- just to add important examples. There are literally hundreds more but these are some of the major examples of statutory laws that allow the federal government and specifically CDC to take action in a public health emergency.
So I want dig a little deeper now in to what a public health emergency declaration means and this slide is titled 319 Public Health Emergency Declarations because it refers to Section 319 of the Public Health Service Act.
And this section of the law says that the HHS Secretary may declare a public health emergency.
So well what’s the big deal about a declaration?
Well before a declaration is made it first requires consultation with public health officials as necessary. That’s what the statute says. A public health emergency declaration is only in place for 90 days, but every 90 days it can be renewed so long as Congress is notified.
You still may be asking well what’s the big deal anyway, what’s the practical impact of a public health emergency declaration? Well once a public health emergency declaration is made, the HHS Secretary, now that person is Secretary Kathleen Sebelius, she may take such action as may be necessary to respond to a public health emergency.
There’s something called a public health emergency fund that may be made available to the Secretary. As far as I know however there is zero dollars in that fund right now. But there is a fund that exists and appropriations can be made. Congress can put money in to the fund if necessary and if there’s a public health emergency declaration, then the secretary can have access to those funds.
There are also certain options that the secretary can pursue once a public health emergency is declared. For example if there’s a Section 319 public health emergency declaration, the secretary may choose to waive certain sanctions that arise from noncompliance with HIPAA.
The secretary may choose to waive or modify provisions of EMTALA -- which is the Emergency Medical Treatment and Active Labor Act.
And also and this is new, this is a new section of the law that’s only been in place for a month or two, states may now, if there is a public health emergency declaration, states may requests the reassignment of individuals whose salaries are paid by the Department of Health and Human Services in order to work on matters related to a 319 public health emergency declaration.
If there is a public health emergency declaration and let’s talk about Hurricane Katrina as a good example of this, during the chaos that ensued after Hurricane Katrina there was understandably a lot of confusion, a lot of questions about where people were located, what hospitals were housing what people, family members were very worried about their loved ones and wanted access to information that hospitals might have about their loved ones.
Well the HHS Secretary said I’m not going to pretend that the HIPAA privacy rule doesn’t exist, but what I’m going to say is entities that are covered by the HIPAA privacy rule -- which would include health care providers and hospitals among others -- if they violate HIPAA, for example if they choose not to hand out these so-called notices of privacy practices -- which I’m sure we’ve all gotten dozens of over the last decade or so.
When we’ve gone to our local pharmacy or visited our local primary care physician, we’re handed a notice of privacy practices. Well that’s an administrative burden that technically if that action isn’t taken by a covered entity, they are violating HIPAA and they can be fined a lot of money.
Well during a public health emergency, it may not be very practical for a covered entity to be handing out notices of privacy practices. So the Secretary said don’t worry about that. Don’t worry about keeping confidential the list of all of your patients. If you violate the HIPAA privacy rule during this declared public health emergency, I am exercising my right to waive sanctions that arise from such noncompliance.
So that eased the minds of a lot of health care providers and a lot of hospitals in the aftermath of Hurricane Katrina who wanted to be able to share otherwise protected health information with family members. And they didn’t want to have to worry about the administrative burdens of HIPAA and they didn’t have to because of the Secretary’s decision to waive these sanctions.
EMTALA -- the Emergency Medical Treatment and Active Labor Act -- this is the statute that says if you are a hospital and if you have an emergency room, you must evaluate every single person who walks into your emergency room. And furthermore, before you transfer a person who walks into your emergency room, you have to stabilize them.
So EMTALA requires the evaluation and stabilization of anyone who walks into an emergency room regardless of the person’s ability to pay. And this is assuming that the emergency room accepts Medicare payments because the penalty for violating EMTALA is you’re cutoff from Medicare, so pretty stiff penalty.
Well during a public health emergency declaration the HHS Secretary can choose to waive or modify provisions of EMTALA. So for example hospitals can turn people away. So for example someone comes to a hospital emergency room with a broken arm but there might be a public health emergency involving some, you know, very scary infectious disease.
During a public health emergency declaration the Secretary can say hospitals instead of evaluating and stabilizing every single person who comes to your emergency room, you can transfer certain individuals in order to more effectively deal with the public health emergency at hand. And provisions of EMTALA were in fact waived and modified in the aftermath of Hurricane Katrina.
So those are just examples of some of the practical options pursuant to a 319 public health emergency.
So I’ve been talking about public health emergencies and I wanted to just show everyone a picture of what CDC’s Emergency Operations Center looks like. And CDC is very appreciative and thankful to Bernie Marcus. I don’t know if you know the name Bernie Marcus, but Bernie Marcus was one of the founders of Home Depot. Home Depot is based in Atlanta and Bernie Marcus actually funded the creation and establishment of this Emergency Operations Center.
Contrary to popular belief, even though CDC is a federal agency and even though for the most part we operate and exist because of taxpayer money, CDC has the legal authority to accept gifts and we do get an incredibly generous amount of private donations every year. And one example of how such private donations were used is in the creation of this Emergency Operations Center.
This Emergency Operations Center is activated or it’s not activated at any given time but it is staffed 24/7. And the reason for its existence during any given public health emergency people all around CDC, you know, and CDC has 10,000-plus employees, employees and contractors all around CDC might be called together to focus and respond to a specific public health emergency.
That’s when the Emergency Operations Center is going to be activated and this is what allows a group of subject matter experts and others to come together and work in one location to most effectively and efficiently respond to a public health emergency.
And even the CDC lawyers have a spot at the table in the Emergency Operations Center. We’re way in the back corner. You can’t even see where the legal office sits, but there’s always a lawyer who is present during a public health emergency activation just to answer any legal questions that come up and there always are numerous legal questions that do arise.
Turning now to an example of another public health emergency and here’s one where there was an emergency declaration made under Section 319 of the Public Health Service Act. I want to talk for a few minutes about H1N1 -- which happened during 2009, 2010. Most of you on the phone probably remember it.
Up in the right-hand corner of this slide, you’ll see what a public health emergency declaration actually looks like. It’s not really a big deal. It’s just a sentence or two.
When H1N1, when it first became apparent that this was indeed a public health emergency, we had an acting HHS Secretary and that was Charles Johnson and he’s the one who issued this determination that a public health emergency exists.
CDC responded legally to H1N1 in a variety of different ways and used different legal instruments to do so. And before we go in to some of these legal instruments used, I do want to and I mentioned earlier on the call that I would say a bit more about H7N9, H7N9 is a new strain of bird flu and it’s been found in birds and people in China.
Currently as we speak there is no ongoing person-to-person spread of this virus, nothing like that has been found at this time. But CDC nonetheless has started responding. CDC is working to develop a vaccine candidate virus that could be used to make a vaccine if it’s needed.
But right now at this moment there are no cases of human or bird infection within the U.S. So at this time the risk to people in the United States is considered to be low. But it is possible that human cases of H7N1 flu will be found in the U.S. and right now it’s thought that the most likely scenario would be that H7N9, that that infection would happen in a traveler from China.
So it remains to be seen. But if H7N9 becomes a problem and if it starts becoming easily spread from person to person, then CDC will take a more active role in the response -- including responding possibly in ways similar to how CDC responded to H1N1.
So during H1N1 CDC relied on the international health regulations to react and also to something called the PREP Act or the Public Readiness and Emergency Preparedness Act and I want to talk about what those mean.
The International Health Regulations it is a legally binding document. There are actually no sanctions in place for violating the international health regulations and yet the U.S. government voluntary agreed to be legally bound by these regulations.
And these regulations were - they’ve been in place actually since 1969 but they were in a very major way amended by the World Health Organization in 2005 and they were amended in 2005 to address so-called public health emergencies of international concern.
So what is a public health emergency of international concern? Well it’s considered an extraordinary event that constitutes a public health risk to other countries through international spread of disease and also that potentially requires a coordinated international response.
There’s a list of diseases actually leading to immediate notification and that list includes smallpox, SARS, wild polio virus and any new subtype human influenza.
I’m going to speed up a little bit now just in the interest of time. I have several slides on the international health regulations, but I’m just going to sort of hit the highlights so that we can move on and finish in a timely manner.
I will say that the World Health Organization took certain actions and CDC also responded consistent with the international health regulations to H1N1. Specifically back in April of 2009, CDC issued a travel warning warning U.S. travelers to avoid any nonessential travel to Mexico. That was something that was based on WHO recommendations.
Moving on to another statute that CDC relied upon to respond to H1N1, there’s a law called the PREP Act. That stands for the Public Readiness and Emergency Preparedness Act. I think I mentioned it briefly a few minutes ago. I want to talk about in a bit more detail now.
This is a law that was signed by the President in December of 2005. It authorizes the Secretary of Health and Human Services to issue a declaration to provide immunity from liability except for willful misconduct for certain claims. And those claims include things like death, physical, mental, emotional injury, even business interruption so long as these claims are causally related to the development, distribution, administration or use of so-called covered countermeasures. And this immunity from liability protects so-called and it’s defined in the law covered persons.
So that’s one very important component of PREP Act, that it provides immunity from liability, and I’ll talk in a minute about what that means.
The second major component of the PREP Act though is it does authorize an emergency fund in the U.S. Treasury for compensation for injuries from covered countermeasures. So if someone is injured by an action taken by the U.S. government or by a covered person, then there is still a way for an injured person to be compensated. They just don’t have the right to sue the person or entity who actually caused the harm so long as the harm wasn’t from willful misconduct, so long as it was just something called a tort or basically an accident or something that was caused by negligence.
So the PREP Act protects from individual liability manufacturers, distributors, program planners, qualified persons, officials, agents and employees of all of these above named entities and also the U.S. government.
Covered countermeasures include qualified pandemic or epidemic products, security countermeasures, any product authorized by the FDA under an emergency use authorization or an EUA and even additional products that are still to be determined actually may also be covered.
During H1N1 there were declarations made for antivirals -- including Tamiflu, Relenza and also I believe Peramivir. There were PREP Act declarations for influenza diagnostics, personal respiratory protection devices and respiratory support devices and very importantly and so important that I’m going to take a few minutes to focus on this last one there was a PREP Act declaration for the H1N1 vaccine.
So I want to talk now about the scope of the PREP Act and I’m talking about the scope of the PREP Act specifically regarding the H1N1 vaccine.
There was actually a lawsuit brought and the case has now been decided and it has been fully decided. In other words, the time for appeal has even run out, so it is done. And this case answered the question does the PREP Act protect persons who accidentally administer the vaccine, meaning the H1N1 vaccine, to a child without her parents’ consent.
So now I want to tell you a story. There was a young girl. Her name was Madison Parker. Madison Parker was a kindergartener in the St. Lawrence County school system. And Madison Parker was vaccinated when she shouldn’t have been.
And what happened was in Madison Parker’s kindergarten class there were actually two little girls named Madison. One Madison was present on a particular day and one Madison was absent. Well a nurse came down to Madison Parker’s classroom and called for Madison -- Madison Smith or I don’t know the other Madison’s last name. But she called for Madison somebody. It’s time for you to be vaccinated.
Instead Madison Parker stood up hearing Madison and knowing her name was Madison. She was a kindergartner and wasn’t paying attention to the last name. She followed the nurse down to the school clinic and she was vaccinated without her parents’ authorization. And in fact her parents had chosen, they had made a deliberate decision, not to have their child, Madison Parker, vaccinated against H1N1 and yet she was vaccinated anyway.
So her parents brought an action in state court alleging negligence resulting in battery upon the student. And battery sounds a lot worse than it really is. It’s really a legal term that just means being touched really without your consent.
So the public health department in the school claims that the PREP Act vests exclusive subject matter jurisdiction in the federal government over all claims having a causal relationship with the administration of the flu vaccine during this vaccination program.
The judge disagreed. The judge said that the purpose of the act was to protect administrators from liability for adverse physical reactions to the vaccine but surely the PREP Act was not meant and could not protect against the intentional or negligence unauthorized administration of a vaccine.
This was a decision that really devastated the public health community. Well the St. Lawrence County Public Health Department filed an appeal. The Department of Health and Human Services of which CDC is a component agency filed what’s called an amicus brief or a brief, a friend of the court brief it’s called arguing that the PREP Act indeed should protect from liability the public health department and school.
And what happened then was that the appellate court concluded that the plaintiff’s state law claims, so Madison Parker’s state law claims, were preempted by the PREP Act and therefore the complaint was dismissed. And preemption is this concept that if there is a federal law that is in direct conflict with a state or local law, then the federal law wins essentially.
The PREP Act statute itself says that it preempts any state law that might be contradictory and under the U.S. Constitution’s so-called Supremacy Clause any federal law that directly conflicts with a state law is going to be superior. The federal law is going to take precedence over the state law.
So the complaint was dismissed and that was that and the case went away and this was a very, very good decision for public health.
And by the way, just as an aside, there was never a claim or never an allegation that Madison Parker suffered any physical harm or physical injury whatsoever from the vaccine. Rather it was the claim was just she experienced a battery because she was inoculated against H1N1 without her parents’ consent.
Moving on and needing to speed up because I recognize we are running out of time, I want to talk a little bit more about quarantine. I’ve touched on it but I want to get a little bit more in to the meat of it.
Quarantine under the U.S. Constitution is a very interesting thing because as we’ve talked about state and local governments have primary responsibility for public health and that’s because public health is a police power retained by the states under the Tenth Amendment. We talked about this a few minutes ago.
The federal authority to quarantine or take any other public health action is derived from the constitutional authority to regulate foreign and interstate commerce and also among the Indian tribes.
Several quarantine authority is actually also given to the U.S. government and specifically to CDC in the U.S. code -- which is part of the U.S. Public Health Service Act -- which is codified or made part of the U.S. code -- at 42 U.S.C. Section 264.
And this gives specifically CDC the authority to apprehend, examine and conditionally release individuals for the purpose of preventing communicable diseases that are specified in an executive order.
Now currently there are only nine such diseases. There are literally only nine diseases for which the federal government -- specifically CDC -- can quarantine someone and that would be cholera, diphtheria, infectious TB, plague, smallpox, yellow fever, viral hemorrhagic fevers and that would be like Ebola, also Marburg, Lassa, SARS and also influenza that are pandemic or could become so.
So there is this statute, there’s an executive order that actually lists the diseases and there are regulations and the regulations I think I mentioned that a regulation is a type of law passed by federal agencies. And in this case there are regulations found in the code of federal regulations Part 70 and 71 of Title 42. Part 70 concerns domestic interstate quarantine and Part 71 concerns travelers seeking entry into the U.S.
And I want to end here and I know it feels like a bit of an abrupt ending but I’m really hoping that this last 45 minutes or so that we’ve talking has at least given everyone a taste for the legal basis for the government’s response and particularly for the federal government’s response to public health emergencies. And now I am more than happy to take questions.
Thank you so much. We will now open up the lines for question-and-answer session. And also remember you can send questions through the webinar system.
And we actually do have one from the webinar system. It’s a question relating to health clinics on sovereign tribal lands, “Are they required to report communicable disease to public health
authority or do they exempt from reporting? And if they are required, which agencies have the authority to enforce them to be compliant to report communicable diseases?”
That is an excellent question and would you repeat just the very beginning of it. Did it have to do with health clinics on tribal lands? I didn’t quite get that part.
Yes on tribal lands, if they are required to report communicable diseases to the public health authority or are they exempt from reporting.
That’s an excellent question and unfortunately I have to defer because I’m not sure of the answer to that. CDC has a sister agency called the Indian Health Service and HIS, or the Indian Health Service, they have a group of attorneys who are experts in this area. And I am actually not sure of the requirements of health clinics on tribal lands to report communicable diseases. I’m just not sure. I’m sorry.
Okay. Thank you. Operator?
To ask a question over the phone, please press star 1 and record your name. One moment please. Your first question comes from Dr. (Norman Castel). Your line is open.
I was wondering if the PREP Act protects us from liability for the day or two that we’re working prior to the formal declaration of a health emergency.
Oh that’s an excellent question. I’ll answer that in two parts. First of all, there can be a PREP Act declaration completely independent and separate from a public health emergency declaration. So there can be a PREP Act declaration made if the Secretary thinks that something might possibly turn into a public health emergency. There doesn’t activity have to be an emergency in existence at the time. And a PREP Act declaration exists, and liability protections exist, for as long as the declaration itself says it shall exist.
So I hope that answers your question. It’s not - the key is the liability protections afforded by the PREP Act are not actually tied to an actual public health emergency. The key is has the HHS Secretary made a PREP Act declaration for a specific product. So there currently is a PREP Act declaration for H1N1 for antivirals for the H1N1 vaccine, for influenza diagnostics.
So every time a declaration is made -- a PREP Act declaration is made, not a public health emergency declaration -- at that point the liability protections exist.
Dr. (Norman Castel):
Okay. We plan - I’m with a Medical Reserve Corps through my county health department and we train to start working in an emergency such as dispensing antibiotics or giving vaccines while we’re waiting for the declaration to be made. So that I think helps. Thank you.
And just to follow up then, at this moment in time, there is no PREP Act declaration that would protect you. You may be protected from liability under some other statute, like for example there are Good Samaritan statutes that exist and there’s a federal Volunteer Protection Act statute, there are other state and federal laws that may currently be in existence to protect you from liability as you’re planning for an emergency.
But there is not currently any PREP Act declarations in place that would deal with the antibiotic situation that you’re referring to.
Well that’s good. We don’t a real emergency at the moment.
That is good. You’re right.
Dr. (Norman Castel):
All right thank you.
There are no other questions at this time.
We do have another question that came through the webinar. Has there been any PREP Act litigation other than the New York case that you mentioned?
There has been one other case. It’s not nearly as well known and it’s currently still working its way through the court system. It’s a case called Keller versus Hood. This is a very new case. It came about in 2012.
And in this case the plaintiff alleged that the physician and her employing hospital were negligent in failing to obtain the adult patient’s informed consent and a consult from a special prior to the administration of the vaccination and I’m talking about the H1N1 vaccination.
And this resulted in a severe case of something called transverse myelitis and if I’m mispronouncing that, pardon me. Remember that I’m an English major attorney not a doctor or scientist, so I could be mispronouncing that.
But there was also a claim of loss of consortium to the spouse. The defendants -- which were the hospital and the physician herself -- the defendants brought a third-party product liability failure to warn claim against the manufacturer of the vaccine.
The parties in the case did not dispute that the manufacturer of the vaccine was protected. The manufacturer was protected from liability with the PREP Act. The parties also did not allege that the defendants engaged in any willful misconduct. And because there was no willful misconduct and because the manufacturer of the vaccine was clearly protected by the PREP Act, the Federal Eastern District Court of Missouri, who heard the case -- again this happened in Missouri -- the Federal Eastern District Court is Missouri -- dismissed the claim against the manufacturer.
The court found that it had no jurisdiction though over plaintiff’s remaining claims and so the federal court then remanded the case to another state court for further consideration of the plaintiff’s claims. So stay tuned. But the way this case is looking, it is again looking like the PREP Act’s purpose is going to be fulfilled and the PREP Act will indeed protect from liability the physician, the hospital and the manufacturer of the vaccine.
At the same time, if there were a true injury to the plaintiff, there is this compensation fund that the PREP Act established. So it’s not that the injured parties might not be able to be compensated. They simply won’t be able to be compensated by suing successfully the physician, the hospital or the vaccine manufacturer.
So that’s the other PREP Act case and the only other PREP Act case that I know of.
You have another phone question. (Fred Buckman) and (Pam Camry), your line is open.
Okay. Hi can you hear us?
Okay great. We’re at UC Berkeley. We had a question if in the event a catastrophic earthquake or similar type disaster, would there need to be a declaration of emergency or a PREP Act declaration for us to be able to release to campus officials the extent of injury of patients, possibly names of patients, names of deceased and would the declaration of emergency or PREP
Act give us the freedom to do that and would that have to be done at the federal level, at the state level, both?
Okay. So that’s a great question and I think really you’re mostly referring to HIPAA I think, is that right?
Are you worried, are you concerned about the HIPAA privacy rule in particular?
Yeah, well HIPAA in particular and we’re also governed by FERPA. But we have, you know, these debates when we go through these drills about what we can release and what we can’t and need some guidance.
Sure. No I understand that. In a catastrophic emergency like you’re talking about, there is an exception in the HIPAA privacy rule. I’m sorry that I’m not as familiar with FERPA. But HIPAA, the HIPAA privacy rule does have a provision that allows for the disclosure of otherwise protected health information in the event of a public health emergency.
Now I don’t have the HIPAA privacy rule language in front of me, but I do want to refer you to a Web site. If you go to HHS.gov and then look for the Office for Civil Rights, the Office for Civil Rights is in charge of interpreting and enforcing the HIPAA privacy rule. And they have a gazillion Q&As -- including a lot of Q&As on emergency situations and what information can be shared or not in an emergency.
So again it’s the Office for Civil Rights -- which is within the Department of Health and Human Services -- and that is the component of HHS that can answer your question and that actually probably already has answered that question. And I bet you’ll find that question or one that’s very similar on the Office for Civil Rights Web site.
Great. Thank you very much.
Operator, we have time for one more question please.
Actually at this time there are no questions in the queue.
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