Jennifer Anton | 00:05
Hi everyone, I’m Jennifer Anton and today we are focusing on the subject of pharmacists, specifically criminal charges against pharmacists. Our guest today is John Helms. John is a criminal defense lawyer from Dallas, Texas, who’s tried multiple criminal cases involving pharmacists. John is also a former federal prosecutor From Dallas who never lost a trial or an appeal as a prosecutor. So he knows a lot about both sides of these federal criminal cases. Welcome, John.
John Helms | 00:41
Thank you. Thanks for having me.
Jennifer Anton | 00:42
Thanks for being here. So John, pharmacists, stays a complicated web of legal challenges, which can include regulatory penalties, civil lawsuits, criminal prosecutions. Can you explain how all of this works together?
John Helms | 01:01
Sure and it’s absolutely correct that it is a complicated world that pharmacists face. First of all, obviously, you have your state licensing authority. In Texas, that’s the Texas Board of Pharmacy. They license pharmacists and if they believe that a pharmacist has done something improper they can fine them, they can suspend their license, or they can completely borrow them from practicing pharmacy, and then there are other things in between.
So the State Board of Pharmacy can investigate you. In order to dispense controlled substances, a pharmacist has to have a license from the U.S. Drug Enforcement Administration, the DEA. They can take action against a pharmacist that they believe should not have their DEA license for any type of improper conduct. So those are the main regulatory bodies that are going to affect pharmacists.
On top of that, you have Law enforcement at the state level in Texas, the Attorney General’s office, and they can bring civil or even criminal actions against pharmacists. And others and pharmacy companies for violating state laws. And then on top of that, you have the federal government and they can bring civil lawsuits against pharmacists. Pharmacy companies and criminal prosecutions against them. So the difference between a civil lawsuit and a criminal prosecution is that in a civil lawsuit, the state or the federal government is trying to either Okay. Pharmacist or pharmacy company to pay fines and or to shut them down or to require them to change their practices, but nobody’s going to go to jail. In a criminal prosecution, people can go to jail. So that’s kind of how they all fit together.
Jennifer Anton | 03:18
Okay, so just this year, we’ve seen pharmacists sentenced to really long prison terms in federal cases. One of those cases involved over $13 million in healthcare fraud, and one involved $110 million in federal billings in a kickback scheme. What can you tell us about those cases and the kinds of situations where pharmacists can be prosecuted for federal crime?
John Helms | 03:48
So the two cases you mentioned are important. The $13 million case was from a federal court in Arizona, and it was just a straight up fraud case. The pharmacists were billing federal medical programs like medicare or prescriptions that they were not filling. So they are billing and they are not filling. That’s pretty obvious. And so there were prison terms in that case.
The second one, the kickback case was from the Southern District of Texas in McAllen, which is right down on the international border and that was a situation where a pharmacist hired some people to be marketers for the pharmacist and what they ended up doing was they gave kickbacks to doctors to prescribe medication through this one particular pharmacist. And so they got some lengthy prison terms as well.
Besides those types of cases, just fake filling of prescriptions and kickbacks another common type of federal prosecution is the so-called pill mill case. This is where people use a complicit doctor to get access to lots of controlled substances that they can then sell on the street. There are certain types of medications, especially pain medication, that have street value. And there are some unscrupulous people out there who will try to work with doctors to get them to prescribe large amounts of these types of drugs. And examples are Hydrocodone. Xanax. Promethazine with codeine, promethazine is a cough syrup. These types of drugs can be sold on the street. And so people will often recruit patients to go to a doctor’s office. The doctor will write them a prescription after barely seeing them, if at all. And then the prescriptions will be sent to a pharmacist to fill. Then the people will go up, the fake patients will go up and pick up their prescriptions at the pharmacist and then give them. To the person running the scheme who will then sell them on the street for a profit. So pill mill cases are very common.
Jennifer Anton | 06:30
So, I understand there was a recent Supreme Court case even involving pharmacists and it affects the criminal prosecution of pharmacists. Can you tell us a little bit about that case?
John Helms | 06:43
Yes, that’s a case called United States versus Ruin. And that case involved doctors. But it applies as well to pharmacists. And, The ruin case involved doctors prescribing medication. And the government claimed that these doctors, these two doctors that were involved in the case, were prescribing illegitimate prescriptions along the lines that I just described.
And the issue in the ruin case was that, what type of state of mind? Does the government have to prove to show that pharmacists or doctors are acting illegally? So let me step back for just a second. The way that these cases are prosecuted. Is that under the Controlled Substances Act, It’s illegal. To distribute controlled substances. However, there is an exception if they are authorized by law to be distributed. So the types of drugs we’re talking about, like hydrocodone and Xanax, those are controlled substances. Now, it is okay to distribute them if it is legally authorized. And there are federal regulations under the federal statutes that say that doctors and pharmacists, are authorized to distribute controlled substances, if they meet the legal requirements for licensing and things like that, and if the prescription is for a legitimate medical purpose in the course of an ordinary medical practice.
So, in that situation, you can, if you’re a pharmacist or a doctor, you can distribute controlled substances. Well, if you are filling a prescription as a pharmacist, and it is not for a legitimate medical purpose. And not in the regular course of medical treatment, then it’s not authorized. And so it’s illegal. – So if you’re being prosecuted for doing that, To what extent do you need to know that the prescription is not for a legitimate medical purpose and not in the ordinary course of regular medical treatment. How do you know as a pharmacist or how does a doctor know, that it’s an illegal prescription.
Well, The Supreme Court in the Ruin case said that in order to be convicted of a federal crime of illegally distributing controlled substances, you have to show that the doctor or the pharmacist intended or new that the prescription was unlawful. So, that was a victory or pharmacists because in many situations the government tried to convict pharmacists based on the idea that Objectively, a reasonable pharmacist should have known that this was unlawful. But the Supreme Court has said that is not enough. It’s not an objective standard. The individual pharmacist has to intend or know that it is an illegal prescription. So, that is what the Ruin case did and that is very significant in terms of federal prosecutions.
Jennifer Anton | 10:31
So that’s a higher burden for the federal prosecutors that to have to prove, how do you think that they are going to going forward prove these pharmacists are guilty?
John Helms | 10:43
Well, I think that they’re going to do it in the same way that they’ve done it before. I think the type of proof will be very similar. The Supreme Court in the Ruin case said that you can prove the level of knowledge that’s required by circumstantial evidence. So in a typical pill mill prosecution, the government is going to have witnesses that include the fake patients, who may have been recruited to go to a doctor and get prescriptions that they didn’t really need.
They’ll have them describe how they were recruited, what the doctor visits were like, how the doctor barely even saw them, and then how the recruiter would take them over to the pharmacist and get the drugs, and then they would just give them to the recruiter. Then they’ll have the recruiter who’s going to testify about how they went out and got people to participate in this, go to the doctor’s office, and then how they would work with the doctor’s staff to bring in lots of people at once. And it was kind of a wink-wink situation with the doctor’s staff. They may even have the prescribing doctor testify, although most of the time the doctor is not going to plead guilty and will probably go to trial and have a jury prove their guilt or lack of guilt. And they’re going to have, they’ll have an agent.
Like an FBI agent or a DEA agent who’s going to testify, but they’ve looked at all the pharmacist records and they have seen lots and lots of indications that the pharmacist had to know that what the doctor was doing was not in the course of regular medical practice and was not for legitimate needs. So they will continue to do that, but the jury’s going to be told, the government has to prove beyond a reasonable doubt that the pharmacist intended or knew that the prescriptions were illegal.
Jennifer Anton | 12:57
So as a criminal defense attorney, what are some of the biggest misconceptions that pharmacists have about criminal prosecutions?
John Helms | 13:06
Well, there are a couple. The biggest one that I’ve seen, and this applies mostly the pharmacists who may have been trained and gone to pharmacy school 25, 30 years ago or more. They were typically trained that you don’t second-guess a doctor. And that you should fill the prescription and let the doctor decide whether things are medically necessary. Nowadays, the world is different. And pharmacists clearly have a duty to check and look for red flags. That’s the term that they use. They’re required to look for red flags to see whether the prescriptions really look legitimate or not. And that is what is called the corresponding duties. That pharmacists have.
The regulation, the federal regulations speak of the doctor’s duty to make sure that the prescriptions are for a legitimate medical purpose and in the regular course of medical treatment. And then they say that a pharmacist has a corresponding duty. To make sure that they are using their judgment and their knowledge to help verify that those things are true. So Pharmacists can’t just rely on the fact that a doctor issued a legitimate prescription or what appears to be one. They have to go behind that and they have to make checks for indications that something could be wrong. So that’s the first misconception.
The second major misconception is that before you can be criminally prosecuted, that there has to be some sort of action taken on your license and The State Pharmacy Board has to suspend you. The DEA has to suspend your license. That there has to be some action like that before you can be criminally prosecuted. And that’s just not the case. If the government… Can prove that you have violated the law beyond a reasonable doubt. That can be done without any type of action. On your license. Now, in a trial, you can try to persuade a jury that there are licensing authorities that have never taken action against you. And that’s an indication that you didn’t know anything was wrong. If something was wrong, Well, presumably the licensing authorities would have done something about it. So you can make that argument, but it does not prevent a criminal prosecution. So I’d say those are the two biggest ones that I see.
Jennifer Anton | 16:08
So can we go back to your point earlier about what pharmacists can do to make sure they’re not filling illegal prescriptions? Can you give pharmacists out there some examples of what that might be?
John Helms | 16:21
Sure. First of all, let’s talk about some of the common red flags that the government sees. Now, these are things, pharmacists should have checklist of these types of red flags that they get from the state pharmacy. There is a document in Texas that’s called, you might be a pill mill if, and then it has a list of things that you should look for.
So let me talk about some of them. One is, a doctor prescribing High opioid doses and high quantities of opioids. So if a doctor’s prescriptions include the highest strength and large quantities of opiates consistently, that can be an indication that maybe this is not something that is being tailored to the individual patient’s needs and it’s really more tailored to the street value of it. Another thing that you can look for, a red flag that’s common is a combination of drugs of abuse being prescribed to lots of patients. And so the drugs of abuse that often go together in combination are an opioid and then a benzodiazepine, which is like a sedative, like Xanax, and a muscle relaxant like Soma.
So if you see that combination, they call that the trinity in the federal law enforcement community. If you see that combination, that can be dangerous for patients because the combination can lead to overdoses. And so it’s maybe not something that you would normally think should be prescribed in normal medical practice. So if you see a doctor prescribing a lot of those things, or the opioid and then the sedative, and then the cough syrup with the coating. You don’t necessarily think that someone would have pain management issues and have a cough issue. So if you consistently see a doctor prescribing those things, that can be an indication.
Another indication is doctor shopping or pharmacist shopping. So that’s where the patient will have multiple doctors prescribing the same types of pain management drugs. Medications in high quantities and things like that, where it looks like they’ve gone to one doctor and maybe that doctor has cut them off. Then they go to another doctor until that one cuts them off and then another doctor.
Well, that’s an indication that these doctors are cutting them off because the doctors don’t think that their prescriptions are legitimate. And then there’s pharmacist shopping, which is similar if they have the same type of prescription, but they keep going to different pharmacies to get it. That may be an indication that the pharmacy has cut them off. So look for doctor or pharmacist shopping. Now in Texas, you can do that in the PMP system that we have. That’s called the prescription monitoring program. And the PMP has a database where you can look and see the history of the patient and their prescriptions. You’re required every time you prescribe or every time you fill a prescription for an opiate, you’re required to check the PMP before you do that.
So you’ll be looking for these kinds of red flags within the patient’s history.
Another red flag that’s very common is the pharmacy being a long distance from the doctor’s office. Normally you would think that for convenience sake, doctors would send prescriptions to a pharmacist that is nearby them. But if the pharmacy is at a long distance from the doctor’s office or a long distance from the patient’s home, that can be an indication that they’re going to a pharmacist that is playing along. And so that’s a red flag. Another is Cash payments. If. you’re seeing, patients that are paying in cash as opposed to through insurance coming through a doctor. That can be an indication that they have to go or they feel that they have to go outside of insurance because insurance can look carefully at patterns or it may be an indication that they don’t have insurance and they’re having to pay for cash and maybe this is a way for them to get money.
Another big red flag is if you see multiple patients coming to your pharmacy together in a group, that can be an indication that they have been recruited by someone and they’ve all been taken to the doctor together, then they’re all being taken to your pharmacy together to all get their prescriptions filled. Groups coming together is a big red flag. And then finally, if you notice that you’re doing business filling prescriptions for a doctor and that all of a sudden your controlled substances prescriptions have gone up. And you see that that’s because of a particular doctor. That can be an indication that the doctor maybe is starting to over prescribe controlled substances. And if those controlled substances are drugs of abuse, then that’s a big red flag.
So you need to monitor The PMP. Be vigilant to be aware of potential signs that something might not be regular, and you need to make sure that you’re documenting all of the prescriptions you fill on time as soon as you’re required to. With controlled substances, when you dispense, you have to document that within a day. So make sure that you do that and make sure that you document everything about the prescriptions that you’re filling.
Jennifer Anton | 22:46
So John, recently, Walgreens and other major Drugstore chains have faced over $300 million in settlements for allegedly pressuring their pharmacists to fill prescriptions quickly without getting the proper kinds of verification. How do you defend the individual pharmacists who claim they’re following their corporate policies if they have actually violated federal law?
John Helms | 23:13
First of all, if you are a pharmacist and you’re violating the law, it’s not a defense that your employer was pressuring you to go quickly. You have a duty not to violate the law. That means you have to follow your corresponding duty and so if you still went along with that and knowingly violated the law, then that’s not going to be a legal defense.
However, this kind of situation is probably going to come up where the federal government is trying to either promote a civil lawsuit against the pharmacy company or has larger corporate interests in mind. In that situation, one of the things that you can do as a criminal defense lawyer is to see if an individual pharmacist could cooperate with the government and help them in their case against the pharmacy company in return for benefits like leniency in some way. So that’s a likely way that it can be done.
And then If you violate the law, that doesn’t mean that your punishment is going to be the same as everybody else. So the fact that you were pressured to do something may mean that you’re going to get a punishment that’s less than and certainly to people who are doing the pressuring. So those are the kinds of things that you can do in that situation.
Jennifer Anton | 24:57
So tell us a little bit about, since you’ve been a federal prosecutor, what is a federal prosecutor looking at when they’re making the determination of whether to charge someone in these pharmacy cases or to impose civil penalties against someone or an entity.
John Helms | 25:18
Well, okay, so first of all, the basic difference between a civil case and a criminal case, is that in a criminal case, someone can go to jail, and the government has to prove that they’re guilty beyond a reasonable doubt, and they have to prove in the case of pharmacists, they have to prove that the pharmacist intended or knew that what they were doing was wrong. Inconsistent with normal medical practice and legitimate medical need.
So they have to prove all those things if they are trying to prosecute an individual pharmacist. If they are filing a civil lawsuit, they are not going to be getting someone to go to jail. They’re going to be getting money if they went. Fines, for example, and they’re going to be changing policies, they hope.
Typically, if the government sees a human being that they think is doing a lot of illegal things, then they might charge the person criminally if they believe they can meet that very high burden of proof. If what they are seeing is a pattern of corporate or business behavior that suggests that there is a corporate or business policy or culture that is promoting illegal prescriptions, then they will file a civil lawsuit against the business or against the corporation that owns the business and will try to get fines and to change their policies. And so they’re looking at a what is it that they hope to achieve?
So, for example, in the Walgreens case, Walgreens had entered into a settlement with the Justice Department, and I believe it was 2013. Then, over a period of about 10 years after that, the government claimed that even after Walgreens had settled the previous lawsuit, they continued to have a corporate culture that promoted illegal prescribing. And so they went after Walgreens because they had lots of evidence that Walgreens was pressuring pharmacists to fill prescriptions quickly, was pressuring pharmacists to overlook obvious patterns by doctors suggesting that the prescriptions were not legitimate and so these were corporate policies, and that’s why the government sued Walgreens for fines and to change corporate behavior and that’s what resulted in that $350 million settlement with Walgreens just a couple of months ago.
Jennifer Anton | 28:06
Okay. So with, If the federal government pursues someone, a pharmacist criminal. How do factors like loss amount? Or patient harm, or And you mentioned intent earlier, the intent. How do those factor into making their prosecutorial decisions?
John Helms | 28:32
Well. Federal prosecutors, first of all, have to be satisfied that there’s a federal interest involved.
So they want to make sure that whatever the person was doing was not just a one-off or isolated incident. They want to make sure that it’s enough for the federal government to spend its money and time and resources pursuing this person. They want to make sure that it’s a case that they believe they can prove beyond a reasonable doubt. They shouldn’t be indicting a case that they don’t believe they can win beyond a reasonable doubt. And they’re going to want to look into the harm if there were overdoses or things like that. If there were sales, where A federal entity like Medicare was being asked to reimburse so that The federal government was losing money from fraudulent prescriptions. They’re going to look at all of those things to determine whether it’s a case they want to bring crime to.
Jennifer Anton | 29:34
Well, John, thanks for being here with us today. This is John Helms, criminal defense attorney in Dallas, Texas, here with us today. I’m Jennifer Anton with your legal news of the day, and please come and revisit us for our next episode coming soon your way.