CVS Pushes Back Against DOJ’s Latest Opioid Lawsuit

By Crystal Lindell

The U.S. Justice Department’s latest opioid lawsuit against CVS is getting some push back from the pharmacy chain. The DOJ alleges that CVS knowingly filled “unlawful prescriptions” for opioids and other controlled substances, and then sought reimbursement for them from federal healthcare programs like Medicaid and Medicare.

Specifically, the DOJ claims that CVS had “corporate-mandated performance metrics” that incentivized pharmacists to fill the prescriptions. The government also alleges that CVS “set staffing levels far too low” for pharmacists to meet their corporate goals and legal obligations.

“Our complaint alleges that CVS repeatedly filled controlled substance prescriptions that were unlawful and pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity,” Deputy Assistant Attorney General Brian Boynton said in a statement. “The practices alleged contributed to the opioid crisis and opioid-related deaths.”

CVS issued a statement in response to the lawsuit that “strongly disagrees with the allegations and false narrative.” The company said the standards the DOJ is claiming CVS didn’t meet are so vague and ever-changing as to be useless. 

“The government’s lawsuit seeks to impose a shifting standard for pharmacy practice,” CVS said. “Many of the litigation theories laid out in the complaint are not found in any statute or regulation, and relate to topics on which the government has declined to provide guidance.

“Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized, and empowered to write controlled-substance prescriptions.”

I have to say, it’s good to see CVS defend itself in these situations. 

Especially by pointing out the obvious: The prescriptions were written by doctors who were licensed by the government. Although pharmacists have a “corresponding authority” to make sure a prescription is legitimate, why should a private pharmacy chain be held to a higher standard than the government itself?

The government’s lawsuit intensifies a serious dilemma for the pharmacy industry, which is simultaneously second-guessed for dispensing too many opioids and for filling too few. 

Over the last few years, it seems like every government agency in existence has been looking for anyone they could possibly sue in relation to opioids. As a result, about $50 billion in opioid settlement money will be paid in coming years by opioid makers, distributors and pharmacies.

However, there’s one glaring aspect of this tactic that makes it clear the lawsuits aren’t about helping people hurt by opioids, but about finding ways for the government and plaintiff law firms to get more money. Much of the settlement money received so far has been earmarked for law enforcement and other government projects that have little to do with opioids.

‘We Will Defend Ourselves’

CVS has already agreed to pay about $5 billion to settle opioid litigation. The company says the latest lawsuit, which seeks unspecified additional penalties, is just another cash grab.

“We will defend ourselves vigorously against this misguided federal lawsuit, which follows on the heels of years of litigation over these issues by state and local governments — claims that already have been largely resolved by a global agreement with the participating state Attorneys General,” the company said. 

CVS says it has been an “industry leader” in developing programs to fight opioid misuse. In recent years, the nation’s largest pharmacy chain has refused to fill controlled substance prescriptions written by over 1,250 doctors, about half of whom the government continues to license. 

The company also points to its “Our Opioid Response” website, which features a telling headline about government regulations and the scrutiny faced by pharmacists: 

“Fill this opioid prescription. No, wait, actually you can’t do that. Or, maybe, you can: The dilemma for community pharmacists.”

The text on the site then goes on to again point out the DEA’s vague guidance and inconsistent stance on the issue. 

“Whichever decision they make, community pharmacists know they can – and will – be second-guessed later. Too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain. While simultaneously being accused of dispensing too few opioids and too many, pharmacists and pharmacies face threats of liability no matter their actions,” CVS said.

A recent court case suggests that CVS and other pharmacy chains are making some headway in defending themselves. The Ohio Supreme Court ruled this week that CVS, Walmart and Walgreens are not “public nuisances” under the state’s product liability law. Similar rulings have also been made in West Virginia, California and Oklahoma, rejecting public nuisance claims that resulted in costly opioid settlements.

CVS says it is standing up for “patients enduring relentless pain,” and as a patient who faces relentless pain, I’m happy to see it. While I’m skeptical that the overall tide is turning when it comes to public attitudes about opioids, it’s good to know at least one company is pushing back. 

DEA Gaslights Pain Patients Over ‘Unwillingness’ to Find Doctors

By Pat Anson, PNN Editor

Faced with record high overdoses, a fentanyl crisis, medication shortages and corruption within its own ranks, you’d think the Drug Enforcement Administration would have better things to do than gaslight chronic pain patients.

You’d be wrong.

In a blatant case of victim-blaming, a Department of Justice attorney claims that patients of a California doctor whose license to prescribe opioids was suspended last year by the DEA were not making any effort to find new physicians.

The DEA’s suspension of Dr. David Bockoff effectively shuttered his practice and left 240 patients – including many who suffer from rare and chronic health conditions – scrambling to find new providers and pain medication.

While Bockoff appealed his suspension, nearly a dozen of his patients went to the U.S. Court of Appeals in Washington DC, asking the court to let them intervene in the case – which would essentially give patients and their lawyers a seat at the table while the DEA decides whether to make Bockoff’s suspension permanent. 

It’s an unusual legal strategy that the DOJ and DEA are resisting. Last week Anita Gay, the DOJ’s lead attorney, filed a 6-page motion to have the patients’ case dismissed, saying they have no legal right to intervene in a DEA case against their doctor. Then she gaslighted Bockoff’s patients, blaming them for the life-threatening predicament that the DEA created for them. 

“Petitioners have had since October 25, 2022, to find a new physician and their unwillingness to do so does not warrant intervention,” wrote Gay, who works in the Criminal Division of the DOJ’s Narcotic and Dangerous Drug Section.

The alleged “unwillingness” to find new providers angered many of the patients, who have struggled for years to find doctors willing to treat their pain with high-dose opioids. Some traveled thousands of miles from out of state to see Bockoff.  

Patients say Gay was either misinformed or misleading judges in her motion to the DC Court of Appeals. Even her reference to “October 25, 2022” was puzzling, because patients didn’t learn about Bockoff’s suspension until November 1. Some went to his office that day for appointments and were turned away.  

“Ms. Gay’s assertion that patients are unwilling to find other providers to assist them in continuing successful treatment or even tapering their medication could not be further from the truth,” says Anne Fuqua, a disabled nurse in Alabama who lives with painful dystonia and arachnoiditis. Fuqua was able to find a palliative care doctor in Florida to take her as a patient. Others have not been as fortunate.

“The 60 plus patients I have spoken with who have been unable to find a new source of care have searched extensively for a new health care provider,” Fuqua told PNN. “The problem is that physicians are loathe to accept any new patients, much less those whose physician was the subject of a DEA investigation.” 

“Ms. Gay is aware of the medical environment that her office created. We have diligently tried to locate a pain management physician, but all of them fear losing their freedom and who can blame them with the current frenzied atmosphere?” said Dustin Parker, who also suffers from the painful spinal disease of arachnoiditis.

“It was awful, calling each time was full of anxiety, the little hope that we held onto was quickly extinguished each time we dialed. I began feeling an impending doom build. I thought if I could lose access to medical care, how would I care for my family, would I ever achieve my goals, and my dream of earning a retirement?”

‘To Say We’re Not Trying Is Absurd’ 

Gay did not respond to an email request for comment. Her assertion that patients were unwilling to find new providers seems particularly cruel, because two of Bockoff’s patients died after his suspension – not because of his medical care, but from the lack of it. 

Danny Elliott and his wife Gretchen were so distraught over his inability to find another doctor that they both committed suicide in their Georgia home on November 7.  Four weeks later, Jessica Fujimaki died at her home in Phoenix after unsuccessful attempts to find proper pain care.

Both Elliott and Fujimaki had incurable conditions that cause severe pain and needed high dose opioids to have any quality of life. 

“To say that this group of patients hasn’t made efforts to find alternative medical care is just bullshit. The last door open to them was slammed shut by the DEA.”

— Jim Elliott, brother of deceased patient

“To say that this group of patients hasn’t made efforts to find alternative medical care is just bullshit. The last door open to them was slammed shut by the DEA,” said Jim Elliott, Danny’s brother  

“It’s not like Jessica wasn’t trying to look for another doctor, because we tried. And no one would take her in the state of Arizona,” said Tad Fujimaki, Jessica’s husband. “The doctors don’t want to deal with (high dose opioid patients) because they know they’re going to get exposed. They’re going to be put under the microscope by DEA.” 

The Fujimakis were so desperate for pain medication that they made three trips to Mexico to buy opioids for Jessica – a risky move because counterfeit medication has been found in some Mexican pharmacies that cater to U.S. visitors.  

“For them to say we’re not trying is just absurd,” Fujimaki said. “It’s not just Jessica. All the other patients went through multiple doctors before they got to Dr. Bockoff. And they got denied, denied and denied. No one would take them as patients. And then finally Dr. Bockoff took them.”

Little has been revealed publicly about the DEA’s investigation of Bockoff. DEA agents first searched his office in September, 2021 and confiscated the medical records of all 240 patients. They determined that five of them were in “imminent danger” from Bockoff’s prescribing practices, but then waited over a year to suspend his license.

Much of the government’s case against Bockoff appears to be dependent on the opinions of Dr. Timothy Munzing, a family practice physician and outspoken critic of opioids, who has a lucrative sideline working as a consultant and expert witness for the DEA and DOJ. According to GovTribe, a website that tracks federal contracts, Munzing has made over $3.4 million in recent years working for the government.

In court documents, the DEA said Munzing was prepared to testify that Bockoff’s treatment of the five patients “fell below the standard of care in California” and was “not for a legitimate medical purpose.” But the DEA has produced no evidence that any of Bockoff’s patients overdosed, became addicted or harmed in any way while under his care. The 80-year old Bockoff has practiced medicine for over 50 years in California, and according to the state medical board has no prior record of disciplinary action or complaints.

Bockoff is appealing his suspension to a DEA Administrative Law Judge, but a final ruling could be months away. It would be unusual for the courts to intervene and give his patients a seat at the table, but many consider it a life-and-death issue. In their eyes, the “imminent danger” is from the DEA, DOJ and their attorneys.

“I’d like to ask Ms. Gay if this was willful ignorance or does her affluent position afford her an alternate to my reality?” said Parker. “It’s offensive saying that it’s a patient’s fault for not trying hard enough.”

Walmart Sues Feds Over Prescribing Regulations

By Pat Anson, PNN Editor

In an unusual move, Walmart has filed a lawsuit against the Department of Justice and Drug Enforcement Administration, asking a federal court to clarify the “roles and legal responsibilities of pharmacists and pharmacies” in filling opioid prescriptions.

“We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” the company said in a statement.

Walmart and other pharmacy chains are defendants in multiple class action lawsuits alleging the companies helped fuel the opioid crisis by dispensing opioids irresponsibly. They have also been fined tens of millions of dollars by the DEA for lax controls on opioid prescriptions. According to ProPublica, federal prosecutors in Texas even sought criminal charges against Walmart, but were overruled by top officials at the Department of Justice.

Walmart is the largest retailer in the world and operates over 5,000 in-store pharmacies in the United States. The company said it filed suit against the DOJ and DEA because it was caught “between a rock and a hard place” over opioid prescribing.    

“Unfortunately, certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis. They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions,” Walmart said.

“At the same time that DOJ is threatening to sue Walmart for not going even further in second-guessing doctors, state health regulators are threatening Walmart and our pharmacists for going too far and interfering in the doctor-patient relationship. Doctors and patients also bring lawsuits when their opioid prescriptions are not filled.”

‘Corresponding Responsibility’

Under current law, pharmacists have a “corresponding responsibility” when filling prescriptions – a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but Walmart and other pharmacies have gone even further by blacklisting doctors deemed to have questionable prescribing practices.  

That’s what happened to a nurse practitioner at an Arizona pain clinic, who received a letter from Walmart in 2018 saying it would no longer fill her prescriptions – even though there was no indication any of her patients had been harmed by opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states.

“It was very humiliating. I was upset about it,” said nurse practitioner Carolyn Eastin. “We’ve already had patients who can’t get prescriptions there.”

A former Walmart pharmacist told PNN the company closely monitors opioid prescriptions and the doctors who write them.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," the pharmacist explained.

In its statement, Walmart said its pharmacists “refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic” and had “blocked thousands of questionable doctors from having their opioid prescriptions filled.” The company also said it frequently assisted law enforcement agencies in “bringing bad doctors to justice.”

Caught in the middle of this are pain patients with legitimate prescriptions that are not getting filled. In August, two patients filed class action complaints against Walgreens, Costco and CVS alleging they were discriminated against by the pharmacies.

As PNN has reported, Sen. Elizabeth Warren (D-MA) and other members of Congress are urging the DEA to update a regulation that would allow pharmacists to only partially fill an opioid prescription. Patients would have to return a second time to get the rest of their medication.

Pain Doctor on DOJ Settlement: ‘It Was Extortion’

By Pat Anson, PNN Editor

A southern California doctor who paid a $125,000 fine to settle allegations of illegal opioid prescribing says federal prosecutors threatened to ruin his practice and reputation if he didn’t pay up.

“They could care less if I was innocent or guilty. They wanted to see how much they could gouge out of me,” said Dr. Roger Kasendorf, an osteopathic physician who specializes in pain management in La Jolla. “They tried getting $24 million from me until they saw my bank account. I had to hire a good lawyer and pay them too.

“It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic.”

The U.S. Attorney’s Office in San Diego announced the settlement last week in a press release, alleging that Kasendorf “illegally prescribed opioids to his patients.”

“This investigation arose from data analytics tools which allow the Department of Justice to perform a variety of functions, including identifying statistical outliers, such as which doctors prescribe the highest opioid dosages and which doctors prescribe combinations of opioids and other drugs known to increase the risk of addiction, abuse, and overdose,” the office said in a statement.

“Based on the investigation, the United States contends that Dr. Kasendorf wrote prescriptions for opioids, including fentanyl, that were not issued for a legitimate medical purpose and while not acting in the usual course of his professional practice in violation the Controlled Substances Act and the False Claims Act.”

The DOJ statement makes no mention of any patients being harmed or overdosing while under Kasendorf’s care, and no formal criminal charges were filed against him.

Kasendorf says the DOJ’s case was based on inadequate medical records he kept on five of his sickest patients, who were prescribed relatively high doses of opioids for pain. One of the patients has since died from cancer.

“I didn’t know my EMR (electronic medical records) very well. I didn’t keep good notes. And as a result, they went through my notes and said, ‘Oh look you didn’t do this and you didn’t do this.’ I did, but I kept poor documentation,” Kasendorf told PNN.

“Nowadays, if you see any of my notes over the last three years, they’re perfect. But back in the day I didn’t have great notes.”

DR. ROGER KASENDORF

Kasendorf has a simple explanation for why he agreed to settle rather than defend himself in court.

“It was cheaper to pay it than defend it. So, I just paid it,” he said. “If I didn’t settle, they said they would call the DEA and then the state (medical) board. That’s what they said. ‘If you don’t settle, we’re going to make it a lot worse for you.’   

“If I defend myself, I’m risking my (medical) license, even though I don’t feel like I did anything wrong. Now I’m dealing with three separate entities and then I can’t work anymore. So I almost had no choice but to settle.”

“Without reviewing the medical records, I cannot assess the fairness of this outcome,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. 

“If the physician were merely a big-data outlier because he took on patients with the most complex needs, and if his prescribing were CSA (Controlled Substances Act) compliant, then the behavior of the federal government would fall squarely under the Black’s Law Dictionary definition of extortion.”

That legal dictionary defines extortion this way: “Any oppression by color or pretense of right, and particularly the exaction by an officer of money, by color of his office, either when none at all is due, or not so much is due.”

Assistant U.S. Attorney Dylan Aste, who led the case against Kasendorf, did not respond to a request for comment. As for the doctor’s claim about extortion, a DOJ spokesperson told PNN, “We’re not going to have any comment about that.”

DOJ Threatens Criminal Prosecution

Kasendorf is the latest example of the DOJ’s heavy-handed tactics in fighting the opioid crisis. Dozens of doctors around the country have been arrested and prosecuted for illegal opioid prescribing, many of them targeted by DOJ task forces that use prescription drug databases to identify high-dose prescribers.

"Sometimes the only difference between a doctor and a drug dealer is a white coat," U.S. Attorney Jay Town told reporters after federal raids in April that resulted in criminal charges against 60 practitioners in seven states.

Those cases may be legitimate, but hundreds of doctors who face no charges are still being harassed by federal prosecutors – not because their patients became addicted or overdosed – but because their names turned up in a database search.

In February, U.S Attorneys in Wisconsin sent letters to 160 high-dose prescribers in the state, warning them that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.” 

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent.”

— Michael Barnes, attorney

Similar warning letters have been sent to doctors in Georgia, Massachusetts and other states.

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent,” said Barnes. “Detailed medical records are the only affordable way for a provider to prove his innocence — or at least make the prosecutor think twice about proceeding with criminal charges.”

Although the DOJ lacked credible evidence that any of Kasendorf’s patients were harmed by his care, the lack of detailed medical records was enough to intimidate the doctor into settling on the advice of his attorney. 

“Dr. Kasendorf’s ability to provide high quality pain management to those in need of treatment never was questioned. No charges ever were filed against Dr. Kasendorf,” said attorney Robert Frank. “The government’s allegations arose from an incomplete story of Dr. Kasendorf’s care for a few patients.  No patients suffered any adverse outcomes or complications from his care.   

“Economically, it made sense for Dr. Kasendorf to put an end to yet another Government pursuit of a physician successfully treating patients for true chronic pain problems, in what now has become an opiophobia world brought on by the overzealous promotion of opioids by pharmaceutical companies and misuse of them by relatively few physicians, Dr. Kasendorf excluded.“ 

‘Glad I Found Dr. Kasendorf’

Kasendorf continues to practice medicine and remains in good standing with the Osteopathic Medical Board of California. The board has no record of any disciplinary actions, malpractice judgments or citations against him.

Online reviews of Kasendorf by patients are largely positive.  

“I am so glad I found Dr. Kasendorf. I have dealt with debilitating neck pain for years. Dr. K treated my neck and my pain not only went away, but my headaches and numbness in my fingers went away also. He is very good at what he does,” wrote Gina in a Yelp review.  

“Dr. Kasendorf is one of the most caring pain management doctors I have ever seen, and I have seen a lot of them. He is truly empathetic towards his patients which is very hard to find. He is very strict about his opiate contract rules, but most pain management doctors are nowadays,” wrote Natalie. 

“He fired me from treatment with opiates despite a chronic painful condition,” wrote Gary, who said Kasendorf cut his opioid medication in half and then dropped him for being non-compliant.

“He is afraid the DEA is going to threaten his practice. Suggest you find an MD with the integrity to stand by his patients and stand by his past decision to prescribe opiates.” 

Guilt by Association 

Federal prosecutors initially became interested in Kasendorf not because of his prescribing practices, but because of his association with Insys Therapetics, a controversial Arizona drug maker.  

Insys’ founder and four former executives were recently convicted of bribing doctors with millions of dollars in kickbacks to prescribe the company’s flagship product: Subsys, a potent fentanyl spray that costs about $5,000 for a single day’s supply.

Subsys is only FDA approved for the treatment of cancer pain, but like other drugs it can be prescribed off-label for other pain conditions. Because of its high cost, Medicare and other insurers often wind up paying for Subsys.

Some doctors were paid lucrative speaking fees by Insys to promote Subys, while others were wined and dined at upscale restaurants or taken to a strip club for free lap dances.   

Kasendorf was a promotional speaker and consultant for Insys from 2013 to 2017. For that he was paid over $167,000, according to ProPublica.

“I was starting my practice. I had no money. The fact I was able to earn money through speaking was a miracle for me. That’s what kept me afloat and my family when I first moved here,” said Kasendorf, who moved to California from the east coast after his home was destroyed by Hurricane Sandy.

“And I was actually good at it. They wanted me to go all over the place because they felt I did a good job and was very thorough. I made it entertaining. I’m a very good speaker and I’m very proud of that.”

In addition to Insys, Kasendorf also did promotional speaking and consulting for several other drug companies, including Purdue Pharma, Egalet, Pfizer, Pernix and Indivior. But it was his work for Insys that federal prosecutors focused on.

“I never took bribes. I never got lap dances or all this stuff they were talking about,” Kasendorf told PNN. “This company did a lot of bad things and I completely agree. The problem is their product happens to be very, very good.”  

Subsys was so effective at pain relief that Kasendorf prescribed it to all five patients who were flagged by DOJ investigators.

“After all this time and all this effort, I think DOJ was upset I didn’t have more money.”

— Dr. Roger Kasendorf

It’s not the first time the DOJ has gone after a doctor for prescribing Subsys and making speeches for Insys. In 2017, the DEA raided the home and clinic of Dr. Forest Tennant, alleging that he took kickbacks from Insys and ran a “drug trafficking organization.” Like Kasendorf, no charges were filed against Tennant, who decided to retire on the advice of his attorneys rather than fight a protracted legal case.    

According to Kasendorf, the DOJ initially wanted him to pay a $24 million fine, but prosecutors settled for far less.

“They were so upset when they saw they could only get $125,000. But I sent them all my records and they could see I literally had no money in the bank,” said Kasendorf. “I had to borrow $100,000 from my parents to pay them.

“They almost put me out of business. But after all this time and all this effort, I think DOJ was upset I didn’t have more money.”

Lawyer Calls for DOJ to End ‘Indiscriminate Raids’ on Doctors

By Pat Anson, PNN Editor

In recent years, hundreds of physicians, pharmacists and addiction treatment doctors have had their offices raided and searched by DEA agents.

Many of the raids were orchestrated by the Justice Department’s Opioid Fraud and Abuse Detection Unit, a special team of investigators created in 2017 to mine opioid prescribing data to identify suspicious orders and practices. The investigations have resulted in the high-profile arrests of healthcare providers for fraud and risky opioid prescribing.

"If you're a doctor and you want to act like a drug dealer, we're going to treat you like one. And sometimes the only difference between a doctor and a drug dealer is a white coat," U.S. Attorney Jay Town said about a federal takedown in April that resulted in charges against 60 practitioners in seven states.

Rarely publicized are the cases where criminal charges are never filed because the evidence against doctors is weak or non-existent.

“It’s quite frustrating to see how their careers were ruined even though they never faced criminal charges. That’s because the government was incapable of bringing credible charges against them,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. “When I read a criminal complaint, what I would see as ‘best practices’ is construed as criminal exploitative behavior on the part of the prosecutors.

“There’s a heavy bias against medications to treat pain and opioid use disorder that is driving some of the aggressive enforcement actions. Also, an overzealousness combined with a lack of understanding of the practice of medicine.”

Barnes recently wrote an op/ed, published online by American University’s Washington College of Law, calling for an end to the DOJ’s “indiscriminate raids” on doctors.

“DOJ raids and searches of professionals’ homes and medical clinics interrupt the delivery of health care, put patients’ lives at risk, and unjustly destroy careers and livelihoods. They also create confusion and fear,” wrote Barnes. “Not all health care professionals subject to the DOJ’s searches and seizures are ‘dirty docs.’ In fact, some of them are nationally recognized leaders not just in pain management, but also in addiction medicine.” 

Barnes cites the case of Dr. Stuart Gitlow, an addiction psychiatrist whose Rhode Island home and office were raided by FBI agents in March 2018. Sixteen months later, the reasons for the raid remain unclear and Gitlow, the former president of the American Society of Addiction Medicine, has not been charged with a crime.  

MICHAEL BARNES

Neither has Dr. Forest Tennant. In November 2017, DEA agents raided the office and home of Tennant, a prominent California pain physician who was flagged for “very suspicious prescribing patterns.” In a search warrant, the 76-year old Tennant was depicted as the kingpin of a drug trafficking organization that spanned several states.

“I know based on my training and experience that patients traveling long distances to obtain controlled substance prescriptions is another ‘red flag’ of drug abuse and addiction,” wrote DEA investigator Stephanie Kolb, who led a two-year investigation of Tennant.

But Kolb, who was self-employed as a dog walker and pet groomer before she started working for the DEA in 2012, failed to note that Tennant only treated intractable pain patients, many from out-of-state, and often prescribed high doses of opioids because of their chronically poor health. Some patients were in palliative care and near death, and one committed suicide after learning of the raid, fearing she would lose access to opioid medication.

Tennant denies any wrongdoing and was never formally charged, but retired from clinical practice a few months after the raid.

“It’s hard to continue operating when they never closed my case, and so I’m going to retire and move on,” Tennant told PNN at the time. “That’s on the advice of both my lawyers and my doctors."

(Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.)  

Biased Investigations

Barnes says the biases of some prosecutors extends to the expert witnesses they hire to help build their cases. The role of these witnesses is important because they help DOJ persuade judges to sign off on search warrants that are key to gathering evidence. It’s a lucrative sideline for some paid witnesses, who charge the government hundreds of dollars an hour for their time and expertise.

“Expert witnesses are eager to give DOJ business to get the expert witness fees, and they of course will help to spin the facts in a way that is prejudicial to the defendant,” Barnes said. “What we’re seeing here is people who are really not qualified to be making assessments of other practices serving as experts for the government.” 

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has worked as a medical consultant for the DEA, FBI and DOJ on over 100 investigations, most of which involve prescriptions for opioids and other controlled substances.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1 million in DOJ contracts since 2017 and is currently working on nearly two dozen DEA investigations, mostly reviewing patient files and data from prescription drug monitoring programs.

It would be unusual for a family practice physician to treat an intractable pain patient without making a referral to a pain or palliative care specialist. But Munzing was one of the expert witnesses hired by the DEA to analyze Tennant’s prescribing.

“I find to a high level of certainty that after review of the medical records… that Dr. Tennant failed to meet the requirements in prescribing these dangerous medications,” Munzing wrote in an affidavit. “These prescribing patterns are highly suspicious for medication abuse/and or diversion. If the patients are actually using all the medications prescribed, they are at high risk for addiction, overdose, and death.”  

Munzing’s affidavit and the DEA search warrant identified no patients who were actually harmed while under Tennant’s care. As PNN reported, some patients found the allegation that they were selling their medication and funneling the profits back to Tennant laughable.      

“It’s like everything else they do. They don’t talk to any patients. They don’t talk to any doctors. They just go and throw all this stuff out there and making all these incriminations against people. They don’t have any evidence that I’ve sold anything. It’s just ludicrous,” said Ryle Holder, a Tennant patient who lives in Georgia.  

Barnes says the bias against opioid prescribing “is inherent in the work of many of the investigators and prosecutors.”

“Then there is the incompetence as it relates to many of the law enforcement officers not having the medical expertise to make judgements of a medical nature. And then, when they do consult with the experts, those experts are typically trying to please their clients and getting repeat business as a result,” he told PNN. 

State Medical Boards

To bring more expertise into investigations of healthcare providers, Barnes is proposing that state medical boards play a more prominent role. He wants Congress to amend federal law to require DOJ investigators and prosecutors to get a referral from a state licensing board before investigating a practitioner for misconduct. Similar laws at the state level would also need to be changed to require state and local law enforcement to get a referral from a medical licensing board.

To make sure complaints are handled in a timely manner, Barnes says federal funds should be used to bolster the budgets of state licensing boards so they can investigate allegations of misconduct.  

“There are some detractors who say medical boards didn’t do an adequate job leading up to the overdose crisis. But the reality is neither did law enforcement,” Barnes says. “The medical boards could get up to speed and make these assessments on medical needs and patient care to make sure that healthcare providers can be assessed with medical expertise, rather than law enforcement trying to guess about standard of care and best practices.”

“Making it more difficult for law enforcement to investigate potential diversion of dangerous and addictive controlled substances, including powerful painkillers, is probably not going to happen right now,” says DEA spokesman Rusty Payne.

“This idea that people need to worry about the DEA hiding in the bushes if they write an oxycodone prescription is ridiculous.”

— Rusty Payne, DEA spokesman

Payne points out the DEA is both a law enforcement and regulatory agency, one that oversees 1.3 million practitioners licensed to prescribe controlled substances. He says enforcement actions are relatively rare and not “indiscriminate” as Barnes suggests.

“The numbers are incredibly low. It is a very, very, very small number.  So this idea that people need to worry about the DEA hiding in the bushes if they write an oxycodone prescription is ridiculous,” he told PNN. “We don’t have the resources. We don’t track individual prescriptions. We look for patterns and large-scale significant diversion.”  

Getting state medical boards involved, according to Payne, is not a good idea.

“I don’t think making it harder for us to scrutinize those that are acting outside the law is in anyone’s best interest,” he said.

But Barnes’ proposal makes sense, according to Dr. Lynn Webster, a PNN columnist and former president of the American Academy of Pain Medicine. 

“Barnes makes a sensible recommendation. If the law enforcement suspects a provider is not complying with the law, then the first step should be a referral to the medical board where the provider can be evaluated by their peers,” Webster said. “If a doctor goes to trial, they will not be evaluated by their peers. That is not the way the justice system is supposed to work.” 

Webster was once the target of a federal investigation of his opioid prescribing practices and DEA agents raided his Utah pain clinic in 2010. Four years later, the DOJ said it would not prosecute Webster, who said his “reputation was tarnished forever.”  

“DEA investigations are often designed to entrap a provider on technicalities.  Even if an investigation never leads to any charges the doctor's reputation is damaged.  In the court of public opinion an investigation must mean something was wrong,” Webster said. 

Is the DEA Overreaching Its Authority?

By Lynn Webster, MD, PNN Columnist 

The U.S. Department of Justice (DOJ) does not have the legal authority to determine which health care activities constitute a “legitimate medical purpose.” However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of federal law.

In 1970, Congress passed and President Nixon signed into law the Controlled Substances Act (CSA). In its broadest sense, the CSA regulates every aspect of controlled substances, from production to delivery, distribution, prescribing, possession and use. The CSA’s impact is far-reaching, touching many different sectors of our society, including healthcare, pharmaceuticals, law enforcement, politics, and state and federal judiciaries.

According to the CSA, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This statutory language is at the root of the issue. But who decides what is a legitimate medical purpose?

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken a proactive approach in determining which medical practices have a legitimate medical purpose and which do not. This hands-on approach is in direct contravention with the CSA. 

The DEA is effectively preempting state law as it relates to the regulation of controlled substances. In Gonzales v. Oregon, the U.S. Supreme Court ruled in 2006 that the authority to determine a legitimate medical purpose rests with state governments.

This means it is state lawmakers, not federal officials, who should regulate the practice of medicine. Medical boards are established by the authority of each state to protect the health, safety and welfare of patients through proper licensing and regulation of physicians and other practitioners.

If a doctor engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that doctor is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ, as well as state regulators.

The key phrases -- "legitimate medical purpose" and "in the usual course of a professional practice" -- are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years. The only way the phrase "legitimate medical purpose" would have any legal meaning would be if the concept of an "illegitimate medical purpose" were defined by the CSA -- and it is not.

Moreover, the words "legitimate" and "medical" are redundant. The practice of medicine is inherently legitimate, according to the CSA. The phrase "legitimate medical purpose" can be reduced to "medical purpose" without changing its meaning.

Any practice that is medical is legitimate and should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

Standard of Care

The DOJ is now using deviation from the “standard of care” to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids. A standard of care is generally considered the customary or usual practice of the average physician.

In an attempt to address the opioid problem, the DOJ has hired medical experts who claim that any deviation from standard of care amounts to practicing without a legitimate medical purpose. In some instances, the government's experts have even used the CDC opioid guideline’s dose recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose.

Using deviations from "standard of care" as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling in Gonzalez v Oregon, which found that the Attorney General “is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ. This is supported by a 1983 statement in a DEA newsletter that declares acts of prescribing or dispensing controlled substances lawful when they are done within the course of a provider’s professional practice. Even if a physician's behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

The information provided in the newsletter isn't an opinion. It's the law.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard. It is not the DOJ's role to determine the quality or boundaries of the practice of medicine.

 Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

I’m Ashamed of the U.S. Justice Department

By Drew Pavilonis, Guest Columnist

I was a federal law enforcement officer with the U.S. Department of Justice (DOJ) for 14 years. Hard work, a willingness to transfer, and a graduate degree brought fast promotions and a coveted position in management at a DOJ training academy just outside of Denver.

However, a rare type of brain tumor deep in the thalamus brought everything to a sudden halt after ten years in Denver. My doctors initially said the brain tumor was inoperable due to its sensitive location, but the tumor continued to grow, and I eventually flew to Phoenix to have a talented neurosurgeon perform the difficult surgery to remove it.

The thalamus and brainstem proved to be a very challenging surgery and I suffered permanent disability because of it. I spent several months as an inpatient at a neuro-rehabilitation hospital, relearning how to walk and speak, dress and bath myself.

The DOJ medically retired me because cripples can't be law enforcement officers. Fortunately, I had 19 years of federal service and was able to retire with a pension, which was a good thing since I was not able to work due to my significant disability. 

However, the suffering didn’t end there. I developed chronic, debilitating pain 3 years after the surgery.

DREW PAVILONIS

Fortunately, at the urging of my sister, I had moved close to Duke University Hospital in North Carolina for follow up medical care. The doctors at Duke hypothesized that my pain was due to scar tissue that formed in my thalamus after the brain surgery. The thalamus is the brain's pain center and my pain “switch” had been permanently turned on.

I was bedridden and prayed for death daily. The pain was so bad that I could not walk. I was taken by ambulance to Duke Hospital for a one week stay as an inpatient and was medically tested to the extreme. Eventually, the doctors determined that I had real pain and referred me to pain management. 

I was prescribed methadone, four times a day. Additionally, to fight the debilitating nerve pain that I also have, I was put on the maximum dose of gabapentin. The medications just allow me to live, much like diabetics need insulin to survive. I am always in pain, but the medications control it to a tolerable level.

I am able to travel internationally (I write this from my hotel room in Berlin, Germany), do volunteer work, and ride an outdoor wheelchair. However, I worry that that I will someday become collateral damage in this “war on opioids.”

I cringe every time I see a journalist cite the CDC report about opioid related deaths in America. That report was full of errors and incorrect by the CDC's own admission. Also concerning are the jack-booted tactics of the DEA, which attacks legitimate pain treatment as if doctors were responsible for all the heroin in the country.

Those rogue tactics have had a chilling effect on the practice of pain management and contributed to a growing number of patient suicides. Many chronic pain patients have taken their own lives because they could not get the appropriate medication that they so desperately need to live.

I never thought I would see human rights violations conducted by my own government against fellow Americans. It is unbelievable.  I no longer tell people that I am retired from the DOJ because I am ashamed of it. I just say that I’m retired from the federal government. That's sad.

Drew Pavilonis lives in North Carolina.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.