An illegal drug ring has been operating unchecked in South Carolina for the better part of a decade, according to attorneys for Dorchester County.
Members of the drug ring come to work every day wearing business suits and lab coats, sitting in meetings and giving professional advice to people who trust them.
In May, a central figure in the alleged drug ring was toppled. Dr. Mackie J. Walker Jr., a former podiatrist in Aiken, was sentenced to more than 15 years in federal prison for selling prescriptions of oxycodone without any legitimate medical purpose.
Walker is one of 42 defendants in a Dorchester County lawsuit that accuses opioid manufacturers, distributors and prescribers of neglecting their duty to protect the public from drug abuse, leading to excess prescriptions and overuse of a variety of opioid medications.
The U.S. Attorney’s Office for the District of South Carolina said Walker was working with several co-conspirators who recruited individuals for sham medical examinations, some of which never happened. Walker earned as much as $1,000 per prescription, and he wrote enough prescriptions to be considered a drug dealer — over 1 kilogram worth.
In South Carolina, 792 people died from opioid overdose in 2017, 28 of them in Dorchester County. Across the country, opioid misuse has an economic impact of $78.5 billion per year, according to the Centers for Disease Control and Prevention, including the costs of health care, lost productivity, addiction treatment and law enforcement.
“There’s no grasp on the magnitude of this problem that manifests itself in so many different ways,” said Andy Savage, one of the attorneys for Dorchester County.
‘Convince doctors and patients’
Dorchester County says it has spent millions of dollars each year to fight “the public nuisance created by defendants’ deceptive marketing campaign,” which the lawsuit says included drug manufacturers writing articles and creating educational materials that the manufacturers knew to be false.
Manufacturers also conducted sales visits to individual doctors and created a network of professional societies and advocacy groups to create the illusion of a consensus on the drugs’ long-term safety that was, in fact, patently false, according to Dorchester County.
Opioids such as heroin and OxyContin are synthetic or partially synthetic manufactured drugs that mimic the properties of opiates — morphine and codeine are among the best-known — which are created from the opium poppy plant.
Opioids are approved by the Food and Drug Administration for management of moderate to severe pain, typically for a few days or more. Patients experiencing extreme levels of pain from cancer are also sometimes prescribed opioids to make the end of their life as pain-free as possible.
According to the National Institutes of Health, the longer that opioids are used, the more the body becomes accustomed to the medication, decreasing its effectiveness and requiring increased dosages to achieve the same effect. The higher the dosage, the greater the chance of side effects and addiction, something Dorchester County says drug companies knew and did nothing about.
“Defendants knew that to increase their profits from the sale of opioids, they would need to convince doctors and patients that long-term opioid therapy was safe and effective,” the lawsuit says. And so manufacturers, acting individually and collectively, misrepresented and minimized the adverse effects of opioids, such as addiction and loss of function, and overstated the risks of alternative pain treatments, such as acetaminophen and non-steroidal anti-inflammatory drugs, the lawsuit continues.
The accused drug companies have denied any wrongdoing.
“Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation,” said John Parker, a senior vice president at the Healthcare Distribution Alliance — a trade association that includes McKesson Corp., Cardinal Health Inc. and Amerisource-Bergen Drug Corp. — in a statement.
‘Recklessly disregarded the truth’
The lawsuit also accuses manufacturers of making payments to certain doctors, referred to as “key opinion leaders” in the lawsuit, to promote aggressive treatment of pain with opioids. The manufacturers also ghostwrote articles and treatment guidelines that were published under the doctors’ names.
Studies by the key opinion leaders were cited and promoted by the manufacturers as independent research, but truly independent doctors who were critical of chronic opioid use were not given the same support.
“The KOLs knew that their statements were false and misleading, or they recklessly disregarded the truth in doing so, but they continued to publish their misstatements to benefit the defendants,” the lawsuit says.
“The sales techniques were at the very least unethical, if not illegal, and resulted in the market being flooded with opioids that were not needed,” said Paul Tinkler, one of the attorneys for Dorchester County.
Drug companies often meet with doctors to promote their products and sometimes pay doctors for speaking engagements or for advice and expertise on particular products. The federal government has required all such payments to be reported since 2013, and records are available in an online database managed by the Centers for Medicare and Medicaid Services.
A study by the New York State Health Foundation in June found doctors who received payments from opioid manufacturers prescribed more opioids to Medicare patients than doctors who didn’t.
A 2016 study published by the Journal of the American Medical Association found a similar correlation between other prescription drugs and doctors who received meals worth more than $20 from drug company representatives.
The lawsuit says drug distributors also failed in their legal duty to detect and report suspicious orders of opioid medications to the Drug Enforcement Administration, as required by federal law and by the S.C. Poisons, Drugs and Other Controlled Substances Act.
Additional distributors may have contributed to opioid misuse, the lawsuit says, but the DEA and the distributors have refused to voluntarily disclose data to identify all of the distributors who might share responsibility.
‘De facto drug dealers’
The lawsuit also alleges that some doctors in the state, four of whom remain unnamed, “operated as de facto drug dealers in white coats” by prescribing opioids for nonmedical purposes.
“Without Defendants’ actions,” the lawsuit says, “opioid use would not have become so widespread in Dorchester County and the opioid epidemic that now exists would have been averted or would be much less severe.”
Rite Aid of South Carolina Inc. has filed a motion to dismiss the case against it, as have LeAvis Sullivan, Leigh Varnadore and Paul Kitchin, three former sales representatives for Purdue Pharma L.P., the maker of OxyContin.
As of Aug. 28, only Smith Drug Co., a wholesale distributor located in Spartanburg, had filed a response to the lawsuit that is not a motion to dismiss. Smith Drug Co. says Dorchester County lacks the standing to bring the lawsuit and denies the allegations, saying that it complied with all governmental and industry rules, regulations and standards.
No manufacturer or distributor companies agreed to speak on the record about the Dorchester County lawsuit; those who responded to requests for comment provided only written statements.
In most of the statements, the companies acknowledge the misuse of opioids is a public health problem and commit to being part of the solution; but each company denied any wrongdoing.
“Our actions in the marketing and promotion of these medicines were appropriate and responsible,” Janssen Pharmaceuticals Inc. wrote. “The labels for our prescription opioid pain medicines provide information about their risks and benefits, and the allegations made against our company are baseless and unsubstantiated.”
Parker, of the Healthcare Distribution Alliance, said, “The idea that distributors are responsible for the number of opioid prescriptions written defies common sense and lacks understanding of how the pharmaceutical supply chain actually works and is regulated.”
Marc Bern, a New York-based lawyer who is helping coordinate similar litigation across the country, says lawsuits like this are among the few resources that counties have left to deal with opioid misuse in their communities.
“They can only do so much,” Bern said. “Their economics prevent them from doing everything that they could possibly do because there are other services that depend on the tax dollars that clearly are going to the treatment and the raising children, addicted babies — you name it. The counties are doing the best that they can under the current circumstances.”
‘You just can’t add it all up’
Dorchester County Administrator Jason Ward said in an email that like many counties, Dorchester County and its citizens have been affected firsthand by opioid misuse.
“We want to recoup some of the additional costs that the county has incurred due to the increased demand for treatment,” Ward said. “We want to provide more education to our citizens on the dangers of opioid overdose. The goals are to prevent deaths due to overdose and to reduce the abuse of opioids.”
Since Jan. 1, Dorchester County Emergency Medical Services administered 123 doses of Narcan, a narcotic blocker used to treat drug overdoses, said Doug Warren, director of Dorchester County EMS. Each dose costs $36.50, not including equipment needed to administer the medication intravenously or nasally.
“This is only the cost of the medication, not the increased demand for service that this problem creates, nor any of the myriad of other associated matters that this problem creates,” Warren said.
2017 was the third year in a row opioid deaths increased in the Palmetto State; in 2014, 508 people died statewide because of opioid overdose, 10 of them in Dorchester County.
And this year, as of Aug. 21, 23 people in the county had died because of opioids, according to Dorchester County coroner Paul Brouthers.
Savage said he sees the repercussions of the overproduction and overdistribution of opioids “on a daily basis.”
“To big businesses, the loss of productivity, to small businesses, the loss of productivity because of these addictions — you just can’t add it all up,” Savage said.
‘These damages will continue’
A report from the National Safety Council, a nonprofit organization promoting health and safety in the United States, found workers between 25 and 54 are less likely to hold jobs in areas with high opioid prescription rates. Seven in 10 companies said they are directly affected by prescription drug misuse.
“The bad news is that these damages will continue,” Tinkler said. “There are a lot of people addicted to opioids now all over the country, including in Dorchester County, and these impacts will be felt for years to come.”
Increases in opioid use have also led to an increase in crime and arrests, according to the Dorchester County lawsuit, “because not only are drug laws violated more, but also those becoming addicted often resort to committing petty crimes to afford their habit and other basic necessities.”
Prescription opioid misuse is a significant risk factor for heroin use, according to Dr. Wilson Compton, deputy director of the National Institute on Drug Abuse; 80% of heroin users first misuse prescription opioids.
Only 4% of people who misuse opioids begin using heroin, Compton told the House Committee on Energy and Commerce, but “for this subset of people, the use of the cheaper, often easier to obtain street opioid is part of the progression of an opioid addiction.”
Savage said when he talks to people in his social circles, everyone has a story about a person they know who has been affected by opioid misuse, and Bern said his family has been affected, which is one of the reasons he is pursuing the cases.
“I have yet to really meet a quote ‘street addict,’ someone who starts out with the intent of using pain medication,” Savage said. “They’re almost universally, ‘I had a broken arm,’ ‘I was in an automobile accident,’ ‘I had this issue or that issue.’ ‘I started out on whatever dosage it was and before I knew it, I didn’t want to say anything about it, I started shopping doctors, I started doing all these things, fooling myself that these were medications that were backed by health care officials.’ ”
He said a problem for prescription medicine in general is that drug companies are marketing directly to patients, giving patients the ammunition to ask their doctors for specific medication for their symptoms.
“Patients now are geared if you come to the doctor, you leave with a prescription,” Savage said. “So there is no longer a willingness of the patient when their child has a sore throat to hear, ‘Take an aspirin and it’ll clear up in a couple of days, really this is a minor thing.’ ”
Savage thinks the lawsuit is the right thing to do “for many reasons, and those are really not legal reasons as much as they are community interest reasons, if you will.”
“This is a crisis that’s affecting St. George, Harleyville — every community, every place where people live, there’s a story to be told about someone, somewhere affected by the opioid crisis,” he said.
Tinkler said the closest historical comparison he could think of for a lawsuit of this nature is the tobacco litigation, which was primarily state governments suing tobacco companies to recoup financial damages caused by tobacco.
“I really think it’s important for all counties in South Carolina to go in this litigation because the impact has adversely affected the taxpayers in the past and will continue to do so in the future, and this is one way the taxpayers can attempt to recoup that money and hopefully come to grips with the opioid epidemic,” Tinkler said.
This story originally appeared in the Sept. 3, 2018, print edition of the Charleston Regional Business Journal.