Burke County Takes on Big Pharma

Deaths caused by unintentional overdoses cost the state upwards of $2.1 billion in 2016.

Burke County is taking the fight against the opioid epidemic to its source.

Morganton, NC – County officials announced that they are joining a growing movement across the nation and filing a lawsuit against manufacturers and distributors of opioid-based pharmaceuticals such as OxyContin, Hydrocodone, and Fentanyl.

These medications are Schedule II controlled substances under the United States Controlled Substance Act. This means that while there are medical uses for the substances, there is an increased risk of abuse and dependence and are therefore highly restricted.

Burke Country claims the drug companies, which include the “big three” distributors—Amerisourcebergen, Cardinal Health, and the McKesson Corporation—simply ignore those restrictions. Other manufacturers included in the suit are Purdue Pharma Inc. and Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson.

The 166-page complaint, which the county’s attorneys filed with the District Court in Asheville, claim that the companies are guilty of creating a public nuisance, racketeering, negligence, and fraudulent misrepresentation. The county is seeking to recoup monetary damages for the increased cost of public services such as law enforcement and medical treatment, as a result of the companies’ failure to uphold their regulatory and legal duties.

Appalachia has been front and center in the nation’s opioid crisis. North Carolina ranks thirteenth in the nation for opioid prescriptions, and in a 2014 survey more than 300,000 North Carolinians admitted to misusing opioids. That same year, 1,100 overdose deaths were reported in the state. The complaint states that “The problem is only getting worse: between 2015 and 2016, opioid related overdose deaths in North Carolina are expected to rise to approximately 1,200.”

Burke County has seen a spike in opioid-related deaths in recent years, climbing from 105 between 1999 and 2007 to 174 deaths between 2008 and 2016. They have also seen an increase in the number of children born addicted to opioids; many of those children consequently enter the foster care system as a result of parents who are addicted or, in some cases, die from misuse and overuse of the medications.

The Department of Health and Human Services estimates that deaths caused by unintentional overdoses cost the state upwards of $2.1 billion in 2016, a figure that is expected to rise.

The complaint also states that the companies knowingly misled both physicians and the public about the dangers of long-term opioid use and the risk of addiction, using intricate disinformation campaigns through collaboration with third-party individuals and companies in an attempt to circumvent the Food and Drug Administration and the Drug Enforcement Agency.

One of the most glaring examples is the use of the term “pseudoaddiction,” coined by Purdue employee Dr. David Haddox and popularized by Dr. Russell Portenoy, who was on the payroll of both Purdue and Janssen. They claimed that if a patient was asking their doctor for an increased dose of medication or the patient had been going to multiple doctors, a tactic called “doctor shopping,” that the patient is not addicted to opioids, but rather the doctor is under-prescribing the medication and the patient was still in pain. Contrary to the scientific evidence, they claimed that the medications had no maximum dosage, therefore the doctor should simply increase the amount of the patient’s prescription.

The distribution of these substances to doctors and pharmacies, according to federal and state law, is supposed to be strictly tracked by both the manufacturers and distributors. This includes reporting, investigating, and halting suspicious orders. The suit claims that the companies not only failed to report questionable orders to the DEA through the data collection system known as ARCOS, but in some cases, were denying that they had a legal obligation to investigate such orders.

Instead, they were compiling databases of their own and increased marketing to doctors they knew were over-prescribing their medications, while turning a blind eye to the overwhelming evidence that the prescriptions were being sold on the black market.

The companies’ actions and omissions have not only cost North Carolina and Burke County residents money, but lives. And the lawsuit is one more battle in the war to end the opioid epidemic that is raging across the United States.

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