Earlier this year, dozens of health systems in Texas filed a civil lawsuit against opioid manufacturers, distributors, and retailers. Two local entities, Parkland Hospital and Health System and McKesson Corp., are on opposite sides of the lawsuit. But why are the health systems taking legal action, and should distributors be held accountable for what physicians are prescribing?
In 2010, opioid prescriptions peaked when providers wrote 81.2 prescriptions per 100 persons. In 2017, around 57 million people had at least one prescription for opioids, with 191 opioid prescriptions dispensed, according to CDC data.
Darren Nicholson, of Burns Charest LLP in Dallas, is one of the lead attorneys for the plaintiffs and says the lawsuit centers around unreimbursed care. When a patient shows up at the emergency room, hospitals have to treat them, and uninsured patients are increasingly being admitted for opioid abuse, passing those costs along to the hospital. While uncompensated care is reimbursed by the government, the full costs are rarely recovered.
But treating addiction isn’t the only complication. If a patient comes in for another illness or injury, opioid addiction magnifies the hurdles to recovery. If the patient needs surgery and requires pain management medication, an they can’t be treated like everyone else. “The costs associated with treating people with opioid addiction are greater than non-opioid patients,” Nicholson says.
But are the distributors and manufacturers responsible for questioning decisions approved by physicians who allegedly have the best interest of the patients in mind? Nicholson says the recent epidemic is due to the behavior of the defendants. “Opioids are one of world’s oldest drugs, and are not new by any measure. So what has happened that has caused this epidemic to arise?” Nicholson says.
Nicholson describes a well-funded and specific marketing campaign that began in the 1990s, where key opinion leaders were paid to come up with a narrative that these drugs were safe and effective, expanding their use beyond palliative care, trauma, or hospice care. The campaigns said the drugs could be for long term use and wouldn’t cause addiction, and were targeted toward physicians and even made it into medical school literature. “That is what changed. The drugs weren’t new,” Nicholson says.
But could it be just poor training and understanding by physicians, who should have known better? Nicholson says the scale of the problem is evidence that it is not just bad doctors, but bad information. “It is not the case that entire medical profession went rogue, which is a common pharmaceutical defense, to point to physicians,” he says. Physicians rely on accurate medical literature, trustworthy pharmaceutical representatives, and others to gain the expertise they need to prescribe the medicine. “We poisoned the tree of knowledge that doctors rely upon, and now it is all on them,” Nicholson says.
The case has been in the works for a while, but verdicts around the country have been leaning the plaintiffs’ way. There has also been discussion of a nationwide or several statewide settlements totaling billions of dollars, but those negotiations are still underway.
But pharmaceutical distribution advocates, including the Healthcare Distribution Alliance, see it differently. The trade association that represents McKesson, Cardinal Health, and other pharmaceutical distributors says that opioid addiction is complex, but punishing the distributors is missing the root cause.
“The misuse and abuse of prescription opioids is a complex public health challenge that requires a collaborative and systemic response that engages all stakeholders. It’s also critical to understand the role of each stakeholder across the supply chain. Distributors do not conduct research, manufacture, market, or prescribe medications, nor do they influence prescribing patterns, the demand for specific products, or patient-benefit designs.” says John Parker, SVP of Communications, Healthcare Distribution Alliance. “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. Those bringing lawsuits would be better served addressing the root causes, rather than trying to redirect blame through litigation.”
In addition, HDA says that all sales of opioids are reported to the DEA, who has the opportunity to intervene with physicians and pharmacies if they see suspicious prescribing patterns. The DEA is actually responsible for determining the number of opioids that are produced, but between 1993 and 2015, the DEA approved a “39-fold increase of oxycodone and a 12-fold increase of hydrocodone to meet what it believed were legitimate medical needs.”
The opioid epidemic is a complex one, with many players at fault. When the Centers for Medicare and Medicaid Services began evaluating and paying hospitals based on patient surveys that asked how patients’ pain was managed in 2006, providers had an added incentive to avoid pain and increase opioid prescriptions. In 2016, the DEA decreased the opioid production quotas, and in 2017 CMS removed the questions from the survey.
But there are thousands of cases across the country with plaintiffs that include consumers, state attorneys general, cities, municipalities, and hospitals being decided against the opioid producers and distributors, they seem to be receiving much of the blame. Though the cases are different, “The fundamental liability and bad conduct is the same across the board,” Nicholson says.