It is no secret that opioid use (and abuse) has reached an all-time high in the United States over the past decade. Over 92 million individuals were prescribed opioid pain medication in 2015, representing 38% of the total U.S. population. Despite no overall change in the amount of pain reported by Americans, the sales of prescription opioids quadrupled from 1999 to 2014. With approximately two million reporting that they struggle with an addiction to pain medication, the opioid epidemic in this country has also resulted in an increasingly alarming number of deaths.
The Center for Disease Control reported 22,000 prescription opioid-related deaths in 2015, the equivalent to about 62 deaths each day, and an increase from 19,000 deaths reported in 2014. As the number of prescriptions has increased, so has the number of medical malpractice claims. If recent trends are any indication, lawsuits against medical providers, pharmaceutical companies, and drug wholesalers will likely increase as the opioid epidemic in the United States shows no sign of waning.
A History of Pain Medication Litigation
When it comes to opioid use, pharmaceutical companies are no stranger to lawsuits and have predated the eventual claims against the prescribing doctor themselves. Back in 2003, Purdue Pharma, the maker of OxyContin, was sued for its failure to warn patients against the risk of addiction in its medications. Four years later, the company eventually settled with its 5,000 pain patients for $75 million. At the same time, the company and three of its executives pled guilty to federal criminal charges for misleading patients and physicians and covering up clinical evidence about their medication’s addictive properties.
Since then, the same attorney in the Purdue suit filed claims against opioid manufacturers on behalf of cities and counties in five states that have suffered what has been described as a “public health and safety crisis,” costing hundreds of millions of dollars. Governmental officials from all over the country have filed suits against drug manufacturers and distributers, seeking to hold the companies responsible for “the strain on public services that drug addiction has caused.” Lawsuits allege that the companies engaged in deceptive marketing practices, including rewarding doctors for writing prescriptions. In addition, this past June a bipartisan coalition of 35 state attorney generals launched a multi-state investigation into opioid manufacturers. Many have compared the recent surge of lawsuits and investigations to the infamous movement against Big Tobacco, which resulted in cigarette companies paying out a $248 billion civil settlement.
A Doctor’s Responsibility: Medical Malpractice Claims
The pharmaceutical companies are but one entity in the supply chain of opioid medication, as the lawsuits have also trickled down to the prescribing doctors. Over the past four years, medication-related claims have been cited as the fourth most common medical malpractice cause of action, ahead of obstetrics-related complications. Forty-two percent of the alleged errors occurred in an office or clinic, with thirty-one percent related to inadequate patient monitoring, according to a study conducted by the medical liability insurer, Coverys. Thirty-eight percent of the claims involve the death of a patient.
In the same study, prescription computation was found to be the leading cause of medication errors, followed by the management of the medication. The majority of medication-related errors occurred within general medicine practices, opposed to other specialties. Opioid prescriptions make up almost twenty-five percent of such claims, making pain medication the most frequent root cause of medical malpractice actions involving prescriptions.
The claims often involve overdoses, with alleged medical errors occurring during the patient’s follow-up visit. According to Robert Hanscom, M.D., the Vice President of Coverys and co-author of the study: “Physicians continued to renew prescriptions without monitoring patients to see if they were getting better or not, if there were any changes in their clinical status…If patients are still in pain, that’s a red flag. It’s not helpful to keep prescribing the same opioid if they’re not improving.” When treating a patient with any kind of medication, there are risks involved at every stage, particularly during the initial clinical assessment and prescription.
Likewise, responsibly dispensing, administering, and monitoring are critical in determining whether a patient is on the right medication, at the right dosage, and for the right amount of time. Researchers point to patient mismanagement as a possible cause of such medical malpractice actions, while noting that doctors sometimes renew a patient’s prescription without reevaluating their current health status. Another cause of medical malpractice is physicians failing to properly advise patients of other treatment options.
However, proper care is not given when patients obtain such prescriptions through “pill mills,” where doctors perfunctorily write opioid prescriptions without first examining the patient. In July 2016, a Missouri jury awarded a plaintiff $17.6 million in a medical malpractice case against his primary care doctor after the patient was routinely prescribed pain medication that exceeded the recommended amount. The plaintiff, who was suffering from back pain at the time, ended up battling a drug addiction. The verdict was thought to send a strong message to doctors about the need for opioid reform.
One particularly egregious example of abuse is former doctor, Robert Rand. In 2015, the Nevada Board of Medical Examiners charged Rand with 74 counts of medical malpractice, alleging that he “violated the standards of practice in regard to opioid prescribing, practiced medicine beyond the scope of training and competence, engaged in unsafe and unprofessional conduct and maintained substandard medical records.” The complaint alleged that Rand prescribed massive amounts of opioids to his patients which were several times more than the high dose threshold. One such patient subsequently died from alcohol oxycodone intoxication.
Rand was also found guilty in federal criminal court for involuntary manslaughter and distribution of controlled substances, to which he was sentenced eight and ten years concurrently.
Like the lawsuits filed against the pharmaceutical companies, cities and states are taking action against doctors as well. Dozens of medical malpractice lawsuits have been filed by West Virginia (the state with the highest overdose death rate) and McDowell County (the county with a death rate three times higher), alleging that doctors overprescribed pain medication and flooded the market with substances that led to the plaintiffs’ uncontrollable addiction and subsequent deaths.
The future of opioid-related medical malpractice claims will likely depend on the accepted standard of care established by researchers and experts in the field. All agree that no doctor should be prescribing opioid medication to patients without first examining them, and to do so would be an obvious deviation from the acceptable standard of care. As established by the Drug Enforcement Administration, medical providers must first apply for and be granted a DEA number, which is connected to each of the provider’s prescriptions. In conjunction, the doctor must maintain a record of the patient’s examination that substantiates the prescription.
Likewise, a full medical history (including any history of addiction) should be taken by the doctor. While pain medication is ideally a short-term solution, sometimes a patient’s pain cannot be relieved. In which case, the patient can be referred to a pain management doctor who specializes in the management of chronic pain. Such a referral avoids a general practitioner from treating a pain that is beyond his scope of practice.
While most medical experts would attest to the above practices, as the opioid epidemic continues to pervade, recommendations and standards of care are continually being reevaluated and revised. Some medical professionals have proposed urine screening to ensure patients are taking the correct dosage of medication. The advent of computer tracking of prescriptions can make it easier to hold doctors and pharmacists accountable. Also, some states, such as Pennsylvania, are passing legislation that limits the amount of opioids that can be described at any given time but for certain exceptions.
As long as humans experience pain, there will always be a need for pain medication. In which case, the regulation of opioid prescriptions needs to be closely monitored and constantly reevaluated in light of the current drug use trends.