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Civil Liability for Diversion of Opioids

Mon, 04/24/2017 - 09:25 -- admin25

by Kay L. Van Wey

An estimated 1.9 million people in the United States have an opioid addiction and another 586,000 suffer from heroin addiction. Eighty percent of heroin addicts started with opioids. More than 28,000 people die every year from an unintentional opioid overdose. The United States consumes 90 percent of the world’s supply of hydrocodone. Although addiction was once believed to be reserved for people of ill repute or poor willpower, it is now recognized as a brain disease which alters the brain circuits responsible for reward, habit and decision making.

So, how did we get here?

At one time, opioids were reserved for patients with post-surgical pain, acute injury pain or cancer pain. But, a movement inspired by the drug manufacturers created a new disease known as “chronic pain syndrome.” By 2013, doctors were writing a quarter of a BILLION prescriptions for opioids every year…enough for every American adult to have their own bottle of pills.

So, what causes of action are available for patients?

Physicians, Physician’s Assistants, Nurse Practitioners, and Pain Clinics are liable under traditional negligence and negligence per se standards. It is illegal to prescribe a drug without a valid medical need. The Texas Medical Board has very specific guidelines on prescribing to try and limit doctors who abuse their DEA license, as well as to give guidance to legitimate pain physicians on how to avoid trouble.

Pharmacists and Pharmacies have a corresponding duty to ensure that a prescription is written for a valid medical purpose before filling it. The Texas Pharmacy Board gives clear guidance on how pharmacists can spot suspicious prescriptions and suspicious prescribers.

All of the above are traditional subjects of medical malpractice cases and are therefore subject to all of the limits and restrictions imposed upon Texas patients.

An often-overlooked defendant is the wholesale distributor of the drugs. In a situation where a doctor or clinic is prescribing an excessive amount of illegitimate pain killers and a pharmacy is filling them indiscriminately, a drug wholesaler has a legal duty to stop the flow of drugs to the pharmacy. This is commonly referred in the industry as “know your customer.”

The law requires drug wholesalers to have sophisticated monitoring programs which can detect “suspicious orders.” They can slice and dice the data to spot suspicious orders, investigate the cause and stop shipment to the pharmacy, if the pharmacy appears to be diverting the drugs for non-legitimate purposes. In addition, field representatives for the drug wholesalers are required to “know their customer” in order to determine whether, in the context of the patient demographics of the pharmacy’s customers, the orders are suspicious and indicative of drug diversion. If, and when the drug wholesaler suspects a suspicious order, they are required to report it to the DEA so that the agency can suspend or revoke the DEA license of the pharmacist and/or pharmacy and potentially the doctor who prescribed the high number of opioids.

The DEA and other government agencies have the authority to bring civil enforcement actions against drug wholesalers, who fail in their duty to monitor the fulfillment of suspicious order and to report DEA registrants who are making suspicious orders. The efforts of the government, however, have been lackluster at best. Civil case filings by government entities against manufacturers, pharmacies, and doctors dropped from 131 in 2011 to 40 in 2014. Immediate suspension orders fell from 65 to 9. In 2016, Congress passed a bill allowing distributors, accused of failing to report suspicious orders, to file a “corrective action plan” to avoid enforcement proceedings against them. Additionally, many of the officials at the DEA who were responsible for enforcement were hired away by the drug industry.  See Scott Higham, Lenny Bernstein, Steven Rich and Alice Crites, “Drug industry hired dozens of officials from the DEA as the agency tried to curb opioid abuse,” The Washington Post, December 22, 2016.

In conclusion, there is a societal need for litigation to be pursued on behalf of persons who have become addicted to opioids, as a result of improper prescribing practices. Once believed to merely be medical malpractice cases with all the attendant difficulties due to “tort reform”, a negligence and negligence per se cause of action may be considered with the correct fact pattern.

Kay L. Van Wey is the owner of Van Wey Law, PLLC. She can be reached at kay@vanweylaw.com.

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