Earlier in February 2012, the DEA accused both CVS Pharmacy, one of the nation’s largest drug store chains, and Cardinal Health, one of the nation’s largest legitimate distributors of pharmaceuticals, of endangering the public by selling excessive amounts of oxycodone to four Florida pharmacies. For Cardinal Health, the charges came in an immediate suspension order served Feb. 3, 2012, when the DEA suspended Cardinal’s license to distribute controlled substances from its Lakeland, Florida location, which serves four states, according to USA Today. Lakeland is located between Orlando and Tampa.
Cardinal immediately challenged the suspension in federal court denying the charges. The DEA’s suspension was temporarily lifted and a hearing was scheduled in the federal district court in Washington, D.C. In preparation for the hearing, the DEA and Cardinal filed hundreds of pages of documents that provide a look into how prescription painkillers have infiltrated the black market. We are attempting to obtain copies of some of these so that we can share them with other interested attorneys and individuals.
As reported in various media sources, the investigation into Cardinal’s operation began after a Cardinal investigator became aware of a rumor that a local pharmacy was selling oxycodone by the pill for cash. This Florida pharmacy was reported to be one of Cardinal’s biggest customers.
Over the next two years, Cardinal employees allegedly visited the same pharmacy at least four more times. Each time, they noted the following suspicious signs: Customers paid cash, oxycodone was the top seller, and young people came into the pharmacy in groups to have their prescriptions filled. The pharmacy allegedly dispensed 462,776 oxycodone pills over a two month period — which is what the DEA states is approximately seven times what the average pharmacy dispenses in a year. Additionally the pharmacy allegedly asked Cardinal for more. Cardinal filled the order for more oxycodone but terminated the pharmacy as a customer.
By the time Cardinal cut the pharmacy off in October 2011, police had arrested at least three doctors who were associated with or had their patients’ prescriptions filled at the pharmacy. Law enforcement officials charged them with trafficking in oxycodone, racketeering and over-prescribing narcotics.
Then, in early February 2012, the DEA reportedly suspended the DEA registrations (sometimes called “DEA numbers” or “DEA licenses”) of four of Cardinal’s largest Florida customers. These suspensions demonstrate the DEA’s strategy to combat the country’s prescription drug abuse problem at the highest levels, regardless of the size or reputation of the company. After years of attacking doctors who dispense drugs from pain clinics, DEA agents are now targeting the legitimate pharmaceutical distributers — the top of the legitimate drug supply chain.
The number of overdose deaths involving prescription pain medications allegedly now exceeds deaths from heroin and cocaine combined, which motivates state and federal agents to be more aggressive in fighting against misuse of drugs.
Under the federal Controlled Substances Act, the DEA regulates every link in the supply chain for controlled substances such as oxycodone and hydrocodone, including manufacturers, distributors, doctors and pharmacies. According to the DEA, approximately 1.4 million entities have DEA registrations to handle controlled pharmaceuticals. The law requires pharmaceutical distributors, like Cardinal Health, to have systems to detect suspicious orders, which must then be reported to the DEA. Additionally, federal regulations require that any thefts, losses or shortages of controlled medications be reported to the DEA.
In court documents filed in response to Cardinal’s challenge, the DEA said Cardinal ignored “red flags” raised to detect suspicious orders. However, Cardinal argues that volume alone is not enough to determine whether a pharmacy is diverting the drugs, because it does not account for a pharmacy’s location, the age and health of the population, and the proximity to hospitals, nursing homes and cancer centers.
The DEA routinely cites the volumes of drugs a pharmacy fills or the numbers of tablets of a certain type of medication for which a doctor writes prescriptions. This is also a factor the DEA uses in cases we have seen where it seeks to suspend or revoke the DEA registrations of physicians and pharmacies in administrative cases. However, some judges have expressed a reluctance to admit such “bean counting” or naked numbers as being irrelevant, when not supported by testimony or evidence placing the numbers into context with other factors, such as the physician’s practice, patient mix, standards of treatment, severity of illness, etc.
In the federal court case now pending, Cardinal has stated in papers filed that it has a “robust” detection system and has cut off more than 330 pharmacies, including 140 pharmacies located in Florida, over the past four years that it decided posed an unreasonable risk of diversion.
In a news article posted late on February 29, 2012, the Associated Press advised that federal Judge Reggie Walton had ruled against Cardinal Health earlier in the day. Apparently Cardinal Health had originally obtained a “stay” (sometimes referred to as a “temporary restraining order” or “temporary injunction”) against the DEA’s suspension order. However, after a hearing held on February 29 in which Cardinal Health sought an injunction against the DEA’s enforcement of its suspension, Judge Walton announced a decision form the bench. He reportedly refused to grant Cardinal Health an injunction against the DEA, apparently agreeing with the DEA’s position.
This battle between Cardinal Health and the DEA is an important one as it demonstrates the DEA continued efforts to attempt to exert more control over pain clinics, pain management physicians, pharmacists, pharmacies, and now, pharmaceutical distributors. If you believe that the DEA is investigating you, your facility, your company or if you want to learn more about the legal implications of pain management, visit our website to learn more.
Sources for this article included; the Orlando Sentinel, Boston Globe, Associated Press, USA Today and Florida Today.
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law