Senator Warns FDA about New, Stronger Painkillers

New York Senator Charles Schumer has seen the effects of prescription drug addiction in his state and has vowed to fight it.  He warns that a new painkiller promising to be 10 times stronger than Vicodin could lead to more violent and deadly drug store robberies.

In June 2011, New York resident David Laffer was charged with robbing a Long Island drug store of more than 10,000 highly addictive prescription painkillers and killing four people in the pharmacy.  He and his wife had been doctor shopping before the robbery in an effort to get prescription pain pills like hydrocodone, which is highly addictive.

Nationwide, more than 1,800 pharmacies have been robbed in the past three years alone.  Long Island alone has experienced a 125 percent increase drug store robberies.

“It’s tremendously concerning that at the same time policymakers and law enforcement professionals are waging a war on the growing prescription drug crisis, new super-drugs could well be on their way, flooding the market.  The FDA needs to grab the reins and slow down the stampede to introduce these powerful narcotics” Senator Schumer said.

The new painkillers, which contain pure hydrocodone, could come onto the market as early as 2013, with big pharmaceutical companies looking to cash in on the $10 billion prescription painkiller market.  At present, hydrocodone is classified as a strictly controlled Schedule II drug under the 1970 Controlled Substances Act. 

Products that contain hydrocodone and another painkiller like acetaminophen fall into Schedule III, which is less strictly controlled.  Some experts argue that because of this, highly addictive hydrocodone has been given to more patients, which has increased abuse of the drug and overdose rates in the United States.

A prescription painkiller that contains pure hydrocodone could lead to more accidental overdoses, leading to more emergency room visits.  Experts say that already thin hospital emergency room resources could become even more strained if this new drug is allowed on the market.  In 2008 alone, emergency room visits related to hydrocodone abuse totaled more than 86,000, up more than 400 percent from 2000 when an estimated 19,000 visits were recorded.

To learn more about prescription drug addiction, read my article “America’s Growing Addiction” at www.vanweylaw.com

A Tribute to Ken & Esther Scarborough

Far too many families have been devastated by a loved one’s addiction to prescription drugs. Unlike the images we conjure up when we think of a typical drug addict, the faces of prescription drug addiction are the faces of ordinary Americans. One of the casualties of prescription drug addiction was Christopher Scarborough, the 25 year-old son of Ken and Esther Scarborough of Kountze, Texas.

I came to know the Scarboroughs when I represented them in a legal case, which sought to hold the negligent parties accountable for Christopher’s death and to raise awareness about these pill mills, which often masquerade as pain management clinics. In the lawsuit, we alleged that the healthcare providers and clinic owners were nothing more than “drug dealers” who were trying to pass off their “pill mill” as a legitimate pain management clinic.

When Christopher went to this walk-in “pain management clinic,” he was prescribed a cocktail of more than 300 highly addictive narcotic pills, without even receiving an exam or seeing a doctor. Shortly thereafter, Christopher tragically died of an accidental overdose.

Rather than dwell on their son’s heartbreaking death, the Scarboroughs have chosen to help other families who have lost loved ones to prescription drug addiction and accidental overdose.

Since their son’s death, the Scarboroughs have worked every day to fight against the prescription drug epidemic in their son’s name. In 2009, they founded Parents Against Prescription Drug Abuse (PAPDA), a 501(c)(3) nonprofit corporation. They have also testified before the Texas Senate, worked to pass legislation to regulate the so-called pain clinics, given countless talks, and comforted other parents who have also lost their children to prescription drug overdoses.

The Scarboroughs need your help to continue their fight. You can help by making a tax deductible contribution to PAPDA at www.papda.net. Your contribution, no matter how slight, will help Ken and Esther keep fighting every day to prevent the reckless prescribing of narcotics from claiming another innocent life.

Sanchez v. Wal-Mart Update

 On December 25, 2010, the Nevada Supreme Court issued its opinion in Sanchez v. Wal-Mart et al. Disappointingly, the Court held that under the circumstances of this case, pharmacies do not owe a duty of care to unidentified third parties like those injured by the impaired driver, Patricia Copening, in this case. The Court further held that Nevada’s pharmacy statutes and regulations, including NRS 453.1545, are not intended to protect the general public from the type of injury sustained in this case and do not express standards of care that extend to unidentified third parties like the appellants in this case. 

The good news is that the Nevada Supreme Court left open important questions that deserve answers different from the conclusions arrived at in this case. Significantly, the Court limited its holding to unidentifiable third parties affected by pharmaceutical practices before 2006 because the events in this case took place before 2006. The Court related that under 2006 amendments to its regulations, reflected in NAC 639.753, the Board of Pharmacy may have imposed a duty on pharmacies or created a special relationship that could justify imposing a duty in favor of third parties. The Court expressly did NOT determine whether that regulation does impose such a duty or create such a relationship.

Further, the Court did not discuss whether pharmacies owe a duty of care to customers or to identifiable third parties, such as relatives of customers. The Court’s holdings applied only to unidentifiable third parties.

 

Although I had hoped that the majority would reach different conclusions, I do applaud Justice Cherry and Justice Saitta for their well-reasoned dissent in this case. They argued that in the same way that the courts recognize that a special relationship exists between an innkeeper and guest, a teacher and student, and an employer and employee, a special relationship also exists between a pharmacist and a pharmacy customer. Therefore, pharmacies have a duty to take measures to protect foreseeable victims, like the third parties injured in this case, from foreseeable harm. The pharmacies should have foreseen the possibility that Patricia Copening would harm the victims in this case because of the actual notice that the pharmacies received from the Task Force, warning them that Copening had bought $4,500 hydrocodone pills within a 12-month period by having numerous prescriptions filled at 13 different pharmacies. After receiving this notice, the pharmacies should have recognized that Copening may be misusing the prescription drugs and that continuing to fill Copening’s prescriptions for hydrocodone or SOMA could result in harm to Copening or to others. They had a duty to review her records and to consider the Task Force letter before filling additional prescriptions.

 

The dissent also argued that the legislature designed various Nevada statutes to protect others against the type of injury that the appellants suffered in this case. According to the language of NRS 639.213 and 639.0070(1)(a), pharmacology affects the public safety and welfare, and the Board must adopt regulations pertaining to pharmacy practice in order to protect the public. Those provisions, coupled with other statutes that require pharmacists to ensure that substances are being dispensed only for medically necessary purposes, make it apparent that the legislature “intended to prevent pharmacy shopping and the overfilling of certain controlled substances, and ultimately to protect the general public from prescription-drug abuse and its effects.” Based on those statutes, the appellants in this case should be able to file a lawsuit against the pharmacies for negligence per se.

 

The law provides standards for pharmacists confronted with suspect prescriptions.  The Controlled Substances Act (Title 21 CFR 1306.04) recognized a pharmacist's independent duty to determine whether a prescription has been issued for a "legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" before dispensing the controlled substance to the customer.  The DEA's Pharmacist's Manual emphasizes this responsibility in its chapter "Prescription Requirements," section "Purpose of Issue," and again in its  chapter "Dispensing Requirements," sections "Internet Pharmacy" and "Central Fill Pharmacy." 

 

It is important to remember that sometimes pharmacies are the last line of defense and that a prescription is only worth the paper it is written on until it is filled.  Pharmacies and pharmacists cannot morally or legally turn a blind eye to suspect prescriptions and expect to suffer no consequences.

Nevada Supreme Court weighs pharmacists' liability for narcotics distribution

In the legal profession, we have an expression: "an oral contract is worth the paper it's written on." I think of this when considering the distribution of controlled substances. My rendition is : "a prescription is worth the paper it's written on until it is filled".

Pharmacists have the legal responsibility to ensure that a prescription is written for a valid medical purpose prior to filling it. However, a case that is currently pending in the Nevada Supreme Court may help to better define the duty of pharmacists in preventing prescription drug diversion.

The case, Sanchez vs. Wal-Mart et al, asks whether drugstores must use information at their disposal to protect the public from potentially dangerous customers.

As Amy Merrick reported in her article on SanchezCase Spurs Pharmacies' Fears of Lawsuits Over Drug Abuse, Patricia Copening bought nearly 4,500 doses of prescription painkillers in one year.  In June 2003, the Nevada Prescription Controlled Substance Abuse Prevention Task Force, which administers a computerized program mandated by Nevada Revised Statutes 453.1545 to track prescriptions for controlled substances, sent letters to 14 pharmacies in the Las Vegas area “warning them that Ms. Copening had purchased during the prior year 60 prescriptions, or nearly 4,500 doses, of controlled substances.” There is no record of any pharmacist so much as noting the task-force letter in Ms. Copening’s records.  Instead, the pharmacies continued to allow Ms. Copening to buy large quantities of hydrocodone and Soma, a cocktail “said to produce a euphoria similar to that induced by heroin.” 

On June 4, 2004, a year after the warning letters were sent to the pharmacies, Ms. Copening, under the influence of hydrocodone, ran her car into a 21-year-old delivery van driver, killing him at the scene, and hit a 33-year-old man, causing a head injury, broken right leg, and other wounds.  Ms. Copening faced charges of reckless driving, driving while intoxicated, and being involved in a fatal accident.  The injured and his family and the family of the deceased filed suit against Ms. Copening, the doctors responsible for most of the prescriptions, and multiple pharmacy-chain owners, including Wal-Mart, Walgreen, CVS Pharmacy and Rite-Aid.  Now the Nevada Supreme Court is left to define the responsibility that the pharmacies should have taken to protect the public from the effects of prescription drug abuse. 

In my opinion, this should serve as a wake-up call to pharmacies and large drugstore chains. They have the tools at their disposal to fight prescription drug diversion. If they can develop sophisticated systems to track the productivity of the pharmacists and to track inventory losses, they can also do a better job of slowing the flow of controlled substances for illicit purposes. Tracking productivity and inventory losses is good for drug stores because it helps make them more profitable. Saying no, on the other hand, costs money. Warranted refusals to fill prescriptions means "no sale." Make no mistake that these drugstores are about making money. This is one reason why holding pharmacies responsible for monetary damages is important. It is only when they think that they could be hit in the pocketbook for their negligence that they might take heed.

We at the Pill Mill Monitor will be watching this interesting case and will keep you posted.