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October 28, 2009 -- Wall Street Journal (US)

Case Spurs Pharmacies' Fears Of Lawsuits Over Drug Abuse

By Amy Merrick

Return to Drug War News: Don't Miss Archive

When Patricia Copening, a petite, 35-year-old doctor's office receptionist, bought nearly 4,500 doses of prescription painkillers one year, alarm bells sounded at the Nevada controlled-substance task force. The state board sent letters to 14 pharmacies in the Las Vegas area warning that Ms. Copening could be abusing drugs.

On the afternoon of June 4, 2004 -- a year after the letters were sent -- Ms. Copening climbed into a gray Dodge Durango, veered onto U.S. 95 and was seen weaving erratically in and out of three-lane traffic, witnesses later said. She plowed into 21-year-old Gregory Sanchez Jr., a delivery-van driver who had pulled over to repair a flat tire on the highway's shoulder, killing him at the scene. She also hit Robert Martinez, 33, who had been helping Mr. Sanchez move packages out of his van. Mr. Martinez suffered a head injury, a broken right leg and other wounds. Ms. Copening wasn't injured.

A lawsuit filed by Mr. Martinez, his family and Mr. Sanchez's family, now pending before the Nevada Supreme Court, may be the first U.S. case to address whether pharmacies can be held liable when a customer causes a fatal car accident. The case, Sanchez vs. Wal-Mart Stores et al, asks whether drugstores must use information at their disposal to protect the public from potentially dangerous customers.

The Nevada case is part of a broader movement under way to place more responsibility for patients' prescription-drug use on pharmacies.

Abuse of prescription drugs has risen dramatically over the past two decades, along with a surge in the number of controlled-substance prescriptions being written.

In 2007, U.S. retail pharmacies dispensed nearly 180 million prescriptions for opiates, such as hydrocodone and oxycodone, up from about 40 million in 1991, according to congressional testimony last year from the National Institute on Drug Abuse.

At the same time, pharmacists have much more patient information at their disposal, thanks to pharmacy computer systems and a proliferation of state online prescription-tracking databases. The availability of patient information is only expected to increase as electronic health records are adopted by more and more doctors.

As a result, consumers, government officials and pharmacies themselves are increasingly asking what a pharmacy is legally and ethically obligated to do with this newly available information.

This week, the National Association of Boards of Pharmacy is convening a task force to discuss pharmacies' roles in prescription-tracking programs. Separately, the association is considering whether to develop new guidelines about pharmacists' responsibilities to the general public. The issue "is not even an area we'd thought about until recently," says Carmen Catizone, executive director of the group.

Prescription-tracking systems are operating in 33 states, with the goal of identifying potential addicts and referring them for treatment, or getting law enforcement involved if necessary. Most have been set up since 2002. Last month, California launched the largest such database, covering 7,500 pharmacies and 158,000 prescribers.

With such programs, "there's certified information coming across, and that's where pharmacies are struggling" to know exactly how to respond, Mr. Catizone says. Earlier this year, the association passed a nonbinding resolution urging pharmacists to help reduce the excessive use of controlled substances by their customers.

The pharmacy industry -- which includes big chains such as Wal-Mart Stores Inc., CVS Caremark Corp. and Walgreen Co., all parties in the Nevada case -- acknowledges the growing public pressure to curb prescription-drug abuse. At a recent conference of the National Association of Chain Drug Stores, conference materials called preventing prescription-drug abuse "the new focus in the war on drugs." It noted that "public and private initiatives are looking to the entire supply chain, including retail pharmacy, to be part of the solution."

The drugstore chains contacted for this story declined to comment on the issue. The National Association of Chain Drug Stores also declined comment.

The chains are watching the Nevada case closely. Legally, it's one thing for a pharmacy to be held liable for hurting an individual customer by, say, filling a prescription with the wrong drug. But drugstores worry Sanchez could open them to broader and more ambiguous responsibility with significant consequences to the industry.

Some predict higher insurance costs and more expensive prescriptions, to absorb the costs of additional lawsuits. In court filings, Wal-Mart argued that pharmacies might decide not to stock certain regulated painkillers. Walgreen suggested that the judgment of pharmacists could be pitted against that of doctors, as pharmacists struggle to decide whether to refuse a prescription.

Michael Wall and L. Kristopher Rath, attorneys for Longs Drug, now owned by CVS Caremark, predicted a "tsunami of litigation" if the families prevail. Drugstores could be sued by their own customers if pharmacists refuse to fill valid prescriptions and customers are harmed, they said. Drugstores could also be sued by those who claim to be injured by a customer who purchased prescription drugs.

In their defense, the drugstore chains argue that they face a dilemma similar to that faced by bartenders in some states. Bartenders can be held liable for the acts of customers served too much alcohol. Similarly, doctors have been successfully sued by car-crash victims for failing to warn patients not to drive under the influence of certain medications.

Nevada was one of the first states to systematically share prescription information among doctors, pharmacists and law-enforcement officials when it set up a computer database to track potential drug abuse in 1997.

Under Nevada law, pharmacies must report their patients' controlled-substance prescription records each month. Staff members of the state's Prescription Controlled Substance Abuse Prevention Task Force filter that data for warning signs of abuse, such as purchasing drugs from multiple pharmacies. If a customer sets off enough red flags, the task force sends a form letter to the pharmacies the patient has visited.

"The focus of the task force is to get people into treatment and help them," says Larry Pinson, executive director of the state pharmacy board. "The primary option is for the pharmacist to speak with the patient."

But the law creating the task-force database isn't explicit about what pharmacies should do with the letters, he says.

In June 2003, the task force sent letters to the 14 pharmacies in the Las Vegas area, including Wal-Mart, Walgreen, CVS and others, warning them that Ms. Copening had purchased during the prior year 60 prescriptions, or nearly 4,500 doses, of controlled substances. Most were for medications containing hydrocodone, a frequently abused narcotic.

"It is not the Task Force's intent to determine how you dispense prescriptions," the letter said. "Well-informed pharmacists can and will use their professional expertise to assist patients who may be abusing controlled substances."

In Ms. Copening's case, there's no documentation of any pharmacist making a note in her customer records about the task-force letter, counseling her about drug addiction or refusing to give her prescriptions. She continued to buy large quantities of hydrocodone, as well as Soma, a muscle relaxant, from numerous pharmacies, according to her prescription records, which are part of the lawsuit. The combination of the two drugs, which is said to produce a euphoria similar to that induced by heroin, is known locally as the "Las Vegas cocktail."

That June afternoon in 2004, Ms. Copening left the Las Vegas OB-GYN clinic where she worked as a receptionist. She drove a Durango owned by her employer, Richard M. Groom.

Witnesses reported later that Ms. Copening was driving haphazardly, jerking her steering wheel from side to side. She appeared to be either laughing to herself or having a seizure.

Around the same time, Mr. Sanchez got a flat tire. He pulled his silver Airborne Express van onto the shoulder of U.S. 95 and sent a text message to a dispatcher: "Yo my tire blew."

Mr. Martinez, his co-worker, parked his own van behind Mr. Sanchez's vehicle, and the two men started moving freight out of the disabled vehicle. Ms. Copening swerved off the road and hit them both. Mr. Sanchez died at the scene. The coroner discovered tire tracks across his lower back. Mr. Martinez suffered multiple injuries and was taken to the hospital.

In Ms. Copening's car, police found prescription bottles and loose pills, 167 in total, of hydrocodone, Soma and other drugs. Police reports said Ms. Copening appeared confused. She took off her low-heeled sandals and tried to walk barefoot in a straight line, following a patrol officer's directions, but struggled to keep her balance. When police asked, she couldn't remember the name of one of her two children.

She claimed she had taken only medicine for a migraine headache that day; a blood test detected hydrocodone. She was charged with reckless driving, driving while intoxicated and being involved in a fatal accident.

Ms. Copening pleaded guilty to two counts of reckless driving and served nine months in jail. Through a spokeswoman, she and her attorney declined to comment. The state revoked the license of Dr. Groom's business partner, Doyle S. Steele, the doctor who wrote most of Ms. Copening's prescriptions. A few months after the accident, the Sanchez and Martinez families sued Ms. Copening and the doctors.

After the task-force records came to light in pretrial discovery, lawyers for Messrs. Sanchez and Martinez added seven pharmacy-chain owners -- including Wal-Mart, Walgreen, CVS Caremark and Rite Aid Corp. -- and one independent drugstore as defendants.

Individual pharmacists have been successfully prosecuted for knowingly filling controlled-substance prescriptions that weren't issued for legitimate medical needs. In guidelines to pharmacists, the federal Drug Enforcement Administration says: "The pharmacist who deliberately looks the other way when there is reason to believe that the purported prescription had not been issued for a legitimate medical purpose, may be prosecuted...." Pharmacies have said that the guidelines leave open questions about what practices are unacceptable.

In general, courts have found that doctors owe greater duties to patients when issuing prescriptions than pharmacists do when filling them.

But recent court decisions have expanded pharmacists' responsibility. In 1994, the Indiana Supreme Court ruled in Hooks SuperRx Inc. vs. McLaughlin that a pharmacy had a duty to stop dispensing painkillers to a patient who was refilling a prescription faster than normally would be appropriate.

In the Nevada case, Clark County district court Judge Douglas W. Herndon dismissed the pharmacies from the suit, noting that the Nevada law creating the task force doesn't specify what action, if any, is required by the pharmacies.

The families appealed to the state Supreme Court, which heard oral arguments in March.

Lawyers for the pharmacies argue that, while drugstores may choose not to sell drugs to a customer, they had no legal obligation to turn away Ms. Copening or to protect the general public from her actions.

In a statement, Walgreen said: "While we're sympathetic to those injured in Ms. Copening's car accident, we agree with the district judge's decision that our pharmacists fulfilled their legal duties." Similarly, Wal-Mart said, "This is a deep personal tragedy for the families involved." Because the court hasn't issued its decision, "we don't believe it's appropriate to say more at this time," the company said.

CVS Caremark, Rite Aid and Albertson's Inc., the parent company of Sav-On Drug, all declined to comment on the case. The parent company of Lam's Pharmacy, a Las Vegas drugstore, declined to comment.

Some regulators say that even if the drugstore chains are absolved of any legal responsibility in the Nevada case, their pharmacists still had ethical duties to respond to the task-force report. "That requirement is still there professionally, if not legally," says William Winsley, executive director of the Ohio Board of Pharmacy, which isn't involved in the Nevada case.

The Nevada Supreme Court is expected to issue its opinion by the end of the year.

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