Lawsuit: Walgreens prescription error killed man

JACKSONVILLE -- When Terry Paul Smith complained about the drug he'd been taking for back and leg pain, his doctor changed the 46-year-old roofer's prescription to methadone, a narcotic pain reliever.

Smith filled the prescription at a Walgreens pharmacy here and took the first pills soon after returning to the long-term-stay motel where he'd been living with his wife and children.

Within 36 hours, he was dead, curled up on the shower floor.

Next week, a Duval County jury is scheduled to begin weighing allegations that a small yet catastrophic Walgreens error in the directions on the pill bottle caused the July 2001 tragedy.

"I was angry and very devastated. I didn't understand how that mistake could be made," Smith's widow, Pearl, said in an interview.

The case is the fourth prescription-error trial involving a fatality since September 2006 for the nation's largest drugstore chain in sales and profits. Jurors in Illinois, Arizona and Florida have rung up more than $61 million in prescription-error verdicts against Walgreens WAG in the three previous trials.

The Illinois-based pharmacy chain has challenged the three verdicts and has moved to dismiss the court complaint filed by attorneys for Smith's family. Nonetheless, the cases could pose a safety and image challenge for the company that calls itself "The Pharmacy America Trusts" as the rapidly expanding chain vies with industry rivals that have been similarly sued in prescription-error lawsuits.

"If it gets a lot of press, and these things recur every month and the press keeps picking up on it, publicity could end up hurting them a little bit," said Joseph Agnese, a Standard & Poor's equity analyst who covers the drugstore industry. "If it's something that's recurring and you see the risk (of a prescription error) as being really high, it could begin to impact your behavior. But we're not anywhere near that right now."

Like Agnese, John Ransom, an equity analyst and director of health care research for Raymond James & Associates, said prescription errors account for a fraction of the more than 583 million prescriptions Walgreens dispensed during the fiscal year that ended in August.

"I'm sure it has an effect, but it's hard to quantify it," Ransom said of the cases and attending publicity. "It's not great."

Walgreens took a similar stance, emphasizing what it contended was a relatively small number of misfills. "These cases span a number of years, during which millions of prescriptions were filled by Walgreens and other pharmacies every day. The verdicts are clearly outside the norm, rather than a trend," said company spokesman Michael Polzin.

"We strongly disagree with these verdicts, none of which are final," he said.

Like most pharmacies, Walgreens is coping with a market shortage of pharmacists at a time when national prescription volume is increasing. Parts of 42 states were identified as facing a pharmacist shortage in a January employment survey by the National Association of Chain Drug Stores.

And the number of prescriptions for all retail, long-term care and mail-order pharmacies nationally rose from 3.3 billion in 2002 to 3.7 billion in 2006, according to data from IMS Health, a pharmaceutical and health care consulting company.

In part, the trends have resulted in pharmacies' increased reliance on technicians, who have less training and lower salaries than pharmacists, to help fill prescriptions.

Walgreens has spent more than $1 billion in the last decade on pharmacy safety systems, safety training and technology, Polzin said. "These investments have made prescription errors a rare occurrence, but when they do occur, we handle the situation as fairly and compassionately as possible," he said.

But a court complaint submitted by Smith's attorney, Carl Scott Schuler, alleges that Walgreens failed to establish a system "that was reasonably likely to track and to prevent prescription errors." That failure, said Smith, proved tragic.

The day Terry Paul Smith died

Plagued by neuropathy, a disorder of the peripheral nerves that caused pain in his legs and back, Pearl Smith's husband had been taking prescriptions for OxyContin and Neurontin, she said. But he didn't like the way the drugs made him feel, such as the way he'd sometimes "drop out" in the middle of a conversation.

The family's primary care physician, William Carriere, prescribed a switch to 10-milligram pills of methadone on July 23, 2001, court records show. The prescription contained instructions to take four tablets twice a day for chronic pain.

But the Walgreens pharmacy on Jacksonville's Merrill Road dispensed the prescription with instructions to "take four (4) pills as needed for chronic pain," according to court records.

Smith says the medication vial made no mention of any dosage limits. And no one from Walgreens counseled her husband about how to take the painkiller. Instead, the employee who handed out the prescription when the couple drove up to the pharmacy's drive-through window asked, "You don't have any questions for the pharmacist, do you?" Smith said, describing her recollection of the exchange.

"It was a negative question the way they asked it," she said.

Her husband took the methadone tablets several times over the next day. The couple argued that night, Smith said, then patched up the quarrel before bedtime. She went to sleep while her husband, scheduled to leave for a roofing job early the next morning, went into the bathroom to wash up.

Smith said she awoke the next morning, and found him dead in the shower.

The death certificate initially stated that he had died of a heart attack. But Smith, who said her initial requests for an autopsy went unheeded, persuaded the county medical examiner to have her husband's body exhumed for testing in October 2001 by stressing that he had started taking methadone shortly before he died.

The autopsy report showed Terry Paul Smith had died of methadone toxicity, court records show. Pearl Smith contacted attorneys, who spotted the alleged error in the instructions for her husband's prescription.

"It swept me at the knees," she said, recounting her reaction when she was first told about the discovery. "I couldn't understand how that mistake could be made."

In a motion seeking dismissal of the case, Walgreens argued that lawyers for Smith's family should be barred from alleging direct negligence by the company. The company has also contended that Smith's death was caused by heart-related problems, not methadone.

Smith's death was one of several recent fatality cases involving Walgreens:

•In August, a Polk County jury in Florida handed up a $28.5 million verdict for the family of Beth Hippely, whom a Walgreens pharmacist in 2002 gave blood-thinner medication 10 times stronger than her doctor had prescribed. Jurors concluded the error caused the 42-year-old mother of three, who was undergoing treatment for breast cancer at the time, to suffer a serious stroke. The attack left her an invalid and forced a halt in her cancer treatment. Hippely ultimately died from the cancer earlier this year.

In a motion for a new trial, Walgreens argued that the size of the verdict was excessive and "contrary" to evidence in the case. Lawyers for the company wrote that jurors had been "unduly influenced by passion, prejudice or other matters." A court hearing on the motion Thursday ended with no immediate ruling.

•Last month, an Arizona jury awarded $6 million to the family of Eric Warren, a 31-year-old insurance agent and high school wrestling coach who died of a toxic drug interaction in 2002. A Walgreens pharmacist failed to counsel Warren about the danger of simultaneously taking the two drugs — methadone and tramadol — and also failed to double-check the prescription with his doctor, court filings by Warren's family charged. The alleged failures were violations of Walgreens' safety procedures, the family charged.

Arguing that the company was not negligent, Walgreens lawyers contended that Warren bore some responsibility for his own death, according to a trial summary prepared by the Warren family attorney. Walgreens spokeswoman Laurie Meyer declined to comment on the accuracy of the summary because the company is weighing an appeal of the verdict. She said, however, that the prescription was filled as prescribed.

•In September 2006, a Cook County, Ill., jury decided Walgreens should pay a $31 million judgment for the 2002 death of Leonard Kulisek. The 79-year-old was given an incorrect prescription by a Walgreens pharmacist instead of his gout medication. The pharmacist, who later admitted he'd been abusing prescription painkillers, dispensed Glipizide, a drug that caused Kulisek's kidneys to fail. The error forced him to undergo regular dialysis and started what proved to be a fatal health slide, argued David Axelrod, a lawyer who represented the administrator of Kulisek's estate.

Attorneys for Walgreens acknowledged that Kulisek was given the wrong drug but argued that the mistake did not cause his death. They filed a motion for a judgment in the company's favor notwithstanding the verdict. Among other arguments, Walgreens contended that its conduct did not rise to the level of recklessness legally necessary to justify the punitive damages awarded by the jury.

Negligence or 'mental mistake'?

Walgreens said the company regularly upgrades its Intercom Plus pharmacy computer system in an effort to maximize patient safety and prevent repetition of any prescription errors that occur. Among other things, the system features alerts about sound-alike medications and provides screen images of the original prescriptions from doctors.

Schuler, however, said the error that killed Terry Paul Smith occurred despite the Walgreens precautions. The court complaint he filed for Smith's family accuses the company of corporate negligence, an allegation echoed by Pearl Smith but questioned by the judge assigned to the case.

In a September pretrial ruling, Judge L. Haldane Taylor wrote that the incorrect dosage directions "appears to be an act of mental mistake as opposed to any intentional act or wanton and gross conduct."

The ruling denied Schuler's effort to seek punitive damages against Walgreens. Schuler said he still hoped to raise questions during the trial about Walgreens' corporate responsibility, a strategy Smith's widow supported.

"It happened for nothing," she said of her husband's death. "It happened because somebody wasn't doing their job. Somebody didn't care enough to be right."

"Has a pharmacy ever made a mistake filling your prescription? Do you check your prescription for accuracy after you pick it up?"