Suits filed against OxyContin maker may be mere `tip of the iceberg'.

In the past six months, more than a dozen lawsuits have been filed against the maker of the highly addictive painkiller OxyContin and many doctors who prescribed it, seeking compensation for a recent surge in deaths and injuries associated with the drug. And more are on the way, according to lawyers representing the injured.

Dozens of plaintiffs have filed class action lawsuits in Kentucky, Ohio, and Virginia against the drug's manufacturer, Purdue Pharma LP, and others; the state of West Virginia, through its attorney general, is suing for reimbursement of state prescription and health care costs associated with OxyContin abuse; and several individual lawsuits in those states and others claim that doctors negligently prescribed the drug.

"We're looking at potential claims in a broad range of states," said Troy Giatras of Charleston, West Virginia. He heads a recently formed OxyContin litigation group for ATLA members. "We had an organizational meeting at [ATLA's Annual Convention in July] and about 50 attorneys showed up. About 18 to 20 states were represented by those 50 people," he said.

A highly addictive, synthetic form of morphine, OxyContin has been linked to more than 100 deaths nationwide. The news has been filled with stories about a fast-growing population of OxyContin addicts and abusers--especially in rural areas of Kentucky, Maine, Ohio, Virginia, and West Virginia. Recent reports indicate the problem is spreading to urban areas, including Boston and Miami.

Giatras said he first became aware of OxyContin through his criminal defense practice when he noticed a surge in clients who were being prosecuted for sale and distribution of the drug. Many of these people, chronically ill and often poor, took the drug legitimately on doctors' orders, got hooked, and soon began buying, stealing, or selling it, he said.

"We're talking about good, upstanding people who had never been anything but law-abiding citizens. They get so addicted to this drug that they turn to a life of crime," Giatras said.

Injuries alleged by individual plaintiffs and potential class members include death; physical and emotional pain associated with either addiction or the risk of it; and the consequences of a severe and disabling addiction, including social problems like drug abuse and criminal behavior.

Federal prosecutors in at least four states--Kentucky, Ohio, Virginia, and West Virginia--have set up task forces to deal with rising crime linked to demand for the drug.

When OxyContin won approval by the FDA in 1996, it made big news in the medical community as a powerful new weapon against severe pain associated with certain long-term illnesses like cancer and osteoarthritis. Like other powerful analgesics in pill form, including Percocet and Vicodin, OxyContin's active ingredient is a synthetic opioid similar to morphine called oxycodone.

But the new drug differs from its predecessors in two significant ways. First, it comes in doses that deliver much higher levels of oxycodone. Initially, Purdue Pharma manufactured the drug in 10-mg, 20-mg, and 40-mg doses, but 80-mg and 160-mg pills--which contain as much oxycodone as 30 of the highest-dose Percodan tablets--were soon available. The company voluntarily pulled the 160-mg dose from the market in May following reports of its illicit use.

Second, the drug's time-release mechanism allows users to go as long as 12 hours between doses. Other opioid analgesics must be taken every three to six hours.

These two features also make the drug particularly susceptible to abuse, plaintiffs claim in their lawsuits. The euphoric "high" associated with the morphine-like drug-especially in its higher-dose forms--makes it powerfully addictive. And it wasn't long before someone realized that crushing the pills destroys the time-release feature. The drug can then be snorted or mixed with water and injected, delivering a highly concentrated, and sometimes fatal, amount of the drug to the bloodstream.

Last month, Purdue Pharma announced it is working on developing an abuse-resistant pain reliever. The company has scheduled clinical trials early next year on a pill containing a drug that counteracts the narcotic effects of opioids.

If that pill is swallowed whole, the counteractive drug passes through the body. But if the pill is crushed, the drug is released into the bloodstream.

Claims against the manufacturer allege that the company failed to adequately warn about OxyContin's extremely addictive nature and aggressively marketed the drug in a way that minimized it.

"The drug was pushed by [salespeople] who would go to doctors' offices and downplay the dangers," said Boston lawyer Mike Hugo, whose office is reviewing more than 100 OxyContin-related claims. Hugo said these salespeople would tell doctors that the drug's packaging included warnings about its addictive nature because they were FDA-required, but that Purdue Pharma was unaware of any problems.

"The packaging included warnings, but everything else the company did watered these down," Giatras said. "It's like a beach where there's this big sign saying 'Don't enter! Shark attacks daily!' But then there's this guy on the beach selling masks and snorkels."

Purdue Pharma vigorously denies any misconduct. "The marketing of this drug was absolutely within the letter of the law," said Robin Hogen, the company's executive director of public affairs. "It conformed to FDA requirements, and Purdue absolutely stands by its marketing representatives.

"Are our sales representatives aggressive? Yes. Are they coercive or deceptive? No. A good salesman is an aggressive salesman. But as to allegations that our representatives misrepresented the drug, or overpromised its benefits, or made statements outside the label--that's not the case," Hogen said.

In a press release responding to the Virginia class action, Purdue Pharma lawyer William Eskridge of Abingdon, Virginia, derided it as irresponsible and legally flawed.

"At the heart of this litigation is a transparent effort by plaintiffs' lawyers to exploit false statements as to OxyContin which have been made in a series of uninformed and misleading news articles. If that effort is allowed to succeed, it will end up hurting legitimate pain patients," Eskridge said.

A little more than a week after that press release, the FDA--after consulting with Purdue Pharma officials--strengthened the drug's labeling by requiring the agency's highest-level warning: a "black box" with an alert that the drug is potentially as addictive as morphine and is not indicated for relief of short-term or mild pain. Purdue Pharma sent information about the changed labeling to more than 800,000 health care professionals.

Although litigation is still in the early stages, Giatras said it could turn out to be "a kind of hybrid between tobacco and fen-phen. I've heard that attorneys general in Connecticut and Maryland are considering suits similar to West Virginia's, and many lawyers have filed suit against doctors. Not everyone wants a class action lawsuit," he said.

One thing is certain, he added: The issue won't die anytime soon. "Since the litigation group meeting in July, I've received at least two calls a day from attorneys who have seen or heard something related to the OxyContin problem. They just want to know what is going on," he said.