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NEWARK, N.J. — The debate triggered by radio talk show host Rush Limbaugh’s announcement 10 days ago that he was undergoing rehabilitation to kick an addiction to OxyContin did not surprise lawyers who have been battling over the painkiller drug since 2000. That’s when the first suit was filed against OxyContin’s manufacturer. Since then, 285 state and federal suits in more than 20 states, including class-action complaints, have been brought against the privately held company, Purdue Pharma LP of Stamford, Conn. The plaintiffs’ main allegations are that they have become hooked on the prescription drug in part because of misrepresentations and hyped marketing. Some also claim that OxyContin’s time-release tablets, which are supposed to allow the opiate substance into the bloodstream during a 12-hour period, actually release most of the narcotic during the first five hours. This, plaintiffs’ lawyers say, whets the patient’s appetite for more as the pain returns before the 12-hour period, leading to possible addiction. One of the class actions is in Mercer County. In Devoe v. Purdue, MER-L-653-02, a national firm has joined with a local plaintiffs’ firm in seeking to be certified as a class under the state’s Consumer Fraud Act rather than alleging addiction or seeking medical monitoring. Three other cases have been filed in New Jersey against Purdue, which has a plant in Totowa and a laboratory in Cranbury. The cases are in Camden, Middlesex and Union counties, though two have been dismissed. The third case was just removed from Union to federal court by the defense. Stegmaier v. Acromed Inc. CIV-03-4093, is now before U.S. District Judge William Martini. So far the battle over the synthetic opiate drug has been a slam-dunk for the defense: 50 dismissals, no judgments and no settlements. That initial case in Ohio’s Southern District, Burton v. Purdue, was voluntarily dismissed by the plaintiffs in October 2002, a month before trial. MILLIONS FOR DEFENSE Taking an aggressive strategy from the start, the company has not paid a dime to a plaintiff. Instead, it has paid many millions in fees to defend OxyContin, which has caused a firestorm nationwide because of its potency and potential for abuse. “It’s clearly costing [Purdue] tens of millions to litigate in 20 to 30 states,” says Lowenstein Sandler partner Michael Dore, who has represented Purdue for many years. Dore, a toxic tort litigator, adds, “It’s a very expensive proposition. They’re not happy, but they’re going to spend what they have to spend to defend their product.” Dore calls OxyContin “a very great drug that has garnered many patient and doctor testimonials.” In addition to litigation costs, Purdue has spent another $200 million on the product, which represents more than 75 percent of its annual revenues of a little more than $2 billion in 2002. Purdue in-house special counsel Tim Bannon says about $150 million of that is for the development of an “antagonistic” substance that would make it difficult for users to get the heroin-like rush if they crushed and then snorted or injected the tablet, thus thwarting the time-release mechanism. That practice, say law enforcement officials, is common. Plaintiffs’ lawyers counter, and one state judge in Ohio agrees, that the technology for the “antagonistic” substance was available well before OxyContin was brought to market in 1996. Bannon says the other $50 million represents the costs of educating the public and medical community about the dangers of prescription drug abuse, including radio and television ads, as well as security efforts to combat thefts and illegal trafficking of OxyContin. The company retained Giuliani Partners LLC in May 2002, with Bernard Kerik, the former police commissioner under New York Mayor Rudy Giuliani, assigned to oversee security. Kerik is now working to develop a police force in Iraq. In August 2002, Purdue brought on board J. Aaron Graham as vice president for security. Graham is a former top official with the federal Drug Enforcement Administration and the Food and Drug Administration. New Jersey has seen its share of OxyContin criminal mayhem. In December 2002, a truck transporting $800,000 worth of the tablets was intercepted en route from Newark International Airport to a lab in Swedesboro. Law enforcement experts say the tablets sell for 10 times their price on the street. In another heist last May, masked men hijacked a truck with several drugs, including OxyContin, after it left a warehouse in Thorofare. This past January, a Pennsauken doctor was sentenced in federal court to 57 months for conspiring to distribute OxyContin and other drugs. Some pharmacies, including at least one national chain, Stop & Shop, have stopped carrying the drug for fear of break-ins. Dozens of doctors across the nation have had their licenses lifted by state medical boards, and a few have been criminally convicted, including one in Florida who is now serving 55 years for manslaughter and racketeering. Addiction to OxyContin “is monstrous,” says Nick Colangelo, who runs Clear Manor, a drug and alcohol rehab center in Wilkes Barre, Pa. He adds, “We have no security over pharmaceuticals, and OxyContin is more powerful than morphine.” Colangelo says he sees abusers who obtained the drug illegally as well as those who started taking it legally but nevertheless got hooked. “Some normal people can be addicted to it right away, even if taken properly,” he says. ABUSERS OR INNOCENT VICTIMS? The plaintiffs’ lawyers say their clients are not traditional drug abusers, and certainly not pushers, but ordinary people for whom OxyContin was prescribed after surgery or serious accidents or ailments that brought on severe pain. The first named plaintiff in an Ohio class action, LaDonna Howland, was, according to plaintiff attorney Louise Roselle, “a woman in her 70s who was suffering post-surgery pain following breast cancer, and wound up in a detox.” Roselle, an associate with Cincinnati’s Waite, Schneider, Bayless & Chesley, says Howland is typical. But the defense maintains otherwise. Says Purdue’s Bannon, “We see three types of plaintiffs. One is the substance abuser. The next are those who get the drug appropriately from their doctor, perhaps innocently, but then begin taking too much of it and not following the instructions. The third are those who have a pain problem, are taking OxyContin and are not addicted, but then stop abruptly, sometimes because of the plaintiff ads seeking clients, and they experience withdrawal problems.” Bannon says the defense has yet to encounter a plaintiff who is injured from addiction who followed the instructions and did not abuse the drug. So far, at least, the company can still make that claim; as cases move along in the pipeline, they disappear. Last month, another case was drawing close to trial — this one in federal court in Mississippi. But after 21 depositions and the production of tons of documents, the six plaintiff firms in Poston v. Economy Drugs in the Northern District of Mississippi voluntarily dismissed the case on Sept. 15. Purdue’s chief legal officer, Howard Udell, issued another in a series of stinging press releases saying that the claims were false and a smear on the product. “We wanted to go to trial so that [the issues] could be resolved conclusively,” said Udell. “By ending the case, they may have been trying to avoid the damaging legal precedent of a verdict against them.” Udell has retained Donald Strauber of New York’s Chadbourne & Parke and Chilton Varner of Atlanta’s King & Spalding as co-lead counsel to fight the OxyContin wars. These national firms are coordinating with counsel across the country, including Lowenstein Sandler in New Jersey. Abbott Laboratories of Chicago, which markets the drug for Purdue, is also named in most of the suits, as are pharmacists and physicians. Abbott has taken a position similar to Purdue thus far. Allied against them are several dozens of plaintiffs’ firms, the biggest of which is the 60-lawyer Washington, D.C., firm of Cohen, Milstein, Hausfeld & Toll. Cohen, Milstein is handling cases in nine states, including the Devoe consumer fraud class action now before Superior Court Judge Jack Sabatino in Trenton. Lisa Rodriguez, name partner with the Philadelphia and Haddonfield firm of Trujillo, Rodriguez & Richards, is co-counsel in Devoe and says depositions will start in November. The plaintiffs charge that OxyContin, approved by the FDA in December 1995 for severe and moderate pain, is too dangerous, too addictive and has been marketed irresponsibly, especially in rural areas where it is sometimes called “hillbilly heroin.” The suits further allege that the warnings on the label and on sales literature have been inadequate. The company notes, and several judges have agreed thus far, that the warnings clearly say the drug can be habit forming and is a Schedule II drug similar to morphine. Douglas McNamara, an associate with Cohen, Milstein, says the initial label, or package insert, used “fuzzy language” about the dangers of addiction, and went on to say that only 1 percent of users have a reasonable chance to get hooked. Company special counsel Bannon denies that but acknowledges that the labels were changed in July 2001, although he says they were only amplified. OxyContin, say critics, has been the cause, in part or whole, of several hundred overdose deaths. In particular, plaintiffs’ attorneys cite an April 2002 report from the Drug Enforcement Administration that OxyContin might have played a role in 464 drug overdose deaths in a two-year period. The DEA report said it could verify 146 deaths as somewhat related to OxyContin, with another 318 likely to have played a role. But an FDA official quickly issued a caution, saying the agency’s continuing studies have found no evidence that the drug posed a threat to people who took it as prescribed, according to The New York Times of April 15, 2002. The company, which vehemently denies the DEA study, can point to a study issued last March that came to the opposite conclusion . The Journal of Analytical Toxicology, according to the Times, examined 919 deaths related to oxycodone, the ingredient in OxyContin, that occurred in 23 states between August 1999 and January 2002. It found only 12 cases in which OxyContin alone was found during the autopsy, with the remaining victims taking either an overdose of other oxycodone-related drugs, such as Percoct, or a combination of drugs. In fact, the study found that in 97 percent of the cases, a combination of at least three other drugs were found in the system. The company also cites a U.S. Chamber of Commerce study from this past July that says the suits are changing the way doctors prescribe, pharmacists dispense and patients use medicine. The study says a “troubling pattern is emerging” in which the fear of litigation is “interfering with the way health care professionals practice medicine.” The company has taken up this line, framing the argument by saying the litigation is a bad way to conduct a national health policy. PLAINTIFFS WIN IN OHIO Obviously, it is the class actions that are the biggest threat to Purdue and Abbott Laboratories. Federal judges in Kentucky and Ohio have ruled against class certification in four cases. In the two Ohio national class actions, U.S. District Judge Arthur Spiegel found there were no common issues of law or fact to support a class action, saying the cases are too individual. In addition, he went on in dicta to cite the so-called learned intermediary doctrine, saying that it is the doctor who prescribes, who monitors the patients, and who is responsible for ensuring the patients do not fall victim to addiction. But the plaintiffs have scored one major victory in Ohio’s state court. In Howland v. Purdue Pharma, CV2001-07-1651, a three-judge appeals court in Butler County unanimously upheld the certification of a class for all lawful OxyContin users in Ohio, Indiana, Kentucky and West Virginia. The ruling has been appealed, and both sides are waiting to see if the Ohio Supreme Court will accept certification. Plaintiffs’ lawyer McNamara of Cohen, Milstein says the plaintiffs’ bar is still probing to find the right legal strategy to pierce Purdue’s defenses, either federally or with certain state statutes, such as New Jersey’s strong consumer fraud act. “Purdue has been extraordinarily lucky in the litigation so far,” he says. “They have lucked out because the proper vehicle to nail them has yet to be devised. I’m not surprised. It’s hard to develop a case with drug addicts.” But Purdue spokesman Bannon counters, “It’s not luck. There’s no liability, and there will be no liability no matter how long they look.” Tim O’Brien is a senior writer for the New Jersey Law Journal , a Recorde r affiliate based in Newark.

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