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Products Liability and the Misuse of OxyContin
Lars Noah
Georgetown Univ. Law Center
October 2001

Plaintiffs’ lawyers already have begun to target the companies that make and sell OxyContin. The drug’s active ingredient, oxycodone hydrochloride, is a synthetic form of morphine, and the DEA regulates oxycodone as a Schedule II controlled substance, which means that it has a high potential for abuse. Older painkillers such as Percocet and Percodan also contain oxycodone, but OxyContin uses a time-released formulation, which offers sustained relief over a 12 hour period to patients with chronic moderate or severe pain. In contrast, the older products in this class (including the related hydrocodone drugs such as Vicodin and Lortab) provide uneven relief over just a 3-4 hour period. Introduced five years ago, OxyContin quickly became the most widely prescribed narcotic painkiller, with more than $1 billion in sales last year.

In addition, the time-released formulation seemed to make OxyContin less prone to abuse because it would not provide a quick euphoric effect upon initial ingestion. As a result, Purdue Pharma and Abbott Labs promoted their drug as presenting a lower risk of abuse. The companies apparently failed to appreciate the creativity of drug abusers. To defeat the slow-release feature, these individuals chewed, crushed, dissolved, or scraped the coating off of the tablets, leaving stronger dosages of oxycodone than found in individual Percocet or Percodan tablets. They would then ingest, snort, or inject the substance. More than 100 people have died after overdosing in this fashion, usually as a result of acute pulmonary edema.

OxyContin diversion has occurred in several ways. Individuals might feign pain and shop for doctors willing to prescribe the drug, or they might engage in prescription fraud and theft. These people then might use the drugs themselves or sell them to others. A few desperate addicts have committed armed robberies at pharmacies, seeking OxyContin supplies rather than cash. Certain regions of the country have been particularly hard hit: in Appalachia, for instance, rampant misuse of the drug has led some to characterize OxyContin as “hillbilly heroin.” Most of the deaths and other injuries linked to the drug have occurred in persons other than legitimate patients.

In the last year, a number of lawsuits have been filed-including class action lawsuits and state Medicaid recovery claims modeled on the tobacco litigation-against Purdue and Abbott. Although the precise allegations and theories of recovery vary, three types of claims predominate. First, plaintiffs argue that the defendants provided inadequate warnings to health care professionals of the potential for abuse. Second, plaintiffs argue that the defendants overpromoted the drug (through advertisements in medical journals, sales visits to doctors, and a Website targeted to lay persons) for the treatment of temporary or less serious pain. Third, plaintiffs argue that OxyContin is defectively designed for using high dosages with an easily-defeated time-release safeguard. Purdue and Abbott strenuously deny the factual allegations underlying these claims.

Even if the plaintiffs’ allegations have some basis in fact, their products liability claims will raise difficult issues for the courts if this litigation forges ahead. In order to better frame this discussion, assume that the victim died after ingesting a crushed OxyContin tablet at a party and that a friend of his had purchased the tablet from a dealer who had stolen a supply from a local pharmacy. Causation will pose a serious hurdle to a wrongful death claim against the manufacturer in this case. (Of course, comparative negligence will also come into play, but this defense typically would not keep the case from reaching a jury.) Although inadequate warnings and overpromotion may lead to excessive prescribing and create a larger supply for potential diversion, more alarming risk information and circumspect marketing would not have prevented this death.

To overcome this obstacle, the plaintiff might argue that the defendants acted negligently in making OxyContin generally available (consistent with DEA requirements) for prescribing by any physician and dispensing by any pharmacy. Although the companies might have decided to supply the drug only to hospital pharmacies for dispensing only in response to a prescription by a pain management (or similar) specialist, such a restricted distribution network would be unprecedented (and perhaps even unlawful in antitrust terms). Only twice in recent years has the FDA insisted that a drug manufacturer “voluntarily” implement such a system, and its authority to do so remains very much in question. In this case, of course, the FDA did not call for restricted distribution at the time that it approved the drug, and it does not appear that the sellers’ failure to adopt such restrictions would amount to negligence. If a court nonetheless decided to entertain such a claim, it would risk denying access to OxyContin to many legitimate patients.

The design defect claim offers a more plausible way of surmounting the causation hurdle. Manufacturers have a duty to anticipate and, when feasible, design against misuses of their products. For instance, companies have added bittering agents to household chemicals in order to discourage accidental ingestion, especially by children. Unlike other products, however, prescription drugs are not easily redesigned to add a safety feature. In fact, Purdue recently announced plans to investigate the possibility of using another ingredient (naltrexone) that might counteract efforts to defeat the slow-release mechanism, but it will have to conduct trials to determine the safety and effectiveness of this combination and then await FDA approval of a supplemental NDA, which could take several years. Perhaps Purdue should have anticipated this misuse more than a decade ago when it began developing OxyContin and done the R&D on this safer version from the outset. But what if naltrexone reduces the effectiveness of OxyContin or causes adverse reactions in some subset of users? From the perspective of the cancer or other patient with intractable pain, such a new form of the drug definitely does not represent an improvement. And what if naltrexone does not really help prevent misuse, but a court concludes that OxyContin is defective (and should never have been marketed) because it poses greater risks to non-users than some of the older opioids? Although the new Restatement (Third) of Torts would not countenance the imposition of liability under those circumstances, judges and juries in other drug products liability cases have sided with plaintiffs on similar facts. Ultimately, such a response to patterns of misuse may undermine recent efforts to provide better pain management to patients through the use of improved analgesic products.