DRUGS AND NARCOTICS

Drugs are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals, and any articles other than food intended to affect the mental or body function of humans or animals. Narcotics are any drugs that dull the senses and commonly become addictive after prolonged use.

Burgess v. U.S.

The Supreme Court in 2008 resolved a conflict in federal law about the meaning of a “felony drug offense.” The defendant in the case was convicted under a state law that defined a drug crime as a misdemeanor . The Court, however, concluded that the conviction amounted to a felony because the crime was punishable by more than one year's imprisonment. Accordingly, the Court affirmed the defendant's sentence under federal law. The case gained notoriety because a South Carolina felon successfully helped the defendant file his appeal.

Keith Lavon Burgess was arrested in 2002 in Florence, South Carolina for possessing a small amount of cocaine. Under South Carolina law, Burgess's crime for simple possession was classified as a misdemeanor, which was punishable by up to two years imprisonment. A state court gave Burgess a one-year suspended sentence along with two years probation and fifty hours of community service.

About one year after his arrest, Burgess was again arrested in a Florence, South Carolina shopping mall for selling 240 grams of crack cocaine. In 2003, he pleaded guilty to a single count of conspiracy to distribute 50 or more grams of base cocaine, which violated 21 U.S.C. § 841(a). Though the state law under which Burgess was convicted in 2002 was defined as a misdemeanor, prosecutors sought to enhance his sentence by classifying the first conviction as a felony. Under § 841(b)(1)(A), “[i]f any person commits [a drug violation] after a prior conviction for a felony drug offense after a prior conviction for a felony drug offense has become final,” then the defendant is subject to a 20-year minimum sentence of imprisonment.

Under 21 U.S.C. § 802(44), a “felony drug offense” is defined as “an offense that is punishable by imprisonment for more than one year under any law of … a State … that prohibits or restricts conduct relating to narcotic drugs. Under another section, 21 U.S.C. § 802(13), a “felony” is defined as “any Federal or State offense classified by applicable Federal or State law as a felony.” Burgess argued that the trial court should define “felony drug offense” by incorporating the definition of “felony.” Under Burgess's argument, the court would have concluded that his 2002 conviction was not a felony drug offense because state law defined his crime as a misdemeanor.

The federal government, in turn, argued that his previous conviction was indeed a felony because federal law defined felony as a crime punishable by more than one year in prison. Prosecutors stressed that it did not matter how state law defined the crime, because federal law is clear that any crime punishable by more than one year in prison is a felony. The prosecution's argument prevailed at the trial court, as U.S. District Judge Terry L. Wooten sentenced Burgess to 156 months in prison.

Following Burgess's sentencing, two federal courts of appeals reached conflicting results about the meaning of felony drug offense under § 841(b)(1)(A) and § 802(44). In United States v. West, 393 F.3d 1302 (D.C. Cir. 2005), the U.S. Court of Appeals for the District of Columbia concluded that the sentencing enhancement applied only in “those instances in which the prior drug offense is both punishable by more than one year and classified as a felony by the controlling authority.” The First Circuit Court of Appeals, however, ruled that the enhanced sentence applied when the crime was punishable under state law by more than a year, irrespective of whether state law defined the crime as a felony.

Burgess appealed his sentence to a three-judge panel of the Fourth Circuit Court of Appeals. The appellate court agreed with the First Circuit that the language of the statute was unambiguous with respect to the definition of a felony drug offense. According to the court, “We discern no basis from the plain language or statutory scheme of the [Controlled Substances Act] to indicate that Congress intended ‘felony drug offense’ also to incorporate the definition of § 802(13).” The court also ruled that Burgess was not entitled to a more lenient sentence because the court did not agree that the law was ambiguous.

While Burgess was serving his sentence in South Carolina, he enlisted the assistance of a felon named Michael R. Ray, a so-called jailhouse lawyer in the facility. Ray drafted a petition for writ of certiorari on Burgess's behalf and submitted it to the Supreme Court. Though the Court typically agrees to hear less than one percent of the cases presented to it, the Court granted certiorari to review Burgess's case. This made Ray something of a celebrity, even though he did not argue the case before the Court, nor was he released to see the argument in person. Stanford law professor Jeffrey L. Fisher instead argued the case before the Court.

A unanimous Court had little trouble affirming the Fourth Circuit's decision. In an opinion by Ruth Bader Ginsburg, the Court found no ambiguity in the federal sentencing law, noting that had Congress wanted to incorporate § 802(13)'s definition into § 802(44), the legislature could have done so rather easily. The Court also noted that the legislative history of the Controlled Substances Act suggested that Congress intended for enhanced sentencing to apply where the state law provided for a length of a sentence, no matter how the state classified the crime. “Before 1994, the definition of ‘felony drug offense’ depended on the vagaries of state-law classifications of offenses as felonies and misdemeanors,” wrote Ginsburg. “The 1994 amendments [to the Controlled Substances Act] replaced that definition with a uniform federal standard based on the authorized length of imprisonment.” Because Congress clearly did not intend the result that Burgess urged, the Court rejected his argument and affirmed the Fourth Circuit's judgment.

Ray was scheduled to be released from prison near the time that the decision was handed down. He claimed to have written about 75 appeals to the Supreme Court in the past. His success in the Burgess case, however, led the South Carolina Attorney General's office to consider taking action against Ray for practicing law without a license. Ray was at one time a paralegal but became involved with various fraud schemes that led to his imprisonment.

Purdue Frederick Pleads Guilty to Misbranding Oxycontin

Purdue Frederick Co. and three top executives in May 2007 pleaded guilty to charges related to the misbranding of OxyContin, a powerful painkilling drug. The company and the executives agreed to pay more than $634 million in damages, representing one of the largest fines imposed in a misleading marketing campaign.

OxyContin was developed as a painkiller that was supposed to be less dangerous than morphine. It was designed for patients with cancer as well as those with chronic pain. Purdue Frederick, a Connecticut-based subsidiary of Purdue Pharma, L.P., introduced the drug in 1995. The drug is an opium derivative and is prescribed to patients with moderate to severe pain. Promoted as a “miracle drug,” the manufacturer earned $2.8 billion in revenue from the sale of OxyContin.

Despite its claims regarding the safety of the drug, evidence surfaced that OxyContin (which is the trade name for oxycodone) was anything but safe for its users. When the drug is crushed and injected, it gives users a powerful high. Use of the drug caused death in some cases, and law enforcement officials claimed that criminals broke into homes and robbed pharmacies for the drug. The drug earned the street name “hillbilly heroin.”

Court documents in the case indicated that the company was aware that the drug was dangerous and yet Purdue Frederick continued to market the drug as a safer alternative to morphine. In fact, Purdue's market research department found as early as 1996 that “[t]he biggest negative of [OxyContin] was the abuse potential.” These findings persisted through 2001. Nevertheless, Purdue continued to claim that the drug was “less addictive, less subject to abuse, and less likely to cause withdrawal than other pain medications,” according to court documents.

Purdue Frederick misbranded OxyContin in several ways. The company trained its sales representatives to tell health care providers that the drug had a less euphoric effect and had less abuse potential than other painkilling drugs. Company supervisors used graphs that exaggerated the blood level effects that the drugs had. These graphs suggested that OxyContin had different effects than other opioids, the morphine-like substances used for pain relief. The sales representatives were trained to use the graphs during role-playing exercises at the company's Connecticut headquarters.

Several reports indicated that patients could become addicted to OxyContin. A 1999 study focused on patients who suffered from osteoarthritis. The study indicated that the patients showed withdrawal symptoms and that some patients showed signs of physical dependence on the drug. Other studies conducted in 2000 and 2001 provided further evidence that patients experienced withdrawal symptoms when taken off the drug.

Despite this evidence, supervisors and employees drafted a medical journal article regarding a study of osteoarthritis patients showing that those who took less than 60 mg of Oxy-Contin did not display withdrawal symptoms even when their use was disrupted abruptly. The article also concluded that patients taking less than 60 mg of the drug would not develop a tolerance for the painkiller. Even though these statements contradicted the actual findings that studies had shown, sales representatives provided these articles to health care providers to show that OxyContin was a weaker alternative to morphine.

The warning labels that appeared on OxyContin packages also contained false information. The package indicated that “[d]elayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of the drug.” This statement suggested that the delayed release of OxyContin meant that it was less likely to result in addiction than immediate-release alternatives. However, Purdue Frederick's own research showed that a drug abuser “could extract approximately 68% of the oxycodone from a single 10 mg OxyContin tablet merely by crushing the tablet, stirring it in water, and drawing the solution through cotton into a syringe.”

The Drug Enforcement Administration in a 2002 report determined that Oxy-Contin had caused 142 deaths and had contributed to 318 others. Nevertheless, company executives did nothing to warn the public of the drug's possible harms. “Even in the face of warnings from health care professionals, the media, and members of its own sales force that OxyContin was being widely abused and causing harm to our citizens, Purdue, under the leadership of its top executives, continued to push a fraudulent marketing campaign that promoted OxyContin as less addictive, less subject to abuse, and less likely to cause withdrawal,” said John Brownlee, U.S. attorney for the Western District of Virginia. “In the process, scores died as a result of OxyContin abuse and an even greater number of people became addicted to OxyContin.”

As part of the plea agreements for their own actions as well as the company's actions, Purdue Frederick's executives signed written agreements to pay a total of $634,515,475. More than $430 million of this amount went to the United States and to federal and state agencies. Another $130 million was set aside to resolve private claims. Heavy fines were also paid by top executives Michael Friedman, president and chief executive officer; Howard Udell, executive vice president and chief legal officer; and Paul D. Goldenheim, executive vice president for worldwide medical affairs. The three agreed to pay a combined $34.5 million as part of the plea agreement. Purdue Frederick's lead counsel in the case was former New York City Mayor Rudolph Giuliani, who was then a candidate for President. He helped to negotiate the plea bargain agreement. The fines paid by Purdue Pharma and Purdue Frederick were believed to represent 90 percent of the company's profits on the sale of the drug.

No Right of Access to Unapproved Drugs

In the United States, access to medication by private persons is limited to those drugs approved by the U.S. Food and Drug Administration (FDA). Acting as a gatekeeper, the FDA is tasked with ensuring that products are not only safe for human consumption, but also, that they perform and/or are as effective as indicated by the manufacturers, and that risks/side effects/untoward consequences are made known to end-users. In January 2008, the U.S. SUPREME COURT denied review of an appellate court decision finding no constitutional right of terminally ill patients to access drugs not yet approved by the FDA. By denying review, the high court let stand the lower court's decision. Abigail Alliance for Better Access to Developmental Drugs and Washington Legal Foundation v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2006 en banc)

Back in 1979, the Supreme Court had considered the merits of such an argument, and rejected a constitutional right to use unapproved drugs, i.e., drugs not yet having completed the rigorous testing needed to be approved by the FDA (in that case, laetrile). U.S. v. Rutherford, 442 U.S. 544. A growing number of advocates for the terminally ill had since sought to have the Supreme Court overrule that case, or at least, provide exceptions.

This was primarily because FDA approval may take years. Drug testing usually consists of three phases or “trials,” each one involving a larger number of patients. Following completion of the drug trials, the FDA then evaluates both data received from the manufacturers on efficacy and side effects, as well as Phase 3 results, which involve double-blind, placebo-controlled trials comparing actual efficacy and side effects with the data previously provided by the manufacturers.

In 2001, University of Virginia student Abigail Burroughs died of head and neck cancer at the age of 21. Her last months alive had been spent fighting to gain access to an ostensibly-promising new experimental anti-cancer drug (Iressa) recommended by her oncologist at Johns Hopkins University Hospital. (The drug Iressa was later approved by the FDA but shown to be relatively ineffective in most cancer patients.) Following her death, her father founded the Abigail Alliance for Better Access to Developmental Drugs and sued the FDA in federal district court in 2003. The Alliance was joined in its suit by the Washington Legal Foundation. The gist of the argument was that terminal patients had a fundamental right to access such medicines. The suit also proposed a new three-tier model for experimental drug regulation, arguing that such drugs should be available to certain legally-competent terminally ill adult patients “as early as the conclusion of the first of three phases of clinical trials.” The constitutional arguments were couched in terms of depriving patients of their right of “self defense” and violating their FIFTH AMENDMENT right to life, liberty, or property without adequate due process.

The district court dismissed the case for failure to state a claim, but a three-member panel of the U.S. Circuit Court of Appeals for the D.C. Circuit reversed by a 2–1 vote, holding in part that the right to access unapproved drugs could be inferred from an individual's due process right to refuse life-sustaining medical treatment. Finding that plaintiff's argument deserved a constitutional strict-scrutiny review, the appellate court remanded the case to the district court to determine whether FDA's policy was “narrowly tailored to serve a compelling [governmental] interest.”

Notwithstanding, Alliance's victory was short-lived. The entire D.C. Circuit Court, sitting en banc, vacated the judgment of the three-member panel in January 2008 and summarily dismissed all of Alliance's arguments. It essentially distinguished the right of access to treatment from a claimed right of access to unapproved treatments. The appellate court found no such fundamental right grounded in the Constitution.

Going back to the 1979 Rutherford decision, the issue was whether Section 505 of the

1938 Food, Drug, and Cosmetic Act (which the FDA oversees enforcement of) precluded terminally ill patients from obtaining Laetrile. At that time, the Supreme Court noted, “To accept the proposition that the safety and efficacy standards of the Act have no relevance for terminal patients is to deny the Commissioner's authority over all drugs, however toxic or ineffectual, for such individuals.” In another relevant Supreme Court case, Gonzales v. Raich, 545 U.S. 1 (2005), the high court held that the dispensing of new, unapproved drugs (in this case Cannabis) was nonetheless subject to prior FDA approval, even if the State of California and individual physicians approved of its use.

Despite the adverse court decision, terminally ill patients still had four legal and readily available means to access unapproved drugs: (1) by enrolling in a clinical trial sponsored by a pharmaceutical company or clinic; (2) obtaining a compassionate or otherwise special exemption for treatment from an investigator in a clinical trial; (3) contacting a manufacturer or sponsor directly; and/or (4) requesting a single patient or emergency IND (investigational new drug) application through the FDA. The majority of patients enrolled in clinical trials are receiving drugs that are in either Phase 2 or Phase 3 testing. In “compassionate use” or other exceptions, Phase 2 drugs are generally used, but there is no hard fast rule precluding use of Phase 1 drugs.