Drug Companies Face Legal Peril for Opioid Crisis

OpioidsCourts have rarely held drug companies responsible for the consequences of drug use. As long as the drug has been approved by regulators and is marketed with approved warnings about potential side effects, courts generally shield drug makers from liability for harm. The primary exceptions to that rule concern drugs that are contaminated (that is, the company is not marketing the exact product that was approved for sale) and drugs that are known to be dangerous when those dangers are concealed during or after the approval process.

When drugs are addictive, regulators might require labels to warn about the danger of addiction. Courts have tended to blame patients for becoming addicted, rather than the drug manufacturer, when patients become addicted despite the warning.

Warnings may not be a shield against liability, however, when a company’s marketing practices encourage addiction. Recent lawsuits and criminal prosecutions have called attention to the remedies that consumers and the government may have when drug companies try to maximize their profits by encouraging dangerous drug consumption habits.

Opioid Addiction

While legislators and the law enforcement community were waging war against street drugs like heroin and methamphetamine, they largely ignored the risks posed by prescription drugs. Unless the drugs were stolen, acquired with fake prescriptions, or manufactured illicitly, law enforcement agents had little ability to tackle prescription drug use, no matter how much harm it caused.

Legislators and drug regulators have historically been protective of the pharmaceutical industry, an attitude that drug industry lobbyists have fostered with large expenditures in their efforts to influence legislation. That attitude may be changing in light of growing awareness that addiction to prescription opioids poses a greater public health concern than the harm caused by illicit drugs.

According to the Centers for Disease Control and Prevention, almost 400,000 people died from opioid overdoses between 1999 and 2017. The first wave of deaths coincided with a dramatic increase in the number of prescriptions that were written for oxycodone and other opioid pain medications.

While heroin, illicitly-manufactured fentanyl, and other non-prescription opioids contributed to later waves of opioid deaths, most people with opioid addictions became addicted through the use of prescription medications. Many turned to illicit drugs to feed an addiction that started with prescribed drugs.

Purdue Pharma Sued for Encouraging Addictive Behavior

OxyContin, the brand name of oxycodone, is manufactured by Purdue Pharma. Thousands of lawsuits have been filed against Purdue Pharma and other drug companies that market oxycodone and other opioid pain medications. The lawsuits allege that the companies engaged in marketing campaigns to encourage doctors to prescribe (and overprescribe) opioids, despite the companies’ knowledge that patients were likely to become addicted to the drugs. Addiction, the lawsuits allege, leads to more drug sales and higher profits.

A coalition of more than 500 municipal and tribal governments sued Purdue Pharma and members of the Sackler family who own and control the company. The lawsuit, filed in a federal court in New York, alleges that the Sacklers are responsible for creating “the worst drug crisis in American history.” The communities are seeking compensation for the cost of managing that crisis.

The State of New York has filed its own lawsuit against Purdue Pharma and the Sacklers. New York’s Attorney General accused the Sacklers of profiting from the deaths and misery of addicted patients. The suits filed by state and local governments presumably joined the Sacklers as individuals to make it harder for Purdue Pharma to avoid liability by declaring bankruptcy.

Documents cited as evidence in the lawsuits suggest that the Sacklers pursued a double-edged strategy to maximize their profits: first by encouraging addiction so they could sell more of their addictive drugs, and then by marketing drugs to treat the addictions they caused. The Sacklers have denied wrongdoing.

Thousands of earlier lawsuits against Purdue Pharma and other drug companies have been consolidated in a multidistrict litigation proceeding in Cleveland. The presiding judge refused to dismiss most of the grounds alleged against the companies, including fraud, negligence, conspiracy, and creating a public nuisance. Bellwether trials, which are intended to encourage settlement of all the lawsuits by giving parties a chance to see how juries respond to the claims, are scheduled to begin in October.

Reuters reports that Purdue Pharma and the Sacklers want to reach a global settlement that will include “a constructive way to get the monies to the communities that need them, to the people that are addicted.” Presumably the Sacklers hope to find a way to keep as much of their money as possible while putting an end to unfavorable publicity that has damaged the Sacklers’ philanthropic image.

Bribing Doctors to Prescribe Opioids

Bad behavior by drug company executives is also leading to criminal prosecutions. John Kapoor, the founder of Insys Therapeutics, was recently found guilty of federal racketeering charges based on evidence that he conspired to bribe doctors to prescribe opioid medications and then defrauded insurance companies so that they would pay for the drugs.

Federal prosecutors usually bring drug charges against dealers in illicit drugs, a strategy that has done little to stem the tide of drug abuse. Pursuing billionaires who helped create the opioid crisis might prove to be a more productive use of the government’s resources. Whether Kapoor will face a sentence that is commensurate with sentences regularly visited upon street dealers who cause more limited harm remains to be seen.

Update

Some of America's largest companies are cutting ties with Purdue Pharma as the maker of OxyContin deals with growing fallout over its role in perpetuating the opioid crisis. CBS News.

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