How to Solve the Opioid Epidemic

DrugsLegal Analysis

The worst drug overdose crisis in American history shows no sign of slowing, despite growing public awareness.

More than 50,000 Americans died from drug overdoses in 2015—the most ever. Nearly two-thirds of the deaths were linked to opioids such as OxyContin, Percocet, heroin, and fentanyl.

Drug overdoses are now killing more people than during past heroin, cocaine, and methamphetamine epidemics. The 33,091 opioid related deaths in 2015 represents a fourfold increase since 1999. Nearly half of those deaths involved a prescription opioid.

Efforts are underway that could finally produce a breakthrough in the crisis.

Every day, news headlines speak to the deepening opioid crisis. In Eerie County, New York, there were ten opioid deaths during a single week in April. Fifty people recently died in a single day from a batch of heroin in Philadelphia, where 900 people are projected to die from opioids this year. Hennepin County, Minnesota experienced a nearly 60 percent jump in opioid deaths from 2015 to 2016. In Palm Beach County, Florida, opioid overdose deaths nearly doubled in 2016. Colorado saw 56 homicides in 2016, compared to 442 opioid-related deaths.

Our country desperately needs new solutions for this unprecedented public health crisis. Initiatives such as more drug treatment and increasing access to overdose antidotes—while helpful—ignore the role of Big Pharma, which every year floods the market with enough painkillers to provide every U.S. adult with a bottleful. They also ignore the role of prescribing patterns on chronic opioid use.

Many experts believe that a three-pronged approach involving opioid addiction prevention and treatment—as well as pain pill supply control—is needed.

Efforts on the local, state, and national levels are currently underway that could finally produce a breakthrough in the crisis. They include lawsuits against prescription opioid manufacturers and distributors, a special opioid commission created by President Donald Trump, a congressional investigation, and new state laws.

The Challenges of Opioid Litigation

Lawsuits against opioid manufacturers such as Purdue Pharma (maker of OxyContin) have been an uphill battle.

The U.S. opioids market is expected to reach $17.7 billion by 2021.

Big Pharma’s deep pockets and cozy relationship with government make it a powerful adversary. The U.S. market for opioids is worth more than $11 billion and is expected to reach $17.7 billion by 2021. Opioid makers’ huge profits have allowed them to stack the regulatory deck in their favor and hire high-powered legal teams that include former government insiders.

And even though the actions of opioid makers seem indefensible, pharmaceutical companies have successfully invoked sound legal defenses in many of cases they’ve faced. The stigma surrounding opioid addiction is yet another factor working in drugmakers’ favor.

Individual Lawsuits

Arguing before the Philadelphia Court of Common Pleas in February, Judge Frederica Massiah-Jackson told an attorney (who was trying to convince her that the opioid industry was responsible for his client’s overdose death), “I’m not as sympathetic to this whole opiate thing. When it was cocaine and heroin there wasn’t all of this.”

Judge Massiah-Jackson added, “Find some legal arguments for me.”

Unfortunately, the legal arguments often favor opioid manufacturers. A review of cases against Purdue Pharma published in the West Virginia Law Review found that Purdue won most individual plaintiff lawsuits at the summary judgment level by claiming lack of causation, misuse, wrongful conduct, or expiration of the statute of limitations.

Product liability law is the typical recourse for pharmaceutical-related harm. But arguments that OxyContin and other opioid medications are defectively manufactured, defectively designed, or defectively marketed are a tough sell.

Manufacturing defect means that the product is not made to specification. While such opioid cases have succeeded, they’re usually limited to a particular opioid product or batch that doesn’t work the way it’s supposed to.

Design defect claims—in particular, arguments related to higher strength opioid pills having an excessive drug dose, lack of antagonistic (euphoria-suppressing) formulations, and the ability of users to bypass time-release mechanisms (by, for example, crushing the drugs and snorting or injecting them)—are more feasible. However, when opioid patients misuse or alter the drugs, which commonly occurs among patients who’ve become opioid addicts, manufacturers can use patients’ behavior as a defense.

Failure to warn claims have been mostly unsuccessful because many opioid pill inserts warn about the drugs’ potential toxicity, addictiveness, and potential for abuse. In addition, the “learned intermediary” doctrine followed in many states—whereby the physician serves as the gatekeeper between drugmaker and patient—breaks the chain of causation and provides legal cover for manufacturers.

Drugmakers’ aggressive marketing allowed them to alter prescribing patterns and turn drugs like OxyContin into blockbusters.

Also instrumental to opioid makers’ legal successes is that they’ve done relatively little direct-to-consumer advertising, instead targeting physicians in an attempt to alter their prescribing habits. Purdue, in fact, engaged in no direct-to-consumer advertising. This strengthens the physician’s role as a learned intermediary and shields drugmakers from failure to warn and other marketing claims.

But while manufacturers’ aggressive (and, many argue, false and misleading) marketing allowed them to fundamentally alter opioid prescribing patterns and turn drugs like OxyContin into blockbusters, their tactics have produced legal consequences.

Opioid Class Actions

Class action lawsuits brought by opioid users against drug companies remain a possibility, but they too have failed to gain traction.

Class action lawsuits must receive certification before they can proceed. Certification is based on several requirements; failure to meet any of the requirements results in the case not being certified.

Perhaps most troublesome has been the “commonality” requirement that says there must be a legal or factual question common to all class members. Courts have supported drugmakers’ assertion that questions regarding class members’ medical histories, the factual circumstances of their addiction, and whether drug companies misrepresented opioids or inappropriately promoted them could only be determined on an individual—not a class-wide—basis.

State Lawsuits

Government legal action against opioid manufacturers has been much more successful than individual and class action lawsuits, although some of the settlements reached are seen as disappointments.

Parens patriae lawsuits—cases in which the state asserts its standing to sue to protect its “quasi-sovereign” interests, such as its interests in the wellbeing of its residents—have effectively allowed state officials to bypass the individual claims requirements that have hampered other lawsuits by naming the state itself as the injured party and seeking damages that can replenish welfare, healthcare, justice, and other social systems stressed by rampant opioid addiction.

Kentucky settled with Purdue Pharma in 2015 for $24 million.

Liability theories also differ in parens patriae cases. For example, they often include public nuisance claims. Public nuisance laws were originally designed to allow the demolition of run-down buildings that threatened the community’s safety.

The state of West Virginia and Pike County, Kentucky settled parens patriae cases with Purdue Pharma for $10 million (2004) and $4 million (2013), respectively. Pike County used the settlement money to expand a drug rehabilitation facility.

Non-parens patriae state lawsuits have made inroads against opioid makers as well.

In 2007, Purdue Pharma settled with 26 states and the District of Columbia for $20 million for unlawfully marketing OxyContin. The multi-state class action lawsuit was inspired by the West Virginia settlement and alleged that Purdue misbranded OxyContin as “less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.”

While a $20 million settlement might seem like a big win, an assistant attorney general in the case expressed “tremendous buyer’s remorse” that the case did not settle for more money or lead to substantive changes in opioid prescribing patterns. Indeed, the opioid epidemic has only deepened over the last decade.

Kentucky refused a $500,000 offer in the case, fought for more money, and in 2015 settled with Purdue for $24 million. Former Kentucky Attorney General Greg Stumbo, who filed the 2007 lawsuit, believes the case could be worth $1 billion if it ever reached a jury. But accepting the settlement suggests that the Attorney General’s lawyers had doubts about a win at trial.

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