Overview of Opioid Lawsuits against Drug Manufacturers
In the wake of a wave of lawsuits filed by individuals against drug manufacturers of highly addictive opioids, dozens of cities, counties, and states have filed lawsuits seeking reimbursement for the costs associated with the opioid epidemic.
Drug overdoses cause more than 55,000 deaths annually with sixty percent of these fatalities being caused by opioids. The devastating toll on the lives of victims and the spiraling public health expenditures associated with the opioid abuse epidemic continues to grow at an exponential rate.
Lawsuits filed by government entities seek reimbursement of tens of billions of dollars in losses that arise annually from opioid addiction, including public healthcare expenditures, rehabilitation facilities and services, as well as the cost of law enforcement, criminal justice, and incarceration.
Prescription Pain Medications Involved in the Defective Drug Litigation
Lawsuits brought by government entities seeking reimbursement for costs associated with the opioid crisis have focused on the following drugs:
- Oxycodone (trade names: Oxecta, OxyContin, Roxicodone)
The powerful pain-relieving function of these drugs stems from their binding to opioid receptors in the body to diminish feelings of pain. OxyContin, developed by Purdue Pharma and marketed by Abbot Laboratories, has been at the center of many of the lawsuits brought by government officials. Oxycodone hydrochloride is the active ingredient of this synthetic opioid. While most oxycodone based painkillers only provide pain relief for 4 to 6 hours, OxyContin uses a time-release formula, so its effects can last up to 12 hours. This extended release version usually includes a larger dose of oxycodone.
Magnitude of the Opioid Epidemic
Over 55,000 people die each year in the U.S. from drug overdoses, which make overdoses the leading cause of death for Americans below the age of fifty. Public health officials have estimated that approximately two million Americans are addicted to opioids and that more than 300,000 Americans have lost their lives to opioid overdoses since the late 1990s. Some public health experts have predicted that opioids will kill another 500,000 people in the next decade. While this data is alarming, statistical evidence suggests the problem is growing at an exponential rate. The number of opioids sold in the U.S. has quadrupled since the 1990s as has the number opioid fatalities. The New York Times reported the number of opioid deaths in America in 2016 probably exceeded 59,000 which would amount to the largest annual increase in U.S. history.
While opioid-type prescription drugs were originally used for cancer, sales of the drugs exploded as they were promoted for use by patients with conditions that cause chronic long-term pain like arthritis. This expanded use led to OxyContin sales exploding from $48 million in 1996 to $1.1 billion during a recent four-year period. Retail sales of the pain medication continued to grow until OxyContin was the most widely prescribed Schedule II narcotic in the U.S.
Financial Costs of the Opioid Epidemic
The Centers for Disease Control and Prevention (CDC) has estimated that the annual cost of opioid addiction and abuse is approximately $78.4 billion. The agency further broke down the staggering price tag to governments, communities, and municipalities. These costs include:
- Criminal Justice Proceedings – $7.6 billion
- Lost Productivity – $42 billion
- Substance Abuse Treatment – $2.8 billion
- Health Insurance – $26.1 billion
The objective of lawsuits brought by government officials against companies that manufacture and distribute opioids is to recoup the costs associated with this healthcare crisis. The lawsuits seek to recoup the types of expenses identified by the CDC and related costs.
Product Liability of Drug Companies for Defective Drugs
Lawsuits against drug companies that manufacture and distribute dangerous or defective drugs are part of a larger area of law referred to as product liability. Product liability can refer to harm caused by defective drugs or misrepresentations to doctors and patients regarding the effectiveness or adverse side effects of medications. Several legal theories can be asserted against drug companies based on negligence or strict liability, such as:
Drugs with Dangerous Side Effects:
When drugs are manufactured according to specifications and without adulteration, they still can have dangerous side effects that cause serious injury or death. When companies fail to adequately test their drugs or ignore adverse incident reports, patients can be harmed by adverse side effects, which include a high level of addictiveness.
Many claims against pharmaceutical manufacturers for injuries and fatalities allege harm caused by the inclusion or omission of instructions, warnings, and recommendations involving the drug. This type of claim often involves drug companies failing to give adequate warnings regarding side effects or inadequate instructions for proper and safe use of a drug. This type of claim often involves drug companies promoting drugs for “off-label use,” which refers to uses not approved by the FDA. In the context of a lawsuit involving opioid overdoses, lawsuits allege opioid manufacturers failed to warn patients and their physicians of the highly addictive nature of the drugs and the risks associated with prolonged use of the drugs to treat conditions like back pain.
This type of defective drug claim applies when problems occur in the manufacturing process, or the drugs become tainted.
Lawsuits Filed by Government Entities against Opioid Manufacturers
Our law firm represents government agencies in lawsuits against pharmaceutical companies that manufacture and distribute opioids. These lawsuits filed by cities, counties, and states seek reimbursement for the enormous costs of the opioid public health epidemic. Drug companies generate tens of billions of dollars in profits from the sale of opioids while financially strained public entities seek compensation for the immense damages generated by the opioid epidemic.
Illegal Acts Pursued by State and Local Governments Against Opioid Makers
Government entities that have filed opioid lawsuits against pharmaceutical companies have alleged illegal conduct in multiple forms:
- Promulgating misleading medical literature that indicated opioids pose minimal risk of addiction
- Failing to detect, report, or stop orders that should have set off red flags because they were unusually large or otherwise suspicious
There are many examples of pharmaceutical companies burying their head in the sand when receiving suspicious orders. However, Jim Gelhed, a 40-year DEA veteran and whistleblower, cites Kermit, West Virginia, with a population of 392 people, as an example. The small town received over 9 million pills over a two-year period.
Legal theories asserted in complaints filed by public officials against pharmaceutical companies include:
- Corrupt practices under state laws
- Federal Racketeer Influenced and Corrupt Practices Act (RICO)
- Public nuisance
Will a Multi-District Litigation Hear Opioid Overdose & Addiction Cases?
Litigation against pharmaceutical companies that profited from suspicious orders of opioid drugs is still in the relatively early stages. However, a significant number of local and state governments pursuing lawsuits involving similar facts and legal issues has led plaintiffs to seek the coordination and consolidation of multi-district litigation (MDL). The litigation can be handled as an MDL provided that the cases involve a “common question of fact” and that the cases can be more conveniently and efficiently adjudicated as an MDL.
When an MDL is litigated a single court/judge oversees all pretrial matters, such as discovery disputes while attempting to guide the parties toward a settlement. If the case cannot be settled, trials will occur in the original courts where the cases were filed. An MDL offers a couple of important benefits: (1) it prevents the risk of inconsistent rulings on similar issues in different courts and (2) efficiencies from handling multiple cases in a single court can reduce the cost of litigation.
Regulatory Penalties and Settlements Involving Opioid Wholesale Manufacturers & Distributors
Lawsuits brought by state officials against drug makers have generated far better results than those brought by plaintiffs or class action lawsuits. Government entities have pursued these claims in the form of parens patriae lawsuits. This type of claim involves state entities pursuing lawsuits based on the economic and physical well-being of its residents. This model is like that used by government entities to pursue financial reimbursement for the astronomical healthcare costs associated with tobacco products. In the wake of this success, a few states filed similar lawsuits against manufacturers of lead pain and firearms.
These legal claims have employed a range of legal theories, such as fraud, engaging in an abnormally dangerous activity, public nuisance, negligent marketing, unjust enrichment, and negligent entrustment, the most significant in this context include:
Unjust enrichment & Restitution:
This type of claim is based on benefit (such as financial gain) to Party A at the expense of the Party B where Party B receives no form of consideration despite an expectation of reciprocation.
These claims typically have focused on marketing efforts targeting vulnerable populations without appropriate efforts to monitor distribution at the retail level. After Purdue settled for $10 million with West Virginia based on claims of negligent marketing, 26 other states and the District of Columbia followed this example alleging the company promoted OxyContin for off-label use and failed to adequately warn of addiction risks. West Virginia OxyContin prescriptions amounted to 433 per resident during one period because of aggressive marketing aimed at a population with a high level of chronic pain.
This legal claim involves an unreasonable interference with rights that are held in common by the public. The Restatement of Torts identifies three factors to be considered when evaluating whether interference is unreasonable:
- whether the acts interfere with safety, comfort, public health, convenience or peace
- whether the acts violate an administrative regulation, statute, or ordinance
- whether the acts are of an ongoing nature or will cause a permanent impact to a public right
All three of these factors are implicated in the opioid epidemic. Widespread addiction and related-public health issues are clearly implicated in the opioid crisis. Allegations related to deceptive marketing practices and promotion of off-label use of the drug to treat back pain and arthritis meet the second criteria. The final factor is satisfied by the loss of life and billions in public health, law enforcement, criminal justice, and incarceration costs.
Opioid Settlements and Verdicts
Drug companies that manufacture and distribute opioid drugs have paid massive civil penalties and reached large settlements with government entities, including the following:
Purdue Pharma — $24 Million Settlement (2015): This large pharmaceutical company is the manufacturer of OxyContin. The drug company settled a lawsuit with the State of Kentucky for $24 million based on misleading marketing regarding the addictiveness of the prescription pain killers.
Cardinal Health, Inc. — $44 Million Settlement (2016): The company agreed to pay $44 million to federal regulators related to allegations of failing to report suspicious opioid orders by pharmacies in Florida, Maryland, and New York.
Mallinckrodt PLC — $35 Million Settlement (2017): This manufacturer of oxycodone settled a regulatory action for $35 million regarding failing to report or monitor suspicious orders of opioids.
Cardinal Health, Inc — $20 Million Settlement (2017): This distributor of hydrocodone and oxycodone pills along with other distributors provided 780 million of the two types of pills to people in West Virginia over a six-year period, which amounts to 433 pills per state resident. During this period, the state experienced 1,728 opioid overdoses.
McKesson Corporation — $150 Million Settlement (2017): The company, which is one of the largest distributors of pharmaceuticals in the U.S., paid a $150 million civil penalty for failure to report orders of hydrocodone and oxycodone, which should have raised red flags based on the size, pattern, and frequency of the orders.
Costco Wholesale — $11.75 Million Settlement (2017): The wholesale store paid $11.75 million to settle claims that the chain’s pharmacies improperly filled prescriptions for painkillers under the Controlled Substances Act.
Some Opioid Manufacturers Settle Lawsuits While Others Move to Trial
(09/06/2019) OHIO – A United Kingdom-based manufacturer of generic opioid medications has recently settled lawsuits brought by two Ohio counties that alleged the manufacturer contributed to the nationwide opioid crisis in those communities. Specifically, manufacturer Mallinckrodt agreed to pay a total of $30 million, including $6 million worth of products used to treat drug addiction. The deal was struck between Mallinckrodt and Cuyahoga and Summit counties in Ohio on Friday, September 6 and made Mallinckrodt the third opioid manufacturer to resolve allegations before trial.
Other Opioid Manufacturers Inch Closer to Trial
Even as Mallinckrodt reached a settlement with Cuyahoga and Summit counties, OxyContin manufacturer Purdue Pharma and other defendants facing an October trial for their own, independent role in contributing to the opioid epidemic saw their motions to have the case summarily resolved denied by the federal judge overseeing the matter. Among other rulings, the judge decided that claims of a conspiracy could proceed to trial to be determined by a jury and that claims based on both state and federal laws could remain. Purdue Pharma has offered to settle the claims against the company by paying $10 billion or more and by agreeing that the owners of Purdue Pharma, the Sackler family, would relinquish control of the company.
The Future of Opioid Litigation in America
Just last month, Johnson & Johnson was ordered to pay $572 million for its role in fueling the opioid crisis. This was the first verdict achieved in a state court against an opioid manufacturer. As Ohio, Oklahoma, and other states pursue lawsuits against opioid manufacturers for claims that these manufacturers conspired with others in the healthcare system to distribute opioids and fill orders that should have appeared suspicious, downplayed the risks and dangers of opioid medications, and did not take prompt corrective actions when the addictive nature of opioid medications became apparent.
Generic Opioid Drug Maker from the United Kingdom Agrees to Settle Lawsuits in Ohio
September 19, 2019 – CLEVELAND, OH. — The Wall Street Journal reported that U.K. opioid drug manufacturer Mallinckrodt PLC agreed in principle to settle a lawsuit brought by Cuyahoga and Summit counties in Ohio for $30 million. The parties agreement obligates Mallinckrodt PLC to pay Cuyahoga and Summit counties a sum of $24 million and provide $6 million in generic drugs and therapies to help people addicted to opioids get themselves clean. The parties must mutually agree on all of the terms to complete the settlement, and, if they do, Mallinckrodt PLC will avoid going to trial against the two counties who allege that this drug company, along with others, contributed to the devastating opioid crisis that has ravaged numerous communities across the U.S., including Cleveland and Akron.
The number of prescription opioid pills that poured into Ohio from 2006 until 2012 is astonishing and nearly unfathomable. During that timeframe, some 3.7 oxycodone and hydrocodone pills were shipped to Ohio, and according to Cleveland.com, 298 million pills wound their way into Cuyahoga County. The figures were developed during the ongoing opioid litigation after analysis of federal databases that tracked drug shipments.
The opioid litigation accuses drug manufacturers like Mallinckrodt PLC, a company based in the United Kingdom, of downplaying the addictive qualities of the prescription painkillers and minimizing the risks. Additionally, the lawsuits allege that the pharmaceutical companies failed to stop large shipments of opioid painkillers despite addicts dying at an alarming rate.
The Cuyahoga and Summit county lawsuits are just two of 2,000 pending in the United States against pharmaceutical companies. The two counties previously settled litigation it filed against Allergan and Endo International for their roles in the opioid crisis. The counties settled the cases for a combined total of $16 million.
Purdue Pharma, along with several other drug makers, continues to defend opioid litigation cases around the U.S. Purdue Pharma is currently negotiating a settlement of all of the cases pending for $10 billion to $12 billion.
Pending Investigation of Opioid Manufacturers
In September 2017, the attorney generals of 41 states announced that they were going to embark on a joint effort to investigate manufacturers and distributors of opioid pain medications linked to the sharp increase in addiction and fatal overdoses. The group of AGs issued subpoenas to Teva Pharmaceuticals, Endo International, Janssen Pharmaceuticals, Purdue Pharmaceuticals, and Allergan. The coalition also has requested information and documents from McKesson, AmericsourceBergen, and Cardinal Health. The group indicated they are seeking evidence that the drug companies misrepresented the efficacy of opioids while understating their addictive nature. Congressional and Senate investigations into the practices of opioid manufacturers related to the overdose and addiction crisis also are ongoing.
Some examples of public entities that have filed lawsuits against large pharmaceutical companies that manufactured opioids include:
- Municipalities: Everett, WA, Kermit, WV, Chicago, Il
- Counties: Nassau, NY, Mingo, WV, Orange, CA
- States: Ohio, Mississippi, New Mexico
- Cherokee Nation
Frequently Asked Questions (FAQs) about Opioid Claims
How widespread is the litigation against pharmaceutical drug-makers based on opioid overdoses and addiction?
Although the litigation is still in the relatively early stages, the nationwide public health crisis has prompted many public entities to file lawsuits. Just this month, 28 separate counties in Wisconsin filed separate lawsuits in the eastern federal district court of Wisconsin pursuing reimbursement for millions in public funds spent on emergency care, social services, and law enforcement related to opioid addiction. These lawsuits join those of over two dozen states, cities, and counties across the nation. Some complaints filed against the drug-makers indicate the pharmaceutical companies lobbied politicians and targeted physicians with marketing to artificially increase the volume of opioids prescribed to patients and that the companies willfully allowed the drugs to be a commodity on the black market.
What pharmaceutical companies are typical defendants in these opioid addiction lawsuits?
Some of the most common defendants in these opioid abuse lawsuits include the following:
- McKesson Corporation
- Purdue Pharma
- Endo International
- Watson Pharmaceuticals
- Janssen Pharmaceuticals (subsidiary of Johnson & Johnson)
- Cardinal Health
- Teva Pharmaceutical
- Allergan (formerly Actavis)
What are some of the most common types of claims in lawsuits brought by public officials against opioid distributors?
In general terms, these complaints allege the drug companies acted in violation of federal law under the Controlled Substances Act because they neglected to alert the U.S. Drug Enforcement Administration of questionable opioid purchases that include unusually large or frequent orders. These complaints also typically allege that the pharmaceutical companies overstated the benefits of this class of painkillers and that the defendants were aware the drugs were being excessively prescribed. Despite this knowledge, the defendants neglected to warn doctors that the drugs were highly addictive and that the dose should be strictly restricted. The lawsuits also contend that opioid distributors unlawfully marketed the drugs for off-label long-term use for conditions like arthritis and back pain. The lax opioid prescription practices promoted addiction that progressed for many users to heroin and other illicit narcotics.
What are some of the specific damage claims being sought in these lawsuits?
State officials are seeking reimbursement of billions of dollars in expenses related to the opioid addiction epidemic, such as:
- Medicaid and related public health expenditures stemming from addiction treatment, such as antidotes to treat overdoses, hospitalization, and the costs of inappropriately prescribed opioids
- Expenses associated with the construction and operation of treatment facilities
- Reimbursement of criminal justice and law enforcement expenses
- Costs related to increased medical, emergency, and law enforcement personnel to cope with the opioid epidemic
- Emergency medical transportation expenses
- Costs of repair of property damage
- Increased expenses of incarceration related to drug offenses
Are there responsible parties other than pharmaceutical manufacturers and distributors being sued by public entities related to the opioid crisis?
Some lawsuits brought by government entities also allege that “pill mills” and physicians exploited patients by getting them hooked on these powerful prescription drugs, which cost cities, counties, and states billions of dollars in medical, law enforcement, judicial, and penal expenses.
Why have some media sources drawn an analogy between the tobacco industry and the opioid crisis?
The analogy has been drawn between these two public health epidemics because the tobacco litigation brought by financially strapped public entities might serve as a partial roadmap for opioid lawsuits. The tobacco industry was sued by 46 states and six other jurisdictions that requested the companies assume the financial burden of paying for public expenses associated with lung cancer and other smoking-related illnesses. In what amounted to the largest civil-litigation settlement in U.S. history, tobacco companies agreed to make perpetual payments to states as well as to contribute to anti-smoking campaigns and public-health programs. This comparison has garnered a fair amount of attention since opioid lawsuits have so far settled without proceeding to trial.
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Speak to an Opioid Lawsuit Attorney Today
The experienced attorneys at the national law firm of Parker Waichman LLP are currently reviewing cases against pharmaceutical companies that manufactured or distributed opioids.
We are committed to holding the drug-makers and distributors that pushed their highly addictive opioids accountable for the social and economic costs of their conduct, so call us today at 1-800-YOURLAWYER (1-800-968-7529) or fill out our online form to schedule a free case evaluation.
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