America is in the midst of a public health crisis that has been fueled by rising rates of opioid addiction. The solution to this problem lies with increased access to safe and effective medications, but it will require cooperation from pharmaceutical corporations. There are many ways for legislators and citizens alike to challenge their reliance on these companies for treatment options.
Despite increased public awareness, the deadliest drug overdose catastrophe in American history shows no signs of abating.
In 2015, over 50,000 Americans died from drug overdoses, the highest number ever. Opioids including OxyContin, Percocet, heroin, and fentanyl were related to almost two-thirds of the fatalities.
More individuals are dying from drug overdoses currently than during previous heroin, cocaine, and methamphetamine outbreaks. Since 1999, there has been a fourfold rise in opioid-related mortality, with 33,091 deaths in 2015. A prescription opioid was implicated in almost half of the fatalities.
Efforts are now ongoing that may lead to a breakthrough in the problem.
Every day, the news reports on the escalating opioid catastrophe. During a single week in April, 10 people died from opioid overdoses in Eerie County, New York. In Philadelphia, where 900 people are expected to die from opioids this year, fifty people died in a single day from a batch of heroin. Between 2015 and 2016, the number of opioid fatalities in Hennepin County, Minnesota, increased by approximately 60%. Opioid overdose fatalities in Palm Beach County, Florida, almost quadrupled in 2016. In 2016, there were 56 killings in Colorado, compared to 442 fatalities from opioid overdoses.
For this unparalleled public health problem, our nation urgently needs fresh answers. While initiatives like expanding drug treatment and boosting access to overdose antidotes are beneficial, they neglect the role of Big Pharma, which annually floods the market with enough opioids to provide every adult in the United States with a bottle. They also dismiss the impact of prescription habits on long-term opioid addiction.
Many experts feel a three-pronged strategy is required, including opioid addiction prevention and treatment, as well as pain medication supply regulation.
Efforts are presently ongoing on a local, state, and national level that might lead to a breakthrough in the problem. Suits against prescription drug makers and distributors are among them, as are President Donald Trump’s special opioid commission, a congressional probe, and new state regulations.
The Opioid Litigation Challenges
Suits against opiate producers like Purdue Pharma (which makes OxyContin) have proved difficult to win.
By 2021, the opioids market in the United States is estimated to reach $17.7 billion.
Big Pharma is a formidable foe because to its enormous coffers and intimate connections with the government. The opioids industry in the United States is currently over $11 billion and is anticipated to grow to $17.7 billion by 2021. Because of their enormous revenues, opioid manufacturers have been able to rig the regulatory system in their favor and recruit high-powered legal teams that include former government officials.
Even if opioid manufacturers’ activities seem to be unjustified, pharmaceutical corporations have successfully used good legal arguments in many of the instances they’ve faced. Another element in drugmakers’ favor is the stigma surrounding opiate addiction.
Suits brought by individuals
“I’m not as sympathetic to this whole opiate issue,” Judge Frederica Massiah-Jackson told an attorney seeking to persuade her that the opioid business was to blame for his client’s overdose death in February while arguing before the Philadelphia Court of Common Pleas. There wasn’t any of this when it was just cocaine and heroin.”
“Find some legal reasons for me,” Judge Massiah-Jackson said.
Regrettably, legal considerations often benefit opioid producers. Purdue Pharma won most individual plaintiff actions at the summary judgment stage, according to a study published in the West Virginia Law Review, by asserting lack of causality, abuse, unlawful conduct, or statute of limitations expiry.
When it comes to pharmaceutical-related injury, the most common option is product liability law. Arguments that OxyContin and other opioid drugs are defectively made, developed, or marketed, on the other hand, are difficult to sell.
A manufacturing fault occurs when a product is not manufactured according to the manufacturer’s specifications. While such opioid instances have been successful, they are generally restricted to a single opioid product or batch that isn’t working as it should.
Arguments about greater strength opioid tablets having an excessive drug dosage, absence of antagonistic (euphoria-suppressing) formulations, and users’ ability to circumvent time-release mechanisms (by crushing the medications and snorting or injecting them, for example) seem increasingly plausible. Manufacturers may cite patients’ conduct as a defense when opioid users abuse or change the medications, which is prevalent among patients who have become opioid addicts.
Because many opioid tablet inserts warn of the medications’ potential toxicity, addictiveness, and misuse potential, failure to warn accusations have been mainly effective. Furthermore, the “learned intermediary” theory, which is used in many jurisdictions and entails the physician acting as a gatekeeper between the pharma and the patient, breaks the chain of causation and gives manufacturers legal protection.
Drug companies used aggressive marketing to change prescription practices and convert blockbusters like OxyContin.
Opioid manufacturers’ legal victories have also been aided by the fact that they have done very little direct-to-consumer advertising, instead focusing on doctors in an effort to change their prescription patterns. In truth, Purdue did not participate in any direct-to-consumer marketing. This reinforces the physician’s position as a skilled intermediary and protects drugmakers against marketing accusations such as failure to warn.
However, although aggressive (and, many say, fraudulent and misleading) marketing helped manufacturers to radically change opioid prescription habits and generate blockbusters like OxyContin, their techniques have resulted in legal repercussions.
Opioid Class Actions are a kind of lawsuit that involves a group of people who are
Opioid users’ class action lawsuits against drug corporations are still a possibility, but they have yet to get pace.
Before a class action lawsuit can be filed, it must first be certified. Certification is based on a set of criteria; if any of the criteria are not met, the case will not be certified.
The “commonality” condition, which states that all class members must have a legal or factual matter in common, has proven the most challenging. Courts have agreed with drugmakers that inquiries about class members’ medical history, the facts surrounding their addiction, and whether pharma firms misrepresented or improperly pushed opioids could only be answered on an individual basis, not as a group.
Suits filed by the state
Although some of the settlements negotiated are perceived as disappointments, government legal action against opioid makers has been much more effective than individual and class action cases.
State officials have effectively bypassed 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 through 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—by naming the state itself as the injured party and seeking damages
Purdue Pharma and Kentucky reached a $24 million settlement in 2015.
In parens patriae situations, liability theories varied as well. They often contain charges of public annoyance, for example. Originally, public nuisance laws were enacted to enable for the removal of dilapidated structures that posed a hazard to the community’s safety.
Purdue Pharma resolved parens patriae claims with the states of West Virginia and Kentucky for $10 million in 2004 and $4 million in 2013, respectively. The money from the settlement was used to build a drug rehabilitation center in Pike County.
Non-parens patriae state cases have also been successful against opioid manufacturers.
Purdue Pharma agreed to a $20 million settlement with 26 states and the District of Columbia in 2007 for illegally marketing OxyContin. Purdue misbranded OxyContin as “less addictive, less vulnerable to misuse and diversion, and less likely to develop tolerance and withdrawal than other pain drugs,” according to the multi-state class action case, which was prompted by the West Virginia settlement.
While a $20 million settlement may seem to be a significant victory, one assistant attorney general involved in the case voiced “tremendous buyer’s remorse” because the lawsuit did not result in more money or significant improvements in opioid prescription habits. Over the previous decade, the opioid crisis has only worsened.
Kentucky turned down a $500,000 settlement offer in the case, pushed for additional money, and eventually reached a $24 million settlement with Purdue in 2015. Greg Stumbo, the former Kentucky Attorney General who initiated the complaint in 2007, says the case may be worth $1 billion if it ever goes to a jury. Accepting the deal, however, shows that the Attorney General’s attorneys were concerned about a trial victory.
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Suits filed by the federal government
Federal law enforcement has struggled to bring opioid manufacturers responsible.
The Drug Enforcement Administration (DEA) started building a case against Mallinckrodt Pharmaceuticals, a major maker of generic oxycodone, in 2011 for breaking rules intended to prevent the diversion of legal painkillers to the black market. It was the DEA’s largest-ever prescription drug investigation, spanning six years and five states.
A former federal prosecutor and a former DEA assistant general counsel were among Mallinckrodt’s legal team.
Prosecutors said Mallinckrodt produced 500 million oxycodone tablets in Florida between 2008 and 2012, accounting for two-thirds of all oxycodone sold in the state during that time period, and failed to disclose questionable orders.
According to data, a single distributor transported 41 million Mallinckrodt oxycodone tablets to Florida in 2010, enough to provide every man, woman, and kid in the state 2.5 pills. Over the course of 11 months, a single physician got more than 92,000 oxycodone tablets from the distributor. In just one day, he prescribed 1,000 tablets to a patient, a sum worth $30,000 on the black market.
Based on these results, the DEA intensified its investigation against Mallinckrodt and sought a civil conspiracy charge that could have resulted in a punishment of $2.3 billion. Mallinckrodt put up a legal team that included a former federal prosecutor and a former assistant head counsel for the Drug Enforcement Administration’s diversion section.
Mallinckrodt did not face any legal action in the end. It is said to have agreed to pay a $35 million fine and acknowledge no wrongdoing in exchange for a $35 million fine.
For a corporation with $3.4 billion in sales last year, the punishment was “chump change,” according to one government official.
The settlement, according to another source, is about more than money and will “put the industry on notice.”
Suits Against Drug Distributors
States have had success going after the drug distribution middlemen who supply pharmacies with drug corporations’ opioids, in addition to directly attacking opioid producers.
In early 2017, wholesaler McKesson Corporation reached a $150 million settlement with the Justice Department for failing to monitor and report questionable opioid sales. A 2008 federal lawsuit for similar offenses led to the settlement.
West Virginia is pursuing its own lawsuits against opioid distributors, as the state with the highest opioid overdose rate in the US. In January 2016, Pennsylvania Attorney General Patrick Morrisey filed a lawsuit against McKesson for failing to halt huge opioid shipments. Cardinal Health and AmerisourceBergen agreed to pay the state $36 million earlier this year. A total of $11 million has been paid to the state by ten additional drug wholesalers.
The successful prosecution of opioid distributors in West Virginia should pave the way for similar trials in other hard-hit jurisdictions.
New lawsuits provide hope to those seeking justice.
New legal routes are being examined in addiction-ravaged places such as Chicago, Mississippi, and Everett, Washington, as the opioid crisis deepens.
Purdue Pharma allegedly failed to fulfill its duties to the state of Washington under a 2007 multi-state deal to create opioid diversion detection mechanisms, according to Everett. Purdue allegedly allowed its goods to flow into “pill mills” and drug rings, resulting in an increase in overdose fatalities, homelessness, and crime, according to the city.
Suits involving opioids, similar to those that helped bring Big Tobacco down, are now being sought.
Lawsuits filed in Chicago and Mississippi go even farther, claiming that drugmakers’ false opioid marketing is a fraud that has caused direct injury to the government and communities.
Mississippi, for example, argues that medically unjustified opioid prescriptions cost the state’s Medicaid program $5.6 million in claims and an estimated $141 million in extra healthcare expenses due to opioid misuse.
The Mississippi opioid case has been likened to “the one that finally brought big tobacco to heel,” according to the Washington Post.
“For over two decades, these pharmaceutical companies have made billions of dollars in profits by misrepresenting to tens of millions of doctors and patients the significant dangers of prescription opioids—marketing the drugs as rarely addictive and a safe substitute for non-addictive pain medications, such as Advil, Motrin, or Aleve,” Mississippi Attorney General Jim Hood told ClassAction.com.
“The action aims to put a halt to these misleading marketing methods, levy civil fines, and get an order forcing drug firms to remedy the damages caused by their fraudulent behavior, such as increasing medical expenditures and crime,” Hood said. “I want these few drug firms to pay for the harm they’ve created, as well as the treatment of addictions they’ve induced.”
Mississippi has won two court rulings so far in the lawsuit, which has gone farther than others. Pretrial discovery might, at the very least, compel pharma corporations to provide internal documents, something they have vehemently fought.
When patients and others have sued opioid manufacturers, the firms have sought protective orders preventing the release of business papers used as evidence.
Any inconsistencies between what pharmaceutical companies told physicians, regulators, and patients about opioids and what they knew or suspected internally might be the key to breaking through Big Pharma’s defenses.
In the best-case scenario, Purdue and other opioid manufacturers will be forced to confront a jury in Mississippi, something they have so far avoided: a town where their medications have caused death and ruin.
Alternatives to the Epidemic
Suits alone will not be enough to stop the opioid crisis. Because the issue is systemic, new state and federal policies are required to address the variables that contribute to widespread opiate addiction.
The FDA’s Complicity with Big Pharma
Changes should start with the FDA, the government body in charge of regulating prescription medications (FDA).
Experts such as Dr. Andrew Kolodny of Physicians for Responsible Opioid Prescribing (PROP) have highlighted how the FDA modified the standards dictating how painkillers are authorized, making it easier for firms to market opioids to family physicians as well as palliative care doctors and hospices.
Even though there is no data to support this assumption, the FDA went along with Big Pharma’s propaganda that opioids are safe and beneficial for common chronic pain. In fact, the data shows that opioids may aggravate pain. However, palliative care medicine does not develop blockbuster medications.
“From the outset, when Purdue Pharma produced OxyContin, the FDA warned to them, ‘You can’t advertise this to the family doctor…’ “I don’t believe we would have had this pandemic if they had done it,” Dr. Kolodny said in a 2015 speech.
The FDA, according to Dr. Kolodny and other addiction specialists, could—and should—do more. They propose new regulations such as stronger opioid warning labels, technology-based medication packaging and pill designs that hinder misuse and diversion, a more rigorous risk-benefit analysis for opioids, and more conservative opioid prescription recommendations.
The FDA agreed to change its opioid prescription standards in 2016, but Dr. Kolodny dismissed the statement as “public relations.”
Dr. Kolodny also believes that President Trump’s FDA commissioner nominee, Dr. Scott Gottlieb, who has close links to the pharmaceutical sector, would make significant anti-opioid initiatives.
Christie is set to lead the Presidential Commission.
During his campaign, President Donald Trump made opioids a priority. He recently named Chris Christie, the governor of New Jersey, to head a special panel charged with identifying federal financial sources that may aid in the fight against the pandemic.
Attorney General Jeff Sessions, Health and Human Services Secretary Tom Price, Veterans Affairs Secretary David Shulkin, Defense Secretary James Mattis, and five other members from state governments, law enforcement, and other organizations make up the panel.
A representative from the FDA, on the other hand, is conspicuously absent from the panel.
McCaskill has started an investigation.
Missouri Senator Claire McCaskill has begun a probe into the drug industry. Senator McCaskill is looking for papers that indicate what pharma firms knew about the hazards of opioid misuse, as well as specifics on their marketing strategies.
In 2012, the Senate launched an inquiry into attempts by opioid manufacturers and charitable organizations to mainstream medicines for common ailments like as back pain. The investigation’s findings have yet to be made public.
Ten States Pass Anti-Abuse Legislation
Opioid prescriptions are now limited to 10 days or fewer in eleven states.
New Jersey and Ohio were the most recent states to impose restrictions on opioid prescriptions. New Jersey has one of the tightest opioid prescription laws in the nation, restricting opioid prescriptions to a five-day supply (excluding cancer and end-of-life care). In addition, the bill eliminates insurance obstacles to drug addiction treatment.
Ohio’s legislation restricts primary care physicians’ opioid prescriptions to seven days (down from 90 days) and requires doctors to provide a particular diagnostic and procedure code for each opioid prescription. Doctors who do not obey the new guidelines, according to Governor John Kasich, would lose their medical licenses.
New study reveals that a single opioid prescription may lead to persistent usage, and Ohio, New Jersey, and other states with comparable prescribing regulations are seemingly hearing the message.
By amending state mental illness legislation to include drug dependence, bills in New Hampshire, Pennsylvania, and Washington State want to push opioid addicts into treatment. While the proposals are problematic, they do recognize the need of treating opioid addiction as a mental health issue, something health professionals agree on but which laws sometimes overlook.
According to Dr. Andrew Kolodny, framing the opioid crisis as a disease pandemic makes it simpler to employ disease outbreak control concepts. In this view, the opioid crisis may be addressed by containing, treating, and preventing future cases.
The opioid crisis has been in the works for more than two decades, and it will take time to resolve. However, the present attempts are a start in the right direction.
Contact ClassAction.com to share your opioid addiction experience, understand your rights, and stay informed as we fight back against the biggest drug epidemic in American history.