With the opioid crisis continuing to worsen, drug manufacturers are facing thousands of lawsuits that have been filed by patients and loved ones of those who suffered addiction and overdose or whose loved ones died because of opioid medications. Many of these life-threatening events occurred because of the use of prescription pain relievers. In addition to the lawsuits that have already been filed, manufacturers like Purdue Pharma may be expecting tens or even hundreds of thousands of future lawsuits.
Purdue and other companies have already faced multiple lawsuits filed by federal, state and local governmental or law enforcement agencies over marketing and manufacturing of opioid medications which are prone to abuse and are responsible for thousands of deaths each year in the U.S.
Opioid Crisis Statistics
The National Institute of Drug Abuse states that the opioid epidemic claims more than 47,000 American lives every year. While most people think that overdoses occur with those using illegal or “street” drugs, thousands of overdoses are caused by prescription opioid medications. In addition to overdoses, an estimated 1.7 million Americans suffer from substance abuse disorder related to prescription pain killers.
- 21-29% percent of patients prescribed an opioid for chronic pain abuse the medications
- 8-12% develop of patients prescribed an opioid for chronic pain develop an opioid use disorder
- 4-6% of those who misuse prescription opioids will transition to heroin
- 80% of heroin users started on prescription opioids
- Opioid overdoses are increasing at a rate of about 30% annually, faster in some large cities
Purdue Pharma and OxyContin
Much of the blame for the current opioid crisis has been laid on one pharmaceutical company, Purdue Pharma. Its flagship drug, OxyContin (oxycodone), has been responsible for
In 1995, Purdue Pharma introduced OxyContin, a controlled release formulation of oxycodone. It was marketed as a “safe” alternative to currently existing painkillers due to the controlled release formulation. Purdue promoted the drug as abuse-proof and virtually non-addicting. Purdue had a marketing strategy of obtaining 70% of prescriptions written for pain relievers. By 2002, OxyContin sales topped 7.2 million prescriptions per year and Purdue spent about $200 million to market the medication. At the same time OxyContin sales were rising, and by 2000, there had already been a significant increase in the number of opioid-related deaths.
In 2003, the Food and Drug Administration (FDA) issued a warning letter to Purdue stating that advertising was misleading regarding the information about the dangers of addiction and about overstated efficacy. The agency also required that several “black box warnings” be added to the prescribing information. Black box or boxed statement warnings are the most severe warnings that can be issued or required by the FDA. OxyContin’s black box warning stated that the higher strength tablets should only be used in opioid-tolerant patients and that the tablets should not be broken or crushed. OxyContin’s manufacturer was also required to issue a black box statement warning of the risk of addiction, overdose and death.
In 2010, OxyContin was reformulated in an attempt to make it “harder” to abuse the medication. The abuse-deterrent formulation was harder to crush and snort or inject but abuse of the medication continued to increase. Some industry critics have speculated that the reformulation was done under pressure by the DEA and FDA but was, in reality, simply a ploy to ensure that Purdue maintained patent protection against generic competition for a longer period of time.
A 2015 study on OxyContin use and abuse showed that two-thirds of OxyContin abusers continued to abuse the drug after changing to the new formula, another third had discontinued OxyContin abuse in favor of other drugs, including heroin. Of the abusers who continued with OxyContin us, about half transitioned to oral use but nearly one-third were able to circumvent the anti-abuse mechanism in the pills.
In 2017, the agency required that labeling include a new black box statement with information that abuse-deterrent properties of OxyContin does not prevent or reduce the chance of addition and that abuse by IV or intranasal (snorting) is still possible.
Opioid Lawsuits and Settlements
In 2007, Purdue Frederick Co (Purdue Pharma) pled guilty to misbranding of OxyContin and agreed to pay over $600 million in fines when it was shown that a 10mg tablet could be dissolved and withdrawn into a syringe to be injected. Purdue was also accused of misrepresenting how much an OxyContin user could experience “euphoria” after taking the medication and how much withdrawal symptoms could be expected. There is also some evidence that shows Purdue simultaneously invested in drug rehab facilities, even though they claimed their product was not addicting, showing financial benefit of continuing to sell a dangerous drug that harmed people.
Although the company has already paid hundreds of millions in fines, more federal, state and local government agency lawsuits have been filed. Now, the company and other manufacturers are facing thousands of lawsuits filed by people who have experienced addiction or overdosed or by family members of those whose loved ones died after using OxyContin or other prescription opioid medications.
Past medical injury lawsuits have provided compensation for medical costs, lost wages, pain and suffering and in some cases, punitive damages when the plaintiffs could prove that the company knew about the dangers and sold a product anyway. Some family members have also been able to gain compensation for wrongful death if a loved one died due to a dangerous medication.
Users of OxyContin or other prescription opioid pain reliever drugs who suffered addiction, overdose, or whose loved one died due to these medications should seek legal advice from an opioid lawsuit attorney.