Opioids - A National Emergency
Opioids are a class of drugs used for relieving pain. They act by binding to the receptors that block or decrease the sensation of pain. Physicians generally prescribe them post surgery or when the patient is injured and needs alleviation from pain. A number of situations like high doses, higher frequency of prescription, prescription by inadequately trained personnel for stronger doses, and patients who are not ideal candidates for the drug have resulted in overdose and addiction situations. Other than physicians roped in by the manufacturer to generate prescriptions, certain pharmacies have also contributed to increased opioid sales, further leading to a national epidemic. Over the years, prescriptions soared along with an alarming increase in death rates from these drugs. The most commonly prescribed opioids are Oxycodone (brand names: OxyContin, Roxicodone, Oxecta), Hydrocodone, Methadone, Fentanyl and Morphine.
Related article: Race and the Opioid Epidemic
Opioid addiction grew steadily as prescriptions came with the psychological security of physician affirmation and were thought to be safer than illicit drugs. Many people took to these drugs for their sedative effect in ways or amounts not intended by a doctor. The usage when combined with other drugs or alcohol proved to be most fatal.
Today, there is no more hiding from this blatant truth: we are in the midst of an ‘Opioid Epidemic’. The situation has reached an alarming state where President Trump labeled it a ‘’national emergency’. Further, the FDA Commissioner is now willing to consider abuse of opioids in evaluating their safety.
Opioids and FDA
With over 500,000 deaths estimated by public health experts over the next 10 years, many measures have been taken to bring the situation under control. An ‘action-plan’ has been established by the FDA, to restrict opioid use while at the same time trying to provide doctors and patients with access to a nasal spray version of naloxone hydrochloride, an antidote for an opioid overdose. The FDA approved this treatment option in 2015. In addition, opioid labels have been updated to convey to prescribers and patients alike the risks associated with these drugs. The FDA has also approved a number of drug products to address opioid addiction or overdose: Methadone and buprenorphine products including a prescription of naloxone hydrochloride injection.
To control the opioid drug abuse, development of abuse-deterrent opioid formulations have been encouraged by the FDA aiming to have most or all opioid medications in formulations that are less susceptible to abuse.
Civil lawsuits have been filed against the manufacturers by individuals who have been affected by the dangerous consequences of the drug, or by the people who lost their loved ones due to the drug usage. Numerous states, cities, and counties have also filed lawsuits against opioid manufacturers and distributors. In addition, some large drugstore chains, physicians, pharmacists, and drug wholesalers also face similar lawsuits.
Distributors face lawsuits filed by states and counties for the additional spending on treatment of addicts as well as the cost of eradication of the addiction problems. One major allegation is the failure to warn government agencies like the DEA of suspicious opioids purchases as evident from the unusual order size, pattern, and frequency of ordering.
The manufacturers include companies such as McKesson Corporation, AmerisourceBergen, Purdue Pharma, Allergan, Johnson & Johnson’s Janssen Pharmaceuticals, Endo International, Cardinal Health, Teva Pharmaceutical, Watson Pharmaceuticals, and Covidien. The main allegations faced by them include the following: failure to warn doctors of the addictive nature of the pain reliever in spite of knowing about it being overly prescribed; failure to warn doctors about the need to strictly monitor the dosage; exaggerating the benefits of the drug.
With the number of lawsuits piling up and with millions of people affected, opioid drugs may soon become one of the largest mass torts in the history of medical drugs and devices’ lawsuits.
Year 2017 has already witnessed approximately over $220 million paid by McKesson Corporation, Mallinckrodt Plc, Costco Wholesale, Cardinal Health in all, either as a civil penalty or a settlement amount. In 2016, Cardinal Health, Inc. had agreed to pay $44 million for violating the Controlled Substances Act in Maryland, Florida, and New York. This was preceded by a $24 million lawsuit settlement amount agreed to be paid by Purdue Pharma to the state of Kentucky, in 2015.
As per the reports from Centers for Disease Control and Prevention (CDC), overdose deaths involving prescription opioids have quadrupled since 1999, along with sales of these prescription drugs. The period from 1999 to 2015, witnessed more than 183,000 deaths in the U.S. from overdoses related to prescription opioids. With a shocking number of deaths predicted for the next 10 years due to overdose of opioid drugs, a barrage of lawsuits are expected to be filed. Law firms are busy across the nation, prepping cases to help clients battling opioid addiction to be a party to a lawsuit that is targeting one of these companies.
This article was submitted by Neural IT. Neural IT provides cost effective and timely medical reviews for screening potential mass tort cases. For more information, please visit www.neuralit.com. You may email them at [email protected] or call +1-844-NIT-TEAM (648-8326).
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