Opioid Lawsuit

Opioids are a class of drugs used primarily for relief from moderate to severe pain. They can be extracted or refined from the poppy plant (morphine, opium, and codeine) or synthesized in a laboratory (fentanyl, hydrocodone, and oxycodone).

Opioid use has had a long history in the US: The first legislation to regulate the pharmaceutical marketplace was passed partly because of the overwhelming use of morphine back in the 1800s. Over the years, various drug acts were passed to further refine their usage, indications, and availability.

Aside from addiction, the Centers for Disease Control and Prevention (CDC) has identified other side effects associated with opioid use:

• Tolerance
• Physical dependence
• Increased pain sensitivity
• Constipation
• Nausea, vomiting, and dry mouth
• Sleepiness and dizziness
• Confusion
• Depression
• Low levels of testosterone
• Itching and sweating

In March 2016, the FDA released a warning about the potential risks of opioid abuse, requiring safety labeling changes for immediate-release opioid medications. This includes a boxed warning highlighting the risk of misuse, abuse, addiction, overdose, and death related to the drug. Moreover, the FDA also required additional safety labeling changes across all prescription opioid products to give more details on the serious risks of opioid use.

Prior to the 2016 announcement, the FDA had also released a warning in 2013 for extended-release and long-acting opioid medications surrounding the risk of neonatal opioid withdrawal syndrome. Importantly, this change adds a clarification that due to the risk of abuse and addiction, even at prescribed doses, opioid analgesics should only be used when non-opioid medications and immediate release opioids had proven to be ineffective, inadequate, or could not be tolerated by the patient.

In June 2017, the FDA requested pharmaceutical company Endo Pharmaceuticals to remove reformulated Opana ER (oxymorphone hydrochloride extended-release) from the market due to concerns that the benefits of the drug do not outweigh the risks it carries. The decision was based on postmarketing data showing a significant shift of abuse by manipulating the nasal drug to administration via injection.

Meanwhile, in a more recent statement, the FDA issued a reminder to veterinarians regarding the growing issue of pet owners using prescribed opioid pet medication for themselves. The FDA published a resource in their website for veterinarians to become more informed regarding the state and federal regulations on opioid prescription.

Recently, state and federal governments have filed lawsuits against opioid manufacturers, alleging that the manufacturers deceived the public regarding the safety of these drugs. Fabricated research had been widely disseminated (research showing opioids carried low risks of misuse, addiction, and overdose). President Trump has declared the opioid crisis a nationwide public health emergency, prompting his administration to “use every appropriate emergency authority to fight the opioid crisis.”

One pharmaceutical company that is facing multiple lawsuits for their opioid product is Purdue Pharma, the manufacturer of Oxycontin. To date, several states, cities, and counties, including Massachusetts, New York, Colorado, and Oregon have filed lawsuits against the company.

Thousands of affected patients and families are also filing lawsuits against opioid manufacturers on the grounds of false advertising, aggressive marketing, over-distribution, and lack of proper monitoring of users. The pharmaceutical companies and manufacturers enjoyed huge profits from opioids, raking in $500 billion in revenues annually. These companies placed profits over people, deceiving the medical community and patients alike about the terrible risks and abuse of opioids.