Fentanyl, The Opioid Crisis, and Products Liability Law

Michael GrossmanJune 21, 2018 6 minutes

You've probably heard or read the phrase "opioid crisis" in the news.

Better and more careful explanations of the growing worldwide problem are available with a quick Google search. For now let me just say that one of the panic's major elements is the pharmaceutical opiate fentanyl. Everyone from medical professionals to government agencies seem to agree that fentanyl sits at the heart of the dramatic rise in opiate-driven overdoses and deaths.

If drug companies continue to make and circulate fentanyl, knowing what it can do to its users, could they be held legally responsible for the damage it causes?

A Brief Background on Fentanyl

Fentanyl is a powerful opioid-class medication used mostly for the relief of serious pain, like that of surgical recovery or chronic illness. It works quickly and has a duration of roughly one to two hours. It's prescribed in a variety of forms including skin patches, slow-dissolving lozenges and lollipops, nasal sprays, sublingual tablets, and dissolving sheets placed on the tongue.

While it only gained its notoriety in the last few years, fentanyl has been around for decades. It was first developed by Janssen Pharmaceutica around 1960 and approved for American medical use in 1968 as an injectable anesthetic called Sublimaze. Janssen continued to tinker with the product and in the mid-1990's it released the Duragesic transdermal patch. The medication quickly gained wider-spread use through its various forms and manufacturers. These days it's available under the names Actiq, Durogesic, Fentora, Matrifen, Haldid, Onsolis, Instanyl, Abstral, and Lazanda. Tthey're all fentanyl-based medications, with more likely on the way.

As of 2017 fentanyl is the most widely-used synthetic opioid in modern medicine. It's on the World Health Organization's (WHO) List of Essential Medicines--sort of a "Who's Who" of drugs that should always be stocked in clinics and hospitals. It's considered vital to the health care industry because it's affordable and powerful--a little goes a very long way.

Fentanyl use often leaves a patient feeling euphoric and relaxed in addition to its pain-relief properties, which is why it sometimes leads to abuse. Like many prescriptions, though, the drug is not without possible side effects. Some are pretty common; for example, drowsiness, disorientation, nausea, or constipation could occur.

Less common but more serious effects include dropping blood pressure, serotonin syndrome, respiratory depression (difficulty taking and holding breaths), extreme sedation, and addiction--a serious risk with any opiate.

Needless to say (and yet I will say it), I strongly encourage anyone prescribed this drug to carefully follow their doctor's instructions and if in doubt, call the prescribing physician.

Sounds Pretty Helpful for Pain Sufferers. What's the Problem?

Fentanyl is much stronger than naturally-derived opiates like morphine or heroin. According to estimates from the U.S. Drug Enforcement Agency (DEA), a dose of fentanyl is 50 to 100 times as powerful as one of morphine. Some types of fentanyl, such as the large-animal analgesic carfentanil, are estimated to be around 10,000 times stronger than morphine and 5,000 times more powerful than heroin. Below you can see how little of either drug it takes for a lethal dose compared to heroin, the former "heavy hitter" of drug abuse before fentanyl made its big debut.

2016 is the most recent year with available statistics about U.S. overdose deaths. According to those numbers fentanyl was responsible for more than 20,000 fatal overdoses that year, making 2016 the year that synthetic opioids became the deadliest drugs in the U.S.--surpassing heroin and other prescriptions like Oxycontin. In some of those cases fentanyl likely was used to "cut" other drugs like heroin or cocaine, heightening their effects but magnifying their dangers.

A drug as powerful as fentanyl should never be made outside of carefully-regulated settings. However, many drugs created in professional laboratories are later reproduced by groups with less oversight and few if any moral conflicts. Unsafe "bootleg" drug analogues are made overseas and sold online, warts and all, to anyone who wants some, from the naively curious to the hopelessly addicted. Even now, a Google search of "fentanyl for sale" will yield dozens of results.

Some international vendors are more than willing to export large amounts of the dangerous product as long as the money's good. The law tries to stop them every chance it gets, but rather than stamp out the problem it just motivates other distributors to be more crafty.

Even Normal or Accidental Contact Can Be Dangerous.

Even above-board fentanyl production made and distributed by American "Big Pharma" companies can cause addiction and overdoses. Some legitimate users of fentanyl have accidentally overdosed while trying to medicate properly, sometimes because the painkiller's delivery method was defective. The transdermal patch, one of the most-prescribed forms of fentanyl, has perhaps the worst track record of dangerous failures. Over the years several makers of fentanyl patches have issued recalls after hundreds of fentanyl-related deaths were reported to the FDA.

The most serious and common reported defect with the pain patches was issues with leaking. In essence this means the patches' seals were breached or torn, allowing too much highly-potent fentanyl gel to be delivered directly onto users' skin. These leaks often cause overdoses, many of them fatal. Direct exposure of fentanyl to the skin is extremely hazardous, to the point that healthcare professionals and first responders are trained not to directly come in contact with fentanyl in any form.

An example of this hazard comes from East Liverpool, Ohio. Around this time last year, a police officer participated in a drug bust that involved a supply of fentanyl. In the course of the bust, some powdered fentanyl got on his uniform; not thinking anything of it, he brushed the powder off with his bare hands. Because fentanyl can absorb through the skin, the officer overdosed from this simple contact and had to be rushed to the hospital.

As fentanyl makes its way further into the world of drug abuse through health care providers (honest or crooked), drug dealers (presumably crooked), and international vendors, the number of lives it claims will continue to rise. If that's not a reason to call something a "crisis," I don't know what is.

What This Means

For those who have been hurt or killed by prescribed fentanyl, there may be legal remedy for them or their families. Given its high potency even a tiny dosage imbalance could be lethal, which has caused much grief to some patients and their families.

In the cases of manufacturers who create and distribute faulty treatment methods (oversaturated lollipops, compromised patches), there's already some history of litigation. Relatives of several users of the Duragesic fentanyl patch sued Johnson & Johnson (parent company of Janssen and ALZA, makers of the patch) in the mid-2000's. The patches supposedly leaked, allowing too much of the drug to enter the patients' bloodstreams, killing them via overdose.

In these cases it was alleged that Johnson & Johnson's subsidiary companies did not exercise a proper standard of care when making and marketing the patches. It's fair to say that when a product carries considerable risk even when used properly, it's important that all possible types of misuse or error be considered and prevented. The companies create sheet after sheet of meticulous instructions and warnings, printed in every known language, to tell users what they can and cannot do with a product. Heck, they have to do it for plastic grocery bags (look on the side and see NOT A TOY printed there), so a patch full of poisonous feel-good juice definitely needs a thorough walk-through.

If a patient follows the instructions to the letter and the patch just ruptures and causes an overdose, the responsibility for that product failure lies with its maker, not its end user. The defect suggests negligent manufacture, where the company churned the products off its factory lines without taking appropriate care to make sure the final product wouldn't leak or rupture. Since in this case that defect can cause death, a very high standard of care must be demanded from the manufacturers.

Like many lawsuits, not every instance of fentanyl injury will be actionable. For instance, many overdoses and deaths are suffered by people who did not obtain their fentanyl legally. Some people might buy leftover pills from their friends, others might seek out the drug from street dealers, and still others may accidentally overdose if the drugs they thought they were taking are combined or "cut" with fentanyl (or even worse, carfentanil). Over the past few years the U.S. Drug Enforcement Agency (DEA) has made several busts involving imported "bricks" of fentanyl worth upwards of a million dollars. In situations of illicit drug use it's unlikely that the victims or their families will be able to sue, though if the dealers can be identified at least criminal justice might be rendered.

I recognize the value of fentanyl in a world full of hurting patients; there's a reason the stuff is considered "essential" by the WHO. I'm only suggesting--and I wish I had more opportunities to quote Spiderman comics--that "with great power comes great responsibility." In some ways fentanyl may be a godsend for patients with severe pain, but I must caution great care in its use, and even more so in its creation.