Most of you have heard reports about the devastating effects of opioids. Millions of people have become addicted, and many of those people have overdosed and died while taking the addictive pain medication. Even in cases when death does not occur, addiction has caused job losses, ravaged families, and cost billions of dollars in treatment for victims.

Up to this point, most of the recent litigation involving opioids has involved lawsuits against the makers of opioids on behalf of states and local governments. The essential complaint is this: [Blank] State has incurred millions of dollars in losses because citizens in the state became addicted to opioids and required government assistance in the form of hospitalization, treatment programs, unemployment, welfare, and other governmental expenditures.

But what about individuals? It is plain to see how a state or county can articulate damages from the direct and indirect costs of widespread opioid addiction, but individuals have been injured as well. In 2018, do these individuals have valid claims? Increasingly, it appears the answer is yes. And if so, this litigation will eventually be massive.

Let’s take a look.

Individual Claims for Injuries Caused by Opioids

So when the opioid litigation shifts from states and counties to individuals, what kinds of injuries could these injured plaintiffs base their claims for compensation?

1. Opioid Addiction. It starts here. This claim must be established through the medical records, but it should not be difficult to prove. Doctors (and families of the victim) know addiction when they see it. It is estimated that over 2 million people suffer from opioid addiction in the United States.
2. Opioid Overdose. Opioid overdose can permanently injure the victim and cause years of required health care.
3. Opioid Overdose Causing Death. This tragic result is the most obvious and most painful of the potential injuries caused by opioids. The wrongful death claim would be brought by estate for the deceased victim and the victim’s family.
4. Neonatal Abstinence Syndrome (NAS). This condition occurs when a baby is born addicted to opioids. The newborn becomes addicted when the pregnant mother abuses the medication while pregnant. Some symptoms a newborn may experience when suffering from NAS include diarrhea, fever, sleep problems, seizures, trembling, birth defects, and many others.
5. Lost earnings and other financial losses. For this claim, the plaintiff must show the financial losses were directly caused by the opioid addiction, leading to lost jobs, lost savings, etc.

But What About the Learned Intermediary Defense?

Make no mistake, the manufacturers of opioids will present every defense they can find. Check out my post on Opioid Drug Company Defenses.

One of the more insidious of these potential defenses is the learned intermediary doctrine. I’ve written about this defense often on this site, but it essentially goes like this: if the drug company crafts a drug label detailing the risks of taking a medication, the company may rely on the patient’s doctor–the learned intermediary–to explain to the patient the risks and benefits of taking the drug. In this scenario, the doctor is expected to know (often in granular detail) the contents of the warning label and be able to give precise medical advice on whether the patient should take the medication. It’s a lot to ask of a general practitioner or a surgeon, but the defense has been used often by drug companies to escape liability for harm caused by dangerous medications.

But here is the reason the learned intermediary doctrine may not be the get-out-jail-free-card for drug companies in the new emerging opioid litigation:

1. The FDA and the medical community have learned much more about the devastating effects of opioids in recent years. This means that the medical community simply was not sufficiently informed (“learned”) about the serious risks until very recently, and so could not have been expected to give precise and proper caution to a patient taking the drug;
2. The FDA has recently added new “black box warnings” on opioid labels. The warnings have gotten stronger and more comprehensive. This means that individuals who were harmed by opioids prior to the latest warnings may not have to contend with the learned intermediary defense;
3. State medical boards have issued new guidelines for doctors who may prescribe opioids;
4. Doctors and their patients may overcome the learned intermediary defense by arguing that the drug companies informed doctors for years that opioids were not addictive. We now know that opioids are highly addictive and can be destructive to a person’s health. The drug companies’ representations in the past may eliminate or severely weaken the learned intermediary defense.

All that said, I believe many new individual claims for injuries caused by opioids will emerge over the next few years. In fact, the litigation could become huge over the next decade. You can read more about opioid litigation on this site. And you can always call me to discuss your potential opioid case at any time (919.830.5602). Good luck.

Despite the addictions, injuries, and deaths, and despite reports of awful business practices by the makers of these prescription painkillers, defense lawyers have developed certain legal defenses to help these drug companies avoid liability. Let’s look at a few:

The FDA Approved the Drug, So It’s the Government’s Fault

This is a tough one. Essentially, the drug companies proclaim: the FDA approved the opioid product for manufacture and sale, so we can’t be liable for claims such as defective design. If opioids were a problem, they argue, the FDA should not have approved the drug for sale in the first place.

I have struggled with this defense for years. For one, the FDA is one government agency, and it is tasked with overseeing the review and approval of all new drugs, as well as monitoring practices among drug companies after approval. Plus, and although it shouldn’t be, the FDA inevitably becomes political, and depending on the administration, the policing efforts can range from effective to cozy with drug companies. In political climates with relaxed enforcement, problem drugs can reach the market.

The solution: the FDA must remain independent, and protected from political influence, and serious and competent people must run the operation. If that can happen, this defense would hold more weight.

The Learned Intermediary Doctrine, So It’s the Doctor’s Fault

A drug maker has a duty to warn patients about the risks of its drug. If the drug label is inadequate, leaving out vital information, the person injured by the drug can bring a claim for failure to warn. However, if the label lists all the risks (even if a key risk is buried deep in the package insert) the drug company can often rely on a defense known as the learned intermediary doctrine. This means a manufacturer is not liable for a high-risk prescription drug if the risk was placed on the label and technically made available to the patient’s doctor (the “learned intermediary”). In these cases, the duty to warn shifts away from the drug company and to the physician, who is supposed to give the patient a full explanation of the benefits and risks of the medication he prescribes.

The problem is this: in many cases general practitioners don’t know all the risks of a certain drug. And really, how could they? Doctors must stay current on all kinds of illnesses and conditions, and they can’t be expected to know granular detail of every drug on the market.

I’ve never liked this defense. Of course, I represent individuals injured by defective medical devices and drugs, so I guess it is predictable that I wouldn’t like it, as it can cause me and my clients certain difficulties. But aside from my potential professional bias, the learned intermediary doctrine is a flawed defense, mainly because it occasionally allows drug companies to escape truly negligent and harmful behavior.

The Patient Misused Opioids, So It’s the Victim’s Fault

This defense can be very effective, and in many ways it is galling. A drug company puts a highly addictive drug on the market, pushes the drug in marketing campaigns and in aggressive one-on-one meetings with doctors to push prescriptions, and then, when the patient becomes addicted and misuses the product, the drug company points to the bad behavior as an affirmative defense. And it often works. The alleged misuse can take many forms: taking the drug after recovery from the underlying injury is complete, or, after addiction has set in, attempting to procure opioids from different doctors or for made-up health reasons. Now granted, many people can and have abused these drugs. I get it. But it is a complicated matter when you are dealing with an addictive prescription medication like opioids.

The Statute of Limitations Has Run, So It’s the Calendar’s Fault

I have written about the statutes of limitations many times on this site. As a plaintiff’s lawyer, the statute of limitations haunts my dreams like The Lone Biker of the Apocalypse in Raising Arizona. The statute of limitations is a law limiting the time you may bring a lawsuit for personal injury. In each state you have a certain number of years from the injury, or the date of discovery of the injury, to file a complaint in court. In opioid cases, plaintiffs argue that the court should use the “discovery rule,” which states that the limitations period cannot begin to run until the plaintiff knows or should have known about the specific injury. As you can imagine, however, vicious fights occur in court about the start date for many statutes of limitation.

Now you be the lawyer: what arguments can you make to overcome these defenses? What weaknesses do you see in these defenses? Feel free to email me your thoughts. Or call me to discuss further.