If you have read any newspaper in the last year, you know that prescription opioids have caused massive suffering in this country. Addiction has skyrocketed. Sadly, deaths from overdoses and even opioid-related suicides have dramatically increased as well. In 2016 alone over 14,000 overdose deaths were reported from natural and semi-synthetic opioids, and over 20,000 people died of overdose from synthetic opioids (mostly fentanyl). Centers for Disease Control. Opioids have become a huge public health problem and a national tragedy. Inevitably, litigation has followed the suffering, and more lawsuits are being filed each week.
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.