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Bad Medicine And The Duty To Warn: 11th Circuit Addresses Alabama Learned Intermediary Rule

Alabama Injury Lawyers

This might be a boring technical topic for some readers. But, it’s an important issue in the world of injury claims involving bad drugs. In recent years, we’ve worked numerous personal injury claims involving prescription medications.

Do Drug Companies Have To Warn Patients Of Medicine Risks?

You’ve probably seen a drug ad on television. Those commercials usually follow the same script. Soft music. Smiling people. The actors all appear to be living happy lives courtesy of some pill. Then, at the end, the drug company flashes a really quick list of pretty scary potential side effects. If it’s a 30 second ad, the first 29 seconds talk all about how the pill cured the actor’s arthritis. Then, at the last second, a quick warning appears:  Don’t take this pill if you are a human between the ages of 20 and 90. Otherwise, your arms may fall off! Consult your doctor.

What duty do drug companies have to warn patients? Do they have a duty to warn of risks? Yes, they do. Any company that manufactures an inherently dangerous product must warn of potential dangers. With prescription drug makers, this rule is a little different. Here is how a Federal Court recently explained it:

Under Alabama law, the manufacturer of an unreasonably dangerous product has a duty to warn users of the risks presented by the product. When the unreasonably dangerous product is a drug that requires a prescription, a drug manufacturer’s duty to warn is usually discharged by warning the prescribing physician of the product’s risks.

While manufacturers of other types of dangerous products must directly warn consumers, prescription drug companies do not. Typically, they must only warn the prescribing doctor. Of course, this special rule raises even more questions. Will your doctor read the warnings? Will your doctor tell you the warnings? Will your doctor consider the warnings? Is that prescription drug you were given really safe? I discuss some of these questions in prior posts. The special rule for prescription drug makers allowing them to warn the doctor rather than you is often referred to as:  The Learned Intermediary Rule.

How Does The Learned Intermediary Rule Work?

First up, the rule differs between states. If you are injured by a defective prescription drug, you really need to consult a lawyer in your state who handles these claims. Injury claims can easily be won or lost based on the rule. Because of the unique issues that win or lose your claim, I think it’s a big mistake to hire some nationwide advertising lawyer outside your state. I’ve offered that opinion in several prior posts discussing our law firm’s prescription drug injury cases. But, today I’ll just talk about the rule generally.

Basically, prescription warnings are directed to the doctor as the middleman between drug maker and patient. As our courts have stated:

Because a prescription drug can be obtained only through an intermediary, such as a doctor, Alabama law assesses the adequacy of the warning by asking whether the warning label adequately warns that intermediary.

It’s one thing to look at the label and ask if it warned the doctor of the danger. But, the rule goes beyond that:

That is, the plaintiff must show that curing the label’s inadequacies would have altered the prescribing physician’s conduct in a way that would have prevented the plaintiff’s injury.

That’s a big issue where claims can easily be lost. I’ll give an example. Our law firm represented numerous ladies across northern Alabama who were injured by dangerous transvaginal mesh (TVM) implants. These cases were fascinating. For many years, several different companies marketed these mesh implants to local doctors as a simple cure-all for certain issues like stress urinary incontinence and pelvic organ prolapse. The truth was far different. They were not a cure-all. They were not a simple fix. Instead, they were associated with a whole host of debilitating injuries. Some of our injured clients now suffer lifelong pain and disability following a TVM implant.

Did the TVM manufacturers warn doctors of the very debilitating potential risks? No, they did not. At least, I don’t think they did. Many other injury attorneys across the United States also felt the same way. Does that mean you can win every TVM case where a client suffers permanent injury or chronic pain from the implant? No, it does not. In these cases, the prescribing / implanting doctor was key. Here’s why. The doctors received the inadequate warnings. What if the doctor chose not to read the warnings? What if the doctor ignored the warnings? What if the doctor did not care about the warnings? What if the warnings made NO difference to the doctor and the doctor intended to implant the product regardless. In each of those cases, the manufacturer could likely win the case. If you choose to ignore a warning, you lose. Since the learned intermediary rule requires the warnings to go to the doctor rather than patient, the patient loses if a better warning would have made no difference to the prescribing physician.

We worked our TVM cases hard. I met with the local doctors who prescribed and implanted these products into our clients. We discussed the warnings, including why I thought they were inadequate. We obtained testimony from these local doctors that they would NOT have implanted the product if the manufacturer had warned them of the real dangers. That’s the key testimony you need to win. Did the doctor rely on the inadequate warnings as given? Would the doctor have done something different if he had the accurate information?

A New Case Adds A New Twist To An Old Rule

Now that you have a little background on The Learned Intermediary Rule in Alabama, let’s discuss a recent Federal Court of Appeals decision. I’m writing today because of this recent decision. The case presents an interesting question about the rule.

In Blackburn v. Shire US Inc., the 11th Circuit Federal Court of Appeals raised an interesting question about the Alabama Learned Intermediary Rule. I’ll give you a quick summary of the facts. The patient had Crohn’s disease. His physician in Huntsville prescribed a medication called LIALDA. The drug’s label warned that it presented a risk of kidney disease. After taking the drug for a period of time, the patient did develop advanced kidney disease. So, the drug company warned the doctor of the risk. And, according to the evidence in this case, it appears the doctor did tell the patient. So, both doctor and patient knew the risk.

Many prescription medications carry serious risks. Sometimes, the risk is worth it. If you are a patient, you want to know the risk and to make an informed decision. Case closed, right? Not so fast. In Blackburn, the patient’s lawyers had an interesting argument. Although the label did warn of the risk, an expert concluded the injury was still preventable. How? The expert concluded the label should have been modified to include instructions related to early monitoring and treatment concerning kidney function. And, such instructions would have prevented the advanced kidney disease caused by the drug. The prescribing doctor also testified that he would have followed monitoring or treatment instructions if they had been provided.

Interesting issue! The label warned of the ultimate risk. But, the label should have carried additional instructions as to preventing, catching or mitigating the risk. That’s an issue Alabama court’s have not specifically addressed. Since the issue has not been addressed by an Alabama court, the questions were sent to the Alabama Supreme Court for guidance. They are:

  1. Can a pharmaceutical company’s duty to warn include a duty to provide instructions about how to mitigate warned-of risks?
  2. Can you prove a failure to warn by showing that although the doctor would have still prescribed the medicine, he would have adopted different testing, evaluation or mitigation procedures?

I’m curious as to how the Alabama Supreme Court will answer the questions. I’ve handled prescription injury claims. I’ve worked with doctors to get testimony that the label was inadequate. In most cases, the issue is simply whether or not the doctor would have prescribed the medicine if the truth was known. This is an interesting twist that will impact many bad drug cases. This topic may seem overly technical to you. But, I’ll be watching it closely.


From its office in Huntsville, the Blackwell Law Firm helps people across Alabama following a serious personal injury. If you have questions about an accident or injury, let us know. We are happy to discuss these issues. Our consultations are always free and confidential.