The Learned Intermediary Doctrine And Dollars For Docs

Have you ever seen a commercial on TV, or heard a commercial on the radio, or read an advertisement in a magazine, or saw a commercial on a website, for a prescription drug?

Of course you have, if you’re in the United States (or New Zealand — the rest of the modern world bans the practice). You see them all the time. Why? Because, as io9 profiled extensively, ”For every dollar spent on ads for drugs, over four dollars in retail sales are garnered. A May 2011 study showed that new drugs that feature direct-to-consumer advertising are prescribed nine times more than their new counterparts that lack consumer advertising.” Billions of dollars are spent on ads to patients to convince them (1) to “ask your doctor about” whatever medication is most profitable and lobby for it based on the advertising and (2) to choose the medication over other available options.

There’s nothing novel or even disputable about that, but try pointing out the purpose and effect of prescription drug advertising to the Supreme Courts of the three dozen or so states — including most of the large population states like California, New York, Florida, Illinois, Pennsylvania, Ohio, Michigan, and so on — that have followed some version of the “learned intermediary doctrine.” (Only one court, West Virginia, has expressly rejected the doctrine, in State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 913–14 (W. Va. 2007)). Texas formally joined the ranks of learned intermediary courts about two weeks ago. LexisNexis summarizes here, there’s some defense oriented coverage here and here and here, and I haven’t seen any plaintiff’s comment (but feel free to email me).

Under the most basic version of the learned intermediary doctrine, prescription drug users are considered by law to be lab rats who have no say in what their doctor prescribes and have no ability to turn the medication down. More formally, the doctrine provides:

 (1) that manufacturers of prescription drugs and medical devices discharge their duty to of care to patients by providing adequate warnings to prescribing physicians, and (2) that any failure to warn cannot be considered a proximate cause of a subsequent injury if the physician was fully aware of the dangers that would have been included in an alternative warning.

Greaves v. Eli Lilly, 2011 U.S. Dist. LEXIS 129443 (E.D.N.Y. Nov. 8, 2011). In Greaves, a man developed diabetes as a result of 9 years of Zyprexa use. Six years into his Zyprexa use, the doctor learned Zyprexa could cause diabetes, and continued prescribing it. When the doctor was later asked if knowing Zyprexa could cause diabetes would have changed anything about his interactions with the patient or his prescription, the doctor said no, he would have prescribed it just the same, regardless of the warning and regardless of how his patient felt about that, even though Abilify — which the patient was eventually moved to once he was diagnosed with diabetes — would have worked just as well. That’s when the learned intermediary rule came into play: because the doctor said he wouldn’t have done anything different if the doctor had known about the risk of diabetes, the plaintiff’s testimony was irrelevant, and so the plaintiff’s claim was dismissed.

There are thousands of cases like Greaves. Consider Wendell v. Johnson & Johnson,  2011 U.S. Dist. LEXIS 144437 (N.D. Cal. Dec. 15, 2011), where a young man developed hepatosplenic T-cell lymphoma (and died from it) as a result of irritable bowl syndrome medications. When the young man was diagnosed with lymphome, his treating doctor didn’t even suspect the medications — but not long after the man’s death, the doctor stopped giving that therapy to patients. Under the learned intermediary doctrine, it didn’t matter: the doctor didn’t emphatically state that he would have changed everything in response to an adequate warning, and so ”Plaintiffs lack evidence that any further warning regarding the use of 6-MP, such as a warning about its use in combination with Humira, would have changed the manner in which Dr. Rich treated Maxx.”

It’s a bad rule, a sleight of hand that allows the prescription drug company to avoid liability for misleading prescription drug users by pointing the finger at their doctors. All a doctor has to say — and we’ll get to why they would say this in a moment — is, “a better warning wouldn’t have changed my prescribing decision” and, poof!, the plaintiff’s case vanishes. The whole case is decided without even considering whether the defendant drug company had warned the patient — the one who, at all times, had the final say on whether or not they actually took the medicine — about the real risks. 

The Texas Supreme Court’s reasoning in adopting the doctrine, like many courts before it, is based on this passage by Judge Minor Wisdom:

As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.

Judge Wisdom was a smart and capable jurist — but he was writing nearly forty years ago in a polio vaccine case. Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974). There’s no alternative therapy to a polio vaccine, and the benefits undeniably outweighed the risks. Would Judge Wisdom have the same reaction to, say, the grotesque Topamax fiasco, where Ortho-McNeil Pharmaceutical sales representative systematically misrepresented to health care providers the uses of Topamax (and eventually paid criminal fines and settled a False Claims Act lawsuit), leading thousands of pregnant women to take a drug that causes birth defects? What about the Propecia marketing blitz, so crafty and aggressive it became a Harvard Business School case study, only so men could later learn they unknowingly traded baldness for impotence and sterility?

Neither of these drugs were even necessary to treat a disabling condition — Topamax was  supposed to be an anti-seizure medication, but it was more commonly prescribed for weight loss and mood stabilization, and Propecia is just for hair loss — but due to aggressive marketing campaigns aimed at patients that failed to disclose the real risks, both exploded in sales.

The theory underpinning the “learned intermediary” is only applicable, if at all, to narrow circumstances in which the patient truly has no other choices, and where the patient isn’t capable of fully weighing the risks and benefits of various treatment modalities given the medical complexity of the situation. Most of these drug lawsuits, though, involve situations where the patient is more than capable of understanding and evaluating the risk, like the Type II Diabetes medication that doubled the risk of bladder cancer the blood thinner that causes uncontrollable, irreversible bleeding.

Deep down, the learned intermediary doctrine shouldn’t make a difference in most cases. In most cases, if the medication’s warning label didn’t state a risk, then the doctor should honestly testify that, if the doctor had known of the risk, they would have discussed it with the patient so the patient could make an informed decision about whether or not to take the drug. In many cases, though, the doctor says the same thing the doctor in Greaves said: even if I had known about the risk, I wouldn’t have changed a thing. Why?

One reason might be money. We don’t know the full scope of pharmaceutical company payments to doctors — ProPublica’s partial database has tracked $760 million in payments — but we know all too well that pharmaceutical companies wield extraordinary influence in doctor’s offices. That money isn’t just a couple free samples here and there (although doctors love those, because they save patients money, thereby encouraging them to come back); it’s direct payments for trips, funneling of patients, and opening doors into journals and into the lucrative research and consulting world.

And what does the learned intermediary doctrine have to say about that? Consider this dismissal of another Zyprexa case:

Plaintiff also contends that summary judgment should not be granted because Dr. Reinstein is alleged to be biased. In support of his assertion, plaintiff cites this doctor’s admission in deposition testimony that he has conducted paid research for at least ten pharmaceutical companies, including defendant Lilly, and that he has served as a paid speaker for at least six pharmaceutical companies, including [defendant] Lilly. Plaintiff also cites two articles containing hearsay allegations that Dr. Reinstein has overprescribed the psychotropic drug Seroquel while accepting $490,000 in compensation from its manufacturer, AstraZeneca, and that he has overprescribed the psychotropic drug clozapine at an unreasonably high rate, while not sufficiently taking into account its serious side effects. See Christina Jewett and Sam Roe, Doctor Gives Risky Drugs at High Rate, Chicago Tribune, Nov. 10, 2009; Christina Jewett and Sam Roe, Doctor’s Lucrative Ties to Drug Firm, Chicago Tribune, Nov. 11, 2009.”

Trimble v. Eli Lilly & Co. (In re Zyprexa Prods. Liab. Litig.), 2010 U.S. Dist. LEXIS 109843, at *28–29 (E.D.N.Y. Jan. 22, 2010). The court held the $490,000 was irrelevant, and the doctor’s testimony was “not subject to any reasonable doubt” — the doctor knew there was a link between Zyprexa and diabetes, and the court really didn’t care to consider whether the plaintiff needed to know.

Another reason the doctor might, say, shade their testimony could be liability fears, whether that liability could be real or if it is just imagined. Ask a doctor whose patient just developed cancer or a gastrointestinal bleed or who had a kid with a birth defect, knowing what you know now about the drug, would you have prescribed it?, and the answer is typically, yes. Why? Because the alternative could be construed as conceding fault in reviewing the medical literature or in evaluating the patient. Enough fault for a malpractice case? Usually not — courts have taken a dim view of medication warning cases, all the doctor has to do is say they told the patient of the risks and it’s over — at best a difficult claim for informed consent, but enough to discourage the doctor from admitting anything that could be construed as a mistake.

Many of the courts who have accepted the “learned intermediary doctrine,” however, have at least created common sense exceptions. In Perez v. Wyeth Labs., Inc., 734 A.2d 1245 (N.J. 1999), the New Jersey Supreme Court recognized the obvious:

Our medical-legal jurisprudence is based on images of health care that no longer exist. At an earlier time, medical advice was received in the doctor’s office from a physician who most likely made house calls if needed. The patient usually paid a small sum of money to the doctor. Neighborhood pharmacists compounded prescribed medicines. Without being pejorative, it is safe to say that the prevailing attitude of law and medicine was that the “doctor knows best.”

Id. Thus, the Court held “that when mass marketing of prescription drugs seeks to influence a patient’s choice of a drug, a pharmaceutical manufacturer that makes direct claims to consumers for the efficacy of its product should not be unqualifiedly relieved of a duty to provide proper warnings of the dangers or side effects of the product.” It’s a simple and obvious analysis of the reality of the prescription drug market today.

The Texas Supreme Court, though, wasn’t going to let a little bit of common sense and reality-based thinking get in their way, so they denied the same “direct to consumer” exception, even in the context of misleading consumer advertisements:

We  agree that  it  is  important  to  prohibit  pharmaceutical  manufacturers from disseminating grossly misleading advertising, and we note that Congress has  enacted a comprehensive regulatory scheme, implemented by the FDA, which is meant to control the design, implementation, and marketing of prescription drugs, including both criminal and civil  penalties for manufacturers that violate these regulations. See, e.g., 21 U.S.C. §§ 331, 333, 335b. We acknowledge that some situations may require exceptions to the learned intermediary doctrine, but without deciding whether Texas law should recognize a DTC advertising exception when a prescription drug manufacturer distributes intentionally misleading information directly to patients  or prospective patients, we hold that, based on the facts of this case, no exception applies.

At first blush it seems we should give them a tiny bit of credit for leaving room for plaintiff’s to claim the drug company “intentionally” mislead them — even though we’re talking about civil liability for negligence, where “intentional” is never required — except the court expressed no hesitation in deciding, for itself, that in the case they were reviewing the pharmaceutical company had not mislead the consumers “intentionally.” In other words, when deciding whether a drug manufacturer mislead a prescription drug patient in Texas, you can dispense with both the patient and the jury, and just let the court decide the result based solely on the testimony of a paid or afraid prescribing physician.

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  • Chip

    A third reason it can be difficult to get testimony from a prescriber needed to defeat the inevitable MSJ on learned intermediary is that doctors are loathe to admit that they are influenced by pharmaceutical sales reps (so called “detail men” in the language of the earliest learned intermediary cases). This, despite the research that conclusively demonstrates the enormous influence that pharma marketing has on prescribing habits. (And why would one expect any different from the research? After all, Big Pharma wouldn’t spend billions in advertising, including huge amounts on marketing to prescribers, if they weren’t getting a good return.)

  • Guest

    In fairness to the doctrine, it doesn’t always involve a doctor who wasn’t aware of the risk. If the doctor is aware, but prescribes anyway (which happens with every prescription, since all drugs have some risks and side effects associated with them), then there is no claim against the drug maker for failure to warn. The chain of causation is broken.

    While the testimony of the doctors you recite may be fatal to the plaintiff’s claim, that doesn’t mean it was dishonest. You seem to totally discount that most drugs are heavily warned about, and it’s quite possible that these doctors are testifying honestly that they would have prescribed the drug anyway if they had known of the risk. Many of the warned-of risks are extremely rare occurrences, and adding another to the mix may well not have influenced the doctor’s decision to go with the drug at issue.

    As for the direct marketing exception, TV ads aside, one cannot get prescription drugs without a doctor, hence the name “prescription” drugs. So, the doctor is an essential part the chain of events that leads to the plaintiff getting the drug. Again, that wrecks havoc on some of these legal claims, but the doctrine itself is sound: If the defendant and plaintiff both reasonably rely on the doctor to warn of side effects, then the doctor’s statements about what he would have done in the face of warnings are absolutely critical in the chain of causation. If you discount the doctor’s statement that he would have still prescribed in the face of a warning, then you’re creating a legal presumption that ignores evidence, because it hurts your case or the witnesses are inherently biased, or something like that. No court is going to create a presumption like that.

    It’s not accurate to say that the doctor always claims that the warnings wouldn’t have changed his behavior. There are lots of pharma cases, and they’re not all thrown out on this ground. For instance, if a drug company concealed information that the doctor would have liked to know about, the treating physician would have no fear of exposing himself to liability, since the relevant information was unavailable to him. When those are the facts, I just don’t see a lot of doctors perjuring themselves to help a drug company out of a lawsuit, even if that company sends them on fancy trips.

    • http://www.litigationandtrial.com/ Max Kennerly

      You’ve missed the key point: just as “the doctor is an essential part the chain of events that leads to the plaintiff getting the drug,” so, too, is the plaintiff “an essential part the chain of events” that leads to both the prescription and the actual use. The question in a failure to warn case should not be just if the doctor would have prescribed it, but if either the doctor *or* the patient would have acted differently had they received an adequate warning. If the doctor would have prescribed it nonetheless, the key question remains of if the patient would have taken it.
      Under the “learned intermediary doctrine,” we pretend that, once a doctor decides to prescribe a drug, that’s the end of the story. Of course it isn’t; in the real world, doctors and patients discuss various treatment possibilities to settle upon one the doctor will prescribe and the patient will take. The learned intermediary doctrine simply pretends like that part doesn’t happen, and that patients are mere lab rats who have no input in the process and can only ever take what their doctor decides they should take. Is that how it works when you’re prescribed a medicine? Do you walk in, take whatever the doctor decided without your input, then blindly consume it?

      • Guest

        When it comes to prescription drugs, I do take what the doctor gives me. I’ve been fortunate not to have to take many in my life thus far, but to be honest, if the doctor gives me a particular antibiotic, I’m not going to ask a lot of questions about it. Maybe I’m strange in that. I don’t think so though. Since the doctor is the only one capable of prescription, what the patient knows or should have known isn’t the key question.

        Perhaps if you have a case where your plaintiff testifies that he asked his doctor for the drug because he saw the TV ad, and listened extremely intently to the warnings without having heard any warnings that concerned him, the doctor’s testimony about what he would have done in the face of warnings becomes less important. I just think that’s best left for a case with those facts, rather than fashioning a rule that assumes them whenever a drug company advertises its product.

        One of the undercurrents here that bothers me is the suggestion that it’s wrong for a drug company to advertise. I don’t get it. Their drugs save lives, or make them much better for the people who take them. There’s nothing wrong with getting the word out about that. To expect a comprehensive and understandable warning at the end of a minute long ad is pretty unrealistic. The warnings on the ads seem far less important than what the doctor knows, since he is the one who ultimately pulls the trigger on the prescription and can consider the issue in a more helpful manner than can a minute long TV ad.

        • http://www.litigationandtrial.com/ Max Kennerly

          Why let companies advertise anything? Your argument – the same argument that the learned intermediary doctrine relies on – is that the patient’s thoughts, feelings, and beliefs about a drug are wholly irrelevant. You can’t have it both ways: you can’t claim the doctor alone “pulls the trigger” while extolling the virtues of direct-to-consumer advertising. You’re saying drug companies can have their cake and eat it, too: they can spend billions misleading patients, but patients who say “I wouldn’t have taken the drug if you had not mislead me” should be thrown out of court.

          Saying the doctor is the only one who can write the prescription misses the point: we’re not arguing over whether a patient who wants a medication should get it, we’re arguing over whether a patient who was actually prescribed the medication should have been warned about the medication they did take because an adequate warning would have changed their decision.

          Doctors prescribe medications after discussing options with patients, and then the ultimate decision on whether or not to take the prescribed medication remains with the patient. A patient prescribed Actos or Propecia or Zyprexa or whatever can always decide that they’re not going to take it, and can always discuss with their doctor other options. The
          learned intermediary doctrine, however, requires creating an alternative
          reality in which the patient has no agency over their prescription, not
          even the decision to decline treatment. That’s unjustifiable, little
          more than legislating from the bench an additional immunity for
          prescription drug companies. It’s like saying that you can’t sue a car
          manufacturer for false advertising the virtues of its car because, well,
          the dealer would have bought it anyway. So what? The point is if the
          consumer would have bought it.

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        • Guest

          I said that if the ad played a pivotal role in the facts of the case, it could perhaps negate the defense.

          We just don’t agree about how this works. If I see an ad that promises to restore my hairline to its glory days, that might excite me. I’m not necessarily listening to all the fast talking disclaimers at the end of the ad, I just want my hair back. Then, I go to discuss it with my doctor to get the scrip, and our talk is a more contemplative and informed discussion than that found on the commercial breaks for America’s Got Talent. Ultimately, it’s that interaction that determines whether I get the drug, and if the doctor says that he would have given it to me, even if the drug company had tacked on another warning to its written materials on the drug, then the failure to warn claim is going to have causation problems. There’s a there there. Maybe not in every case, in some, at least.

          Anyway, since it’s your blog and I enjoy it, please have the last word.

        • http://www.litigationandtrial.com/ Max Kennerly

          Nonsense. You’re my guest and you’ve been unfailingly polite, so the last word is yours. Help yourself to virtual tea and crumpets as well.
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