Learned Intermediary Doctrine

[Update, July 15, 2013: The Federal MDL court reached the opposite conclusion, denying summary judgment on liability and causation and on punitive damages. Those cases will now proceed to trial.]

In case you missed it, last week I had a guest post up at TortsProf lamenting how recent changes in civil procedure law have created a situation in which judges are frequently deciding complex cases by improperly deciding for themselves what the true facts were, in advance of a jury trial, and sometimes on nothing but the initial complaint.

Unfortunately, we just had another example: the recent order in the NuvaRing litigation consolidated in New Jersey state court dismissing all of the bellwether cases, primarily on causation grounds. It’s not the end of the game — motions for reconsideration will be filed, as will an appeal, and it doesn’t affect the federal court MDL — but it’s disappointing nonetheless. There’s much to complain about (and, on appeal, to reverse), but I’m going to focus on the “learned intermediary” part. First, a little bit of background.

The most popular form of hormonal contraceptives are combined hormonal contraceptives (“CHC”), which use an estrogen (typically ethinyl estradiol) to prevent ovulation and thicken cervical mucus. Estrogen use, however, is correlated with an increased risk of venous thromboembolism, such as deep vein thrombosis, and thus pulmonary embolisms (blood clots in the lungs) and cerebral venous thrombosis (blood clots in the brain), so CHCs add a progestin to counterbalance that risk.

NuvaRing uses desogestrel as its progestin (that’s different from Mirena, which uses levonorgestrel), making it a “third-generation” CHC. Since 1995 — six years before NuvaRing went on the market — it has been known that third-generation CHCs have a significantly higher risk of causing thrombosis and blood clots than second-generation CHCs. As the New Jersey court opinion recounts (based on the plaintiffs’ filings), by the time NuvaRing went on the market in 2001, 15 studies had examined that difference in risk, and 13 of those studies found an elevated risk, ranging between 1.4 times and 4 times greater risk of venous thromboembolism when using NuvaRing. Implants without a hormone added, like Essure, don’t have these same risks.

NuvaRing’s prescribing information and patient insert warned about the general risk of venous thromboembolism when using CHCs, but then hedged on the increased risk with vague, ambivalent language obviously written more for purposes of litigation than for informing patients and doctors about the risks of the product:

The use of combination oral contraceptives is associated with increased risks of several serious side effects, including blood clots, stroke, or heart attack. NuvaRing is not for women with a history of these conditions. The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills. It is unknown if the risk of blood clots is different with NuvaRing use than with the use of certain birth control pills.

The risk “may be greater” but “is unknown?” That wasn’t even accurate when NuvaRing was first put on the market, and now, more than a decade later, it is even less defensible: last year, a meta-study of 625 studies published between January 1995 and April 2010 found the risk of venous thromboembolism for CHCs that use desogestrel, like NuvaRing, was about double the risk of second generation CHCs. Yet, the manufacturer (Organon and Merck) have refused to update the label; perhaps it’s because they sell over $600 million worth of NuvaRings every year to over a million women.
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Product liability claims are doubly challenging for plaintiffs’ lawyers. First, product liability law is in a state of flux (with the trend going against injured consumers). Second, product liability cases are notoriously time-consuming and expensive to pursue: in addition to all the ordinary expenses and burdens of personal injury litigation, product cases usually require hiring a bevy of experts who then have to spend hundreds of hours examining the products and preparing their reports. It’s not unusual for lawyers to spend over one hundred thousand dollars on a product liability case in out-of-pocket expenses alone (not including lost attorneys fees), and when you start talking about complicated products like cars, you’re talking about a quarter million dollars or more.

That’s part of why product liability court opinions often have such tragic facts: the claim needs to be worth $1 million or more to justify the risk, and generally speaking, brain injury, spinal cord injury, and wrongful death cases are most likely to produce those kinds of awards. Whatever the injury is, it needs to be permanent, otherwise you’re investing six figures into a case that will, after expenses, return far less than that — or nothing at all.

Correspondingly, because the product liability suits brought involve such huge damages, they never follow the sort of routine that car accident and slip and fall cases do — where production of medical reviews and review of any police report or witness statements will answer most of the factual questions, and so the case can be settled with minimal litigation long before trial. The manufacturer or seller of a defective product will virtually never offer any sort of reasonable settlement amounts until after summary judgment and Daubert motions (testing the sufficiency of the plaintiff’s expert witnesses) have been decided.

I’m more than happy to rail all day against the unfair, sometimes downright illogical, restrictions placed on plaintiffs in product liability cases, and I’ve done so many times on this blog (e.g., railing against the Third Restatement of Torts, the learned intermediary doctrine, the judicially-created implied pre-emption doctrine). But sometimes the problem really can be traced back to the plaintiff’s case.

Via Abnormal Use, I learned of two recent product liability summary judgment opinions dismissing the plaintiffs’ respective cases, one in the South Carolina Supreme Court and the other in the federal court in Massachusetts. They’re examples of how the lack of a proper expert opinion can doom a case before it’s ever put in front of a jury.


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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. 
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A few days ago I reviewed the list of “worst” pharmaceutical and medical device liability court opinions of the last year as chosen by the defense lawyers at Drug & Device Law, so I feel obligated to follow-up on their post on the “best” prescription drug and medical device decisions.

The short version is quite simple: drug and device companies really like activist judges legislating from the bench or overruling juries’ factual findings. How else to explain the love for PLIVA, Inc. v. Mensing, in which the United States Supreme Court couldn’t find a federal statute or regulation in support of granting generic drug manufacturers legal immunity and so contrived an argument the Court admitted “makes little sense,” or Garza v. Merck & Co., in which the Texas Supreme Court held that it was unreasonable for a jury to agree with two cardiologists that Vioxx caused a heart attack?

As with their “worst” list, the “best” list is most interesting for what it reveals about the current state of drug and medical device company liability: heads defendant wins, tails plaintiff loses. In Mensing (#1), a plaintiff’s claim was dismissed because the Court didn’t want to speculate about what the FDA would do if a drug company proposed strengthening a warning label, while in Dobbs (#8) a plaintiff’s claim was dismissed because the Court speculated that the FDA wouldn’t accept a drug company’s proposal for a strengthened warning label. In Williams (#4), a plaintiff’s claim was dismissed because her doctors disposed of the pieces of the device in question, while in Wolicki-Gables (#6), a plaintiff’s claim was dismissed because, even though the plaintiff asked in writing for her doctors to preserve the device, a representative of the device manufacturer slipped into the surgery without the patient’s consent, took the device, lied to the patient about testing it and destroyed it, leaving the plaintiff nothing to examine or to test.

Let’s roll the tape.
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[Update: the American Medical Association recently posted an article about how “off-label” marketing is so pervasive that many doctors don’t even know what the approved purposes of the prescription drugs and medical devices are, exposing them to malpractice liability.]

The pharmaceutical defense lawyers at Drug & Device Law, one of my favorite blogs to throw rocks at (we went Jersey Shore over the Wellbutrin litigation a year ago), are at it again, this time attacking a legal theory they refer to as ‘FDA regulatory informed consent.’ Although drug companies aren’t allowed to market drugs for any purpose other than those purposes approved by the Food and Drug Administration (it’s called “off-label marketing” and it’s blatantly illegal), the FDA permits individual doctors to prescribe FDA-approved drugs for any purpose, creating a disconnect between FDA approval and actual medical practice. The FDA doesn’t do anything to regulate what doctors prescribe; the closest it comes to informed consent are its regulations for clinical trials.

Under the theory of FDA regulatory informed consent, physicians should be required to tell patients if the physician is prescribing a medication for a use not approved by the FDA. Jim Beck at Drug & Device Law thinks it’s a bad idea, and wrote his post in response to a new law review article, “The Case For Legal Regulation Of Physicians’ Off-Label Prescribing,” 86 Notre Dame L. Rev. 649 (2011)(online copy here), by Philip M. Rosoff, a professor at Duke Medical School, and Doriane Lambelet Coleman, a professor at Duke Law School. As Beck notes, most courts don’t accept the explicit version of this — i.e., the requirement that a doctor specifically say the drug or medical device isn’t FDA-approved — but, as Beck doesn’t note, some courts get awfully close. See, e.g., DeNeui v. Wellman, No. 2009 U.S. Dist. LEXIS 114853, at *11–14 (D.S.D. Dec. 9, 2009)(“a jury must determine whether a reasonable person would attach significance to the off-label use of [the medical device] before deciding whether to undergo the surgery in this case”); In re Diet Drug Litigation, 384 N.J. Super. 525, 895 A.2d 480 (Law Div. 2005)(distinguishing Blazoski v. Cook, holding “While obesity is a serious condition, phen-fen is hardly its only cure. While phen-fen may have provided real benefits for those who took it, these patients were entitled to know of its risks. And it is certainly foreseeable that, if advised of the risks, they might well have chosen alternatives.”).

I’m unsurprisingly more on Rosoff and Coleman’s side. I’ll explain.

First, a little bit of background on the subject. As I’ve discussed before, intense lobbying by drug companies — including infiltration of the supposedly neutral legal research groups like the American Law Institute, which publishes the various Restatements — has whittled away at most of the potential claims against defective drug manufacturers. The law’s so hostile to patients that even doctors think it’s too protective of drug companies. (At the same time, those same companies have lobbied for absurd laws like the Prescription Drug User Fee Act that penalize the FDA if it doesn’t approve drugs quickly enough; unsurprising, that has made drugs less safe and more likely to be withdrawn.)

If you try to sue a drug company for inadequately testing or improperly designing a drug, the drug company will cite FDA approval and shout “pre-emption,” arguing that the FDA already signed off on the drug’s safety and efficacy and that the courts aren’t allowed to second-guess that — even if neither the FDA nor Congress said they meant to foreclose tort lawsuits. Defense lawyers call that dubious argument “implied pre-emption.”

Courts will too often buy those arguments; consider the lengths to which Judge Posner jumped to deny a toxic epidermal necrolysis / Stevens-Johnson syndrome victim a $3.5 million jury award. I’m not sure why he bothered with that long and winding factual argument, leaping from assumption to assumption and begging his own questions; he could have just said, “I’d prefer they lose” and be done with it.

In short: under a variety of names (“implied preemption,” “learned intermediary,” “unavoidably unsafe product,” etc) the drug manufacturers routinely claim that FDA approval is the be-all, end-all of drug safety, and so no injured patient should ever be allowed to sue the manufacturer of an FDA-approved drug. It’s thus more than a little hypocritical for them or their lawyers to now claim that FDA approval is irrelevant to patients. It’s the sole reason they believe they’re entitled to special legal immunities not granted to other manufacturers.

Although every defective drug lawsuit these days alleges a variety of claims like strict liability, negligence, breach of warranty, and violations of consumer protection laws, in the end most of the prescription drug lawsuits tend to boil down to one type of claim: the “failure to warn” of a certain side-effect or problem with the drug. The Supreme Court held in Wyeth v. Levine that failure to warn cases could go forward, so patients’ lawyers have held on to that will all their might. All the big prescription drug cases these days — Accutane, Actos, Chantix, Darvon-Darvocet, Depakote, Fosamax, Plavix, Topamax, Yaz — are primarily failure to warn cases. The Accutane plaintiffs allege that Roche failed to warn about side effects like inflammatory bowel disease and birth defects. The Actos plaintiffs allege that Takeda failed to warn about an increased risk of bladder cancer. The Chantix plaintiffs allege that Pfizer failed to warn about the risk of depression and suicidal thoughts. Et cetera.

Lurking under the surface of many of these cases is the scourge of off-label marketing. You wouldn’t know it from Beck’s critique, but doctors and medical researchers have long fretted about off-label prescription. One study in 2006 found over 150 million off-label mentions by physicians each year — totalling over one-fifth of overall prescriptions — and found that three-quarters of those off label prescriptions had “little or no scientific support.”

Worse, many patients don’t know that doctors are allowed to prescribe drugs for unapproved and unsupported uses: “A 2006 poll suggests that much of the U.S. public is confused and ambivalent about off-label prescribing, with about half the respondents believing that physicians are permitted to prescribe drugs only for on-label indications and about half believing that physicians should be prohibited from prescribing drugs for off-label indications.” (Source).
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At Day on Torts:

This study in PLoS Medicine reports that, based on estimates from publicly available data, drug manufacturers probably spend more money on advertising than they do for research and development.

In the words of the study:   "From this new estimate, it appears that pharmaceutical companies spend almost twice as much on