The recent law review article, Johns, “Informed Consent: Requiring Doctors To Disclose Off-Label Prescriptions & Conflicts Of Interest,” 58 Hastings L.J. 967 (May, 2007), came to our attention because it cited Buckman (we at least glance at anything citing Buckman). It kept our attention because it advocated what has to be one of the most widely discredited tort claims around – that doctors should be liable in informed consent for not telling patients about the FDA regulatory status of the drugs/medical devices they use (i.e. that off-label use is not “FDA approved”).

Huh? Is there something new that we missed? We thought we’d driven a stake through the heart of that one years ago. Bexis wrote his own law review article on that subject back in 1998 and explained in excruciating detail why this was a very bad idea. Ultimately the courts agreed (he’s a persuasive guy) . They agreed with unanimity that’s rare in the law.

After we picked our collective jaws off the floor, we took a look at the article. Right out of the box, we’re pleased to report that there’s nothing new out there. The cases are still virtually unanimous in holding that FDA regulatory status – as opposed to the medical risks and benefits of a particular course of treatment – is not something that doctors are legally required to discuss with their patients. See Southard v. Temple University Hospital, 781 A.2d 101, 107-08 (Pa. 2001); Earle v. Ratliff, 998 S.W.2d 882, 891-92 (Tex. 1999); Hansen v. Universal Health Services, 974 P.2d 1158, 1159-60 (Nev. 1999); Packard v. Razza, 927 So.2d 529, 534 (La. App. 2006); Sita v. Long Island Jewish-Hillside Medical Center, 803 N.Y.S.2d 112, 114 (A.D. 2005) Blazoski v. Cook, 346 256, 787 A.2d 910 (N.J. Super. A.D. 2002); Osburn v. Danek Medical, Inc., 520 S.E.2d 88, 92 (N.C. App. 1999), aff’d, 530 S.E.2d 54 (N.C. 2000); Alvarez v. Smith, 714 So. 2d 652, 654 (Fla. App. 1998); Klein v. Biscup, 109 3d 855, 673 N.E.2d 225, 231 (Ohio App. 1996); Balderston v. Medtronic Sofamor Danek, Inc., 285 F.3d 238, 239 n.2 (3d Cir. 2002) (applying Pennsylvania law); Bogle v. Sofamor Danek Group, Inc., 1999 WL 1132313, at *7 (S.D. Fla. Apr. 9, 1999); In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 107556, at *3-5 (E.D. Pa. Mar. 8, 1996), reconsideration denied, 1996 WL 900351 (E.D. Pa. May 21, 1996).

Even California, home of the Hastings Law School, rejects tort claims for FDA-related informed consent unless FDA regulations – limited to sanctioned clinical trials – require it. Daum v. Spinecare Medical Group, 61 Cal. Rptr.2d 260, 271-73 (App. 1997) (informed consent obligation includes FDA regulatory status only if applicable FDA regulations require it; FDA regulatory status not required by common law).

The only cases that ever entertained an FDA-regulatory-status-based cause of action, however briefly, are Reetz v. Jackson, 176 F.R.D. 412, 415 (D.D.C. 1997), which ultimately dismissed the claim on causation grounds, and Corrigan v. Methodist Hospital, 869 F. Supp. 1202, 1207 (E.D. Pa. 1994). Corrigan’s purported interpretation of Pennsylvania law was specifically repudiated by the Pennsylvania Supreme Court. Southard, 781 A.2d at 108 n.9. Gaston v. Hunter, 588 P.2d 326, (App. 1978), which the article cites as “requiring disclosure” of FDA regulatory (“investigational”) status, in fact did nothing of the sort. Rather the court held the entire issue “simply irrelevant,” since “FDA status” had “no tendency to prove negligence on the part of the doctors or the drug companies,” did not concern “causation,” and did “not tend to prove that [the drug] was a defective, unreasonably dangerous product.” Id. at 335.

OK, you ask – but why should anybody care about this now? Aren’t you guys just engaging in a Bone Screw nostalgia trip?

We don’t think so, for two reasons. First, any attempt to inject regulatory issues into informed consent is a back door (and in the case of this article – a not so back door) attack on our manufacturer clients. Second, the cause of action that Prof. Johns advocates is really a form of strict liability, and we think that’s a really bad idea for medical care.

On the first point, we’re in luck because so much of the article just a blatant attack on the supposed marketing practices of the pharmaceutical and medical device industries. Pages 980-1008 are devoted to a litany of attacks on “industry” marketing practices. It’s the usual kind of thing – pick one or two bad examples (the prime “example,” pp. 985-87, is Neurontin, but the only cited case, Franklin v. Parke-Davis, 147 F. Supp. 2d 39 (D. Mass. 2001), decided a motion to dismiss and thus had to assume the truth of all the plaintiff’s allegations). Then tar the entire industry by implying that “everybody does it.” We see that kind of thing in our cases all the time, and we’re disappointed (although not particularly surprised) to see the same sort of anecdotal attack bubbling up from academia. But then, every cause of action, no matter how widely scorned, seems to have a friend somewhere.

The Hastings article also claims that industry promotional practices exaggerates product benefits and conceals their risks (primarily pp. 980-82). We’re told that the industry bribes doctors in various ways (pp. 984-85, 996-97 999-1001). We’re told that industry finances research into new uses for existing drugs – and that this is bad (pp. 988-93). We’re told that industry supports continuing medical education concerning new uses for existing drugs – and that this is bad (pp. 993-95). We’re told that the industry shouldn’t give away free samples of drugs (pp. 997-98).

The trouble is that these complaints are just as applicable to on-label, as well as off-label, uses (if not more so). Giving physicians all sorts of paraphernalia with drug names and logos on them hardly seems peculiarly conducive to off-label use. Giving them free samples allows them to provide these samples to patients at little or no cost, whether for on- or off-label use. Thus the article’s extensive treatment of supposedly (and some definitely) dodgy marketing practices when the main premise is about off-label use immediately leads us to wonder what’s really going on.

We think our own position is clear enough. (1) Our opinion is that truthful promotion of off-label use is First Amendment protected, and not even the FDA (let alone private tort actions) has any business trying to suppress truthful speech about scientific and medical issues, even if it is in some sense “commercial” speech. We’ve said so before at some length, here. (2) In contrast, untruthful promotion of off-label use (or anything else) isn’t in any way protected, and will expose a manufacturer to liability.

Aside from the First Amendment, our basic response to a lot of these supposedly “abusive” marketing practices is, “If the manufacturers don’t do this, who will?”

For instance, if research into new uses for old drugs is a good thing, and we think it is, there isn’t anyone out there besides industry with an interest in doing it. The government certainly doesn’t fund such research, nor for the most part do universities (except in collaboration with industry). Full-blown “gold-standard” clinical trials are hideously expensive and time consuming, so we think the article’s criticism of the industry for conducting smaller, or un-controlled, or whatever, kinds of studies is unfair. It’s a classic example of the perfect becoming the enemy of the good. There’s no law that forces manufacturers to bring off-label uses on label, and a lot of the drugs involved are off-patent anyway. Demanding double-blinded, case controlled studies or nothing, as the article seems to do, will likely result in nothing – and nothing helps nobody.

Much the same can be said with continuing medical education. If drug and device manufacturers didn’t subsidize it, CME would cost a lot more than it does now. The result would be less CME, more expensive CME, or both. Limiting CME to only on-label uses puts medical practice into a regulatory straitjacket, because the FDA is rarely proactive, and only passes upon uses that somebody in the industry finds profitable enough to pursue. The present CME system’s like democracy. There’s plenty to criticize about it, but it’s better than any other system that’s yet been tried. We don’t think having the government dictating CME content would work any better – not after the way government has treated science with respect to stem cells, global warming, and morning-after pills, to name a few recent examples.

But for present purposes, the even more fundamental problem is that all of this has next to nothing to do with informed consent and off-label use. All the article’s criticism, even if it were valid, doesn’t support the premise that informed consent should include the FDA regulatory status of off-label use. The FDA does not regulate off-label use, and almost everyone (save former commissioner Kessler) recognizes that off-label use is a good thing – that advances in medical care should not be held hostage to the often glacial pace of FDA regulatory approvals.

Not only does the Hastings article contain a direct, and we’d say gratuitous, attack on our clients, but the regulatory informed consent claim it advocates poses an even broader indirect threat. That’s because of the learned intermediary rule. Under the learned intermediary rule doctors are responsible for warning patients about the risks of the drugs they prescribe. Manufacturers, conversely, owe no such direct warning duties. The rule does not let manufacturers off the hook, however. Our clients can still be liable if they don’t tell the prescribing doctors what they need to know. FDA regulatory status is something pretty uniquely within a manufacturer’s, rather than a doctor’s bailiwick, because our clients are FDA regulated and doctors aren’t. In fact, Congress has expressly forbidden the FDA from regulating off-label use as part of the practice of medicine. 21 U.S.C. §396.

What the role of the learned intermediary rule means is that, if it ever became a tort for doctors not to tell patients about off-label use, then the next shoe to drop would be plaintiffs suing doctors over not getting the right (or enough) information about off-label use. Faced with those claims, the docs would inevitably push back against the manufacturers, because the most logical source for FDA-related information is the FDA-regulated party. We’ve seen this happen (that’s what Bone Screw was all about), so we view FDA-related informed consent claims as stalking horses for a wave of state-law litigation attacking what federally-regulated manufacturers should say about the regulatory status of their products.

This is what we strongly suspect is the real motivation for the Hastings article’s affinity for FDA-based informed consent. The intent is to use tort law, and specifically suits against physicians, as a blunt instrument to force manufacturers to do less promotion (both on- and off-label) than the FDA lets them do. In a telling point, the article concedes that it would really be “preferable” to “prohibit” the promotional practices about which it complains: “Although I agree that prohibition [of various marketing practices] is preferable, disclosure is a feasible step in the right direction.” 58 Hastings at 1022.

Thus what’s really at work is another thinly veiled attempt at using state tort law to overcome perceived inadequacies in federal regulation. The author thinks that off-label use is bad – or at least inadequately regulated – therefore, the solution is to let everybody sue over it (there’s a lot of off-label use, after all). The manufacturers, however, are largely protected by their compliance with FDA regulations. No problem! Sue the unregulated doctors, and their resultant discomfort with liability will trickle back up the chain of sale and ultimately force the manufacturers to change what they do.

In this respect, we think that the article combines the worst attributes tort triumphalism (lawsuits can solve anything), with a chilling disrespect for science and medicine – especially the ability of doctors to exercise their professional judgment independently in the best interests of their patients.

Number two. We also don’t like the idea strict liability for doctors practicing medicine. And make no mistake about it, strict liability is what FDA-based informed consent is all about. A central, undeniable fact is that off-label use is very widespread. Back before blogs, when Bexis wrote law review articles, he found estimates of off-label use that ran as high as 60% overall. Beck & Azari, “FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions,” 53 Food & Drug L.J. 71, 80 (1998). The Hastings article suggests that by 2007 little has changed. 58 Hastings at 978 (also citing 60%).

These fifty and sixty percent figures tell us that a lot of off-label use – probably most of it – is standard of care medical practice. Unusual or experimental practices simply won’t drive the numbers that high. As the article mentions all too briefly, in a lot of cases, “if you didn’t use the drug in the off-label way you’d be guilty of malpractice.” 58 Hastings at 968-69. So the bulk of what we’re talking about is standard of care medicine. We just don’t think that, assuming a doctor follows the medical standard of care, s/he should nevertheless be subject to liability.

The article’s informed consent theory would do just the opposite, and hold a lot of doctors liable whose treatments represented the standard of care. Why? Because the treatments also in some way involved the 50-60% of all prescriptions that are off-label use, and the doctor didn’t bother to tell that to the patient. We ask, why should they? Informed consent already requires doctors to tell patients about all material medical risks and benefits of treatments, and in many jurisdictions, things like treatment alternatives.

So if a patient is: (1) already receiving standard of care treatment and (2) is accurately informed of all the material risks and benefits of that treatment, what benefit is there to telling that patient, “Oh, by the way, the FDA hasn’t approved using this or that drug for this treatment”?

Nada. Zip. Zilch.

In the great majority of cases, the new cause of action could only serve to harm to patient treatment – by driving a patient away from standard of care medicine in the mistaken belief that, because the FDA hasn’t passed on the treatment, there must be something wrong with it. It encourages more lawsuits, and higher costs for everything, without increasing patient safety one iota, since the standard of care is precisely what the law otherwise encourages doctors to maintain.

What ends up happening is that doctors providing standard of care treatment are made into insurers for anything that might go wrong because they don’t recite that some of what they are doing uses drugs or medical devices in ways that the FDA has not reviewed – not that the FDA has rejected, just not reviewed. The upshot? There will be windfall recoveries as doctors are held liable to patients who received medically proper treatment. After a few of those, another couple of boilerplate lines get typed into standard informed consent forms. They recite something like “some of the medical treatment that you receive may involve the use of prescription drugs or medical devices in ways that have yet to be approved by the FDA.”

Satisfied?

We didn’t think so. So then what? Maybe the original informed consent duty gets expanded to require “specific” discussions. Thus, a lot of doctors have to spend a lot of time remembering which of thousands of possible prescriptions are on label and which aren’t. The Hastings article admits that the flood of new medical information already threatens to swamp doctors. 58 Hastings at 981. If that’s the case, don’t we want doctors spending their limited time learning about things that are medical, not things that are regulatory?

And what might these “specific” FDA-related informed consent discussions look like? Many courses of medical treatments, especially the more serious ones, involve a dozen or more prescriptions of one thing or another. There’s a limit to how much information most people can process, especially in stressful, tell-it-to-me-straight,-doc situations. A lot of physician time would be spent explaining “well, [blank] is approved for that, but not for this.” That’s worse than a waste of time. If such extraneous regulatory information is thought by the patient to be more important than medical considerations, the result would be downright harmful, to patients. See our previous post, here.

Our bottom line is this. There are good reasons why every jurisdiction in the country that’s considered whether to expand informed consent to include FDA approval status has said “no.” The law of informed consent already requires patients to be told about medical risks and benefits – regardless of FDA regulatory status. If the situation is so dire that some experimental treatment with unknown risks is indicated, then patients should be told about that medical uncertainty. Do off-label uses have medical risks? Of course they do. But patients should be (and are) told about those medical risks directly. They should not be bothered with an FDA legal status that often means only that research into new drugs is more profitable than research into drugs with little or no patent protection left.

Medical information – risks, benefits, and alternatives – is what patients need to know to give true informed consent. That’s the kind of information that medical doctors are trained to be able to convey, and that’s what the law requires. Forcing medical professionals to go beyond medical information and to bother with FDA approval information that may be years behind the times does neither the patient nor the doctor any good.

The only people who profit from injecting legal information such as FDA regulatory status into medical informed consent discussions are lawyers. For anyone needing medical care, we think that’s a truly lousy idea.