It wasn’t a bad living. 360 (requires subscription) recently named one of our old Bone Screw cases (Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)) as the top product liability case of the last decade. (It also stole a post idea we’d kicked around but never gotten off our duff to write up). Even though we've moved on, our pet peeves haven't.
But probably the most singularly "Bone Screw" issue was the theory that a surgeon could be liable under an "informed consent" rationale just because s/he didn't tell a patient about the FDA regulatory status (that is to say, off-label use) of the drugs/medical devices used in the patient’s treatment. And we Bone Screwers killed that theory dead – maybe not as dead as we killed fraud on the FDA, but pretty darn close.
The claim was essentially unheard of until Bone Screw plaintiffs invented it to make doctors (who had always discussed only how a drug or device could help/hurt you) sitting ducks for liability. When Bone Screw was over, the overwhelming majority rule rejected that kind of claim, holding that informed consent didn’t go beyond medical information, the risks, benefits (and in some places, alternatives to) medical procedures. Legal stuff, like how thin the FDA chose to slice a particular regulatory approval salami, was beyond the pale of informed consent:
[T]he FDA labels given to a medical device do not speak directly to the medical issues surrounding a particular surgery. The category into which the FDA places the device for marketing and labeling purposes simply does not enlighten the patient as to the nature or seriousness of the proposed operation, the organs of the body involved, the disease sought to be cured, or the possible results. The FDA administrative label does not constitute a material fact, risk, complication or alternative to a surgical procedure. It follows that a physician need not disclose a device’s FDA classification to the patient in order to ensure that the patient has been fully informed.Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001). See also 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); Blazoski v. Cook, 787 A.2d 910 (N.J. Super. A.D. 2002); Alvarez v. Smith, 714 So. 2d 652, 654 (Fla. App. 1998); 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); Klein v. Biscup, 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 *7 (S.D. Fla. April 9, 1999); In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 107556 (E.D. Pa. March 8, 1996), reconsideration denied, 1996 WL 900351 (E.D. Pa. May 21, 1996); cf. Daum v. Spinecare Medical Group, 61 Cal. Rptr.2d 260, 271-73 (Cal. App. 1997) (FDA regulatory status not part of common law informed consent obligation; discussion of status only required where FDA regulations say so).
All of them, even the 2006 straggler, involved “spinal fixation” (read: bone screws). And once that appellate wave got going, there was essentially nothing on the other side. A lot of these case, moreover, cited Bexis’ 1998 article in the Food and Drug Law Journal, which when published was the first major law review article on off-label use (there are a bunch more good ones since).
So why the trip down memory lane?
Because we haven’t said a peep on this issue in over two years, and it’s never a good idea, as a defense lawyer, to let your guard down. That’s especially true when the issue is primarily faced in medical malpractice cases, and its relation to product liability is indirect – strong, but indirect.
It’s indirect because the primary threat posed in the product liability context from the informed consent/regulatory status theory is, and always has been, its potential to get doctors at odds with our clients. If docs are obligated to discuss FDA stuff, where would that information have to come from? Given the learned intermediary rule, 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. Forced to defend that sort of claim, doctors may well point fingers at the FDA-regulated manufacturers.
The indirect nature of the interest becomes a problem because we (that is, product liability defense lawyers) don’t ordinarily represent doctors in malpractice cases. FDA-related issues often seem foreign and arcane to our colleagues who do practice malpractice defense. And worse, the insurance companies that pay for most med-mal defense don’t often want to pay for a lot of legal research of the sort necessary to get their counsel up to speed on this sort of peculiar theory. Usually, they’d rather settle.
That’s why Bexis wrote the 1998 article, and then followed with dozen or so amicus briefs on the same issues in most of the cases that we've cited. It's a good idea to provide doctors using our clients' products with the wherewithal to defeat a theory against them before it becomes a theory against us. That way we could praise the Lord and pass the ammunition in cases where our clients weren't (yet) directly involved.
And so we arrive at the catalyst for this post, DeNeui v. Wellman, 2009 WL 4847086 (D.S.D. Dec. 9, 2009), in which the informed consent/FDA regulatory status theory reared its ugly head yet again. (Maybe) Ironically, DeNeui was also a spinal fusion surgery case, but in the neck (“cervical”), not lower down where doctors normally use those bone screws. And since the FDA has long since bowed to medical reality and moved bone screws on-label for spinal use, bone screws weren’t at issue in DeNeui.
Instead, DeNeui involved something called “bone morphogenetic protein (BMP).” Id. at *1. We didn’t know what that was, so we Googled it. Here’s what Wikipedia has to say (among other things). There are apparently 20 of these proteins:
Clinical usesAfter surgery, the plaintiff alleged she suffered a suite of symptoms that sound like something happened to one or more of the cervical nerves, “difficulty breathing, swallowing, and speaking.” DeNeui, 2009 WL 4847086, at *1. How that relates to bone growth, we don’t know, but along with the usual malpractice claims, the plaintiff threw in that the defendant surgeon “breached his duty to obtain [plaintiff’s] informed consent by failing to inform her about the material risks associated with the surgery, including. . .the use of [the product] in a manner that was not approved by the FDA.” Id.
Members of the BMP family are potentially useful as therapeutics in areas such as spinal fusion. BMP-2 and BMP-7 have been shown in clinical studies to be beneficial in the treatment of a variety of bone-related conditions including delayed union and non-union. BMP-2 and BMP-7 have received Food and Drug Administration (FDA) approval for human clinical uses. At between $6000 and $10,000 for a typical treatment, BMPs can be costly compared with other techniques such as bone grafting. However, this cost is often far less than the costs required with orthopaedic revision in multiple surgeries.
Defense counsel (we presume med-mal counsel) moved to dismiss, citing a couple of the cases we've already mentioned. Surprisingly (to us) the court elected not to follow what it characterized as “the apparent majority viewpoint that a physician does not have to inform a patient about an off-label use of an FDA-approved drug in order to obtain that person's informed consent.” Id. at *3. It did so because of its view that South Dakota had adopted the “rule that the standard measuring the performance of the physician's duty to disclose is conduct which is reasonable under the circumstances.” Id. (referring to the state’s adoption of Canterbury v. Spence, 464 F.2d 772, 785 (D.C. Cir. 1972)). From Canterbury, the court leaped directly to the question of what was “material” (“a risk is generally defined as material when a reasonable person. . .would be likely to attach significance to the risk”) and held that to be a jury question (“the issue of the materiality of the off-label use of [the product] is to be decided by a jury”). WL 4847086, at *3-4.
Slow down Fast Eddie. Sorry to say, but the court missed a step – a critical one. Before there can be a “material” risk, there first has to be a risk. FDA regulatory status, whether use of a product is on or off the label, isn’t a risk at all. Let’s look at the court’s initial description of Canterbury, which we don’t have any problem with:
[South Dakota] adopt[ed] the Canterbury v. Spence rule that the standard measuring the performance of the physician’s duty to disclose is conduct which is reasonable under the circumstances.” Id. (citing Canterbury v. Spence, 464 F.2d 772, 785 (D.C. Cir .1972)). The South Dakota Supreme Court elaborated that “a reasonable disclosure [is] one which appraises the patient of all known material or significant risks inherent in a prescribed medical procedure, as well as the availability of any reasonable alternative treatment or procedures."DeNeui, 2009 WL 4847086, at *3 (emphasis added). Thus, neither Canterbury nor the South Dakota Supreme Court case adopting it held that informed consent requires disclosure of everything “material” (in the sense the it might, rightly or wrongly, impact upon a patient’s decision). Informed consent requires the disclosure of “risks” – “material risks.”
Not having a piece of paper from the FDA, saying this product is approved for that intended use, isn’t a risk. Nor is having that piece of paper going to do the patient any good. An FDA regulatory approval does not make the likelihood of any medical complication more or less likely. It makes the cure of the condition being treated no more or less likely. All it means is that the FDA found enough information to permit the agency to make a judgment as to safety and effectiveness. A drug approved on January 1, 2010 is no safer than it was the day before. See the Southard quote, above.
Law isn’t medicine. That’s where the DeNeui court made its fundamental mistake. But the reasons why that decision is truly wrong-headed come from the corresponding fact that doctors aren’t lawyers – and if we’re smart, we’ll leave the medical profession to what it does best and won’t use threats of liability to try to force doctors to subscribe to the FDA Law Blog.
We don’t like the idea of strict liability for doctors practicing medicine. And make no mistake about it, strict liability is what DeNeui-style FDA-based informed consent is all about. A central, undeniable fact is that off-label use is very widespread. In Bexis’ 1998 law review article, the then-current estimates of off-label use ran as high as 60% overall. 53 Food & Drug L.J. 71, 80 (1998). We don’t think that’s changed much. See 2006 Caputo WLF brief, at 20 (percentages in the same range).
Percentages this high tell us that a great deal of off-label use – probably most of it – is standard of care medical practice. And you don't have to believe us. Here's what the FDA said in 2008:
Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product's approved labeling (or, in the case of a medical device cleared under the 510(k) process, in the product's statement of intended uses). These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care.That’s why, as we’ve discussed in other contexts, off-label use is paid for by government programs such as Medicare. 42 U.S.C. §§1396r-8(k)(6), 1395x(t)(2)(B)(ii). For all we know from the DeNeui opinion, the use of the bone growth proteins in that case was also standard of care. The Wikipedia article (admittedly, not the most authoritative source) suggests that it may well be.
We should be encouraging doctors to follow the standard of care. We should not be imposing liability upon a doctor who practices standard-of-care medicine, just because s/he didn’t also tell the patient that, of the 20 bone growth proteins, this particular one wasn’t FDA approved for this particular bone in the body even though it could be malpractice (defined as deviating from the standard of care) not to do it..
The informed consent theory allowed in DeNeui has the potential to do just that – hold bunches of doctors liable for medical treatments that represent the standard of care. What good does that do? Requiring every doctor on pain of liability to tell every patient about every off-label use is a recipe for a monumental waste of physician time (telling patients useless information) and energy (having to learn that useless information to tell it to the patient). For another thing, it adds no benefit. Legally compliant 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. That’s what patients need to know – how likely is this to help me; how likely is it to hurt me? Not that “the FDA has allowed the manufacturer to put this on the label.”
So if a patient – say Ms. DeNeui – is: (1) already receiving standard of care treatment and (2) accurately informed of all the material risks and benefits of that treatment, what benefit is there to telling her, “Oh, by the way, the FDA hasn’t approved using this or that drug for this treatment”?
Not much. In fact, we think it would do more harm than good.
In the great majority of cases, the regulatory informed consent theory allowed in DeNeui threatens to hurt medical treatment – by turning a patient away from standard-of-care medicine in the mistaken belief that, because the FDA hasn’t given it the Good Housekeeping seal of approval, there must be something wrong with it. That’s what any lawyer would have to say, anyway, because otherwise where’s the causation? This kind of suit, allowing liability where the doctor met the medical standard of care, only encourages more lawsuits, and thus higher costs for everything, without doing anything to benefit patient safety, since the standard of care is precisely what the law otherwise encourages doctors to maintain.
Nor do we place much stock in the court’s disclaimer that “[h]ere the issue is whether the physician should have informed plaintiffs of off-label use of [this product] under the facts of this case, not whether such disclosure is required in all cases.” DeNeui, 2009 WL 4847086, at *4 n.5. There’s simply no way to predict – when a doctor’s trying to decide what s/he should tell the next patient – whether that patient is going to become the next “this case” in a judicial footnote. There’s always a next case. And doctors, as potential defendants, have to worry about that. So every doctor in every case in South Dakota is potentially staring down the muzzle of this blunderbuss theory, wondering if his/her next case might also be a court's next case.
After all, in "this case," DeNeui, 2009 WL 4847086, at *4 n.5, there isabsolutely no indication that the FDA ever rejected a submission concerning either the product or the use. So what ends up happening? Doctors giving their patients standard of care treatment become 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.
DeNeui involved major neck surgery. It's safe to say that (unless Ms. DeNeui was given a bullet to bite) there was probably more than one drug and more than one device being used – in all likelihood lots more. Is the doctor supposed to recite the FDA regulatory history of each? Let's be conservative here. If in a surgery there were just five different drugs/devices utilized, assuming an general average of 50% off-label use, then 97% of such surgeries are likely to involve at least one off-label use (50% multiplied five times is a little more than 3%). Thus the De Neui theory, wrongly equating FDA regulatory status with “risk,” has the potential to expose a lot of doctors to a lot of liability.
The upshot? There will be windfall recoveries as doctors are held liable to patients who received medically proper treatment. After a few of those, the boilerplate in standard informed consent forms gets changed. Insurance companies require them to include, say: “some of your medical treatment may include prescription of drugs or medical devices for purposes that have yet to be reviewed or approved by the FDA.”
When are plaintiffs’ lawyers ever satisfied?
Where do we go from there, if the fallacy of FDA status = risk is accepted? Perhaps the initial informed consent duty gets expanded to require “specific” discussions. Then we’ve turned doctors into lawyers. Doctors end up having to spend the limited time that they could be learning about the latest medical advances and (hopefully improving) standards of care, and instead try to sort out which of thousands of possible uses of prescription drugs and devices are on label and which are not. There’s a good reason that, in this area, the majority rule – indeed, every appellate court that we know of – rejects precisely what the court in DeMeui allowed. It’s a theory of liability with huge downsides that either the court didn’t hear about or ignored.
Our bottom line is this, and we know it from experience. The law of informed consent already requires patients to be told about medical risks and benefits – even if the FDA never existed. Many, probably the majority of, off-label uses are standard of care. At worst, off-label status implies a need for more study. And if a plaintiff’s medical condition is grave enough that an experimental treatment with unknown risks is the best medicine can offer, then certainly that patient should know that what’s being proposed is a crapshoot. But the law already requires that, without going further and turning doctors into lawyers and requiring them to recite FDA regulatory status of the drugs and/or medical devices involved.
Do off-label uses have medical risks? You betcha. And warnings about those risks are what the law (and all that the law) should require. Doctors should tell patients directly about material medical risks. There’s no need to filter that discussion through the carnival mirror of FDA legal status. There are lots of reasons why something could be off-label that have nothing to do with medical risk/benefit. “Gold standard” FDA studies are expensive and time consuming. FDA approval could be underway (it can take years). The medical condition may be so rare that doing those studies isn’t cost effective. The drug could be off-patent and subject to generic competition. Are doctors supposed to try to explain that, too, to their patients?
So tell patients what they need to know to give truly informed consent – medical risks, benefits, and alternatives. Doctors know how to do that. It’s the kind of information they’ve been trained to handle since medical school. Forcing medical professionals to go beyond what they’ve been trained to do, and to grapple with FDA approval information that may well be unrelated to medical risks 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 - so they can play "gotcha." For anyone needing medical care, it’s a spectacularly lousy idea.
We hope that DeMeui gets overturned or reversed. Otherwise, will the last doctor to leave South Dakota please turn out the lights?