We’ve saidbefore that we thought autism litigation against vaccine manufacturers was utterly meritless (not to mention harmful to children in particular and society as a whole). Here’s to another (belated) silver stake through the heart.

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It wasn’t a bad living. 360 (requires subscription)recently namedone 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 onlyhow 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 alsoEarle 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 issuesin most of the cases that we’ve cited. It’s a good idea to provide doctors using our clients’ products with the wherewithalto 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 Wikipediahas to say (among other things). There are apparently 20 of these proteins:

Clinical uses

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.
After 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.

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)). FromCanterbury, 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 havinga 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 theDeNeui 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 theDeNeui opinion, the use of the bone growth proteins inthat 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 wouldhave 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 theDe Neuitheory, 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.”

Satisfied?

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?

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Newsflash: more people care about mousepads than about drug and medical device product liability litigation. What does that say about what we do for a living? About our chosen topic? About us? Don’t answer that last one – we get enough comments along those lines from our families and coworkers (we won’t even mention our friends).

We also got 27 comments – also a record. Most fell into three categories. The first (at least we’ll put it first) agreed with us and thought we were right to call the hospitality industry to task for not providing mousepads for guests with computers. Why inconvenience your guests?

Not too many of those, though.

The second group thought we were just annoying whiners, and that we should suck it up and carry mousepads with us. Well, most of the time we do, but sometimes we’re cheap and use firm-issued laptops, and these aren’t standard equipment. But why should we? The same proposition applies to coat hangers, soap – heck, even toilet paper. It’s the “hospitality” industry – not the rooming industry. They’re supposed to be hospitable, aren’t they? They provide “free” (yeah, we know, that means part of overhead – just like “free” Internet service itself) hair dryers, shower caps, shoe shining (some places), stationery, etc. Why not mousepads?

A third group criticized us as technicological slackers for even using computer mouses (mice?) that need friction to operate. Get an optical mouse, or a trackball, they say. As for them – we don’t care. The mouse in use at the moment in preparing this post has a little red light on the bottom; what does that mean it is? We’ve proudly proclaimedourselves to be the blogging Luddites already. Heck, we just got used to broadband. As far as we’re concerned, critics of that ilk can take their optical mice and run them all they want on the glass tabletops in their hotel rooms.

Finally, one comment seems to advocate a government mandate. That’s silly. Between healthcare reform, the economy, global warming, Afghanistan, and lots of other things, the government has plenty to keep it busy right now. We advocate just the opposite – that some smart hotelier will get a competitive edge by providing customers with mousepads with their logos (and contact information, of course) on them – and even encourage their guests to take them with them on their travels.

That’s free enterprise, and we suspect, good business.

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In Morrison v. Eli Lilly, the drug helped the plaintiff with fewer adverse effects than any of the other medications he tried. There was evidence that the plaintiff refused to be taken off the drug despite weight gain. Plaintiff’s medical records and his treater’s deposition demonstrated knowledge of associations between the drug and weight gain/diabetes, well before the statute of limitations ran. Thus, under the Missouri discovery and learned intermediary rules, the claims were time barred. There was also no causation, as the physicians prescribed and maintained the plaintiff on the drug with knowledge of its potential effects because it was effective in treating the plaintiff’s psychological condition.

In Leggett v. Eli Lilly, the plaintiff had been locked up as criminally insane, but the drug helped enough that he could be released. For almost twice the period of the relevant California statute of limitations, plaintiff’s medical records and his treater’s deposition demonstrated knowledge of associations between the drug and weight gain/diabetes. There was also no causation under the learned intermediary rule because the treater testified that he would prescribe the drug regardless of any diabetes warning because it helped the plaintiff so much.

In Neal v. Eli Lilly, use of the drug alleviated the plaintiff’s various auditory hallucinations and suicidal depression. All four of the treating physicians were aware of the alleged diabetes association, and prescribed the drug anyway, given its beneficial effect on his condition. Because no additional warning would have changed the result, there was no causation under California law. There was no medical causation either, because the plaintiff’s expert had been thrown out, and his treaters doubted that the drug caused plaintiff’s diabetes.

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But we also learned something else – our peers (often more than that, actually) among the trial bar, agree with us that the excesses of modern discovery warrant adoption of tougher standards for pleading than the gloss put on “short and plain” by the now-overruled Conley case. Reader Tom Hurney, over at Jackson Kelly (one of the great things about blogging is what we learn from our readers) was good enough to pass along a 2008 “interim report” about discovery conducted by the American College of Trial Lawyers and the Institute for the Advancement of the American Legal System. Importantly, the American College isn’t a knee-jerk pro-defense organization. Its membership is drawn from both sides of the “v.” Interim Report at 2.

Briefly, this interim report asks the question what to do now about the “expense and burden of discovery” and its “substantial adverse effects on the civil justice system.” Interim Report at 1. It summarizes the results of a survey that over 1400 members of the American College answered. One of the major points of agreement was that tougher pleading was a necessary step to curbing excessive discovery expense.

Lawyers are inherently conservative and the Task Force did not anticipate that the responding Fellows would call for radical surgery. . . . Certain rules and practices, however, emerged as causes of significant discontent.

Nearly half of the respondents said that notice pleading has become a problem because extensive discovery is required to narrow the claims and defenses and 57 percent said that with notice pleading, motions to dismiss on the pleadings are not effective in limiting claims and narrowing litigation issues. More than 76 percent said that answers to complaints likewise do not accomplish the goal of narrowing issues. This suggests that a further look at notice pleading may be in order.Interim Report, at 4 (emphasis added).

So regardless of the flack that we take from our law professor friends, we feel better about things – knowing that our opinion that “it’s about time” is shared by a large number of our colleagues who are actually in the business of trying cases. We think that, in this area, experience is probably more valuable than theory. And in Twombly and Iqbal, the Supreme Court essentially agreed.

One of the critiques that we’ve received is that tougher pleading standards disproportionately hurt the little guys (who are plaintiffs) and favor big business and government (who are defendants). That may be true – we’re defense lawyers, after all – but it conversely means that the original Conley rule did just the opposite. Which still begs the question, why is one side better than the other?

One view is, of course, that more litigation is intrinsically better than less. We’re more familiar than we care to be with that argument. We’ve seen it made (usually in private, with a wink and a nod) in opposition to preemption. But occasionally such sentiments go public. For instance, here’s the response of “The Younger Lawyer” to Wyeth v. Levine:

What does all this [preceding discussion of Levine] mean for young lawyers? Well, as an initial matter, it means that plaintiffs will be able to continue pursuing state law claims against pharmaceutical manufacturers. Manufacturers will not be entirely precluded from continuing to assert federal pre-emption in the future, but complex legal and factual questions regarding the evidence necessary to establish the pre-emption defense will need to be resolved.

Translation: There will be plenty of work for plaintiffs counsel and defense counsel alike. Young lawyers will continue to be busy!Well, we’re sorry, but we don’t subscribe to this view – and anybody who does won’t be working for us. We don’t see litigation as a conspiracy of lawyers against their clients to keep themselves “busy” and to enrich themselves at client expense. The law is (or at least should be) a means of resolving legitimate disputes as quickly and efficiently as possible, and to get rid of the rest, again, as quickly and efficiently as possible.

So we reject the normative view, implicitly taken by much of the academic response (yes, we know they have graduating classes to place), that it’s better to let unmeritorious cases proceed than to take the risk that meritorious cases will be dismissed. We believe that either way represents error, and neither error is inherently better than the other. Putting aside philosophy, we tend to favor Type II over Type I errors in this context for two reasons: (1) the mere fact of litigation creates enormous transaction costs that the absence of litigation does not, and (2) we’re defense lawyers.

But on a more practical basis, the assumption that all plaintiffs are “little guys” and all defendants are “big mules” isn’t accurate. In mass torts and class actions, for example, there are no little guys anymore. Rather, there are very sophisticated plaintiffs’ lawyers – also repeat players in the system – who frequently take advantage of “anything goes” pleading to make broad allegations that are as difficult to disprove as they are expensive to defend. In the Bone Screw litigation, for example, we had the “omni” conspiracy claims that: (1) the entire industry (which did and still does sue each other constantly over IP issues) got together to defraud doctors, and (2) companies and doctors got together to deceive other doctors. E.g., In re Orthopedic Bone Screw Products Liability Litigation, 1997 WL 186325 (E.D. Pa. April 16, 1997) (dismissing claims but denying Rule 11 sanctions), affirmed, 193 F.3d 781 (3d Cir. 1999).

To treat mass tort/class action plaintiffs as if they are legal babes in the woods denies reality.

Moreover, there are lots of cases where “big business” and “government” are found on both – or exclusively the other – sides of the “v.” Third-party payer cases are an obvious example, as are state attorney general actions involving similar overpayment (and all kinds of other) claims. The aforementioned IP cases, with large medical device companies on both sides, are another. And that’s just in (or in the vicinity of) our own legal sandbox. To justify meaningless pleading standards on the grounds that they favor the little guy gives an unwarranted assist to a lot of large and sophisticated plaintiffs who don’t by anyone’s standards deserve any such a break.

On the other end of the spectrum, we already cut pro se plaintiffs all kinds of breaks. But pro se plaintiffs aren’t usually the ones who file interrogatories with hundreds of subparts or who demand production of millions of documents and untold gigabytes of electronic information.

Another point that’s made is that any change “should be established through the notice-and-comment, increasingly democratized and political, Rules Enabling Act process.”

Why? Conley was a court decision. For fifty years nobody argued that the Court shouldn’t have done what it did. Why the sudden emphasis on formalism once the wheel finally turns? Courts construe statutes and rules all the time. They create, alter, and abolish legal actions and defenses. It’s called the “common law.” It’s been around for quite a while.

To be fair, as an abstract proposition, we don’t deny that a formal rules change would be a more rational approach. But Conley persisted for fifty years, and nobody did anything. Advantages in terms of process from formal rulemaking are unfortunately more than counteracted by disadvantages in terms of improbability and just plain inertia. Twombly and Iqbal aren’t perfect, but they promise a significant improvement. In the law, as in other areas, the perfect is all too often the enemy of the good.

We have the same response – only moreso – to Lumen Mulligan’s comment to the original critique of our post. That comment is essentially, if discovery is the problem, fix discovery, and don’t bother with pleading.

In the abstract we’d agree. But a lot of time and effort have gone into “fixing” discovery. Rule 26, governing discovery, has metastasized to the point that it now fills more than five pages of single-spaced type. Since broad discovery was permitted in 1966, Rule 26 has been amended in 1980, 1983, 1987, 1993, 2000, and 2006. Yet the consensus of the country’s best trial lawyers is still:

The discovery system is, in fact, broken. Discovery costs far too much and has become an end in itself. As one respondent noted: “The discovery rules in particular are impractical in that they promote full discovery as a value above almost everything else.” Electronic discovery, in particular, clearly needs a serious overhaul. It is described time and time again as a “morass.” Concerning electronic discovery, one respondent stated, “The new rules are a nightmare. The bigger the case, the more the abuse and the bigger the nightmare.”Interim Report, at 3, item 2. Ideally, we could fix discovery. But that fix has eluded the Rules Committee’s best efforts for well over a quarter century. Since pursuit of the perfect was obstructing the accomplishment of anything good, it was past time to try something else.

At least at the moment, Twombly/Iqbal is that something. Is it perfect? Hardly. Is it better than where we were? We hope so, and we’re pleased to have the opportunity to find out.

Besides, from Prof. Mulligan’s comments elsewhere on the subject, we doubt whether he’s really interested in addressing the problem at all. Rather, he asserts that once plaintiffs allege anything about anything, that should get them to the jury, because only the jury decides credibility (“robs the jury of its historic role in assessing the veracity of civil allegations”). The suggestion that we continue tilting exclusively at the discovery windmill thus seems designed to perpetuate an unacceptable status quo.

Finally, it just isn’t that hard to plead the facts necessary to bring a “plausible” claim – but it’s a lot harder to support a complicated and difficult-to-prove claim. Look at what Twombly and Iqbal were about. The first was an antitrust claim alleging a long-term, industry-wide conspiracy in a situation where such a conspiracy wasn’t economically plausible. The second alleged the involvement (maybe a conspiracy, maybe less) of multiple governmental officials, some extremely senior, to violate a prisoner’s civil rights. Those weren’t simple claims.

Simple claims are easy to plead. A simple product liability claim alleges that there was something wrong with a product (the drug warning didn’t mention something; the medical device broke), that there was no substantial change, that the problem caused an injury, and damages. A plausibility standard won’t cause much of a problem.

If something less plausible then turns up in subsequent discovery – the defendant intentionally suppressed evidence of the unwarned-of drug risk or deviated from the FDA-approved design of the device – that’s what amended pleadings are for. Amendments to pleadings are “freely given” where “justice so requires,” Fed. R. Civ. P. 15(a)(2), so that rare plaintiff who actually finds a smoking gun in discovery would be free to add whatever claims such a discovery would support.

Conversely, there is no justification for allowing the same sort of allegations to be made at the outset in the absence of any factual basis – nor is there a reason to permit a broad, vague claim of “FDA violation” simply to serve as a jumping off point for a fishing expedition.

We can hear the next objection coming from a mile away – “but Riegel requires a ‘parallel’ violation and if we can’t plead it, we’re out court.” Right. That’s not a problem with pleading, but rather a consequence of preemption. The whole purpose of preemption is to cut off claims. That’s why it’s so controversial. Riegel means that fewer PMA product liability claims should be brought, period. It doesn’t give plaintiffs a license to allege “violations” that have no known basis in fact, and then force defendants through millions of dollars of discovery on the off-chance that something unknown might turn up. Congress has stated in the FDCA that violations are exclusively for the FDA to enforce. In cases where Riegel applies, the “plausibility” pleading standard ensures that the Supreme Court’s preemption ruling is not evaded.

Carl Sagan once said that extraordinary claims require extraordinary proof. He should have been a lawyer. In today’s legal environment, given the huge expense of discovery as a means of generating the necessary proof, at the outset extraordinary claims properly demand more rigorous pleading.

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