Photo of Bexis

Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.”  Here are a couple of recent ones that looked interesting to us.

Tort Liability and Medical Innovation

The first one is Anna B. Laakmann, “When Should Physicians Be Liable For Innovation?,” 36 Cardozo L. Rev. 913 (Feb. 2015).  The title caught our eye because of our interest in off-label use, which is sometimes (when not yet the recognized standard of care) considered medical “innovation.”  Since Bexis’ 1998 law review article popularized the now-overwhelmingly adopted position that informed consent includes medical risks, not regulatory matters such as off-label use, we are particularly interested in patrolling that boundary.  If a treatment is so new that its risks and benefits cannot accurately be assessed, then a warning about its experimental nature is appropriate, but that kind of warning is a small subset of “off-label use” as an FDA regulatory status.

Here is the article’s thesis:

This Article proposes a fiduciary framework to regulate physician innovation under conditions of endogenous [we think that means “inherent” in this context] uncertainty.  The proposed approach could be described as a “libertarian paternalism” model of medical decisionmaking.  It mandates close scrutiny of the decisionmaking process but deference to the substance of medical decisions.  Under this framework, the physician should be held liable for failing to act in the patient’s best interests, taking into account the patient’s unique clinical condition and value preferences.  Within these constraints, however, patients should have the freedom to choose − and assume the associated risks and uncertainties − from among a range of clinically acceptable alternatives.  Properly applied, fiduciary principles can strike a desirable balance that respects patient autonomy, deters unreasonable risks, and encourages beneficial innovation.

Id. at 914.  Okay, let’s see what this is all about.

When we see a phrase like the “black-letter law that defines medical malpractice as deviation from customary care is a quaint anachronism,” id. at 915, that is like professorial fingers scratching the legal blackboard.  That is all too likely to translate into “what follows has no basis in existing law.”

The most useful part of the article, from our perspective as defense lawyers, is the discussion of current medical and legal doctrines.  Here are the headings:  “medical practice,” mostly concerned with the “uncertainty” that makes medicine almost as much an art as a science (id. at 918-20); “evidence based medicine,” the science part of medicine (id. at 920-22); “preference-sensitive care,” the extent to which treatment alternatives are governed by what patients want (id. at 922-24); “customary standards and exceptions,” the medical standard of care issues including practice guidelines (id. at 924-30); and “informed consent,” how much doctors should tell patients about what they propose to do to them (id. at 924-94).  As to the last, the author is not one of these liabilityloving law lecturers advocating some form of regulatory informed consent.  She plays that issue relatively straight (for an academic):

A few courts have held that the absence of FDA approval for an off-label use might itself be material information that a physician is obligated to disclose to a patient. Other courts and commentators reject the notion physicians’ disclosure duties extend to revealing a medical product’s regulatory status.

Id. at 940-41 (footnotes omitted).  We say “relatively,” because while “few” is apt as to the number of courts finding off-label status  material, a more accurate description of the number of courts rejecting that notion would be “many more” because “other” suggests false equivalence.  For the gory details, see here, and much more recently here and here (describing two more favorable 2014 decisions).

Another strong section is “research vs. practice,” which correctly explains how research is highly regulated by the government, whereas physician autonomy is much greater in the field of clinical practice.  Id. at 934-38.  Here we’re singing from the same hymnals, such as Dr. Levine’s book (“Ethics & Regulation of Clinical Research”) and the Belmont Report.  Statements like “FDA regulations reflect Congress’s clear position that the FDA lacks regulatory authority to interfere with the practice of medicine,” id. at 925-36, and “[p]hysicians have even been sued for malpractice for failing to prescribe an investigational drug not yet approved by the FDA,” id. at 936-37,  could well end up in our briefs.  Then we find this:

Regulatory status does not provide a clear line between standard and innovative uses of medical products. Questions about the safety and efficacy of FDA-approved uses of medical products persist long after their entry onto the market.  Moreover, the FDA has explicitly endorsed physicians’ “off-label” uses of medical products to treat patients in ways that the agency has not reviewed and approved. . . .  Perhaps most importantly, a physician may prescribe a drug to treat a disease or condition for which it has not been tested for safety and efficacy.  Off-label prescribing is a widespread, generally accepted clinical practice.  Although it is particularly prevalent in the fields of oncology and pediatrics, off-label use is frequent across a broad range of medical specialties.  In some cases, off-label use constitutes the standard of care.

Id. at 938-39 (a half-dozen footnotes, including to Bexis’ 1998 article, omitted).

Since we litigators use law review articles the way a drunk uses a lamppost – for support rather than illumination – we start to lose interest once the article shifts from “what is” to “what should be.”  Three supposed alternatives for modifying the current system are discussed:  (1) mandatory clinical trials for all innovative practice, a strait-jacket approach that would harm many patients and drive cost through the roof; (2) using special boards to evaluate whether novel procedures should be approved as standard of care, which suffers from lack of good information in addition to adding another (smaller than #1) level of cost; and (3) allowing physicians and patients to allocate risk of innovative procedures by contract, where we fear inherent inequalities in knowledge and bargaining power would lead to overreaching.  Id. at 943-51.  This discussion feels to us like the author is setting up straw men, to knock down with her preferred proposal.  If it ain’t broke, don’t break it.

Finally, we get to the author’s “fiduciary framework.”  Essentially, at least in the area of “innovative” treatment, the author proposes to impose fiduciary duties on doctors, running to their patients.  Id. at 954-55.  That is not exactly a new idea – the article cites a number of decisions (and indicates, correctly, that there are more) that already characterize the physician-patient relationship as “fiduciary.”  Id. at 954.  So what’s different?  In what situations would the proposed new regime change a legal result, and in what direction?  We want to know the bottom line.

In one place the article describes its alternative as “adopting more subjective patient-centered legal standards of care.”  Id. at 957.  More expansively, the author states:

Physicians should be compelled to take into account both generalized data and specific patient characteristics to identify reasonable treatment options.  The focus should be on whether the physician reviewed relevant guidelines and other data to ascertain their applicability to the particular patient, . . ., discussed known material information with the patient, and acted in good faith to advance the patient’s interests.

Id. at 958.  In addition, “[p]hysicians should be compelled to disclose their own ignorance about the safety and efficacy of untested therapies.”  Id.  All this “compelling” looks to us like a device to impose still more liability on physicians, although the article nowhere outright comes out and admits this.  Would the same law “compel” patients to comply with doctor’s orders and refrain from other risky behavior that jeopardizes the possible success of their treatments?  If doctors are to be fiduciaries with respect to their patients’ health, should not patients equally be fiduciaries of their own health?

The article’s emphasis on fiduciary principles derived from corporate governance suggests a “business judgment rule” analogy akin to the “honest error in judgment” principle found in some jurisdictions.  Id. at 962-63.  That could be a limiting principle that alleviates the “concern” for “excessive liability” that the author recognizes has limited the applicability of fiduciary principles to medical malpractice cases in the past.  Id. at 960.  But nope, the article neuters that, taking the position that “honest error” principles “should not shield physicians from liability.”  Id. at 963.  Only medical decisions that are “informed” and “consensual” “should be entitled to substantial deference.”  Id. Compared to existing malpractice standards, this fiduciary system would also impose “enhanced scrutiny” – beyond even “mandatory disclosure” wherever “conflicts of interests exist.”  Id. at 963-64.  Another liability-reducing possibility, physician-patient covenants not to sue, is also significantly limited – that article would allow them only “so long as the patient’s choice is informed and rational.”  Id. at 966.  We are not sure what that means, but with the emphasis on “subjective” rather than “objective” standards, the most likely interpretation in practice is “as long as the patient doesn’t have a bad outcome.”

Thus, the end result of the article’s proposed reworking of tort liability involving innovative medical treatment unfortunately seems like the kind of “let’s employ more lawyers (that is, law school graduates) by increasing liability” scheme that we have come to expect from academia.  That’s not all bad, because to get to that result, the article necessarily describes existing law as relatively restrictive of liability – here, with respect to legitimate, albeit innovative (and thus off-label) medical therapy − which is just the way we like it.

TwIqbal, Fee Shifting, and Discovery in PMA Preemption “Parallel Claims”

Our interest in the second article, Cameron T. Norris, “Drugs, Devices & Discovery:  Using Fee-Shifting To Resolve The Twombly/Iqbal Problem For Parallel Claims Under The FDCA,” 70 Food & Drug L.J. 187 (2015) (a mouthful that we’ll abbreviate to “D3 Article”), is obvious – both TwIqbal and PMA preemption are right in the title.  The D3 Article is  predicated (as the title indicates) on the proposition that TwIqbal is a “problem” in PMA medical device cases where plaintiffs are limited to “parallel” violation claims.  Why is that?  Because “it leaves injured consumers uncompensated and device manufacturers underdeterred.”  Id. at 188.  See also Id. at 199 (“tort remedies are essential
to compensate plaintiffs for their injuries”) (emphasis original).  Ouch.  Closing argument rhetoric like that in what is intended to be serious scholarship makes our skin crawl.  Somewhat later, we find a longer and more nuanced – but in the end, equally pro-plaintiff − rationale:

The Twombly/Iqbal problem for parallel claims stems from the confidential nature of PMA agreements. . . .  PMA agreements contain the design, manufacturing, and labeling requirements that FDA imposes on a Class III medical device − i.e., the federal-law requirements that a plaintiff would rely on when asserting a parallel claim.  However, because PMA agreements contain trade secrets and other sensitive business information, they are confidential and cannot be obtained by the public (absent formal discovery).  Twombly and Iqbal require plaintiffs to include enough factual material to “nudge[] their claims across the line from conceivable to plausible.”  Yet, plaintiffs possess virtually no relevant factual information until they obtain a copy of the PMA agreement . . . .  [W]ithout the PMA agreement, the plaintiff does not know what federal requirements the defendant was supposed to follow, whether the defendant violated any of those requirements, or whether that violation caused the plaintiff’s injury.  Put simply, plaintiffs need the facts to get discovery, but they need discovery to get the facts.

Id. at 194 (footnotes omitted) (emphasis added).  We beg to disagree.  As an aside, we’ve never heard the term “PMA agreement,” before, but that somewhat off-putting phrase is all over the D3 Article.  We assume that it means the manufacturer’s PMA application (and any PMA supplements) provided to the FDA for regulatory approval purposes.

When one considers “parallel claims” in the context of the FDCA as a whole, this “problem” isn’t really a problem at all, at least from the defense perspective.  Why?  Number one, the Medical Device Amendments contain an express preemption clause, 21 U.S.C. §360k(a), explicitly barring any state “requirements” (including tort requirements) that are “different from or in addition to” what the FDA requires. That means that Congress generally disfavors, inter alia, state tort claims against PMA medical devices.  Number two, that preemption clause was layered on top of the FDCA’s original prohibition against private enforcement, §337(a) (“exclusive” enforcement by the federal government).  This provision “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001).

Those of us on the right side of the “v.” thus believe that “parallel claims” are (or should be) doubly disfavored by the law – that Congress twice put the brakes on such claims, in first enacting and in later amending the FDCA.  Parallel claims are widely recognized as falling into a “narrow gap” limned by express preemption on one side and implied preemption on the other.  E.g., Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013); In re Medtronic, Inc. Sprint Fidelis Products Liability Litigation, 623 F.3d 1200, 1204 (8th Cir. 2010).  Being doubly disfavored by the applicable statutory scheme, “parallel claims” should not entitled to any specially lenient treatment, whether under TwIqbal or anything else.  That a plaintiff may well be precluded from pleading a parallel claim, unless and until some sort of FDA enforcement provides an “plausible” factual basis for what was previously rank speculation, is part and parcel of these claims’ disfavored status under the law.

That’s our main point of departure with this article.  But we have a second, less global, beef that we also wish to address.  The article states, in discussing Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), “Riegel did not hold, however, that all state-law claims against device manufacturers are preempted by the MDA.  Rather, the Court carved out an exception for so-called ‘parallel claims.’”  D3 Article at 190.  Actually, the Riegel Court didn’t “carve” anything.  The parallel claim discussion is dictum – made in the context of a waiver holding – thus the Court did not even reach “parallel” claims:

State requirements are pre-empted under the MDA only to the extent that they are “different from, or in addition to” the requirements imposed by federal law. §360k(a)(1).  Thus, §360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements. . . .  Although [plaintiffs] now argue that their lawsuit raises parallel claims, they made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari.  We decline to address that argument in the first instance here.

552 U.S. at 330 (emphasis added); see also id. at syllabus (“The Court declines to address in the first instance [plaintiff’s] argument that this lawsuit raises ‘parallel’ claims that are not pre-empted”).  The D3 Article correctly observes that, “[g]iven the Supreme Court’s lack of clarity in Riegel, the law on parallel claims remains murky.”  70 Food & Drug L.J. at 190.  Given that the current concept has been extrapolated from dictum about a waived argument, that is not all that surprising.

Those two points aside, the D3 Article does have its uses, for the same reason that the first article we described did.  To justify cutting plaintiffs a break, the D3 Article necessarily (and correctly) characterizes current law as quite restrictive of the litigation of parallel claims in the PMA preemption context.  The article’s distillation of the necessary elements of a parallel claim is square on the mark.  See Id. at 191.  So is the article’s general description of the heightened pleading requirements imposed by TwIqbal, id. at 192-94, with two exceptions:  (1) it gives too much credence to those who say that TwIqbal has “had little, if any effect.”  Id. at 193.  Actual litigators know damn well that it
has.  (2) We prefer to spell “transsubstantive” without the hyphen.

The highlight of the D3 Article, from our perspective, is its epic takedown of the awful decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).  Under the heading, “The Seventh Circuit Misapplied Twombly and Iqbal,” the article explains:

The Seventh Circuit’s decision to relax the normal pleading requirements for parallel claims is perhaps appealing from a policy perspective, yet its legal moorings are somewhat shaky. . . .  Bausch misapplied the Supreme Court’s holdings in Twombly and Iqbal in two primary ways.  First, the Seventh Circuit got the rationale behind Twombly and Iqbal exactly backward.  According to the Seventh Circuit, plaintiffs need access to discovery before they can be expected to make out a parallel claim.  Yet, Twombly and Iqbal both emphasize the opposite:  plaintiffs should not be able to access discovery until they can state a plausible claim to relief with factual detail.  The Twombly Court held that “some threshold of plausibility must be crossed at the outset before a . . . case should be permitted to go into its inevitably costly and protracted discovery phase.”  Likewise, the Court in Iqbal reiterated that “Rule 8 . . . does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.” Twombly and Iqbal equipped Rule 8(a)(2) with some real teeth and instructed the federal courts to be gatekeepers of the discovery process.  The Seventh Circuit’s approach in Bausch seems like a statement from the bygone era of Conley v. Gibson, where pleadings were not much more than a formality.

The Seventh Circuit also departed from the other major holding from Twombly/Iqbal, i.e. that the Federal Rules of Civil Procedure are trans-substantive.  Bausch endorsed a sliding-scale approach to pleadings, where the plaintiff’s burden is “commensurate with the amount of information available.”’  However, the Iqbal decision directly undermines this argument. . . .  Much of the information that Iqbal needed to state his claims was likely classified, . . ., [y]et the Iqbal Court refused to modify the pleading standards to account for Iqbal’s lack of access to information.  It is hard to see why the confidentiality of PMA agreements is meaningfully different from the confidentiality of national security information — if anything, the latter seems less accessible to plaintiffs. Instead, the better reading of Iqbal is that the Federal Rules of Civil Procedure are trans-substantive; they do not change even when a plaintiff lacks access to information.

Id. at 197-98 (numerous footnotes omitted) (emphasis added).  We bashed Bauschtoo, so this part was fun to read.  We only wish that the author had been a little more even-handed, such as using a less pejorative label for the non-Bausch (that is to say, the majority) rule than the “too-bad-so-sad approach.”  See Id. at 197.  If characterizations of that sort (more appropriate for our blog than a law review piece) need be made, we would prefer something more neutral, like “pleading fundamentalism” or “foursquare TwIqbal.”

The D3 Article does claim that Bausch identified confidentiality as an “important problem.”  Id. at 198.  We have already forcefully stated how we feel about that, so we’ll just focus on the analysis here.  The article admits that regulation trumps tort litigation throughout Europe.  Id. at 199.  Why not here, at least for PMA medical devices?  Primarily to compensate plaintiffs, the article asserts.  Id.  But what makes us different from Europe?  That is not really answered except for a brief reference to “hospital bills and doctors’ fees.”  To us, that’s a better argument for European-style health insurance than it is for more litigation – the former is far more cost-efficient means of paying those bills without needlessly enriching a whole new class of middlemen, called “lawyers.”

Then the article trots out “agency capture,” citing one law review article, and underfunding of the FDA.  Id.  As to the former, we think that the last half-decade has shown that the FDA is equally capable of being “captured” by the plaintiffs’ bar.  As to the latter, the obvious solution is better funding of the FDA, rather than incessant litigation that seeks to ignore the designs, labeling and manufacturing processes that the FDA has approved for PMA medical devices – why we have preemption in the first place.

The D3 Article also posits that “parallel claims” are not that bad because such claims “must exactly parallel federal law” or else be preempted.  Id. at 200.  What planet is this guy living on?  Didn’t he just read BauschBausch is a lousy decision precisely because it allows parallel claims for violations of vague regulations that can be interpreted in various ways, most of which, by definition, are not the FDA’s interpretation.  630 F.3d at 555 (“we do not see a sound legal basis for defendants’ proposal to distinguish between general requirements and ‘concrete, device-specific’ requirements”).  On top of this error, courts generally have allowed plaintiffs to pursue supposed “parallel” claims for “violations” that the FDA has never found to exist.  E.g., Hughes v. Boston Scientific Corp., 631 F.3d 762, 772-73 (5th Cir. 2011); Howard v. Sulzer Orthopedics, Inc., 382 Fed. Appx. 436, 440-41 (6th Cir. 2010).  If parallel claims could only be predicated on violations of precise requirements (e.g., the part in question not being the specified FDA-approved design) or based on violations already found by the FDA, we would probably agree with the D3 Article on that point.  The law has not evolved that way, so we don’t.

In any event, the D3 Article’s solution to a problem, created not by TwIqbal but by over-expansive definitions of parallel claims, is to create a special discovery procedure.  That procedure would essentially force the manufacturer of a preemption-protected PMA medical device to sell a copy of its confidential (because of valid trade secret concerns – the article recognizes this as a legitimate concern, 70 Food & Drug L.J. at 194) PMA documents.  The article calls it “one way fee shifting.”  Id. at 204.  It correctly recognizes that it would take a statute, id., since a forced sale of intellectual property to a litigation adversary – with apparently no constraints on a plaintiff sharing it with anyone else, like other plaintiffs – is quite substantive and would violate the Rules Enabling Act if attempted by rule.

The D3 Article’s “solution” seems dangerously unrealistic to us.  It mentions the “one-shot plaintiff,” id. at 206, but does not seem to appreciate the prevalence of attorney solicitation and mass torts – how most product liability litigation involving PMA medical devices is now conducted.  The biggest problem under this proposal is that the defendant gets compensated once for discovery expenses, after which the PMA documents are shared amongst multiple plaintiffs, every one of whom can take separate shots at the defendant’s PMA trying to invent violations.  Never mind that that the FDA has never found and probably would never find such violations because the Agency does not interpret its regulations in the same way as paid plaintiff experts.  The article seems to assume that “several plaintiffs” will each have to utilize the fee-shifting mechanism to “access” the PMA.  Id. at 207.  The world does not work that way – plaintiffs will share, and courts will not stop them with protective orders they consider draconian.  Once the PMA toothpaste is out of the tube, it’s not going back.  All those other cases after the first one (brought as a “loss leader” by counsel expecting to solicit many plaintiffs) aren’t subject to the proposed cost-shifting rules, id. at 206 (proposal is “optional”); thus in a mass-tort situation, defendants are right back into the discovery cost morass that TwIqbal was intended to prevent.

Thus, not only do we think the D3 Article gets the “problem” wrong, since parallel claims are doubly disfavored under the FDCA as currently written, but, even assuming a problem, the proposed fix does not fit the mass tort world where plaintiffs are allowed, even expected, to share information with other plaintiffs.  Try again.

Or better yet, don’t.