The Fifth Circuit Abandons The Rule Of Law To Spite A Transgender Inmate

On March 29, 2019, a divided Fifth Circuit panel issued their decision Gibson v. Collier, No. 16-51148, involving a transgender inmate. The majority’s opinion by Judge James Ho is outrageous, an example of the very worst sort of result-driven judicial activism. The majority cast aside multiple foundational principles of law — including basic respect for the litigants, the right to be heard before judgment is entered, the requirement that a party which seeks court relief meet its burden, the right to present contrary evidence, and the right to have a case decided on its own evidentiary record — all so the majority could publish their personal opinions on a subject that has been in the news lately: gender reassignment surgery.

The Fifth Circuit’s opinion in Gibson v. Collier reflects an ugly truth about our current politics: although some people claim “trans rights” are “special rights,” the movement for “trans rights” is really an effort to provide transgender persons the same rights everyone else has, because they are often denied those rights simply because they are trans. All the plaintiff wanted in her lawsuit was the same treatment every prisoner is entitled to have under the Constitution, i.e., appropriate treatment for what everyone agreed was a “serious medical need.” She didn’t get it, and her case did not benefit from the same procedural and evidentiary rights that every litigant in court is entitled to receive. As the dissent from Judge Rhesa Hawkins Barksdale correctly observed, procedurally, the case violated “bedrock bases for ensuring fundamental due process,” and, substantively, “numerous reasons” compelled the Court to rule the other way.

But this post is not just about trans rights. It is also about how cavalier federal courts can be in deciding cases. If a transgender inmate’s case can be decided by way of a federal court denying her any opportunity to present her arguments and evidence, cherry-picking factual conclusions from other cases, and deeming itself a medical expert, then your case can be decided that way, too.

Vanessa Lynn Gibson was designated male at birth, has lived as a female since the age of 15, and, after being incarcerated, was formally diagnosed with gender dysphoria, and prescribed estrogen and spironolactone. District Court Opinion, p. 2. The opinion also describes that she was depressed and had a history of harming herself and attempting suicide.  She asked a prison doctor if she could have sex-reassignment surgery and was told she could only be treated with hormones “because [Texas’s] policy bans sex-reassignment surgery.” District Court Opinion, p. 3. She asked the prison officials if, because she can’t have the surgery, “she could have a pass to live and dress as a female and keep her hair at least seven inches long,” but that, too, was denied. Id.

She thus filed the lawsuit for a simple reason:

“Plaintiff alleges [Texas’s] policy is unconstitutional on its face because it prohibits transgender inmates with severe [gender dysphoria] from being referred to a specialist to determine whether [sex-reassignment surgery] is necessary to adequately treat their disorder on an individual basis.”

Id., p. 3. The core of her claim was not a specific demand for sex-reassignment surgery, but rather a request for an evaluation by a gender-dysphoria specialist, to determine, among other issues, whether sex-reassignment surgery was indicated. Slip op., p. 26 (dissent). She did not seek any monetary damages, but merely injunctive relief to compel the prison system to provide that evaluation.

No one disputes that her gender dysphoria represents a “serious medical need, in light of [her] record of psychological distress, suicidal ideation, and threats of self-harm.” Slip op., p. 8. Cases in other Circuits have held the same. See Kosilek v. Spencer, 774 F.3d 63, 86 (1st Cir. 2014) (“That [gender dysphoria] is a serious medical need, and one which mandates treatment, is not in dispute in this case.”); De’lonta v. Johnson, 708 F.3d 520, 525 (4th Cir. 2013) (“De’lonta has alleged an objectively serious medical need for protection against continued self-mutilation.”); accord Allard v. Gomez, 9 Fed. App’x 793, 794 (9th Cir. 2001); Murray v. United States Bureau of Prisons, 1997 U.S. App. LEXIS 1716, *11 (6th Cir. Jan. 28, 1997); Meriwether v. Faulkner, 821 F.2d 408, 413 (7th Cir. 1987).

In a sensible court system, this case would be a no-brainer. As the Fifth Circuit held, and as is well-settled law, the State violated an inmate’s Eighth Amendment rights if they “refused to treat [her], ignored [her] complaints, intentionally treated [her] incorrectly, or engaged in any similar conduct that would clearly evince a wanton disregard for any serious medical needs.” Slip op., pp. 8-9, quoting Johnson v. Treen, 759 F.2d 1236, 1238 (5^th Cir., 1985). The State of Texas has an inmate with an admittedly serious medical need, but they refuse to provide her with the specialist consultation that would determine what treatment she should have, so they have violated her Eighth Amendment rights.

But our federal courts are too often not sensible, and Gibson had the misfortune of drawing Fifth Circuit Judge James Ho, a Trump appointee who appears to delight in disregarding the norms of the federal bench, often using his position to publish political op-eds. Judge Ho used Gibson’s case for a similar political purpose, plowing over decades of law regarding civil procedure, summary judgment standards, the facts of record in the case, and the Eighth Amendment just so he could write a diatribe about sex-reassignment surgery, while also denying Gibson her rights in the process.

The problems with Gibson’s case, which she filed pro se, began at the District Court level. (Counsel was appointed for her by the Fifth Circuit after she filed her opening brief in the appeal.) The primary defendant in the case, the Director of the Texas Department of Criminal Justice (due to irrational quirks in civil rights law, a person can rarely sue a State itself, but instead has to personally sue the individuals carrying out State policy), moved for summary judgment on qualified immunity and sovereign immunity, but not on the merits of Gibson’s Eighth Amendment claim. In its order, the District Court rightly rejected both immunity defenses, but then sua sponte considered the Eighth Amendment claim and granted summary judgment — even though the issue hadn’t been briefed by the parties, and even though no discovery whatsoever had been taken. No interrogatories had been served, no depositions had been taken, and the inmate hadn’t had the opportunity to find witnesses or experts to testify on her behalf.

That’s not how litigation is supposed to work. As Judge Rhesa Hawkins Barksdale, a George H.W. Bush appointee, wrote in dissent:

Procedurally, summary judgment was improperly granted for several reasons, in violation of bedrock bases for ensuring fundamental due process to the nonmovant in a summary-judgment proceeding. Substantively, numerous reasons compel summary judgment’s not being granted, most especially the requested medical relief’s not being considered based on Gibson’s individual needs.

Slip op., p. 25 (dissent). Any one of these “numerous reasons” should have been sufficient for the appellate court to vacate the judgment and remand for further proceedings.

For example, the Court should have remanded because of the District Court’s failure to give Gibson notice that it was going to sua sponte decide summary judgment on her Eighth Amendment claim:

… Ruling on the merits without compelling the Director to respond to Gibson’s discovery requests, after denying the Director’s qualified-immunity defense, flies in the face of clear Supreme Court precedent.

More to the point concerning the district court’s addressing the merits sua sponte, Rule 56(f) provides, inter alia: “After giving notice and a reasonable time to respond, the court may . . . grant the [summary-judgment] motion on grounds not raised by a party . . . .” Fed. R. Civ. P. 56(f)(2) (emphasis added). Contrary to this Rule, the district court ruled on the merits without giving Gibson any notice or opportunity to respond.

(Italics in original.)

Or the Court should have remanded due to the District Court’s failure to give Gibson an opportunity to present evidence, particularly given that she must rely on the prison system and the Court to allow her to gather that evidence:

Gibson was not given every opportunity to present evidence and contentions in opposing summary judgment on the basis for which it was granted. Gibson, as an inmate, must rely on [Texas Department of Criminal Justice] or the court to allow an evaluation to determine if [sex-reassignment surgery] is necessary for Gibson. Accordingly, we have not been able to evaluate all the evidence to determine if there are no genuine disputes of material fact, as that evaluation has not been allowed.

Or the Court should have remanded due to the District Court’s disregard for the very first step of summary judgment, which required the defendants to demonstrate the absence of a genuine dispute:

Because the Director, not Gibson, moved for summary judgment, it was the Director’s burden to “demonstrate the absence of a genuine [dispute] of material fact”. Little v. Liquid Air Corp., 37 F.3d 1069, 1075 (5th Cir. 1994) (en banc) (citing Celotex, 477 U.S. at 323; Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 885–86 (1990)). “If the [movant] fails to meet this initial burden, the motion must be denied, regardless of the nonmovant’s response.” Id. Only if the Director met his burden would the burden shift to Gibson to “go beyond the pleadings and designate specific facts showing that there is a genuine [dispute] for trial”. Id. (citing Celotex, 477 U.S. at 325). …

Therefore, because the Director did not provide evidence showing an absence of a dispute as to the medical necessity of SRS in treating gender dysphoria, he did not meet his burden; summary judgment was improper.

All of these are, as Judge Barksdale wrote, “bedrock bases for ensuring fundamental due process.” The party moving for summary judgment bears the burden of establishing the absence of any genuine dispute of material fact, and the party opposing summary judgment must have an opportunity to respond to the motion and to develop a record. The Fifth Circuit reiterates these principles all the time, like so: “The moving party must show that if the evidentiary material of record were reduced to admissible evidence in court, it would be insufficient to permit the nonmoving party to carry its burden.” Ballard v. Burton, 444 F.3d 391, 396 (5th Cir. 2006).

The District Court (Judge Walter S. Smith, Jr., appointed by Reagan) simply ignored them. It is not hyperbolic to summarize the proceedings as: the District Court wasn’t even asked to rule on the Gibson’s Eighth Amendment claim, but the District Court decided to rule on it anyway, ruled on it without giving Gibson any opportunity to respond, disregarded Texas’s burden to show the absence of a genuine dispute, then faulted Gibson for not providing evidence that she wasn’t asked to provide and, even if she had been asked, had no opportunity to obtain.

As I wrote above, this case should have been a no-brainer: the District Court’s summary judgment order was flawed in multiple ways, and it should have been vacated so that Gibson had an opportunity to respond and to develop the evidence demanded of her. Judge Ho, however, had other plans — and somehow convinced Judge Jerry E. Smith, a Reagan appointee, to sign off on these plans, thereby taking a majority of the three-judge panel and making it the law of the case.

Judge Ho’s opinion is littered with problems, only four of which I elaborate here.

First, although the District Court had consistently referred to the inmate using female pronouns — because she identifies as female — Judge Ho could not resist subjecting her to the indignity of using solely male pronouns, which he dubiously claimed in a footnote was “consistent with TDCJ policy.” Slip op., p. 3, Fn 2. In support, he cited a handful of cases going back to 1973, including a Supreme Court opinion that had nothing at all to do with transgender persons. There was no legal reason whatsoever to do that; whatever Judge Ho’s motivation was for insulting Gibson, who Judge Ho knows and admits suffers from severe psychological distress due to her gender dysphoria, it had nothing to do with the responsibilities of being a federal appellate judge.

Second, Judge Ho blithely disregarded the procedural errors committed by the District Court. In her appellate briefing, Gibson appropriately addressed the merits of her claim — whether it was cruel and unusual punishment to deny her treatment by a gender dysphoria specialist — and so Judge Ho used that against her: “We accept Gibson’s invitation to reach his [sic] deliberate indifference claim on the merits, rather than reverse based on any procedural defects in the district court proceedings. In doing so, we note that, had Gibson presented any such procedural concerns, we might very well have remanded this case for further proceedings.” Slip op., p. 6.

Initially, Gibson’s pro se appellate brief, filed before counsel was appointed, did raise procedural issues, as issues #1 and #2 in the “Statement of Issues Presented for Review.” The arguments weren’t fully developed, but, for purposes of a pro se brief, where rules on waiver and issue preservation are relaxed, the impropriety of summary judgment itself was adequately raised. As Judge Barksdale wrote in dissent, Judge Ho didn’t even apply his own dubious analysis consistently:

The majority at 3 states Gibson has “forfeit[ed]” any procedural objections because Gibson has now asked for a ruling on the merits. (In that regard, the majority is inconsistent: it notes that Gibson has asked our court to rule on the merits, but also states at 15 that Gibson has asked our court to remand, so that evidence of Gibson’s individual need for SRS can be presented.)

Slip op., p. 29 (dissent). I wish I could say Judge Ho’s chicanery was unusual, but Circuit Courts routinely use issues of “waiver” and “forfeit” like a game of three-card monte: if a Circuit Court wants to dodge an issue, they claim waiver, but if they want to rule on it, then they fall back on the rule they “may affirm on any basis raised below and supported by the record.” Quibodeaux v. Nautilus Ins. Co., No. 15-40567, at *4 (5th Cir. 2016).

Moreover, as Judge Barksdale noted, “just as a party cannot decide our standard of review, a party also cannot decide an insufficient record is sufficient.” Slip op., p. 29. On an appeal, there are some issues, which, if not raised, divest the court of jurisdiction (an issue that is also often gamed, but which we can leave for another day). But the sufficiency of a record for assessing the merits of a case is not one of them. Circuit Courts, including the Fifth Circuit, routinely find that a record is not sufficient for them to affirm the underlying District Court order, and so remand for further proceedings. See, e.g., Brenem v. Harris, 621 F.2d 688, 690 (5th Cir. 1980)(“the record as it stands is insufficient to affirm”). Moreover, as described below, the minimal record in this case was actually quite favorable to Gibson, so favorable that Judge Ho selectively took facts from an entirely different case to justify his decision.

Third, because there was no basis for Judge Ho to reject Gibson’s claim that her request to be seen by a gender dysphoria specialist was “medically necessary,” Judge Ho skipped right past it entirely, with reasoning that is charitably described as willfully obtuse:

The dissent correctly observes that no evaluation for sex reassignment surgery was ever provided in this case, because Texas prison policy does not authorize such treatment in the first place. The dissent suggests that a blanket ban is unconstitutional—and that an individualized assessment is required. But that defies common sense. To use an analogy: If the FDA prohibits a particular drug, surely the Eighth Amendment does not require an individualized assessment for any inmate who requests that drug.

Slip op., p. 2. Judge Ho’s “common sense” analogy makes no sense at all, because the FDA does not “prohibit” sex-reassignment surgery. Just ask the Center for Medicare & Medicaid Services (CMS): “Surgical procedures per se are not subject to the Food and Drug Administration’s (FDA) approval. Inflatable penile prosthetic devices, rigid penile implants, testicular prosthetic implants, and breast implants have been approved/cleared by the FDA.” (We’ll come back to this CMS memo, which Judge Ho himself cited.)

Not one to be bothered by a blatantly false analogy, Judge Ho went further, and applied the sort of casually unfair and unjust reasoning that the Fifth Amendment and Seventh Amendment were ratified to prevent:

Gibson nevertheless asks this court to remand so that he can present evidence of his individual need for sex reassignment surgery. Oral Arg. 11:35–12:10; 13:27–16:22. We do not see how evidence of individual need would change the result in this case, however.

Slip op., p. 15. Thus, Judge Ho held that, although the Court admittedly did not have enough evidence about Gibson’s case to decide her case one way or another, the Court could dispense with due process, the right to a jury trial, and the bother of actually hearing Gibson’s case and instead issue a blanket ruling that consultation with a gender dysphoria specialist could never, ever be medically necessary because sex reassignment surgery could never, ever be medical necessary. Those sorts of gratuitous across-the-board holdings are why, as NPR recounted, lawyers from across the political spectrum have started to question whether Judge Ho sees himself as a federal judge or as a political columnist who happens to sit on the federal bench.

And Judge Ho’s claim that there is no need to review “evidence of individual need” for gender reassignment surgery does not make sense. It cannot be squared with basic legal practice relating to medical evidence, much less with the current case law relating to gender reassignment surgery. In every case, whether it involves an inmate or a car accident or anything else, medical issues are decided by way of evidence from qualified medical professionals. Indeed, the Center for Medicaid & Medicare Services itself — in a memo Judge Ho obviously was aware of, because he cited it, see slip op., p. 14, fn 7 — evaluates coverage for gender reassignment surgery on “a case-by-case basis,” which is exactly what Gibson wanted, an individualized review by a gender dysphoria specialist.

The need for individual evaluation is so critical that State Departments of Human Services which have tried to block coverage for gender reassignment surgeries have often found themselves overruled by their State Supreme Courts, like what just happened in Iowa. Judge Ho’s “common sense” rationale thus defied not just the federal government’s own policies and the current interpretation of anti-discrimination laws, but also the most “common sense” of medical issues: the only way to know what treatment any patient needs is for a qualified medical provider to provide an expert medical opinion after examining the patient.

Fourth, as the dissent pointed out, the actual record in front of the Fifth Circuit was quite minimal — because Gibson’s case had been dismissed before any discovery had been taken, and without any notice to her the Court was going to decide that issue — and that record was unambiguously favorable to Gibson:

In moving for summary judgment only on the basis of immunity, the Director provided the following evidence in support: Gibson’s grievance records; Gibson’s medical records from January 2014-August 7, 2015; and TDCJ Policy No. G-51.11. The Director submitted no evidence regarding the medical necessity vel non of SRS in treating gender dysphoria.

In response, Gibson offered as evidence: Gibson’s affidavit, grievance records, and psychiatric records from a psychiatric facility; literature on health care and transgender individuals, including excerpts from a report detailing the [World Professional Association for Transgender Health] WPATH Standard of Care, which state “for many . . . surgery is essential and medically necessary to alleviate their gender dysphoria”; a copy of TDCJ’s policy on surgical castration for sex offenders; and copies of correspondence to Gibson from TDCJ Correctional Managed Health Care.

Slip op., p. 30 (dissent).

Judge Ho, too, recognized “the sparse record before us,” slip op., p. 10, which left him with a problem: there was no way for him to rule what he wanted to rule, i.e., that gender reassignment surgeries were never medically necessary. The only medical information in front of the Court were Gibson’s medical records, which showed an indisputable serious medical need, and the WPATH Standard of Care, which bluntly says gender reassignment surgery may be “essential and medically necessary.”

So what did Judge Ho do? He cherry-picked facts from a completely different case, Kosilek v. Spencer, 774 F.3d 63 (1st Cir. 2014). It is difficult to imagine a more egregious violation of due process than to have your case dismissed without any reference to your facts because some other court, reviewing someone else’s facts, came to a particular conclusion.

Judge Ho began by misrepresenting the First Circuit’s opinion in Kosilek, claiming that case established a bright-line rule that, because sex reassignment surgery is “medically controversial,” nothing relating to sex reassignment surgery could ever rise to the level of an Eighth Amendment claim:

As part of its deliberate-indifference analysis, the First Circuit considered whether WPATH and its proponents reflect medical consensus. It concluded that, notwithstanding WPATH, sex reassignment surgery is medically controversial. Accordingly, Massachusetts prison officials were not deliberately indifferent when they “chose[] one of two alternatives—both of which are reasonably commensurate with the medical standards of prudent professionals, and both of which provide [the plaintiff] with a significant measure of relief.” [Kosilek] at 90. The court held that this choice between treatments “is a decision that does not violate the Eighth Amendment.” Id.

Slip op., p. 11.

In fact, the First Circuit said precisely the opposite, on the very same page cited by Judge Ho:

Kosilek admits that the DOC’s current treatment regimen has led to a significant stabilization in her mental state. Kosilek’s doctors testified to the same, highlighting her “joy around being feminized.” This claim is also borne out by the passage of significant time since she exhibited symptoms of suicidal ideation or attempted to self-castrate. In addition to alleviating her depressive state, this treatment has also resulted in significant physical changes and an increasingly feminine appearance. The significance of a future risk of suicidality is not one that this court takes lightly, and Kosilek is right to note that a clear risk of future harm may suffice to sustain an Eighth Amendment claim. …

That the DOC has chosen one of two alternatives-both of which are reasonably commensurate with the medical standards of prudent professionals, and both of which provide Kosilek with a significant measure of relief—is a decision that does not violate the Eighth Amendment.[Footnote 12]

[12] This holding in no way suggests that correctional administrators wishing to avoid treatment need simply to find a single practitioner willing to attest that some well-accepted treatment is not necessary. We do not establish here a per se rule allowing a dissenting medical opinion to carry the day. Rather, our determination is limited to the particular record on appeal, which involves a medical condition that admits of a number of valid treatment options.

Kosilek, 774 F.3d at 90 n.12 (1st Cir. 2014)(emphases added). The First Circuit thus specifically held that, even in Kosilek’s own case, if Kosilek had not benefited from her current treatment regime — which included treatment denied to Gibson, such as “feminine clothing and accessories” — and still had a risk of suicide, then that “may suffice to sustain an Eighth Amendment claim.” Id. Moreover, the First Circuit reiterated “our determination is limited to the particular record on appeal,” and was not a “per se rule.” Gibson, however, had no opportunity to develop her record, and the record she did develop was substantially different from the record in Kosilek.

These problems are part of why courts are not supposed to simply take facts from one case and then apply them wholesale to another case.

Judge Ho then deemed himself a medical expert in the treatment of gender dysphoria, and went through the First Circuit’s summary of the expert testimony in Kosilek — there is no indication Judge Ho bothered to obtain, much less read, the actual trial transcripts — before concluding “there is no medical consensus that sex reassignment surgery is a necessary or even effective treatment for gender dysphoria.” Slip op., p. 14.

Again, Judge Ho made this finding of fact despite having no evidence at all in the record to do so. The only evidence of record about medical standards in Gibson’s case was the WPATH Standards of Care that say gender reassignment surgery is “essential and medically necessary” for some patients, and those WPATH Standards have been recognized by federal courts across the country. See De’Lonta v. Johnson, 708 F.3d 520, 522-23 (4th Cir. 2013) (describing WPATH as “the generally accepted protocols” for treatment of gender dysphoria); Norsworthy v. Beard, 74 F. Supp. 3d 1100, 1104 (N.D. Cal. 2015) (describing WPATH as the “leading medical research and standards of care” and granting prisoner suffering from gender dysphoria a preliminary injunction for SRS based on the expert medical consensus from WPATH); Soneeya v. Spencer, 851 F. Supp. 2d 228, 231 (D. Mass. 2012) (recognizing “the ‘Standards of Care’ promulgated by the [WPATH]” as “the course of treatment for Gender Identity Disorder generally followed in the community”); Fields v. Smith, 712 F. Supp. at 838 n.2 (E.D. Wis. 2010) (acknowledging WPATH’s Standard of Care as “the worldwide acceptable protocol for treating GID”), aff’d 653 F.3d 550 (7th Cir. 2011). In a fair proceeding, the Fifth Circuit would have deemed it undisputed that gender reassignment surgery is, for some patients, medically necessary, because the only evidence in the record were medical guidelines that said exactly that and which have been accepted by federal courts across the country. But Judge Ho did not want to give Vanessa Lynn Gibson a fair proceeding, he wanted to make a political statement.

***

We can only hope the plaintiff petitions for en banc review, the review is granted, and this opinion is reversed, because the alternative is to accept that the most basic norms of court procedure can be suspended whenever a judge feels like airing their opinion about current events.

 

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The Unjust “Sporting Theory Of Justice” In Federal Courts

Over a century ago, in 1906, law professor Roscoe Pound outlined “The Causes of Popular Dissatisfaction with the Administration of Justice” in a speech to the American Bar Association. After conceding “dissatisfaction with the administration of justice is as old as law,” Pound went on to perform a “diagnosis” of the “more than the normal amount of dissatisfaction with the present-day administration of justice in America.”

One particularly “potent source of irritation” was “our American exaggerations of the common law contentious procedure,” which produced a bizarre, unjust, and “sporting” sense of justice:

It grants new trials because by inability to procure a bill of exceptions a party has lost the chance to play another inning in the game of justice. It creates vested rights in errors of procedure, of the benefit whereof parties are not to be deprived. The inquiry is not, What do substantive law and justice require? Instead, the inquiry is: Have the rules of the game been carried out strictly? If any material infraction is discovered, just as the football rules put back the offending team five or ten or fifteen yards, as the case may be, our sporting theory of justice awards new trials, or reverses judgments, or sustains demurrers in the interest of regular play.

Pound’s discussion about the inherent lawlessness of a “sporting” justice system — one that over-emphasizes procedural “correctness” and judicial “umpiring” as if justice were a game — feels like it was written in our time, not over a hundred years ago:

The effect of our exaggerated contentious procedure is not only to irritate parties, witnesses and jurors in particular cases, but to give to the whole community a false notion of the purpose and end of law. Hence comes, in large measure, the modern American race to beat the law. If the law is a mere game, neither the players who take part in it nor the public who witness it can be expected to yield to its spirit when their interests are served by evading it. And this is doubly true in a time which requires all institutions to be economically efficient and socially useful. We need not wonder that one part of the community strain their oaths in the jury box and find verdicts against unpopular litigants in the teeth of law and evidence, while another part retain lawyers by the year to advise how to evade what to them are unintelligent and unreasonable restrictions upon necessary modes of doing business. Thus the courts, instituted to administer justice according to law, are made agents or abettors of lawlessness.

Today, when such concerns are dismissed, and the view of judges as “umpires” is claimed to be an ideal. A Century ago, it was different. Back then, Pound’s complaints were taken seriously, and they helped set in motion the process that lead to the creation of the Rules of Civil Procedure in 1938, which included, right at the beginning, the all-important Rule 1:

These rules govern the procedure in all civil actions and proceedings in the United States district courts, except as stated in Rule 81. They should be construed, administered, and employed by the court and the parties to secure the just, speedy, and inexpensive determination of every action and proceeding.

The law was not supposed to be a game. And, yet, it often is. Let’s look at some recent examples.

First up is Husky Ventures, Inc. v. B55 Investments, Ltd., a published, precedential decision from the Tenth Circuit (Case No. 17-6034, December 18, 2018). The case is a dispute between companies that were trying to extract oil and gas from fields thought to be depleted. B55 stirred up trouble and didn’t honor its agreements. Husky Ventures sued, and a jury award Husky Ventures $4 million in compensatory damages and $2 million in punitive damages against B55 and its President. Reading the opinion, it seems the jury was right to do so, but the defendant had a right to appeal.

After judgment was entered against them, B55 filed a timely notice of appeal and a motion for a new trial, which was denied. That quite reasonable course of action proved fatal for most of their arguments, because they did not go back and amend their notice of appeal to include the order denying their motion for new trial:

On appeal, B55 and Mr. McArthur’s first three claims of error concern the district court’s order denying their motion for a new trial. For example, in specifying the appellate issues, they ask: “Did the District Court err by denying B55’s motion for new trial because of the errors in the verdict form and final judgment which awarded liability on a joint and several basis rather than a several basis?” Before we consider the merits of these claims, however, we must determine whether we have appellate jurisdiction to do so. Given that B55 and Mr. McArthur did not file a new or amended notice of appeal addressing this denial of relief, we conclude that we lack appellate jurisdiction over these claims.

By the time the case was being briefed for the Tenth Circuit, it was far too late to amend the notice of appeal. B55 tried the common sense argument “in this case, there is nothing new in the order denying the motion for new trial that changes or alters the judgment or rulings made by the district court” and it got them exactly nowhere. The Court decided against them, saying:

That argument is untenable in light of the plain text of Appellate Rule 4(a)(4)(B)(ii), which speaks of the order being challenged, not the issues raised in the specified post-judgment motions. See FED. R. APP. P. 4(a)(4)(B)(ii) (“A party intending to challenge an order disposing of [a Rule 59(a) motion] . . . , must file a notice of appeal, or an amended notice of appeal . . . .” (emphasis added)). And the rule certainly does not speak to whether the issues presented in those motions might also have been properly the subject of an appeal from the final judgment. Having elected in their appellate briefing to frame three of their claims of error as challenges to the district court’s order denying their Rule 59(a) motion for a new trial, B55 and Mr. McArthur must abide by the consequences of doing so.

Chalk up another victory for the “sporting theory of justice,” in which the law is considered such a game that a party can lose and be penalized for filing an appeal, arguing the important issues, but failing to file a pro forma single-sentence document.  

This “sporting” attitude isn’t limited to disputes between oil extractors. Just this week, in the RoundUp litigation, in which plaintiffs allege that the glyphosate in RoundUp caused them to develop non-Hodgkin’s lymphoma, Monsanto convinced the court overseeing the multi-district litigation to “bifurcate” the trial, so that it’s really two trials: a trial solely on “causation” and then, if plaintiffs prevail, a trial on “liability” and “damages.” This is akin to splitting up a murder trial so that the prosecution first has to prove whether the defendant could have committed the murder, without allowing in evidence of the defendant’s motive and their actions to conceal the crime.

The key evidence in question in the RoundUp case involves Monsanto’s extensive efforts to influence regulators and to manipulate public opinion. The court’s two-page opinion tosses this evidence aside, justified by the sporting theory of justice:

The plaintiffs assert that this type of bifurcation is unfair because jurors will be left wondering, during the causation phase, how glyphosate could possibly be dangerous if it has gone largely unregulated for decades. But this relatively minor concern is best addressed by an instruction to jurors that they must not defer to regulatory agencies, and must instead reach their own judgment based on the evidence presented at trial. This concern is further obviated by the likelihood that jurors will learn during the causation phase that IARC has classified glyphosate as a probable carcinogen. In arguing against bifurcation, the plaintiffs assume that evidence of the IARC classification would be inadmissible during the causation phase. Although the Court will reserve final judgment on this question until the pretrial conference, it seems likely that jurors will, during the causation phase, need to receive at least some limited information about the IARC classification through expert testimony (albeit with an appropriate instruction about its limited utility in this context). In addition, if the plaintiffs have evidence that Monsanto manipulated the outcome of scientific studies, as opposed to agency decisions or public opinion regarding those studies, that evidence may well be admissible at the causation phase. Any such evidence will likely overlap with evidence of liability, but it will not be impossible, as the plaintiffs contend, to separate evidence of causation from evidence of liability.

The plaintiffs also assert that bifurcating causation from the remaining issues limits the informational value of the bellwether trials. But a trial court’s primary goal, even in an MDL bellwether, should be to conduct the fairest trial possible for the parties who are actually at trial.

Notice first how the sporting theory of law isn’t even consistently applied: the plaintiff’s concerns about a confusing, unfair partial trial with some of the evidence is dismissed as a “relatively minor concern,” whereas Monsanto’s desire to conduct a partial trial — leaving out the parts where they tried to manipulate the very “causation” evidence in question — is elevated to a necessary component of “the fairest trial possible.”

Then notice how the court has taken it upon itself to create a new sport within the sport: rather than simply admit relevant evidence at trial, as is the law, the court has generated a new task for itself in sorting out what evidence is relevant to causation and what is relevant to another issue. It is a one-sided game stacked against the plaintiffs, who have to withstand this arbitrary sorting of evidence.

Cases like these have strayed too far away from the principles that led to the system of legal rules we use today, making the courts once again, like Professor Pound warned, “agents or abettors of lawlessness.” People often complain that the law is tied too firmly to the past, but, sometimes, the problem is that the past has been forgotten.

 

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TAAR at Academy of Truck Accident Attorneys 2018 Symposium

Truck Accident Attorneys Roundtable co-founders Joe Fried, Steve Gursten & Michael Leizerman teach nuts and bolts of truck crash litigation at AATA seminar

Members of the Truck Accident Attorneys Roundtable (TAAR) will be speaking at the Academy of Truck Accident Attorneys (AATA) 2018 Annual Symposium in Nashville, TN, September 20-22, 2018.

This is important not … Read More

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Watch “The Bleeding Edge” And Demand Medical Device Safety Reform

 
Imagine if lights, kitchen equipment, and home electronics didn’t need to be tested for electrical shock and fire hazards, and that no one ever certified that the devices were safe. Would you put them in your home?
 
 
What about a car that had just one crash test, at low speed, and Congress had passed a special law making it impossible for anyone to sue the car company, so the company couldn’t be held responsible for people’s injuries? Would you put your family in one?
 
 
Yet, those examples above describe the state of the $156 billion American medical device market. Most medical devices aren’t tested with clinical trials. The medical devices which are tested can pass with a minimal showing, and Congress passed a special law that says that this minimal showing is enough to shut the courthouse doors on victims.
 
 
The Bleeding Edge, a documentary just released on Netflix, details the many problems with medical devices today, with an emphasis on the suffering of thousands of people due to Bayer’s Essure contraceptive, DePuy’s ASR hip implant, Johnson & Johnson’s transvaginal mesh, and the Da Vinci surgical robot. I know these awful products well; most of my law practice is representing victims of medical devices and pharmaceuticals.
 
 
If no one ever watched The Bleeding Edge, the film would still be a remarkable success: soon after it premiered, Bayer announced it will discontinue sales of Essure.
 
 
But everyone should watch it. Essure was just one part of a broken regulatory system and a corrupted market, and medical device companies often lobbying Congress to make it even worse.
 
 
It doesn’t have to be this way.
 
 

The Broken Regulation Of Medical Devices

 
 
As The Bleeding Edge points out, one key problem is the 510(k) loophole, which I’ve written about many times before, and which the Institutes of Medicine long ago recommended be abolished. Most medical devices need not undergo any testing because they are approved under a provision that only requires the manufacturer to show “substantial similarity” to some other approved medical device. The FDA’s interpretation of “substantial similarity,” however, has gone so far off the rails that the FDA regularly approves medical implants with different designs, different materials, and different purposes. The DePuy ASR hip implant used never-before-tested components, and transvaginal mesh was used for a never-before-tested purpose—yet both sailed through the 510(k) loophole.
 
 
If a medical manufacturer doesn’t want to or can’t use the 510(k) loophole, then they go through the “premarket approval” (“PMA”) process for “Class III” medical devices. As the FDA says, “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.” We can already see one obvious problem: there’s no doubt a complete hip replacement (like the DePuy ASR) or the surgical implantation of a foreign object (like transvaginal mesh) “present a potential, unreasonable risk of illness or injury,” and so should have to go through the premarket approval process. But the FDA doesn’t see things that way, and so routinely allows inherently risky devices to glide through the 510(k) loophole without any studies.
 
 
Essure went through this “PMA” process, which, as we’ll discuss in a minute, is often referred to as “rigorous.” You can read the “safety and effectiveness data” used to approve it. As The Bleeding Edge points out through interviews of clinical trial participants, this data was inaccurate, and the researchers routinely changed the participants’ answers to make the device look safer than it was. Yet, even the data taken at face value isn’t much: Essure was approved and sold to the public after a single “Phase II” clinical trial (a trial designed mostly to look at whether the implant can function, rather than if it is safe) of 227 women and a single “Phase III” clinical trial of 518 women.
 
 
Look carefully at page 8 of that summary of Essure safety data: that table of “adverse events” only includes those events the clinical trial investigator (who was paid by the manufacturer) said were “possibly” related to the Essure and only those events that occurred in the first year after the implantation. If something terrible happened to a woman but the investigator didn’t think or didn’t want to say it was “possibly” related to the Essure—such as autoimmune disorders and inflammatory reactions to the toxic metals in Essure—then it wasn’t included. If something terrible happened to a woman more than a year after implantation, it wasn’t included.
 
 
The FDA thought this sham of a report was good enough. The FDA panel meeting on Essure approval was videotaped and has to be seen to be believed; I won’t spoil it, I’ll just urge you again to watch The Bleeding Edge, which includes clips from it.
 
 
The regulatory process for medical devices is, in a word, indefensible. But the problems don’t stop there. Another reason why America is now awash in dangerous medical devices is money.
 
 

How Medical Devices Use Money To Control Medicine, And How They Make You Pay For Their Negligence

 
 
The Bleeding Edge pulls back the curtain on the unholy alliance between doctors, sales representatives, medical organizations, and medical device manufacturers. For example, several members from the Essure Problems group go to a conference for the American College of Obstetricians and Gynecologists (“ACOG”), where they are dismissed and ignored by members. ACOG is hardly a friend to patients: when they’re not helping shuttle along dangerous medical devices so their member OB/GYNs can make an extra buck, they’re writing unscientific “guidelines” to help negligence doctors evade responsibility for malpractice.
 
 
One issue The Bleeding Edge did not go into, however, was the many legal hurdles put in place to prevent patients injured by defective medical devices from bringing lawsuits. The Bleeding Edge follows several women whose lives were destroyed by Essure. They likely qualify for lawsuits and probably have them—but Bayer has still refused to settle Essure lawsuits and among the reasons why are the many dubious legal defenses available to them.
 
 
We’ll get to those in a moment, but it’s important to recognize that an injured patient’s ability to bring a lawsuit and to have it promptly go to trial are not just a matter of justice. Lawsuits are also a matter of patient safety. If a medical device company can’t be sued, then they won’t be financially responsible for the harm they negligently cause, and they won’t have nearly the same incentive to make a safe product. Fact is, lawsuits made cars safer by making car manufacturers accountable for the damage they caused, and removing the many barriers to lawsuits against medical device manufacturers will help do the same.
 
 
Lawsuits are also a way of shifting the costs of the damage—including medical costs—onto the entity responsible for them. The costs of medical care are part of the damages in a lawsuit and, if a plaintiff is successful in a lawsuit, the very first thing that happens is a payment to the plaintiff’s health insurer (or to the government if the plaintiff was on Medicare or Medicaid) reimbursing them for the cost of treatment related to the claim. Right now, for example, because Bayer refuses to settle the Essure lawsuits, the entire cost of treatment for Essure victims is being paid by the victims, their health insurers, and the taxpayers—which means that you are paying for an injury Bayer negligently caused.
 
 
To explain the special exemption Congress granted “premarket approved” medical devices like Essure, I’ll just quote a brief Bayer filed in an attempt to dismiss Essure lawsuits as soon as they were filed, before the plaintiffs could even put any Bayer employees under oath:

Congress did not provide plaintiffs with a federal cause of action under the FDCA, either expressly or impliedly. Recognizing the “undu[e] burden[]” imposed by differing state regulations, Congress also adopted a “general prohibition on non-Federal regulation” of medical devices. H.R. Rep. No. 94-853, at 45 (1976). Therefore, Congress incorporated an express preemption clause – a “general prohibition on non-Federal regulation” (id.) – providing that no state may impose “any requirement” relating to the safety or effectiveness of a medical device that “is different from, or in addition to, any requirement applicable … to the device” under federal law. 21 U.S.C. § 360k(a).

A victim’s state-law negligence lawsuit is considered a state “requirement,” and so they are “preempted” and thus cannot proceed.
 
 
Bayer added in a footnote, “This Court should not be swayed by concern that the application of federal preemption would effectively leave Plaintiffs without any recourse.” Bayer doesn’t want the court to be “swayed by concern” that it’s asking the Court to shut the courthouse doors on Essure victims and leave them (and taxpayers) paying for Bayer’s negligence, but Bayer itself routinely tries to “sway” courts, including the United States Supreme Court, by filing amicus briefs on its own behalf or through shadowy corporate advocacy groups, like the Medical Information Working Group and the Product Liability Advisory Council.
 
 
Here, for example, is an amicus brief filed by the Product Liability Advisory Council—which includes major medical device manufacturers Bayer, Johnson & Johnson, Medtronic, and St. Jude Medical—trying to “sway” the Supreme Court by complaining about “the profound impact of state law claims seeking to impose obligations on manufacturers regulated by the FDA.” In the brief, those companies argued they should be totally immune from lawsuits even when they violated “the Current Good Manufacturing Practices standards or the general obligation to report to FDA information concerning the occurrence of adverse device-related events.”
 
 
There is an extremely narrow way plaintiffs can sometimes still bring a case, if they can show their negligence claim is “parallel” to a violation of FDA regulations—the same regulations medical device companies constantly lobby over and sometimes help write—but most plaintiff cases are dismissed anyway.
 
 
It does not have to be this way, and it should not be this way. Congress should eliminate the “preemption” clause contained in the Medical Devices Act, and there’s even a bill pending on this issue, H.R. 2164, the Medical Device Safety Act, but Congress refuses to even hold hearings on it.
 
 

What Can Be Done?

 
 
First, remember this issue and talk about it. The Bleeding Edge just got a dangerous medical device taken off the market. Congress and corporations will sometimes listen, if you speak loudly enough. Last week, even a small amount of public attention helped correct an injustice against sexual abuse victims who had brought a lawsuit against a State entity.
 
 
Second, contact your Representative and Senators in Congress and tell them:

1. You saw The Bleeding Edge and you are concerned about medical devices;
2. You want them to pass a bill fixing the 510(k) loophole in the Food, Drug, and Cosmetic Act, like what would have been done by H.R. 3847, the SOUND Devices Act of 2012;
3. You want them to pass a bill like H.R. 2164 that will allow victims to bring lawsuits against “premarket approved” medical devices;
4. You want them to regularly hold hearings about the FDA and its decisions and to invite patient advocates to those hearings, to ensure the FDA is always acting in the best interest of patients; and,
5. For Senators, you want them to only confirm judicial nominees that respect your Seventh Amendment right to a jury trial.

In all likelihood, you will get from them a form letter response. That’s okay: the point of contacting your legislators is to let them know that their constituents care about this issue. Three months later, contact them again, and ask them what they’ve done since you last asked them. Keep doing it. The more people who make themselves heard, the more likely it is that we can make medical devices safer.

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The Solicitor General’s Brief In Fosamax – An End To Levine Preemption?

I’ve written many times before about the Supreme Court’s opinion Wyeth v. Levine, 555 U.S. 555 (2009), such as when the opinion came out in 2009 and when opioid manufacturers tried to use it and related preemption case law to stop the cases filed against them. Levine is by and large a good case: the Supreme Court held that, when a drug manufacturer fails to warn patients about the real harms of their drugs and injured patients bring lawsuits, the drug manufacturer can’t blame the FDA for the problem (for having approved the drugs) and demand the court throw out the patients’ cases.
 
 
 
The underlying logic of Levine was quite simple: the Food, Drug, and Cosmetic Act (“FDCA”) says that drug manufacturers, not the FDA, are responsible for the “Prescribing Information” and “Medication Guide” provided with each medication, and the FDCA does not say that injured patients can’t bring state tort lawsuits.
 
 
 
The Supreme Court, however, appeared to leave open the potential that some lawsuits could be “preempted” — as in, kicked out of court, even if the patient could prove the drug company was negligent — if the drug company could show “clear evidence that the FDA would not have approved a change to [the drug’s] label.” Levine at 571. Years later, the Supreme Court stated the rule a little bit more clearly: a drug company can “show, by ‘clear evidence,’ that the FDA would have rescinded any change in the label and thereby demonstrate that it would in fact have been impossible to do under federal law what state law required.” Pliva, Inc. v. Mensing, 564 U.S. 604, 624 fn 8.

 
 
 
The Supreme Court didn’t give much guidance on what it meant by “clear evidence.” The most natural interpretation is that courts should require the drug manufacturer to prove the FDA would have rescinded a change by “clear and convincing” evidence (which is higher than “preponderance”), which is what “clear evidence” meant in other Supreme Court cases, like Microsoft Corp. v. i4i Ltd. Partnership, 131 S. Ct. 2238, 2243 (2011). In practice, however, few District Courts or Circuit Courts ever needed to reach this question, because the evidence provided by the drug manufacturer to support preemption wasn’t enough under any standard. See, e.g., In re Incretin-Based Therapies Prod. Liab. Litig., 2017 WL 6030735, at *3 (9th Cir. Dec. 6, 2017)(holding there was no need to interpret “clear evidence” because “Uncertainty about whether the FDA considered the ‘new safety information’ and whether it would have altered the FDA’s conclusion establishes that a disputed issue of material fact should have prevented entry of summary judgment on the defendants’ preemption claim.”); see also Mason v. Smithkline Beecham Corp., 596 F.3d 387, 395 (7th Cir. 2010); Koho v. Forest Labs., Inc., 17 F. Supp. 3d 1109, 1117 (W.D. Wash. 2014); Dorsett v. Sandoz, 699 F. Supp. 2d 1142, 1157 (C.D. Cal. 2010).
 
 
 
In the Fosamax case, 852 F.3d 268 (3d Cir. 2017)(cert pending as Merck v. Albrecht, No. 17-290), in which people who used osteoporosis drug Fosamax suffered serious thigh bone fractures (the drug label warns about them now, although it didn’t then), the case had complicated enough facts that the Third Circuit reached the issue of “What is ‘clear evidence’? And who should determine whether clear evidence exists?” Id. at 282. The Third Circuit answered, “at the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change.” Id.
 
 
 
The Third Circuit provided a thorough explanation for how it reached its ruling, but, in truth, a thorough explanation wasn’t needed. Defendant drug companies typically raise preemption as a matter of summary judgment (the whole point for them is to try to avoid having a jury hear the case), but summary judgment — when a court decides there’s no “genuine dispute of material fact,” and so a jury trial won’t be held on that issue — is the exception, not the norm. The standards for applying summary judgment are well-settled, and in 2014 the Supreme Court reiterated:

Summary judgment is appropriate only if the movant shows that there is no genuine issue as to any material fact and the movant is entitled to judgment as a matter of law. Fed. Rule Civ. Proc. 56(a). In making that determination, a court must view the evidence in the light most favorable to the opposing party. …

The witnesses on both sides come to this case with their own perceptions, recollections, and even potential biases. It is in part for that reason that genuine disputes are generally resolved by juries in our adversarial system. By weighing the evidence and reaching factual inferences contrary to Tolan’s competent evidence, the court below neglected to adhere to the fundamental principle that at the summary judgment stage, reasonable inferences should be drawn in favor of the nonmoving party.

Tolan v. Cotton, 134 S. Ct. 1861, 1866, 1868 (2014)(quotations omitted). The drug companies try to avoid this well-settled law by claiming that what the FDA “would have” done if presented with the labeling change is solely a question of law, not of fact, but that doesn’t work, either. Whether or not the FDA would have rescinded a labeling change under the FDCA is a mixed question of law and fact, and those questions also go to the jury. As the Supreme Court held earlier this year,

We here arrive at the so-called “mixed question” of law and fact at the heart of this case. Pullman-Standard v. Swint, 456 U. S. 273, 289, n. 19 (1982) (A mixed question asks whether “the historical facts . . . satisfy the statutory standard, or to put it another way, whether the rule of law as applied to the established facts is or is not violated”). …

For all their differences, both parties rightly point us to the same query: What is the nature of the mixed question here and which kind of court (bankruptcy or appellate) is better suited to resolve it? See Miller v. Fenton, 474 U. S. 104, 114 (1985) (When an “issue falls somewhere between a pristine legal standard and a simple historical fact,” the standard of review often reflects which “judicial actor is better positioned” to make the decision). …

[In a mixed question] [t]he court takes a raft of case-specific historical facts, considers them as a whole, [and] balances them one against another…

U.S. Bank National Association v. Village at Lakeridge (U.S., March 5, 2018). Such “mixed” questions of law and fact go to the fact-finder, which is the jury. In the Oracle v. Google litigation, the Federal Circuit just applied the same analysis to a jury finding:
 

The Supreme Court has recently explained how we are to determine what the standard of review should be in connection with any mixed question of law and fact. Id. Specifically, the Court made clear that an appellate court is to break mixed questions into their component parts and to review each under the appropriate standard of review. Id. at *5-7. …

Where applying the law to the historical facts “involves developing auxiliary legal principles of use in other cases—appellate courts should typically review a decision de novo.” Id. (citing Salve Regina College v. Russell, 499 U.S. 225, 231-33 (1991)). But where the mixed question requires immersion in case-specific factual issues that are so narrow as to “utterly resist generalization,” the mixed question review is to be deferential. Id.

Even one of the very few cases to find preemption of a branded drug injury lawsuit — a case that was settled before the appeal was finished, so we don’t know if it would have been affirmed — held “application of the clear evidence standard is necessarily fact specific.” Dobbs v. Wyeth Pharms., 797 F. Supp.2d 1264, 1270 (W.D. Okla. 2011). If the “clear evidence” standard of Levine is “fact specific,” which no one denies, then it is the type of question that goes to the jury.
 
 
 
In other words, Fosamax wasn’t any sort of departure from the ordinary. Rather, it was a straight-forwarded application of well-settled law. Such is likely why the Third Circuit panel’s order was unanimous and why the Third Circuit denied en banc review.
 
 
 
Unsurprisingly, the drug company (Merck) disagreed, and so sought certiorari from the Supreme Court. Justice Alito recused himself (properly, because he owns Merck stock) and thereafter the Supreme Court requested the Solicitor General of the United States to file a brief expressing their views on the case.
 
 
 
Which brings us to yesterday, when the Solicitor General filed their brief.
 
 
 
I have no doubt that my frenemies over at Drug and Device Law Blog (they represent drug manufacturers–I call them “frenemies” in jest because our blogs have had a good rapport for years) would go ballistic over the description I just gave of Fosamax, which they considered “pure hogwash,” “based on crazy reasoning,” and myriad other colorful phrases, raising some other lawyers’ eyebrows. They were quite happy to see yesterday that the Solicitor General’s office has recommend the Supreme Court grant certiorari in the Fosamax case and reverse it.
 
 
 
In my humble opinion, however, the Solicitor General’s brief is not the silver bullet the drug companies have been looking for. In many ways, it supports the arguments plaintiff-patients usually make more than the arguments made by defendant drug companies.
 
 
 
First, the Solicitor General’s brief essentially concedes that this case presents none of the usual reasons for granting certiorari. Supreme Court Rule 10 isn’t binding on the Court, but it’s a good guide, and it lists the three primary circumstances in which certiorari is granted:

(a) a United States court of appeals has entered a decision in conflict with the decision of another United States court of appeals on the same important matter; has decided an important federal question in a way that conflicts with a decision by a state court of last resort; or has so far departed from the accepted and usual course of judicial proceedings, or sanctioned such a departure by a lower court, as to call for an exercise of this Court’s supervisory power;

(b) a state court of last resort has decided an important federal question in a way that conflicts with the decision of another state court of last resort or of a United States court of appeals;

(c) a state court or a United States court of appeals has decided an important question of federal law that has not been, but should be, settled by this Court, or has decided an important federal question in a way that conflicts with relevant decisions of this Court.

The Solicitor General’s brief admits right up front that they don’t have any of these: “[n]o circuit conflict yet e​xists, however, and further percolation in the courts of appeals could potentially refine the issue for review.” They even admit that they have no argument for how a decision in Fosamax could make any difference in other cases: “It is also unclear whether the decision below will influence other courts addressing similar preemption defenses.”
 
 
 
The Solicitor General’s brief tries to squeeze in an argument, in the very last sentence, that “the Court’s consideration of the proper method for resolving the preemption issue in this case may inform the proper analytical framework for resolving FDA preemption issues in light of Wyeth more generally.” Problem for them is that the new “analytical framework” they present, on pages 18-19, has never been adopted by any court in the country, as revealed by the absence of any citations in support.
 
 
 
The Solicitor General is thus asking the Supreme Court to take up a case where there’s no conflict and no reason to believe it will make any difference in future cases, all so the Supreme Court can obliterate nine years of precedent interpreting Levine and make up an entirely new rule for cases with different facts that aren’t in front of the Court.
 
 
 
I suspect the drug companies begged the Solicitor General’s office to file this brief — I spotted some language that is almost verbatim to language I’ve seen in drug company briefs — but the brief admits every way that it can that this just isn’t the type of circumstance that warrants certiorari.
 
 
 
Second, the Solicitor General’s brief makes a concession that could be devastating to the preemption arguments made by drug companies in most drug injury lawsuits:

This case does not present circumstances in which there is no actual FDA labeling decision to interpret—for instance, because the manufacturer did not submit a labeling supplement. In such circumstances, Wyeth’s use of the phrase “clear evidence” could arguably be read to suggest that determining what FDA would have done with respect to such a supplement presents a question of fact for the jury to decide.

Fact is, Fosamax is unique because there is arguably an “actual FDA labeling decision to interpret.” In the vast majority of drug injury lawsuits, the manufacturer “did not submit a labeling supplement” at all, or did not submit a labeling supplement with either the language proposed by the plaintiff or with the scientific evidence identified by the plaintiff. Nexium and Prilosec? No warning for stomach or esophageal cancer proposed. Mirena? No warning for intracranial hypertension proposed. Januvia and Victoza? No warning for pancreatic cancer proposed. Onglyza? No warning for heart failure proposed (that is, in the time period when the plaintiffs took it — it has one now.)
 
 
 
Drug manufacturers try to use their own negligence to their advantage, claiming that, even if they didn’t submit a labeling change, they can establish preemption based on some hand-waving arguments about regulatory standards, but the Solicitor General’s brief knocks that down, too: “Wyeth therefore may be understood as consistent with the view that, to establish impossibility preemption, a name-brand drug manufacturer cannot rely on speculation or merely plausible interpretations of ambiguous features of FDA’s regulatory framework and practices.”
 
 
 
The fact that the United States has adopted those two positions is bound to make its way into plaintiffs’ briefs from now on. If the Supreme Court adopts them, too, then it will make most branded drug preemption arguments even more frivolous than they already are.
 
 
 
Third, the Solicitor General’s brief includes a paragraph and footnote that justifies everything plaintiffs’ lawyers have been saying since Levine was originally decided:

FDA’s May 2009 decision rejecting petitioner’s proposal to modify Fosamax’s Warnings and Precautions section to address atypical femoral fractures was based on the agency’s determination that the data was then insufficient to justify such a warning. That conclusion flows directly from the terms of the agency’s May 2009 Complete Response Letter, the relevant regulatory context, and the agency’s subsequent actions. Given FDA’s determination, respondents’ claim that petitioner should have updated its Warnings and Precautions labeling at that time is preempted.10

Footnote 10: The question presented is based on the premise that petitioner provided FDA with “the relevant scientific data,” Pet. i, and respondents’ brief in opposition does not appear to contend otherwise.

In every drug case, the drug manufacturers have inevitably withheld scientific data from the FDA, and so the drug manufacturers always try to avoid discovery into their scientific data by claiming that it’s irrelevant whether or not the FDA actually had and reviewed “the relevant scientific data.” The Solicitor General’s brief blows that argument up entirely.
 
 
 
Under the Solicitor General’s view, a drug manufacturer not only has to show the FDA rejected the same warning proposed by the plaintiff, but must also show that, along with the proposed warning, the drug manufacturer provided all of “the relevant scientific data.” But the drug companies never do that in the circumstances that lead to litigation; if they had done so, the drug would have had an adequate warning and there would be no case.
 
 
 
***
 
 
 
It’s usually folly to predict what the Supreme Court will do, but I’ll do it anyway: with Justice Alito recused, I don’t see how certiorari would be granted. Justice Roberts has been scrupulous about avoiding plurality decisions, and, way back when Levine was originally decided, Justice Thomas wrote a concurrence in support of the plaintiffs, and so he would be unlikely to up-end Levine in favor of the drug companies, and that would still likely produce a 4-4 opinion. There’s no clear path to victory for the drug companies here and, as the Solicitor General’s brief shows, there’s no good reason why the drug companies should be victorious.

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DNC Lawsuit Part 2: U.S. Intervention, Mueller, Free Speech, And The End-Game

 
My prior post went through the basics of the DNC Lawsuit against Russia, the Trump campaign, Wikileaks, and the individuals affiliated with each of them, specifically:

1. Why Now
2. Why The Complaint Alleges Those Causes Of Action
3. Whether Russia And Its Agents Have “Sovereign Immunity”
4. The “Plausibility” Pleading Requirement For The Case To Go Forward

Today we’ll follow up with four big-picture issues:

5. The Potential Role Of The U.S. Government
6. The Role Of Parallel Criminal Prosecutions
7. The First Amendment Issues
8. What This Lawsuit Can Actually Accomplish

V. The Potential Role Of The U.S. Government

 
 
My prior post talked about the Foreign Sovereign Immunities Act (“FSIA”), which sets out when foreign governments can be sued in United States courts. To sum up that discussion in a sentence, it’s unclear whether Russia (and the GRU and its agents) can be sued at all for hacking the DNC. “Computer network exploitation,” or “CNE,” is far closer to a matter of governmental policy than, say, an employee at the Russian embassy running a red light and hitting a pedestrian, or the Russian embassy ordering a pizza delivery and refusing to pay for it, both of which would clearly fall within the FSIA’s grant of jurisdiction to sue.
 
 
 
This post discusses something different: whether the United States under the Trump Administration can (and might) intervene in the DNC’s lawsuit.
 
 
 
The United States frequently intervenes in lawsuits against foreign governments. As a Congressional Research Service report from 2008 said,

In 1996 Congress amended the Foreign Sovereign Immunities Act (FSIA) to allow U.S. victims of terrorism to sue designated State sponsors of terrorism for their terrorist acts. The courts have handed down large judgments against the terrorist State defendants, generally in default, and successive Administrations have intervened to block the judicial attachment of frozen assets to satisfy judgments.

As one example, in Acree v. Republic of Iraq, 17 American soldiers who were captured and tortured during the 1991 Gulf War sued the Republic of Iraq for compensatory and punitive damages. The United States tried to intervene in the case, the District Court denied the intervention, but the D.C. Circuit reversed, holding “the District Court abused its discretion in finding the United States’ motion to intervene to be untimely and erred in denying that motion. The United States possesses weighty foreign policy interests that are clearly threatened by the entry of judgment for appellees in this case.” Acree, 370 F.3d 41, 43 (D.C. Cir. 2004).
 
 
 
In many ways, our analysis here is far less complicated than in most of the cases, because (a) the DNC does not raise claims relating to terrorism, which have their own statutes and (b) Congress has not passed a statute specific to this situation, which it has done in other lawsuits against foreign governments. The DNC lawsuit instead has a rather straightforward application of Federal Rule of Civil Procedure 24(a), which says:

(a) Intervention of Right. On timely motion, the court must permit anyone to intervene who …  claims an interest relating to the property or transaction that is the subject of the action, and is so situated that disposing of the action may as a practical matter impair or impede the movant’s ability to protect its interest, unless existing parties adequately represent that interest.

That was the basis for the United States intervening in Acree. It’s difficult to dispute that the United States has “an interest relating to … the subject of the action,” not least because of the potential effect on diplomatic relations, the existence of multiple governmental investigations into the DNC hack (i.e., the same reports referenced by the DNC’s complaint, as discussed in my prior post), and the ongoing Special Counsel investigation and the indictments already filed. If the United States wants to intervene in the case, it’s hard to see how a court could tell them “no.”
 
 
 
Will the United States intervene? I wouldn’t be surprised if they did, and, if they did, there’s nothing necessarily suspicious about it. As discussed above, the United States has a history of intervening in lawsuits involving foreign governments. (That isn’t to say anything the Trump Administration does with respect to this case is beyond criticism; if, for example, the Administration intervened and took positions that appeared designed more to benefit the Trump campaign than to serve the foreign policy interests of the United States, that would be worth evaluating more closely.)
 
 
 
Attorney General Sessions has recused himself “from any existing or future investigations of any matters related in any way to the campaigns for President of the United States.” Presumably by “investigations” he meant investigations by the Department of Justice, which wouldn’t necessarily apply to intervention in the DNC’s civil suit. However, I hope for everyone’s sake he recuses himself from this issue as well, so that the decision is made by Deputy Attorney General Rosenstein, which would mitigate the appearance of a conflict of interest. Indeed, it’s possible that Special Counsel Mueller files to intervene, on the basis of the on-going investigation. Neither of these actions would suggest anything untoward — they are what we would expect in this situation, regardless of the underlying politics.
 
 
 
Once the United States intervenes, they can raise a host of arguments, from immunity under FSIA to the “political question” doctrine.
 
 
 
If you saw Narcos on Netflix, you might recall the real-life case of Kiki Camarena, a DEA agent abducted, tortured, and murdered by drug cartels — and the DEA’s retaliatory response, which was so aggressive that cartels thereafter refrained from harming DEA agents. Part of that response involved kidnapping, without the permission of the Mexican government, a physician alleged to have participated in the torture and bringing him back to the United States. He was tried, acquitted, then returned to Mexico, after which he brought suit against the DEA and the people involved. I mention his case because of a footnote in the Supreme Court’s opinion dismissing it:

Another possible limitation that we need not apply here is a policy of case-specific deference to the political branches. For example, there are now pending in federal district court several class actions seeking damages from various corporations alleged to have participated in, or abetted, the regime of apartheid that formerly controlled South Africa. The Government of South Africa has said that these cases interfere with the policy embodied by its Truth and Reconciliation Commission, which “deliberately avoided a `victors’ justice’ approach to the crimes of apartheid and chose instead one based on confession and absolution, informed by the principles of reconciliation, reconstruction, reparation and goodwill.” The United States has agreed. In such cases, there is a strong argument that federal courts should give serious weight to the Executive Branch’s view of the case’s impact on foreign policy. Cf. Republic of Austria v. Altmann, 541 U. S. 677, 701-702 (2004) (discussing the State Department’s use of statements of interest in cases involving the Foreign Sovereign Immunities Act of 1976, 28 U. S. C. § 1602 et seq.).

Sosa v. Alvarez-Machain, 542 U.S. 692, 733, Fn 21 (2004)(record citations omitted). The full passage in the case referenced, Altmann, rejected the idea that the courts have to defer to the United States’ interpretation of FSIA, but added:

[S]hould the State Department choose to express its opinion on the implications of exercising jurisdiction over particular petitioners in connection with their alleged conduct, that opinion might well be entitled to deference as the considered judgment of the Executive on a particular question of foreign policy. See, e. g., Verlinden, 461 U. S., at 486; American Ins. Assn. v. Garamendi, 539 U. S. 396, 414 (2003) (discussing the President’s “`vast share of responsibility for the conduct of our foreign relations'”). We express no opinion on the question whether such deference should be granted in cases covered by the FSIA.

Republic of Austria v. Altmann, 541 U. S. 677, 701-702 (2004). As the Supreme Court elaborated in Altmann, “we do not hold, however, that executive intervention could or would trump considered application of the FSIA’s more neutral principles,” and thus the Executive doesn’t have a blank check to stop lawsuits against foreign governments by simply asserting the case could affect foreign policy.
 
 
 
Nonetheless, one of the central issues raised by the DNC’s lawsuit — whether Russia should be held accountable for hacking into the DNC’s servers and then using that information to affect the 2016 election — sounds very much like a “political question.” The “Countering America’s Adversaries Through Sanctions Act” was passed by Congress to impose “sanctions with respect to activities of the Russian Federation undermining cybersecurity,” and it referenced intelligence community findings that “Russian President Vladimir Putin ordered an influence campaign in 2016 aimed at the United States presidential election.”
 
 
 
The decision whether or not to allow the case to continue remains in the power of the federal courts, not the Executive; that’s a basic Marbury v. Madison issue. Nonetheless, the Executive’s views on whether or not the DNC’s lawsuit could impact foreign policy will factor into the District Court’s analysis (and, if it gets there, the Circuit Court’s and potentially the Supreme Court’s analyses).
 
 
 

VI. The Role of Parallel Criminal Prosecutions: Mueller’s Investigation Doesn’t Necessarily Stop The DNC Lawsuit

 
 
In general, “The Constitution does not ordinarily require a stay of civil proceedings pending the outcome of criminal proceedings.” Keating v. Office of Thrift Supervision, 45 F.3d 322, 324 (9th Cir. 1995). Yet, as Keating continued, “Nevertheless, a court may decide in its discretion to stay civil proceedings when the interests of justice seem to require such action.” Id. (citations omitted). The Second Circuit Court of Appeals would hear any appeal from the DNC lawsuit, and it has similarly ruled:

The power to stay proceedings is incidental to the power inherent in every court to control the disposition of the causes on its docket with economy of time and effort for itself, for counsel, and for litigants. Courts may defer civil proceedings pending the completion of parallel criminal prosecutions when the interests of justice seem to require such action. Although civil and criminal proceedings covering the same ground may sometimes justify deferring civil proceedings until the criminal proceedings are completed, a court may instead enter an appropriate protective order. How this can best be done calls for the exercise of judgment, which must weigh competing interests and maintain an even balance.

Louis Vuitton Malletier SA v. Ly USA, Inc., 676 F. 3d 83, 97 (2d Cir., 2012). The Second Circuit noted, “so heavy is the defendant’s burden in overcoming a district court’s decision to refrain from entering a stay that the defendants have pointed to only one case in which a district court’s decision to deny a stay was reversed on appeal, and that case was decided more than thirty years ago.” Id. at 100.
 
 
 
My point in raising all this is simple: to show that the court has ample flexibility in deciding whether or not to stay the litigation and wait for the Mueller investigation (and, e.g., the Papadopolous prosecution) to conclude, or to limit the proceedings in some way, or to plow forward with all deliberate speed.
 
 
 
In terms of testimony and the production of documents, five years ago I wrote about “Pleading The Fifth Amendment And Adverse Inferences In Civil Litigation.” Although “taking the Fifth” has tremendous power in criminal prosecutions, the effect on civil litigation is far more limited. As I wrote then,

Although in a criminal procedure, the court must instruct the jury that it cannot draw an inference of guilt from a defendant’s failure to testify about facts relevant to his case, Griffin v. California, 380 U.S. 609 (1965), in civil cases, “the Fifth Amendment does not forbid adverse inferences against parties to civil actions when they refuse to testify in response to probative evidence offered against them.” Baxter v. Palmigiano, 425 U.S. 308, 318 (1976).

Thus, when a defendant’s criminal rights are at stake, the defendant can still choose to “take the Fifth” and avoid testifying or producing documents, but the court and the plaintiffs can use that against them, and can even instruct a jury to use that against them, and to presume that the defendant plead the Fifth to avoid revealing incriminating information.
 
 
 

VII. First Amendment Issues: Most Of The Defendants Have Colorable Free Speech Defenses

 
 
Let’s go back to January 27, 2010, when President Obama delivered his State of the Union, which included:

Last week the Supreme Court reversed a century of law that I believe will open the floodgates for special interests –- including foreign corporations –- to spend without limit in our elections. Well I don’t think American elections should be bankrolled by America’s most powerful interests, and worse, by foreign entities. They should be decided by the American people, and that’s why I’m urging Democrats and Republicans to pass a bill that helps to right this wrong.

Obama was referring to the Citizens United opinion. Justice Alito, who was in attendance and who had joined the majority in Citizens United, famously shook his head and mouthed “not true.”
 
 
 
I don’t raise this to re-litigate Citizens United, but to note that the zone of “free speech” surrounding political figures is quite broad under the current precedent. In McDonnell v. U.S., 136 S. Ct. 2355 (2016), for example, the Supreme Court invalidated a corruption conviction in part because:

[T]he Government’s expansive interpretation of “official act” would raise significant constitutional concerns. … [C]onscientious public officials arrange meetings for constituents, contact other officials on their behalf, and include them in events all the time. The basic compact underlying representative government assumes that public officials will hear from their constituents and act appropriately on their concerns — whether it is the union official worried about a plant closing or the homeowners who wonder why it took five days to restore power to their neighborhood after a storm. The Government’s position could cast a pall of potential prosecution over these relationships if the union had given a campaign contribution in the past or the homeowners invited the official to join them on their annual outing to the ballgame. Officials might wonder whether they could respond to even the most commonplace requests for assistance, and citizens with legitimate concerns might shrink from participating in democratic discourse.

The scope of McDonnell is so broad that it effectively ruined the corruption prosecution against Senator Robert Menendez.
 
 
 
There’s of course no First Amendment right to hack into someone’s computer servers and steal information. But what about a political candidate exploiting the fruits of a hack of their opponent? It doesn’t seem like there were any smoking guns contained within the DNC’s files, but it’s hard to deny that they were, at least to some extent, matters of “public interest.” That gets us into far more complicated territory. We don’t have enough facts yet to develop these arguments, but it’s likely everyone associated with the Trump campaign will raise a free speech defense to some, potentially all, of the allegations.
 
 
 
A similar analysis applies to Wikileaks. Media outlets frequently utilize materials that obviously came to them from unlawful activity of some sort, like the Panama Papers, which changed the political landscape world-wide for the better. At some point, a media outlet’s advance cooperation with hackers might subject them to joint liability for the unlawful conduct — but, as of yet, it does not appear there is any publicly-available evidence suggesting Wikileaks coordinated the hack with Russia or its GRU intelligence unit.
 
 
 
The disclosed communications reveal Wikileaks was hardly a neutral or objective player in its use of the DNC’s documents, and that it sought specifically to boost the Trump campaign, but “neutral” and “objective” aren’t the standard for free speech protections. To the contrary, courts tend to avoid looking at the viewpoint advanced by the speaker, and instead look to the overall nature of the conduct. “The First Amendment forbids the government to regulate speech in ways that favor some viewpoints or ideas at the expense of others.” Lamb’s Chapel v. Center Moriches Union Free School Dist., 508 U.S. 384, 394 (1993).
 
 
 

VIII. What Can This Lawsuit Actually Accomplish?

 
 
As I mentioned in my first post, it seems to me the DNC’s lawsuit was prompted by a simple fact: the statute of limitations for their claims was about to run. (Specifically, the statute of limitations for the Computer Fraud & Abuse Act and Stored Communications Act claims.) It was now or never, and the DNC made the decision to file it now rather than lose their right to ever file it.
 
 
 
So, what’s next? In my humble opinion, the DNC has solid CFAA and SCA claims against Russia, Russia’s GRU, and any hackers it can personally identify. The DNI investigation into Russia’s efforts to influence the election, the DHS/FBI investigation into “Grizzly Steppe,” and the CrowdStrike investigation into the DNC hack provide more than enough for a “plausible” claim that should survive a motion to dismiss.
 
 
 
But that’s just about all the DNC has going for it – even for those claims, pursuing them now walks right into Russia’s FSIA defense (and potential intervention by the United States), and if Russia and its agents are dismissed early, the rest of the case will likely fall apart completely, because Russia’s role in the alleged facts is likely so central that the other parties cannot be held liable without them. Moreover, the current facts against the other parties are weak. As a political matter, there is a lot that can be drawn from what we know about the contacts between the Trump campaign, Wikileaks, and Russia, but as a legal matter it is hard to see how the non-Russia parties can be held liable for anything on the existing record. It is likely in the DNC’s best interest to wait for the Mueller investigation to continue producing something, be it more indictments or a report that is made public or something else that can help bolster their allegations.
 
 
 
If I represented the DNC, I’d probably upfront admit the statute of limitations issue to the court and ask the court to stay all of the proceedings until, at the earliest, the Special Counsel investigation either concluded or at least indicated that it had finished its work relating to the Trump campaign. Whether they do that, and whether the court would grant it, is another matter.

DNC Lawsuit Part 2: U.S. Intervention, Mueller, Free Speech, And The End-Game posted first on http://helloinjuryhelpnowposts.tumblr.com