The transvaginal mesh litigation has for some time been the largest medical mass tort ever, at least as measured by filings in the federal multi-district litigation (MDL), which is currently being handled in the Southern District of West Virginia. There are over 42,000 cases in the MDL — more than the combined total of cases ever filed in the Prempro MDL (9,761), the Yasmin and Yaz MDL (11,423), the Vioxx MDL (10,319), and the DePuy ASR Hip Implant MDL (8,900). (See this chart under “Total Actions.”) Add to that the over 6,000 mesh cases pending in New Jersey state court, and numerous cases filed in other state courts, and there are nearly 50,000 transvaginal mesh claims pending in courts across the country against six different manufacturers.
So what are the courts supposed to do with that many cases?
There’s no shortage of inventive (and often problematic) suggestions for how to resolve mass torts cases, ranging from ‘offensive collateral estoppel’ to ‘statistical sampling of verdicts.’ (Naturally, defense-oriented interests are quite fond of coming up with “solutions” that are merely veiled ways either to drag the litigation on forever or to put insurmountable pre-trial barriers in front of plaintiffs.) But the only tried-and-true method is the one I mentioned a year and a half ago in “How Judges Can Settle Mass Torts Cases:” “defendants and their insurance companies don’t willingly make reasonable settlement offers. The only thing that brings them to the table is the immediate threat of trial. If judges want to resolve these cases, they need to move them along to trial.”
But when you’re talking about 50,000 medical device cases, that’s easier said than done. The federal courts conduct fewer than 3,500 civil trials each year.
So where can we look for guidance? The closest analogy to the transvaginal mesh litigation is the Diet Drugs litigation, which had roughly 20,000 claims filed in the federal MDL and about 12,000 filed in Philadelphia’s Complex Litigation Center, making it about three-fifths the size of the transvaginal mesh litigation. But some of the lessons learned there might not help us here, because that litigation was comparatively less complicated: the litigation was against a single company (Wyeth), and it involved products that the company had at least implicitly admitted were defective by way of withdrawing them from the market. In the transvaginal mesh lawsuits, however, there are four different major defendants — Ethicon, C.R. Bard, Boston Scientific, and American Medical Systems each have thousands of cases filed against them — and, not only do the defendants adamantly maintain that their products are perfectly fine, but many of the products are still on the market. There’s thus a potential, perhaps even a likelihood, for this litigation to grow endlessly as only a handful of claims are resolved each year while hundreds, potentially thousands, of new claims accumulate each year.
That scenario raises the question: is the transvaginal mesh litigation headed towards the same “black hole” in which the over 180,000 cases in the asbestos MDL sat for nearly thirty years? If so, how do we get out?
Via Amaris Elliott-Engel and TortsProf, Judge Robreno of the Eastern District of Pennsylvania — who successfully moved the asbestos MDL from a so-called “black hole” where cases lingered for years to an efficient MDL that resolved thousands of cases — just published “The Federal Asbestos Products Liability Multidistrict Litigation (MDL-875): Black Hole or New Paradigm?” in which he describes the long, painful process in which the federal courts continued to accumulate stagnant asbestos claims, and how MDL-875 was able to move forward with procedural changes that swiftly moved the cases through the MDL and towards trial.
There’s plenty of useful lessons there for current and future MDL courts. I was elated to see Judge Robreno address head-on the disturbingly common view that an MDL judge is somehow personally responsible for resolving the whole litigation through summary judgment or a handful of bellwethers: “As a matter of judicial culture, remanding cases [to local District Courts for trial] is viewed as an acknowledgment that the MDL judge has failed to resolve the case, by adjudication or settlement, during the MDL process.” As Judge Robreno rightly notes, “That view, together with the business model of aggregation and consolidation of cases for settlement, interfered with the litigation of individual cases in the MDL court,” and thus he concludes: “The objectives of the MDL process are best served by a commitment of the MDL courts to address pretrial issues, but promptly remand cases to the transferor court once the goal of addressing pretrial issues has been achieved.”
Hallelujah! If judges want to resolve mass torts cases, they need to keep an eye on discovery disputes, finish discovery, then move them all along to trial. But the devil is in the details — how do we get 50,000 transvaginal mesh cases to trial? And do we really want to hold 50,000 separate transvaginal mesh trials — e.g., do we really need to hold, in each case, two weeks of the same general liability testimony before we get to the specifics for each plaintiff?
The asbestos MDL had numerous problems that were obviously unique to asbestos. Plaintiffs often filed claims against dozens of defendants – sometimes rightly, because the plaintiff had in fact been exposed to asbestos from a variety of sources, and sometimes wrongly, in the foolish hopes that peripheral defendants would it at least contribute a nuisance value towards settling case – many of which defendants went bankrupt at some point during the litigation, complicating matters further. There also seemed to be a surprising number of cases filed that the plaintiffs’ lawyers had no intention of truly pursuing, because the cases were dropped as soon as they were asked to support the claims with medical documentation. (For all the tort reform-minded readers who just thought to themselves “that proves trial lawyers business model involves frivolous lawsuits,” stop and reflect upon the fact that the plaintiffs’ lawyers in those cases were never paid.)
Those same systemic problems will not be found in the transvaginal mesh MDL. There are only a few potential defendants, all of which are solvent, and the MDL’s pretrial orders require every plaintiff to swiftly serve on the defendants information from their medical records specifically identifying the implanted product in question. Then, within two months after filing and serving the complaint, the plaintiff also has to serve a detailed plaintiff profile form (as an example, here’s the Ethicon form) that identifies, among other issues, all the symptoms they’ve had, and whether or not they had the mesh revised or removed — and, if so, they have to identify the doctor and the hospital involved. They also have to identify their primary care physicians, OB-GYNs, urologists, psychiatrists(!), psychologists(!), endocrinologists, and rheumatologists, and then sign authorizations allowing the defendants to obtain their medical records.
Even beyond that detailed information, on an individual case basis, the transvaginal mesh cases are easier for defendants to evaluate for settlement purposes than asbestos cases. Defendants don’t need to, say, go through 40 years of a plaintiff’s work history to see where they may have encountered asbestos, or to have a doctor examine each plaintiff’s biopsy slides to see if they really show signs of mesothelioma or silicosis. As much as Defendants like to reference Lore v. Lone Pine Corp., 1986 WL 637507 (N.J. Super. Ct. Nov. 18, 1986)(an order from a chemical exposure case which required each plaintiff get their own experts early in the litigation) as a panacea for all litigations because it dramatically increases the costs for the plaintiffs, truth is, in the transvaginal mesh MDL, most of what the defendants would want to know to generally assess the case is right there in front of them within 60 days or so of the lawsuit being filed.
So what’s the holdup?
The bellwethers. As Judge Robreno said, there’s a strong sense among judges and lawyers that the MDL court is supposed to whip up a resolution to the litigation as a whole, and the preferred method is by way of “bellwether” trial, in which a handful of cases are cherry-picked for trial in the hopes that the results of those cases will encourage settlement by showing the parties how these cases fare at trial. It worked in Vioxx, which in the mass torts world is almost as good as saying the Supreme Court requires it.
But the bellwether process isn’t perfect. Consider the law review article “Jackpot Justice: Verdict Variability and the Mass Tort Class Action,” which summaries a variety of options for resolving mass torts, eventually recommending the bellwether trial process, i.e. “individual litigation with multiple individual trials, the verdicts of which would be used to develop accurate claim values that could be used for broad-reaching settlements that would reduce transaction costs.” But what if the defendant doesn’t want to enter into “broad-reaching settlements?” What if they want to fight the cases forever, picking off a couple good bellwethers with settlements and then litigating all the others until the end of time? The big drug and medical device companies can often do that with impunity, like Roche has been doing in the Accutane cases.
Sometimes the bellwethers don’t tell us much anyway. The Ethicon case that was just tried is a perfect example: I wasn’t involved in that case, but, as best I can tell from the filed papers, the case involved a plaintiff with several comorbidities (like morbid obesity), who, prior to the implementation of her mesh, had already undergone two failed bladder surgeries to treat stress urinary incontinence. Her implant was removed, and she has largely returned to the problems she had before. Judge Goodwin dismissed the whole case for a lack of scientific and medical evidence before it was even submitted to the jury. I disagree with many of those rulings, but the essential point is: that case — which any mesh plaintiffs’ lawyer would have readily admitted was weak and unlikely to prevail — did little to move either me or the lawyers for the mesh manufacturers closer to settlement.
On February 19, 2014, Judge Goodwin saw the light. He must have realized that the rest of his tenure was going to be devoted to trying transvaginal mesh cases, with no end in sight, and so he entered Pretrial Order # 78 in the Boston Scientific cases, which consolidated 11 Obtryx cases together for a single trial.
That simple shift — grouping together a couple plaintiffs for trial where the evidence against the defendant will all be pretty much the same — is how to avoid the black hole. There’s no reason that those cases need to be tried separately: Boston Scientific didn’t do a thing differently with regard to any of those 11 women, and they’ve been delaying the litigation for too long by demanding, like Ethicon and C.R. Bard and American Medical System, that the litigation be resolved by way of 50,000 individual trials. There’s no sound reason for the courts to force each plaintiff to individually reinvent the wheel at trial; it’s just another delay tactic.
As Judge Goodwin saw, the solution for the transvaginal mesh conundrum is to hold consolidated trials, and that’s what’s finally going to move the litigation closer to a resolution.