[Drug and Device Law] Further Deconstruction of the Law in Pelvic Mesh
This post is from the non-Reed Smith side of the blog.
In the latest decision from the Pelvic Mesh MDL, the court ordered a consolidated trial of no fewer than thirty-seven plaintiffs with nothing in common save claiming injury from the same product. See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op. (S.D.W. Va. Aug. 4, 2015). The consolidation is an attempt at a Rule 23(c)(4) single-issue class certification without the class action – since class actions are never certified anymore in personal injury prescription medical product litigation (as demonstrated here). To reach the same procedural result, Mullins limits consolidation to defect/breach of duty and “general causation”:
[T]he consolidated trial will only involve . . . issues concerning the design of the [defendant’s mesh] and whether that design was reasonably safe. Determining reasonable safeness necessarily involves consideration of the [product’s] capability to cause injury. As a result, causation will be relevant to the consolidated trial but only in the general sense. In other words, the pertinent issue will be whether the [product] can cause injury (general causation), not whether it did in fact cause injury to a particular plaintiff (specific causation).
Mullins, slip op. at 5 (citation omitted).
We’ve already posted at length on the nature and sources of the prejudice to defendants of these types of mass consolidations, so we’re not going to repeat ourselves. If the issue is truly “non-specific,” then what is gained by having more than one plaintiff, since “[p]laintiff-specific evidence is not required for general causation, nor will it be accepted”? Id. at 5.
In other words, what is gained from the consolidation that could not occur without the prejudice to defendants inherent in putting 37 plaintiff chairs at the same counsel table? Nothing resembling this mass consolidation has been seen on the federal level in some twenty years since appellate courts stepped in and called a halt to jumbo asbestos consolidations in Cimino v. Raymark Industries, Inc., 151 F.3d 297 (5th Cir. 1998), and Malcolm v. National Gypsum Co., 995 F.2d 346 (2d Cir. 1993).
Perhaps more troubling is what Mullins did to the law to get to mass consolidation. It had to conclude that West Virginia wouldn’t follow Restatement (Second) of Torts §402A, comment k (1965). Mullins, slip op. at 15-16 (calling comment k a “useless relic”). Because no West Virginia court has ever “expressly or implicitly” addressed comment k, slip op. at 15, it had to predict an expansion of West Virginia law that is completely unsupported by state-court precedent. All prior West Virginia federal precedent held that comment k was part of that state’s law. See Rohrbough v. Wyeth Labratories, Inc., 719 F. Supp. 470, 477 n.1 (N.D. W. Va. 1989); Smith v. Wyeth Laboratories, 1986 WL 720792, at *5 (S.D. W. Va. Aug. 21, 1986), aff’d mem., 916 F.2d 970 (4th Cir. 1990). “[W]ith the advantage of hindsight,” Mullins declined to follow prior predictions.
How about the law elsewhere? Only two years ago the Supreme Court stated:
New Hampshire − like a large majority of States − has adopted comment k to § 402A of the Restatement (Second) of Torts, which recognizes that it is “especially common in the field of drugs” for products to be “incapable of being made safe for their intended and ordinary use.” Under comment k, “[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” This Court has previously noted that, as of 1986, “a large number of courts” took comment k to mean that manufacturers “did not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings.” Bruesewitz v. Wyeth, 562 U.S. ––––, ––––, n. 41, 131 S.Ct. 1068, 1077, n. 41, 179 L.Ed.2d 1 (2011).
Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2476 n.2 (2013) (comment k citations omitted) (emphasis added). Twice, dealing with other states’ law, the Fourth Circuit (where West Virginia is) has predicted adoption of comment k. Doe v. Miles Laboratories, Inc., 927 F.2d 187, 191 (4th Cir. 1991) (applying Maryland law); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230-31 (4th Cir. 1984) (applying South Carolina law). There’s no legal basis for Mullins to dispense with comment k.
We agree with the Supreme Court in Bartlett and Bruesewitz. In 2011, we took a 50-state (and more) look at who’s adopted comment k and how. The only jurisdictions that declined to adopt comment k were Alaska and Nevada. A few other places (Delaware, Vermont, Puerto Rico, and the Virgin Islands), had no comment k jurisprudence at all. Every other state – 46 of them – had at least some precedent applying comment k. The main division wasn’t between comment k or nothing, but instead whether its preclusion of design defect strict liability for “unaviodably unsafe” products is “across the board” or “case by case.”
We think that mattered. If West Virginia were to follow the “across the board” version of comment k, then there’s no design defect issue to consolidate. If West Virginia were to follow the “case by case” approach (which is the majority rule), then consolidation remains impractical. In order to force through a consolidation of scores of cases, comment k had to go − even though it’s the ovewhelming majority rule and nothing in West Virginia prescription medical product law is to the contrary.
We’ve said it before, and we’ll say it again: A federal court sitting in diversity jurisdiction is not supposed to make novel predictions of state law that expand liability beyond anything the state courts have adopted. The Supreme Court and every court of appeals has so held. That includes, of course, the Fourth Circuit:
[O]ur role in the exercise of our diversity jurisdiction is limited. A federal court acting under its diversity jurisdiction should respond conservatively when asked to discern governing principles of state law. Therefore, in a diversity case, a federal court should not interpret state law in a manner that may appear desirable to the federal court, but has not been approved by the state whose law is at issue. Mindful of this principle, we decline the plaintiffs’ invitation to predict that the West Virginia Supreme Court of Appeals would adopt the specific provisions of the Restatement advanced by the plaintiffs.* * * *We decline to recognize such an exception in the first instance because, as we have stated, a federal court in the exercise of its diversity jurisdiction should act conservatively when asked to predict how a state court would proceed on a novel issue of state law.
Rhodes v. E.I. du Pont de Nemours & Co., 636 F.3d 88, 96, 98 (4th Cir. 2011) (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)). Accord Time Warner Entertainment-Advance/Newhouse Partnership v. Carteret-Craven Electric Membership Corp., 506 F.3d 304, 314 (4th Cir. 2007) (“sitting in diversity, a federal court should not create or expand a State’s public policy” and “should not elbow its way into this controversy to render what may be an uncertain and ephemeral interpretation of state law”); Wade v. Danek Medical, Inc., 182 F.3d 281, 286 (4th Cir. 1999) (“we are mindful of the general principle that, in trying to determine how the highest state court would interpret the law, we should not create or expand that State’s public policy”); Talkington v. Atria Reclamelucifers Fabrieken BV, 152 F.3d 254, 260 (4th Cir. 1998) (same as Wade); St. Paul Fire & Marine Insurance Co. v. Jacobson, 48 F.3d 778, 783 (4th Cir.1995) (“the federal courts in diversity cases, whose function it is to ascertain and apply the law of a State as it exists, should not create or expand that State’s public policy.”).
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Posted By Michelle Yeary to Drug and Device Law at 8/07/2015 02:30:00 PM --
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