We aren’t the first to note the latest class action denial in the prescription medical product liability field, In re Panacryl Sutures Products Liability Cases, No. 5:08-MD-1959-BO, slip op. (E.D.N.C. Nov. 13, 2009). 360 (subscription only) beat us to the punch the other day. But just because we aren’t first, doesn’t mean there’s nothing in Panacryl worth blogging about.
We view decisions like Panacryl as vindication of all the fuss we made for more than two years about the ALI’s Principles of Aggregate Litigation project.
We’ve pointed out before – and consider it a significant legal accomplishment – that class certification in personal injury actions involving prescription medical products are routinely denied these days. Earlier this year, we gave the defense bar its highest grade – an “A” – for largely eliminating this sort of class action. We said then:
[I]n the late 1980s, we had to take class actions in product liability litigation very seriously. While there were never a lot of certifications, there were enough of them that – during the Bone Screw litigation, for example – plaintiffs would argue that there was some sort of “modern trend” favoring certification of personal injury class actions. . . .
Then our side prevailed in [Amchem and Ortiz]. After that – with a lot of blood, sweat, and good legal argument from our side – class actions (at least successful ones) largely disappeared from mass torts. . . . The few courts willing to certify class actions in drug and medical device cases have so far gotten shot down on appeal. . . . And with the enactment of CAFA, most class action decisions going forward, and essentially everything in mass torts, will be made by federal courts applying post Amchem/Ortiz law. . . .
As a measure of how far out of the mainstream tort class actions have become over the last couple of decades, the ALI’s Aggregate Litigation principles project, for all its pro-plaintiff leanings in other areas of the law, states quite clearly that personal injury class actions are disfavored for a variety of reasons.
“Taking Stock” post.
More or less removing the threat of class actions in mass tort litigation involving prescription drugs and medical devices has gone a long way to making the risks of this type of litigation manageable – as opposed to the existential threat pharmaceutical mass torts posed back in the days of Bone Screw and Fen-Phen. With the class action threat gone, the likelihood of a mass tort settlement gone wild has become quite remote.
Cases like Panacryl remind us why that is. In Panacryl, the plaintiffs claimed that the defendant’s synthetic surgical stitches (a medical device) were defective and caused or facilitated various types of post-surgical infections. Mass tort litigation followed an FDA Class II recall (It seems like every recall of a drug or medical device turns into a mass tort these days, doesn’t it?), and in the inevitable MDL, plaintiffs sought a nationwide class action that would have joined together more than 2 million users of these stitches – the vast majority of whom suffered no complications from using this product.
Because it was a nationwide class action, the first and foremost question raised was whether the law of all fifty states would apply. If it did, then there’s lots of law holding that the multiplicity of jurisdictions makes renders the class action uncertifiable. What did plaintiffs argue? Why, that the defendant’s principal place of business should apply to all claims, of course. Slip op. at 4. Last refuge of a scoundrel and all that.
Fortunately, the Panacryl court rejected that argument:
First, the court had no trouble finding that the states’ approach to products liability created numerous conflicts. Slip op. at 4-5. Well . . . duh. You’ve got a court in California, but nobody else, allowing “misrepresentation” liability for a brand-name company in a generic drug case. Then you’ve got West Virginia, but nobody else, rejecting the learned intermediary rule. Could anybody really deny the conflict question with a straight face?
So what does a court do with that conflict? Before ending up in the MDL, these plaintiffs filed in New Jersey, a state known both for having a lot of drug and device companies headquartered there, and for having relatively (not as much as before, though) pro-plaintiff substantive law. That meant that New Jersey choice of laws principles applied.
That means the court had to decide whether principal place of business could trump the place of injury as a choice of laws principle. Well, that’s one of the main issues that had to be fought out in the ALI’s Principles of Aggregate Litigation project. In fact, one of the three floor motions at the ALI annual meeting last May, was on that precise subject. We – and a lot of other folks – fought long and hard to keep principal place of business as a choice of laws rule out of the final Principles. In that, we were successful. The result, as we reported shortly after the meeting, was:
Principal place of business and choice of law – The reference is still there, but the next sentence now reads: “At the present time, choice-of-law principles that point towards application of the law of the defendant’s principal place of business remain quite rare across the various states.” This position is also now described as an “outlier” in the Reporters’ Notes. The Schwartz amendment will add language to the effect that whatever choice of law principles are applicable to litigation generally apply equally to aggregated litigation. We’d rather not see principal place of business mentioned at all, but short of that, it’s essentially a complete fix.
Final report on ALI Principles of the law of Aggregate Litigation, available here.
The defendant in Panacryl succeeded, too. Relying on a recent and directly on point case out of the New Jersey Supreme Court, Rowe v. Hoffman LaRoche, Inc., 917 A.2d 767 (N.J. 2007) (which we reviewed here), the court held that in personal injury actions, the individual plaintiff’s home state/place where the injury occurred should control:
[H]aving considered the contacts relevant to the competing interests of the states in light of Rowe, this Court concludes that the competing interests of the states, the most important factor, weighs in favor of applying the law of each plaintiff’s home jurisdiction.
Panacryl, slip op. at 10.
That’s one – and it’s the big one. Once the court concluded that the plaintiffs’ nationwide class action had to be governed by the law of all 50 states, denial of class certification occurred pretty much as a matter of course.
Except. . . .
Plaintiffs argued that, if the court couldn’t certify the whole class, it should still give them half a loaf and certify an single-issue class action under Fed. R. Civ. P. 23(c)(4). Slip op. at 18-19.
That’s another biggie – the misuse of “single-issue” certifications where the litigation as a whole is too diverse to be certified. This issue, as well, was a major bone of contention in the ALI’s consideration of the Principles of Aggregate litigation. Making sure that single-issue classes stayed rare was the subject of another of the floor amendments offered last May at ALI. Again, we think we got most of what we wanted:
Broad Use of Single Issue Classes – this is the subject of the Beisner amendment that the Reporters largely agreed to. We expect it to end up some neutral language and a statement regarding the law being divided on the point. We expect a substantial, if not complete, fix.
Final report on ALI Principles of the law of Aggregate Litigation, available here.
We pointed out back then that the bulk of precedent rejected the use of Rule 23(c)(4) as a way to break up inherently individualized litigation into bite-sized, certifiable bits. The leading case is Castano v. American Tobacco Co., 84 F.3d 734 (5th Cir. 1996), which flatly held that a “district court cannot manufacture predominance through the nimble use of [bifurcation],” because “a cause of action, as a whole, must satisfy the predominance requirement of (b)(3).” Id. at 745 n.21. Rule 23(c)(4) isn’t a way to make the predominance requirement of Rule 23(b)(3) disappear:
Reading Rule 23(c)(4) as allowing a court to sever issues until the remaining common issue predominates over the remaining individual issues would eviscerate the predominance requirement of Rule 23(b)(3); the result would be automatic certification in every case where there is a common issue, a result that could not have been intended.
84 F.3d at 745. The problem with broad use of single-issue certifications is that it invites courts to ignore what’s left over – which is entirely improper. Cf. McLaughlin v. American Tobacco Co., 522 F.3d 215, 234 (2d Cir. 2008) (rejecting piecemeal certification; “given the number of questions that would remain for individual adjudication, issue certification would not ‘reduce the range of issues in dispute and promote judicial economy”); In re St. Jude Medical, Inc., 522 F.3d 836, 841-42 (8th Cir. 2008) (Rule 23(c)(4) certification improper where “trials will still be required” for remaining individualized issues).
And beyond Castano, a raft of federal district court decisions have reached the same conclusion – a lawsuit that’s individualized and not certifiable as a whole can’t be broken down into smaller, certifiable parts by the use of Rule 23(c)(4). We start with Blain v. Smithkline Beecham Corp., 240 F.R.D. 179 (E.D. Pa. 2007), one of Bexis’ cases that we discussed here. Blain rejected Rule 23(c)(4) single-issue certification, holding that “only after the court has found that the cause of action satisfies the predominance requirements of Rule 23(b)(3) may it certify common issues pursuant to Rule 23(c)(4).” Id. at 190. See also Rowe v. E.I. duPont de Nemours & Co., 2009 WL 2424086, at *2 (D.N.J. July 29, 2009) (“Because the medical monitoring . . . is not applicable to the “class as a whole” . . . [it has] not met the 23(b)(2) requirement and, thus, certification under 23(c)(4) would be improper”); Henry v. St. Croix Alumina, LLC, 2008 WL 2329223, at *4-5 (D.V.I. June 3, 2008) (“a claim for relief taken in its entirety must satisfy the predominance requirement of Rule 23(b)(3) before the court may select certain issues for piecemeal certification”); In re Welding Fume Products Liability Litigation, 245 F.R.D. 279, 312 (N.D. Ohio 2007) (“a court must not manufacture adherence to the requirements of Rule 23 through the nimble use of subdivision (c)(4)”); In re General Motors Corp. Dex-Cool Products Liability Litigation, 241 F.R.D. 305, 314 (S.D. Ill. 2007) (same); Taylor v. CSX Transportation, Inc., 2007 WL 2891085, at *14 (N.D. Ohio Sept. 28, 2007) (“Plaintiffs must still satisfy that the issues to be determined by class adjudication predominate over the claims as a whole, including the claims in the separate individual issue trials.”); In re Katrina Canal Breaches Consolidated Litigation, 2007 WL 2363135, at *1 (E.D. La. Aug. 16, 2007) (“Rule 23(c)(4) issue certification is allowed only if the Rule 23(b) requirements are first met as to the claim”); O’Neill v. The Home Depot U.S.A., Inc., 243 F.R.D. 469, 481 (S.D. Fla. 2006) (“[n]or may the Court certify a single issue when the case as a whole fails to meet the requirements of Rule 23”); Fisher v. Ciba Specialty Chemicals Corp., 238 F.R.D. 273, 316 (S.D. Ala. 2006) (“courts have emphatically rejected attempts to use the (c)(4) process for certifying individual issues as a means for achieving an end run around the (b)(3) predominance requirement”); Hyderi v. Washington Mutual Bank, FA, 235 F.R.D. 390, 398-99 (N.D. Ill. 2006) (quoting and following Castano); Hamilton v. O’Connor Chevrolet, Inc., 2006 WL 1697171, at *6 (N.D. Ill. June 12, 2006) (“a class action movant cannot gerrymander predominance by suggesting that only a single issue be certified for class treatment . . . when other individualized issues will dominate or be meaningfully material to the resolution of the absent class members’ claims”); Snow v. Atofina Chemicals, Inc., 2006 WL 1008002, at *9 (E.D. Mich. March 31, 2006) (“Rule 23(c)(4) may not be used to circumvent the predominance requirement”); Perez v. Metabolife International, Inc., 218 F.R.D. 262, 273 (S.D. Fla. 2003) (“sub-issues cannot be separated out from those that require individualized treatment unless the common issues in the action as a whole predominate”); Rink v. Cheminova, Inc., 203 F.R.D. 648, 651 (M.D. Fla. 2001) (finding Castano analysis of Rule 23(c)(4) “persuasive”); Robertson v. Sikorsky Aircraft Corp., 2000 WL 33381019, at *19 (D. Conn. July 5, 2001) (“[a]n action must be considered as a whole in order to determine whether or not the predominance requirement has been satisfied”); Neely v. Ethicon Inc., 2001 WL 1090204, at *5 (E.D. Tex. Aug. 15, 2001) (Rule 23(c)(4) “does not operate independently from the rule of predominance found in 23(b)(3)”; predominance inquiry cannot be limited to “common issues” alone); In re Jackson National Life Insurance Co. Premium Litigation, 183 F.R.D. 217, 225 (W.D. Mich. 1998) (“certification of the question . . . is inappropriate, for the cause of action as a whole certainly does not satisfy the predominance requirement of Rule 23(b)(3)); Arch v. American Tobacco Co., 175 F.R.D. 469, 496 (E.D. Pa. 1997) (“Plaintiffs cannot read the predominance requirement out of (b)(3) by using (c)(4) to sever issues until the common issues predominate over the individual issues”), aff’d, 161 F.3d 127 (3d Cir. 1998).
To this line of cases can now be added the Panacryl decision. The court held, as to Rule 23(c)(4):
But Rule 23(c)(4) may not be used to manufacture predominance for purposes of Rule 23(b)(3). Plaintiff’s trial plan does not eliminate the necessity of applying the laws of several jurisdictions or the individualized inquiry into whether [the product] caused each plaintiff’s injuries.
Slip op. at 19 (Castano quote omitted).
Panacryl thus demonstrates why engaging on the ALI’s Principles Project for Aggregate Litigation was both a good and necessary thing to do. In Panacryl, as in many class actions involving prescription drugs and medical devices, the key certification questions are those that were most controversial in the ALI – strained choice of law arguments to get around the importance of the plaintiff’s residence in personal injury actions, and slicing, dicing, and pureeing causes of action to avoid the predominance requirement for damages class actions. Of the three main issues that we took to the floor of the ALI, only medical monitoring didn’t raise its ugly head in Panacryl.
There’s always good reason to fight the good fight.