Thursday, November 30, 2006

Buckman Scorned (Implantable Defibrillators)

We just read one of the more remarkable decisions we’ve ever seen, insofar as it disregards controlling precedent. That opinion is In re Medtronic, Inc., Implantable Defibrillators Litigation, 2006 WL 3420285 (D. Minn. Nov. 28, 2006). To understand how this decision puts the preemption rabbit in the hat and then makes it disappear first requires some discussion of the controlling precedent involved – Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), in which a unanimous court held that tort claims alleging fraud on the FDA were preempted. Indeed, in Buckman seven justices held that such claims were preempted even where the FDA itself determined it was defrauded.

In Buckman the plaintiffs claimed that, in a state-law action, they could undertake to prove that the defendants had obtained FDA approval fraudulently. The Supreme Court found the claim impliedly preempted due to the inherent conflict presented by state law presuming to determine when a federal agency decision was fraudulently obtained, and therefore could be treated as illegitimate. Buckman made the following points in finding preemption:
  • Policing submissions by regulated entities to federal agencies “is hardly “a field which the States have traditionally occupied.” 531 U.S. at 347.
  • The submissions at issue “were prompted by the [federal statute], and the very subject matter of [the submissions] were dictated by that statute's provisions.” Id. at 347-48.
  • The preemptive “conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud” and the FDA uses “this authority. . .to achieve a somewhat delicate balance of statutory objectives” – a “balance [that] can be skewed by allowing fraud-on-the-FDA claims under state tort law.” Id. at 348.
  • Administrative “flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives.” Id. at 349.
  • Thus, fraud on the FDA allegations “inevitably conflict with the FDA’s responsibility to police fraud consistently with [its] judgment and objectives.” Id. at 350.
  • The conflict also has “practical” aspects – such claims would “dramatically increase the burdens facing potential applicants” in ways “not contemplated by Congress” – specifically, “applicants may be discouraged from seeking [product] approval,” or else might compensate for “fear that their disclosures to the FDA. . .[might] later be judged insufficient in state court” by “submit[ting] a deluge of information that the Administration neither wants nor needs.” Id. at 350-51.
  • Fraud on the FDA claims do not present “parallel” state-law requirements because such claims “exist solely by virtue of the FDCA disclosure requirements.” FDA fraud claims “would not be relying on traditional state tort law [that] predated the federal enactments” but rather “the existence of these federal enactments is a critical element in their case.” Id. at 353.
There is controlling Eighth Circuit precedent that FDA pre-market approval (which these defibrillators had) mandates extensive preemption of state-law product liability claims. See Brooks v. Howmedica Inc., 273 F.3d 785, 798 (8th Cir. 2001) (en banc), cert. denied, 535 U.S. 1056 (2002). To avoid preemption under Brooks, the Implantable Defibrillators decision relies entirely upon allegations that the defendant either failed to disclose information to the FDA or affirmatively withheld such disclosure. It then concludes that, notwithstanding multiple claims challenging the design, manufacture, and warnings passed upon by the FDA during several pre-market approvals, there was no “conflict” with federal requirements. Implantable Defibrillators, 2006 WL 3420285, at *7.

The specific allegations mentioned in the opinion are that the defendant supposedly: (1) “withheld critical information from the FDA while seeking the PMA Supplement approval,” id.; (2) “failed to notify the FDA. . .that the battery was defective,” id.; (3) “sought PMA approval for three new devices, but continued to use the known-to-be defective battery in them,” id.; and (4) “did not advise the FDA that it knew-for longer than a year-that the [battery] had exhibited a ‘previously undetected failure mode.’” Id. “Lacking such knowledge,” the allegations continue, “the FDA approved [defendant’s] PMA Supplement applications.” Id. Only later, after the defendant received field reports concerning failures previously seen only in laboratory tests, did the defendant issue a “Dear Doctor” letter which prompted the FDA “to order a recall.” Id.

These allegations are in substance, if not name, a fraud on the FDA claim. They make the same claim that was before the Supreme Court in Buckman: that the defendant withheld and/or manipulated the information it submitted to the FDA, and as a result the duped Agency took action approving (here through supplemental approvals) the product in question. Had the FDA had that information, these allegations continue, it would not have issued these approvals. Under Buckman there is no doubt that this type of claim is preempted. The only practical difference here is that, instead of captioning the allegations “fraud on the FDA,” these plaintiffs couched them in terms of traditional state-law causes of action. The discussion of these causes of action in the opinion, however, confirms that they are merely disguised fraud on the FDA claims.

The opinion starts with “parallel requirements.” 2006 WL 3420285, at *8. What, however, is the “parallel” pre-existing state-law requirement that takes the case out of Supreme Court’s analysis in Buckman? The opinion lists violations of 21 C.F.R. §803.50 (“Individual Adverse Event Reports”), §803.53 (“Five-Day Reports”), §814.3 (the “definitions” section of the Part concerning “Pre-Market Approval”), §814.39 (“PMA Supplements”), and §814.84 (“Reports”). Every one of these provisions deals with FDA reporting and/or approval. None of them directly concerns design, warnings, or manufacture – the sort of pre-existing state-law claims that Buckman holds are necessary to distinguish unpreempted “parallel” claims from preempted claims relating to a manufacturer’s interactions with the FDA.

Other than a claim of defective manufacture (which is not addressed by any of the regulations the opinion cites), most of the litany of allegations relate solely to the defendant’s interactions with the FDA:
[Defendant] failed to comply with PMA approval requirements; failed to comply with FDA reporting obligations; misrepresented and concealed information during the FDA approval process.
Implantable Defibrillators, 2006 WL 3420285, at *8 (record citations omitted). In substance, it is unmistakable that the “parallel requirements” claim the opinion allows to escape preemption is the same claim that the unanimous Supreme Court held to be preempted in Buckman as not involving a “parallel” requirement.

There is, of course, the mandatory allegation of failure to warn, 2006 WL 3420285, at *8, but the opinion goes on to reveal that these “warning” claims are just another repackaging of the same FDA-related allegations – that the defendant failed to warn about the same information it supposedly withheld from the FDA. Id. at *9 (defendant “discovered the battery defect. . .but made no report to the FDA”; “it thereafter submitted PMA Supplement applications. . . without disclosing the possibility of this defect to the FDA”). Indeed, the analysis relies upon these same FDA non-disclosure claims in an attempt to distinguish Brooks. 2006 WL 3420285, at *9. Because the warning claims depend upon the identical allegations that information was withheld from the FDA, they are merely fraud on the FDA claims in disguise.

The implied warranty discussion contains reference to allegations of departures from FDA-mandated “manufacturing standards.” Id. A manufacturing-based claim – if supported by evidence – might well escape preemption as a “parallel requirements” claim. The trouble here is the nature of the purported manufacturing claims is never described in the opinion, and neither is any separate count alleging a manufacturing defect mentioned. To the extent that the implied warranty claims are yet another restatement of the FDA-related allegations already discussed, they would be preempted under Buckman regardless of what FDA regulations concerning the scope of express preemption state about implied warranty (Buckman holds that implied preemption operates independently of express preemption, 531 U.S. at 352).

Express warranty is another type of claim that may escape preemption under some circumstances. Once again, the opinion does not contain a sufficient discussion of the claims to determine whether they are yet another iteration of the plaintiffs’ fraud on the FDA allegations. 2006 WL 3420285, at *10. The absence of any other articulated factual basis strongly suggests that they are.

The same is true of the consumer fraud allegations – except that, since this type of claim is entirely informational, it is highly likely that this is yet another guise under which the plaintiffs’ fraud on the FDA claims are masquerading. The failure of the opinion, id. at *11, to include any description of any aspect of the defendant’s supposed “promotion” that does not involve the information allegedly withheld from the FDA further reinforces this impression.

The fraud on the FDA rabbit that the Implantable Defibrillators opinion put into the hat in its analysis of express preemption vanishes entirely in the subsequent discussion of implied preemption – which is what the Buckman decision is all about. All of the essential facts are the same as in Buckman: there was no dispute that, (1) the product “received [FDA] approval”, and (2) “the FDA has never found or cited [defendant] for a regulatory violation.” 2006 WL 3420285, at *11. Here, as in Buckman the plaintiffs deprecate in-force FDA product approvals.

To avoid Buckman, the decision relies on the labels plaintiffs give to their allegations rather than the substance of those claims. 2006 WL 3420285, at *11 (“the claim at issue in Buckman was actual ‘fraud-on-the-FDA,’ and not state tort claims involving the plaintiffs' personal injuries”). The opinion thus takes the view that preemption is governed solely by whatever caption the plaintiffs choose to name their allegations of FDA-related misconduct. Because no plaintiff will be so foolish as to call anything “fraud on the FDA” after Buckman, this reasoning is tantamount to ignoring controlling Supreme Court authority. No precedent is cited for this singular holding – only an article from a CLE program sponsored by the American Trial Lawyers Association. 2006 WL 3420285, at *12.

Next, the opinion asserts “[p]laintiffs do not complain of fraud on the FDA. Rather, they claim they, themselves, were deceived.” Id. Some courts have drawn this distinction, but only where there are facts showing both: (1) statements other than those concerning FDA-related information, and (2) individual reliance upon those statements. Neither prerequisite for non-FDA-related fraud is mentioned here. The continued marketing of allegedly fraudulently approved devices and the same battery defect involved in the FDA-related allegations are all that is opinion cited. Id. Reliance is ignored entirely. Id. Instead, the opinion resorts to the “historic primacy of the states” argument, id., that was decisively rejected in Buckman. 531 U.S. at 347.

The opinion then seeks to distinguish Buckman as involving off-label use. 2006 WL 3420285, at *12. Off-label use, however, was cited by the Supreme Court in Buckman only as an “example” of the “difficult task of regulating” that the FDA has to carry out. 531 U.S. at 349-50. There is no suggestion either in Buckman or in any of the many cases applying it that fraud on the FDA claims not involving off-label use somehow escape preemption. Preemption of FDA-related misconduct claims having nothing to do with off-label use is frequently affirmed. E.g., Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir.) (“disguised fraud on the FDA claim” preempted), cert. denied, 126 S. Ct. 420 (2005); Kemp v. Medtronic Corp., 231 F.3d 216, 235 (6th Cir. 2000), cert. denied, 534 U.S. 818 (2001); Mitchell v. Collagen Corp., 126 F.3d 902, 914 (7th Cir. 1997), cert. denied, 523 U.S. 1020 (1997). “[P]laintiffs cannot bootstrap their arguments regarding defendant’s alleged failure to report and to investigate adverse incidents to the FDA into a defective warning case.” Webster v. Pacesetter, Inc., 259 F. Supp. 2d 27, 36 (D.D.C. 2003).

The “final” reason for denying implied preemption is that an “expansive” reading of Buckman “would place [the decision] outside the legion of cases upholding parallel requirements to federal violations as actionable.” 2006 WL 3420285, at *12. As already discussed, however, each and every one of the claimed “parallel” violations of FDA regulations listed in the opinion, id. at *8, involves a claimed FDA reporting or approval violation. Thus, these claims are not like the other cases the opinion cites, but rather fit snugly within Buckman’s discussion of why allegations involving FDA-related misconduct are simply not “parallel” violation claims. See 531 U.S. at 353.

The decision closes with dictum that even it concedes is not the law, suggesting that there should be “no preemption at all” if the defendant violated “a Congressionally-imposed affirmative duty to disclose this information to the FDA.” 2006 WL 3420285, at *13. Here the true thrust of the opinion’s analysis is revealed. This final discussion is nothing more and nothing less than a call for resurrection of the very fraud on the FDA claims the Supreme Court unanimously declared to be preempted in Buckman. Fraud on the FDA may well have been “a condition Justice Breyer never contemplated in Lohr.” 2006 WL 3420285, at *13. However, it was a condition that all nine of the justices directly confronted in Buckman – and all nine of them found preemption because this sort of claim “inevitably conflict with the FDA’s responsibility.” 531 U.S. at 350.

Medical Device Preemption

Judge Rosenbaum's decision in the Medtronic Defibrillator Litigation brought to mind medical device preemption. We'll be doing a post on that decision in the relatively near future.

In the meantime, we've decided that this doesn't have to be only our blog; it can also be our file cabinet. We can clip and save here useful precedents, and then we'll know where to find them when we need them.

In the area of medical device preemption, the recent cert petition and opposition filed in Riegel v. Medtronic collected between them most of the leading cases on medical device preemption for devices that entered the market through premarket approval. So here's a link to the cert petition and here's a link to the opposition. Now, whenever we need cites for PMA preemption, we won't be rummaging around through our file drawers, cursing.

Tuesday, November 28, 2006

Federal Courts Should Remember Federalism

A couple of recent federal appeals decisions in the prescription drug area, while substantively unrelated, raise the same question of the scope of federal predictions of state law in cases brought under diversity jurisdiction – whether a federal court has any business making novel interpretations of state law that purport to expand state-law liability.


The first of these, Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), interpreted the fraud on the FDA exception to a Michigan immunity statute, Mich. Comp. Laws §600.2946(5), so that it survived federal preemption under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). 467 F.3d at 97-98. In allowing a Rezulin suit brought by a Michigan plaintiff to continue, the Second Circuit interpreted the Michigan act in a way diametrically opposed to the reading given the statute by the Sixth Circuit – the circuit responsible for Michigan. 467 F.3d at 97 (rejecting Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004)). It also gave no weight to the Michigan Supreme Court’s determination that the statute, which was intended to restrict liability, was severable and allowed for partial Buckman preemption. 467 F.3d at 96 (minimizing Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 130 (Mich. 2003)).


The second of these decisions, Tingey v. Radionics, 2006 WL 2258872 (10th Cir. Aug. 8, 2006) (unpublished), emasculated another state tort reform statute, Utah Code Ann. § 78-15-6, that provided a rebuttable presumption of non-defectiveness for products “in conformity with government standards.” At a stroke, Tingey exempted over 95% of medical devices from the statute by ruling that FDA approval of so-called §510k devices meant nothing – that there were no applicable “government standards” applicable to devices approved in this fashion. 2006 WL 2258872, at *6.


In both of these decisions, novel questions of state law, involving state statutes intended to reduce tort liability, were answered so as to expand liability in ways that no state court had endorsed. Under established principles of federalism, that should not have happened. The Supreme Court made clear in Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3 (1975), that “[a] federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.” Id. at 4.


Similar precedent to this effect exists in every Court of Appeals. E.g., Joy v. Bell Helicopter Textron, Inc., 999 F.2d 549, 567 (D.C. Cir. 1993); Wilson v. Bradlees of New England, Inc., 250 F.3d 10, 16 (1st Cir. 2001); Travelers Insurance Co. v. Carpenter, 411 F.3d 323, 329 (2d Cir. 2005); City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002); Wade v. Danek Medical, Inc., 182 F.3d 281, 286 (4th Cir. 1999); Holden v. Connex-Metalna Management Consulting GmbH, 302 F.3d 358, 365 (5th Cir. 2002); Kurczi v. Eli Lilly & Co., 113 F.3d 1426, 1429 (6th Cir. 1997); Hollander v. Brown, 457 F.3d 688, 692 (7th Cir. 2006); Karas v. American Family Insurance Co., 33 F.3d 995, 1000 (8th Cir. 1994); Hemmings v. Tidyman’s Inc., 285 F.3d 1174, 1203 (9th Cir. 2002); Taylor v. Phelan, 9 F.3d 882, 887 (10th Cir. 1993); Seaboard Surety Co. v. Garrison, Webb & Stanaland, P.A., 823 F.2d 434, 438 (11th Cir. 1987).


No less of a jurist than Learned Hand cautioned against “embrac[ing] the exhilarating opportunity of anticipating a doctrine which may be in the womb of time, but whose birth is distant.” Spector Motor Service v. Walsh, 139 F.2d 809, 823 (2d Cir. 1943) (dissent), vacated, 323 U.S. 101 (1944) (quoted and followed in Garland v. Herrin, 724 F.2d 16, 17 (2d Cir. 1983)). Defendants, when faced with novel liability claims or other unprecedented state-law arguments being asserted in diversity actions in federal courts, need to assert strongly the principle of conservative prediction of state law. When a state-law action proceeds in federal court, the jurisprudential thumb is planted firmly on the scale to weigh against novel expansions of state law. In such situations, the federal courts can bear being reminded of what “federal” means.

Saturday, November 25, 2006

A Vioxx aside: Master MDL complaints

On Wednesday, November 22, Judge Fallon issued his decision denying class certification for the Vioxx personal injury cases. That decision fits squarely in the mainstream of current class action jurisprudence in pharmaceutical product liability cases. If Baycol, Paxil, Prempro, Propulsid, and Rezulin, for example, could not be certified for classwide treatment, then it's hard to say that the result in Vioxx should have been different.

Judge Fallon does, however, enter the fray on a more obscure issue that has many litigators in multidistrict litigation proceedings scratching their heads: What is the precise effect of filing a "master complaint" in an MDL? If a product liability complaint is filed in federal court in, say, New York, and the MDL Panel then transfers the case to, say, Chicago, everyone knows the rules. The MDL transferee court (in Chicago) would apply New York choice of law rules to the New York complaint to determine the applicable law. After the MDL transferee court concluded the pretrial proceedings, the transferee court would ask the MDL Panel to remand the New York case back to a New York federal court for trial.

Suppose, however, the MDL transferee court orders the plaintiffs' steering committee to file a "master complaint" in the Chicago federal court. The master complaint has then been filed in an Illinois court, and Illinois choice of law rules should apply to determine the applicable law. Moreover, at the conclusion of pretrial proceedings, there is no longer a pending New York case. Does that mean that the case is not remanded, and the Chicago judge presides at trial? Is that really what the court had in mind when it ordered the filing of a master complaint? And can Lexecon (and its requirement of remand for trial) really be evaded so easily?

The case law on this issue is scant, and there appears to be no commentary on point. On the one hand, in In re Bridgestone/Firestone, Inc. Tires Prods. Liab. Litig., 155 F. Supp. 2d 1069, 1078 (S.D. Ind. 2001), the MDL transferee court in Indiana applied Indiana choice of law rules to pick the substantive law applicable to a master complaint filed in Indiana. On the other hand, in In re Propulsid Prods. Liab. Litig., 208 F.R.D. 133, 140-41 (E.D. La. 2002), the court applied the opposite rule, applying the choice of law rules of the court where the complaint had originally been filed, rather than Louisiana choice of law rules, to analyze a master complaint. Vioxx now joins the fray, again applying home state choice of law rules (here, New Jersey), rather than Louisiana choice of law rules, to select the substantive law governing a master complaint filed in Louisiana. See In re Vioxx Prods. Liab. Litig., MDL No. 1657, Case No. 2:05-md-01657-EEF-DEK, slip op. at 7 (E.D. La. Nov. 2, 2006).

Frankly, we could live with either rule, but it would sure be nice to know what the rule is. When plaintiffs have filed putative class actions pleading state law claims in 25 different states, the MDL Panel coordinates all of those case in one court, and there's then a single master complaint filed in the MDL transferee court in, say, Dallas, just what should we move to dismiss? The causes of action pleaded in the master complaint? Under Texas choice of law rules? Or is the master complaint a mere administrative convenience, and defendants must move to dismiss all of the causes of action pleaded in the 25 underlying complaints under the choice of law rules of 25 different states?

The confusion doesn't stop there. When the pretrial proceedings are over, where will the case (or is it "cases") be tried? In Dallas, because that's where plaintiffs filed the master complaint, so there's no need to remand the case to a different court for trial? Or are the consolidated master proceedings somehow broken up and remanded back to 25 different courts? If so, the process has subverted much of the efficiency that the MDL process was meant to engender.

As we said, we can operate in whatever procedural environment the courts choose to create (at least on this score). But it would sure be helpful if someone thought this through and devised an elegant solution, which the courts could then adopt and give clear guidance to those of us who toil in the litigation fields.

Wednesday, November 15, 2006

The Presumption Against Preemption

Preemption, of course, can be a valuable defense in pharmaceutical and medical device product liability cases. The presumption against preemption originated in “field” preemption cases. In a sentence, field preemption is the total exclusion of state regulation from a particular “field” by the nature or comprehensiveness of the federal assertion of responsibility. From there, it’s been imported into express preemption cases as sort of a canon of statutory interpretation. With one arguable exception, the presumption against preemption hasn’t been employed – by the Supreme Court, anyway – to take the edge off actual conflicts between federal and state law. That’s not to say that the Court might not extend the presumption to every form of preemption, only that it has yet to do so, and that there are good reasons for not doing so.

Foremost among the recent cases applying the presumption is Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), an express preemption case involving medical devices. In Lohr, the presumption was used as a narrowing principle of statutory construction: “[W]e use[] a presumption against the pre-emption of state police power regulations to support a narrow interpretation of such an express command.” Id. at 485 (plurality). In the express preemption context, the presumption was viewed as “consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety.” Id. Significantly, Justice Breyer, whose vote was necessary to create a majority in Lohr, relied upon conflict preemption principles in his concurrence. Id. at 507-08. Consistent with that reliance, Justice Breyer did not apply a presumption against preemption in his analysis.

The presumption asserted by the Lohr plurality originated in preemption discussions involving neither express nor conflict preemption – but rather “field” preemption. Thus, in Rice v. Santa Fe Elevator Corp., 331 U.S. 230 (1947), the Court noted, “the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id. at 230 (citations omitted). Rice held that a federal statute regulating certain warehouse fees did away with a previous “dual” system of regulation, and completely ousted state power. Id. at 234-35. Rice involved the most sweeping form of preemption – field, not conflict preemption.

The Rice assumption became a presumption in Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 715-18 (1985), and Jones v. Rath Packing Co., 430 U.S. 519, 525 (1977) (cases also cited in Lohr). Both of these cases rejected field preemption before turning to additional preemption arguments raising actual conflicts with federal regulation. Both courts invoked a “presumption” against preemption solely in their discussions of field preemption. Neither Hillsborough (an FDCA case) nor Jones referred to any “assumption” or “presumption” as somehow minimizing claimed conflicts between federal and state law. See 471 U.S. at 719-22 (finding no conflict preemption); 430 U.S. at 431-43 (finding conflict preemption). Far from being authority for extending a presumption against preemption to conflict preemption, if anything Hillsborough and Jones stand for the opposite proposition.

Lohr also relied (518 U.S. at 484-86) upon Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), which more than any other case converted the original Rice/Jones presumption against field preemption into a rule of construction for express preemption clauses. See 505 U.S. at 518 (“[W]e must construe these provisions in light of the presumption against the pre-emption of state police power regulations. This presumption reinforces the appropriateness of a narrow reading.”). As in Lohr itself, there was no implied conflict preemption issue in Cipollone (the pre-emptive scope. . .is governed entirely by the express language,” 505 U.S. at 517).

The Court also raised the presumption against preemption in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), an FDCA implied preemption case. It did so solely to hold that the presumption was inapplicable in the first instance, since its fundamental premise – a field traditionally occupied by the states – did not exist:


Policing fraud against federal agencies is hardly “a field which the States have traditionally occupied,” such as to warrant a presumption against finding federal pre-emption of a state-law cause of action. To the contrary, the relationship between a federal agency and the entity it regulates is inherently federal in character.
Id. at 347 (citation to Rice omitted). Buckman is certainly not precedent for applying the presumption against presumption to a case of actual state-federal conflict.

The application of the presumption against preemption in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), is also noteworthy. Geier was a hybrid express and implied preemption case involving product liability design defect claims. Express preemption failed because the statute had conflicting preemption and savings (anti-preemption) clauses that effectively cancelled each other out. Id. at 867-68. The demise of express preemption, however, did not affect implied preemption at all. Id. at 870. Rather the two clauses combined to create “neutral” ground upon which “ordinary” preemption principles applied:


Why, in any event, would Congress not have wanted ordinary pre-emption principles to apply where an actual conflict with a federal objective is at stake? Some such principle is needed. In its absence, state law could impose legal duties that would conflict directly with federal regulatory mandates.

Id. at 87. The Geier court thus did not mention (much less rely upon) any presumption against preemption in concluding that the tort claims in question were impliedly preempted. Id. at 882-86. The majority rejected the dissent’s position (which explicitly advocated applying the presumption against preemption to implied preemption, id. at 907-08) because the dissent “relies on cases, or portions thereof, that did not involve conflict pre-emption. And conflict pre-emption is different in that it turns on the identification of ‘actual conflict,’ and not on an express statement of pre-emptive intent.” Id. at 884 (citations, including to Hillsborough, omitted).

The analysis in Smiley v. Citibank (South Dakota), N.A., 517 U.S. 735 (1996), decided almost contemporaneously with Lohr, also merits comment. In opposing preemption, the petitioner argued that the presumption essentially trumped deference to administrative determinations under Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). 517 U.S. at 743-44. The Court rejected this argument because no question concerning the scope of the statute’s preemption provision was presented. Id. at 744 (“there is no doubt that [it] pre-empts state law”). Because scope of express preemption was not at issue, the case “d[id] not bring into play the considerations [the presumption against preemption] petitioner raises.” Id.

Doubts about the validity of a presumption against preemption in implied preemption cases are further heightened by the lack of any discussion of such a presumption in so many of the Supreme Court’s landmark implied preemption decisions. This is true of cases involving preemption of state tort suits. See International Paper Co. v. Ouellette, 479 U.S. 481 (1987) (no presumption raised to resist preemption of state nuisance law); Chicago & Northwest. Transportation Co. v. Kalo Brick & Tile Co., 450 U.S. 311 (1981) (same with respect to state negligence law). The same lack of any presumption analysis is also found in major conflict preemption cases involving state statutes or regulations. See, e.g., City of New York v. F.C.C., 486 U.S. 57 (1988); Fidelity Federal Savings & Loan Ass’n v. de la Cuesta, 458 U.S. 141 (1982); Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963).

The presumption against preemption is not even applied in all express preemption cases. In one recent decision, Engine Manufacturers Ass’n v. South Coast Air Quality Management District, 541 U.S. 246 (2004), the majority found preemption on the basis of “categorical” statutory language, and expressly declined to apply any presumption against preemption. Id. at 256.

Other Supreme Court cases invoking the presumption against preemption likewise have not applied it to implied preemption situations. These cases:

  • Like Lohr involve interpretation of the scope of express preemption clauses. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 432-33 (2005); Egelhoff v. Egelhoff, 532 U.S. 141, 515-52 (2001); De Buono v. NYSA-ILA Medical & Clinical Services Fund, 520 U.S. 806, 813 (1997); New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Insurance Co., 514 U.S. 645, 654-55 (1995); California Div. of Labor Standards Enforcement v. Dillingham Construction, 519 U.S. 316, 325 (1997); CSX Transportation, Inc. v. Easterwood, 507 U.S. 658, 668 (1993); Morales v. Trans World Airlines, Inc., 504 U.S. 374, 419-21 (1992); FMC Corp. v. Holliday, 498 U.S. 52, 62 (1990); Metropolitan Life Insurance Co. v. Massachusetts, 471 U.S. 724, 741 (1985). Cf. Pharmaceutical Research and Manufacturers v. Walsh, 538 U.S. 644, 664 (2003) (applying presumption against preemption to interpretation of scope of savings clause); Gade v. National Solid Wastes Management Ass’n, 505 U.S. 88, 98 (1992) (same).
  • Like Buckman involve fields not traditionally occupied by the states. Merrill Lynch, Pierce, Fenner & Smith, Inc. v. Dabit, 126 S. Ct. 1503, 1514-15 (2006); United States v. Locke, 529 U.S. 89, 108-09 (2000).
  • Involved the scope of Congress’ underlying delegation of preemptive power, to which no presumptions apply. New York v. F.E.R.C., 535 U.S. 1, 19-20 (2002).

In the only case in which the presumption seems to have been invoked in a pure conflict preemption case, it did not play any ascertainable part in the ultimate holding. See California v. ARC America Corp., 490 U.S. 93, 101 (1989) (mentioning presumption as something to “overcome”). ARC was an antitrust case, and the Court held that decisions interpreting federal antitrust statutes did not purport to “defin[e] the interrelationship between the federal and state antitrust laws.” Id. at 105. With neither preemptive intent nor any actual conflict in evidence, there was thus no basis for preemption of any sort. In the end there was nothing for the presumption to “overcome” – undoubtedly why it was not invoked when the Court actually analyzed the respondent’s substantive preemption arguments. Id. at 102-06.

Beyond the ARC case, the only other Supreme Court basis for applying the presumption against preemption in implied conflict preemption cases is erroneous dictum in F.E.R.C., a case that
ultimately “d[id] not involve a ‘presumption against pre-emption’” at all. 535 U.S. at 18. F.E.R.C. described the inapplicable presumption as “most often stated. . .when a controversy concerned not the scope of the Federal Government’s authority to displace state action, but rather whether a given state authority conflicts with, and thus has been displaced by, the existence of Federal Government authority.” Id. The three cases it cited, however, were
Hillsborough, which applied the presumption only as to field preemption, and not as to implied preemption; Lohr, solely an express preemption case; and Cipollone, also exclusively involving express preemption. Ironically, F.E.R.C. did not even cite ARC, the one case that arguably could have supported the Court’s dictum.

Moreover, there are sound doctrinal reasons why application of a presumption against preemption isn’t appropriate in cases of actual conflict – beyond it being virtually unprecedented. Black letter constitutional law holds that the Supremacy Clause preempts any state law conflicting with the exercise of federal power. E.g., Fidelity Federal Savings
& Loan Ass’n v. de la Cuesta
, 458 U.S. 141, 153 (1982) (“state law is nullified to the extent that it actually conflicts with federal law”). The importance of the state law is immaterial. “The relative importance to the State of its own law is not material when there is a conflict with a valid federal law, for the Framers of our Constitution provided that the federal law must prevail.” Id. (citation and quotation marks omitted). Conflict preemption thus starts and ends with the principle that federal law is supreme: “This principle was made clear by Chief Justice Marshall when he stated for the Court that any state law, however clearly within a State’s acknowledged power, which interferes with or is contrary to federal law, must yield.” Free v. Bland, 369 U.S. 663, 666 (1962) (citing Gibbons v. Ogden, 22 U.S. 1 (1824)). Once a federal-state conflict is established, preemption is “inescapable and requires no inquiry into congressional design.” Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963).

Because conflict-preemption rests upon a finding of conflict, rather than in any express statement of congressional intent to preempt, conflict preemption analysis necessarily focuses on the existence of a conflict, rather than on congressional intent. “[A] narrow focus on Congress’ intent to supersede state law is misdirected, for a pre-emptive regulation’s force does not depend on express congressional authorization to displace state law.” City of New York v. FCC, 486 U.S. 57, 64 (1988). This “correct focus” requires only determining that any particular federal action is statutorily authorized. Id. If the exercise of federal power is legitimate, then any conflict is preemptive. Id. Accord Brown v. Hotel & Restaurant Employees & Bartenders International Union Local 54, 468 U.S. 491, 501 (1984) (“[e]ven in the absence of such express language or implied congressional intent to occupy the field, we may nevertheless find state law to be displaced to the extent that it actually conflicts with federal law”). Holding that a presumption against preemption requires something more than simply a conflict with supreme federal law in order to preempt state law would fly in the face of Supreme Court precedent dating back to Gibbons v. Ogden.

MDLs in 2006

We thought it would be interesting to collect in one place the hot, new drug and device product liability litigation. These are the seven drug or device proceedings coordinated by the MDL Panel to date in 2006:

In re Celexa and Lexapro Products Liability Litigation, MDL 1736

Ø Filed 11/9/2005 and ordered to be transferred on 2/16/2006
Ø Transferee Judge and Court: Rodney W. Sippel, Eastern District of Missouri
Ø Nature of Suits: Consists of 11 pending actions against Forest Laboratories and Forest Pharmaceuticals arising from ingestion of Celexa and Lexapro, two drugs used to treat depression. Plaintiffs challenge the safety of Celexa and Lexapro and Forest’s warnings concerning possible side effects, including the alleged risk of suicide.

In re Ortho Evra Products Liability Litigation, MDL 1742

Ø Filed 11/28/2005 and ordered to be transferred on 3/1/2006
Ø Transferee Judge and Court: David A. Katz, Northern District of Ohio
Ø Nature of Suits: Consists of 13 pending actions against Johnson & Johnson and Ortho-McNeil Pharmaceutical for alleged personal injuries and economic damages of users of Ortho Evra, a contraceptive patch. Plaintiffs allege that Ortho Evra was defectively designed and that defendants misrepresented and failed to warn them of the drug’s harmful side effects, including the risk of blood clots and strokes.

In re Aredia and Zometa Products Liability Litigation, MDL 1760

Ø Filed 1/27/2006 and ordered to be transferred on 4/18/2006
Ø Transferee Judge and Court: Todd J. Campbell, Middle District of Tennessee
Ø Nature of Suits: Consists of 27 pending actions against Novartis Pharmaceuticals, Merck, Procter & Gamble Pharmaceuticals, and Aventis arising out of plaintiffs’ ingestion of Aredia and Zometa, prescription medications manufactured by Novartis and used to treat cancer and osteoporosis. Plaintiffs allege that Novartis failed to test and failed to warn users of the drugs’ alleged adverse side effects including, in particular, the risk of osteonecrosis of the jaw—jaw bone loss.

In re Human Tissue Products Liability Litigation, MDL 1763

Ø Filed 2/7/2006 and ordered to be transferred on 6/21/2006
Ø Transferee Judge and Court: William J. Martini, District of New Jersey
Ø Nature of Suits: Consists of 7 pending actions against BioMedical Tissue Services, et al., alleging a scheme by BioMedical Tissue Services to harvest tissue from human corpses without proper consent and to sell the tissue to other defendants, which are tissue processing companies. Plaintiffs allege that the tissue processing companies failed to follow procedures to determine the origin, nature, or suitability of the tissue for human transplantation, and failed to screen the tissue for disease.

In re Seroquel Products Liability Litigation, MDL 1769

Ø Filed 2/22/2006 and ordered to be transferred on 7/6/2006
Ø Transferee Judge and Court: Anne C. Conway, Middle District of Florida
Ø Nature of Suits: Consists of 59 pending actions against AstraZeneca Pharmaceuticals, the maker of Seroquel, an antipsychotic medication used to treat schizophrenia and bipolar disorder. Plaintiffs allege that AstraZeneca failed to test and to warn users of the drug’s alleged harmful side effects, including the risk of diabetes and related medical complications.

In re Bausch & Lomb Inc. Contact Lens Solution Products Liability Litigation, MDL 1785

Ø Filed 5/4/2006 and ordered to be transferred on 8/14/2006
Ø Transferee Judge and Court: David C. Norton, District of South Carolina
Ø Nature of Suits: Consists of 10 pending actions against Bausch & Lomb regarding B&L’s contact lens solution “ReNu” with “MoistureLoc,” which B&L withdrew from the market after its use was reported to be associated with fungal keratitis—a type of eye infection. Plaintiffs allege that B&L knew but failed to warn users about ReNu with MoistureLoc’s alleged adverse effects, including the risk of fungal keratitis.

In re Fosamax and Actonel Products Liability Litigation, MDL 1789

Ø Filed 5/24/2006 and ordered to be transferred on 8/16/2006
Ø Transferee Judge and Court: John F. Keenan, Southern District of New York
Ø Nature of Suits: Consists of 19 pending actions against Merck, Procter & Gamble, and Aventis arising out of users’ ingestion of Merck’s drug, Fosamax, a prescription medication used to treat osteoporosis. Plaintiffs allege that defendants knew about but failed to warn users of the drug’s alleged dangerous side effects, including the risk of osteonecrosis of the jaw—jaw bone loss.