Consumer Class Actions and Mass Torts : Class Action Lawyer & Attorney : J. Russell Jackson : Skadden Law Firm : Complex Class Actions : Consumer Class Actions & Mass Torts Law Blog

Today we have two cases that illustrate the maxim that if you have a beef with an airline, you're screwed, plain and simple, thanks to federal preemption.

In Hickcox-Huffman v. US Airways, Inc., 2011 WL 1585560 (N.D. Cal. Apr. 27, 2011), a passenger who had paid a $15 baggage fee sued the airline for the return of the fee because it lost her bag.  Naturally, this was a putative class action on behalf of all passengers who were charged such fees and their bags were lost or delayed.  Her theory was that by charging the $15, the airline assumed a duty to deliver the baggage in a timely manner.  She asserted a variety of causes of action, including breach of contract, unjust enrichment, and misrepresentation.

The airline moved to dismiss the claims as preempted by the Airline Deregulation Act of 1978, which provides that "no State . . . shall enact or enforce any law . . . relating to rates, routes, or services of any carrier."

What, then, is a service?  And does the timely conveyance of baggage fit within the definition?

The Ninth Circuit has held that although service involves the prices, schedules and other things associated with getting people and "cargo" from point A to point B, it does not include the "provision of in-flight beverages, personal assistance to passengers, the handling of luggage, and similar amenities."  Id. at *2 (quoting Duncan v. Northwest Airlines, Inc., 208 F.3d 1112, 1114-15 (9th Cir. 2000)).  Naturally, the airline said the plaintiff's bag was "cargo," while the plaintiff said it was "luggage," the handling of which is not a preempted "service."

The court looked to whether the underlying claims frustrate the goal of economic deregulation by interfering with the forces of competition:

Using this approach, this Court believes that Plaintiff's state law claims would do just that.  It is obvious that baggage fees are just one of the many fronts on which airlines are doing competitive battle.  Indeed, the baggage fees imposed (or not imposed) by each airline has become an important consideration for consumers. . . .  In these circumstances, Plaintiff's claims would impermissibly "frustrate the goal of economic deregulation by interfering with the forces of competition."

Id. at *4 (citation omitted).  Accordingly, it held that the plaintiff's claims were preempted, and US Airways could keep the $15 it charged to deliver her baggage late.

The passengers were similarly unlucky in National Federation of the Blind v. United Airlines, Inc., 2011 WL 1544524 (N.D. Cal. Apr.25, 2011).  There, blind plaintiffs brought a class action because the airline used ticketing kiosks that -- unlike Automatic Teller Machines -- use only visual prompts and fail to include an option for audio prompts for the blind.  The plaintiffs sought equitable and declaratory relief under various statutes.

Once again, the court held that the claims were preempted, this time by the Air Carrier Access Act, which prohibits discrimination against disabled people in air travel.  The Department of Transportation has specifically addressed the issue of automated kiosks, concluding that if they cannot be used by passengers with a disability, "you must provide equivalent service to the passenger (e.g., by assistance from your personnel in using the kiosk or allowing the passenger to come to the front of the line at the check-in counter)."  Id. at *3 (citation omitted).  DOT expressed its intent that the regulations have preemptive effect.

The court concluded that "[b]ecause the DOT has pervasively regulated airport kiosk accessibility, plaintiffs' claims are field preempted by the ACCA."  Id. at *4.

The court found an additional source for federal preemption in the Airline Deregulation Act that was at issue in Hickcox-Huffman.  The court concluded that the airport kiosks -- because they facilitate checking in, printing tickets, selecting seats, and other tasks related to air travel, they are a "service" that falls within the express preemption provision of the ADA.

The plaintiff argued for the "presumption against preemption" and suggested that the Federal Airline Act's savings clause -- "a remedy under this part is in addition to any other remedies provided by state law" -- augured against federal preemption.  The court disagreed:

The Airline Deregulation Act unequivocally declared that no state may enact a law related to airline service.  Congress could have drawn the preemption provision more narrowly; it did not.  The provision does not except discrimination claims from its scope.  Thus, this argument must fail.

. . .

. . . This area [of airline travel] has . . . "long been reserved for federal regulation."  The presumption against preemption, therefore, does not apply in the instant action.  Thus, neither the FAA savings clause nor the presumption against preemption undermine this order's holdings.

Id. at *7 (citations omitted).

As these two decisions -- rendered two days apart -- demonstrate, airlines have powerful preemption arguments against consumer class actions.  It remains to be seen whether the reasoning from these decisions -- especially the field preemption conclusion from National Federation of the Blind -- can be easily translated other federal regulatory schemes.

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Yesterday the SCOTUS handed down the long-awaited decision in Bruesewitz v. Wyeth LLC, No. 09-152 (U.S. Feb. 22, 2011).  In a 6-2 decision, the Court held that the National Childhood Vaccine Injury Act of 1986 preempts state law claims for design defect.  Justice Scalia wrote the majority opinion for Chief Justice Roberts and Justices Kennedy, Thomas, Breyer and Alito.  Justice Breyer wrote a concurrence.  And Justice Sotomayor wrote a dissent joined by Justice Ginsburg.  Justice Kagan took no part in the decision.

This opinion has and will have a lot of coverage, so I'm not going to give it the long-form analysis here.  I'll trust my colleagues at Drug & Device Law to do that better than I could.

But there are a few things I'd like to point out about this opinion.  First, the majority opinion is written in a very chatty style by Justice Scalia.  Second, nowhere in the majority opinion do you hear anything about the dreaded "presumption against preemption."  Grant it, this is an express preemption case.  The Vaccine Act provides that:

"No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."

Slip op. at 7.

But as Justice Sotomayor points out in her well-written dissent, there also is a savings clause:

Section 22(a) expressly provides that the "[g]eneral rule" is that "State law shall apply to a civil action brought for damages for a vaccine-related injury or death.

Sotomayor's dissent at 18.

And yet there is no discussion in the majority opinion of narrowly construing the preemption provision as a result of any presumption against preemption.

Third, the majority looks exclusively to the text of the statute to conclude that design defect claims are categorically preempted.  It does not need legislative history to make that conclusion. 

The whole question posed in Bruesewitz was what do the clauses after the "if" mean in the preemption provision.  Looking solely to the text of the statute, the majority concluded that it meant that all design defect claims are preempted and did not impose additional prerequisites to establishing that preemption.  Justice Sotomayor argued forcefully in dissent that the provision did not even mention the terms "design defect," let alone preempt it, and that the provision set up three prerequisites for preemption upon which manufacturers bear the burden of proof:  (1) that the harm was "unavoidable," (2) that the vaccine was properly prepared (i.e., had no manufacturing defects), and (3) that the vaccine bore proper directions and warnings (i.e., there was no failure to warn).  The majority rejected this approach, arguing that the "even though" clause is a "concessive subordinate clause" that clarifies and describes the word that precedes it:  "unavoidable."  Slip op. at 7-11.

Justice Sotomayor, on the other hand, argues that "the 'even though' clause requires a vaccine manufacturer in each civil action to demonstrate that its vaccine is free from manufacturing and labeling defects to fall within the liability exemption of section 22(b)(1)."  Sotomayor's dissent at 3.  She supports this by saying that the conditional term, "if," is used in two other provisions of the Vaccine Act that require an inquiry to establish preemption.  Id. at 3-4.  She concludes that "[i]t would be highly anomalous for Congress to use a conditional 'if' clause in [these sections] to require a specific inquiry in each case while using the same conditional 'if' clause in section 22(b)(1) to denote a categorical exemption from liability."  Id. at 4.

To support her argument that another prerequisite to Vaccine Act preemption is the "unavoidable" nature of the harm, Justice Sotomayor cites Committee Reports describing the principle at issue in comment k to Section 402A of the Restatement (Second) of Torts.  Justice Sotomayor argues that in 1986 -- when the Vaccine Act was drafted -- it was generally held that to receive the protection of comment k, medicines had to be proven to be "unavoidably unsafe," and that this is the concept that was written into the Vaccine Act.  Justice Scalia points out, however, that many courts treated comment k as a categorical exemption from liability for prescription medicines.  He also argues that comment k is irrelevant here, as the word "unavoidable" is not a term of art and can be read -- given its ordinary meaning -- to be generally describing side effects of prescription medical products. 

A fourth thing that struck me about Bruesewitz is the majority's clear concession that the preemption provision could have been written more clearly to preempt design defect claims, but that this fact did not matter:

Petitioners and the dissent contend that the interpretation we propose would render part of [section 22(b)(1)] superfluous:  Congress could have more tersely and more clearly preempted design defect claims by barring liability "if . . . the vaccine was properly prepared and was accompanied by proper directions and warnings."  The intervening passage ("the injury or death resulted from side effects that were unavoidable even though") is unnecessary.  True enough.  But the rule against giving a portion of text an interpretation which renders it superfluous does not prescribe that a passage which could have been more terse does not mean what it says.  The rule applies only if verbosity and prolixity can be eliminated by giving the offending passage, or the remainder of the text, a competing interpretation.  That is not the case here.

Slip op. at 12.

The fifth thing that struck me about Bruesewitz was that much of what the Court relies on to find preemption also applies in the ordinary prescription medicine context, except for the Vaccine Act's unique compensation scheme:

. . . But the lack of guidance for design defects combined with the extensive guidance for the two grounds of liability specifically mentioned in the Act strongly suggests that design defects were not mentioned because they are not a basis for liability.

The mandates contained in the Act lead to the same conclusion.  Design-defect torts, broadly speaking, have two beneficial effects:  (1) prompting the development of improved designs, and (2) providing compensation for inflicted injuries. . . .  And the Act provides many means of improving vaccine design.  It directs the Secretary of Health and Human Services to promote "the development of childhood vaccines that result in fewer and less serious adverse reactions. . . . The [National Vaccine] Program is to set priorities for federal vaccine research, and to coordinate federal vaccine safety and efficacy testing.  The Act requires vaccine manufacturers and health-care providers to report adverse side effects, and provides for monitoring of vaccine safety through a collaboration with eight managed-care organizations.  And of course whenever the FDA concludes that a vaccine is unsafe, it may revoke the license.

These provisions for federal agency improvement of vaccine design, and for federally prescribed compensation, once again suggest that [section 22(b)(1)'s] silence regarding design-defect liability was not inadvertent.  It instead reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.

Slip op. at 14-15.

Justice Breyer's concurrence goes beyond the plain language and looks to legislative history and agency interpretation to conclude that the Vaccine Act preempts design defect claims.  See Breyer's Concurrence at 7.  Like the majority opinion, the concurrence exhibits a trust of agencies and scientists -- rather than juries -- with issues of promoting the optimal design of prescription medicines.

Does Bruesewitz represent a sea change in SCOTUS preemption jurisprudence?  Probably not, although it arguably is too early to tell.  It does, however, provide a tool for addressing some of the hyperbole from earlier preemption decisions, and for that, the defense bar can be grateful.

Bruesewitz also reveals Justice Sotomayor to be a strong advocate for state tort litigation who can be expected to narrowly construe even express preemption provisions to allow state law claims.

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Who says conflict preemption is dead?  On Friday, the Third Circuit -- in an excellent opinion by Judge Anthony Scirica -- held that the Federal Communication Commission's regulations preempt claims that sales of cell phones that emit radio frequency radiation are violations of state consumer protection statutes.  The decision comes in a litigation that has ping-ponged back and forth between federal and state courts for nearly ten years.

In Farina v. Nokia Inc., No. 08-4034, Slip op. (3d Cir. Oct. 22, 2010), plaintiff sued in Pennsylvania state court on behalf of Pennsylvania purchasers and lessees of cell phones who have not been diagnosed with a physical injury resulting from cell phone usage.  Plaintiff alleged that, because they emit RF radiation, cell phones are unsafe for use without headsets.  Accordingly, the sales of such cell phones without headsets amount to civil conspiracy, breach of implied and express warranties, violation of the Magnuson-Moss Warranty Act, and violation of Pennsylvania's Unfair Trade Practices Act.

This case initially was filed in state court in 2001.  It subsequently was removed to federal court and then transferred to an MDL transferee in Baltimore.  The MDL transferee had denied a motion to remand and then granted a Rule 12 dismissal of the litigaiton.  But the Fourth Circuit subsequently reversed, finding that there was no federal question jurisdiction because the issue of preemption did not arise on the face of a well-pleaded complaint.  See Slip op. at 22.  The Farina case was remanded to Pennsylvania state court, and in 2005, plaintiff filed a Second Amended Complaint, naming new parties.  One of the new defendants removed the complaint to federal court, asserting federal jurisdiction under the newly passed Class Action Fairness Act.  On renewed motions, the trial court found that it had federal jurisdiction under CAFA, and subsequently dismissed the case based on the preemptive effect of the FCC's regulations.

The Third Circuit has just affirmed in a thoughtful opinion.  First, the court concluded that it properly had jurisdiction under CAFA because the filing of a new complaint adding new defendants commenced a new action, making CAFA -- which applied to actions commenced after its enactment -- applicable.  Slip op at 33-34. 

As for preemption, the court first confronted the defendant's argument that the so-called "presumption against preemption" should not apply to this case because the regulation of the airwaves has historically been a federal -- not state -- function.  The court rejected this argument, explaining that states have historically acted to protect health and welfare.  Slip op. at 42.  But although the court applied the "presumption against preemption," it noted that such a presumption is "'overcome where a Congressional purpose to preempt or the existence of a conflict is "clear and manifest."'"  Id. (citation omitted).

Next, the court considered and rejected the defendants' argument that plaintiff's complaint is preempted by the statute's express preemption provision:

No State or local government or instrumentality thereof may regulate the placement, construction, and modification of personal wireless service facilities on the basis of the environmental effects of radio frequency emissions to the extent that such facilities comply with the Commission's regulations concerning such emissions.

Id. at 46 (citation omitted).  Defendants argued that each mobile phone is a wireless service "facility."  The court -- reading the rest of the statute in context -- rejected this approach, holding that, instead, it means the physical infrastructure of the wireless network, not individual mobile phones.  Id. at 48.  Accordingly, there was no express preemption.

Next, the court considered the argument that Congress preempted the field of RF emission regulation, i.e., whether the federal interest is "so dominant that the federal system will be assumed to precclude enforcement of state laws on the same subject."  Id. at 54.  The court rejected this argument as well, noting that the relevant statutes contain a savings provision and thus Congress envisioned some role for state law in this field.

Finally, the court considered whether conflict preemption applied to plaintiff's claims.  The court explained that conflict preemption exists where it is impossible for a party to comply with both federal and state regulation and the state law is an obstacle to the accomplishment of the federal law's objectives.  Id. at 55.

The FCC has determined that the evidence for human harm from the levels of RF emissions inherent in mobile phone use is "ambiguous," "unproven," and "unknown," and it has stated that "any cell phone legally sold in the United States is a 'safe' phone."  Id. at 14-15.  Indeed, the FCC's regulations reflect "a 'consensus view of the federal agencies responsible for matters relating to the public safety and health.'"  Id. at 18-19.  They set maximum exposure levels, and the FCC is committed to monitoring the science to ensure human safety in the use of mobile phones.  Id.

The court recognized that plaintiff's lawsuit is a fundamental conflict with the FCC's regulations:

But although he disavows any challenge to the FCC's RF standards, that is the essence of his complaint.  The representations in the advertising and instructional literature that Farina has identified as false or misleading are warranties that the phones are 'safe to operate without the use of a headset and that they were and would be free from defects.'  In order for Farina to succeed, he necessarily must establish that cell phones abiding by the FCC's SAR guidelines are unsafe to operate without a headset.  In other words, Farina must show that these standards are inadequate--that they are insufficiently protective of public health and safety.  Whether or not Farina intends to expressly challenge the FCC standards at trial, the inescapable effect of his complaint is to do so. 

Id. at 57-58.

The court explained the reasoning behind conflict preemption:

The reason why state law conflicts with federal law in these balancing situations is plain.  When Congress charges an agency with balancing competing objectives, it intends the agency to use its reasoned judgment to weigh the relevant considerations and determine how best to prioritize between these objectives.  Allowing state law to impose a different standard permits a re-balancing of those considerations.  A state law standard that is more protective of one objective may result in a standard that is less protective of others.

Id. at 59.

After describing how the FCC has engaged in a balancing of policy objectives with respect to RF emissions, it then analyzed how plaintiff's claims would impact the choices the FCC made as a result of that balancing:

Allowing juries to impose liability on cell phone companies for claims like Farina's would conflict ith the FCC's regulations.  A jury determination that cell phones in compliance with the FCC's SAR guidelines were still unreasonably dangerous would, in essence, permit a jury to second guess the FCC's conclusion on how to balance its objectives.  Were the FCC's standards to constitute only a regulatory floor upon which state law can build, juries could rebalance the FCC's statutory objectives and inhibit the provision of quality nationwide service.  Because the intensity of RF emission levels and the strength and range of cell phone signals are positively correlated, allowing additional state law restrictions on these levels could impair the efficiency of the wireless market. . . .  As an agency engaged in rulemaking, the FCC is well positioned to solicit expert opinions and marshal the scientific data to ensure its standards both protect the public and provide for an efficient wireless network.  Allowing juries to perform their own risk-utility analysis and second-guess the FCC's conclusion would disrupt the expert balancing underlying the federal scheme.

Id. at 64-65.  The court also noted that allowing standards to vary state to state would eradicate the uniformity necessary to regulate a nationwide wireless network.  And it gave deference to the FCC's stated position in its rulemaking that its regulations preempt state law.

The court rejected plaintiff's argument that the US Supreme Court's decision in Wyeth v. Levine requires a different result.  First, it noted that there was no evidence that Congress viewed state regulation of RF emissions as a complement to federal regulation, unlike in Wyeth, where state liability laws were seen as complementing federal regulation.  Slip op. at 74.  Moreover:

We do not read Wyeth's reference to Congress's decision not to enact an express preemption provision . . . as standing for the proposition that conflict preemption should not be found absent an express preemption provision.  Such a reading would come too close to subsuming conflict preemption into express preemption analysis, and is inconsistent with the axiom that an express preemption provision does not 'bar the ordinary working of conflict preemption principles.'

Id. at 75.

Finally -- and perhaps most important -- Wyeth was not a balancing case where the agency was charged with advancing public policy by balancing conflicting objectives.  Id. at 76.  As the court noted:

The inexorable effect of allowing suits like Farina's to continue is to permit juries to second-guess the FCC's balance of its competing objectives.  The FCC is in a better position to monitor and assess the science behind RF radiation than juries in individual cases.

Id. at 84.

Judge Scirica's opinion in Farina is a strong argument for why conflict preemption still exists, even in situations where there are express preemption provisions and statutory savings clauses. 

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Thanks largely to the Hydra-headed jurisprudence that has emanated in recent years from the U.S. Supreme Court, decisions about federal preemption get harder and harder to follow.  Take, for example, In re Aurora Dairy Corp. Organic Milk Marketing and Sales Practices Litig., No. 09-2762, Slip op. (8th Cir. Sept. 15, 2010).

Aurora Dairy forced the Eighth Circuit to consider the preemptive scope of the federal laws governing organic foods, namely the Organic Foods Production Act of 1990 ("OFPA"), 7 U.S.C. sec. 6501 et seq., and its implementing regulations, the National Organic Program ("NOP"), 7 C.F.R. pt. 205.  OFPA sets national standards for the sale and labeling of organically-produced agricultural products, and provides for the accreditation of certification agents who inspect producers and can make recommendations to the US Department of Agriculture about the producers' certification.

Aurora Dairy is a certified organic milk producer that sold its own "High Meadow" brand and also packaged house brands of organic milk for Wal-Mart, Target, Costco, Safeway, and Wild Oats Markets.  At all times, Aurora was a certified organic producer, having been inspected and certified by QAI, Inc.  In early 2007, however, the USDA proposed revoking Aurora's certification as an organic producer because of fourteen alleged violations, including using nonorganic cows to produce organic milk, failure to notify its certifying agent of certain facts, and failing to report and keep records as required by statute and regulation.  In August 2007, Aurora entered into a consent agreement with the USDA requiring it to take a number of remedial actions, including removing non-organic cows from its herds, reducing the size of its herds, and removing the certification of one of its facilities. 

This sparked a flood of nineteen class actions filed around the country, which were consolidated for pretrial purposes into an MDL in the Eastern District of Missouri.  The district court ordered the plaintiffs to file a consolidated complaint.  The defendants moved to dismiss, and the district court granted the motion, finding that the state law causes of action -- including alleged violations of state consumer protection statutes -- were preempted by OFPA.  Specifically, the district court held that both field preemption and conflict preemption applied to preempt plaintiffs' state law claims.

The Eighth Circuit reversed, in large part.  Its preemption analysis ultimately is as confusing as it is instructive.  The court began by applying the "presumption against preemption" recently resurrected in Altria Group, Inc. v. Good, 129 S. Ct. 538, 543 (2008).  (This, even though the OFPA statute itself has an express preemption provision, evincing that Congress clearly intended some form of preemptive effect.)  The court then looked to the statute's express preemption provision, concluding that although it expressly preempted state certification laws, it did not preempt state common law or statutory claims by private litigants.  Moreover, the court concluded that the fact that Congress included a narrow preemption provision should generally weigh against finding any implied preemption.  Slip op. at 20.

The trial court had held that OFPA preempted the entire field of certification, labeling and marketing of organic agriculture, likening OFPA's broad scope to that of the Occupational Health and Safety Act of 1970.  The Eighth Circuit, however, rejected this analysis, finding that OFPA's scope was not nearly as comprehensive as OSHA's.  Thus, field preemption did not apply, either.

The Eighth Circuit then analyzed whether conflict preemption applied.  It observed that Congress had intended to "replace the patchwork of existing state regulations with a national standard for defining organic food" and reasoned that "State law that poses an obstacle to the establishment of the national standard should therefore be preempted."  Id. at 23.  The court held that state consumer protection suits against QAI, which was the certifying inspector for Aurora, would directly interfere with and contradict the federal laws governing how QAI was to do its job, so conflict preemption required dismissal of the suits against QAI.  Id. at 24-25 ("it would be impossible, on the one hand, for QAI to comply with the OFPA and its regulations, which detail the process for revoking certifications, and, on the other hand, to comply with any additional state law duty and process to revoke certifications").

The Eighth Circuit also held that the claims against Aurora and the retailers that amounted to imposing liability on them for selling product as certified organic that was not, in fact, organic (or did not comply with federal regulations) was preempted under conflict preemption principles:

Aurora maintained its certification at all times relevant to this appeal.  Therefore, any attempt to hold Aurora or the retailers liable under state law based upon its products supposedly not being organic directly conflicts with the role of the certifying agent . . .  To the extent the class plaintiffs, relying on state consumer protection or tort law, seek to set aside Aurora's certification, or seek damages from any party for Aurora's milk being labeled as organic in accordance with the certification, we hold that state tort law conflicts with federal law and should be preempted.  

Id. at 27-28.

But the Eighth Circuit held that conflict preemption did not require the dismissal of state law claims against Aurora or the retailers based on the so-called "facts" underlying the organic certification.  Id. at 30.  Thus, the court held that the following would state a cause of action that would not be preempted:

"misrepresenting the manner in which its dairy cows were raised and fed," and "suppressing or omitting material facts regarding the production of its 'organic' milk or milk products, specifically that . . . the dairy cows were not raised at pasture."

Id. at 32.  Accordingly, the court remanded the case to the district court to determine what claims survived against Aurora and the retailers.

To me, this is a distinction without a difference.  If you can be held liable for not "disclosing" that your cows were raised in a barn -- rather than in a field, as the organic laws apparently require -- then it's the same exact thing as being liable for marketing a certified organic product that is out of compliance with the federal laws (which claim the court held would be preempted).

I continue to hope for a day when there is a synthesized preemption jurisprudence that courts (and laywers like me) can easily apply.

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Today there is no joy in Mudville, folks.  Mighty Preemption has struck out and is on the injured players list for the foreseeable future.  See Wyeth v. Levine, No. 06-1249 (U.S. March 4, 2009).

This happened in a game where the facts seemed to weigh heavily in Preemption's favor.  The FDA had known about the risk of gangrene resulting from IV push of Phenergan for more than 40 years.  It had, over time, approved separate revisions to the medicine's label so that -- by the time the physician's assistant decided to give Ms. Levine an IV push of Phenergan at one of the riskiest of all vein sites and ignore the shooting and burning pain described in the label -- there were six separate places in the labeling that addressed the risk of harm that Ms. Levine experienced.  The FDA continued to allow doctors to choose IV push as a last-resort form of Phenergan administration even after the labeling had been studied by an advisory panel.  The label even provided in bold, all-caps type:  "INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY."  Levine, slip op., dissent at 15-16 (Alito, J., dissenting).

And at the trial, plaintiffs' counsel had clearly set up the state law conflict, declaring that the label should say "Do not use this drug intravenously."  Wyeth, slip op., dissent at 2 (Alito, J., dissenting).  Panels of preemption Poo Bahs predicted that this was a case where implied conflict preemption would be found, but its parameters very, very narrowly defined.

So much for the academics.  As we all now know, the court -- in an opinion written by Justice Stevens -- held that there was no implied conflict preemption.  Mark Herrmann and Jim Beck have a good discussion of the court's basic holding here.

I want to focus in this post on three aspects of the opinion.

The first aspect is the "presumption against preemption."  This "presumption" is a canard that generally has been trotted out only when the Court is going to find against preemption.  Moreover, Levine and this term's decision in Altria Group, Inc. v. Good, 129 S. Ct. 538 (2008) represent a complete turnaround on this presumption and a stunning reversal of position for Justice Stevens.  Justice Thomas's dissent in Good lays out well how the court's reliance on the "presumption against preemption" had waned in the express preemption context.  Good, 129 S. Ct. at 555-58 (Thomas, J., dissenting). 

But the presumption also had been expressly rejected by the Court in the implied conflicts preemption context.  To begin with, in Freightliner Corp. v. Myrick, 514 U.S. 280, 287-88 (1995), the Court expressly rejected the argument that implied preemption cannot exist where there is an express preemption provision.  Then, in Geier v. American Honda Motor Co., 529 U.S. 861, (2000), Justice Breyer wrote a majority opinion that expressly rejected Justice Stevens's call in the dissent for the use of a presumption against preemption in analyzing implied preemption. 

In Geier, the Court was faced with a statute that not only had an express preemption provision, but also a savings clause that preserved state law causes of action that were not preempted.  Nevertheless, the Court held that implied conflict preemption still could apply where a state law directly conflicted with a federal regulation:

Neither do we believe that the pre-emption provision, the saving provision, or both together, create some kind of "special burden" beyond that inherent in ordinary pre-emption principles--which "special burden" would specially disfavor pre-emption here.  The two provisions, read together, reflect a neutral policy, not a specially favorable or unfavorable policy, toward the application of ordinary conflict pre-emption principles.

Id. at 870-71 (citations omitted).

Taking Justice Stevens to task, the Court refused to impose the presumption against preemption that he advocated in the dissent:

Nothing in the statute suggests Congress wanted to complicate the ordinary experience-proved principles of conflict pre-emption with an added "special burden."  Indeed, the dissent's willingness to impose a "special burden" here stems ultimately from its view that "frustration-of-purpos[e]" conflict pre-emption is a free-wheeling, "inadequately considered" doctrine that might well be "eliminate[d]."  In a word, ordinary pre-emption principles, grounded in longstanding precedent, apply.  We would not further complicate the law with complex new doctrine.

Id. at 874 (citations omitted).

Even as recently as 2001 the Court reiterated its commitment to ordinary conflict preemption principles.  See Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 353 (2001) ("our ordinary pre-emption principles apply" even in the face of the Medical Device Amendments' express preemption provision).

And yet in Levine, Justice Stevens -- who for years had been dissenting from preemption decisions for their failure to employ a special "presumption against preemption" -- suddenly was able to assemble a majority willing to sign on to a presumption against preemption (Levine, slip op. at 8) and bolster it with reliance on the statute's express preemption provision (id. at 10-11, 18).

As I have commented in previous posts, the "presumption against preemption" can be a troubling substitute for actual analysis of the conflicts preemption arguments, and since its articulation in Good last December, it already is being applied in a variety of contexts outside of drugs and medical devices to deny motions based on federal preemption.  Justice Stevens's use of the presumption in Levine undoubtedly will further impede the effectiveness of conflict preemption arguments far beyond the drug and medical device arena.  Defendants arguing preemption must use the language of Geier to focus the courts on the "ordinary" principles of conflicts preemption if they are to have any hope of receiving a thoughtful analysis of the issue.

The second aspect I'd like to focus on is the striking lack of deference to the relevant agency here.  NYU Professor Catherine Sharkey has pointed out on numerous occasions that for the most part, the result in the Supreme Court's preemption cases follows what the relevant federal agency has advocated.  In fact, Professor Sharkey has articulated her own approach to preemption called the "agency reference model" that would facilitate input from federal agencies on preemption questions. 

Given the Supreme Court's general deference to agency viewpoints in preemption cases, Levine is all the more remarkable for its utter rejection of the FDA's explanation as to how the state law cause of action conflicts with the FDA's labeling determination.  Levine, slip op., dissent at 22 (Alito, J., dissenting).  It is, of course, understandable that the Court may have had some skepticism of the FDA's "preemption preamble" and the manner in which it was enacted.  Id., slip op. at 20-23.  And the Court noted that the agency's position appeared to have changed over time.  Yet, to refuse even to consider the arguments made in the FDA's amicus brief or accord them any deference (id. at 24, n.13) seems unprecedented.

The third aspect I'd like to focus on are the three stratagems that underlie the opinion and may be the basis for distinguishing it in future cases. 

Stratagem #1:  The jury verdict established only that the warning was insufficient and did not require contraindicating IV administration.  Horse feathers.  The labeling addressed the problems with IV administration in six places.  The only way that the labeling could have been stronger was to completely contraindicate IV administration of the medicine -- a method of administration the FDA clearly chose to allow.  The dissent makes it clear that contraindication is exactly what the plaintiff's lawyer argued for at trial.  And yet the only way Justice Stevens could cobble together a majority was to engage in the artifice that the jury verdict was about the strength of the warning.  In future lawsuits where the defendant is able to show a direct conflict between the state law claim and the federal regulation, Levine will be distinguishable on this ground.

Stratagem #2:  The "Change Being Effected" Rule gave defendant the authority to change its label without FDA approval.  The majority clings to the notion that the CBE Rule gave Wyeth actual discretion to do something with its label other than what the FDA had approved.  That conclusion seems obviously false, and the subsequent curative regulations make that plain.  Indeed, the Court stretches so far as to say that Wyeth could have unilaterally changed its label from what the FDA previously approved not just upon new evidence, but upon merely a new interpretation the company might have of old evidence the FDA was aware of.  This argument, of course, effectively makes FDA approval of labeling meaningless. 

Levine is patently distinguishable because of this stratagem; if the statutory scheme at issue in future cases does not give the defendant discretion to make changes, then a true conflict between the state law and the federal rule is more likely to exist. 

Stratagem #3:  The FDA made no determination regarding the IV-push method of administering Phenergan.  This argument came in various forms.  The Court repeated a trial court finding that there was no evidence the FDA gave more than passing attention to IV-push administration.  Id., slip op. at 16.  Elsewhere, the Court distinguished Geier by observing that the FDA had not issued a formal regulation with notice and comment.  The dissent does a fine job of demonstrating the careful consideration FDA gave to IV administration over the years.  And the dissent makes it plain that an agency's decision does not have to be manifested in a regulation adopted after notice and comment to have the force and effect of federal law.  But this much is plain:  in future cases asserting preemption, if there is an actual agency regulation at issue (as opposed to an individual determination), Levine is easily distinguishable.

One final note regarding the concurring opinions in Levine.  It seems clear that Justice Breyer remains open to the possibility that a federal agency may set a standard that is both a "ceiling as well as a floor."  He merely would require that the agency be very explicit about doing so. 

Justice Thomas, however, seems to have thrown in the towel on implied conflict preemption as articulated in Geier, at least as it relates to those instances in which compliance with the federal and state standards may be technically possible, but the state standard stands as an obstacle to the achievement of the federal purposes:

This Court's entire body of "purposes and objectives" pre-emption jurisprudence is inherently flawed.  The cases improperly rely on legislative history, broad atextual notions of congressional purpose, and even congressional inaction in order to pre-empt state law.  I, therefore, cannot join the majority's analysis of this claim, or its reaffirmation of the Court's "purposes and objectives" jurisprudence.

Levine, slip op., Thomas concurrence at 13 (Thomas, J., concurring in the judgment); see also id. at 16-21.

  Justice Thomas also remains a formalist; it matters greatly to him exactly how the federal law with purported preemptive effect was made:

The Supremacy Clause thus requires that pre-emptive effect be given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text that was produced through the constitutionally required bicameral and presentment procedures.

 Id. at 5; see also id. at 22-23.

In sum, the result in Levine is profoundly disappointing from a defense perspective.  A pharmaceutical company was held liable for a side-effect that the medical community and the FDA had been aware of for decades and was warned about six times in an FDA-approved label.  Nevertheless, despite Levine, defendants in a variety of regulatory schemes still have a number of compelling arguments in favor of implied conflict preemption; they must simply pay attention to how Levine was decided and do their best to articulate their conflict preemption arguments in ways that make Levine easily distinguishable.

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