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

Food companies increasingly are being hit with claims about their labeling.  "You may have included this particular ingredient on your label, and you may have accurately reported how much of it is in your product," plaintiffs' counsel seem to be saying, "but we want you to pay us huge sums of money because you didn't tell us where the ingredient came from."  Diplomatically speaking, such claims are horse puckey.

That's why it's fitting that Judge Posner's recent decision affirming dismissal of such a claim came in a suit about fiber.  See Turek v. General Mills, Inc., No. 10-3267, Slip op. (7th Cir. October 17, 2011).  In Turek, plaintiff sued the makers of certain brands of "chewy bars," including Kellogg's chocolate-chip chewy bar called "Fiber Plus."  The Nutrition Facts on the package discloses that a serving contains 9 grams of dietary fiber, and that this is 35% of a person's Daily Value of dietary fiber.  The front of the package touts, "35% of your daily fiber."  

The fiber in these chocolate chip chewy bars is inulin that has been extracted from chicory root.  In fact, it's listed that way in the ingredients right on the Nutrition Facts on the label.  Plaintiff claimed that such fiber is somehow inferior to the unprocessed fiber found in bananas, onions, leeks, Jerusalem artichokes and other veggies.  She alleged that it causes some people to have stomach problems and can be harmful to women who are pregnant or breast feeding.  And thus plaintiff sued under the Illinois Consumer Fraud and Deceptive Practices Act, alleging that the Act is violated and consumers are defrauded by the defendants' failure to disclose that the inulin is not "natural," but instead is processed.

The trial court had dismissed the case for lack of federal subject matter jurisdiction, based on its conclusion that the claims were preempted by the federal Nutrition Labeling and Education Act. 

Judge Posner, writing for a unanimous panel of the Seventh Circuit, said the trial court had gotten it only partially wrong.  Yes, the claim was preempted, but the disposition should have been a dismissal on the merits under Rule 12(b)(6), rather than a dismissal for lack of jurisdiction.

The NLEA disclaims any intent to occupy the field of food product labeling.  Nevertheless, it does preempt state law claims by prohibiting states from imposing any requirement respecting a food label that is not identical to the requirement of section 343(r) of the Food, Drug, and Cosmetic Act.  Thus, a state may impose penalties for violating a federal requirement under section 343(r), but it cannot require anything different than federal law.  Slip op. at 5.  As Judge Posner explained,

It is easy to see why Congress would not want to allow states to impose disclosure requirements of their own on packaged food products, most of which are sold nationwide.  Manufacturers might have to print 50 different labels, driving consumers who buy food products in more than one state crazy.

Slip op. at 6.

The court then looked at federal regulations governing labeling regarding fiber.  They require disclosure of the amount of dietary fiber contained in each serving size, but do not require any statement regarding whether it is "natural" or processed.  Accordingly, plaintiff's claims are preempted because they would require different labeling than the federal law.  Judge Posner conceded that the disclaimers plaintiff proposed might be consistent with the federal regulatory scheme, but "consistency is not the test; it identity is."  Slip op. at 7-8.  Because the state law claim imposed requirements that were not identical to federal law, the state law claim was preempted.

Judge Posner also noted that even if plaintiff's claim had not been preempted, it would have been subject to dismissal under Illinois law because ICFA has a safe harbor provision for actions that are specifically authorized by a regulatory body or federal or state law.  Because "[t]he representations on the packaging of the defendants' chewy bars concerning dietary fiber are specifically authorized by the federal statutes and regulations that we've discussed," there could be no consumer fraud claim brought under ICFA.  Slip op. at 8.

Judge Posner's decision in Turek -- dumping the putative fiber class -- makes tremendous sense.  It remains to be seen, however, whether it will have the effect of flushing similar cases against food companies from the system.

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In the wacky world that is Supreme Court preemption jurisprudence, I always liked Geier v. American Honda Motor Co., 529 U.S. 861 (2000).  It was the decision holding that one could have implied conflict preemption, even in the face a savings clause.  In Geier, the Department of Transportation had, in federal motor vehicle safety standard 208, preserved the ability of a manufacturer to choose whether to have seatbelts or airbags (or both).  Geier held that a state common law claim that effectively removed that choice conflicted with the federal standard and thus was preempted.

So today, along comes Williamson v. Mazda Motor of America, Inc., 562 U.S. ___ (2011).  It, too, involved manufacturer choice under a subsequent version of FMVSS 208, which left it to the manufacturer to decide whether to have merely lap belts or lap-and-shoulder belts for rear inner seats (i.e., seats that are not by the door).  In a decision written by Justice Breyer, the Court held that, as in Geier, the express preemption provision prohibiting conflicting state safety standards did not preempt state common law claims.  Slip op. at 4.  It also held that, as in Geier, the presence of a savings clause ("compliance with" a federal safety standard "does not exempt any person from any liability under common law") did not necessarily preclude a finding of conflict preemption.  Id.  The issue, according to the Court, thus was "whether, in fact, the state tort action conflicts with the federal regulation."  Slip op. at 5.

On this question, however, virtually the entire court differed with Geier.  The Williamson majority found that preserving the choice between a lap belt and a lap-and-shoulder restraint was not a major policy of the DOT.  It posited that the reason why FMVSS 208 gave the manfuacturer a choice was not to promote safety or the future development safety data; rather, it was simple economics and convenience:

We turn now to the present case.  Like the regulation in Geier, the regulation here leaves the manufacturer with a choice.  And, like the tort suit in Geier, the tort suit here would restrict that choice.  But unlike Geier, we do not believe here that choice is a significant regulatory objective.

. . .

. . .  But [DOT's] 1989 reasons for retaining that choice [in rear seat restraints] differed considerably from its 1984 reasons for permitting manufacturers choice in respect to airbags.  DOT here was not concerned about consumer acceptance; it was convinced that lap-and-shoulder belts would increase safety; it did not fear additional safety risks arising from use of those belts; it had no interest in assuring a mix of devices; and, though it was concerned about additional costs, that concern was diminishing.

Slip op. at 8.  The court concluded that although DOT had determined that it would be more expensive for manufacturers to include lap-and-shoulder seatbelts in the rear middle seats of their cars, the fact that DOT still allowed manufacturers to make the cheaper choice of lap belts did not mean that Congress had sought to preclude compensatory suits at common law.  Simply put, according to the Court, there was no important governent policy being advanced that a state common law suit could conflict with.

Just a few interesting asides.  First, this is a Breyer opinion.  He clearly gives deference to the agency's position, which agreed with the plaintiffs.  He also cites the legislative history.

Second, the majority opinion does not wield the "presumption against preemption" as justification for its position. 

Third, Justice Sotomayor's concurrence, like her dissenting opinion yesterday in Bruesewitz, relies heavily on the savings clause to narrow the possible scope of preemption:

Geier does not stand . . . for the proposition that any time an agency gives manufacturers a choice between two or more options, a tort suit that imposes liability on the basis of one of the options is an obstacle to the achievement of a federal regulatory objective and may be preempted. . . .  [C]ourts should only find preemption where evidence exists than an agency has a regulatory objective . . . whose achievement depends on manufacturers having a choice between options.  A link between a regulatory objective and the need for manufacturer choice to achieve that objective is the lynchpin of implied preemption when there is a savings clause.

Sotomayor's Concurrence at 2.

Fourth, Justice Thomas stakes out his position that the Savings Clause answers the question definitively and Geier thus was wrongly decided:

. . . Read independently of the express preemption clause, the saving clause simply means what it says:  FMVSS 208 does not preempt state common-law actions.

. . .

Purposes-and-objectives preemption -- which by design roams beyond statutory or regulatory text -- is thus wholly illegitimate.  It instructs courts to preempt state laws based on judges' "conceptions of a policy which Congress has not expressed and which is not plainly to be inferred from the legislation which it has enacted." . . .

. . .

The dispositive difference between this case and Geier -- indeed, the only difference -- is the majority's "psychoanalysis" of the regulators.

Thomas's concurrence in the judgment at 4-5 (citations omitted).

Fifth, we still do not know what position Justice Kagan might take on these issues.  Once again, she sat this one out.

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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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