The topic of preemption comes up regularly in our posts, because it is such an important issue in products liability litigation.  As you can imagine, most of the cases come out of the drug context – the design, manufacture, and labeling of prescription drugs, so heavily regulated and controlled by the Food and Drug Administration, makes the drug industry a perfect forum to litigate preemption issues in products cases.

Recently, the U.S. District Court for the District of South Carolina heard a case in which the primary issue was preemption.  In Fisher v. Pelstring, et al., No. 4:09-cv-00252, 2011 WL 4552464 (D.S.C. Sept. 30, 2011), the court considered the case of William Fisher, who was diagnosed with a neurological condition after taking the generic version of a prescription drug used to treat acid reflux that was manufactured by a company called PLIVA.  Mr. Fisher and his wife brought medical malpractice causes of action against the doctor who prescribed the drug, as well as products liability causes of action against Pliva and two makers of the prescription brand of the drug, including strict liability, breach of express warranty, negligent misrepresentation, breach of undertaking special duty, fraud and misrepresentation, and constructive fraud.

There is something very important to note about the labeling of prescription drugs versus the labeling of generic drugs, as the court noted in its decision.  Brand name manufacturers are responsible for “the accuracy and adequacy of [a drug’s] label,” meaning that they must go through the expensive and lengthy process of getting FDA approval for its label.  Generic manufacturers, on the other hand, are only responsible for making sure that the label they use is the same as the one used for the brand-name drug.

The plaintiffs argued that PLIVA failed to adequately warn consumers of the risk of neurological disease on its label, and that such a failure constituted a violation of state products liability laws.  Now, while the Fisher case was moving along, the U.S. Supreme Court was considering the case of PLIVA, Inc. v. Mensing, —U.S.—, 131 S. Ct. 2567 (2011).  In Mensing, the Court sided with PLIVA, which argued that if it were to unilaterally change its label to comply with state law as the plaintiffs in that case argued, it would violate federal law as prescribed by the FDA.

Good news for PLIVA in the Fisher case, right?  Well, it would have been, except for the fact that the plaintiffs were able to show that PLIVA’s generic label did not comply with the label on the brand name drug, and that the correct label would have warned the consumer to limit use of the drug to 12 weeks.  As the court noted, “[o]nce the FDA approved the addition of these warnings to the [brand-name] label, PLIVA has not indicated that any federal law prevented PLIVA from also adding these warnings to its generic . . . products.”

Based on this fact, the district court denied PLIVA’s motion to dismiss based on preemption.  The court did, however, base its decision to grant summary judgment for PLIVA on several causes of action on preemption analysis, including the causes of action for design defect, breach of express warranty, negligent misrepresentation, breach of undertaking a special duty, fraud and misrepresentation, and constructive fraud.

Plaintiff’s counsel and defense counsel are equally guilty of the well-known and respected legal strategy called “throw everything against the wall and see if something sticks” strategy.  It starts with the complaint when Plaintiff’s counsel pleads every cause of action under the sun.  It is perpetuated when defense counsel pleads every affirmative defense in the known universe (including our favorite, laches).  Both are hoping, sometimes beyond hope, that when the issues are finally clarified, and both sides begin to determine what the case is actually about, they will have pled correctly.

Sometimes, though, it doesn’t work out that way.  In Haynes v. Cyberonics, Inc., No. 1:09-CV-2700-JEC, 2011 WL 3903238 (N.D. Ga. Sept. 6, 2011), Plaintiff Cloys Haynes sued the manufacturer of a device called a Vagal Nerve Stimulator, which had been implanted in his neck to control epileptic seizures.  He claimed that a few months after the device was implanted, he suffered various symptoms, including feelings of electric shock and tingling.  He also alleged that he suffered permanent left side neurological damage and chronic pain in parts of his body, including his throat and ear.  Ultimately, Plaintiff underwent surgery to remove the original device and replace it with a new, identical device. Problem for Plaintiff:  During the surgery to replace the device, a diagnostic test was performed on the original nerve stimulator. It was found to be normal.  No other testing was done.

Plaintiff’s original causes of action included strict liability, negligence, breach of warranty, punitive damages, and loss of consortium. Plaintiff later amended the Complaint to add a negligent manufacturing defect claim. He also sought attorneys fees for his troubles.

Just prior to the expiration of the discovery deadline, Plaintiff moved to have the case dismissed without prejudice.  Not surprisingly, the defendant opposed the motion and filed a motion for summary judgment, as well.  It also subsequently filed a motion to allow for supplemental briefing based on new preemption law in the 11th Circuit.  That motion was granted by the Court.

The Defendant based its summary judgment motion on the doctrine of preemption and asserted that all of Plaintiff’s causes of action failed in the face of this super-defense.  We’ve blogged about this defense before.  It’s awesome.  As the Court in this case noted, “[u]nder the doctrine of federal preemption, state laws that conflict with federal law are ‘without effect.'”  The Court also provided a very nice articulation of the test used in such cases:

In Riegel v. Medtronic, Inc., the Supreme Court determined that this express preemption clause will bar common law claims arising from injuries caused by FDA-approved medical devices in many circumstances. Tracking the language of the statute, Riegel set forth a two-pronged test for deciding whether state claims are preempted. First the district court must determine whether the federal Government has established requirements applicable to the device. If so, the court must then determine whether the plaintiff’s common-law claims are based upon state law requirements (1) that are “different from, or in addition to” the federal ones and (2) “that relate to safety and effectiveness.”

Last month’s Mwesigwa v. DAP, Inc., —F.3d—, 2011 WL 1584760 (8th Cir., April 28, 2011) [PDF] centered around the warnings on a can of DAP Weldwood Gel Formula Contact Cement. The cement is a construction adhesive, and the can looks harmless enough:The warnings on the can, however, tell a different story and were cited extensively by the Court, which described the instructions as follows:

“WARNING! FLAMMABLE! VAPORS HARMFUL AND MAY CAUSE FLASH FIRE” and “BEFORE USE TURN OFF MAIN GAS VALVE.” The lid further instructs the user to keep the product away from heat, electrical sparks, and flame; to shut off pilot lights; to refrain from smoking; to prevent buildup of vapors by opening windows and doors; and to shut off stoves, heaters, and appliances. In addition, the lid depicts an open can with vapors emanating toward a cigarette labeled “smoking,” a gas valve labeled “gas,” a flame labeled “flame/heat,” and electrical volts labeled
“electricity/sparks.” Each of the four pictures contain a bold red line crossed through the black-and-white image.The can further includes “Precautionary measures for use, handling, storage and disposal”:Use in a well ventilated area. Provide fresh air such that chemical odors cannot be detected during use and while drying. Vapors are heavier than air and will collect in low areas. Check all low areas (basements, sumps, etc.) for vapor before entering. Vapor may ignite explosively. Keep away from heat, sparks, and flames. Do not smoke. Extinguish all flames and pilot lights. Turn off stoves, heaters, electric motors and other sources of ignition during use and until all vapor is gone. Keep container closed when not in use. Do not reuse the empty container. Do not use in areas where static electric sparks may be generated. Empty container may contain explosive vapors. Do not weld, cut or torch on or near this container. Store away from oxidizers and caustics. Wear gloves. Avoid skin contact. Wear eye protection with side shields.

The can also included the following warnings: “DANGER! FLAMMABLE LIQUID AND VAPOR HARMFUL OR FATAL IF SWALLOWED,” “VAPOR HARMFUL,” “BEFORE USE TURN OFF MAIN GAS VALVE,” “VAPORS CAN TRAVEL ALONG FLOOR TO ANY SOURCE OF HEAT, SPARK OR FLAME IN NEXT ROOM OR BASEMENT .”

Obviously, when not handled properly, this product can have grave consequences. The plaintiff’s decedent in this case unfortunately learned this fact first-hand. He purchased a can to install new baseboards in his house, and accidentally spilled some of it in his laundry room. When he went to wipe it up, the vapors ignited and caused a flash fire. Mr. Mwesigwa suffered extensive burns and died because of his injuries. His widow and children sued the manufacturer, DAP, for (1) wrongful death on theories of negligence, strict liability, and failure to warn; (2) for negligent misrepresentation; and (3) for violations of the Consumer Product Safety Act. The district court granted summary judgment in favor of DAP. The plaintiffs appealed the summary judgment on the wrongful death failure to warn claims.

The Court did a nice job summarizing its findings in this way: “The label complies with the FHSA because the principal hazard to be avoided is flammability, and the way to avoid that hazard is to remove all potential ignition sources.” Because the extensive labeling on the can of DAP complied with those requirements, summary judgment was affirmed as to the failure to warn claims.

Today, Abnormal Use continues its series, “Abnormal Interviews,” in which this site will conduct interviews with law professors, practitioners, and other commentators in the field. For the latest installment, we turn to New York University law professor Catherine Sharkey, who has dedicated a great amount of study to federal preemption. With the U.S. Supreme Court recent preemption jurisprudence, we thought the best person to interview was Professor Sharkey, who was kind enough to give us her thoughts on those new cases. The interview, beginning with a preliminary summary of the opinions authored by Professor Sharkey, is as follows:

The last full week of February was a big week for federal preemption at the U.S. Supreme Court. On Tuesday of that week, the Court handed down Bruesewitz v. Wyeth, a 6-2 pro-preemption decision holding that the National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. And the next day, on Wednesday, the Court followed with Williamson v. Mazda Motor of America, Inc., an 8-0 anti-preemption decision holding that the National Traffic and Motor Vehicle Safety Act of 1966 and Federal Motor Vehicle Safety Standard 208, which gave manufacturers a choice of installing either lap belts or lap-and-shoulder belts on rear inner seats of passenger vehicles, do not preempt state tort lawsuits premised on the manufacturer’s failure to install lap-and-shoulder belts.

1. Were the results in these cases a surprise to you?

No, I predicted both the pro-preemption result in Bruesewitz and the anti-preemption result in Williamson. This Supreme Court tends to interpret express preemption provisions, such as the one at issue in Bruesewitz, broadly, whereas the Court has narrowed the scope of implied preemption, as was at issue in Williamson. However, the Court’s 8-0 line-up in Williamson came as a complete surprise. Not only do the Court’s implied preemption cases tend to be hotly contested (such as the 6-3 decision in 2009 in Wyeth v. Levine, the case holding that FDA approval of a pharmaceutical drug did not preempt state tort lawsuits), but Chief Justice Roberts and Justices Scalia and Alito (dissenters in the Levine case) had signaled their embrace of a broad interpretation of implied preemption, at least in highly regulated areas such as pharmaceuticals (and by extension, automobiles). One might have reasonably predicted these three to have dissented in Williamson. (In hindsight, a key difference may be the presence of an express savings clause in the Motor Vehicle Safety Act, which is absent in the Food Drug and Cosmetic Act).

2. In a previous 2000 case, Geier v. American Honda Motor Co., the Court held that the very same statute and federal regulation at issue in Williamson did preempt a state tort lawsuit that would effectively remove a manufacturer option, in that case airbags as opposed to other passive restraints. Can Williamson be reconciled with Geier?

Justice Breyer wrote the majority opinions in both Geier and Williamson (although Geier divided the Court 5 to 4). There are some striking similarities between the two cases. First, the same statute and federal regulation were at issue. Second, the federal regulation provided manufacturers with options in each case: the choice to install airbags or other restraints in Geier; the choice to install a lap or lap-and-shoulder belt in Williamson. And, in each, plaintiffs brought a state tort lawsuit premised on the manufacturer’s failure to install a particular option: airbags in Geier and lap-and-shoulder belt in Williamson. Justice Breyer in fact conceded “the history of the regulation before us [in Williamson] resembles the history or airbags to some degree.” So, what was different? According to Justice Breyer, “unlike Geier, we do not believe here that choice is a significant regulatory objective.” He based this conclusion on “the agency’s contemporaneous explanation, and its consistently held interpretive views.” The majority, in other words, interrogated the reasons behind the agency action to probe whether providing manufacturers with options was a “significant regulatory objective.”

Justice Thomas, however, was not convinced. Not mincing words, he charged: “That the Court in Geier reached an opposite conclusion reveals the utterly unconstrained nature of purposes-and-objectives pre–emption.”

3. Going forward, how might courts discern whether a particular federal regulation embodies a “significant regulatory objective” that conflicts with a state tort lawsuit?

Following Williamson, courts will closely examine the federal regulation, including its history, the promulgating agency’s contemporaneous explanation of its objectives, and the agency’s current views of the regulation’s preemptive effect.

Here, again, Justice Thomas was highly skeptical. He dismisses the majority’s approach as resting, at its core, on some form of “‘psychoanalysis’ of the regulators.” And he notes with chagrin that courts must henceforth “sift[] through the Federal Register, examin[e] agency ruminations, and ask[] the Government what it currently thinks.”

4. What about the presumption against preemption?

Surprisingly, the presumption was never discussed in Williamson and it surfaced only in a single footnote of Justice Sotomayor’s dissent in Bruesewitz, more as an aside. The presumption hardly lives up to its reputation as a pillar of the Court’s preemption framework. To my mind, all along, the presumption has been deployed by the Court in a haphazard way—rearing its head in some cases, while remaining utterly silent in others (including the majority in Geier, as pointed out with vitriol by the dissent). While many scholars continue to see it as the linchpin of an analytic preemption framework, I have long argued that it rests on extremely weak empirical and theoretical foundations.

5. In light of all of the new opinions, what is the analytic framework for preemption decisionmaking?

The role played by the underlying regulatory agency has been underappreciated in preemption cases. Even in Bruesewitz, an express preemption case authored by Justice Scalia, the most loyal adherent to textualist statutory interpretation, the majority nonetheless looks to the regulatory framework for vaccines for additional support for its holding that the Vaccine Act preempts design defect claims. The majority points to the role of the Secretary of Health and Human Services (HHS) in prompting the development of improved vaccine design and post-approval monitoring by various federal agencies. Justice Breyer, who places even more weight on the views of HHS (as expressed through the government’s amicus brief), was convinced that the “rigorous administrative safety review” of vaccines and HHS’s thorough understanding of vaccine production and safety was sufficient to read the Vaccine Act as preempting state tort design defect claims.

Williamson brings this approach front and center, with its emphasis on the regulating agency’s views both at the time the regulation is promulgated and at the time the case is before the Court. The majority reiterated its statement in Geier that “the agency’s own views should make a difference.” But, at the same time, the Court does not simply defer to the agency’s obiter dictum. For example, “the fact that DOT [Department of Transportation] made a negative judgment about cost effectiveness . . . cannot by itself show that DOT sought to forbid common-law tort suits in which a judge or jury might reach a different conclusion.” More would be needed form the rulemaking record to substantiate the agency’s intent to preempt. The agency’s views, moreover, will be deemed worthy of consideration only to the extent that they are “consistently held interpretive views.”

In my own work, I have proposed an “agency reference model” to guide judicial preemption decisions. Williamson is a significant step in this direction. And it is particularly momentous in that seven Justices seem to have signed on to this approach. (Again, Justice Thomas notes his strong objection to what he views as “[t]he Court wad[ing] into a sea of agency musings and Government litigating positions and fish[ing] for what the agency may have been thinking 20 years ago when it drafted the relevant provision.”) But more is needed to guard against agency political flip-flop with each Administration’s change of view on implied preemption and state tort law. The next step is to articulate the level of deference to accord to agency positions on preemption and to specify the heightened judicial scrutiny of the agency’s regulatory record that supports its position.

BIOGRAPHY: Catherine Sharkey is Professor of Law at New York University School of Law. She is one of the nation’s leading authorities on federal preemption in the realm of products liability. Professor Sharkey has published more than twenty-five law review articles, essays, reviews, and book chapters in the fields of preemption, punitive damages, administrative law, mass torts, class actions, and empirical legal studies. Her scholarship has been cited by numerous federal appellate and trial courts. Professor Sharkey will join Professor Richard Epstein as co-author of one of the leading torts casebooks and is co-editor with Professor Saul Levmore of the second edition of Foundations of Tort Law. She also serves as a consultant to the Administrative Conference of the United States. Professor Sharkey earned a bachelor’s degree in economics, summa cum laude, from Yale University. A Rhodes Scholar, she received a master of science in economics for development, with distinction, from Oxford University (Magdalen College), and her J.D. from Yale Law School, where she was Executive Editor of the Yale Law Journal. She clerked for Judge Guido Calabresi of the U.S. Court of Appeals for the Second Circuit and Justice David Souter of the U.S. Supreme Court.

As a defense lawyer, I dream about preemption; it can bar a staggeringly wide range of claims. The plaintiffs in Gelber v. Stryker, — F.Supp.2d —-, No. 09-CIV-1322, 2010 WL 4740432 (S.D.N.Y. Sept. 14, 2010), however, do not view preemption so fondly. After Jeannette Gelber’s hip was replaced with a Stryker Trident hip, she began to have pain and noticed a squeaking sound when she walked. She was told the artificial hip was defective, and thereafter, filed suit. The defendants filed a motion to dismiss, and the plaintiff conceded the dismissal of claims based on failure to warn, improper labeling, improper or misleading marketing and/or defective design. Therefore, the only claims remaining in the defendants’ motion to dismiss were those of negligence, strict liability and breach of warranty claims based on alleged violations of the FDA’s manufacturing requirements.

And then, the defendants dropped the atom bomb: federal preemption based on the rigorous review the FDA had used in approving the Trident hip for use and distribution; in fact, as a so-called “Class III” device, the Trident hip had been subject to the “rigorous regime” of premarket approval (“PMA“) within the FDA, a process under which only 1% of devices were scrutinized in 2005:

The PMA process is lengthy-it takes over 1,200 hours to review each application-and involves the submission of volumes of comprehensive information on the device. The FDA only grants premarket approval if it finds there is a reasonable assurance of the device’s safety and effectiveness. After approval, the FDA still retains regulatory control over the device. The manufacturer is prohibited from changing “design specification, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness” without first obtaining FDA’s approval.

There is a way around federal preemption, and the plaintiffs tried it in this case: the plaintiffs claimed that the defendants violated FDA manufacturing requirements, a so-called “parallel” claim. Here’s how a parallel claim would work, in the Court’s opinion

Riegel [v. Medtronic, Inc., 552 U.S. 312, 316, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008)] specifically found that claims of strict liability, negligence and breach of implied warranty were expressly preempted. However, there is an absence of Supreme Court guidance on whether the [Medical Device Amendments of 1976] preempts state requirements of general applicability that only incidentally regulate medical devices, e.g., Uniform Commercial Code or unfair trade practice laws, since Riegel refrained from analyzing the exception provided by 21 U.S .C. § 808.1(d)(1). Riegel, 552 U.S. at 328-29 (” § 808.1(d)(1) can add nothing to our analysis but confusion…. Neither accepting nor rejecting the FDA’s distinction between general requirements that directly regulate and those that regulate only incidentally[,] the regulation fails to alter … the outcome of this case”). Post-Riegel, courts have struggled to determine whether state-law claims that only incidentally regulate medical devices are still available insofar as they are “parallel” to federal requirements. . . . This Court finds it persuasive that since the Supreme Court did not carve out a safe harbor for state laws that only incidentally regulate medical devices, the same preemption analysis applies and only those claims that are parallel to federal requirements are permissible.

(internal citations omitted). This might have been a great argument for the plaintiffs, except that the court held that they did not sufficiently plead claims “grounded in violations of federal law and/or requirements.” The pleadings didn’t provide the requisite amount of factual detail and specificity to survive the defendants’ motion to dismiss and, therefore, the remaining claims of the plaintiffs were dismissed. Pesky pleadings. However, the Court stated that “because courts have only recently articulated how a plaintiff can successfully plead a parallel claim,” the plaintiffs would be allowed to replead.

Recently, the Third Circuit affirmed the dismissal of a plaintiff’s complaint seeking damages for injuries as a result of cell phone usage on the ground that his claims were preempted by Federal Communications Commission (“FCC”) regulations. Farina v. Nokia, Inc., No. 08-4034, 2010 WL 4138502 (3d Cir. Oct. 22, 2010) [PDF]. In that case, the Plaintiff, Francis Farina (“Farina”), brought a class action against numerous cell phone manufacturers and retailers. Farina asserted that cell phones were unsafe to be operated without headsets because, without a headset, the user is exposed to dangerous amounts of radio frequency (“RF”) radiation and current marketing of cell phones as safe violated state law. The FCC regulations at issue adopted a maximum absorption rate that measured the amount of energy absorbed in human tissue.

In reviewing the decision of the District Court, the Third Circuit discussed the three types of federal preemption of state law — express preemption, field preemption, and conflict preemption. First, the Third Circuit found no express preemption by 47 U.S.C. Section 332(c)(7)(B)(iv) that provided the following: “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 effect of radio frequency emissions to the extent that such facilities comply with the Commission’s regulations concerning such emissions.” (emphasis added). Defendants argued that the term “facilities” included alternations to cell phones. The Third Circuit disagreed finding that “facilities” related to infrastructures and not transient cell phones, concluding no express preemption.

Next, the Third Circuit found no field preemption stating that “[w]hile the FCC may have ‘primacy over the areas of technical standard and competitive market structure for cellular service . . . neither Congress nor the FCC has evinced an intent to occupy the entire field.”

Finally, however, the Third Circuit found conflict preemption accepting Defendants’ argument that “Farina’s suit would erect an obstacle to the accomplishment of the objectives of Congress.” Farina’s claims were based on alleged false and misleading statements that cell phones were safe to use without a headset. The Third Circuit pointed out that in order to establish his claims, “Farina must show that [the FCC] standards are inadequate that they are insufficiently protective of public health and safety.” That said, the Third Circuit was tasked with determining “whether suits challenging the adequacy of the FCC’s RF regulations are preempted.” Defendants argued that Farina’s suit conflicts with the FCC regulations because a finding of liability would “upset the FCC’s delicate balancing of efficiency and uniformity with the health and safety of the public.” Permitting a jury to find that cell phones that meet the FCC standards are nevertheless unreasonably dangerous would upset its objectives and balance, and thus the Third Circuit decided such suits are preempted.

The Drug and Device Law blog offers an interesting discussion and analysis of the decision here. It appears that this is another in a series of cases in which the courts try to make sense of conflict preemption in the wake of Wyeth v. Levine, 129 S. Ct. 1187 (2009).

Important to the Court’s analysis was the National Highway Traffic Safety Administration’s withdrawal of a proposed rulemaking. The NHTSA contemplated authoring rules in the early 1990s requiring laminated glass to be used for side windows in vehicles. After studying the matter, the NHTSA withdrew its advanced notice of proposed rulemaking, and cited its study that the use of laminated glass increased the chances of injury to restrained occupants. See Notice of Withdrawal, 67 Fed. Reg. 41,365. The Court then examined three recent opinions from the Fifth Circuit, the West Virginia Supreme court, and the Tennessee Court of Appeals examining the potential preemption of Regulation 205. The state court opinions were driven by Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861 (2000), which found that Regulation 208 had preemptive effect. Following the state court decisions, it seems that the NHTSA’s withdrawal was the crucial factor:

Because the federal government authorized that choice, Regulation 205 must preempt a state claim. Note, however, that the Court footnoted the Foreword to ANS Z26, which does not support a finding of preemption, but the Foreword “is not part of” ANS Z26.

The Fifth Circuit decision in O’Hara v. General Motors Corp., 508 F.3d 753 (2007) went the other way. O’Hara reasoned that the NHTSA’s notice of withdrawal did not operate as a rejection of laminate glass in side windows. Moreover, the language of Regulation 208 “strongly supports the conclusion that it expresses a federal policy,” while Regulation 205 did not. Therefore, Regulation 205 was best understood as a minimum safety standard, leaving states free to regulate via tort.

The South Carolina Supreme Court footnoted multiple cases in which courts have dealt with the preemptive effect of Regulation 205. Although it seems both sides have valid arguments, there is the underlying current of rewarding risky behavior in not finding preemption. That is, laminate glass can protect unrestrained occupants from being ejected from a vehicle. Does a court really want to reward a risk-taking plaintiff by denying a defendant the defense of preemption. O’Hara involved the claims of a minor, so perhaps she was a more sympathetic plaintiff. At any rate, be aware of the split of authority, and look for the United States Supreme Court to take a Regulation 205 case on certiorari.