Preemption Returns to South Carolina

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.

Georgia federal court finds preemption of breach of warranty claim

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.”
Plaintiff did not dispute that the nerve stimulator, as a Class III medical device, was subject to federal requirements for purposes of a preemption analysis.  It also conceded that, as a result, his design claim was preempted.  He didn’t concede, however, that preemption barred his other causes of action.
As to Plaintiff’s cause of action for manufacturing defect, a strict liability claim, the Court held that the claim was preempted:
Clearly, the FDA regulates the manufacturing practices of Class III medical devices.  Further, a manufacturer could comply with all FDA regulations, but nevertheless produce a product containing an unintended flaw or abnormal condition. That being so, by holding a manufacturer liable under such circumstances, Georgia law would be in the position of imposing requirements “in addition to” federal law.  Accordingly, [as] defendant argues, plaintiff’s strict liability manufacturing defect claim is therefore preempted.
Even if the claim were not preempted, the Court reasoned, Plaintiff had failed to provide any proof that the device was negligently manufactured.  He also failed to provide evidence that the symptoms and/or injuries he suffered were caused by the device.  (There’s that pesky lack of expert testimony thing again).
Plaintiff also argued that the device contained an inadequate warning, which is a design defect under Georgia law.  An inadequate warning may amount to a design defect and permit the imposition of strict liability.  However, because the FDA regulates content and appearance of prescription medical device labels, Georgia law would be imposing “requirements” that were “in addition to” federal regulations. As such, this claim was also preempted.
Plaintiff almost succeeded in surviving summary judgment on his negligent manufacturing defect claim.  As the Court noted, a “negligent manufacturing claim would not be preempted to the extent it relied on an allegation that the particular device had not been manufactured in accordance with the FDA’s pre-market approval process.”  However, although Plaintiff survived preemption on this claim, he failed to survive the summary judgment motion because he had failed to offer any evidence of any manufacturing defect claim. Oh, well.
The most interesting analysis in this case, however, centered on the issue of preemption in the context of a breach of warranty claim.  The Court stated, “Riegel did not address a breach of express warranty claim.  Nor has the Eleventh Circuit decided whether a breach of express warranty claim can be preempted by the MDA. Other federal courts remain divided over the issue.”
The Court held that preemption does apply in the context of a breach of warranty claim.  Its reasoning follows:
In any event, the express representation claims in this case would interfere with the FDA’s pre-market approval regime. Plaintiffs claim that defendant expressly warranted the stimulator to be “safe, and generally fit for use as an implanted stimulator,” when in fact the device was not safe.  In order to prove that defendant breached this warranty, plaintiff would need to show that the stimulator was not safe: a finding that would directly conflict with the FDA’s pr-emarket approval of the device as reasonably safe and effective.  Moreover, if these warranties were made in materials approved by the FDA in the pre-market approval process, then allowing a claim to proceed under Georgia law would subject defendant to state duties above and beyond the federal requirements.  Such a claim would fall within [the] preemption clause prohibiting state requirements that are in addition to, or different from, federal requirements.
Accordingly, the Court concluded that Plaintiff’s express warranty claim was also preempted.

Federal Hazardous Substances Act Preempts Recovery on Failure to Warn Claim in Fire Death Case

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.


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.

DAP’s product is a hazardous substance sold for household use, and therefore, falls under the purview of the Federal hazardous Substances Act (FHSA). The FHSA requires such products to “bear adequate cautionary labels,” but, as the Court pointed out, the statute also preempts any failure to warn claims based on an argument that the label should have included particular warnings not required by the FHSA. Rather, the only claim that the plaintiffs could bring would be an allegation that the label did not comply with the FHSA.

The plaintiffs attempted to assert that the label did not comply with the FHSA because it failed to warn that one of the principal hazards of the cement was the risk of fire from an accidental spill, separate and apart from the general flammability. “Principal hazard” is a defined term under the law, meaning “the principal or primary hazard(s) associated with a hazardous substance.” The Court affirmed the grant of summary judgment as to this argument, since “the risk of fire from an accidental spilling of DAP cement is not a principal hazard that the FHSA requires the label to state affirmatively.”

The plaintiffs also argued that the label failed to state that, in the event of a spill, the product should not be wiped but absorbed with an inert absorbent. The Court also rejected this argument because “the FHSA does not require the DAP cement label to warn consumers against spreading the product after a spill as a precautionary measure.” The term “precautionary measures” is referred to under the statute as steps needing to be followed to avoid or minimize the “principal hazard” of the product.

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.

Side note: DAP cement apparently also comes in a non-flammable version:

Abnormal Interviews: Law Professor Catherine Sharkey

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 preemption.”

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.

The Abnormal Use Guide to Last Week’s SCOTUS Preemption Opinions

To many of non-lawyers, “preemption” is that nefarious word associated with a network’s decision to alter its television line-up with irksome breaking news. For defense attorneys, however, the term has a far more positive connotation. Preemption is a fan favorite because it can bar many types of claims. Needless to say, any time the United States Supreme Supreme Court issues a case involving preemption, we here at Abnormal Use pay close attention. Last week, the Supreme Court delivered two such rulings within a matter of days. It was a good week for express preemption, but for implied preemption, not so much. To assist you, our dear readers, in your review and analysis of this new jurisprudence, we’ve created this crib sheet.

In Bruesewitz v. Wyeth LLC, No. 09-152, 2011 WL 588789 (U.S. Feb. 22, 2011), the Court held that the National Childhood Vaccine Injury Act (NCVIA) preempts all design defect claims against vaccine manufacturers arising out of injury or death caused by vaccine side effects. In reaching this result, Justice Scalia, writing for a six justice majority, navigated through the depths of the English language, bringing to mind those halcyon grammar school days of sentence diagramming. While we needed a copy of the Cambridge Grammar of English to fully appreciate the opinion, here is a simple, though not as grammatically pleasing, synopsis:

  • The Court examined whether 42 U.S.C. 300aa(b)(1) preempted all design defect claims against vaccine manufacturers. The statute reads as follows: “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.” The words of this statute would be parsed thoroughly in this jurisprudential inquiry.
  • The statute establishes unavoidability (given safe manufacture and adequate warning) with respect to the particular design as a complete defense.
  • The use of the term “unavoidable” in the statute does not incorporate comment k to Section 402A of the Restatement (Second) of Torts. (Comment k exempts from strict liability “unavoidably unsafe products.”). According to Justice Scalia, there is no obvious intent to incorporate comment k because the statute uses the adjective “unavoidable” while the Restatement itself uses the adverb “unavoidably.”
  • The statute’s “even though” clause grammatically is a concessive subordinate clause. Justice Scalia argued that the dissent’s reading of this phrase incorrectly linked proper preparation and labeling with unavoidability – the job of a coordinating conjunction.
  • While seemingly admitting that the majority’s interpretation renders part of the statute superfluous, Justice Scalia contended that there is no rule indicating that a “passage which could have been more terse does not mean what it says.”
  • The lack of guidance from the federal regulations for design defects compared to the plethora of guidance for proper manufacturing and warning, specifically mentioned in the NCVIA, suggests that design defects were not a basis for liability.
  • While the Court has previously expressed doubt that Congress would preempt product liability claims without providing a federal substitute, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), Justice Scalia insisted that the Court has never suggested it would be skeptical of preemption unless the congressional substitute operated like the tort system.
  • Post-enactment legislative history is not a proper tool for statutory interpretation. (We all know how much Justice Scalia abhors any legislative history).
  • Justice Breyer filed a concurring opinion. In so doing, he examined the legislative history and the statute’s basic purpose to reach the same result.
  • Justice Sotomayor, joined by Justice Ginsburg, authored a lengthy dissent. According to her dissent, the statute does not preempt all design defect claims. Rather, Justice Sotomayor argued that where a plaintiff has proven that he was injured by a design defect, vaccine manufacturers are only protected if they demonstrate that the side effect was unavoidable and is otherwise free from manufacturing and design defects.

After all of that analysis, the Court couldn’t possibly have enough grammatical energy to decide another preemption case for some time, right? Apparently, the average preemption second-wind of a Supreme Court Justice is approximately 24 hours, because the following day, the Court rendered its second opinion of the week. In Williamson v. Mazda Motor of America, Inc. No. 08-1314 (U.S. Feb. 23, 2011), the Court held that Section 208 of the Federal Motor Vehicle Safety Act (FMVSS) does not preempt state tort suits claiming manufacturers should have installed lap-and-shoulder belts in lieu of lap belts in rear inner seats. Much to the chagrin of elementary school teachers across America, however, this decision didn’t demand such a precise stranglehold on the English language. The following is an overview of the opinion:

  • Justice Breyer wrote the opinion for the seven justice majority (Justice Thomas concurred in the judgment and Justice Kagan took no part in the decision). As aforementioned, in Bruesewitz, Justice Breyer filed a concurring opinion advocating a broader approach to the preemption analysis. Williamson gave him the chance to demonstrate that approach.
  • Breyer used the majority of the opinion to distinguish this case from Geier v. American Honda Motor Co., 529 U.S. 861 (2000) (holding that Section 208 of the FMVSS preempted a state tort suit against a auto manufacturer for failure to install airbags).
  • In light of Geier, neither Section 208’s express preemption clause, nor its savings clause, limit the operation of conflict preemption principles. Instead, the Court must determine whether the state tort action conflicts with the federal regulation.
  • According to Geier, giving auto manufacturers a choice between various passive restraint devices was a significant objective of the federal regulations. In allowing for this choice, the Department of Transportation (“DOT”) was concerned about a consumer backlash if airbags were required.
  • In Williamson, the regulation gave auto manufacturers a choice between lap-and-shoulder belts and lap belts. That choice, however, was not a significant regulatory objective. The DOT enacted the regulation because it was convinced lap-and-shoulder belts would increase safety. The regulation’s history indicates that manufacturers were given a choice because lap-and-shoulder belts could cause “entry and exit problems for occupants.” Moreover, the DOT indicated it did not think a lap-and-shoulder belt requirement would be cost-effective.
  • Even though the state tort suit may limit manufacturer choice, the Court held it is not an obstacle to accomplishing the purpose and objective of the federal regulation.
  • Justice Sotomayor wrote a concurring opinion to emphasize the Court’s rejection of an overreading of Geier. She reiterated that the “mere fact that an agency regulation allows manufacturers a choice between options is insufficient to justify implied preemption.”
  • Justice Thomas, concurring in the judgment, indicated that plain text of the FMVSS would lead to the same conclusion. Thomas argued that the FMVSS’s savings clause expressly preserved state tort actions.

While the advocates of preemption ended last week with only a .500 record, we here at Abnormal Use will not hang our heads. Unashamed of a moral victory, we can recognize the importance of distinguishing, rather than overruling, Geier.

Artificial Hip Case Prompts Preemption Analysis

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.

Claims for Injuries Allegedly Related to Cell Phone Usage Found Preempted

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).

Obstacles Can Be Good: South Carolina Supreme Court Affirms Trial Court’s Grant of Summary Judgment on Preemption Grounds in Products Case

Obstacles can be good, especially when they represent preemption defenses against state products liability claims. As we reported yesterday, the South Carolina Supreme Court issued a decision that Federal Motor Vehicle Standard 205 preempts a state claim. Standard 205 deals with glass used in vehicles. The lawsuit sprung from an automobile accident in which an occupant of a Ford F-150 was thrown from the cab. The personal representative filed suit, alleging the Ford should have used glass that would not shatter and would “retain occupants inside the vehicle.” Ford argued that Regulation 205 permitted discretion in which glass to use, and, therefore, the state law claim was preempted.

The South Carolina Supreme Court affirmed the trial court’s order granting Ford summary judgment. The legal issue was whether Regulation 205 merely sets a minimum safety floor (no preemption) or permits the manufacturer a range of choice in the production of its vehicles (preemption). Regulation 205 begins as follows:

S1. Scope. This standard specifies requirements for glazing materials for use in motor vehicles and motor vehicle equipment.
S2.Purpose. The purpose of this standard is to reduce injuries resulting from impact to glazing surfaces, to ensure a necessary degree of transparency in motor vehicle windows for driver visibility, and to minimize the possibility of occupants being thrown through the vehicle windows in collisions.

The court noted that Regulation 205 does not specify standards for which glass to use, but instead it references a safety code (ANS Z26) developed by the American National Standards Institute, a nonprofit entity. The code allows two different types of glass: 1) a tempered glass that shatters into dull pieces (safer for restrained occupants) and 2) a laminated glass that does not shatter (safer for unrestrained occupants by decreasing risk of ejection.

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:

In issuing the notice of withdrawal, NHTSA declined to modify Regulation 205 and require advanced glazing. Thus, the notice of withdrawal kept Regulation 205 intact, thereby preserving the manufacturer’s option to use tempered glass on side windows.

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.

South Carolina Supreme Court Finds Products Liability Claim Preempted by Federal Motor Vehicle Standard 205

This morning, the South Carolina Supreme Court issued an opinion in Priester v. Ford Motor Co., Op. No. 26846 (S.C. August 2, 2010), in which it ruled that a state law products liability claim is preempted by Federal Motor Vehicle Standard 205 (49 C.F.R. § 571.205). After examining the current split of persuasive authority, the Court ruled that the regulation provides a “range of choices among” different types of glass that could be used in a vehicle, rather than a minimum safety standard. Thus, the Supreme Court affirmed the trial court, which had granted Ford’s motion for summary judgment on those grounds. We’ll write up a full analysis of this decision for tomorrow’s post.