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.

U.S. Supreme Court Ruling Will Have Ripple Effect on Cases Alleging Vaccine-Autism Link

The United States Supreme Court heard arguments recently in a case that is expected to have significant implications for hundreds of pending lawsuits against vaccine makers. In these suits, various plaintiffs contend there is a link between childhood vaccines and autism. While the case presently before the Supreme Court does not involve a claim that autism was caused by a childhood vaccination, a recent article in The New York Times states that approximately 75 percent of similar claims do involve the disorder. This alleged association has been a hot-button issue for years, as repeated scientific studies have found no connection between vaccines and autism.

SCOTUSblog has previously set forth the particulars of this case, which is styled Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3rd Cir. 2009) (see the Third Circuit Court of Appeals’ order here, from which Plaintiffs appealed). Essentially, the case calls into question whether the National Childhood Vaccine Injury Act (NCVIA) should protect manufacturers from virtually all product liability lawsuits. The NCVIA, established by Congress in 1986, provides that vaccine manufacturers cannot be sued for injuries from vaccines if the injuries resulted from side effects that were “unavoidable.” Elsewhere in the Act, Congress also created an administrative process known as the “Vaccine Court,” which was designed to provide money to children injured by vaccines. Accordingly, the law would preempt such claims in state court. This was critical, Congress believed, because vaccine manufacturers otherwise might have gone bankrupt due to judgments against them and would be unable to make vaccines critical to public health.

Hannah Bruesewitz, the plaintiff in the present case, is an 18-year-old woman who suffered seizures when she was six months old and subsequently suffered developmental problems, according to her parents, after receiving a type of D.T.P. vaccine that is no longer sold. Bruesewitz’s parents initially brought a claim on her behalf in Vaccine Court, but the severe injuries she reported had been removed from the list of those that qualified for compensation. Her claim was thus rejected, and her parents subsequently filed a product liability lawsuit against Wyeth. Lower courts ruled that her claims were barred by the Vaccine Act.

The parties disagree about the meaning of the statutory language of the Vaccine Act. The plaintiffs argue that if the vaccine could have been manufactured in a safer way, Hannah Bruesewitz’s injury was not “unavoidable.” They have argued that the manufacturer knew at the time their daughter was immunized that there was a safer version of D.T.P. vaccine but did not produce it. According to The New York Times, Bruesewitz’s father has said that he and his wife are not opposed to vaccines, but they have pressed their daughter’s claim because they believe vaccine manufacturers needed to face the threat of litigation to produce safer medications.

Wyeth, for its part, argued that the only types of claims that are not preempted are those alleging manufacturing defects or a failure to warn. A number of Amicus Briefs were filed in support of each party. Those arguing that Congress intended to bar such claims were filed by the solicitor general of the United States, the Chamber of Commerce, and several professional medical groups including the American Academy of Pediatrics. This case certainly will be one to watch. It likely will have huge implications both as to a number of lawsuits filed and to be filed, and within the drug manufacturing industry in general. This case before the Supreme Court has become a true battle of the experts, with constitutional law heavy-hitters weighing in on both sides of the issue.

The debate regarding the alleged vaccine-autism link is sure to rage on. In spite of the numerous scientific studies showing no such causal link, CNN reports that one in four parents is concerned that vaccines cause autism. The report points out that parents simply are refusing to have their children vaccinated due to unreasonable fears, which can cause a resurgence of preventable diseases.