From litigating pharmaceutical and medical device cases to litigating worker safety and motor vehicle cases, pre-emption is an issue. While one can appreciate that new facts continually invite the re-examination of old law, the seemingly inconsistent opinions regarding pre-emption — in addition to the "pro-pre-emption" affinity of the Supreme Court of the United States — give many practitioners pause.

Mutual Pharmaceutical v. Bartlett (Docket No. 12-0142) is the most recent example of the U.S. Supreme Court's attempts to guide the lower courts to broadly pre-empt state tort law. The 5-4 decision, authored by Justice Samuel Alito (joined by Chief Justice John Roberts and Justices Antonin Scalia, Anthony Kennedy and Clarence Thomas), bars state design-defect claims regarding the adequacy of a drug's warnings against generic drugmakers. The decision directly opposes the high court's holding regarding pre-emption and brand-name drugs. In barring claims against generic-drug manufacturers, the court hinged its opinion on the fact that generic manufacturers do not have the right or responsibility to change their warning label. Bartlett gives less rights to plaintiffs injured by generic drugs for claims against off-patent producers than a similarly injured plaintiff has against brand-name manufacturers. Generic manufactures have a free ride while brand-name manufacturers remain liable for manufacturing, informational and design defects, and the injured have less rights.

What is Pre-emption?

The legal doctrine of pre-emption is rooted in the supremacy clause of the U.S. Constitution. The Supreme Court has recognized two main categories of pre-emption: express and implied, which is subdivided into field pre-emption and conflict pre-emption. Conflict pre-emption is further subdivided into impossibility and obstacle pre-emption.

In short, absent the clear intent of Congress, the supremacy clause requires federal law to prevail over state law if there is a conflict. The heart of the pre-emption argument often lies in identifying the conflict between federal and state law.

Traditionally, the Supreme Court declined to find pre-emption of state law in the absence of a clear indication of congressional intent to pre-empt. The presumptive effect of federalism and the states' historic role in protecting public health and safety preserved consumer safety regulation as a classic police power of the states.

Interestingly, pre-emption juxtaposes conservative and liberal political ideologies. A decision in support of the federal government, generally considered liberal, results in a vote for pre-emption and for big business. Contrastingly, a decision for state rights, generally viewed as conservative, results in a vote against pre-emption and against industry. Arguably, this flip of political preferences is one explanation for the unpredictability of pre-emption rulings.

Inconsistent Rulings

An assortment of Supreme Court cases highlights the lack of consistency in pre-emption rulings.

Medical device and pharmaceutical cases

Medical device and unsafe drug cases provide an excellent example of the logical gymnastics the Supreme Court employs to reach inconsistent holdings. The Supreme Court reasoned around the states' historic police powers in deciding Bartlett, in addition to the cases below:

Riegel v. Medtronic, 552 U.S. 312 (2008): Federal law bars injured consumers from challenging the safety or effectiveness of medical devices when they have been approved by the U.S. Food and Drug Administration. Win for pre-emption.

Wyeth v. Levine, 555 U.S. 555 (2009): Injured consumers can sue pharmaceutical companies for failing to warn about the risks of taking brand-name drugs. Loss for pre-emption.

Pliva v. Mensing, 131 S.Ct. 2567 (2011): Injured consumers could not bring failure-to-warn claims for injuries caused by FDA-approved generic pharmaceuticals. Win for pre-emption.

Bartlett (2013): Injured consumers cannot bring design-defect claims that turn on a generic drug's warning for injuries caused by the generic drug when the brand-name drug is approved by the FDA. Win for pre-emption.

In sum, in the past six years, the court denied state health and safety claims for FDA-approved medical devices, allowed failure-to-warn claims for brand-name pharmaceuticals, yet denied the same claims for generic pharmaceuticals. Consequently, most consumers harmed by medications now lack access to justice.

Motor Vehicle Cases

In Geier v. American Honda Motor, 529 U.S. 861 (2000), the court held that a state law injury claim for the lack of an airbag was pre-empted because of the U.S. Department of Transportation's regulatory decision to allow manufacturers to choose among safety devices in motor vehicles. Specifically, the court found "obstacle" pre-emption barred a common-law claim: The DOT's regulatory allowance of choice precluded a jury finding that a manufacturer should have put an airbag in place under common law. Many lower courts applied Geier expansively in finding for pre-emption until Williamson v. Mazda Motor of America, 562 U.S. __ (2011), where the court again addressed whether a federal regulation on motor vehicle safety pre-empted state common law.

While Geier addressed airbag regulation, the safety regulation specifically at issue in Williamson was the installation of seatbelts. Like Geier, the seatbelt statute provided vehicle manufacturers a choice of what type of seatbelt to install on certain seats. However, the court looked closely at what the DOT actually did with respect to the seatbelt regulation, and limited Geier and held that the design-defect claims under state law were not pre-empted.

Vaccine Cases

The court is clear with respect to vaccine cases. Bruesewitz v. Wyeth, 562 U.S. ___ (2011), concerned whether the National Childhood Vaccine Injury Act of 1986 (NCVIA), which created a no-fault program to provide compensation for vaccine-related injuries, expressly pre-empts certain design-defect claims. The court held that the NCVIA pre-empts all design-defect claims against vaccine manufacturers by individuals seeking compensation for injury or death. Therefore, all claims involving vaccines are now governed by the NCVIA and cannot be brought under state law. This decision undeniably has profound implications for vaccine companies setting product standards.

'Pre-emptive' Agency Action

Congress is known to enact laws that are either silent on pre-emption or unclear, leaving the courts to determine Congress' intent. Starting in the George W. Bush administration, various governmental agencies began taking noticeable strides in support of pre-emption, absent congressional enactment of new law.

The National Highway Traffic Safety Administration (NHTSA) and the Consumer Product Safety Commission (CPSC) each made agency history by declaring rulemaking preambles with tort pre-emption language. In the summer of 2005, the NHTSA announced the pre-emption of state tort law in proposed rules, 70 Fed. Reg. 36094 and 70 Fed. Reg. 79223, addressing the placement of seatbelts and roof-crush resistance. The CPSC also issued a rule for pre-emption of tort liability in the preamble to its mattress-flammability rule, 71 Fed. Reg. 13472, 13496-97. The Federal Railroad Administration also pushed for pre-emption through its issuance of a rule, 71 Fed. Reg. 59677, 59690.

In 2006, the FDA joined the administrative drive for tort pre-emption and declared pre-emption of tort liability regarding the content and form of drug labeling. Unlike the NHTSA, the FDA did not provide any opportunity for public comment and only included pre-emption language in the final version of the drug-labeling rule, published five years after the original proposed version.

Agencies have also filed countless amicus briefs in support of state tort pre-emption. For example, the U.S. Environmental Protection Agency filed an amicus brief in support of Dow's assertion of pre-emption in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005). A close reading of the brief shows that the EPA did not add any novel insight on pre-emption but merely echoed the arguments articulated by the corporate defendant.

The FDA has similarly filed amicus briefs in many cases, including Kallas v. Pfizer, No. 2:04-CV-0998 (D. Utah 2005), and Colacicco v. Apotex, 432 F. Supp. 2d 514 (E.D. Pa. 2006). Interestingly, or perhaps distressingly to some, the courts have given deference to the agencies' self-proclaimed interpretation of Congress' intent.

Just last week, in seeming response to Bartlett, the FDA announced that it plans to issue a new rule that would allow generic-drug companies to make changes in their labeling by September. This rule could open the generic drugmakers up to liability if their drugs injure patients.

Mercy of the Courts

Pre-emption rulings from the courts and "rules" from government agencies will continue to intrigue — and frighten — the legal community and the American public. Without Congress' intervention to protect its decision-making authority, we are at the mercy of the courts to implement their policy preferences against state tort actions and will continue to be bound to seemingly inconsistent and unfair laws.

Adrianne Walvoord Webb is an associate at Anapol Schwartz, handling pharmaceutical and medical device mass tort litigation and class action litigation. She practices in federal court as well as in Pennsylvania and New Jersey state courts. She can be contacted at