A Florida jury recently ordered two cigarette companies to pay a total of $26.6 million to the widow of a longtime smoker who died of lung cancer after smoking for more than 50 years.
The verdict, handed down on March 24, was the latest in a string of “Engle progeny” cases to be submitted to Florida juries in recent years. Engle v. R.J. Reynolds was a landmark class-action lawsuit filed in 1994 against makers of cigarettes, in which a Florida jury awarded the plaintiffs $145 billion. This award was subsequently overturned by the Florida Supreme Court in 2006.
However, in doing so, the court reportedly did allow the approximately 700,000 Florida smokers in that class to pursue their claims individually. In addition, the state supreme court actually allowed the findings of the original jury pertaining to causation, addiction of cigarettes, negligence, and breach of implied warranty to stand, thereby reducing the burden of proof required in these subsequent actions. This likely has served as a significant advantage for plaintiffs’ counsel, who go to trial without having to jump the causation hurdle. As a result, the defendants’ strategy is also limited.
Of the 13 Engle progeny cases to reach juries in the last 13 months, plaintiffs have won 11. Counsel for the tobacco companies have alleged that each of these cases raises constitutional issues, though, because allowing one jury to rely on the findings of a prior jury that are totally unrelated to the individual smoker at each trial is in violation of both Florida law and due process.
Representatives for Philip Morris have said it will appeal the jury’s latest verdict on the grounds that the trial court improperly eliminated the majority of the plaintiff’s burden of proof. However, as of now, at least, it appears as though the latest will be one of a continuing string of verdicts to strike blows to the tobacco industry.
Since the fall of 2008, the U.S. Food and Drug Administration has routinely refused to allow the importation of electronic cigarettes, or “e-cigarettes,” into this country. A recent opinion might require a change of that policy. In Smoking Everywhere, Inc. v. U.S. Food & Drug Admin, No. 09-771(RJL), 2010 WL 129667 (D.D.C. Jan. 14, 2010), the U.S. District Court for the District of Columbia granted the Plaintiffs’ request for a preliminary injunction prohibiting the FDA from denying entry of e-cigarettes into the United States and from regulating e-cigarettes as a drug-device combination.
The plaintiffs in this action, Smoking Everywhere, Inc. and Sottera, Inc., are importers and distributors of e-cigarettes. These products are designed “to replicate the adult experience of smoking without combustion or the use of cancerous by-products.”Id. at *1. They import their products from manufacturers located overseas. However, their shipments were denied entry into the United States by the FDA on the basis that the shipments “appear to be adulterated, misbranded or otherwise in violation” of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. Id. at *2.
Due to the action’s procedural posture, the court analyzed the likelihood of the Plaintiffs’ success on the merits, whether the Plaintiffs would suffer irreparable injury were an injunction not to be granted, and whether an injunction would further the public’s interest. Id. at *3. The court’s analysis required it to consider federal tobacco legislation, the FDCA, and the landmark decision of U.S. Food and Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), wherein the Supreme Court held that tobacco products were not subject to FDA regulation as a drug or device.
The Smoking Everywhere court rejected the FDA’s arguments that the term “tobacco product” should be narrowly defined and that e-cigarettes were drug-device combinations. The court stressed that due to the marketing of the e-cigarettes “for customary recreational use, those products (just like traditional cigarettes) are properly excluded from the meaning of drug or device under the FDCA.” Id. at *8. As such, the court determined that the Plaintiffs were “substantially likely to succeed on their claim that the FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.” Id. The court also determined that the Plaintiffs had suffered irreparable harm due to the FDA’s refusal to allow the importation of their e-cigarette shipments. Id. at *10. In the court’s final analysis, the factors weighed in the Plaintiffs’ favor, and therefore, the court granted the Plaintiffs’ request for an order enjoining the FDA from refusing admission into the U.S. e-cigarettes on the basis that such products are unapproved drugs, devices or drug-device combinations under the FDCA.