A South Carolina family-owned tomato farm recently sued the United States Food and Drug Administration under the Federal Tort Claims Act  seeking to recoup damages it suffered from the 2008 nationwide tomato recall over fears of salmonella contamination.  Seaside Farm, Inc. of St. Helena Island filed suit in federal court in the U.S. District Court for the District of South Carolina.   The complaint alleges causes of action of negligence, violation of the takings clause, violations of the South Carolina Unfair Trade Practices Act, and defamation.  Seaside Farm, Inc. v. United States, C.A. No. 9:11-cv-1199-CWH (D.S.C. May 2011).

According to the complaint, Seaside Farm cooperated with and and assisted in all audits and inspections of its operation prior to the start of the tomato season in 2008 and passed all inspections.  Then, in June of 2008, “at the precise time when South Carolina tomatoes are coming to market, the FDA announced a national recall of all tomatoes in the U.S.” (See South Carolina news coverage of the 2008 recall here ).  The complaint goes on to say that the FDA “improperly assumed” that tomatoes were the source of the curent salmonella outbreak, though following the recall, the FDA ultimately conceded that tomatoes were not the source the salmonella contamination.  At that point, however, Seaside Farm says the damage was done.  It seeks compensation for loss of its property, in the form of its 2008 tomato crop, as well as other general and special damages.

The FDA Law Blog reports that though the FDA issued a nationwide warning in June of 2008 for consumers to refrain from eating tomatoes, later, certain types of peppers were identified as the likely culprit of the salmonella outbreak.  The FDA thus lifted its tomato ban, but not before significant damage was done.  There was significant fallout, with some predicting that litigation likely would most certainly ensue.   According to FDA Law Blog, statutory law directs the Government Accountability Office to submit a report to Congress that reviews “new or existing mechanisms available to compensate persons for general and specific recall-related costs when a recall is subsequently determined by the relevant agency to have been an error,” and that “considers models for farmer restitution implemented in other nations in cases of erroneous recalls.”  Such provisions may fall short of the expectations of small businesses like Seaside Farm, who took the brunt of the error.

“It threatens to extract significant competitive harm on extremely vulnerable pregnant women, and it threatens to significantly inflate health-care costs at a time when controlling health-care costs is a critical national priority,” said David Balto, a Washington antitrust lawyer who worked at the FTC.

This is an issue that will continue to force some tough choices. And, cynical though it may seem, we are certain that litigation about this very issue is inevitable, if not with this drug than with the next one down the line.

If you are a fan of Bravo’s “Real Housewives of Beverly Hills” series, you will undoubtedly recall the episode featuring the appearance of psychic Allison DuBois at a dinner party hosted by Camille Grammer. DuBois was quite irksome, but surprisingly, not due to the cigarette she puffed at the dinner table. While DuBois’s cigarette caused little conflict at the party, the product has been at the forefront of some intense litigation and proposed legislation in recent months.

DuBois’s “cigarette” was an electronic cigarette or “e-cigarette.” As such, it was a battery-powered device that allows users to inhale vaporized nicotine, minus the tobacco, tar, and carbon monoxide. E-cigarette advertisements claim that the product is “the smarter and safer alternative to smoking” which looks, tastes, and feels like a real cigarette. If true, the e-cigarette could dramatically impact the nation’s health. Apparently, though, the Food and Drug Administration (“FDA”) has its doubts.

The emergence of the e-cigarette presented the FDA with a new opportunity to extend its regulatory reach. However, over a decade ago, the FDA lost its initial bid to regulate cigarettes and smokeless tobacco under the Federal Food, Drug, and Cosmetic Act (“the Act”) via the U.S. Supreme Court’s decision in FDA v. Brown & Williamson Tobacco Corp., 539 U.S. 120 (2000) (holding that Congress had not vested the FDA with the power to regulate cigarettes and smokeless tobacco products). Despite that loss, the FDA has made other attempts to regulate e-cigarettes, and we’ve created the handy list below to summarize those attempts:

• In 2009, the FDA warned that e-cigarettes contain carcinogens and toxic chemicals such as diethyline glycol (an ingredient used in antifreeze). According to its statement, the FDA was concerned that e-cigarettes would increase nicotine addiction and tobacco use in young people. The FDA began detaining shipments of e-cigarettes at the border. Following the examination of the seized goods, it determined that the product meets the Act’s definition of a combination drug-device product and, accordingly, was subject to FDA regulation. E-cigarette distributors challenged the FDA’s jurisdiction.

• In January 2010, the U.S. District Court for the District of Columbia granted a preliminary injunction to allow e-cigarette distributors to continue to import their products into the country. Judge Richard Leon agreed with the distributors that Brown prevented the FDA from regulating e-cigarettes. The FDA appealed the ruling, and the D.C. Circuit Court of Appeals issued a stay on Judge Leon’s injunction. (For a more thorough examination of the Court’s decision, see our earlier discussion of that matter here.)

• In September 2010, the FDA notified five e-cigarette distributors that it was taking enforcement actions against the companies for violations of the Act. The list of violations included “violations of good manufacturing practices, making unsubstantiated drug claims, and using the devices as delivery mechanisms for active pharmaceutical ingredients like rimonabant and tadalafil.” In addition, the FDA announced its decision to regulate e-cigarettes as combination drug-device products. As a consequence of regulation, e-cigarette manufacturers would be required to comply with the FDA’s drug-approval process.

• On December 7, 2010, the D.C. Court of Appeals affirmed the district court decision and held that the FDA lacked the authority to regulate e-cigarettes under the Act as drugs or devices. In addition, the D.C. Court of Appeals held that the FDA may only regulate the marketing of e-cigarettes pursuant to the Tobacco Act.

While the FDA may have been unsuccessful in its legal battles thus far (the FDA is considering an appeal), several states are considering regulating, or in some instances banning, e-cigarettes. Recently, New York took the first steps to becoming the first state to ban e-cigarettes, passing a proposed bill through the Health Committee of the New York Assembly. The bill’s sponsor, Assemblywoman Linda Rosenthal, indicated she wanted to proscribe e-cigarettes until they undergo more investigation and regulation. Assembly Health Committee Chairman Richard Gottfried has urged e-cigarette manufacturers to prove to the FDA the legitimacy of their “smoking cessation” claims.

Rosenthal and Gottfried may have a point: e-cigarettes may pose some yet-to-be-determined health hazards. It is interesting that the FDA and state legislatures have become so adamant at this stage about banning a cigarette alternative. While we may not know the ill-effects, if any, of vaporized nicotine, we do know the risks associated with tar, tobacco, and carbon monoxide. There is always a risk that e-cigarettes can lead to hazards more significant than cancer and emphysema. However, it seems counter-intuitive to protect consumers by banning a product which may have risks in favor of one we know poses the threat of serious illness.

We can all relate to the fear of the unknown. On the one hand, we may discover in the future that the conservative approach of the FDA and the various state legislatures was proper. On the other hand, we may discover Allison DuBois knew what was safe all along. After all, she is a psychic.

Mmmmmm. Now the cigarette is even closer to my lungs. And I get the added benefit of focusing on lung cancer without worrying about any pesky oral cancer or hairy tongue. Yes, hairy tongue is a real disease, and tobacco use is a contributory factor. (Strangely enough, coffee drinking is also a contributing factor, which is unfortunate for the universe of associates who depend on both coffee and cigarettes to stay awake.) As noted in multiple media, including the New York Times and much of the blogosphere, the FDA is proposing new illustrative warning labels to encourage people to quit smoking. Yum. To see some of the other proposed labels, click here. Here are several different opinions on the impact of this move.

Defense Litigation-oriented opinion: I’ll note that this move is a generation away from paying off for Big Tobacco. It’s hard to imagine that a smoker will succeed in ignoring or not understanding these types of warnings, when the warning is designed to take up 50% of the package area surface. So, certainly, these warnings are favorable to future litigation outcomes for Big Tobacco, which will reduce their anticipated exposure to large jury verdicts. In 20 years, cigarette manufacturers may be more profitable than ever.

Conspiracy-theorist opinion: This is a much easier way to pay lip service to the idea that we want to reduce the overall costs of smoking to the public, than say, banning cigarettes. The federal government doesn’t want to ban cigarettes because according to this website that I know nothing about, the federal government took in $8.5 billion in cigarette taxes in 2009. Way to go progressive tax system! Therefore, these new labels are good for both the government and manufacturers.

College student opinion: Moreover, this is sure to be an effective tool to decrease the existing pool of smokers. Does anyone else think that your typical college student will have a large poster of the above graphic hanging in his room while he smokes, while, at the same time, thinking how smart he is because he appreciates the irony? Meanwhile, because the cost of college will continue to skyrocket, the rest of us will appreciate the irony of the graduate struggling to pay off his student loan debt (because college graduates make all the money) while he looks for money in his budget to buy cigarettes.

Realistic opinion: If you want people to quit smoking, tell them about hairy tongue. Surely, the prospect of hairy tongue is scarier than emphysema.

Defense-litigation perspective resumed: The universe of manufacturing defects in this realm is pretty small. Failure to warn claims will soon be extinct, which will leave design defect claims as the viable strict liability alternative. Surely this labeling program will establish significant comparative negligence. Fraud and civil conspiracy claims will begin to die out as the early generations of smokers die out. What kind of new legal theories will be invented to establish liability over the next generation? This seems like a pretty good time to start a cigarette manufacturing company.

Abnormal Use does not want to be accused of failure to warn, so here’s your warning: you might not want to read this post right after lunch. The FDA has issued a warning on the use of frozen mice sold for reptile food. (You may recall that we mentioned this very briefly in a previous Friday Links post, but you must have thought we were kidding.). Now, before you use your mouse to click directly out of Abnormal Use for the day, you might want to keep reading.

The contaminated mice, sold by Biggers and Callaham LLC, doing business as MiceDirect, may be contaminated with salmonella, a nasty little bacteria that can cause some very unpleasant symptoms. The FDA is warning those with compromised immune systems not only to avoid handling the rodents themselves, but also to avoid handling any reptiles who may have already consumed contaminated rodents. Some people have already reported symptoms.

So, if anyone in your family likes to cuddle with snakes, you might want to stop that practice. We think that might be a good idea generally, but even more so now.