Supreme Court’s Bartlett Decision Could Strengthen FIFRA Preemption

The U.S. Supreme Court’s decision in Mutual Pharmaceutical Co., Inc. v. Bartlett, No. 12-142, decided June 24, 2013, may assist defense counsel in defending product liability cases involving FIFRA-regulated products such as herbicides and pesticides. Although Bartlett involved design defect claims against manufacturers of generic drugs, which are regulated by FDA, the principles enunciated in Bartlett potentially have much greater application.

In Bartlett, the court held that the Federal Food, Drug and Cosmetic Act preempts state-law design defect claims against manufacturers of generic drugs. The court rejected outright plaintiff’s contention that under the so-called “stop-selling” theory, a generic manufacturer could comply with both federal and state law merely by removing its drug from the market.

In rejecting that argument, Justice Samuel Alito, writing for the majority, held that “the incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases. In every instance in which the court has found impossibility pre-emption, the ‘direct conflict’ between federal and state law duties could easily have been avoided if the regulated actor had simply ceased acting.”

Thus, in reversing the First Circuit decision, the court slammed the door on plaintiffs hoping to circumvent the preemption defense by contending that a manufacturer might merely stop selling the product.

In an article in Law360 titled, “Bartlett’s Benefits Will Extend Beyond Generic Drug Makers,” 6/28/13, commentators offer the view that pesticide manufacturers may now be protected from plaintiff alleging a stop-selling theory of liability.  If the case’s holding is so extended, plaintiffs should no longer be able to allege that an herbicide manufacturer should not have placed a pesticide into commerce in the first instance. In essence, this is a variation of the often espoused argument that a product should not be marketed because its risks outweigh any potential benefits.  After all, the whole point of federal regulation is the underlying assumption you are going to market the product.

Court Holds Spicy Meatball, Not Pesticide, Caused Plaintiff’s Illness

In an Opinion and Order, dated May 31, 2013, the Hon. Sandra J. Feuerstein granted summary judgment to a defendant pesticide manufacturer after determining that plaintiff”s expert failed to meet the reliability requirements of Rule 702 and Daubert, in Mallozzi v. EcoSMART Technologies, Inc., E.D.N.Y., no. 11-cv-02884, 5/31/13.

Defending toxic tort claims against pesticide manufacturers is always challenging because pesticides, by their very nature, are designed to cause injury and death to pests. Plaintiff’s counsel is only too willing to permit the jury to infer that a pesticide product that can be harmful to bugs can also be injurious to humans. Therefore, if a defendant pesticide manufacturer can subject plaintiff’s expert to Daubert scrutiny prior to trial, it may be possible to dispose of scientifically suspect cases before they reach trial.

In Mallozzi, plaintiff claimed that he developed severe gastroesophageal reflux disease (“GERD”) and laryngopharyngeal reflux (“LPR”) as a result of an inhalatory exposure to EcoSmart Organic Home Pest Control, which contains 1% peppermint oil.

However, it was not until plaintiff returned from dinner at an Italian restaurant the night of the alleged pesticide exposure that he experienced nausea, a racing heartbeat and burning in his stomach and chest. Plaintiff obtained the expert opinion of Dr. Barry S. Levy, an occupational and environmental health physician and epidemiologist, that his exposure to peppermint oil caused his LPR by relaxing his lower esophageal sphincter.

In its motion for summary judgment, the defendant argued that Dr. Levy’s testimony was unreliable and did not meet the Daubert standard primarily because Dr. Levy was unable to establish the amount of peppermint oil inhaled.

The articles that Dr. Levy relied upon discussed ingestion of peppermint oil rather than inhalation, which was the case here. Moreover, none of the articles relied upon by Dr. Levy addressed whether inhalation of a substance containing 1% peppermint oil, over the course of a matter of minutes, could relax the lower esophageal sphincter or cause LPR.

In part, defendant’s motion was successful because defendant’s counsel laid the groundwork for the motion by obtaining helpful testimony from plaintiff’s expert in deposition. During Dr. Levy’s deposition, defendant’s counsel elicited testimony that none of the scientific articles relied upon by Dr. Levy involved inhalation of peppermint oil.

In addition to establishing a strong record in deposition, defendant’s counsel was also able to raise issues concerning the cause of plaintiff’s illness by obtaining a detailed medical history of plaintiff. The court rejected Dr. Levy’s reliance on the temporal proximity between plaintiff’s exposure to the product and the onset of plaintiff’s symptoms. In particular, the court observed that plaintiff began experiencing reflux hours after having a heavy meal of “spaghetti with seafood.”

Indeed, plaintiff had been hospitalized in 2001 for esophageal reflux after eating a donut and drinking coffee. On another occasion, he had experienced reflux prior to April 2010 when he had apparently overindulged on linguini with clam sauce. This prior medical history no doubt predisposed the court to believing plaintiff’s causation claim was suspect. The court found that Dr. Levy had “failed to justify his conclusion that reflux specifically caused by inhalation of the product caused plaintiff’s LPR and not reflux caused by plaintiff’s persistent GERD, both before and after April 19, 2010.” 

No FIFRA Preemption, No Problem!

In Gresser v. Dow Chemical Co., Ind. Ct. App., No 79A02-1111-CT-1014, 4/30/13, the plaintiffs in this toxic tort case alleged that their children developed a variety of illnesses after a purported exposure to Dursban TC in their home following a pesticide application by the co-defendant pesticide applicator.

Plaintiffs alleged that defendants Dow Chemical Company and Dow Agrosciences (collectively, “Dow”) failed to use reasonable care to instruct about the use of the product; warn about its danger; and appropriately test the design of the product. Following discovery, both plaintiffs and Dow filed motions for summary judgment.

On April 13, 2013, the Indiana Court of Appeals reversed a trial court order granting Dow summary judgment on FIFRA preemption grounds, but granted Dow summary judgment on the basis of the rebuttable presumption in Indiana’s product liability statute (the “IPLA”) that a product is not defective if it complies with federal or Indiana standards or regulations. Thus, Dow obtained from the IPLA presumption relief that it could not obtain by preemption.

Ind. Code § 34-20-5-1  provides a rebuttable presumption that a product which caused physical harm is not defective, and the manufacturer or seller of the product is not negligent, if before the sale by the manufacturer, the product “complied with applicable codes, standards, regulations, or specifications established, promulgated, or approved by the United States or by Indiana, or by an agency of the United States or Indiana.”

In determining that Dow was entitled to the statutory presumption, the court held that Dursban TC’s compliance with both FIFRA and Indiana law had a significant impact under IPLA’s consumer expectation-based product liability regime because the risk of harm had been evaluated by agencies with the duty of monitoring the effects of Dursban TC. Furthermore, Dursban TC’s labeling and warnings had been approved by experts.

On the basis of this ruling, the appellate court determined that the trial court correctly granted Dow summary judgment motion on plaintiffs’ failure to warn claims

This decision is significant because Dow was able to obtain through the use of the statutory presumption the same end result that it would have obtained had the appellate court found that the plaintiff’s claims were subject to preemption. Other states, including New Jersey, have similar provisions in their statutes in varying contexts.  In New Jersey, the New Jersey Product Liability Act, N.J.S.A. 2A:58C-1 et seq., specifically provides an evidentiary presumption in the favor of drug manufacturers against failure-to-warn claims:

"If the warning or instruction given in connection with a drug or device or food additive has been approved or prescribed by the federal Food and Drug Administration under the Federal Food, Drug and Cosmetic Act, 52 Stat. 1040, 21 U.S.C. Sec. 301 et seq., … rebuttable presumption shall arise that the warning or instruction is adequate."

Thus, product liability practitioners, in both the FDA and FIFRA contexts, should be mindful of the importance of developing evidence in discovery and at trial concerning the regulatory approval process and the  evaluations performed by the agency of the appropriateness of the product warnings, directions for use, and of the product’s safety and efficacy.

Genetically Modified Food Can Feed The Planet

The publication of “Diet for a Small Planet” in 1971 by Francis Moore Lappé was a conscious-raising event for many Americans. The book makes the case that grain-fed meat production is wasteful and a contributor to global food scarcity. The author argues that eating a planet-centered diet means choosing what is best for the Earth and our bodies – a daily action that reminds us of our power to create a more rational world. The book’s most significant conclusion is that world hunger is not caused by a lack of food but by ineffective food policy. A vegetarian diet can  produce sufficient protein for one’s nutrition, according to the book.

Fast forward some forty years to today. The organic food movement has transformed the way many Americans think about food and has had a significant impact on food shopping. Organic food has become a multi-billion dollar industry with significant influence in education and public policy, and on law makers. We have certainly become more educated consumers by understanding how food products are manufactured and processed, which is an important part of the organic food industry’s message. But as Business Week put it, the organic food industry is a "far cry from the old food co-ops, wheatgrass, tofu, and alfalfa sprouts options, organic food and the industry supporting it has grown up".

There is a certain romanticism about the organic farming, which leads some to ask why can’t we just go back to the way we farmed in the 19th century? From a societal standpoint, what are the pros and cons of organic food vs. “genetically modified” food? How can we differentiate between the myths about the food we eat and the facts? In an article in the Wall Street Journal on December 24, 2012, John R. Block, the former secretary of the Department of Agriculture (1981-1985) tackles this issue head on.

Food Safety  According to Mr. Block, there has never been a single instance in which genetically modified food has caused an illness or contributed to a contaminated product. Nevertheless, you can open a newspaper or a website on any given day and be barraged by scientific-sounding warnings that gene-altered substances can enter our bodies and wreak genetic havoc.  One such article is titled, "Is Genetically Modified Food Killing Us?" or another simply "Genetic Roulette".  

 In fact, America’s farmers and ranchers have built a sophisticated food-safety infrastructure to improve the health of their animals and deliver fresh, clean produce. There is no evidence that organic food is “better for you” from a safety perspective. As a result of the use of biotechnology in agriculture, genetically modified crops taste better, take less time to mature, provide increased nutrients, yields and stress tolerance, and have improved resistance to disease, pests, and herbicides.  According to the Human Genome Project, on the horizon are bananas that produce human vaccines against infectious diseases such as hepatitis B and cows that are resistant to Mad Cow Disease. 

Crops from biotech seeds are identical to those from non-biotech seeds. In addition, organic foods are identical in nutritional value to non-organic foods.   Numerous studies have shown no nutritional difference between commercially available GMO (short hand for "genetically modified organisms") and non-GMO foods.

Food Choices  Not that long ago, what Americans ate depended on the farmer’s skill, the weather and other unpredictable variables. Pre-industrial agricultural yields were low before the introduction of machines, fertilizers, plant and animal breeding, pesticides and genetic engineering. We are no longer limited to a small variety of local and seasonal food. Modern agriculture is simply more productive, providing more variety at lower prices. As romantic as it would be to only eat food grown on a farm where two horses pulled a two-row corn planter, it probably wouldn’t feed the world’s population for all that long.

Environmental Stewardship  Today’s farmers use agricultural practices that improve the sustainability of the land and limits the use of herbicides, pesticides and fertilizers. The goal of the much of the research into genetically engineered crops is higher yield with less water and chemical use.

Sustainability  Most significantly, the large scale sophisticated farming of today is better equipped to sustain the world’s growing population.

According to Mr. Block, America’s farmers grow five times as much corn as they did in the 1930’s on 20% less land. To meet the goal of helping to feed a global population of what the United Nations estimates will be eight billion people in 2030, our farmers and ranchers will have to use the latest and most effective technologies to produce more with less.  

I support organic and conventional farming. I love shopping at Whole Foods. I shop at every Farmer’s Market I come across.  Thanks to the organic farming movement, our collective consciousness about food  has been heightened.  However, a higher consciousness alone cannot meet the world’s food demands. The underlying assumptions are different than they were forty years ago, but the basic premise holds true today.  Effective food policy remains the key to feeding the planet. A strong first step in developing effective food policy is separating fact from fiction when it comes to biotechnology and American agriculture.