Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

Last November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.

The complaint alleges that the FDA failed in its statutory duty to take a “hard look” at how GE salmon will impact the environment. The plaintiffs warn that the FDA did not appreciate the risk that the farmed salmon would inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .”

The plaintiffs also take aim at the FDA’s authority to regulate GE animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), arguing that, back in 1938, Congress did not expect the FDA to regulate genetically engineered animals for human consumption: “GE animals present enormously different risks and impacts than drugs, requiring different expertise, analyses, and regulation than were contemplated when Congress enacted the FFDCA.”

Whether additional lawsuits will follow this one remains to be seen. In our November post, we predicted that consumers could sue to challenge the labeling of the GE fish. Although the FDA initially determined that AquaBounty would not need to label its salmon as GE, a provision in December’s 2016 Omnibus Appropriations Bill required the FDA to ban GE salmon imports until it published labeling guidelines for the fish. In February, the FDA issued that ban and announced its plans to establish labeling guidelines.

Even if AquaBounty puts FDA-approved labeling on its product, consumers still may sue under failure to warn and related legal theories. The food industry has had some success defending state law food labeling claims based on federal preemption. But the federal Nutrition Labeling and Education Act exempts claims based on the adequacy of safety warnings unless the FDA has actually considered a risk and determined that no warning is necessary. So, the key question in any consumer personal injury suit involving GE salmon likely will be whether the FDA considered the risk of the alleged harm in implementing its new labeling guidelines.

Government Turf: Will the CPSC Investigate Rubber Infill?

Calls for a government-led investigation of the potential negative health effects of crumb rubber turf are getting louder, and the Consumer Product Safety Commission is listening. Crumb rubber turf infill consists of black pellets of ground-up rubber, and it’s become increasingly popular in the construction of sports fields. Some are concerned, however, that crumb rubber turf may expose athletes to cancer-causing chemicals.

On Wednesday, January 27, CPSC chairman Elliot F. Kaye, in statements to a Florida television station, indicated that CPSC will investigate the potential risks of rubber turf.

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Supreme Court Says Offering to Settle Cannot Moot Class Action Suits

Last week, the US Supreme Court ruled that an offer of judgment under Federal Rule of Civil Procedure 68 made to the lead plaintiff in a class action lawsuit, in addition to a separate free-standing settlement offer in the same amount, does not render the lawsuit moot.

In Campbell-Ewald Co. v. Gomez, No. 14-857, 2016 WL 228345 (U.S. Jan. 20, 2016), Jose Gomez filed a class-action lawsuit seeking damages under the Telephone Consumer Protection Act as a result of unwanted text messages he and others received from Campbell-Ewald Company.  Before Gomez had filed his motion for class certification, Campbell made an offer of judgment to him under Federal Rule of Civil Procedure 68 which would have satisfied his personal claim entirely.  Gomez allowed this offer to lapse after 14 days, as specified by the rule.  Campbell then moved to dismiss the case, claiming that no controversy remained after its offer provided Gomez with complete relief.  Both the District Court and the Ninth Circuit Court of Appeals disagreed with Campbell. Continue Reading

Researchers Turn Their Attention to Diacetyl in E-Cigarettes

On December 8, 2015, researchers at Harvard University announced that they had examined a small sample of flavored e-cigarette products and found that some contained diacetyl, a chemical suspected of causing respiratory illness. In the wake of this announcement, some news organizations reported that the Harvard paper established a “link” between e-cigarettes and bronchiolitis obliterans, a disease associated with diacetyl exposure.

But the Harvard study did not discuss any connection between diacetyl in e-cigarettes and respiratory illness. The researchers merely noted the presence of diacetyl in e-cigarettes and that diacetyl has been associated with respiratory disease in the industrial context. The study drew no conclusions about the possible health risks that vaping poses to consumers. Instead, the study’s authors recommended that this new potential source of exposure to diacetyl be further evaluated. Continue Reading

Non-Toxic Reform: Senate Passes TSCA Revisions

It’s not very often that manufacturers and many environmental groups agree on a chemical safety regulation. But that’s what’s happening with the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which passed the Senate late last week, and would reform the Toxic Substances Control Act (TSCA). Continue Reading

Oh What Fun It Is To Ride . . . A Hoverboard? This Year’s Must-Have Holiday Gift Poses Potential Litigation Risks for Manufacturers

In 1989, the Back to the Future franchise made several fanciful predictions about 2015.  One prediction may now be coming true: hoverboards have hit the streets — sort of.  The currently-available hoverboards, as opposed to the Hollywood fantasy ones, are more properly described as hands-free, self-balancing scooters.  Fueled by viral videos and celebrity social media posts, these battery-powered scooters are quickly becoming the must-have gift of the holiday season.

As the popularity of these hoverboards increases, however, so too does the potential for claims against manufacturers and sellers.  Over the last three months, the Consumer Product Safety Commission (“CPSC”) has reportedly learned about nearly 20 separate injuries from hoverboard-related accidents, ranging from sprains and contusions to broken bones and at least one head injury.   Continue Reading

FDA Approves First Genetically Engineered Animal for Human Consumption

On November 19, 2015, the Food and Drug Administration (FDA) approved as fit for human consumption a genetically engineered (GE) salmon. AquaBounty Technologies AquAdvantage Salmon has been modified to grow faster than non-engineered farmed salmon. This marks the first time the FDA has authorized the sale of a genetically engineered animal as food.

Because the FDA determined that there are “no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon,” AquAdvantage will not need to label the fish as genetically modified. The FDA further found that approving the GE salmon would have no negative environmental impact. Continue Reading

Hacking Health Care: When Cybersecurity Can Mean Life or Death

Millions of Americans rely on implantable medical devices to stay alive. These battery-operated devices communicate through wireless transmissions — and can be hacked like any other wireless device. For example, a wireless pacemaker regulates a person’s heartbeat and records the heart’s activity, and then transmits this information to doctors who can reprogram the pacemaker. The interconnectivity between medical devices and clinical systems leaves wireless medical devices vulnerable to security breaches.

Cybersecurity no longer just applies to computer networks and financial data; modern implantable medical devices have the same vulnerability and also require cybersecurity. In fact, in a span of six months, hackers attempted to log into MRI and defibrillator machines over ten thousand times and attempted to download malware approximately 300 times. Had these hackers been successful, they could have accessed patients’ personal information or reprogrammed the defibrillators to deliver deadly jolts of electricity to patients’ hearts. Continue Reading

Trial Victory for Dorel Juvenile Group, Inc.

On November 10, 2015, a Charleston, West Virginia jury returned a unanimous verdict for defendant Dorel Juvenile Group, Inc., finding the company’s High Rise booster seat to be neither defective nor responsible for the death of a four-year-old child. Tragically, the child died from injuries sustained in a horrific, multiple-rollover accident that occurred on a snowy section of Kentucky interstate in 2009. Counsel for the minor’s estate argued that Dorel was responsible for the death because serious accidents do happen, and only seats with five-point internal harnesses should be offered for sale. Schiff Hardin’s lawyers showed that booster seats – including the High Rise – offer excellent protection, as demonstrated through testing, and that the child unfortunately was in the worst possible position in the vehicle during this crash. Each party presented multiple experts and fact witnesses over the course of a week and a half. Plaintiffs sought several million dollars in damages.  After an hour and a half of deliberation, the jury unanimously agreed with Schiff Hardin, found for Dorel, and awarded no damages.

Dorel was represented at trial by Jonathan Judge and Matt Schiltz of Schiff Hardin, with able assistance from West Virginia co-counsel Hendrickson & Long.


Peanut Butter Pick-Me-Up

Senator Chuck Schumer (D-NY) is again voicing concern about caffeinated foods. The latest in caffeine-laden food trends is a new caffeinated peanut butter which boasts the equivalent of two cups of coffee in two tablespoons of peanut butter. In a letter to the Food and Drug Administration (FDA), Senator Schumer urged the agency to investigate the effects of an increased presence of caffeinated food products and, in particular, the safety of STEEM’s caffeinated peanut butter product. Schumer is particularly concerned that children could suffer health effects from ingesting too much caffeine (perhaps unknowingly). In 2010, Senator Schumer was involved in the FDA’s decision to send warning letters to four manufacturers of alcoholic beverages containing caffeine because Schumer believed the drinks were packaged to appeal to minors. Those warning letters resulted in each of the four manufacturers ceasing production of their products. Then, earlier this year, Schumer was one of several senators who pushed for a ban on pure powdered caffeine. Now, he urges the agency to consider that an increasing number of “everyday” foods, like Steem Caffeinated Peanut Butter, pose a public health risk, particularly for kids. Continue Reading