Monsanto Uses the Constitution to Challenge Warning Labels for Herbicide

Monsanto has, at least temporarily, lost its fight to avoid a Prop 65 warning label on its products containing glyphosate, a chemical used in the popular herbicide Roundup. On January 27, 2017, a California judge tentatively dismissed Monsanto’s claims that the State of California unconstitutionally turned to an unelected, European organization to decide whether glyphosate posed a cancer risk. Continue Reading

Hotel California: Supreme Court Will Review Whether Plaintiffs Can Check in to California Courts from Afar

On January 9, 2017, the United States Supreme Court granted review over a case from the California Supreme Court that could affect whether plaintiffs can bring product liability and mass tort claims in states where they don’t live and didn’t suffer an injury.

In Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County, No. 16-466, the Court will decide whether the California courts properly asserted jurisdiction over Bristol-Meyers Squibb (BMS). It will consider where companies that operate nationwide businesses can be sued, and how their activities in a state—including marketing or sales—could expose them to a lawsuit there.

If the Court decides that California courts have jurisdiction over BMS in this case, then companies could face more nonresident plaintiff lawsuits, particularly in California. For companies, these lawsuits could mean facing potentially plaintiff-friendly laws and courts and the inconvenience of defending a case in another part of the country. Continue Reading

Food Fight: More Labeling Litigation in 2017

Food labeling litigation increased significantly last year, with many consumer groups alleging that products were misleadingly labeled and violated U.S. Food and Drug Administration labeling requirements. Consumers targeted phrases like “all natural,” “preservative-free,” or having “no preservatives.”

But FDA rules are unclear as to what these terms mean, which will likely spur more labeling litigation in 2017. Here we look at three main reasons for the anticipated increase in litigation. Continue Reading

Truly Exonerated? NHTSA’s Tesla Autopilot Investigation

When the fatal car crash involving a Tesla Model S sedan made headlines last fall, we posted about the accident and predicted that government authorities would classify the crash as being caused by driver error rather than an issue with the “Autopilot” system.

Our prediction turned out to be correct.  The National Highway Traffic Safety Administration (NHTSA) was still investigating the incident when we first posted about it, but on January 19, NHTSA closed its preliminary evaluation, which found that driver error was responsible.

Still, the performance of Automated Driver Assistance Systems, or ADAS, is an area of intense regulatory interest, and it was therefore not surprising to see NHTSA’s Office of Defect Investigation deploy a special crash investigations team to reconstruct the accident.

Several news reports have characterized NHTSA as having “exonerated” or “cleared” Tesla of any wrongdoing in connection with the crash. Officially, NHTSA merely closed the investigation, noting that it reached no conclusion about whether a defect existed and retained its right to reopen the investigation later.

That said, NHTSA was clearly satisfied with the performance of Tesla’s ADAS system during the crash, which allowed the agency to close its investigation. Continue Reading

Medical Device Manufacturers Face A Cybersecurity “Heartache”

Medical device manufacturers are now facing a new challenge: managing the cybersecurity of their products.

On January 9, the FDA issued a Safety Communication setting out potential risks that could be caused by a cybersecurity vulnerability in certain St. Jude Medical cardiac devices. A growing number of devices – including St. Jude Medical’s implantable cardiac devices and corresponding Merlin@home Transmitter – transmit data directly to physicians to allow direct patient and device monitoring. Continue Reading

When Santa Brings a Dud

Most holiday seasons, an “it” toy stands at the top of children’s wish lists. With this instant rise in popularity frequently comes a corresponding rise in consumer complaints. Years ago, the consumer complaints might get some media attention—but that attention usually focused on the consumer competition to acquire the demand-exceeds-supply product.

Now, people turn to social media to detail in words, pictures, and video any perceived problem with their much-hyped purchase. This contributes to a manufacturer’s nightmare, trying to quickly determine which complaints are just disappointed expectation and which might actually be a consumer safety issue. Can manufacturers likewise use social media to help calm the storm? Continue Reading

TSCA and Asbestos—a New Approach or One That Reveals the Same Old Problems?

On November 29, EPA announced that it will review the hazard and exposure risks caused by asbestos. Asbestos will be one of the first ten substances to be evaluated under the TSCA amendments commonly referred to as the Lautenberg Act. As we have discussed elsewhere, TSCA now requires EPA to produce a risk evaluation work plan for these substances by June 2017 and complete its evaluation within three years following. If EPA determines any of these substances pose unreasonable risks, then EPA must take further action to mitigate any risks. Continue Reading

Federal GMO Disclosure Law Creates Uniform Standards for Food Manufacturers & Provides Options for Disclosure

This summer President Obama signed a new federal law requiring food manufacturers to disclose information regarding genetically modified organisms (GMO). The new law is different from the 2015 proposed GMO legislation which restricted states from enacting GMO labeling laws but didn’t contain federal labeling requirements.

The law represents a compromise between consumer groups and food manufacturers: it gives consumers access to information, and manufacturers flexible means of compliance and the benefit of a uniform federal standard.

The federal law, titled The National Bioengineered Food Disclosure Standard, leaves many issues unsettled. Two areas are attracting the most attention: the law’s digital disclosure methods and the definition of bioengineered food.

Background

The July 2016 law (P. Law 114-216) preempts state GMO labeling laws, which had been passed in Vermont, Connecticut, and Maine. Pro-labeling groups argued that federal action was necessary to prevent a confusing system of state requirements, and manufacturers agreed. After the law passed, the Grocery Manufacturers Association stated that a “consistent national standard is far better than a costly and confusing patchwork of different state labeling.”

The USDA has two years to develop and implement the new federal law, including deciding what must be labeled. The law immediately preempted state GMO laws.

Digital Disclosures on Food Products

Many food companies support the law because it gives them multiple labeling options. Manufacturers may use text, symbol, websites, 1-800 numbers, and QR codes –bar codes that consumers can scan with smartphones – on their products. If manufacturers use QR codes or websites, they must include instructions on the package like “scan for more information.”

The federal law is a clear departure from the state laws it preempts. Those laws required the words “genetically modified” on bioengineered food labels. Now manufacturers need not write “GMO” on their food products. Many are already voluntarily complying by using QR codes on food.

Certain pro-labeling organizations are unhappy with this labeling option, arguing that it disadvantages low-income consumers who may not have the technology needed to obtain disclosure information.

But the law recognizes digital links may not be workable and requires the USDA to conduct a study in the first year on “whether consumers would have access to the […] digital disclosure methods.” If the study results indicate consumers do not have access to the digital disclosures, the USDA will provide “comparable options” for disclosure.

Not All GM Ingredients Require Disclosure

The law gives the USDA discretion to determine the amount of GMO material that triggers disclosure. The law also provides exceptions for certain food products:

  1. Oils and Starches: Food manufacturers are not required to disclose highly refined products like corn syrup and soybean oil. These products fall outside the law’s definition of bioengineered food because they contain no genetic “material.”
  2. Certain animal products: Manufacturers need not disclose products made from animals that are fed bioengineered feed.

The second exception mirrors the EU’s GMO disclosure law, but raises a significant point of disagreement among scientists and food activists. Labeling of GMO fed livestock was the basis for a consumer class action lawsuit against Chipotle in 2015. There customers claimed Chipotle’s non-GMO claims were false because Chipotle used ingredients from GMO-fed animals. These claims against Chipotle are still pending, though the plaintiff is struggling to show any injury suffered from consuming GMO-fed animal products.

These exceptions point to the broader GMO debate. Scientists argue that there is no health or safety difference between bioengineered food and non-bioengineered food. But organic food organizations say more testing is needed, and urge manufacturers to disclose all genetically modified ingredients.

A Look to the Future

There are more labeling debates ahead.  Many pro-labeling organizations express concern that the law is too lenient and leaves out significant amounts of bioengineered food. The Organic Trade Association voiced support for the law, calling it “a constructive solution to a complex issue,” but one that requires improvement. It plans to stay involved as the USDA develops the law’s specifics. Food manufacturers are staying involved in the process as well to ensure their interests are represented.

 

*Hannah will be sworn in to the Illinois Bar on November 10, 2016. This article was authored under the supervision of Amy Rubenstein.

California Releases New Prop 65 Warning Regulations

After considering them for more than a year, California’s Office of Health Hazard Assessment (OEHHA) has finally issued new “Safe Harbor” warning regulations for Proposition 65. The new regulations intend to provide consumers “more specificity” about the chemical content of products sold in California.  They take effect on August 30, 2018 and are set forth in California Health and Safety Code sections 25600, et seq. Continue Reading

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