When California enacted SB 327 last year, it became the first state to regulate Internet of Things (IoT) devices, which refer to physical devices that are connected to the internet. Beginning next January, the new law will require manufacturers of IoT devices sold in California to implement reasonable security features that protect the software, data, and information contained within them. While the law regulates only the minimum security standards for IoT devices, its definition of a “connected device” (i.e., an IoT device) may impact product liability claims because “connected devices” are physical objects and not technology. SB 327’s definition suggests that manufacturers of the software in IoT devices may not be held strictly liable for software defects, because the law aligns with and reinforces the view of most courts that software is not a product, but a service.
Continue Reading

The FDA is expected to announce a final rule that could effectively eliminate most trans fat from food in the United States.  In 2013 the FDA announced its preliminary finding that partially hydrogenated oils (PHOs) – – the source of most trans fatty acids in American’s foods – – are not generally recognized as safe (GRAS) for use in any food.  If the FDA makes final its preliminary finding, PHOs will no longer enjoy GRAS status and will be subject to greater scrutiny by the FDA.

The regulation of trans fats can be traced back to 1999 when the FDA first proposed that manufacturers be required to declare the number of grams of trans fat on their nutrition labels.  Due to growing public health concerns, the FDA finalized this rule in 2006.  That rule resulted in reduced amounts of trans fat in food products.  A final rule that strips trans fat of GRAS status would subject food products with trans fat to greater scrutiny and may effectively eliminate all trans fat from those products.
Continue Reading

In California, a federal judge approved a class certification motion in a suit against ConAgra Food Inc. for alleged mislabeling of its Wesson oil products.  The dispute is based on allegations that ConAgra mislabeled oil as “100% natural.”  Plaintiffs argue the oil is not natural because it contains genetically modified ingredients. Further up the coast in Oregon, voters will decide this fall whether to require genetically modified food sold in the state to be labeled as such.  This issue has come up in several states, including Washington and California, where voters have rejected similar proposals in recent years.

The California case, In re: Conagra Foods Inc., includes certified classes of consumers from California, Colorado, Florida, Illinois, Indiana, Nebraska, New York, Ohio, Oregon, South Dakota, and Texas.  U.S. District Judge Margaret M. Morrow will allow plaintiffs to pursue claims brought under the states’ various consumer protection statutes, but she will not allow an injunctive relief class to proceed.
Continue Reading

The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not.  In order to level the field and provide plaintiffs a way to sue generic drug manufacturers, the FDA proposed greater authority (and liability) for generic drug manufacturers over the content of their warning.  Interested parties have until April 27 to weigh in on the consequences of this rule and make suggestions for how the rule could be improved.

Continue Reading

California’s Office of Environmental Health Hazard Assessment (OEHHA) recently released new revisions to Proposition 65’s “safe harbor” warning language regulations.  Under OEHHA’s proposal, businesses selling goods in California will no longer be able to rely on the standard simple warning language that has been used for decades.  Instead, business will be required to issue new Prop 65 warnings.  A public hearing will be held on March 25, 2015 to discuss the new revisions. 

The new warning language includes:
Continue Reading

“Made in the USA” does not necessarily mean the same thing outside of California.  In a recent decision, Paz v. AG Adriano Goldschmied Inc., a federal judge refused to dismiss a class action “Made in the USA” lawsuit, based on California’s strict regulation about the use of “Made in the USA” labels, suggesting that retailers may need to use different labels on the same goods depending on whether they are being sold inside or outside of California.

The issue stems from the fact that California is the only state in the union with its own statute governing the use of “Made in the USA” labels on consumer products.  Most states use the Federal Trade Commission’s (FTC) regulation, which requires “all or virtually all” of the product be made in the United States to qualify for a “Made in the USA” label.  The FTC regulation allows small amounts of foreign parts to be included as long as the product’s final assembly or processing happens in the U.S.  In contrast, California’s stricter regulation prohibits use of the label if the merchandise “or any article, unit, or part thereof, has been entirely or substantially made, manufactured or produced outside the United States.”
Continue Reading

The Consumer Product Safety Commission (CPSC) has made it clear time and time again that product manufacturers may not make product design changes for safety reasons, without considering whether those changes need to be reported to the CPSC.  Failing to comply can lead to millions of dollars in fines.

Under Section 15 of the Consumer Product Safety Act, product manufacturers and importers must report substantial product hazards to the CPSC.  The CPSC tends to view design changes responding to injury reports as proof that the company “knows” the product had a safety issue.  If the company does not immediately report the underlying injury situation to CPSC, it faces severe fines.
Continue Reading

The Food and Drug Administration (FDA) wants to know your opinion.  More specifically, it wants to know how it can better regulate drugs and medical devices.  The Agency is creating a public forum for commentary on its activities under the Food and Drug Administration Safety and Innovation Act (FDASIA), Patient Participation in Medical Product Discussions.  With this public docket FDA intends to gather input from stakeholders, and the public at large, on how it can more effectively (1) obtain the views of patients during the medical product development process, and (2) consider patient perspectives during regulatory discussions.   
Continue Reading

Driverless cars could soon become a reality on our streets and highways. The technology for autonomous vehicles is developing quickly and states are beginning to enact regulation in anticipation of the arrival of driverless cars. Several major companies are developing prototype autonomous vehicles including General Motors, Mercedes-Benz, Google, Audi AG, Toyota Motor Company and Oxford University. The Institute of Electrical and Electronics Engineers (IEEE) has estimated that up to 75 percent of all vehicles will be autonomous by 2040.

But, in the last year, various news sources have reported that fear of increased liability may limit the roll out of driverless cars. As the Wall Street Journal explained, when there is no driver, the possible targets of a lawsuit expands to the company that designed the technology, the car’s owner, the passenger who failed to intervene, or the auto maker, to name a few. U-T San Diego reported that some experts believe the issue of liability, if not solved, could delay or even prevent the widespread use of driverless cars.
Continue Reading