A little over two years ago, the FDA authorized Paxlovid for emergency use for the treatment of adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.  Last year, the FDA approved Pfizer’s new drug application (NDA) for Paxlovid for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. Yesterday, the FDA announced a revision to the Paxlovid emergency use authorization (EUA), stating th ..read more

By Chariese Solorio, Sarah M. Nakamoto, and Kina Wong* A divided court in Madrigal v. Hyundai Motor America (2023) 90 Cal.App.5th 385, as modified on denial of reh’g (May 9, 2023), review filed (June 20, 2023) recently held that the cost-shifting penalty provisions of California Code of Civil Procedure section 998 apply when a case settles for less than the amount of the offer to compromise, and where the settlement agreement either does not identify the plaintiff as the prevailing party or provides that each party is responsible for its own attorney’s fees and costs. In Madrigal, the plaintif ..read more

By Chariese Solorio, Sarah M. Nakamoto, and Anthony Pimentel* The California Court of Appeal in Mega RV Corp. v. HWH Corp. (2014) 225 Cal.App.4th 1318 held that component-part manufacturers are not obligated to indemnify retail sellers under California Code of Civil Procedure section 1792 of the California Song-Beverly Consumer Warranty Act (the “Act”) unless they provide an express warranty to the consumer pertaining to the component part at issue. Id. at 1323. In Mega RV Corp., the plaintiffs purchased a motor home and later sued the retailer, manufacturer, and financer of the sale under the ..read more

By Chariese Solorio, Sarah M. Nakamoto, and Olivia LaCasto* In Kirzhner v. Mercedes-Benz USA, LLC (2020) 9 Cal.5th 966, the California Supreme Court expanded the possible damages that are recoverable under the Song-Beverly Consumer Warranty Act (the “Act”) to include registration renewal and nonoperation fees as incidental damages if such fees were “incurred after the manufacturer’s duty to promptly provide a replacement vehicle or restitution arises.” Id. at 980. In Kirzhner, the plaintiff leased a new vehicle from the defendant manufacturer. The plaintiff alleged that during the warranty per ..read more

By Sarah M. Nakamoto, Chariese Solorio, and Paige Sorensen* In Cummins, Inc. v. Superior Court (2005) 36 Cal.4th 478, 483, the California Supreme Court addressed the issue of “whether a buyer who resides in California may bring suit against a manufacturer under the [Song-Beverly Consumer Warranty] Act when the buyer purchased the vehicle in another state, but brought the vehicle for repair to the manufacturer’s authorized repair facility in California, and repeated attempts to repair the vehicle proved unsuccessful.” The court held that manufacturers are shielded from liability under the Act i ..read more

The Food and Drug Administration has just indicated that a lab-grown meat product developed by a California start-up is safe for human consumption. “Advancements in cell culture technology are enabling food developers to use animal cells obtained from livestock, poultry, and seafood in the production of food, with these products expected to be ready for the U.S. market in the near future,” Dr. Robert M. Califf, the FDA’s commissioner of food and drugs and Susan T. Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said in a statement. The product will be availab ..read more

Today, the FDA proposed updated criteria for when foods can be labeled with the nutrient content claim “healthy” on their packaging. This proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans. Under the proposal, manufacturers can label their products “healthy” if they contain a meaningful amount of food from at least one of the food groups or subgroups (such as fruit, vegetable or dairy) recommended by the dietary guidelines. They must also adhere to specific limits for ..read more

Today, the US House of Representatives to decriminalize marijuana. The House bill, called the Marijuana Opportunity Reinvestment and Expungement Act, or MORE Act, would remove marijuana from the list of scheduled substances and impose a federal tax on marijuana products. It would also establish a process to expunge prior cannabis convictions. The House voted 220-204 to pass the bill predominantly along party lines. Thirty six states and the District of Columbia have legalized medical marijuana over the last few years, and 19 states plus D.C. have decriminalized recreational marijuana use for a ..read more

Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster. The CDC later added its recommendation and said it would include the FDA’s action in its vaccine guidance. See the agency’s announcement here – Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals | FDA ..read more

In the medical device industry, there exists a longstanding divide between device manufacturers (i.e., those who design, manufacture, fabricate, or process a finished device) and the third-party entities that service the devices (i.e., those that maintain, restore, refurbish, or repair a finished device after it has been distributed, for purposes of returning the device to the safety and performance specifications established by the manufacturer and to meet its original intended use). The divide stems in part, from the way these entities are regulated by the U.S. Food & Drug Administration ..read more