Safe Assumption About EPA’S Safer Choice Labels

The U.S. Environmental Protection Agency (EPA) Safer Choice labeling program “helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” The EPA offers lists of Safer Choice-Certified Products for different industries including all-purpose cleaners, car care products, dish soaps, floor cleaners, laundry products, and tub and tile cleaners. The Safer Choice Standard includes criteria for chemical ingredients and requirements for performance, packaging, pH, and VOCs (i.e., volatile organic compounds. Manufacturers, importers, and distributors of…
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Using Old Legislative Frameworks to Regulate Alternative Meat Product Labeling

aFor  variety of reasons–among them, economic efficiencies, environmental concerns, dietary health, and expanding access–the plant-based and cellular-grown foods industry is growing at a rapid rate. This fast expansion of a new kind of alternative food, however, has triggered concerns about how it is marketed and labeled for consumption. By the end of 2019, at least half of U.S. states introduced legislation addressing labeling of plant-based or cell-grown foods, with a particular focus on meat. Two states with the most recent legislative developments demonstrating the hesitation…
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FDA Alert Concerning Consumption of Certain Food Products Infused with Liquid Nitrogen

The U.S. Food and Drug Administration (FDA) has recently issued an advisory about the potential harmful effects of a new food trend – the consumption of food and/or beverages infused with liquid nitrogen when the infusion is performed at the point of sale.  According to the FDA, examples include infused solid food products, such as cheese puffs, and beverages.  The infused products emit a smoke-like vapor or fog effect.   The liquid nitrogen is infused just before they are served and are often available at food…
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Massachusetts Supreme Judicial Court Expands Liability for Branded Drug Companies to Consumers of Generics

On March 16, 2018, the Supreme Judicial Court of Massachusetts, the state’s highest appellate court, issued a decision of importance for branded drug companies. In Rafferty v. Merck & Co., the Massachusetts high court held that a brand-name drug company can be liable to a consumer of a generic drug for injuries arising from the failure to update the brand-name drug’s label that results from a “reckless disregard of an unreasonable risk of death or grave bodily injury.” The background for this decision is…
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New FDA Labeling Changes to Require “Black Box Warning” on Immediate Release Opioid Pain Medications

In an effort to combat what it calls “epidemic levels of opioid addiction and overdose”, the U.S. Food and Drug Administration (FDA) announced that it will require class-wide safety labeling changes for immediate release opioid pain medications, including a new “black box warning” informing patients and prescribers of the serious risks of misuse, abuse, addiction, overdose and death. In addition, the FDA will also require several safety labeling changes across all prescription opioid products to include additional warnings addressing the risks of opioids. The FDA…
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California Court of Appeals Rules Plaintiffs Can Pursue Claims Against Novartis for Alleged Damages Arising From Ingestion of Generic Drug Six Years After Novartis Divested its Interest

On March 9, 2016, the California Court of Appeals ruled that the plaintiffs’ claims of failure to warn and misrepresentation against Novartis were legally viable. The critical dispute raised by Novartis was that it did not manufacture the prescription medication that allegedly harmed the plaintiffs. In T. H. v. Novartis Pharms. Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Ct. App. Mar. 9, 2016), two minor plaintiffs alleged that Novartis was liable for neurological injuries they sustained in utero after their mother was prescribed,…
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Plaintiffs’ Product Case Trumped by the Learned Intermediary Doctrine

A large pharmaceutical manufacturer recently won a fundamentally important victory both within the mass tort it is facing and for all life science companies needing to rely upon the learned intermediary doctrine. In the consolidated litigation proceeding in New Jersey state court, the plaintiffs’ claim the manufacturer failed to properly warn its users of known gastro-intestinal complications associated with the drug. Relying on the learned intermediary doctrine, the judge granted the manufacturer summary judgment in some cases because the treating physicians testified they prescribed the…
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First Circuit Affirms Preemption of State-Law Claim for Consumer Fraud

labelIn a key preemption ruling late last month, the United States Court of Appeals for the First Circuit affirmed the dismissal of a putative class action. The First Circuit affirmed dismissal where the plaintiffs alleged consumer fraud, holding that state-law claims for false or misleading labeling are preempted by federal law. Read the full decision here. The First Circuit’s ruling built upon recent United States Supreme Court decisions holding that state-law claims aimed at generic drug labeling are preempted by applying this important defense to…
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Will Supreme Court End Split Over Whether Generic Drug Companies Can Face “Failure to Timely Update” Claims?

The U.S. Supreme Court (SCOTUS) has (again) been asked to determine the question of whether claims can be made against generic drug manufacturers for failing to timely update and/or disseminate their labels following U.S. Food and Drug Administration (FDA) approvals. Essentially, the issue is whether the time taken by a generic company to effect a labeling change can be tortious and subject to a private cause of action.  A Law360 article with the Petition for Writ of Certiorari in Pliva Inc., v. Huck can be…
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Pennsylvania Supreme Court Holds Plaintiffs May Assert Negligent Design Claims Against Drug Companies

The Pennsylvania Supreme Court in Lance v. Wyeth (2014 Pa.LEXIS 205) recently ruled that pharmaceutical companies can be held liable for negligent design, testing, marketing, and distribution of drugs regulated by the FDA. This decision alters the landscape of Pennsylvania law because pharmaceutical companies previously succeeded in having similar claims dismissed based upon the learned intermediary doctrine. Under this doctrine, the manufacturer of prescription medications discharges its duty to warn users of the risks associated with its products by warning the prescribing physician of…
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