Northern District of California Sours Plaintiff’s Claims against “Vanilla” Soymilk Maker

The Northern District of California recently dismissed a Plaintiff’s claim that the term “vanilla” was misleading on the label of a soymilk product, but left the proverbial door open for the filing of an amended pleading.

In Clark v. Westbrae Natural, Inc., Case No. 20-cv-03221, Plaintiff alleged that Defendant’s use of the word “vanilla” on the label of its organic unsweetened soymilk misrepresented to consumers that the product’s vanilla flavor was derived exclusively from the vanilla bean plant. Gas chromatography‒mass spectrometry analyses showed that the flavor came from a non-vanilla source. Plaintiff alleged he would not have purchased the product had he realized the flavor was not derived from the vanilla bean, and asserted claims under California’s Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act.  He argued that the product should be labeled “artificially flavored.”

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FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.

The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).

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California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent

Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer, holding that “California law recognizes a manufacturer’s duty to warn the [U.S. Food and Drug Administration] of adverse events.” Mize concluded that California’s duty to warn FDA was “parallel” to the requirements of federal law, and therefore not expressly preempted.

Cases like Mize involving medical devices approved for sale through the FDA’s Premarket Approval (PMA) process are generally subject to the U.S. Supreme Court’s decision in Riegel v. Medtronic, 552 U.S. 312 (2008). Riegel held that the federal Medical Device Amendments preempt state tort laws if they are “different from, or in addition to” the requirements imposed by federal law. Riegel bars state tort law claims because PMA devices are subject to specific requirements adopted by FDA through the rigorous PMA approval process. However, Riegel left open the possibility, based on an articulated judicially imposed policy, that a state might “[provide] a damages remedy for claims premised on a violation of FDA regulations” because “the state duties in such a case ‘parallel’ federal law.” 552 U.S. at 329.

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New Conferral Requirement for Rule 30(b)(6) Depositions Effective December 1

The last month of the year brought changes to Rule 30 of the Federal Rules of Civil Procedure, specifically Rule 30(b)(6), governing deposition notices to organizations. The rule was amended, effective December 1, 2020.

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Pennsylvania Appellate Court Rejects Application of the Statute of Repose in Effect in the State Where an Injury Occurred Under Pennsylvania’s Borrowing Statute, But Leaves Open Possible Application Under Substantive Choice of Law Rules

The Pennsylvania Superior Court, the state’s mid-level appellate court, recently held in Kornfeind v. New Werner Holding Co., 2020 PA Super 266, that Pennsylvania’s “borrowing statute” applies only to foreign statutes of limitation and therefore does not require application of a statute of repose enacted in the state where the plaintiff used the product and was injured. But the Court also held that statutes of repose are substantive under Pennsylvania law, and therefore the statute of repose from the state of use and injury may bar the claim in a Pennsylvania court if Pennsylvania’s choice of law rules support application of that state’s law.

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New Jury Selection Procedure in California: Is This the End of Peremptory Challenges? Is This the End of Batson?

Jury selection in California is undergoing significant change. In August 2020, the California legislature passed AB 3070, which was signed by Governor Gavin Newsome on September 30. Beginning in 2022, objections to peremptory challenges in criminal cases will have more teeth, including a list of presumptively invalid reasons for striking a prospective juror and a new standard of review for appellate review of a trial court’s decision. While AB 3070 does not apply officially to civil jury trials until 2026, the significant overhaul in procedure effectuated by this new law is likely to influence a court’s analysis of the civil jury selection process before that time. The new law’s aim is noble: to bring an end to discrimination in jury selection. However, critics, including many within the California judiciary, say the new procedure is “unworkable.”

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