As the new year loomed, the Eighth Circuit, sitting en banc, overruled its prior cases dealing with a specific application of the forum-defendant exception to removal on the basis of diversity jurisdiction. Under the forum-defendant rule, a defendant who is a citizen of the forum state cannot remove a lawsuit from state court to federal court if the removal is solely on the basis of diversity jurisdiction. Before this decision, the Eighth Circuit stood alone in holding that the forum-defendant rule was jurisdictional and could never be waived. The unanimous en banc court overruled its prior cases and aligned with all other federal circuits to consider the question, concluding that violation of the forum-defendant rule is not a jurisdictional defect and therefore must be raised as a basis for remanding a case back to state court within 30 days after removal or the argument is waived. Among other practical consequences of the decision, plaintiffs who believe a defendant has improperly removed a case in violation of the forum-defendant rule now must raise the violation in 30 days or risk waiving it.
Florida Supreme Court Ends 2020 With Adoption of the Federal Summary Judgment Standard
The Florida Supreme Court will abandon the state’s previous summary judgment standard in favor of the federal standard — a familiar, achievable standard to dispose of claims that are unsupported by evidence. For pending dispositive motion practice that may be decided during the gap period before the rule amendment takes effect, movants should consider requesting that any decision be made without prejudice to seek summary judgment under the new summary judgment standard once it takes effect.
Witness Coaching by Whisper Leads to Sanctions for Defense Witness and Attorney
As noted in two prior posts, one on May 15, 2020, and the other on May 29, 2020, the COVID-19 pandemic and the resulting explosion in the use of remote depositions present a number of novel issues for lawyers to consider, whether taking or defending depositions. Regardless of these “unprecedented times,” some things remain the same, including that it is improper for a witness to be coached about answers while the deposition is occurring.
Continue reading “Witness Coaching by Whisper Leads to Sanctions for Defense Witness and Attorney”
Second Circuit Affirms Mirena MDL Court’s “Hard Look” at Plaintiffs’ Experts’ Methodology
On December 8, 2020, the Second Circuit Court of Appeals affirmed the Southern District of New York’s granting of summary judgment in favor of Bayer — and resulting closure of all cases against Bayer — in the Mirena multidistrict litigation (MDL). In re Mirena IUS Levonorgestrel-Related Prod. Liab. Litig. (No. II), No. 19-2155, 2020 WL 7214264 (2d Cir. Dec. 8, 2020).
In the MDL, the plaintiffs alleged that the Mirena Intrauterine System had caused them to develop idiopathic intracranial hypertension (IIH). The District Court elected to focus first on whether the plaintiffs had evidence sufficient to establish general causation. The District Court held a Daubert hearing that lasted three days and featured testimony by 19 general causation witnesses — 7 for the plaintiffs and 12 for Bayer. On October 24, 2018, the District Court entered a detailed 156-page opinion granting Bayer’s Daubert motion as to all of the plaintiffs’ experts and denying as moot plaintiffs’ motion to preclude Bayer’s experts. In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 341 F. Supp. 3d 213 (S.D.N.Y. 2018). Bayer then filed a motion for summary judgment, which the District Court granted for lack of general causation and dismissed all cases in the Mirena MDL.
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.”
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).
Continue reading “FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval”
