This Month in Snap Removal: The District of Nevada Muddies Its Snap Removal Waters and Throws Proponents a Life Preserver

Faegre Drinker’s snap removal team continuously monitors snap removal updates across the country (for a basic explanation of snap removal and previous updates, see Faegre Drinker’s prior posts here; for a breakdown on how each federal jurisdiction treats snap removal, see Faegre Drinker’s interactive snap removal map here).

The United States District Court for the District of Nevada is no stranger to consideration of the practice of snap removal—indeed, the District of Nevada has issued a number of decisions in 2020 and 2021, all holding that snap removal was improper unless and until at least one defendant has been served. But a recent opinion out of the District rejects the reasoning in those earlier decisions and holds that snap removal is proper even if no defendant has been served.

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Foreign Manufacturer Dismissed for Lack of Personal Jurisdiction in the Southern District of Indiana

Case:

Patterson v. Chiappa Firearms, USA, LTD, No. 1:20-cv-01430-JPH-MG, 2021 WL 4287431 (S.D. Ind. Sept. 21, 2021).

Significance:

  • First Indiana case to apply the “relate to” standard articulated in Ford Motor Co. v. Mont. Eighth Jud. Dist. Ct., 141 S. Ct. 1017 (2021).
  • Rejects a broad, unlimited stream of commerce theory for establishing personal jurisdiction.
  • Denied plaintiff jurisdictional discovery, noting that foreign nationals should not be subjected to extensive discovery in order to determine whether personal jurisdiction over them exists.

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The Rule 702 Toolbox: How Do You Solve a Problem Like the Ninth Circuit?

There has been much discussion recently about how Rule 702 is in need of a tune-up to better guide district courts’ gatekeeping.  More about that soon.

But a case now pending before the Supreme Court, Monsanto Company v. Hardeman, No. 21-241, demonstrates that it’s not always the fault of the district courts.  (Disclaimer:  This firm (and this author) filed an amicus brief supporting certiorari.)  Sometimes it’s about a lack of stewardship at the circuit level.  Absent direct and unequivocal guidance from the Supreme Court, appellate courts call the tune, and the district courts are required to follow it.  And in the interstices, district judges read the tea leaves and try to follow the circuit court’s leads and signals.  No one likes to get reversed.  Even if the district judges think the circuit has gotten it wrong, they honor the hierarchy and follow the commands of stare decisis, human nature and common sense.

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FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule will go into effect on September 1, 2021.

The new rule may provide an end to a years-long process on knowledge-based labeling directives in the old regulations. Proposed amendments to clarify the “intended use” regulations began in 2015, which we discussed previously.

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FDA Approves First Interchangeable Biological Product Under BPCIA

On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).

Under the Biologics Price Competition and Innovation Act (BPCIA), biological products (e.g., vaccines and therapeutic antibodies) may come to market by showing that they are “biosimilar” to or “interchangeable” with a “reference product,” which is a biological product that has already been approved by the FDA. A biological product is “biosimilar” if it is “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” 42 U.S.C. § 262(i)(2). To date, 28 biological products have been approved as biosimilars.

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District of New Jersey Clarifies New Local Civil Rule Regarding Third-Party Funding Disclosures

Over the last four months, we have tracked the District of New Jersey’s proposal and adoption of a new Local Civil Rule – L. Civ. R. 7.1.1 –  requiring lawyers to disclose details about third-party litigation funding.  The Clerk of the District of New Jersey has now issued a Notice to the Bar clarifying that this new Rule only requires the filing of a statement where third-party litigation funding exists.

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