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FDA Finds Certain E-Cigarette Products “Appropriate for the Protection of Public Health” but Not “FDA Approved”

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On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS e-cigarette and accompanying tobacco-flavored pods.  In issuing the orders, FDA found “that the marketing of these products is appropriate for the protection of public health.”  However, FDA also stated that its orders do not mean “these products are safe or ‘FDA approved.’”  See FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency | FDA.

Although ENDS products, such as e-cigarettes, have been on the market since the mid-2000s, this is the first time FDA has authorized the marketing of specific ENDS products through the Premarket Tobacco Product Application pathway.

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Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device Manufacturer

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A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively prune a plaintiff’s ambitious product defect claims. Conn v. C.R. Bard, Inc., No. 4:14-CV-298.

In 2006, plaintiff’s physicians discovered a blood clot in his inferior vena cava. An IVC filter was inserted to prevent the blood clot from causing potentially fatal further injury. Because of plaintiff’s young age, the physician chose a removable filter. Plaintiff reported abdominal pain just four days after the IVC filter was placed. The blood clot was found to have moved and extended through and above the recently placed filter, and the physicians initiated anticoagulant therapy.

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New Phthalates Study Garnering Media Attention Purports to Show Only an Association – Not Causation – with Certain Mortalities

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A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations.  Some media coverage of this study blurs the important distinction between “association” and “causation.”

What Are Phthalates?

Phthalates, sometimes called plasticizers, are a group of chemicals generally used to make plastics more durable, or to dissolve other materials.  Phthalates may be found in products such as vinyl flooring, food wraps, intravenous tubing, lubricating oils, and some personal care products such as shampoos, soaps, and hairsprays.

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

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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

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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.

Case Analysis:

In Patterson v. Chiappa Firearms, the plaintiff, an Indiana citizen, bought a handgun from an online gun seller in Kentucky and had it delivered to Indy Arms Company in Indianapolis. The gun subsequently exploded in Indiana when the plaintiff test-fired it, fracturing the plaintiff’s finger. The gun was manufactured by Chiappa Italy and distributed by Chiappa USA.

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

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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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