Faegre Drinker on Products, Author at Faegre Drinker on Products

Faegre Drinker on Products

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Articles by Faegre Drinker on Products:

SCOTUS Denies Certiorari in Cases Concerning FCA Liability Requirement, Objective Falsity Circuit Split Remains Intact

The United States Supreme Court denied certiorari without comment in two cases seeking to resolve a Circuit split regarding the proof required to establish that a claim for payment was false or fraudulent under the False Claims Act.

Two Petitioners asked the Court to decide whether the False Claims Act, 31 U.S.C. §§ 3729-3733, requires proof of “objective falsity”, or whether a plaintiff expert’s opinion that differs from the judgment of the defendant is sufficient to show a claim for payment was false or fraudulent under the FCA. Both cases involved allegations that a physician’s certification of medical necessity for hospice services was false, and therefore sufficient to prove plaintiffs’ FCA claims.

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim. The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA). Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines. The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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“Vanilla” Milk Claims Continue to Sour as Southern District of New York Dismisses Putative Class Action Complaint

As we discussed in a previous post, the Northern District of California recently dismissed a plaintiff’s claim that the term “vanilla” was misleading on the label of a soymilk product. The Southern District of New York has now similarly dismissed a putative class action complaint alleging that a “vanilla” almond milk product was labeled in a way that misled customers.

In Wynn v. Topco Associates, LLC, No. 19-cv-11104, Plaintiffs alleged that Defendant’s use of the word “vanilla” on the label of its almond milk product – “Vanilla Almost Milk” – falsely communicated to consumers that the beverage’s flavor was derived entirely from real vanilla, when in fact the product includes non-vanilla flavorings. Plaintiffs claimed, among other things, that this violated the New York General Business Law (NYGBL).

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Preemption Torpedoes State Law Claims against Generics Makers in Zantac MDL

A judge in the United States District Court for the Southern District of Florida presiding over the In Re: Zantac (Ranitidine) Products Liability Litigation multidistrict litigation, MDL No. 2924, has held that state labeling and design defect claims against the makers, re-packagers, retailers, and distributors of generic forms for the popular heartburn medication Zantac were preempted by federal law. The court subsequently dismissed these claims against 32 such Zantac generics makers and distributors.

The Zantac MDL was created by the United States Judicial Panel on Multidistrict Litigation on February 6, 2020. The plaintiffs allege that ranitidine, the active ingredient in Zantac and its generic forms, breaks down into N-nitrosodimethylamine (“NDMA”), which is part of a group of compounds that have been shown to increase the risk of cancer. The plaintiffs allege a variety of product liability and related claims against the makers and distributors of Zantac and its generic forms under federal and state laws.

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Cybersecurity Safeguards Implemented by Federal Judiciary for Filing Highly Sensitive Court Documents

The U.S. Federal Judiciary announced new safeguards and procedures to protect sensitive court records in light of a recent apparent cybersecurity breach.

Last month, the Department of Homeland Security issued an emergency directive regarding “a known compromise involving SolarWinds Orion products that are currently being exploited by malicious actors.” The judiciary was notified of this issue by the Administrative Office of the U.S. Courts, and suspended use of this IT network tool at the national and local levels. An apparent compromise of the confidentiality of the Federal Judiciary’s CM/ECF system is now being investigated in connection with the breach.

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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.

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