Constitutional Law Products Liability

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Update on Prosecution for Truthful Off-Label Promotion

We have been following issues related to the interplay of off-label use, manufacturer statements about off-label use, the First Amendment, and FDA enforcement for a long time. (Like here, here, and here, among many posts.) ...more

More Talk – No Action – From FDA on Off-Label “Communication”

It’s been over two years since the FDA – in March, 2014 Draft Guidelines and then in its June 2014 “grant” of an industry-submitted citizen’s petition – promised to review its restrictions on so-called “off-label promotion”...more

Construction and Infrastructure Update, August 2016

Is it the Dawning of the Age of Strict Products Liability for California Contractors? Strict liability products liability - whereby manufacturers and distributors of a defective product can be found liable to a consumer...more

Off-Label Marketing – Industry Groups Step into the Breach

We have been waiting, literally for years, for the FDA to revise, clarify, update, or simply pay attention to, its off-label promotion regulatory position in light of repeated governmental First Amendment losses in Sorrell v....more

Book Review: The World According to Star Wars

It was right after our selfie with Minion Captain America that we saw it. We were marching up and down the aisles, dodging empire storm troopers. Bright lights and backbone-rattling sounds shot out of the Nickelodeon and Star...more

A One-Two Punch Case With An Off-Label Twist

When we were young(er), we had a pretty good memory. It is not bad now, as far as we recall, particularly when it comes to pulling up bits of esoteric nonsense. For more important stuff, we find qualifiers like “vague” and...more

Pro Te: Solutio - Vol. 8 No. 5

The Spring 2016 issue of Pro Te Solutio deals head-on with issues that are driving litigation in this modern era. And as it is with many issues, there are two sides to every story. The first topic we wrangle involves the...more

General Motors: Protection Granted in Section 363 Sale Orders is Only as Good as the Notice Given

In a recent decision by the U.S. Court of Appeals for the Second Circuit in the General Motors case, the court held certain claimants were not afforded procedural due process with respect to the § 363 sale of General Motor...more

Another Off-Label Promotion Third Party Payor Case Lacks Causation

July in D.C. is hot and sticky. When scorching day follows scorching day, area residents look forward to evening thunderstorms, not just to water otherwise thirsty lawns and gardens but to cool things down. Lightning can be...more

Guest Post – Corn, Justice Brandeis, Litigation Tourism and the Dormant Commerce Clause

We have another guest post for our readers today, this time courtesy of Richard Dean of Tucker Ellis. His point involves personal jurisdiction. As we’ve discussed, some courts have allowed “general jurisdiction by consent”...more

In Limine Gag Orders – Can We Play, Too?

Lately, we’ve seen some plaintiffs add gag order requests to their complement of in limine motions in advance of significant trials. Those of us who participated in the Bone Screw litigation remember plaintiffs attempting –...more

The Supreme Court - June 2016 #7

The Supreme Court of the United States issued decisions in three cases today: McDonnell v. United States, No. 15-474: Former Virginia Governor Robert McDonnell and his wife, Maureen McDonnell, were federally indicted...more

Generalized Products Liability Claims Not Viable Post-Spokeo

The Supreme Court case Spokeo, Inc. v. Robins reaffirmed and clarified the requirements necessary for plaintiffs to establish standing. As evidenced by the recent First Circuit case Hochendoner v. Genzyme Corp., the analysis...more

A Blow Against False Claims Act Liability For Off-Label Promotion

Recently, we noted that one of the first decisions we wrote a post about had been affirmed by the Second Circuit. Of the district court decision, we had penned “It is nice to see a judge with a proper understanding of how...more

Spokeo – Half a Loaf, Maybe More, from the Supreme Court

We can’t stand no-injury class actions – those that allege only “I got exactly what the product I paid for, and wasn’t hurt, but for X reason I paid ‘too much’ for it.” Such litigation is a waste of time and money, and is...more

New Duty To Supply Decision

Ever since we first waded into the issue of “duty to supply” back in 2007 in connection with the litigation that produced Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir....more

Amarin Pharma Comes Out on Top in Federal Case Involving Freedom of Speech

The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more

Breaking News – No General Jurisdiction by Consent in Delaware

From our prior personal jurisdiction posts concerning Daimler AG v. Bauman, 134 S. Ct. 746 (2014), and the plaintiff-side dodge of “general jurisdiction by consent,” regular blog readers were aware that one of the few...more

Federal Preemption of State and Local Laws Governing Children's Products

In January 2015, Albany County became the first of several municipalities in New York to enact a version of the “Toxic Free Toys Act” ("the Act") prohibiting any amount of six heavy metals and benzene in children’s products...more

Class Cert Denial Redux: Plaintiff’s “Manufactured” Standing Falls Short in Yakult Yogurt Action

A California federal district court recently denied a plaintiff’s second attempt to certify a class of Yakult consumers allegedly misled by Yakult’s packaging and advertising claims touting the health benefits of its yogurt,...more

Ninth Circuit Revives Chobani Yogurt Action, But Puts Claims on Ice and Leaves Questions Unanswered

There has been much recent discussion of the primary jurisdiction doctrine, as well as stay motions based on the doctrine, related to FDA’s review of its evaporated cane juice (ECJ) draft guidance. Now, in its recent...more

Will Big Pharma’s free speech rights trump FDA, regulatory safety?

Recent developments in the law may have opened a new path for drug makers to exercise corporate free speech rights in ways that don’t look healthy for consumers. The case that concerns health watchdogs started when...more

Food for Thought: California Court Prevents Second Bite at the Yogurt - Torrent v. Yakult U.S.A., Inc., No. 8:15-cv-00124-CJC-JCG...

Plaintiff Nicolas Torrent filed a putative class action alleging yogurt drink manufacturer, Yakult U.S.A., Inc.’s marketing and advertising claims concerning digestive health benefits were false and deceptive. Plaintiff...more

Indiana Product Liability Act's Statute of Repose Found Unconstitutional For Asbestos Cases

On March 2, 2016, Justice Brent E. Dickson of the Indiana Supreme Court ruled on three appeals involving the constitutionality of the Indiana Product Liability Act statute of repose. Myers v. Crouse-Hinds Division of Cooper...more

Court Stays Away from Trans Fat in General Mills Case

A recent decision from the Central District of California demonstrates the challenges serial plaintiffs may have with pursuing similar class actions and showcases the primary jurisdiction doctrine. On December 29, 2015, in...more

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