Administrative Agency Civil Procedure Products Liability

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Sweet(ener) Confusion: Court Divide Over Role of Primary Jurisdiction Doctrine in “Evaporated Cane Juice” Cases Grows

In Swearingen v. Santa Cruz Natural, Inc., No. C 13-04291 (N.D. Cal. April 2, 2014), Judge Illston of the U.S. District Court for the Northern District of California granted defendant’s motion to dismiss based on the primary...more

The Sixth Circuit Clarifies Admissibility of the CPSC’s Failure to Take Regulatory Action

The admissibility of the Consumer Product Safety Commission’s (CPSC) failure to take action to regulate products has been litigated in many courts throughout the United States, largely due to an ambiguous provision in the...more

CPSC Likely to Proceed with October Hearing on Magnet Rule

This week, the Consumer Product Safety Commission (“CPSC”) will decide whether to hold a full Commission hearing to receive oral comments on a notice of proposed rulemaking on magnet set safety. If the meeting notice is...more

The FDA’s 510(k) Approval Process in Medical-Device Litigation

Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it may be that crucial nudge for a jury to tip the scales of justice for one side or the other. In...more

Product Liability Law Medical Device Law Update: December 2012 - “A State of Profound Uncertainty”: The Crisis in Pennsylvania

Since the mid-1960s, Pennsylvania has adhered to the strict liability tenets of section 402A of the Restatement (Second) of Torts. Its version of strict liability had a number of unique features, including the determination...more

Generic Drug Law Update -- November 2012: Expanding Liability for Ineffective Product Recalls

FDA-regulated companies may face civil liability if they fail to provide adequate notice of product recalls to their customers via information gathered in company customer databases. A group of California plaintiffs sued a...more

Pharmaceutical Law Update -- October 2012: New Jersey Court Grants Summary Judgment Based on Lack of Warning Causation

A New Jersey federal court granted summary judgment to Baxter Healthcare Corporation (Baxter) last month based on a familiar legal concept rarely applied in the Garden State – warning causation. In Baker et al. v. APP...more

9th Circuit’s POM Wonderful Ruling Could Influence Food Class Actions

Originally published in Washington Legal Foundation on August 3, 2012. Class action lawyers looking for a shakedown have gone on a food binge. They have focused on the food industry and the ever-obliging federal court...more

Product Liability Update -- July 2012

In This Issue: *First Circuit Affirms Judgment Against Generic Drug Manufacturer on Plaintiff’s Design Defect Claim, Holding: (i) Product May Be Found “Defective” on Proof It Is “Unreasonably Dangerous”; (ii) Design...more

Sacred Exclusivity: The Ninth Circuit Steers (Well) Clear of the FDA

The Supreme Court’s opinion in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349-50 (2001), recognizes that any attempt by a plaintiff to enforce the FDCA is preempted by federal law, because Congress entrusted...more

Stengel v. Medtronic, Inc.: The Riegel/Buckman Gap Narrows in the Ninth Circuit

The Ninth Circuit Court of Appeals has further curtailed the universe of state law claims pertaining to Class III medical devices that are neither expressly preempted by Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008) nor...more

The Gap Between Express and Implied Preemption Narrows In The Ninth Circuit

The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In Stengel v....more

More Thoughts On Bartlett

Our initial post about Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012), was more or less a crie de coeur over what we saw as an essentially absurd result: that while a simple...more

An Agency "Warning Letter" Does Not a Lawsuit Make: Sometimes a "Warning Letter" Is Really Just a Warning

Unfortunately, the number of consumer class action complaints brought against consumer product manufacturers under state consumer protection and/or false advertising law statutes continues to rise. This increase can be traced...more

If At First You Don't Succeed....

Sometimes good ideas don’t prevail the first time – or even the first few times – they make their appearance. With that in mind we bring to your attention Windle v. Synthes USA Products, Inc., 2012 U.S. Dist. Lexis 52397...more

N.J. Determines to What Extent the Product Liability Act's Presumption of Adequacy Applies to Toll the Statute of Limitations

Statutes of limitations have traditionally served a critical function in the judicial system. Not only do they compel a person to file an action within reasonable time so that the opposing party has fair opportunity to...more

"Fraud-on-the-FDA" Failure to Warn Claims Are Preempted by Federal Law

The extent to which federal law preempts state law claims is an issue that has been in the forefront of drug and medical device litigation throughout the past few years. In the context of medical device litigation, the U.S....more

The Circuit Court Split On 'Fraud On The FDA' Continues

On Feb. 22, 2012, the U.S. Court of Appeals for the Fifth Circuit unanimously affirmed the U.S. District Court for the Northern District of Texas' granting of a defendant drug manufacturer's motion for summary judgment on all...more

U.S. Supreme Court: State Law Claims Against Locomotive Manufacturers Are Preempted by Federal Law

In a decision published on February 29, 2012, the U.S. Supreme Court held that all personal injury and wrongful death claims based on state law causes of action, including defective design and failure to warn, involving...more

Removal Prior to Service Still Viable Under the New Removal Statutes

The recent enactment of the Federal Courts Jurisdiction and Venue Clarification Act of 2011 (Act) will require form removal petitions be dusted off and updated. The Act became effective on January 6, 2012, and in addition to...more

Fifth Circuit Concludes That U.S. Supreme Court's "Fraud-on-the-FDA" Federal Preemption Precedent Has Broad Application

The Lofton decision deepens the split among the U.S. circuit courts on whether or not the U.S. Supreme Court's "fraud-on-the-FDA" preemption decision in Buckman applies broadly and forcefully to all claims...more

New Jersey Supreme Court Confirms “Super Presumption” of FDA Label

Yesterday, the New Jersey Supreme Court decided the case of Kendall v. Hoffman-LaRoche, Inc., A-73-2010 (066802), in which it held that plaintiff’s case was not barred by New Jersey’s two-year statute of...more

Fifth Circuit Breaks Buckman Tie

Does Buckman v. Plaintiff's Legal Commmittee, 531 U.S. 341 (2001), apply any time that a plaintiff raises a fraud on the FDA allegation in litigation, or is it limited to causes of action denominated "fraud on...more

Why Agency Fraud Is Like Fraud On The FDA

In our rather terse (due to firm involvement) post on Monday concerning Merck & Co. v. Ratliff, ___ S.W.3d ___, 2012 WL 413522 (Ky. App. Feb. 10, 2012) – beating both BNA and 360 by two days, BTW – we...more

To Linsanity and Beyond (to the Tierney case)

Some of us on this blog have rooting interests that lie far from where The Schuylkill and The Delaware meet.  They’re up past the New Jersey Turnpike, all the way to New York City.  For us, ever since the...more

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