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Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....more

Albany County, NY Enacts Stringent Children’s Product Safety Law

Do local governments, such as town councils and county legislatures, have a role in regulating consumer products that is typically reserved for the federal and state governments? Apparently, the legislature and executive of...more

Q&A Series: Class Action Litigation Has Focused On Claims By Spirits Producers on Labels, Websites, and In Marketing Campaigns

In some cases class action plaintiffs are making claims based on an allegedly incorrect statement on a label. Does TTB approval of a label protect a producer against claims based on the content of the label? TJC: There...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...more

Generic Drug Law Update -- November 2012: New Bill Seeks to Expand Manufacturers Post-Sale Pharmacovigilance Duties

Democratic legislators in both houses of Congress introduced legislation that seeks to reverse the U.S. Supreme Court’s recent decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which bars state law tort suits against...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

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

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

"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

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

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

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

Latest Generic Preemption Decision

Those of you who check our post-Mensing generic preemption scorecard regularly are aware that a preemption massacre has been going on in Louisiana federal court. By our count, just since October there have been eight...more

Two New PMA Preemption Cases

You all know we love preemption. So, when two favorable medical device preemption decisions are entered on the same day, well that’s a two-fer we can’t wait to blog about. In both cases, plaintiffs tried to plead and argue...more

Ugly Texas Decision Ignores Erie, Tramples State Law

We don't like it, but sometimes we have to present bad news. Such is the case with Murthy v. Abbott Laboratories, 2011 U.S. Dist. Lexis 129102 (S.D. Tex. Nov. 8, 2011). There’s a lot of things wrong with Murthy, but one of...more

More Breaking News - Generic Preemption

Today's decision in Guarino v. Wyeth, No. 8:10-cv-2885-T-30TGW, slip op. (M.D. Fla. Nov. 11, 2011), contains the following interesting holdings: (1) Mensing, being an implied preemption case, contains no exception to...more

Alabama Update

Back in April, we put up a post complaining about Weeks v. Wyeth, 2011 WL 1216501 (M.D. Ala. March 31, 2011), one of the few courts anywhere not to dismiss a Conte-type non-manufacturer liability claim for failure to state a...more

There'll Always Be Posner: Thumbs Up on Preemption

The New Yorker's current issue has a fine article on Pauline Kael. The weekend Wall Street Journal had a similar piece. Why the wall-to-Wall Street coverage of a film critic who wrote reviews from 1953 to 1991 and died in...more

There They Go Again

A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon...more

Search & Destroy Mission Yields Scant Results

We commented on the Obama Administration’s anti-preemption search and destroy mission at the time, back in 2009. To recap, a presidential memorandum directed all federal administrative agencies to seek out, identify, and...more

Successful Class II Medical Device Preemption Decision

We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal. Here's one. Today, in Degelmann v....more

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