Amarin/Caronia: What Lies Ahead for Tort Preemption?
In a strange coincidence, the death of Frances Oldham Kelsey on August 7, 2015 coincided with the release of the decision in Amarin v. FDA, 1:15-CV-03588-PAE, Doc. 73 (SDNY Aug. 7, 2015). Ms. Kelsey is...
View ArticleThe Titanic is Sinking: Caronia, Amarin and now Pacira v FDA
In 2011, the US Supreme Court decided Sorrell v US, holding that “[s]peech in aid of pharmaceutical marketing . . . is a form of expression protected by the Free Speech Clause of the First Amendment.”...
View ArticleThe FDA is getting PCQI: New FSMA Rules Issued
On September 10, 2015, the Food and Drug Administration issued Final Rules on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and for Animal...
View ArticleNinth Circuit Opens Floodgates for Duplicative Mislabeling Claims in California
In Sarah Samet, et al v. Procter and Gamble Co., the court dismissed Plaintiffs’ unjust enrichment claims as duplicative because the Unfair Competition Law (UCL), False Advertising Law (FAL) and...
View ArticleStrasburger Partner Mike Walsh Calls for Clarity in FDCA Enforcement
As appears in For The Defense (September 2015) “Unless or until the Supreme Court or Congress brings clarity to limit state law claims for conduct under the FDCA, courts may follow the government’s...
View ArticleVermont is “Naturally” Genetically Modified
The state of Vermont was not one of the original 13 colonies and did not join the union until 1791, the year the First Amendment was ratified. That tardiness may explain its inability to interpret the...
View ArticleThe Department of Justice and the Yates Memo: Heightened Focus on Individual...
Last month, in what is known as the “Yates Memo,” the United States Department of Justice (DOJ) set a new course on “Individual Accountability for Corporate Wrongdoing” identifying six “keys steps” in...
View ArticleNYC Under “A-Salt”
New York City’s new sodium warning law received its first official challenge this month. On December 3, 2015, the National Restaurant Association (NRA) filed suit against the New York City Department...
View ArticleJust in Thyme for the Holidays – An Organically Grown Preemption Debacle
On December 3, 2015, the California Supreme Court issued a ruling that expands the ability of private claimant to file lawsuits in California alleging intentional organic mislabeling. In Quesada v Herb...
View ArticleDecember is FDA’s Month for Giving and Delaying
FDA capitulates, dropping a meritless enforcement action against Pacira and putting off Amarin until February 17, 2016. Three years have passed since the Second Circuit paved new ground with the...
View ArticleConte Revisited: Innovator Liability for A Generic Manufacturer’s Product
On March 9, 2016, in T.H. v. Novartis 2016 Cal. App. LEXIS 179 (CA 4th App. Dist. March 9, 2016), a California Court of Appeals rejected what every other court in the union has ruled, reversed the...
View ArticleRestaurant Menu Calorie Count Compliance Stayed Indefinitely
Section 747 of the Consolidated Appropriations Act of 2016 has effectively stayed the requirements for nutrition labeling of standard menu items in restaurants and similar establishments. The Act...
View Article$500 Million Dollar Verdict in J&J Ultamet Case: Too Much Green, Even For St....
On March 17, 2016, St. Patrick’s Day, a Dallas federal court jury saw green, awarding almost $500 million to five plaintiffs in a consolidated trial against DePuy Orthopedics and J&J over the...
View ArticleTwo Cases: Wineries and Regulators Are a Unique Blend
Regulatory enforcement can threaten the existence of wineries and small producers. First, the financial costs of regulatory inspection can be high, and new laws and regulations have given the...
View ArticleSanitary Food Transportation: New Rules May Require a Fresh Look
Prompted by the Sanitary Food Transportation Act of 2005 and the Food Safety Modernization Act of 2011 (FSMA), the Food and Drug Administration (FDA) issued a new rule entitled “Sanitary Transportation...
View ArticleFDA is KIND about Healthy and Tasty
As the self-appointed protector of consumers’ ability to understand product labels, the FDA has again attempted to demonstrate what Mel Brooks made famous in his movie The History of the World, it’s...
View ArticleMitigation Strategies Protect Food Against Intentional Adulteration
On May 27, 2016, the Food and Drug Administration (FDA) published the seventh and final rule required under the Food Safety Modernization Act (FSMA), imposing new duties on domestic and foreign food...
View ArticleFDA’s Off-Label Hearing Set for the Day after the 2016 Election
On September 1, 2016 the Food and Drug Administration (FDA) issued its Notice of Public Hearing on Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products (FDA’s...
View ArticleWill the Election Affect the Menu Labeling Rule Section of the ACA?
The election is over and President-Elect Trump, the candidate who promised to repeal and replace the Patient Protection and Affordable Care Act a/k/a Obamacare (the ACA), will be sworn in on Friday,...
View ArticleDrug Law: Off-Label Use – a Paradigm Shift and a Moral Imperative
On December 16, 2016, the State Bar of Texas will host a Webcast on the FDA and Off-Label Uses of Medical Products. Coincidentally in the wake of the 2016 presidential election, the Food and Drug...
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