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Evidence Prescription Drugs

Faegre Drinker Biddle & Reath LLP

California Supreme Court Walks Middle Ground on Warnings Causation but Reaffirms Learned Intermediary Doctrine in Himes

As we reported in April, the United States Court of Appeals for the Ninth Circuit certified a question on California’s Learned Intermediary Doctrine in Himes v. Somatics, LLC, 2022 WL 989469 (9th Cir. Apr. 1, 2022). The...more

Morgan Lewis - As Prescribed

Real-World Evidence: Non-Interventional Studies in Support of Substantial Evidence of Effectiveness

The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the...more

Cozen O'Connor

Notice of Appeal - A quarterly newsletter reviewing Third Circuit opinions impacting white collar defense lawyers - Fall 2023

Cozen O'Connor on

BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more

Arnall Golden Gregory LLP

The Government Cannot Cut Corners: Appellate Courts Reverse Sentences in Three Recent Cases Because the Government Did Not...

Three appellate courts recently reversed sentences because the government did not adequately present evidence to support the alleged loss calculation underlying the court’s determination of the sentencing guidelines range. In...more

Foley Hoag LLP

Product Liability Update - April 2023

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MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more

Faegre Drinker Biddle & Reath LLP

Ninth Circuit Affirms Exclusion of Expert and Resulting Summary Judgment in In re: Incretin-Based Therapies MDL

Early last year, the In re: Incretin-Based Therapies MDL court held that the plaintiffs’ warnings claims were preempted, excluded plaintiffs’ general causation experts, and granted summary judgment to all defendants on dual...more

Faegre Drinker Biddle & Reath LLP

Eastern District of Pennsylvania Issues Lone Pine Order in Zostavax MDL

Multidistrict litigation is often criticized for enabling plaintiffs to file meritless cases and then hide in large inventories, hoping to be swept up in a settlement (whether global or otherwise) before the case is...more

Holland & Knight LLP

Healthcare Law Update: October 2021

Holland & Knight LLP on

Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

HaystackID

[Webcast Transcript] Hatch-Waxman Matters and eDiscovery: Turbo-Charging Pharma Collections and Reviews

HaystackID on

Editor’s Note: On September 16, 2020, HaystackID shared an educational webcast designed to inform and update legal and data discovery professionals on the complexities of eDiscovery support in pharmaceutical industry matters...more

Smart & Biggar

Federal Court of Appeal confirms Janssen’s SPRAVATO not eligible for data protection

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Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more

Hogan Lovells

International Products Law Review 2020: Issue 76

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We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more

White and Williams LLP

Third Circuit Clarifies Intent Requirement for Suicide Exclusion in Life Insurance Policies Under New Jersey Law

White and Williams LLP on

On September 18, 2019, the U.S. Court of Appeals for the Third Circuit issued an opinion in Arena v. Riversource Life Insurance Company, 2019 U.S. App. LEXIS 28052 (3d Cir. Sep. 18, 2019) (non-precedential), affirming the...more

Patterson Belknap Webb & Tyler LLP

Second Circuit Remands for New Trial Based on District Court’s Improper Exclusion of Advice-of-Counsel Testimony

In United States v. Scully, 16-3073-cr (Pooler, Lynch, Cogan[1]), the Second Circuit vacated the defendant’s conviction for various offenses, including mail and wire fraud, conspiracy to defraud the United States, the sale of...more

Farrell Fritz, P.C.

Second Circuit Vacates Conviction of Pharmaceutical Distributor on Advice-of-Counsel Defense

Farrell Fritz, P.C. on

Last week, in United States v. Scully, the Second Circuit vacated the conviction of a distributor of pharmaceutical products on misbranding charges due to evidentiary issues surrounding his advice-of-counsel defense at trial....more

Proskauer - New England IP Blog

Jury Verdict Overturned in Pepcid® Dispute After Court Finds Insufficient Evidence of Infringement

Last year, a jury awarded Brigham and Women’s Hospital (“BWH”) approximately $10 million after it found that defendant Perrigo Company’s (“Perrigo”) generic version of Pepcid® Complete® willfully infringed BWH’s patent. After...more

Smart & Biggar

Rx IP Update - December 2016

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Janssen seeks leave to appeal to SCC regarding FCA decision upholding Minister of Health’s decisions relating to administrative drug submissions - As reported previously, on October 12, 2016, the Federal Court of Appeal...more

Morrison & Foerster LLP - Class Dismissed

Defendants Secure Rare Summary Judgment in Zoloft MDL

In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL. These cases were consolidated in 2012 and involved allegations...more

Morrison & Foerster LLP

Liability for Brand Drug Manufacturers All But Clear

Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand...more

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